44 results on '"SURGICAL excision"'
Search Results
2. Crossing barriers: the burden of inflammatory bowel disease across Western Europe.
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Kumar, Aditi, Yassin, Nuha, Marley, Alexandra, Bellato, Vittoria, Foppa, Caterina, Pellino, Gianluca, Myrelid, Pär, Millan, Monica, Gros, Beatriz, Avellaneda, Nicolas, Catalan-Serra, Ignacio, El-Hussuna, Alaa, Cunha Neves, João A., Roseira, Joana, Cunha, Miguel F., Verstockt, Bram, Bettenworth, Dominik, Mege, Diane, and Brookes, Matthew J.
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INFLAMMATORY bowel diseases , *CROHN'S disease , *MEDICAL care costs , *CLINICAL trials monitoring , *ULCERATIVE colitis , *SURGICAL excision , *GASTROENTEROLOGISTS - Abstract
An estimated 2.5–3 million individuals (0.4%) in Europe are affected by inflammatory bowel disease (IBD). Whilst incidence rates for IBD are stabilising across Europe, the prevalence is rising and subsequently resulting in a significant cost to the healthcare system of an estimated 4.6–5.6 billion euros per year. Hospitalisation and surgical resection rates are generally on a downward trend, which is contrary to the rising cost of novel medication. This signifies a large part of healthcare cost and burden. Despite publicly funded healthcare systems in most European countries, there is still wide variation in how patients receive and/or pay for biologic medication. This review will provide an overview and discuss the different healthcare systems within Western Europe and the barriers that affect overall management of a changing IBD landscape, including differences to hospitalisation and surgical rates, access to medication and clinical trial participation and recruitment. This review will also discuss the importance of standardising IBD management to attain high-quality care for all patients with IBD. [ABSTRACT FROM AUTHOR]
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- 2023
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3. The impact of treatment delay on skin cancer in COVID-19 era: a case-control study.
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Seretis, Konstantinos, Boptsi, Eleni, Boptsi, Anastasia, and Lykoudis, Efstathios G.
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SKIN cancer , *TREATMENT delay (Medicine) , *MANN Whitney U Test , *CASE-control method , *FISHER exact test , *COVID-19 , *SURGICAL excision - Abstract
Background: The outbreak of COVID-19 pandemic led to a 2-month lockdown in Europe. Elective surgeries, including skin cancer excisions, were postponed. The purpose of this prospective case-control study was to assess the impact of the treatment delay on patients with non-melanoma skin cancer (NMSC) or melanoma operated in the first post-lockdown period. Methods: A comparative study of skin cancer operations performed in a 4-month period either in 2020 or in 2019 was conducted. All data were collected from a prospectively maintained clinic database and the pathological reports. Continuous variables were compared with t test or Mann-Whitney U test according to their distribution. Categorical variables were compared with Fisher exact test. Odds ratio (OR) with 95% confidence interval (95% CI) was used to assess the risk of excising high-risk NMSC in 2020 compared with 2019. Results: Skin cancer excision was performed in 158 cases in 2020 compared to 125 cases in 2019 (26.4% increase). Significantly, more SCC were excised in 2020 (p = 0.024). No significant difference for several clinical parameters regarding BCC, SCC, and melanoma was identified. However, the reconstructive method applied, following NMSC excision, was significantly different, requiring frequently either skin grafting or a flap. Conclusion: These results indicate that skin cancer treatment delay, due to COVID-19 pandemic, is related to an increased incidence of SCC and more complicated methods of reconstruction. Considering the relapsing COVID-19 waves, significant skin cancer treatment delays should be avoided. Trial registration: The study adhered to the STROBE statement for case-control studies. [ABSTRACT FROM AUTHOR]
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- 2021
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4. Endocystectomy as a conservative surgical treatment for hepatic cystic echinococcosis: A systematic review with single-arm meta-analysis.
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Al-Saeedi, Mohammad, Ramouz, Ali, Khajeh, Elias, El Rafidi, Ahmad, Ghamarnejad, Omid, Shafiei, Saeed, Ali-Hasan-Al-Saegh, Sadeq, Probst, Pascal, Stojkovic, Marija, Weber, Tim Frederik, Hoffmann, Katrin, and Mehrabi, Arianeb
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HEPATIC echinococcosis , *CONSERVATIVE treatment , *URINARY diversion , *ECHINOCOCCUS granulosus , *SURGICAL complications , *SURGICAL excision , *LIVER surgery , *BLADDER cancer - Abstract
Background: In patients with hepatic cystic echinococcosis (CE), treatment effectiveness, outcomes, complications, and recurrence rate are controversial. Endocystectomy is a conservative surgical approach that adequately removes cyst contents without loss of parenchyma. This conservative procedure has been modified in several ways to prevent complications and to improve surgical outcomes. This systematic review aimed to evaluate the intraoperative and postoperative complications of endocysectomy for hepatic CE as well as the hepatic CE recurrence rate following endocystectomy. Methods: A systematic search was made for all studies reporting endocystectomy to manage hepatic CE in PubMed, Web of Science, and Cochrane CENTRAL databases. Study quality was assessed using the methodological index for non-randomized studies (MINORS) criteria and the Cochrane revised tool to assess risk of bias in randomized trials (RoB2). The random-effects model was used for meta-analysis and the arscine-transformed proportions were used to determine complication-, mortality-, and recurrence rates. This study is registered with PROSPERO (number CRD42020181732). Results: Of 3,930 retrieved articles, 54 studies reporting on 4,058 patients were included. Among studies reporting preoperative anthelmintic treatment (31 studies), albendazole was administered in all of them. Complications were reported in 19.4% (95% CI: 15.9–23.2; I2 = 84%; p-value <0.001) of the patients; biliary leakage (10.1%; 95% CI: 7.5–13.1; I2 = 81%; p-value <0.001) and wound infection (6.6%; 95% CI: 4.6–9; I2 = 27%; p-value = 0.17) were the most common complications. The post-endocystectomy mortality rate was 1.2% (95% CI: 0.8–1.8; I2 = 21%; p-value = 0.15) and the recurrence rate was 4.8% (95% CI: 3.1–6.8; I2 = 87%; p-value <0.001). Thirty-nine studies (88.7%) had a mean follow-up of more than one year after endocystectomy, and only 14 studies (31.8%) had a follow-up of more than five years. Conclusion: Endocystectomy is a conservative and feasible surgical approach. Despite previous disencouraging experiences, our results suggest that endocystectomy is associated with low mortality and recurrence. Author summary: Cystic echinococcosis (CE) is a parasitic zoonosis caused by the larval stage of Echinococcus granulosus sensu lato, which can invade several organs including the brain, lungs, and liver. Liver involvement through hepatic cystic echinococcosis has been reported in up to 75% of CE cases. Although it is a rare disease in Europe, migrations from endemic regions to European countries have increased the prevalence of hepatic CE. Several medical and surgical treatment options have been introduced for hepatic CE. Of these, endocystectomy is a conservative approach which avoids radical surgeries and liver resections. In this systematic review and single-arm meta-analysis, we synthesized evidence on the short- and long-term outcomes of endocystectomy in treating patients with hepatic CE. We searched for relevant articles in PubMed, Embase, and Cochrane databases that were published until May 2020 without any language restriction. Of 3930 articles, 54 were included in the systematic review. A summarized analysis of the study findings suggested that endocystectomy is an effective and safe alternative to radical resection or the PAIR procedure in hepatic CE patients. [ABSTRACT FROM AUTHOR]
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- 2021
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5. Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy: results of a European randomized trial.
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van der Wielen, Nicole, Straatman, Jennifer, Daams, Freek, Rosati, Riccardo, Parise, Paolo, Weitz, Jürgen, Reissfelder, Christoph, Diez del Val, Ismael, Loureiro, Carlos, Parada-González, Purificación, Pintos-Martínez, Elena, Mateo Vallejo, Francisco, Medina Achirica, Carlos, Sánchez-Pernaute, Andrés, Ruano Campos, Adriana, Bonavina, Luigi, Asti, Emanuele L. G., Alonso Poza, Alfredo, Gilsanz, Carlos, and Nilsson, Magnus
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LYMPHADENECTOMY , *NEOADJUVANT chemotherapy , *GASTRECTOMY , *SURGICAL complications , *SURGICAL excision , *STOMACH cancer - Abstract
Background: Surgical resection with adequate lymphadenectomy is regarded the only curative option for gastric cancer. Regarding minimally invasive techniques, mainly Asian studies showed comparable oncological and short-term postoperative outcomes. The incidence of gastric cancer is lower in the Western population and patients often present with more advanced stages of disease. Therefore, the reproducibility of these Asian results in the Western population remains to be investigated. Methods: A randomized trial was performed in thirteen hospitals in Europe. Patients with an indication for total gastrectomy who received neoadjuvant chemotherapy were eligible for inclusion and randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG). Primary outcome was oncological safety, measured as the number of resected lymph nodes and radicality. Secondary outcomes were postoperative complications, recovery and 1-year survival. Results: Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. The mean number of resected lymph nodes was 43.4 ± 17.3 in OTG and 41.7 ± 16.1 in MITG (p = 0.612). Forty-eight patients in the OTG group had a R0 resection and 44 patients in the MITG group (p = 0.617). One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701). No significant differences were found regarding postoperative complications and recovery. Conclusion: These findings provide evidence that MITG after neoadjuvant therapy is not inferior regarding oncological quality of resection in comparison to OTG in Western patients with resectable gastric cancer. In addition, no differences in postoperative complications and recovery were seen. [ABSTRACT FROM AUTHOR]
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- 2021
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6. Desmoid tumors: To treat or not to treat, That is the question.
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Kasper, Bernd, Raut, Chandrajit P., and Gronchi, Alessandro
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SURGICAL excision , *THERAPEUTICS , *OSTEOSARCOMA , *RARE diseases , *JOINT diseases - Abstract
Desmoid tumors (DTs) are a rare disease of intermediate malignancy characterized histologically by a locally aggressive, monoclonal, fibroblastic proliferation and clinically by a variable and often unpredictable course. For decades, surgical resection has been the standard initial treatment approach; however, more recently, a paradigm shift toward a more conservative treatment strategy has been introduced. More than 5 years ago, The Desmoid Tumor Working Group started a consensus initiative in Europe with the aim of harmonizing the strategy among clinicians and setting up treatment recommendations for patients with DTs. This review summarizes the latest joint, global, evidence-based guideline approach to DT management. Moreover, a number of gray areas in the treatment recommendations are discussed, and possible future perspectives on the treatment armamentarium for patients with DTs are presented. [ABSTRACT FROM AUTHOR]
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- 2020
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7. Comparative Effectiveness of Lymphadenectomy Strategies During Curative Resection for Gastric Adenocarcinoma.
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Hu, Yinin, McMurry, Timothy L., Goudreau, Bernadette, Leick, Katie M., Le, Tri M., and Zaydfudim, Victor M.
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MARKOV chain Monte Carlo , *GASTRECTOMY , *LYMPHADENECTOMY , *MARKOV processes , *STOMACH cancer , *ONCOLOGIC surgery , *ADENOCARCINOMA , *STOMACH tumors , *RESEARCH , *RESEARCH methodology , *MEDICAL cooperation , *EVALUATION research , *COMPARATIVE studies , *QUALITY of life , *RESEARCH funding , *SURGICAL excision , *LYMPH node surgery - Abstract
Background: The purpose of this study was to compare the long-term effectiveness of three lymphadenectomy strategies in patients with gastric cancer. We hypothesized that, compared with the traditional standard (D2) lymph node dissection strategy, the less aggressive modified standard (mD2) lymphadenectomy may offer superior effectiveness due to reduced operative morbidity and comparable long-term recurrence-free survival.Methods: A Markov decision analysis model was created to simulate 5-year outcomes across three lymphadenectomy approaches for gastric cancer: limited regional (D1), traditional standard (D2), and modified standard (mD2). The primary outcome was discounted quality-adjusted life-years (dQALY). Model variable estimates were derived from outcomes data and quality of life estimates published in Europe and America within the last 15 years. One-way and probabilistic sensitivity analyses were performed for clinically relevant variables.Results: The mD2 lymphadenectomy offered 3.03 dQALY over 5 years, outperforming D2 (2.62 dQALY) and D1 (2.37 dQALY). Monte Carlo simulations indicated that both mD2 and D2 lymph node dissection strategies outperformed D1 in 94.9% of simulations. Sensitivity analyses demonstrated that the mD2 approach would be less effective than D2 if the perioperative mortality rate of mD2 was greater than 6.9% (3.2% baseline).Conclusions: Across modern series, the modified standard mD2 lymphadenectomy is an effective alternative to the traditional D2 lymphadenectomy for patients with gastric cancer. A D1-limited regional lymphadenectomy is not recommended during gastric cancer resection. [ABSTRACT FROM AUTHOR]- Published
- 2020
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8. European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 2. Treatment.
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Stratigos, Alexander J., Garbe, Claus, Dessinioti, Clio, Lebbe, Celeste, Bataille, Veronique, Bastholt, Lars, Dreno, Brigitte, Concetta Fargnoli, Maria, Forsea, Ana M., Frenard, Cecille, Harwood, Catherine A., Hauschild, Axel, Hoeller, Christoph, Kandolf-Sekulovic, Lidija, Kaufmann, Roland, Kelleners-Smeets, Nicole W.J., Malvehy, Josep, del Marmol, Veronique, Middleton, Mark R., and Moreno-Ramirez, David
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THERAPEUTIC use of monoclonal antibodies , *CANCER relapse , *CANCER invasiveness , *COMBINED modality therapy , *SURGICAL excision , *HEALTH care teams , *HISTOLOGICAL techniques , *LYMPH node surgery , *MEDICAL protocols , *METASTASIS , *PALLIATIVE treatment , *RADIOTHERAPY , *RISK assessment , *SKIN tumors , *SQUAMOUS cell carcinoma - Abstract
In order to update recommendations on treatment, supportive care, education and follow-up of patients with invasive cutaneous squamous cell carcinoma (cSCC), a multidisciplinary panel of experts from the European Dermatology Forum, the European Association of Dermato-Oncology and the European Organization of Research and Treatment of Cancer was formed. Recommendations were based on evidence-based literature review, guidelines and expert consensus. Treatment recommendations are presented for common primary cSCC (low risk, high risk), locally advanced cSCC, regional metastatic cSCC (operable or inoperable) and distant metastatic cSCC. For common primary cSCC (the most frequent cSCC type), first-line treatment is surgical excision with postoperative margin assessment or microscopically controlled sugery. Safety margins containing clinical normal-appearing tissue around the tumour during surgical excision and negative margins as reported in the pathology report are necessary to minimise the risk of local recurrence and metastasis. In case of positive margins, a re-excision shall be done, for operable cases. Lymph node dissection is recommended for cSCC with cytologically or histologically confirmed regional nodal involvement. Radiotherapy should be considered as curative treatment for inoperable cSCC, or for non-surgical candidates. Anti-PD-1 antibodies are the first-line systemic treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation, with cemiplimab being the first approved systemic agent for advanced cSCC by the Food and Drug Administration/European Medicines Agency. Second-line systemic treatments for advanced cSCC include epidermal growth factor receptor inhibitors (cetuximab) combined with chemotherapy or radiation therapy. Multidisciplinary board decisions are mandatory for all patients with advanced disease who require more than surgery. Patients should be engaged with informed decisions on management and be provided with best supportive care to optimise symptom management and improve quality of life. Frequency of follow-up visits and investigations for subsequent new cSCC depend on underlying risk characteristics. • Surgical excision with negative margins is an important goal whenever feasible. • Radiotherapy is indicated for inoperable cSCC or patients not suitable for surgical intervention. • Multidisciplinary board decisions are necessary in the management of patients with advanced disease. • Anti-PD-1 antibody therapy is first-line systemic treatment for locally advanced or mcSCC. • Follow-up evaluations depend on underlying risk characteristics. [ABSTRACT FROM AUTHOR]
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- 2020
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9. Endovascular Treatment of Venous Bypass Graft Pseudoaneurysm with the New Solaris Self-Expanding Covered Stent.
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San Norberto, Enrique M., Fidalgo-Domingos, Liliana A., Cenizo, Noelia, Revilla, Álvaro, Taylor, James H., and Vaquero, Carlos
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POPLITEAL artery , *SURGICAL excision , *HOSPITAL admission & discharge , *SAPHENOUS vein , *LEG , *LIMB salvage - Abstract
Nonanastomotic pseudoaneurysm formation after vascular reconstruction is a rarely encountered problem. Covered stent graft constitutes a minimal approach. To our knowledge, the present study constitutes the first case of implantation of Solaris stent graft in Europe. A 69-year-old man with severe cardiac dysfunction presented a pseudoaneurysm of a popliteal to popliteal artery reversed saphenous vein bypass graft. The patient was successfully treated by the percutaneous placement of a Solaris self-expanding covered stent. The postimplantation arteriogram demonstrated exclusion of the pseudoaneurysm, complete apposition of the stent, and adequate runoff. No complications occurred, and the patient was discharged from the hospital one day later receiving 75 mg of clopidogrel. Endovascular exclusion by covered stent deployment offers a safe, rapid, and minimally invasive alternative to open surgical resection in patients with lower limb venous graft pseudoaneurysm. The Solaris covered stent provides a new catheter-based device with adequate navigability and exceptional accurate delivery system. [ABSTRACT FROM AUTHOR]
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- 2020
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10. European consensus-based interdisciplinary guideline for invasive cutaneous squamous cell carcinoma: Part 2. Treatment–Update 2023.
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Stratigos, Alexander J., Garbe, Claus, Dessinioti, Clio, Lebbe, Celeste, van Akkooi, Alexander, Bataille, Veronique, Bastholt, Lars, Dreno, Brigitte, Dummer, Reinhard, Fargnoli, Maria Concetta, Forsea, Ana Maria, Harwood, Catherine A., Hauschild, Axel, Hoeller, Christoph, Kandolf-Sekulovic, Lidija, Kaufmann, Roland, Kelleners-Smeets, Nicole WJ, Lallas, Aimilios, Leiter, Ulrike, and Malvehy, Josep
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THERAPEUTIC use of monoclonal antibodies , *CONSENSUS (Social sciences) , *FRAIL elderly , *IMMUNOCOMPROMISED patients , *EPIDERMAL growth factor receptors , *DISEASES , *SKIN tumors , *TREATMENT effectiveness , *CANCER patients , *RISK assessment , *INTERPROFESSIONAL relations , *QUALITY of life , *HEALTH care teams , *DECISION making , *DESCRIPTIVE statistics , *RADIOTHERAPY , *SQUAMOUS cell carcinoma , *LONGITUDINAL method - Abstract
In order to update recommendations on treatment, supportive care, education, and follow-up of patients with invasive cutaneous squamous cell carcinoma (cSCC), a multidisciplinary panel of experts from the European Association of Dermato-Oncology (EADO), the European Dermatology Forum (EDF), the European Society for Radiotherapy and Oncology (ESTRO), the European Union of Medical Specialists (UEMS), the European Academy of Dermatology and Venereology (EADV), and the European Organisation of Research and Treatment of Cancer (EORTC) was formed. Recommendations were based on an evidence-based literature review, guidelines, and expert consensus. Treatment recommendations are presented for common primary cSCC (low risk, high risk), locally advanced cSCC, regional metastatic cSCC (operable or inoperable), and distant metastatic cSCC. For common primary cSCC, the first-line treatment is surgical excision with postoperative margin assessment or micrographically controlled surgery. Achieving clear surgical margins is the most important treatment consideration for patients with cSCCs amenable to surgery. Regarding adjuvant radiotherapy for patients with high-risk localised cSCC with clear surgical margins, current evidence has not shown significant benefit for those with at least one high-risk factor. Radiotherapy should be considered as the primary treatment for non-surgical candidates/tumours. For cSCC with cytologically or histologically confirmed regional nodal metastasis, lymph node dissection is recommended. For patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiotherapy, anti-PD-1 agents are the first-line systemic treatment, with cemiplimab being the first approved systemic agent for advanced cSCC by the Food and Drugs Administration/European Medicines Agency. Second-line systemic treatments for advanced cSCC, include epidermal growth factor receptor inhibitors (cetuximab) combined with chemotherapy or radiotherapy. Multidisciplinary board decisions are mandatory for all patients with advanced cSCC, considering the risks of toxicity, the age and frailty of patients, and co-morbidities, including immunosuppression. Patients should be engaged in informed, shared decision-making on management and be provided with the best supportive care to improve symptom management and quality of life. The frequency of follow-up visits and investigations for subsequent new cSCC depends on underlying risk characteristics. • Treatment depends on the characteristics of the patient, e.g. frailty, co-morbidities, preferences, and of cSCC, e.g. primary low-risk or high-risk, locally advanced, regional metastatic (operable or inoperable), or distant metastatic. • Achieving clear surgical margins is the most important treatment consideration for patients with cSCC amenable to surgery. • Multidisciplinary board decisions are mandatory for all patients with advanced cSCC. • Anti-PD-1 agents (cemiplimab) are the first-line systemic treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiotherapy. [ABSTRACT FROM AUTHOR]
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- 2023
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11. Quality of life after postmastectomy radiotherapy in patients with intermediate-risk breast cancer (SUPREMO): 2-year follow-up results of a randomised controlled trial.
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Velikova, Galina, Williams, Linda Jane, Willis, Sarah, Dixon, J Michael, Loncaster, Juliette, Hatton, Matthew, Clarke, Jacqueline, Kunkler, Ian H, Russell, Nicola S, and MRC SUPREMO trial UK investigators
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BREAST cancer risk factors , *BREAST cancer treatment , *CANCER radiotherapy , *QUALITY of life , *FOLLOW-up studies (Medicine) , *RANDOMIZED controlled trials , *BREAST tumor treatment , *BREAST tumors , *SURGICAL excision , *LYMPH node surgery , *MASTECTOMY , *METASTASIS , *PSYCHOLOGICAL tests , *QUESTIONNAIRES , *RADIOTHERAPY , *STATISTICAL sampling , *TIME , *TUMOR classification , *TREATMENT effectiveness , *TUMOR grading , *CANCER & psychology - Abstract
Background: Postmastectomy radiotherapy in patients with four or more positive axillary nodes reduces breast cancer mortality, but its role in patients with one to three involved nodes is controversial. We assessed the effects of postmastectomy radiotherapy on quality of life (QOL) in women with intermediate-risk breast cancer.Methods: SUPREMO is an open-label, international, parallel-group, randomised, controlled trial. Women aged 18 years or older with intermediate-risk breast cancer (defined as pT1-2N1; pT3N0; or pT2N0 if also grade III or with lymphovascular invasion) who had undergone mastectomy and, if node positive, axillary surgery, were randomly assigned (1:1) to receive chest wall radiotherapy (50 Gy in 25 fractions or a radiobiologically equivalent dose of 45 Gy in 20 fractions or 40 Gy in 15 fractions) or no radiotherapy. Randomisation was done with permuted blocks of varying block length, and stratified by centre, without masking of patients or investigators. The primary endpoint is 10-year overall survival. Here, we present 2-year results of QOL (a prespecified secondary endpoint). The QOL substudy, open to all UK patients, consists of questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23, Body Image Scale, Hospital Anxiety and Depression Scale [HADS], and EQ-5D-3L) completed before randomisation, and at 1, 2, 5, and 10 years. The prespecified primary outcomes within this QOL substudy were global QOL, fatigue, physical function, chest wall symptoms, shoulder and arm symptoms, body image, and anxiety and depression. Data were analysed by intention to treat, using repeated mixed-effects methods. This trial is registered with the ISRCTN registry, number ISRCTN61145589.Findings: Between Aug 4, 2006, and April 29, 2013, 1688 patients were enrolled internationally and randomly assigned to receive chest wall radiotherapy (n=853) or not (n=835). 989 (79%) of 1258 patients from 111 UK centres consented to participate in the QOL substudy (487 in the radiotherapy group and 502 in the no radiotherapy group), of whom 947 (96%) returned the baseline questionnaires and were included in the analysis (radiotherapy, n=471; no radiotherapy, n=476). At up to 2 years, chest wall symptoms were worse in the radiotherapy group than in the no radiotherapy group (mean score 14·1 [SD 15·8] in the radiotherapy group vs 11·6 [14·6] in the no radiotherapy group; effect estimate 2·17, 95% CI 0·40-3·94; p=0·016); however, there was an improvement in both groups between years 1 and 2 (visit effect -1·34, 95% CI -2·36 to -0·31; p=0·010). No differences were seen between treatment groups in arm and shoulder symptoms, body image, fatigue, overall QOL, physical function, or anxiety or depression scores.Interpretation: Postmastectomy radiotherapy led to more local (chest wall) symptoms up to 2 years postrandomisation compared with no radiotherapy, but the difference between groups was small. These data will inform shared decision making while we await survival (trial primary endpoint) results.Funding: Medical Research Council, European Organisation for Research and Treatment of Cancer, Cancer Australia, Dutch Cancer Society, Trustees of Hong Kong and Shanghai Banking Corporation. [ABSTRACT FROM AUTHOR]- Published
- 2018
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12. Chemotherapy versus chemoradiotherapy after surgery and preoperative chemotherapy for resectable gastric cancer (CRITICS): an international, open-label, randomised phase 3 trial.
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Cats, Annemieke, Jansen, Edwin P M, van Grieken, Nicole C T, Sikorska, Karolina, Lind, Pehr, Nordsmark, Marianne, Meershoek-Klein Kranenbarg, Elma, Boot, Henk, Trip, Anouk K, Swellengrebel, H A Maurits, van Laarhoven, Hanneke W M, Putter, Hein, van Sandick, Johanna W, van Berge Henegouwen, Mark I, Hartgrink, Henk H, van Tinteren, Harm, van de Velde, Cornelis J H, Verheij, Marcel, and CRITICS investigators
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STOMACH cancer treatment , *CHEMORADIOTHERAPY , *SURGICAL technology , *PREOPERATIVE period , *RANDOMIZED controlled trials , *CANCER treatment , *ADENOCARCINOMA , *ANTINEOPLASTIC agents , *COMBINED modality therapy , *COMPARATIVE studies , *DRUGS , *SURGICAL excision , *GASTRECTOMY , *LYMPH node surgery , *RESEARCH methodology , *MEDICAL cooperation , *PATIENT compliance , *QUALITY of life , *RESEARCH , *STATISTICAL sampling , *STOMACH tumors , *TIME , *TUMOR classification , *EVALUATION research , *TUMOR treatment - Abstract
Background: Both perioperative chemotherapy and postoperative chemoradiotherapy improve survival in patients with resectable gastric cancer from Europe and North America. To our knowledge, these treatment strategies have not been investigated in a head to head comparison. We aimed to compare perioperative chemotherapy with preoperative chemotherapy and postoperative chemoradiotherapy in patients with resectable gastric adenocarcinoma.Methods: In this investigator-initiated, open-label, randomised phase 3 trial, we enrolled patients aged 18 years or older who had stage IB- IVA resectable gastric or gastro-oesophageal adenocarcinoma (as defined by the American Joint Committee on Cancer, sixth edition), with a WHO performance status of 0 or 1, and adequate cardiac, bone marrow, liver, and kidney function. Patients were enrolled from 56 hospitals in the Netherlands, Sweden, and Denmark, and were randomly assigned (1:1) with a computerised minimisation programme with a random element to either perioperative chemotherapy (chemotherapy group) or preoperative chemotherapy with postoperative chemoradiotherapy (chemoradiotherapy group). Randomisation was done before patients were given any preoperative chemotherapy treatment and was stratified by histological subtype, tumour localisation, and hospital. Patients and investigators were not masked to treatment allocation. Surgery consisted of a radical resection of the primary tumour and at least a D1+ lymph node dissection. Postoperative treatment started within 4-12 weeks after surgery. Chemotherapy consisted of three preoperative 21-day cycles and three postoperative cycles of intravenous epirubicin (50 mg/m2 on day 1), cisplatin (60 mg/m2 on day 1) or oxaliplatin (130 mg/m2 on day 1), and capecitabine (1000 mg/m2 orally as tablets twice daily for 14 days in combination with epirubicin and cisplatin, or 625 mg/m2 orally as tablets twice daily for 21 days in combination with epirubicin and oxaliplatin), received once every three weeks. Chemoradiotherapy consisted of 45 Gy in 25 fractions of 1·8 Gy, for 5 weeks, five daily fractions per week, combined with capecitabine (575 mg/m2 orally twice daily on radiotherapy days) and cisplatin (20 mg/m2 intravenously on day 1 of each 5 weeks of radiation treatment). The primary endpoint was overall survival, analysed by intention-to-treat. The CRITICS trial is registered at ClinicalTrials.gov, number NCT00407186; EudraCT, number 2006-004130-32; and CKTO, 2006-02.Findings: Between Jan 11, 2007, and April 17, 2015, 788 patients were enrolled and randomly assigned to chemotherapy (n=393) or chemoradiotherapy (n=395). After preoperative chemotherapy, 372 (95%) of 393 patients in the chemotherapy group and 369 (93%) of 395 patients in the chemoradiotherapy group proceeded to surgery, with a potentially curative resection done in 310 (79%) of 393 patients in the chemotherapy group and 326 (83%) of 395 in the chemoradiotherapy group. Postoperatively, 233 (59%) of 393 patients started chemotherapy and 245 (62%) of 395 started chemoradiotherapy. At a median follow-up of 61·4 months (IQR 43·3-82·8), median overall survival was 43 months (95% CI 31-57) in the chemotherapy group and 37 months (30-48) in the chemoradiotherapy group (hazard ratio from stratified analysis 1·01 (95% CI 0·84-1·22; p=0·90). After preoperative chemotherapy, in the total safety population of 781 patients (assessed together), there were 368 (47%) grade 3 adverse events; 130 (17%) grade 4 adverse events, and 13 (2%) deaths. Causes of death during preoperative treatment were diarrhoea (n=2), dihydropyrimidine deficiency (n=1), sudden death (n=1), cardiovascular events (n=8), and functional bowel obstruction (n=1). During postoperative treatment, grade 3 and 4 adverse events occurred in 113 (48%) and 22 (9%) of 233 patients in the chemotherapy group, respectively, and in 101 (41%) and ten (4%) of 245 patients in the chemoradiotherapy group, respectively. Non-febrile neutropenia occurred more frequently during postoperative chemotherapy (79 [34%] of 233) than during postoperative chemoradiotherapy (11 [4%] of 245). No deaths were observed during postoperative treatment.Interpretation: Postoperative chemoradiotherapy did not improve overall survival compared with postoperative chemotherapy in patients with resectable gastric cancer treated with adequate preoperative chemotherapy and surgery. In view of the poor postoperative patient compliance in both treatment groups, future studies should focus on optimising preoperative treatment strategies.Funding: Dutch Cancer Society, Dutch Colorectal Cancer Group, and Hoffmann-La Roche. [ABSTRACT FROM AUTHOR]- Published
- 2018
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13. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial.
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de Boer, Stephanie M, Powell, Melanie E, Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Petronella B, Ledermann, Jonathan A, Khaw, Pearly, Colombo, Alessandro, Fyles, Anthony, Baron, Marie-Helene, Jürgenliemk-Schulz, Ina M, Kitchener, Henry C, Nijman, Hans W, Wilson, Godfrey, Brooks, Susan, Carinelli, Silvestro, Provencher, Diane, and Hanzen, Chantal
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CHEMORADIOTHERAPY , *RADIOTHERAPY , *ENDOMETRIAL cancer , *RANDOMIZED controlled trials , *LYMPHADENECTOMY , *ANTINEOPLASTIC agents , *CISPLATIN , *COMPARATIVE studies , *SURGICAL excision , *GYNECOLOGIC surgery , *LYMPH node surgery , *RESEARCH methodology , *MEDICAL cooperation , *PACLITAXEL , *RESEARCH , *RESEARCH funding , *STATISTICAL sampling , *TIME , *TUMOR classification , *ENDOMETRIAL tumors , *EVALUATION research , *TREATMENT effectiveness , *CARBOPLATIN , *TUMOR grading , *TUMOR treatment - Abstract
Background: Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy) versus pelvic radiotherapy alone for women with high-risk endometrial cancer.Methods: PORTEC-3 was an open-label, international, randomised, phase 3 trial involving 103 centres in six clinical trials collaborating in the Gynaecological Cancer Intergroup. Eligible women had high-risk endometrial cancer with FIGO 2009 stage I, endometrioid-type grade 3 with deep myometrial invasion or lymph-vascular space invasion (or both), endometrioid-type stage II or III, or stage I to III with serous or clear cell histology. Women were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or radiotherapy and chemotherapy (consisting of two cycles of cisplatin 50 mg/m2 given during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m2) using a biased-coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage of cancer, and histological type. The co-primary endpoints were overall survival and failure-free survival. We used the Kaplan-Meier method, log-rank test, and Cox regression analysis for final analysis by intention to treat and adjusted for stratification factors. The study was closed on Dec 20, 2013, after achieving complete accrual; follow-up is ongoing. PORTEC-3 is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138.Results: 686 women were enrolled between Nov 23, 2006, and Dec 20, 2013. 660 eligible patients were included in the final analysis, of whom 330 were assigned to chemoradiotherapy and 330 were assigned to radiotherapy. Median follow-up was 60·2 months (IQR 48·1-73·1). 5-year overall survival was 81·8% (95% CI 77·5-86·2) with chemoradiotherapy versus 76·7% (72·1-81·6) with radiotherapy (adjusted hazard ratio [HR] 0·76, 95% CI 0·54-1·06; p=0·11); 5-year failure-free survival was 75·5% (95% CI 70·3-79·9) versus 68·6% (63·1-73·4; HR 0·71, 95% CI 0·53-0·95; p=0·022). Grade 3 or worse adverse events during treatment occurred in 198 (60%) of 330 who received chemoradiotherapy versus 41 (12%) of 330 patients who received radiotherapy (p<0·0001). Neuropathy (grade 2 or worse) persisted significantly more often after chemoradiotherapy than after radiotherapy (20 [8%] women vs one [1%] at 3 years; p<0·0001). Most deaths were due to endometrial cancer; in four patients (two in each group), the cause of death was uncertain. One death in the radiotherapy group was due to either disease progression or late treatment complications; three deaths (two in the chemoradiotherapy group and one in the radiotherapy group) were due to either intercurrent disease or late treatment-related toxicity.Interpretation: Adjuvant chemotherapy given during and after radiotherapy for high-risk endometrial cancer did not improve 5-year overall survival, although it did increase failure-free survival. Women with high-risk endometrial cancer should be individually counselled about this combined treatment. Continued follow-up is needed to evaluate long-term survival.Funding: Dutch Cancer Society, Cancer Research UK, National Health and Medical Research Council Project Grant and Cancer Australia, L'Agenzia Italiana del Farmaco, and Canadian Cancer Society Research Institute. [ABSTRACT FROM AUTHOR]- Published
- 2018
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14. Time trends (2006–2015) of quality indicators in EUSOMA-certified breast centres.
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van Dam, P.A., Tomatis, M., Marotti, L., Heil, J., Mansel, R.E., Rosselli del Turco, M., van Dam, P.J., Casella, D., Bassani, L.G., Danei, M., Denk, A., Egle, D., Emons, G., Friedrichs, K., Harbeck, N., Kiechle, M., Kimmig, R., Koehler, U., Kuemmel, S., and Maass, N.
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BREAST tumor treatment , *CLINICAL medicine , *COMBINED modality therapy , *DATABASES , *SURGICAL excision , *LYMPH node surgery , *MEDICAL protocols , *SAMPLE size (Statistics) , *CERTIFICATION , *KEY performance indicators (Management) ,BREAST care - Abstract
Aim of the study The European Society of Breast Cancer Specialists (EUSOMA) has fostered a voluntary certification process for breast centres to establish minimum standards and ensure specialist multidisciplinary care. Prospectively collected anonymous information on primary breast cancer cases diagnosed and treated in the units is transferred annually to a central EUSOMA data warehouse for continuous monitoring of quality indicators (QIs) to improve quality of care. Units have to comply with the EUSOMA Breast Centre guidelines and are audited by peers. The database was started in 2006 and includes over 110,000 cancers from breast centres located in Germany, Switzerland, Belgium, Austria, The Netherlands, Spain, Portugal and Italy. The aim of the present study is assessing time trends of QIs in EUSOMA-certified breast centres over the decade 2006–2015. Materials and methods Previously defined QIs were calculated for 22 EUSOMA-certified breast centres (46122 patients) during 2006–2015. Results On the average of all units, the minimum standard of care was achieved in 8 of 13 main EUSOMA QIs in 2006 and in all in 2015. All QIs, except removal of at least 10 lymph nodes at axillary clearance and oestrogen receptor–negative tumours (T > 1 cm or N+) receiving adjuvant chemotherapy, improved significantly in this period. The desirable target was reached for two QIs in 2006 and for 7 of 13 QIs in 2015. Conclusion The EUSOMA model of audit and monitoring QIs functions well in different European health systems and results in better performance of QIs over the last decade. QIs should be evaluated and adapted on a regular basis, as guidelines change over time. [ABSTRACT FROM AUTHOR]
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- 2017
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15. Evolution of Laparoscopic Liver Surgery from Innovation to Implementation to Mastery: Perioperative and Oncologic Outcomes of 2,238 Patients from 4 European Specialized Centers.
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Berardi, Giammauro, Van Cleven, Stijn, Fretland, Åsmund Avdem, Barkhatov, Leonid, Halls, Mark, Cipriani, Federica, Aldrighetti, Luca, Abu Hilal, Mohammed, Edwin, Bjørn, and Troisi, Roberto I.
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LIVER surgery , *LAPAROSCOPIC surgery , *SURGICAL excision , *ONCOLOGIC surgery , *PATIENT selection - Abstract
Background: First seen as an innovation for select patients, laparoscopic liver resection (LLR) has evolved since its introduction, resulting in worldwide use. Despite this, it is still limited mainly to referral centers. The aim of this study was to evaluate a large cohort undergoing LLR from 2000 to 2015, focusing on the technical approaches, perioperative and oncologic outcomes, and evolution of practice over time.Study Design: The demographics and indications, intraoperative, perioperative, and oncologic outcomes of 2,238 patients were evaluated. Trends in practice and outcomes over time were assessed.Results: The percentage of LLR performed yearly has increased from 5% in 2000 to 43% in 2015. Pure laparoscopy was used in 98.3% of cases. Wedge resections were the most common operation; they were predominant at the beginning of LLR and then decreased and remained steady at approximately 53%. Major hepatectomies were initially uncommon, then increased and reached a stable level at approximately 16%. Overall, 410 patients underwent resection in the posterosuperior segments; these were more frequent with time, and the highest percentage was in 2015 (26%). Blood loss, operative time, and conversion rate improved significantly with time. The 5-year overall survival rates were 73% and 54% for hepatocellular carcinoma (HCC) and colorectal liver metastases (CRLM), respectively. The 5-year, recurrence-free survival rates were 50% and 37% for HCC and CRLM, respectively.Conclusions: Since laparoscopy was introduced, a long implementation process has been necessary to allow for standardization and improvement in surgical care, mastery of the technique, and the ability to obtain good perioperative results with safe oncologic outcomes. [ABSTRACT FROM AUTHOR]- Published
- 2017
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16. Iatrogenic Hip Instability Is a Devastating Complication After the Modified Dunn Procedure for Severe Slipped Capital Femoral Epiphysis.
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Upasani, Vidyadhar, Birke, Oliver, Klingele, Kevin, Millis, Michael, Upasani, Vidyadhar V, Klingele, Kevin E, Millis, Michael B, and International SCFE Study Group
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IATROGENIC diseases , *FEMORAL epiphysis , *JOINT dislocations , *SUBLUXATION , *SURGICAL excision , *THERAPEUTICS , *HIP surgery , *COMPARATIVE studies , *SURGICAL flaps , *HIP joint , *HIP joint dislocation , *JOINT hypermobility , *RANGE of motion of joints , *KINEMATICS , *RESEARCH methodology , *MEDICAL cooperation , *ORTHOPEDIC surgery , *RESEARCH , *TIME , *EVALUATION research , *TREATMENT effectiveness , *RETROSPECTIVE studies , *SEVERITY of illness index , *EPIPHYSIOLYSIS - Abstract
Background: The modified Dunn procedure facilitates femoral capital realignment for slipped capital femoral epiphysis (SCFE) through a surgical hip dislocation approach. Iatrogenic postoperative hip instability after this procedure has not been studied previously; however, we were concerned when we observed several instances of this serious complication, and we wished to study it further.Questions/purposes: The purpose of this study was to evaluate the frequency, timing, and clinical presentation (including complications) associated with iatrogenic instability after the modified Dunn procedure for SCFE.Methods: Between 2007 and 2014, eight international institutions performed the modified Dunn procedure through a surgical dislocation approach in 406 patients. During the period in question, indications varied at those sites, but the procedure was used only in a minority of their patients treated surgically for SCFE (31% [406 of 1331]) with the majority treated with in situ fixation. It generally was performed for patients with severe deformity with a slip angle greater than 40°. Institutional databases were searched for all patients with SCFE who developed postoperative hip instability defined as hip subluxation or dislocation of the involved hip during the postoperative period. We reviewed in detail the clinical notes and operative records of those who presented with instability. We obtained demographic information, time from slip to surgery, type of fixation, operative details, and clinical course including the incidence of complications. Followup on those patients with instability was at a mean of 2 years (range, 1-5 years) after the index procedure. Complications were graded according to the modified Dindo-Clavien classification. Radiographic images were reviewed to measure the preoperative slip angle and the presence of osteonecrosis.Results: A total of 4% of patients treated with the modified Dunn procedure developed postoperative hip instability (17 of 406). Mean age of the patients was 13 years (range, 9-16 years). Instability presented as persistent hip pain in the postoperative period or was incidentally identified radiographically during the postoperative visit and occurred at a median of 3 weeks (range, 1 day to 2 months) after the modified Dunn procedure. Eight patients underwent revision surgery to address the postoperative instability. Fourteen of 17 patients developed femoral head avascular necrosis and three of 17 patients underwent THA during this short-term followup.Conclusions: Anterolateral hip instability after the modified Dunn procedure for severe, chronic SCFE is an uncommon yet potentially devastating complication. Future studies might evaluate the effectiveness of maintaining anterior hip precautions for several weeks postoperatively in an abduction brace or broomstick cast to prevent this complication.Level Of Evidence: Level IV, therapeutic study. [ABSTRACT FROM AUTHOR]- Published
- 2017
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17. Completion of a Liver Surgery Complexity Score and Classification Based on an International Survey of Experts.
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IVLee, Major K., Gao, Feng, Strasberg, Steven M., and Lee, Major K 4th
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LIVER surgery , *STATISTICS , *SURGICAL excision , *COMPARATIVE studies , *TECHNOLOGICAL complexity , *ATTITUDE (Psychology) , *HEPATECTOMY , *MEDICAL personnel , *SURGEONS - Abstract
Background: Liver resections have classically been distinguished as "minor" or "major," based on number of segments removed. This is flawed because the number of segments resected alone does not convey the complexity of a resection. We recently developed a 3-tiered classification for the complexity of liver resections based on utility weighting by experts. This study aims to complete the earlier classification and to illustrate its application.Study Design: Two surveys were administered to expert liver surgeons. Experts were asked to rate the difficulty of various open liver resections on a scale of 1 to 10. Statistical methods were then used to develop a complexity score for each procedure.Results: Sixty-six of 135 (48.9%) surgeons responded to the earlier survey, and 66 of 122 (54.1%) responded to the current survey. In all, 19 procedures were rated. The lowest mean score of 1.36 (indicating least difficult) was given to peripheral wedge resection. Right hepatectomy with IVC reconstruction was deemed most difficult, with a score of 9.35. Complexity scores were similar for 9 procedures present in both surveys. Caudate resection, hepaticojejunostomy, and vascular reconstruction all increased the complexity of standard resections significantly.Conclusions: These data permit quantitative assessment of the difficulty of a variety of liver resections. The complexity scores generated allow for separation of liver resections into 3 categories of complexity (low complexity, medium complexity, and high complexity) on a quantitative basis. This provides a more accurate representation of the complexity of procedures in comparative studies. [ABSTRACT FROM AUTHOR]- Published
- 2016
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18. The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial.
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Jenkinson, Michael D., Javadpour, Mohsen, Haylock, Brian J., Bridget Young, Gillard, Helen, Vinten, Jacqui, Bulbeck, Helen, Das, Kumar, Farrell, Michael, Looby, Seamus, Hickey, Helen, Preusser, Mattheus, Mallucci, Conor L., Hughes, Dyfrig, Gamble, Carrol, Weber, Damien C., and Young, Bridget
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MENINGIOMA , *SURGICAL excision , *RADIOTHERAPY , *SURVIVAL analysis (Biometry) , *ADJUVANT treatment of cancer , *RANDOMIZED controlled trials , *QUALITY-adjusted life years , *CANCER relapse , *COMPARATIVE studies , *COST effectiveness , *EXPERIMENTAL design , *MAGNETIC resonance imaging , *RESEARCH methodology , *MEDICAL care costs , *MEDICAL cooperation , *RESEARCH protocols , *NEUROSURGERY , *PROGNOSIS , *QUALITY of life , *RADIATION doses , *RESEARCH , *RESEARCH funding , *STATISTICAL sampling , *TIME , *EVALUATION research , *MENINGES , *TREATMENT effectiveness , *PREDICTIVE tests , *DISEASE progression , *DIAGNOSIS , *TUMORS , *PREVENTION - Abstract
Background: Atypical meningiomas are an intermediate grade brain tumour with a recurrence rate of 39-58 %. It is not known whether early adjuvant radiotherapy reduces the risk of tumour recurrence and whether the potential side-effects are justified. An alternative management strategy is to perform active monitoring with magnetic resonance imaging (MRI) and to treat at recurrence. There are no randomised controlled trials comparing these two approaches.Methods/design: A total of 190 patients will be recruited from neurosurgical/neuro-oncology centres across the United Kingdom, Ireland and mainland Europe. Adult patients undergoing gross total resection of intracranial atypical meningioma are eligible. Patients with multiple meningioma, optic nerve sheath meningioma, previous intracranial tumour, previous cranial radiotherapy and neurofibromatosis will be excluded. Informed consent will be obtained from patients. This is a two-stage trial (both stages will run in parallel): Stage 1 (qualitative study) is designed to maximise patient and clinician acceptability, thereby optimising recruitment and retention. Patients wishing to continue will proceed to randomisation. Stage 2 (randomisation) patients will be randomised to receive either early adjuvant radiotherapy for 6 weeks (60 Gy in 30 fractions) or active monitoring. The primary outcome measure is time to MRI evidence of tumour recurrence (progression-free survival (PFS)). Secondary outcome measures include assessing the toxicity of the radiotherapy, the quality of life, neurocognitive function, time to second line treatment, time to death (overall survival (OS)) and incremental cost per quality-adjusted life year (QALY) gained.Discussion: ROAM/EORTC-1308 is the first multi-centre randomised controlled trial designed to determine whether early adjuvant radiotherapy reduces the risk of tumour recurrence following complete surgical resection of atypical meningioma. The results of this study will be used to inform current neurosurgery and neuro-oncology practice worldwide.Trial Registration: ISRCTN71502099 on 19 May 2014. [ABSTRACT FROM AUTHOR]- Published
- 2015
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19. Diagnosis and treatment of invasive squamous cell carcinoma of the skin: European consensus-based interdisciplinary guideline.
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Stratigos, Alexander, Garbe, Claus, Lebbe, Celeste, Malvehy, Josep, del Marmol, Veronique, Pehamberger, Hubert, Peris, Ketty, Becker, Jürgen C., Zalaudek, Iris, Saiag, Philippe, Middleton, Mark R., Bastholt, Lars, Testori, Alessandro, and Grob, Jean-Jacques
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CANCER chemotherapy , *COMPUTED tomography , *DERMATOLOGY , *SURGICAL excision , *HEALTH care teams , *PATIENT aftercare , *INTERDISCIPLINARY research , *LYMPH nodes , *LYMPH node surgery , *MAGNETIC resonance imaging , *MEDICAL protocols , *MEDICAL societies , *SKIN tumors , *TUMOR classification , *WHITE people , *LITERATURE reviews , *DISEASE complications , *DIAGNOSIS , *TUMOR treatment ,EPITHELIAL cell tumors - Abstract
Cutaneous squamous cell carcinoma (cSCC) is one of the most common cancers in Caucasian populations, accounting for 20% of all cutaneous malignancies. A unique collaboration of multi-disciplinary experts from the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization of Research and Treatment of Cancer (EORTC) was formed to make recommendations on cSCC diagnosis and management, based on a critical review of the literature, existing guidelines and the expert’s experience. The diagnosis of cSCC is primarily based on clinical features. A biopsy or excision and histologic confirmation should be performed in all clinically suspicious lesions in order to facilitate the prognostic classification and correct management of cSCC. The first line treatment of cutaneous SCC is complete surgical excision with histopathological control of excision margins. The EDF–EADO–EORTC consensus group recommends a standardised minimal margin of 5 mm even for low-risk tumours. For tumours, with histological thickness of >6 mm or in tumours with high risk pathological features, e.g. high histological grade, subcutaneous invasion, perineural invasion, recurrent tumours and/or tumours at high risk locations an extended margin of 10 mm is recommended. As lymph node involvement by cSCC increases the risk of recurrence and mortality, a lymph node ultrasound is highly recommended, particularly in tumours with high-risk characteristics. In the case of clinical suspicion or positive findings upon imaging, a histologic confirmation should be sought either by fine needle aspiration or by open lymph node biopsy. In large infiltrating tumours with signs of involvement of underlying structures, additional imaging tests, such as CT or MRI imaging may be required to accurately assess the extent of the tumour and the presence of metastatic spread. Current staging systems for cSCC are not optimal, as they have been developed for head and neck tumours and lack extensive validation or adequate prognostic discrimination in certain stages with heterogeneous outcome measures. Sentinel lymph node biopsy has been used in patients with cSCC, but there is no conclusive evidence of its prognostic or therapeutic value. In the case of lymph node involvement by cSCC, the preferred treatment is a regional lymph node dissection. Radiation therapy represents a fair alternative to surgery in the non-surgical treatment of small cSCCs in low risk areas. It generally should be discussed either as a primary treatment for inoperable cSCC or in the adjuvant setting. Stage IV cSCC can be responsive to various chemotherapeutic agents; however, there is no standard regimen. EGFR inhibitors such as cetuximab or erlotinib, should be discussed as second line treatments after mono- or polychemotherapy failure and disease progression or within the framework of clinical trials. There is no standardised follow-up schedule for patients with cSCC. A close follow-up plan is recommended based on risk assessment of locoregional recurrences, metastatic spread or development of new lesions. [ABSTRACT FROM AUTHOR]
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- 2015
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20. Endoscopic submucosal dissection in large sessile lesions of the rectosigmoid: learning curve in a European center.
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Probst, A., Golger, D., Anthuber, M., Märkl, B., and Messmann, H.
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ENDOSCOPIC surgery , *DISSECTION , *COLON surgery , *SURGICAL excision - Abstract
Background and study aims: Endoscopic submucosal dissection (ESD) in the colorectum is not currently a standard procedure. Few data are available from the Western world. The aim of the present study was to report on the first experiences and the learning curve of colorectal ESD in a European center. Patients and methods: A total of 82 rectosigmoid lesions were referred for ESD. Lesion characteristics, resection rates, procedure times, complications, and recurrences were recorded prospectively. Results were compared between three consecutive study periods in order to determine the learning curve. Results: Lesions were located in the rectum(86.6 %) and the sigmoid colon (13.4 %). Median diameter was 45.5 mm. Lesions were of Paris type 0-Is with pit pattern type V (n=8), 0-IIa (n=33), 0- IIa+Is (n=36), and 0-IIa+IIc (n=5). The malignancy rate in these groups was 100%, 0%, 14%, and 20%, respectively. ESD was possible in 76 lesions (92.7 %). En bloc resection rate and R0 resection rate were 81.6% and 69.7 %, respectively. Median procedure time was 176 minutes. Between the three consecutive study periods, en bloc resection rate increased (60.0 %, 88.0 %, 96.2 %), R0 resection rate increased (48.0 %, 76.0 %, 84.5 %; P<0.001), and procedure time decreased (200, 193, 136 minutes; P=0.027). The perforation and bleeding rates were 1.3% and 7.9 %, respectively. Recurrence risk was 0% after R0 en bloc resection and 41.7% after piecemeal resection (P<0.05). Median follow-up was 23.6 months. Conclusions: In the European setting, ESD in the distal colon is feasible with acceptable complication risks. Resection rates were not as high as those from Japanese studies; however, a clear learning curve could be shown. Colorectal ESD needs to be further evaluated, particularly in Europe where ESD experience is low. [ABSTRACT FROM AUTHOR]
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- 2012
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21. 2-cm versus 4-cm surgical excision margins for primary cutaneous melanoma thicker than 2 mm: a randomised, multicentre trial.
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Gillgren, Peter, Drzewiecki, Krzysztof T., Niin, Marianne, Gullestad, Hans P., Hellborg, Henrik, Månsson-Brahme, Eva, Ingvar, Christian, and Ringborg, Ulrik
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MELANOMA treatment , *DERMATOLOGIC surgery , *SURGICAL excision , *SURGERY , *NEUROENDOCRINE tumors - Abstract
The article presents a study concerning a randomised multicentre trial on two-centimeter versus four-centimeter surgical excision margins for primary cutaneous melanoma thicker than two millimeters. The objective of the study is to test the survival between the two margins. The study involves patients with cutaneous melanoma thicker than two millimeters. The involved patients are from nine European cities.
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- 2011
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22. International Consultation on Urologic Diseases and the European Association of Urology International Consultation on Locally Advanced Renal Cell Carcinoma
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Margulis, Vitaly, Master, Viraj A., Cost, Nicholas G., Leibovich, Bradley C., Joniau, Steven, Kuczyk, Markus, Mulders, Peter F., Kirkali, Ziya, Wirth, Manfred P., Hirao, Yoshihiko, Rawal, Sudhir, Chong, Tsung Wen, and Wood, Christopher G.
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RENAL cell carcinoma , *URINARY organ diseases , *METASTASIS , *SURGICAL excision , *CANCER invasiveness , *UROLOGY , *SOCIETIES - Abstract
Abstract: Context: Although an ever-increasing number of patients are being incidentally diagnosed with small renal masses, there is still a sizable portion of patients with renal cell carcinoma (RCC) who present with locally advanced or metastatic disease. Those with locally advanced disease present a challenge because they may be difficult to distinguish from those with organ-confined disease at the time of diagnosis. However, this distinction is important because they may require a different management strategy. These advanced RCC patients include those with venous tumour thrombi, extracapsular tumour extension, adjacent organ involvement, as well as nodal disease. Evidence acquisition: A thorough literature search of the following terms was undertaken: advanced renal cell carcinoma, renal cell carcinoma venous tumour thrombi, renal cell carcinoma extra-capsular extension, renal cell carcinoma nodal metastasis, and locally recurrent renal cell carcinoma. An international expert panel convened by the International Consultation on Urologic Diseases and the European Association of Urology reviewed these articles. Evidence synthesis: Review of the available literature allowed for assessment of the level of evidence for the diagnosis, management, and therapy of locally advanced RCC with the ultimate goal of providing a synthesis of this information with a consensus statement from leaders in the field. Conclusions: Despite the advances in prognostic markers and targeted molecular therapies for RCC, currently the only curative treatment for locally advanced RCC is aggressive surgical resection. [Copyright &y& Elsevier]
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- 2011
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23. Postoperative Quality of Life: Development and Validation of the “Dysfunction after Upper Gastrointestinal Surgery” Scoring System
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Nakamura, Misuzu, Hosoya, Yoshinori, Umeshita, Koji, Yano, Masahiko, Doki, Yuichiro, Miyashiro, Isao, Dannoue, Hideo, Mori, Masaki, Kishi, Kentaro, and Lefor, Alan T.
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GASTROINTESTINAL surgery , *CANCER treatment , *SURGICAL excision , *POSTOPERATIVE period , *ESOPHAGECTOMY , *QUALITY of life - Abstract
Background: Although postoperative quality of life is an important outcomes measure, few tools exist to evaluate patients specifically after upper gastrointestinal surgery. The previously developed Dysfunction After Upper Gastrointestinal Surgery (DAUGS)32 scoring system has been further refined to include just 20 items. This study was undertaken to validate the refined evaluation tool. Study Design: The study was performed as a survey, administered to patients after upper gastrointestinal resection at 3 separate institutions. Results: The DAUGS20 score after gastrectomy (n = 662) was 27.8 and that after esophagectomy (n = 221) was 36.1, showing a significant difference (p < 0.05). The score after distal gastrectomy (n = 282) was 25.4 and that after total gastrectomy (n = 149) was 32.0, showing a significant (p < 0.05) difference. The α coefficient of all items on the DAUGS20 system was 0.904 and Cronbach''s α coefficients of the subscales were 0.612 to 0.856, demonstrating high reliability of this evaluation tool. In addition, 7 factors were extracted from the 20 items using definitive factor analysis, to verify validity. Conclusions: Patient quality of life should be evaluated as an outcomes measure after surgical resection for cancer, just as overall survival is analyzed. The DAUGS20 score is reliable, has validity in the evaluation of postoperative patients, and is a valuable tool to assess patient quality of life after upper gastrointestinal surgery for cancer. [Copyright &y& Elsevier]
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- 2011
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24. Endoscopic submucosal dissection in gastric neoplasia - experience from a European center.
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A. Probst
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ENDOSCOPIC surgery , *STOMACH surgery , *STOMACH cancer , *OPERATIVE surgery , *SURGICAL excision , *ADENOMA , *SURGICAL complications - Abstract
BACKGROUND AND STUDY AIMS: Endoscopic submucosal dissection (ESD) is a promising technique for the resection of early gastric neoplasia. There are only a few data from the Western world to date. METHODS: Over a 7-year-period, 104 gastric lesions were treated with ESD in a European referral center, of which 91 were included in this study. A total of 66 lesions were early gastric cancer (EGC) and 25 were adenomas. Of the EGCs, 11 lesions (16.7?%) fulfilled the guideline criteria (EGC-GC) and 55 lesions (83.3?%) fulfilled the expanded resection criteria (EGC-EC) of the Japanese guidelines for the treatment of gastric cancer. RESULTS: ESD was technically possible in 85 lesions (93.4?%). In six lesions ESD was not possible due to non-lifting. En bloc resection rates for all lesions, ECGs-GC, ECGs-EC, and adenomas were 87.1?%, 100?%, 88.2?%, and 79.2?%, respectively. R0 en bloc resection rates were 74.1?%, 90?%, 68.6?%, and 79.2?%, respectively. Complications were: one perforation during piecemeal endoscopic mucosal resection of a lesion in which ESD was judged to be impossible (1.2?%); three clinically relevant bleedings (3.5?%); one gastric ischemia (1.2?%); and four strictures (4.7?%). No mortality was observed. There were five recurrences after piecemeal resection (50?%) compared with only one after en bloc resection (1.5?%; P?0.05). The rate of recurrence for EGCs was 5.6?%, and this were seen exclusively after piecemeal resection. CONCLUSIONS: Our data show that ESD is a feasible technique in Europe even in patients with EGC according to the extended criteria. Resection rates are promising and complication rates are acceptable. Results are worse compared with large studies from Japan but still excellent regarding the learning curve of the method. ESD should be offered as the treatment of choice for early gastric neoplasia especially when en bloc resection cannot be performed with other resection techniques. [ABSTRACT FROM AUTHOR]
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- 2010
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25. En Bloc Excision of the Nail.
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JELLINEK, NATHANIEL J. and BAUER, JACOB H.
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SURGICAL excision , *NAILS (Anatomy) , *CANCER treatment , *SQUAMOUS cell carcinoma , *MELANOMA treatment , *BASAL cell carcinoma treatment , *LOCAL anesthesia , *TUMORS - Abstract
The authors have indicated no significant interest with commercial supporters. [ABSTRACT FROM AUTHOR]
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- 2010
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26. The management of colorectal liver metastases: Expanding the role of hepatic resection in the age of multimodal therapy
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Chiappa, A., Makuuchi, M., Lygidakis, N.J., Zbar, A.P., Chong, G., Bertani, E., Sitzler, P.J., Biffi, R., Pace, U., Bianchi, P.P., Contino, G., Misitano, P., Orsi, F., Travaini, L., Trifirò, G., Zampino, M.G., Fazio, N., Goldhirsch, A., and Andreoni, B.
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LIVER metastasis , *COLON cancer , *COMBINED modality therapy , *CAUSES of death , *SURGICAL excision , *OXALIPLATIN , *CANCER treatment - Abstract
Abstract: Colorectal cancer (CRC) caused nearly 204,000 deaths in Europe in 2004. Despite recent advances in the treatment of advanced disease, which include the incorporation of two new cytotoxic agents irinotecan and oxaliplatin into first-line regimens, the concept of planned sequential therapy involving three active agents during the course of a patient''s treatment and the integrated use of targeted monoclonal antibodies, the 5-year survival rates for patients with advanced CRC remain unacceptably low. For patients with colorectal liver metastases, liver resection offers the only potential for cure. This review, based on the outcomes of a meeting of European experts (surgeons and medical oncologists), considers the current treatment strategies available to patients with CRC liver metastases, the criteria for the selection of those patients most likely to benefit and suggests where future progress may occur. [Copyright &y& Elsevier]
- Published
- 2009
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27. Strongyloides stercoralis: A Rare Cause of Obstructive Duodenal Stenosis.
- Author
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Juchems, Markus S., Niess, Jan Hendrik, Leder, Gerhard, Barth, Thomas F., Adler, Guido, Brambs, Hans-Juergen, and Wagner, Martin
- Subjects
- *
DUODENUM , *BOWEL obstructions , *HELMINTHIASIS , *SURGICAL excision - Abstract
Background: Strongyloidiasis is a rare helminthic infection in Europe, and it may cause duodenal obstruction. Methods: We report a patient who was admitted to our Medical Department with nausea and repeated vomiting since 10 years until food intake became impossible. Subsequent investigations revealed a duodenal obstruction at the upper third of the duodenum, as well as enterocolitis of the terminal ileum with eosinophils dispersed throughout the mucosa. Since food intake was still not possible after treatment with a course of i.v. PPI and prokinetic applications, we decided to perform a resection of the upper duodenum with Y-Roux reconstruction. Results: The histopathological examination of the resected specimen revealed strongyloidiasis. Conclusion: Parasite infections such as strongyloidiasis represent a rare differential diagnosis of duodenal obstruction especially if patients originate from endemic regions. Copyright © 2008 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]
- Published
- 2008
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28. Primary Liver Tumors.
- Subjects
- *
LIVER tumors , *LIVER surgery , *LIVER cancer , *SURGICAL excision , *INJECTIONS - Abstract
Presents abstracts on primary liver tumors presented at the EHPBA European Congress in 2005. Surgical Treatment of Hepatocellular Carcinoma in Non-Cirrhotic Livers; Comparison of Hepatic Resection and Percutaneous Ethanol Injection in the Treatment of Small Hepatocellular Carcinoma.
- Published
- 2005
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29. Miscellaneous Pancreatic Disease.
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- *
PANCREATIC diseases , *PANCREATICODUODENECTOMY , *SURGICAL excision , *SURGICAL drainage , *ENDOSCOPIC ultrasonography - Abstract
Presents abstracts of studies on miscellaneous pancreatic disease presented at the EHPBA European Congress in 2005. "Management of a Difficult Pancreatic Stump During Pancreaticduodenectomy; Risks Factors for Complications in Patients Undergoing Pancreatic Head Resection After Preoperative Biliary Drainage-A Multivariate Analysis of 201 Patients"; "Role of Endoscopic Ultrasonography-guided Fine Needle Aspiration Fluid Analysis for Diagnosis of Large Pancreatic Cystic Lesions."
- Published
- 2005
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30. Chronic Pancreatitis.
- Subjects
- *
PANCREATITIS , *DRUGS , *SURGICAL excision , *SURGICAL drainage - Abstract
Presents abstracts on chronic pancreatitis presented at the EHPBA European Congress in 2005. Diagnosis and Management of Bleeding Pseudoaneurysms Complicating Pancreatitis; Efficacy of the Homotoxic Drug Momordica Compositum in the Treatment of Chronic Pancreatitis; Results of Resection and Drainage Operations for Chronic Pancreatitis.
- Published
- 2005
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31. Unusual Presentation of Feline Leprosy Caused by Mycobacterium lepraemurium in the Alpine Region.
- Author
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Ghielmetti, Giovanni, Schmitt, Sarah, Friedel, Ute, Guscetti, Franco, and Walser-Reinhardt, Ladina
- Subjects
ALPINE regions ,MYCOBACTERIUM ,HANSEN'S disease ,FELINE immunodeficiency virus ,NEEDLE biopsy ,SURGICAL excision ,EAR ,SCLERA - Abstract
A 9-year-old cat was referred with multiple, raised, ulcerative and non-ulcerative nodules in the periocular area, sclera and ear-base region, and on the ventral aspect of the tongue. In addition, a progressive ulcerative skin nodule on the tail was observed. Fine-needle aspirations of multiple nodules from the eyelid and sclera revealed the presence of histiocytes with numerous acid-fast intracellular bacilli. The replication of slowly growing mycobacteria in liquid media was detected from biopsied nodules after three months of incubation. The molecular characterization of the isolate identified Mycobacterium (M.) lepraemurium as the cause of the infection. The cat was treated with a combination of surgical excision and a four-week course of antimicrobial therapy including rifampicin combined with clarithromycin. This is an unusual manifestation of feline leprosy and the first molecularly confirmed M. lepraemurium infection in a cat with ocular involvement in Europe. The successful combination of a surgical and antimycobacterial treatment regimen is reported. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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32. Quality assurance of the EORTC Trial 22881/10882: boost versus no boost in breast conserving therapy. An overview.
- Author
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van Tienhoven, G, Mijnheer, B J, Bartelink, H, and González, D G
- Subjects
BREAST tumor treatment ,BREAST tumors ,CLINICAL trials ,COMPARATIVE studies ,SURGICAL excision ,LYMPH node surgery ,MASTECTOMY ,RESEARCH methodology ,MEDICAL cooperation ,MEDICAL protocols ,IMAGING phantoms ,QUALITY assurance ,RADIATION doses ,RADIOTHERAPY ,RESEARCH ,STATISTICAL sampling ,TUMOR classification ,EVALUATION research ,RANDOMIZED controlled trials - Abstract
Background: The initial quality assurance programme of the EORTC Radiotherapy Cooperative Group in trial 22881/10882 is described. The implications of its results for quality assurance in future trials are discussed.Methods: In the EORTC trial 22881/10882 patients with stage I or II breast cancer are treated with tumor excision, axillary dissection, 50 Gy whole breast irradiation and then randomized to receive a boost dose of 15 Gy or no boost following complete tumor excision or between 10 Gy or 25 Gy in case of incomplete excision. To avoid or diminish protocol deviations and to quantify inevitable variations an extensive initial quality assurance programme was conducted. The programme consisted of a dummy run procedure an individual case review procedure, in vivo dosimetry studies and phantom dosimetry studies.Results: This combination of quality assurance procedures allows a good estimation of patient to patient and inter-institutional variations, and early detection of (potential) systematic protocol deviations of 3 types: 1. Deviations due to ambiguities in the protocol prescriptions. 2. Deviations not known to the institution, such as mistakes in implementation of treatment planning algorithms resulting in a systematic overdosage or underdosage. 3. Inability of an institution to cope with (precise) protocol prescriptions for technical or logistic reasons.Discussion: The first 2 types of deviations may be corrected or avoided by direct discussions and recommendations. With respect to the third type it is up to the trial coordinator to accept participation or not, depending upon the relative importance of the particular deviation(s) for the trial end points. To be effective, such a quality assurance programme must be implemented as early as possible in the course of a clinical trial. [ABSTRACT FROM AUTHOR]- Published
- 1997
33. EMERGENCY SURGERY IN RUPTURED AVM'S: SURVIVAL AGAINST ALL ODDS. REPORT OF TWO CASES.
- Author
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Andrei, Giovani, David, Bogdan, and Gorgan, Radu Mircea
- Subjects
- *
SURGICAL emergencies , *CEREBRAL arteriovenous malformations , *ARTERIOVENOUS malformation , *SURGICAL excision , *DIGITAL subtraction angiography , *THERAPEUTIC embolization , *YOUNG adults , *HEMATOMA - Abstract
OBJECTIVES Arteriovenous malformations (AVMs) are direct communications between the arterial and venous systems without interposed capillary bed representing the most spectacular and surgically demanding cerebral vascular lesions. With an estimated incidence of ~ 1.3 per 100,000 person-years, AVMs usually affect young adults aged 20-40 years. About half of AVMs (38% to 71%) present with more or less devastating intracerebral haemorrhage, so the survival is influenced by the patient's status on admission. Most ruptured AVMs present in poor neurological state and their outcome is reserved, depending on the curative strategy and the success of treatment. Most superficial AVMs only involve one lobe and one cortical surface. Offering surgery for complex AVMs, which involve an entire lobe, multiple surfaces and both superficial and deep drainage, is a very difficult decision, as the risks always outgrow the benefits. MATERIALS AND METHODS We report two cases of young patients with ruptured AVMs both presenting with altered consciousness with large hematomas secondary to AVM rupture, the first complex grade IV Spetzler Martin AVM known to the clinic and refused surgery and embolisation in many neurosurgical centres across Europe and the second diagnosed on Angio CT after rupture. The decision to resect the AVMs in emergency setting, not only to evacuate the hematoma was made after consulting the patients families. We discuss the technical nuances and difficulties related to the surgical removal in each case. RESULTS In both cases the AVMs were completely resected followed by hematoma evacuation. Both patients regained consciousness shortly and showed a rapid improvement in their neurological status. The postoperative DSA and Angio MRI images showed complete removal of the AVMs. Both patients are completely socially reintegrated and returned to their previous jobs. CONCLUSIONS Even if hazardous in as acute setting, emergency AVM resection with hematoma evacuation instead of emergency hematoma evacuation followed by AVM resection in a second surgery is preferable giving the patients the best chance to complete recovery. [ABSTRACT FROM AUTHOR]
- Published
- 2019
34. ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE UPPER GASTROINTESTINAL TRACT: PRESENT AND FUTURE VIEW OF EUROPE.
- Author
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Neuhaus, Horst
- Subjects
- *
HUMAN dissection , *GASTROINTESTINAL surgery , *COLON cancer treatment , *SURGICAL excision , *CLINICAL trials ,WESTERN countries - Abstract
In Western countries endoscopic mucosal resection (EMR) has been widely accepted for treatment of early Barrett`s neoplasia and flat or depressed colorectal adenomas. In contrast endoscopic submucosal dissection (ESD) is infrequently performed for several reasons. It seems to be difficult to overcome the learning curve of this difficult technique because of the low case volume of early gastric cancer. On the other hand ESD of esophageal or colorectal lesions is even more challenging and is considered to be inappropriate for learning. In addition the indication for esophageal or colorectal ESD is controversial in view of excellent results of the well established EMR technique which is less time-consuming and safer than ESD. A recent survey of leading Western endoscopy centers indicated the limited experience with ESD with a low number of cases for all potential indications. Only a few training courses have been established and the number of ongoing clinical studies is limited. Only 12 out of 340 published articles on “endoscopic mucosal dissection” were reported from Western countries. A better acceptance of ESD requires improvement of the technique to allow an easier, faster and safer approach. There is a strong demand for structured training courses and limitations of human cases to selected centers which participate in prospective trials. A close collaboration between Western and Asian centers is recommended for improvement of the ESD technique and its clinical application. [ABSTRACT FROM AUTHOR]
- Published
- 2009
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35. Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial.
- Author
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Lecomte, Fabienne, Thecua, Elise, Ziane, Laurine, Deleporte, Pascal, Duhamel, Alain, Maire, Cyril, Staumont-Salle, Delphine, Mordon, Serge, and Mortier, Laurent
- Subjects
VULVAR diseases ,PHOTODYNAMIC therapy ,PATIENT satisfaction ,SURGICAL excision ,OPEN access publishing ,DERMATOMYOSITIS - Abstract
Background: Extramammary Paget disease of the vulva (EMPV) is a rare skin disorder commonly seen in postmenopausal Caucasian females that appears clinically as red, eczematous, pruriginous, and sometimes painful lesions. Although most cases are noninvasive, EMPV may be associated with an underlying or distant adenocarcinoma. EMPV has a chronic and relapsing course. The reference treatment is based on local surgical excision with negative margins. However, disease frequently extends far from the visible lesion, and surgical margins are frequently positive. Topical photodynamic therapy (PDT) is an established treatment modality for various dermatooncologic conditions. For example, red light irradiation with the Aktilite CL 128 and Metvixia (Galderma SA) as a photosensitizing molecule is a conventional protocol approved and widely used in Europe for PDT treatment of actinic keratosis, but this treatment is not yet widely used for EMPV because it has never clearly been demonstrated and is very painful. Objective: The aim of the study is to investigate the efficacy and safety relating to the medical device PAGETEX as a new painless PDT device using Metvixia in the treatment of vulvar Paget disease. The primary end point is the disease control rate at 3 months in 30% of the patients included, defined as stability, partial response, or total response, considering the extent of the lesion. Secondary end points are the disease control rate at 6 months, patient quality of life, level of pain experienced by the patient at each PDT session, severity of erythema, presence of protoporphyrin IX in Paget cells after each PDT session, and overall satisfaction level of the patient. Methods: The trial is an interventional, exploratory, simple group, nonrandomized, and single center (Lille University Hospital) study. Twenty-four patients will be included according to Simon's optimal plan. Therapeutic procedure is based on a cycle of two PDT sessions with the PAGETEX medical device at 15-day intervals (Metvixia incubation during 30 minutes and 635 nm red light illumination with a low irradiance for 2 hours and 30 minutes for a total fluence of 12 J/cm²). At the assessment session, 3 months after inclusion, if the control of the disease is partial or null, the patient will complete another cycle of two PDT sessions. A final evaluation will be performed in all patients at 6 months. Analyses will be performed using SAS version 9.4 software (SAS Institute Inc). The characteristics of the patients at baseline will be described; qualitative variables will be described by numbers and percentages, and quantitative variables will be described either by the mean and standard deviation for Gaussian distribution or by the median and interquartile range (ie, 25th and 75th percentiles). The normality of the distributions will be tested by a Shapiro-Wilk test and checked graphically by histograms. Results: First patient was included in September 2019 and clinical investigations are planned until August 2022. The final results of this study are expected to be available in January 2023. Conclusions: This clinical trial aims to evaluate the efficacy and safety of a new PDT protocol for the treatment of EMPV. The PAGETEX device could become the treatment of choice if it is effective, painless, and easy to implement and use in hospitals. Trial Registration: ClinicalTrials.gov NCT03713203; https://clinicaltrials.gov/ct2/show/NCT03713203 International Registered Report Identifier (IRRID): PRR1-10.2196/15026 We help JMIR researchers to raise funds to pursue their research and development aimed at tackling important health and technology challenges. If you would like to show your support for this author, please donate using the button below. The funds raised will directly benefit the corresponding author of this article (minus 8% admin fees). Your donations will help this author to continue publishing open access papers in JMIR journals. Donations of over $100 may also be acknowledged in future publications. Suggested contribution levels: $20/$50/$100 [ABSTRACT FROM AUTHOR]
- Published
- 2019
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36. Endoscopic mucosal resection: an evolving therapeutic strategy for non- polypoidcolorectal neoplasia.
- Author
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Kiesslich, R. and Neurath, M. F.
- Subjects
- *
COLON cancer , *ENDOSCOPIC surgery , *PREVENTIVE medicine , *SURGICAL excision - Abstract
This article highlights endoscopic mucosal resection as an evolving therapeutic strategy for non-polypoid colorectal neoplasia. Colorectal cancer is one of the leading causes of cancer death in Europe and the United States. Polypoid lesions are easy to detect by endoscopy but non-polypoid lesions are often overlooked. An important diagnostic tool for detection of non-polypoid colorectal lesions consists of chromoendoscopy. Researchers report their experience with colonoscopic resection of the colorectum. Selection of suitable lesions for endoscopic resection is of crucial clinical importance.
- Published
- 2004
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37. Highlights and future directions from the European Gynecological Oncology Congress 2017.
- Author
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Selçuk, İlker
- Subjects
- *
HUMAN papillomavirus vaccines , *PERITONEUM tumors , *BLOOD transfusion , *CONFERENCES & conventions , *DISEASES , *SURGICAL excision , *GYNECOLOGY , *INTENSIVE care units , *LYMPH node surgery , *ONCOLOGY , *OVARIAN tumors , *PAPILLOMAVIRUS diseases , *PATIENT readmissions , *SURGICAL blood loss , *DISEASE complications , *DIAGNOSIS , *PROGNOSIS , *VACCINATION , *THERAPEUTICS ,CERVIX uteri tumors - Published
- 2018
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38. Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS): study protocol for a multicenter, randomized phase-III trial.
- Author
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Henke, Guido, Knauer, Michael, Ribi, Karin, Hayoz, Stefanie, Gérard, Marie-Aline, Ruhstaller, Thomas, Zwahlen, Daniel R, Muenst, Simone, Ackerknecht, Markus, Hawle, Hanne, Fitzal, Florian, Gnant, Michael, Mátrai, Zoltan, Ballardini, Bettina, Gyr, Andreas, Kurzeder, Christian, and Weber, Walter P
- Subjects
- *
BREAST cancer patients , *AXILLARY lymph node dissection , *BREAST cancer treatment , *RADIOTHERAPY , *RANDOMIZED controlled trials , *BREAST tumor treatment , *BREAST tumors , *SURGICAL excision , *LYMPH node surgery , *METASTASIS , *PROGNOSIS , *QUALITY of life , *RESEARCH funding , *TIME , *LUMPECTOMY - Abstract
Background: Complete lymph node removal through conventional axillary dissection (ALND) has been standard treatment for breast cancer patients for almost a century. In the 1990s, however, and in parallel with the advent of the sentinel lymph node (SLN) procedure, ALND came under increasing scrutiny due to its association with significant patient morbidity. Several studies have since provided evidence to suggest omission of ALND, often in favor of axillary radiation, in selected clinically node-negative, SLN-positive patients, thus supporting the current trend in clinical practice. Clinically node-positive patients, by contrast, continue to undergo ALND in many cases, if only for the lack of studies re-assessing the indication for ALND in these patients. Hence, there is a need for a clinical trial to evaluate the optimal treatment for clinically node-positive breast cancer patients in terms of surgery and radiotherapy. The TAXIS trial is designed to fill this gap by examining in particular the value of tailored axillary surgery (TAS), a new technique for selectively removing positive lymph nodes.Methods: In this international, multicenter, phase-III, non-inferiority, randomized controlled trial (RCT), including 34 study sites from four different countries, we plan to randomize 1500 patients to either receive TAS followed by ALND and regional nodal irradiation excluding the dissected axilla, or receive TAS followed by regional nodal irradiation including the full axilla. All patients undergo adjuvant whole-breast irradiation after breast-conserving surgery and chest-wall irradiation after mastectomy. The main objective of the trial is to test the hypothesis that treatment with TAS and axillary radiotherapy is non-inferior to ALND in terms of disease-free survival of clinically node-positive breast cancer patients in the era of effective systemic therapy and extended regional nodal irradiation. The trial was activated on 31 July 2018 and the first patient was randomized on 7 August 2018.Discussion: Designed to test the hypothesis that TAS is non-inferior to ALND in terms of curing patients and preventing recurrences, yet is significantly superior in reducing patient morbidity, this trial may establish a new worldwide treatment standard in breast cancer surgery. If found to be non-inferior to standard treatment, TAS may significantly contribute to reduce morbidity in breast cancer patients by avoiding surgical overtreatment.Trial Registration: ClinicalTrials.gov, ID: NCT03513614. Registered on 1 May 2018. www.kofam.ch , ID: NCT03513614 . Registered on 17 June 2018. EudraCT No.: 2018-000372-14. [ABSTRACT FROM AUTHOR]- Published
- 2018
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39. Perihilar Cholangiocarcinoma: Number of Nodes Examined and Optimal Lymph Node Prognostic Scheme.
- Author
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Bagante, Fabio, Tran, Thuy, Spolverato, Gaya, Ruzzenente, Andrea, Buttner, Stefan, Ethun, Cecilia G, Groot Koerkamp, Bas, Conci, Simone, Idrees, Kamran, Isom, Chelsea A, Fields, Ryan C, Krasnick, Bradley, Weber, Sharon M, Salem, Ahmed, Martin, Robert C G, Scoggins, Charles, Shen, Perry, Mogal, Harveshp D, Schmidt, Carl, and Beal, Eliza
- Subjects
- *
DATABASES , *SURGICAL excision , *HEPATECTOMY , *LYMPH nodes , *LYMPH node surgery , *METASTASIS , *PROBABILITY theory , *PROGNOSIS , *RESEARCH funding , *TUMOR classification , *RETROSPECTIVE studies ,BILE duct tumors - Abstract
Background: The role of routine lymphadenectomy for perihilar cholangiocarcinoma is still controversial and no study has defined the minimum number of lymph nodes examined (TNLE). We sought to assess the prognostic performance of American Joint Committee on Cancer/Union Internationale Contre le Cancer (7(th) edition) N stage, lymph node ratio, and log odds (LODDS; logarithm of the ratio between metastatic and nonmetastatic nodes) in patients with perihilar cholangiocarcinoma and identify the optimal TNLE to accurately stage patients.Methods: A multi-institutional database was queried to identify 437 patients who underwent hepatectomy for perihilar cholangiocarcinoma between 1995 and 2014. The prognostic abilities of the lymph node staging systems were assessed using the Harrell's c-index. A Bayesian model was developed to identify the minimum TNLE.Results: One hundred and fifty-eight (36.2%) patients had lymph node metastasis. Median TNLE was 3 (interquartile range, 1 to 7). The LODDS had a slightly better prognostic performance than lymph node ratio and American Joint Committee on Cancer, in particular among patients with <4 TNLE (c-index = 0.568). For 2 TNLE, the Bayesian model showed a poor discriminatory ability to distinguish patients with favorable and poor prognosis. When TNLE was >2, the hazard ratio for N1 patients was statistically significant and the hazard ratio for N1 patients increased from 1.51 with 4 TNLE to 2.10 with 10 TNLE. Although the 5-year overall survival of N1 patients was only slightly affected by TNLE, the 5-year overall survival of N0 patients increased significantly with TNLE.Conclusions: Perihilar cholangiocarcinoma patients undergoing radical resection should ideally have at least 4 lymph nodes harvested to be accurately staged. In addition, although LODDS performed better at determining prognosis among patients with <4 TNLE, both lymph node ratio and LODDS outperformed compared with American Joint Committee on Cancer N stage among patients with ≥4 TNLE. [ABSTRACT FROM AUTHOR]- Published
- 2016
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40. Commentary: Rectal Cancer--An Evolution of Treatment.
- Author
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Czito, Brian G. and Willett, Christopher G.
- Subjects
RECTAL cancer treatment ,RADIOTHERAPY ,SURGICAL excision ,THERAPEUTICS - Abstract
The article focuses on the evolution of treatment of rectal cancer. It states that neoadjuvant chemoradiotherapy with total mesorectal excision has become a standard treatment for the locally advanced disease in the U.S. and Europe. It mentions that newer generation cytotoxic chemotherapeutics and targeted therapies are currently being incorporated into the testing of new strategies in rectal cancer.
- Published
- 2007
- Full Text
- View/download PDF
41. Benefits of irradiation for DCIS: a Pyrrhic victory.
- Author
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Silverstein, Melvin J. and Lagios, Michael D.
- Subjects
- *
IRRADIATION , *SURGICAL excision , *CANCER research ,CANCER associations - Abstract
Focuses on the results of the National Surgical Adjuvant Breast and Bowel Project study that showed breast irradiation after excision was indicated for all women with localised ductal carcinoma in situ (DCIS). Debate about whether or not all patients with DCIS require post-excisional radiotherapy; Report of the European Organization for Research and Treatment of Cancer (EORTC).
- Published
- 2000
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- View/download PDF
42. Endoscopy removal of axillary nodes gains ground abroad, toehold in U.S.
- Author
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McNeil, Caroline and McNeil, C
- Subjects
- *
BREAST cancer treatment , *ENDOSCOPY , *METASTASIS , *AXILLA , *BREAST tumors , *SURGICAL excision , *LYMPH node surgery , *TREATMENT effectiveness , *DIAGNOSIS - Abstract
Explores the effectiveness of endoscopy in treating breast cancer. Technique described by Doctor Francois Suzanne at the San Antonio Breast Cancer Symposium in December 1998; Study conducted by Doctor Jonathann Sackier in the United States; Protocol being developed by researchers at the Stanford University.
- Published
- 1999
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- View/download PDF
43. Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Recommendations for diagnosis, treatment and follow-up.
- Author
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Dreyling, M.
- Subjects
- *
LYMPHOMA diagnosis , *ONCOLOGY , *DISEASE incidence , *SURGICAL excision , *BIOPSY , *DIAGNOSTIC specimens , *SOCIETIES - Abstract
The article presents clinical recommendations for diagnosis, treatment and follow-up of newly diagnosed and relapsed follicular lymphoma from the European Society for Medical Oncology (ESMO). There has been a rapid increase in the annual incidence of the disease in Europe during recent decades. The basis for diagnosis is on a surgical specimen or excisional lymph node biopsy. Information is also presented on staging and risk assessment and treatment plan.
- Published
- 2009
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- View/download PDF
44. News from European Cancer Conference.
- Subjects
- *
ENDOTHELINS , *PROSTATE cancer , *BEVACIZUMAB , *DRUG therapy , *COLON cancer , *SURGICAL excision , *ONCOLOGY conferences - Abstract
The article summarizes the findings of studies presented at the European Cancer Conference in September 2007. A phase II study demonstrated the capability of ZD 4054 endothelin A receptor antagonist to increase overall survival among hormone-resistant prostate cancer patients. Another one found that the addition of bevacizumab to standard first-line chemotherapy regimens for metastatic colorectal cancer (mCRC) may result in high successful rate of resection in patients with unresectable disease.
- Published
- 2007
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