15 results on '"Graziana Ronzino"'
Search Results
2. Management of Metastatic Endometrial Cancer: Physicians' Choices Beyond the First Line. A MITO Survey
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Gaia Giannone, Daniele Castaldo, Valentina Tuninetti, Giulia Scotto, Margherita Turinetto, Anna Amela Valsecchi, Michele Bartoletti, Serafina Mammoliti, Grazia Artioli, Giorgia Mangili, Vanda Salutari, Domenica Lorusso, Gennaro Cormio, Claudio Zamagni, Antonella Savarese, Massimo Di Maio, Graziana Ronzino, Carmela Pisano, Sandro Pignata, and Giorgio Valabrega
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MSI ,endometrial cancer ,immune checkpoint inhibitors ,molecular classification ,second line therapy ,survey ,Cancer Research ,Oncology - Abstract
BackgroundEndometrial cancer (EC) therapeutic and diagnostic approaches have been changed by the development of a new prognostic molecular classification, the introduction of dostarlimab in microsatellite instability (MSI) high pre-treated advanced EC patients with further expected innovation deriving from lenvatinib plus pembrolizumab regardless MSI status. How this is and will be translated and embedded in the clinical setting in Italy is not known; this is why we developed Multicentre Italian Trials in Ovarian cancer and gynaecologic malignancies (MITO) survey on the current practice and expected future changes in EC.MethodsWe designed a self-administered, multiple-choice online questionnaire available only for MITO members for one month, starting in April 2021.Results75.6% of the respondents were oncologists with a specific focus on gynaecologic malignancies and 73.3% of the respondents declared the availability of clinical trials in second line treatment for advanced EC. The therapeutic algorithm in second line was heterogeneous, being the most frequent choice administering anthracyclines followed by endocrine therapy or enrolling in clinical trials. While more than half of the clinicians declared that they performed the molecular classification, only six/45 respondents (13.3%) ran all the tests needed for it. On the other hand, 80% of them declared regular assessment of MSI status with IHC as recommended. The therapeutic approach in MSI high advanced EC patients has changed since dostarlimab approval. Indeed the most frequent choice in second line has been chemotherapy (53.3%) before its availability, while dostarlimab has been preferred in more than three-fourths of the cases (75.6%) after its approval. As for MSS patients, 77.8% of clinicians would choose lenvatinib plus pembrolizumab for them in second line once approved.ConclusionsDespite the selected sample of respondents from Italian MITO centres showing good knowledge of diagnostic and therapeutic innovations in EC, these are not fully implemented in everyday clinics, except for MSI status assessment.
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- 2022
3. Cytoreductive surgery followed by chemotherapy and olaparib maintenance in BRCA 1/2 mutated recurrent ovarian cancer: A retrospective MITO group study
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Giorgia Perniola, Michele Bartoletti, Graziana Ronzino, Saverio Cinieri, Gaia Giannone, Francesco Raspagliesi, Giovanni Scambia, Lucia Musacchio, Sandro Pignata, Giorgio Valabrega, Paolo Scollo, Claudia Marchetti, Claudia Carella, Rossella Lauria, Vera Loizzi, Alice Bergamini, Laura Arenare, Cinzia Cardalesi, Vanda Salutari, Emanuele Naglieri, Fabio Martinelli, Elisabetta De Matteis, Domenica Lorusso, Stefano Greggi, Michele Orditura, Sabrina Chiara Cecere, Giuseppa Scandurra, Gennaro Cormio, Cecere, S. C., Musacchio, L., Bartoletti, M., Salutari, V., Arenare, L., Lorusso, D., Ronzino, G., Lauria, R., Cormio, G., Naglieri, E., Scollo, P., Marchetti, C., Raspagliesi, F., Greggi, S., Cinieri, S., Bergamini, A., Orditura, M., Valabrega, G., Scambia, G., Martinelli, F., De Matteis, E., Cardalesi, C., Loizzi, V., Perniola, G., Carella, C., Scandurra, G., Giannone, G., and Pignata, S.
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Oncology ,medicine.medical_specialty ,medicine.medical_treatment ,Carcinoma, Ovarian Epithelial ,Poly(ADP-ribose) Polymerase Inhibitors ,Piperazines ,Olaparib ,cytoreduction surgical procedures ,ovarian cancer ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Internal medicine ,Ovarian Epithelial ,medicine ,Humans ,030212 general & internal medicine ,Retrospective Studies ,Response rate (survey) ,BRCA2 Protein ,Chemotherapy ,Settore MED/06 - ONCOLOGIA MEDICA ,Group study ,business.industry ,BRCA1 Protein ,Carcinoma ,Obstetrics and Gynecology ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Progression-Free Survival ,cytoreduction surgical procedure ,Neoplasm Recurrence ,Settore MED/40 - GINECOLOGIA E OSTETRICIA ,chemistry ,Local ,Recurrent Ovarian Cancer ,030220 oncology & carcinogenesis ,Mutation ,Cytoreduction Surgical Procedures ,Female ,Neoplasm Recurrence, Local ,Phthalazines ,Cytoreductive surgery ,Ovarian cancer ,business - Abstract
IntroductionThe role of cytoreductive surgery in the poly-ADP ribose polymerase inhibitors era is not fully investigated. We evaluated the impact of surgery performed prior to platinum-based chemotherapy followed by olaparib maintenance in platinum-sensitive BRCA-mutated recurrent ovarian cancer.MethodsThis retrospective study included platinum-sensitive recurrent ovarian cancer BRCA-mutated patients from 13 Multicenter Italian Trials in Ovarian cancer and gynecological malignancies centers treated between September 2015 and May 2019. The primary outcomes were progression-free survival and overall survival. Data on post-progression treatment was also assessed.ResultsAmong 209 patients, 72 patients (34.5%) underwent cytoreductive surgery followed by platinum-based chemotherapy and olaparib maintenance, while 137 patients (65.5%) underwent chemotherapy treatment alone. After a median follow-up of 37.3 months (95% CI: 33.4 to 40.8), median progression-free survival in the surgery group was not reached, compared with 11 months in patients receiving chemotherapy alone (P12 months, between 6 and 12 months, and ConclusionCytoreductive surgery performed before platinum therapy and olaparib maintenance was associated with longer progression-free survival and overall survival in BRCA-mutated platinum-sensitive relapsed ovarian cancer patients. In accordance with our preliminary results, the response rate to chemotherapy given after progression during olaparib was associated with platinum-free interval.
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- 2021
4. The impact of locoregional treatment on response to Nivolumab in advanced platinum refractory head and neck cancer: the NEED TRIAL
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Giulia Pomati, Marco Merlano, Alessandra Cassano, Marianna Nuti, Carmela Di Dio, Bruna Cerbelli, Laura Pizzuti, Andrea Botticelli, Patrizia Vici, Paolo Marchetti, Massimiliano Salati, Graziana Ronzino, Michela Roberto, Paolo Sciattella, Antonella Polimeni, Alessio Cortellini, Alessio Cirillo, Giulia Mammone, and Silvia Mezi
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0301 basic medicine ,Oncology ,squamous cell carcinoma ,medicine.medical_specialty ,medicine.medical_treatment ,Immunology ,Population ,lcsh:Medicine ,Article ,03 medical and health sciences ,0302 clinical medicine ,Platinum resistance ,Internal medicine ,Drug Discovery ,medicine ,Pharmacology (medical) ,education ,Prospective cohort study ,head and neck cancer ,immunotherapy ,nivolumab ,locoregional treatment ,Pharmacology ,education.field_of_study ,business.industry ,lcsh:R ,Head and neck cancer ,Immunotherapy ,medicine.disease ,Head and neck squamous-cell carcinoma ,Radiation therapy ,stomatognathic diseases ,030104 developmental biology ,Infectious Diseases ,030220 oncology & carcinogenesis ,Nivolumab ,business - Abstract
Background: Previous locoregional treatment could affect the response to nivolumab in platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The aim of this study is to evaluate the impact of the clinicopathological characteristics and previous treatment in predicting early progression to nivolumab in a real-world population. Methods: This is an observational, multicenter retrospective/prospective study including patients (pts) with platinum refractory R/M HNSCC who received nivolumab 240 mg every 2 weeks from October 2018 to October 2019. We analyzed the association between previous treatment, clinicopathological characteristics, and early progression (within 3 months). Results: Data from 61 pts were reviewed. Median age was 67 years (30&ndash, 82). Forty-two pts (69%) received previous locoregional treatment. Early progression to nivolumab occurred in 36 pts (59%), while clinical benefit (stable disease and partial response) was achieved in 25 pts (41%). Early progression to nivolumab was significantly associated to previous locoregional treatment both at univariate and multivariate analysis (p = 0.005 and p = 0.048, respectively). Conclusion: nivolumab in R/M HNSCC is burdened with a high early progression rate. Previous wide neck dissection and high dose radiotherapy may compromise the efficacy of nivolumab, distorting the anatomy of the local lymphatic system and hindering the priming of immune response.
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- 2020
5. Selection of systemic therapy in patients with locally advanced and recurrent/metastatic head and neck cancer: RAND-based expert opinion by an Italian multidisciplinary panel
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Stefano Maria Magrini, Graziana Ronzino, Marco Merlano, Michela Buglione, Lisa Licitra, Marco Benasso, Livio Presutti, Pierluigi Bonomo, Maria Grazia Ghi, Daris Ferrari, Benasso M., Bonomo P., Buglione M., Ghi M.G., Licitra L., Magrini S.M., Merlano M.C., Presutti L., Ronzino G., and Ferrari D.
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0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Disease ,chemotherapy ,Systemic therapy ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,RAND ,medicine ,Head and neck cancer ,radiotherapy ,Chemotherapy ,business.industry ,Standard treatment ,General Medicine ,medicine.disease ,Head and neck squamous-cell carcinoma ,targeted therapies ,Radiation therapy ,030104 developmental biology ,030220 oncology & carcinogenesis ,business ,Chemoradiotherapy - Abstract
Background: Head and neck squamous cell carcinoma (HNSCC) is a heterogeneous disease often presenting at an already advanced stage. Cisplatin chemoradiotherapy is the standard treatment for locally advanced disease, although its efficacy varies according to different studies. Thus, treatment selection is a challenge, especially in older patients, who frequently have several comorbidities. Moreover, the majority of patients with recurrent and/or metastatic disease are unsuitable for local treatment, either surgery or radiation therapy. The only treatment option for them is systemic therapy, but prognosis remains poor, with a median overall survival of less than 12 months. Methods: A group of Italian key opinion leaders in the field of HNSCC gathered several times in 2018 in order to retrieve a set of statements to help clinicians in their daily decision-making process for the treatment of patients with different scenarios of HNSCC. Results and Conclusion: The panel agreed on 22 statements that were identified as “good clinical points” based on the available literature or after discussion of the most relevant aspect of the underlying diseases when no international consensus was available. The panel identified a number of possible scenarios (namely 71) in which these statements may be helpful to guide decision-making for the best treatment selection.
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- 2020
6. Olaparib as maintenance therapy in patients with BRCA 1-2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome
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Graziana Ronzino, Cinzia Cardalesi, Viola Ghizzoni, Vera Loizzi, Giuseppa Scandurra, Giovanni Scambia, Giorgio Valabrega, Paolo Scollo, Vanda Salutari, Elisabetta De Matteis, Gennaro Cormio, Rossella Lauria, Alice Bergamini, Sabrina Chiara Cecere, Emanuele Naglieri, Gaia Giannone, Laura Arenare, Marilena Di Napoli, Sandro Pignata, Claudia Marchetti, Domenica Lorusso, Enrica Mazzoni, Serena Maria Boccia, Michele Orditura, Claudia Carella, Francesco Raspagliesi, Giuseppa Maltese, Cecere, Sabrina Chiara, Giannone, Gaia, Salutari, Vanda, Arenare, Laura, Lorusso, Domenica, Ronzino, Graziana, Lauria, Rossella, Cormio, Gennaro, Carella, Claudia, Scollo, Paolo, Ghizzoni, Viola, Raspagliesi, Francesco, Di Napoli, Marilena, Mazzoni, Enrica, Marchetti, Claudia, Bergamini, Alice, Orditura, Michele, Valabrega, Giorgio, Scambia, Giovanni, Maltese, Giuseppa, De Matteis, Elisabetta, Cardalesi, Cinzia, Loizzi, Vera, Boccia, Serena, Naglieri, Emanuele, Scandurra, Giuseppa, and Pignata, Sandro
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0301 basic medicine ,Oncology ,Organoplatinum Compounds ,endocrine system diseases ,medicine.medical_treatment ,Genes, BRCA2 ,Genes, BRCA1 ,Piperazines ,chemistry.chemical_compound ,0302 clinical medicine ,Olaparib ,Maintenance therapy ,Ovarian Neoplasms ,BRCA1 Protein ,Obstetrics and Gynecology ,Real world ,Middle Aged ,Progression-Free Survival ,female genital diseases and pregnancy complications ,Local ,030220 oncology & carcinogenesis ,Female ,medicine.medical_specialty ,Maintenance ,Ovarian cancer ,Post progression ,Antineoplastic Agents ,BRCA2 Protein ,Germ-Line Mutation ,Humans ,Maintenance Chemotherapy ,Neoplasm Recurrence, Local ,Phthalazines ,Retrospective Studies ,03 medical and health sciences ,Pharmacotherapy ,Internal medicine ,medicine ,Progression-free survival ,Chemotherapy ,Settore MED/06 - ONCOLOGIA MEDICA ,business.industry ,Retrospective cohort study ,medicine.disease ,BRCA1 ,BRCA2 ,Discontinuation ,030104 developmental biology ,Neoplasm Recurrence ,Settore MED/40 - GINECOLOGIA E OSTETRICIA ,chemistry ,Genes ,business - Abstract
Objectives Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression. Materials ad methods In this non interventional, retrospective study, patients treated with olaparib in 13 centers, according to the label, have been collected and analyzed. Primary objectives of the study are to describe effectiveness and safety of olaparib in a real world setting with a focus on post progression treatments and response. Results 234 patients were analyzed. All patients were BRCA mutated and most of them had germline mutations. Around 50% of the patients received olaparib after 3 or more lines of platinum based chemotherapy achieving a radiologic complete (CR) or partial response. 12.4% patients with stable disease were also included. Median PFS was 14.7 months (95% CI:12.6–18), with statistically longer PFS in patients with normal serum Ca125 at baseline, a CR after last platinum based therapy and that received olaparib after second platinum based therapy. Median OS was not reached. Most frequent G3-G4 toxicity was anaemia (6%) with dose discontinuation and dose reduction in 11 (4.7%) and 49 (20.9%) of cases, respectively. Among 66 patients receiving further treatment after olaparib progression and evaluable for response, ORR was 22.2, 11.1% and 9.5% in patients with Platinum Free interval (PFI) of more than 12 months, between 6 and 12 months and less than 6 months, respectively. Conclusions Olaparib is effective and safe in real world setting. Data on post-progression treatments seem to suggest cross resistance with chemotherapy and need to be confirmed in larger studies because of the potential importance in clinical practice decisions.
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- 2020
7. Neo-adjuvant platinum-based chemotherapy followed by chemoradiation and radical surgery in locally advanced cervical cancer (Lacc) patients: A phase II study
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Luigi Carlo Turco, Vincenzo Valentini, Maria Antonietta Gambacorta, Graziana Ronzino, Maria Vittoria Mattoli, Benedetta Gui, Gabriella Ferrandina, Giovanni Scambia, Eleonora Palluzzi, Gabriella Macchia, Valerio Gallotta, Rosa Autorino, and Francesco Cosentino
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0301 basic medicine ,medicine.medical_treatment ,Uterine Cervical Neoplasms ,Phases of clinical research ,Carboplatin ,chemistry.chemical_compound ,Postoperative Complications ,0302 clinical medicine ,Antineoplastic Combined Chemotherapy Protocols ,Clinical endpoint ,Radical hysterectomy ,Stage (cooking) ,Cervical cancer ,Chemoradiotherapy ,General Medicine ,Middle Aged ,Neoadjuvant Therapy ,Intention to Treat Analysis ,Survival Rate ,Treatment Outcome ,Chemoradiation ,Locally advanced cervical cancer ,Neo-adjuvant chemotherapy ,Pathologic response ,Surgery ,Oncology ,030220 oncology & carcinogenesis ,Carcinoma, Squamous Cell ,Female ,Adult ,medicine.medical_specialty ,Paclitaxel ,Urology ,Antineoplastic Agents ,Adenocarcinoma ,Hysterectomy ,Disease-Free Survival ,Pelvis ,03 medical and health sciences ,medicine ,Humans ,Radical surgery ,Aged ,Chemotherapy ,business.industry ,medicine.disease ,Regimen ,Settore MED/40 - GINECOLOGIA E OSTETRICIA ,030104 developmental biology ,chemistry ,Lymph Node Excision ,Lymph Nodes ,Radiotherapy, Intensity-Modulated ,Cisplatin ,business - Abstract
Purpose The aim of this Phase II, non-randomized study was to assess activity and safety of neoadjuvant chemotherapy (NACT) before chemoradiation (CT/RT) followed by radical surgery (RS) in locally advanced cervical cancer (LACC) patients. Methods and materials The primary end point was rate of pathologic complete response (pCR). FIGO Stage IB2-IVA patients were administered NACT chemotherapy (paclitaxel 80 mg/m2, carboplatin AUC 2), for 6 weeks, followed by Intensity Modulated Radiotherapy plus simultaneous boost (total dose of 50.4 Gy to CTV1, and 39.6 Gy to CTV2). Clinical response was assessed according to RECIST criteria. Responsive patients were triaged to RS. The regimen would be considered active if >20 pCRs were registered in 39 patients. Results 45 patients were enrolled into the study; 25 patients (55.5%) were FIGO stage IIB, 9 cases (20.0%) had stage III disease. At work up, pelvic lymph node involvement was documented in 38 (84.4%) patients; pCR was documented in 18 out of 40 patients (45.0%). Grade 3–4 hematological toxicity after NACT occurred in 4 patients; CT/RT associated grade 3 toxicity was found in 7 patients. Early and late postoperative complications were detected in 16, and 11 cases, respectively. Three-year PFS and OS were 66.0% and 86.0%, respectively. Conclusions NACT followed by CT/RT by IMRT and RS, is feasible and safe; failure to achieve the primary endpoint has to be recognized; however, enrollment of a higher rate of poor prognosis patients compared to historical data used to calculate sample size, could have resulted in reduced activity.
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- 2018
8. The impact of locoregional treatment on response to nivolumab in advanced platinum refractory head and neck cancer: The need trial
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Alessio Cortellini, Michela Roberto, Marianna Nuti, Carmela Di Dio, Alessio Cirillo, Graziana Ronzino, Andrea Botticelli, Massimiliano Salati, Marco Merlano, Laura Pizzuti, Alessandra Cassano, Paolo Marchetti, Patrizia Vici, Paolo Sciattella, Silvia Mezi, Giulia Mammone, and Giulia Pomati
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Oncology ,Cancer Research ,medicine.medical_specialty ,Standard of care ,business.industry ,medicine.medical_treatment ,Head and neck cancer ,Immunotherapy ,medicine.disease ,Head and neck squamous-cell carcinoma ,Internal medicine ,Platinum resistance ,medicine ,Nivolumab ,business - Abstract
e18508 Background: Immunotherapy is the standard of care in the treatment of platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M-HNSCC). Previous loco-regional treatment could have an impact on the immune system and response to Nivolumab. The aim of this study is to evaluate the efficacy and safety of Nivolumab in a real world population, identifying the impact of the clinic-pathological characteristics and previous treatment in prediction of early progression. Methods: This is a observational, multicenter retrospective/prospective study including patients (pts) with platinum refractory R/M HNSCC who received Nivolumab 240 mg every 2 weeks until disease progression or unacceptable toxicity, from October 2018 to October 2019. We analyzed treatment outcomes in term of early progression (within 3 months), clinical benefit, progression free survival (PFS) and overall survival (OS). To determine the influence on outcomes, the following variables were investigated: primary tumor sub-site, age, gender, ECOG, previous loco-regional treatment, previous systemic therapy, metastatic site. Results: Data from 61 pts were reviewed: 15 oral cavity, 14 oropharynx, 7 hyphofarynx, 19 larynx, 6 paranasal sinus. Median age was 66 years (29-82), 48 pts were men. Forty-nine pts (80%) had performance status (ECOG) ≥ 1 at baseline evaluation. Eleven pts (18%) had only loco-regional recurrence, while 50 pts (82%) had one or more metastatic site. 32 (52%) and 17 pts (28%) had smoking and alcohol abuse history, respectively. 44 pts (72%) received surgery followed by adjuvant radiant treatment at standard dose (28, 46%) or concomitant definitive radiotherapy (16, 26%) as upfront treatment with curative intent. With a median follow up of 4 months (range 1-11), early progression occurred in 39 pts during Nivolumab treatment (64%), while clinical benefit (stable disease and partial response) was achieved in 22 pts (36%). No G3-G4 toxicities occurred. Early progression to Nivolumab was significantly associated to previous loco-regional treatment both at univariate and multivariate analysis (p=0.003 and p= 0.04, respectively). Conclusions: Nivolumab in R/M HNSCC is effective and safe even though burdened with a high early progression rate. Loco-regional treatment, including wide neck dissection and high dose radiotherapy, may compromise the efficacy of Nivolumab, distorting the anatomy of the local lymphatic system and hindering the priming of immune response.
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- 2020
9. Feasibility and Safety of High Dose Chemoradiation in Locally Advanced Cervical Cancer: A Preliminary Experience of Gynecologic Oncology Management Italian Team
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Donatella Russo, Graziana Ronzino, Antonella Papaleo, Elisa Cavalera, Angela Leone, Marianna Giampaglia, Simona Caretto, Fabrizio Totaro Aprile, Alex Cristiano De Marzi, Mario Santantonio, Antonio Perrone, and Andrea Tinelli
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Oncology ,Cervical cancer ,medicine.medical_specialty ,business.industry ,General surgery ,Internal medicine ,medicine ,Locally advanced ,Gynecologic oncology ,General Agricultural and Biological Sciences ,business ,medicine.disease - Abstract
Locally advanced cervical cancer has a poor prognosis and is difficult to treat by surgery; authors’ evaluated feasibility and safety of the simultaneous integrated boost (SIB) technique for dose escalation in patients with cervical cancer using a rotational dynamic Intensity Modulated Radiation Therapy Technique (VMAT®). Authors evaluated 10 patients affected by loco-regionally advanced, node negative, inoperable cervical cancer. All women received primary chemoradiation (CRT). Six pts received three cycles of platinum-based chemotherapy (CT) plus CRT. Three Programmed Temperature Vaporization (PTV) were delineated: PTV1 (primary, cervix and parametria with a 1cm-margin); PTV2 (body of uterus with a 1cm-margin); PTV3 (pelvic nodes). PTV1 was defined using image fusion between CT-scan and RM or PET/CT. Treatment plans, calculated using a rotational dynamic Intensity Modulated Radiation Therapy (IMRT) system on Oncentra Masterplan® (VMAT®), and consisted in a simultaneous integrated boost. Total treatment time was 45 days. Concomitant CT consisted of weekly cisplatin 40 mg/m2. Dose–volume histograms and acute gastrointestinal, genitourinary, and hematological toxicity were evaluated. Secondary endpoint was evaluation of short term disease free survival. Three months after CTRT, patients were revaluated with colposcopy and cytology and Pelvic imaging. After six and twelve months from CTRT, reevaluation included PET-CT or Chest CT scan and Abdominal and Pelvic RM. All patients concluded radiation without suspension. Cytology demonstrated complete response (CR) in 4 pts in the ERT fraction of brachytherapy (BRT) group and in 1 pts in ERT alone group. All other patients showed a partial response (PR) > 75%. After a median follow up of 20 month (range 16-22), 5 patients are free from disease (NED), 4 patients are alive with disease (AWD) and 1 patient died after three months (DOD). In 2 AWD patients, re-staging PET showed a RC of pelvic disease with evidence of disease in lomboaortic nodes. One of them received salvage radiation therapy on recurrence. After this preliminary experience, in patients with inaccessible cervical canal, authors could propose the dose escalation on PTV1, with the aim of delivering BED as near as possible to 85Gy.
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- 2013
10. The observational ENCORE study: Cetuximab + platinum-based therapy (PBT) for first-line (1L) treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
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Andrea Sbrana, Jeltje Schulten, Lorenzo Livi, Maria Grazia Ghi, Graziana Ronzino, M. Bretagne, M. Ghiani, D. Messinger, M.C. Cau, Mathilde Saint-Ghislain, C. Le Tourneau, V. Montesarchio, and Roberta Depenni
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0301 basic medicine ,Oncology ,medicine.medical_specialty ,Cetuximab ,business.industry ,First line ,Hematology ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,Medicine ,Observational study ,Basal cell ,business ,Head and neck ,medicine.drug - Published
- 2017
11. Cetuximab + platinum-based therapy (PBT) as a first-line treatment for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): An observational study (ENCORE)
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Jeltje Schulten, Maria Grazia Ghi, V. Montesarchio, C. Le Tourneau, Roberta Depenni, L. Leo, M.C. Cau, M. Ghiani, Graziana Ronzino, Andrea Sbrana, D. Messinger, and P. Bonomo
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Oncology ,medicine.medical_specialty ,Cetuximab ,business.industry ,Hematology ,First line treatment ,Internal medicine ,medicine ,Observational study ,Basal cell ,Head and neck ,business ,medicine.drug - Published
- 2018
12. Weekly administration of paclitaxel: theoretical and clinical basis
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Saı̈k Urien, Graziana Ronzino, Giancarlo Antonini Cappellini, Corrado Ficorella, and Paolo Marchetti
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Chemotherapy ,Paclitaxel ,business.industry ,medicine.medical_treatment ,Hematology ,Pharmacology ,medicine.disease ,Antineoplastic Agents, Phytogenic ,Drug Administration Schedule ,chemistry.chemical_compound ,Therapeutic index ,Breast cancer ,Oncology ,chemistry ,Apoptosis ,Neoplasms ,Toxicity ,medicine ,Humans ,Cytotoxic T cell ,Ovarian cancer ,business - Abstract
The rationale for weekly administration of paclitaxel, which acts on microtubules to arrest mitosis, is that more frequent delivery of moderate doses may achieve greater efficacy than standard doses every 3 weeks, through more sustained exposure of dividing tumor cells to its cytotoxic effects. This dose–dense approach to treatment may inhibit tumor regrowth between cycles and limit the emergence of malignant cell populations resistant to chemotherapy. More frequent exposure to paclitaxel may also enhance its apoptotic and antiangiogenic effects. Paclitaxel activity is considered to be independent of p53 status, in contrast to anticancer drugs that produce lesions on DNA, which achieve a better response if p53 is functional. Weekly therapy also has advantages in terms of improving paclitaxel therapeutic index. Clinical studies show that weekly paclitaxel is effective and that toxicity is acceptable. The response rates of single-agent paclitaxel varied from 21 to 86% in breast cancer, from 20% to 65% in ovarian cancer and from 30% to 56% in non-small cell lung cancer.
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- 2002
13. Palbociclib versus placebo in combination with letrozole for patients with advanced or recurrent endometrial cancer: The NSGO ENGOT-EN3/PALEO trial
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Line Bjørge, Radoslav Chekerov, Gitte-Betina Nyvang, Joan Løhndorf, Vanda Salutari, Cesar Mendiola, Ingo B. Runnebaum, Maria Pilar Barretina-Ginesta, Trine Juhler-Nøttrup, Annika Auranen, Domenica Lorusso, Marta Gil-Martin, René dePont Christensen, Mansoor Raza Mirza, Jalid Sehouli, Frederic Marme, Sandro Pignata, Graziana Ronzino, and M Jesus Rubio
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Endometrial cancer ,Letrozole ,Histology ,Palbociclib ,medicine.disease ,Placebo ,Recurrent Endometrial Cancer ,Internal medicine ,medicine ,Recurrent disease ,business ,Hormone ,medicine.drug - Abstract
TPS5612 Background: Endometrial cancer (EC) patients with advanced or recurrent disease and endometrioid histology have a short progression-free survival (PFS). These malignancies are hormone dependent and endocrine therapy with aromatase inhibitors is well established. Palbociclib is an oral and selective inhibitor of cyclin-dependent kinases CDK4 and CDK6. Studies in breast cancer have demonstrated superiority of letrozole treatment in combination with palbociclib vs. letrozole monotherapy in oestrogen receptor positive (ER+) HER2- advanced disease. The combination is generally well tolerated with an acceptable toxicity profile. This multicenter, prospective, double-blind, placebo-controlled, randomized, phase II trial is evaluating the efficacy of letrozole when combined with palbociclib against letrozole-placebo combination therapy in women with ER+ advanced or recurrent EC. Methods: The primary objective of this trial is to demonstrate superiority of palbociclib against placebo in combination with letrozole, as defined by investigator-assessed progression-free survival (PFS). Key eligibility criteria include: histologically confirmed ER+ EC of endometrioid type; stage 4 or recurrent disease; prior surgery, adjuvant chemotherapy, radiation therapy, hormonal therapy (e.g. megestrol acetate) is permitted; measurable/evaluable disease according to RECIST 1.1. 78 patients will be randomized 1:1 to receive palbociclib 125mg daily or placebo on days 1-21 and letrozole 2.5mg daily on days 1-28 in a 28 days cycle until disease progression, unacceptable toxicity, or withdrawal. Secondary endpoints include PFS in sub-populations, overall response rate, disease control rate, PFS2, time to first subsequent therapy, time to second subsequent therapy, overall survival, safety & tolerability, patient reported outcomes (assessed via EORTC QLQ-C30 and EORTC QLQ-EN24) and PFS in patients with or without retinoblastoma protein-expressing tumors. The following cooperative groups are participating: NSGO (DK, FIN, NOR), MITO (ITA), GEICO (SPA) & NOGGO (GER). Clinical trial information: NCT02730429.
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- 2017
14. Somministrazione Settimanale del Paclitaxel: Peculiarità e Presupposti Biologici
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Enrico Ricevuto, Corrado Ficorella, Giampiero Porzio, Graziana Ronzino, and Paolo Marchetti
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03 medical and health sciences ,Cancer Research ,0302 clinical medicine ,Oncology ,Chemistry ,030220 oncology & carcinogenesis ,General Medicine ,030218 nuclear medicine & medical imaging - Published
- 2001
15. Benefit of chemotherapy after third line and evaluation of post-progression survival (PPS) in metastatic breast cancer (MBC): A single institution study
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G. Cairo, L. Petrucelli, Vincenzo Emanuele Chiuri, Graziana Ronzino, L. Lupo, Mariangela Ciccarese, R. Forcignanò, A Gambino, Antonella Licchetta, Diana Giannarelli, and Antonio Gnoni
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Oncology ,Cancer Research ,medicine.medical_specialty ,Chemotherapy ,business.industry ,medicine.medical_treatment ,Disease ,medicine.disease ,Metastatic breast cancer ,Surgery ,Third line ,Internal medicine ,medicine ,Single institution ,business ,Median survival - Abstract
e11517 Background: MBC remains an incurable disease with median survival of 2-3 years despite new drugs. The gain of benefit from third-line chemotherapy (CT3) in MBC is unknown. The validation of PPS as surrogate endpoint and its correlation to OS is under debate. Methods: From 2006-2012 we analyzed retrospectively consecutive 114 pts treated for MBC, 67 with at least 3 lines CT, to show the gain of benefit after CT3 and predictive factors of response to multiple lines of therapy. Moreover, we evaluated PPS for each line and its relation to OS. Results: Median age at M+ diagnosis was 58 years (29-87), median site of disease 2 (1-6), 66.7% visceral, HER-2+ pts 31.1%, median number of anti-Her-2 treatment 2 (1-6); 56.1% received a maintenance treatment (37% M1, 13% M2), median number of treatment 3 (1-8). Median OS for all pts was 47.1 (95%CI: 36.5-57.6). No difference in OS for pts with maintenance treatment vs not, respectively 49.1 vs 45.6 P=0.17. Multivariate Cox analysis showed that OS is related with ER/Pgr status (positive vs negative p=0.03) number of lines ( >3 vs ≤ 3) p< 0.0001 and number of metastatic sites (>2 vs ≤2) p=0.01. We evaluated relation between PFS and OS and PPS and OS until 6th line of therapy with a linear regression model. Conclusions: These results supported the use of chemotherapy after CT3. PFS and PPS are related to OS until 6th line of treatment. PPS as surrogate endpoint of OS is a valid hypothesis to be evaluated in prospective trials of MBC [Table: see text]
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