15 results on '"Pasciuto, T"'
Search Results
2. Synchronous primary cancers of endometrium and ovary vs endometrial cancer with ovarian metastasis: an observational study.
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Moro, F., Leombroni, M., Pasciuto, T., Trivellizzi, I. N., Mascilini, F., Ciccarone, F., Zannoni, G. F., Fanfani, F., Scambia, G., and Testa, A. C.
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ENDOMETRIAL cancer ,OVARIAN cancer ,METASTASIS ,OVARIES ,FISHER exact test - Abstract
Objective: To compare the ultrasound characteristics of patients with synchronous primary cancers of the endometrium and ovary vs those of patients with endometrial cancer with ovarian metastasis.Methods: This was a single-institution retrospective observational study of patients with a histological diagnosis of endometrial cancer and an ovarian malignant mass, who had undergone preoperative ultrasound examination at our unit. Based on the histological diagnosis, patients were classified into two groups: those with synchronous primary cancers of the endometrium and ovary (synchronous group) and patients with endometrial cancer with ovarian metastasis (metastasis group). We compared the ultrasound features of ovarian malignant masses and of endometrial cancers between the two groups. Student's t-test, Mann-Whitney U-test, χ2 test or Fisher's exact test were used for comparisons of variables between the two histological groups, as appropriate.Results: We identified 131 patients, of whom 51 had synchronous primary cancers of the endometrium and ovary (synchronous group) and 80 had endometrial cancer with ovarian metastasis (metastasis group). On ultrasound examination, ovarian masses in the synchronous group were more often multilocular-solid and less often bilateral than those in the metastasis group. With respect to the ultrasound features of the endometrial lesions, the median largest diameter was 29 (range, 11-118) mm in the synchronous group in comparison with 51.5 (range, 6-150) mm in the metastasis group (P < 0.0001). Endometrial lesions in the synchronous group presented more often with no myometrial infiltration and less often with a multiple-vessel pattern on color Doppler compared with the endometrial lesions in the metastasis group.Conclusions: Synchronous primary cancers of the endometrium and ovary have significantly different sonomorphological patterns compared with endometrial cancer with ovarian metastasis. Ovarian masses in women with synchronous primary cancers of the endometrium and ovary appeared as unilateral multilocular-solid or solid masses, whereas ovarian masses in women with endometrial cancer with ovarian metastasis were mostly bilateral solid masses. The different sonomorphology of these two cancers may facilitate their preoperative identification, helping the surgeon to determine optimum management for the patient. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]- Published
- 2019
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3. The INTERNATIONAL MISSION study: minimally invasive surgery in ovarian neoplasms after neoadjuvant chemotherapy.
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Fagotti, A, S, Gueli Alletti, Corrado, G, Cola, E, Vizza, E, Vieira, M, C, E Andrade, Tsunoda, A, Favero, G, Zapardiel, I, Pasciuto, T, and Scambia, G
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RETROSPECTIVE studies ,SURGERY ,OVARIAN epithelial cancer ,CANCER chemotherapy ,CYTOREDUCTIVE surgery - Abstract
Objectives: The aim of this retrospective multicenter study was to investigate the extent, feasibility, and outcomes of minimally invasive surgery at the time of interval debulking surgery in different gynecological cancer centers. Methods/Materials: In December 2016, 20 gynecological cancer centers were contacted by e-mail, to participate in the INTERNATIONAL MISSION study. Seven centers confirmed and five were included, with a total of 127 patients diagnosed with advanced epithelial ovarian cancer after neoadjuvant chemotherapy and minimally invasive interval surgery. Only women with a minimum follow-up time of 6 months from interval surgery or any cancer-related event before 6 months were included in the survival analysis. Baseline characteristics, chemotherapy, and operative data were evaluated. Survival analysis was evaluated using the Kaplan–Meier method. Results :All patients had optimal cytoreduction at the time of interval surgery: among them, 122 (96.1%) patients had no residual tumor. Median operative time was 225 min (range 60 – 600) and median estimated blood loss was 100 mL (range 70 – 1320). Median time to discharge was 2 days (1–33) and estimated median time to start chemotherapy was 20 days (range 15 – 60). Six (4.7%) patients experienced intraoperative complications, with one patient experiencing two serious complications (bowel and bladder injury at the same time). There were six (4.7%) patients with postoperative short-term complications: among them, three patients had severe complications. The conversion rate to laparotomy was 3.9 %. Median follow-up time was 37 months (range 7 – 86): 74 of 127 patients recurred (58.3%) and 31 (24.4%) patients died from disease. Median progression-free survival was 23 months and survival at 5 years was 52 % (95% CI: 35 to 67). Conclusions: Minimally invasive surgery may be considered for the management of patients with advanced ovarian cancer who have undergone neoadjuvant chemotherapy, when surgery is limited to low-complexity standard cytoreductive procedures. [ABSTRACT FROM AUTHOR]
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- 2019
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4. Imaging in gynecological disease (14): clinical and ultrasound characteristics of ovarian clear cell carcinoma.
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Pozzati, F., Moro, F., Pasciuto, T., Gallo, C., Ciccarone, F., Franchi, D., Mancari, R., Giunchi, S., Timmerman, D., Landolfo, C., Epstein, E., Chiappa, V., Fischerova, D., Fruscio, R., Zannoni, G. F., Valentin, L., Scambia, G., and Testa, A. C.
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RENAL cell carcinoma ,OVARIAN tumors ,OVARIAN cancer diagnosis ,ULTRASONIC imaging ,OVARIAN cancer ,CANCER chemotherapy ,ADENOCARCINOMA ,AGE distribution ,COMPARATIVE studies ,ENDOMETRIOSIS ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,EVALUATION research ,RETROSPECTIVE studies ,DISEASE complications - Abstract
Objective: To describe the clinical and ultrasound characteristics of ovarian pure clear cell carcinoma.Methods: This was a retrospective study involving data from 11 ultrasound centers. From the International Ovarian Tumor Analysis (IOTA) database, 105 patients who had undergone preoperative ultrasound examination by an experienced ultrasound examiner between 1999 and 2016 were identified with a histologically confirmed pure clear cell carcinoma of the ovary. An additional 47 patients diagnosed with pure clear cell carcinoma between 1999 and 2016 and with available complete preoperative ultrasound reports were identified retrospectively from the databases of the departments of gynecological oncology in the participating centers. The ultrasound images of all tumors were described using IOTA terminology. Clinical and ultrasound characteristics were analyzed for the whole group, and separately, for patients with and those without histologically confirmed endometriosis, and for patients with evidence of tumor developing from endometriosis.Results: Median age of the 152 patients was 53.5 (range, 28-92) years and 92/152 (60.5%) tumors were FIGO Stage I. Most tumors (128/152, 84.2%) were unilateral. On ultrasound examination, all tumors contained solid components and 36/152 (23.7%) were completely solid masses. The median largest diameter of the lesion was 117 (range, 25-310) mm. Papillary projections were present in 58/152 (38.2%) masses and, in most of these (51/56, 91.1%), vascularized papillary projections were seen. Information regarding the presence, site and type of pelvic endometriosis at histology was available for 130/152 patients. Endometriosis was noted in 54 (41.5%) of these. In 24/130 (18.6%) patients, the tumor was judged to have developed from endometriosis. Patients with, compared to those without, evidence of tumor developing from endometriosis were younger (median 47.5 vs 55.0 years, respectively), and ground-glass echogenicity of cyst fluid was more common in pure clear cell cancers developing from endometriosis (10/20 vs 13/79 (50.0% vs 16.5%), respectively).Conclusions: Ovarian pure clear cell carcinoma is usually diagnosed at an early stage and typically appears as a large unilateral mass with solid components. Patients with clear cell carcinoma developing from endometriosis are younger than other patients with clear cell carcinoma, and clear cell cancers developing from endometriosis more often manifest ground-glass echogenicity of cyst fluid. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]- Published
- 2018
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5. Imaging in gynecological disease (13): clinical and ultrasound characteristics of endometrioid ovarian cancer.
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Moro, F., Pasciuto, T., Mascilini, F., Moruzzi, M. C., Scambia, G., Chiappa, V., Guerriero, S., Zannoni, G. F., Valentin, L., Magoga, G., Testa, A. C., Fischerova, D., Savelli, L., Giunchi, S., Mancari, R., Franchi, D., Czekierdowski, A., Froyman, W., Timmerman, D., and Verri, D.
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OVARIAN cancer , *OVARIAN diseases , *CARCINOMA , *ADENOCARCINOMA , *ULTRASONIC imaging , *ASCITES , *COMPARATIVE studies , *ENDOMETRIOSIS , *RESEARCH methodology , *MEDICAL cooperation , *OVARIAN tumors , *RESEARCH , *ENDOMETRIAL tumors , *EVALUATION research , *COLOR Doppler ultrasonography , *RETROSPECTIVE studies - Abstract
Objective: To describe the clinical and ultrasound characteristics of ovarian pure endometrioid carcinomas.Methods: This was a retrospective multicenter study of patients with a histological diagnosis of pure endometrioid carcinoma. We identified 161 patients from the International Ovarian Tumor Analysis (IOTA) database who had undergone preoperative ultrasound examination by an experienced ultrasound examiner between 1999 and 2016, and another 78 patients from the databases of the departments of gynecological oncology in the participating centers. All tumors were described using IOTA terminology. In addition, one author reviewed all available ultrasound images and described them using pattern recognition.Results: Median age of the 239 patients was 55 years (range, 19-88 years). On ultrasound examination, two (0.8%) endometrioid carcinomas were described as unilocular cysts, three (1.3%) as multilocular cysts, 37 (15.5%) as unilocular-solid cysts, 115 (48.1%) as multilocular-solid cysts and 82 (34.3%) as solid masses. Median largest tumor diameter was 102.5 mm (range, 20-300 mm) and median largest diameter of the largest solid component was 63 mm (range, 9-300 mm). Papillary projections were present in 70 (29.3%) masses. Most cancers (188 (78.7%)) were unilateral. In 49 (20.5%) cases, the cancer was judged by the pathologist to develop from endometriosis. These cancers, compared with those without evidence of tumor developing from endometriosis, more often manifested papillary projections on ultrasound (46.9% (23/49) vs 24.7% (47/190)), were less often bilateral (8.2% (4/49) vs 24.7% (47/190)) and less often associated with ascites (6.1% (3/49) vs 28.4% (54/190)) and fluid in the pouch of Douglas (24.5% (12/49) vs 48.9% (93/190)). Retrospective analysis of available ultrasound images using pattern recognition revealed that many tumors without evidence of tumor developing from endometriosis (36.3% (41/113)) had a large central solid component entrapped within locules, giving the tumor a cockade-like appearance.Conclusions: Endometrioid cancers are usually large, unilateral, multilocular-solid or solid tumors. The ultrasound characteristics of endometrioid carcinomas developing from endometriosis differ from those without evidence of tumor developing from endometriosis, the former being more often unilateral cysts with papillary projections and no ascites. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]- Published
- 2018
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6. Ultrasound characteristics of ovarian metastases from low-grade appendiceal mucinous neoplasms.
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Moro, F., Pozzati, F., Mascilini, F., Magoga, G., Pasciuto, T., Zannoni, G., Scambia, G., Testa, A. C., Moro, Francesca, Pozzati, Federica, Mascilini, Floriana, Magoga, Giulia, Pasciuto, Tina, Zannoni, Gianfranco, Scambia, Giovanni, and Testa, Antonia Carla
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OVARIAN cancer ,ULTRASONIC imaging ,PERITONEUM tumors ,MUCINOUS adenocarcinoma - Abstract
Low grade appendiceal mucinous neoplasms (LAMNs) include all mucinous tumors of the appendix without an infiltrative histological pattern, either confined to the appendix or that have spread to the peritoneum (pseudomyxoma peritoneii), according to the WHO Classification1 (Suppl 1). The ovarian involvement from LAMN is not uncommon and in most cases is the first evidence of primitive LAMNs. Metastatic LAMNs to the ovary are more indolent and have a better prognosis than metastatic appendiceal adenocarcinomas.2. [ABSTRACT FROM AUTHOR]
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- 2018
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7. OP20.04: Imaging in gynecological disease: clinical and ultrasound features of ovarian clear cell carcinoma.
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Moro, F., Pozzati, F., Gallo, C., Pasciuto, T., Franchi, D., Mancari, R., Savelli, L., Timmerman, D., Landolfo, C., Valentin, L., Epstein, E., Chiappa, V., Fischerová, D., Fruscio, R., Pascual, M., Zannoni, G., and Testa, A.C.
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GYNECOLOGY ,OVARIAN cancer ,ULTRASONIC imaging - Published
- 2017
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8. P30.08: Imaging in gynecological disease: clinical and ultrasound characteristics of ovarian metastasis from low-grade appendiceal mucinous neoplasms (LAMNs).
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Pozzati, F., Mascilini, F., Magoga, G., Moro, F., Pasciuto, T., Zannoni, G., and Testa, A.C.
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OVARIAN cancer ,ULTRASONIC imaging ,GYNECOLOGIC cancer - Published
- 2017
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9. P30.03: Imaging in gynecological disease: clinical and ultrasound features of ovarian endometrioid carcinoma.
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Moro, F., Magoga, G., Pasciuto, T., Di Legge, A., Moruzzi, M., Fischerová, D., Savelli, L., Czekierdowski, A., Timmerman, D., Froyman, W., Verri, D., Epstein, E., Chiappa, V., Guerriero, S., Valentin, L., and Testa, A.C.
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DIAGNOSTIC imaging ,ULTRASONIC imaging ,OVARIAN cancer - Published
- 2017
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10. OP09.05: Clinical and ultrasound features of mucinous ovarian tumours.
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Moro, F., Zannoni, G., Arciuolo, D., Pasciuto, T., Amoroso, S., Mascilini, F., Zorzi, C., Mainenti, S., Scambia, G., and Testa, A.C.
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OVARIAN cancer ,ULTRASONIC imaging - Abstract
An abstract of the article "Clinical and ultrasound features of mucinous ovarian tumours," by F. Moro and colleagues is presented.
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- 2016
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11. OP09.07: Clinical and ultrasound features of different subclasses of serous ovarian tumours.
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Moro, F., Cinzia, B., Zannoni, G., Mancari, R., Pasciuto, T., Ludovisi, M., Moruzzi, M., Martinez, D., Lecca, A., Scambia, G., Franchi, D., and Testa, A.C.
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ULTRASONIC imaging ,OVARIAN cancer ,CARCINOMA - Abstract
An abstract of the article "Clinical and ultrasound features of different subclasses of serous ovarian tumours" by F. Moro and colleagues is presented.
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- 2016
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12. Surgical outcomes of diaphragmatic resection during cytoreductive surgery for advanced gynecological ovarian neoplasia: A randomized single center clinical trial - DRAGON.
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Cianci, S., Fedele, C., Vizzielli, G., Pasciuto, T., Gueli Alletti, S., Cosentino, F., Chiantera, V., Fagotti, A., and Scambia, G.
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GYNECOLOGIC surgery , *CYTOREDUCTIVE surgery , *CHEST tubes , *SURGICAL complications , *TUMORS , *HYPERTHERMIC intraperitoneal chemotherapy , *CLINICAL trials - Abstract
Ovarian cancer (OC) represent nearly 4% of gynecologic malignancies and it is often diagnosed at advanced stage. Diaphragmatic surgery, a fundamental step of advanced stage ovarian cancer (ASOC) debulking surgery, is associated with a high post-operative complication incidence, which is supposedly reduced with thoracostomy tube placement. We assessed the role of intra-operative thoracostomy tube placement, as a prevention measure for post-operative complications, after diaphragmatic resection. This was a single center prospective randomized trial. Ovarian cancer patients, who underwent mono-lateral diaphragmatic resection, were randomized 1:1 into two arms. Arm A included patients receiving intra-operative thoracostomy tube placement (TP); Arm B patients did not receive thoracostomy tube placement (NTP). After surgery, all patients underwent seriate chest x-ray and ultrasound to record thoracic complications. Statistical analysis included uni- and multivariable logistic regression model (proportional odds model). Three hundred seventy-one patients were screened and 88 patients were enrolled: 44 in arm A and B, respectively. No statistically significant differences for intra-operative (p = 0.291) and any grade of post-operative complication (p = 0.072) were detected, while 6.8% of patients in arm A and 22.7% in arm B experienced severe respiratory symptoms (p = 0.035); 18.2% of patients in arm A had a moderate/large pleural effusion versus 65.9% in arm B (p < 0.0001). At multivariable analysis, results confirmed that the NTP-group had a higher risk to receive post-operative thoracostomy tube placement due to pleural effusion than the TP-group (odds ratio [95% Confidence Interval] = 14.5 [3.7–57.4]). Thoracostomy intra-operative tube placement after diaphragmatic resection is effective to prevent post-operative thoracic complications. The extension of resection does not influence outcomes and the risk of post-operative thoracentesis or TP remain elevated. • One of the most frequent complication of ovarian cancer debulking is pleural effusion. • The diaphragmatic surgery during ovarian cancer debulking is a frequent procedure. • The use of intra-operatory chest tube to prevent thoracic complication is still debated. • The use of chest tube after diaphragmatic resection seems to give some benefits in terms of post-operatory complications. [ABSTRACT FROM AUTHOR]
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- 2022
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13. Minimal residual disease at primary debulking surgery versus complete tumor resection at interval debulking surgery in advanced epithelial ovarian cancer: A survival analysis.
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Ghirardi, V., Moruzzi, M.C., Bizzarri, N., Vargiu, V., D'Indinosante, M., Garganese, G., Pasciuto, T., Loverro, M., Scambia, G., and Fagotti, A.
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OVARIAN epithelial cancer , *CYTOREDUCTIVE surgery , *SURVIVAL analysis (Biometry) , *SURGICAL complications , *FALLOPIAN tubes , *PERITONEAL cancer , *SURGICAL excision - Abstract
To compare survival outcomes and peri-operative complications in patients with advanced ovarian cancer with 1–10 mm residual disease (RD) at primary debulking surgery (PDS) versus those achieving no gross residual disease (NGR) at interval debulking surgery (IDS). Patients operated with the intent of complete cytoreduction for epithelial ovarian/fallopian tube/primary peritoneal cancer, FIGO stage IIIC-IV, RD 1–10 mm at PDS and NGR at IDS, between 01/2010 and 12/2016, were retrospectively included. All patients had at least 2-years of follow-up completed. 207 patients were included (59 PDS and 148 IDS). Patients in PDS group were younger and had a higher surgical complexity score. There was a higher rate of intra- and major early post-operative complications in the group of PDS vs IDS (16.9% vs 1.3% and 28.8% vs 2.0%, p < 0.0001 respectively). After a median follow up of 56.4 months (range 59.2–65.4), 117 (56.5%) patients died of disease in the whole population. Forty-eight (81.4%) patients had progression/recurrent disease in the PDS group and 120 (81.1%) in the IDS group. Median PFS was 16.2 months and 18.9 months for PDS and IDS group, respectively (p = 0.111). Median OS was 41.4 months and 52.4 months for PDS and IDS group, respectively (p = 0.022). IDS should be considered the preferred treatment in case millimetric residual disease is expected at PDS in view of the superimposable PFS and the reduced number of perioperative complications. • Surgical complexity score was higher in primary debulking when compared with interval debulking surgery. • Primary debulking was associated with higher incidence of intra- and post-operative complications than interval debulking. • No progression-free survival difference was found between the two groups of patients. • Complete cytoreduction at primary and interval cytoreduction is the major prognostic factor in advanced ovarian cancer. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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14. Surgical outcomes of diaphragmatic resection during cytoreductive surgery for advanced gynecological ovarian neoplasia: A randomized single center clinical trial - DRAGON
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S Gueli Alletti, Giovanni Scambia, C. Fedele, Anna Fagotti, Stefano Cianci, F Cosentino, Tina Pasciuto, Vito Chiantera, Giuseppe Vizzielli, Cianci S., Fedele C., Vizzielli G., Pasciuto T., Gueli Alletti S., Cosentino F., Chiantera V., Fagotti A., and Scambia G.
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Adult ,medicine.medical_specialty ,Diaphragmatic surgery ,Pleural effusion ,medicine.medical_treatment ,Diaphragmatic resection ,Diaphragm ,Diaphragmatic breathing ,Thoracentesis ,Carcinoma, Ovarian Epithelial ,Thoracostomy ,Single Center ,Postoperative Complications ,Ovarian cancer ,medicine ,Humans ,Aged ,Ovarian Neoplasms ,Intraoperative Care ,Cytoreduction Surgical Procedure ,Thoracostomy tube ,business.industry ,Ovarian Neoplasm ,Obstetrics and Gynecology ,Pneumothorax ,Cytoreduction Surgical Procedures ,Middle Aged ,medicine.disease ,Debulking ,Surgery ,Pleural Effusion ,Settore MED/40 - GINECOLOGIA E OSTETRICIA ,Logistic Models ,Oncology ,Chest Tubes ,Female ,Complication ,business - Abstract
Introduction: Ovarian cancer (OC) represent nearly 4% of gynecologic malignancies and it is often diagnosed at advanced stage. Diaphragmatic surgery, a fundamental step of advanced stage ovarian cancer (ASOC) debulking surgery, is associated with a high post-operative complication incidence, which is supposedly reduced with thoracostomy tube placement. We assessed the role of intra-operative thoracostomy tube placement, as a prevention measure for post-operative complications, after diaphragmatic resection. Methods: This was a single center prospective randomized trial. Ovarian cancer patients, who underwent mono-lateral diaphragmatic resection, were randomized 1:1 into two arms. Arm A included patients receiving intra-operative thoracostomy tube placement (TP); Arm B patients did not receive thoracostomy tube placement (NTP). After surgery, all patients underwent seriate chest x-ray and ultrasound to record thoracic complications. Statistical analysis included uni- and multivariable logistic regression model (proportional odds model). Results: Three hundred seventy-one patients were screened and 88 patients were enrolled: 44 in arm A and B, respectively. No statistically significant differences for intra-operative (p = 0.291) and any grade of post-operative complication (p = 0.072) were detected, while 6.8% of patients in arm A and 22.7% in arm B experienced severe respiratory symptoms (p = 0.035); 18.2% of patients in arm A had a moderate/large pleural effusion versus 65.9% in arm B (p < 0.0001). At multivariable analysis, results confirmed that the NTP-group had a higher risk to receive post-operative thoracostomy tube placement due to pleural effusion than the TP-group (odds ratio [95% Confidence Interval] = 14.5 [3.7–57.4]). Conclusions: Thoracostomy intra-operative tube placement after diaphragmatic resection is effective to prevent post-operative thoracic complications. The extension of resection does not influence outcomes and the risk of post-operative thoracentesis or TP remain elevated.
- Published
- 2021
15. Randomized trial of primary debulking surgery versus neoadjuvant chemotherapy for advanced epithelial ovarian cancer (SCORPION-NCT01461850)
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S Gueli Alletti, Francesco Cosentino, Tina Pasciuto, Barbara Costantini, Giuseppe Vizzielli, Giovanni Scambia, P.A. Margariti, Vito Chiantera, Maria Gabriella Ferrandina, Anna Fagotti, Francesco Fanfani, Valerio Gallotta, Fagotti A., Ferrandina M.G., Vizzielli G., Pasciuto T., Fanfani F., Gallotta V., Margariti P.A., Chiantera V., Costantini B., Gueli Alletti S., Cosentino F., and Scambia G.
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operative ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,law.invention ,peritoneal neoplasm ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,peritoneal neoplasms ,postoperative complications ,Medicine ,Epithelial ovarian cancer ,postoperative complication ,030212 general & internal medicine ,Stage (cooking) ,education ,Laparoscopy ,Chemotherapy ,education.field_of_study ,medicine.diagnostic_test ,business.industry ,Obstetrics and Gynecology ,General Medicine ,Perioperative ,epithelial ovarian cancer ,medicine.disease ,Debulking ,surgical procedures ,Surgery ,surgical procedure ,ovarian cancer ,Settore MED/40 - GINECOLOGIA E OSTETRICIA ,medicine.anatomical_structure ,Oncology ,030220 oncology & carcinogenesis ,business ,Ovarian cancer ,Fallopian tube - Abstract
ObjectiveTo investigate whether neoadjuvant chemotherapy followed by interval debulking surgery is superior to primary debulking surgery in terms of perioperative complications and progression-free survival, in advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high tumor load.MethodsPatients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (stage IIIC-IV) underwent laparoscopy. Patients with high tumor load assessed by a standardized laparoscopic predictive index were randomly assigned (1:1 ratio) to undergo either primary debulking surgery followed by adjuvant chemotherapy (arm A), or neoadjuvant chemotherapy followed by interval debulking surgery and adjuvant chemotherapy (arm B). Co-primary outcome measures were progression-free survival and post-operative complications; secondary outcomes were overall survival, and quality of life. Survival analyses were performed on an intention-to-treat population.Results171 patients were randomly assigned to primary debulking surgery (n=84) versus neoadjuvant chemotherapy (n=87). Rates of complete resection (R0) were different between the arms (47.6% in arm A vs 77.0% in arm B; p=0.001). 53 major postoperative complications were registered, mainly distributed in arm A compared with arm B (25.9% vs 7.6%; p=0.0001). All patients were included in the intent-to-treat analysis. With an overall median follow-up of 59 months (95% CI 53 to 64), 142 (83.0%) disease progressions/recurrences and 103 deaths (60.2%) occurred. Median progression-free and overall survival were 15 and 41 months for patients assigned to primary debulking surgery, compared with 14 and 43 months for patients assigned to neoadjuvant chemotherapy, respectively (HR 1.05, 95% CI 0.77 to 1.44, p=0.73; HR 1.12, 95% CI 0.76 to 1.65, p=0.56).ConclusionsNeoadjuvant chemotherapy and primary debulking surgery have the same efficacy when used at their maximal possibilities, but the toxicity profile is different.
- Published
- 2020
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