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Background@#In China, secondary cytoreductive surgery (SCR) has been widely used in ovarian cancer (OC) over the past two decades. Although Gynecologic Oncology Group-0213 trial did not show its overall survival benefit in first relapsed patients, the questions on patient selection and effect of subsequent targeting therapy are still open. The preliminary data from our pre-SOC1 phase II study showed that selected patients with second relapse who never received SCR at recurrence may still benefit from surgery. Moreover, poly(ADP-ribose) polymerase inhibitors (PARPi) maintenance now has been a standard care for platinum sensitive relapsed OC. To our knowledge, no published or ongoing trial is trying to answer the question if patient can benefit from a potentially complete resection combined with PARPi maintenance in OC patients with secondary recurrence. @*Methods@#SOC-3 is a multi-center, open, randomized, controlled, phase II trial of SCR followed by chemotherapy and niraparib maintenance vs chemotherapy and niraparib maintenance in patients with platinum-sensitive second relapsed OC who never received SCR at recurrence. To guarantee surgical quality, if the sites had no experience of participating in any OC-related surgical trials, the number of recurrent lesions evaluated by central-reviewed positron emission tomography–computed tomography image shouldn't be more than 3. Eligible patients are randomly assigned in a 1:1 ratio to receive either SCR followed by 6 cyclesof platinum-based chemotherapy and niraparib maintenance or 6 cycles of platinum-based chemotherapy and niraparib maintenance alone. Patients who undergo at least 4 cycles of chemotherapy and must be, in the opinion of the investigator, without disease progression, will be assigned niraparib maintenance. Major inclusion criteria are secondary relapsed OC with a platinum-free interval of no less than 6 months and a possibly complete resection. Major exclusion criteria are borderline tumors and non-epithelial ovarian malignancies, received debulking surgery at recurrence and impossible to complete resection. The sample size is 96 patients. Primary endpoint is 12-month non-progression rate.
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Background@#Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice. @*Methods@#The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC).The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival.
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Background@#Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice. @*Methods@#The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC).The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival.
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Objective The aim of this study is to evaluate the safety and efficacy of partial pancreatectomy as part of primary cytoreductive surgery in advanced epithelial ovarian cancer (EOC). Methods A total of 8 patients were recruited in this study who underwent partial pancreatectomy during the primary cytoreductive surgeries for advanced EOC in Fudan University Shanghai Cancer Center from April 2009 to July 2015. Their clinicopathological characteristics, diameter of metastatic tumors, the scope of cytoreductive surgeries, residual diseases after cytoreductive surgeries, postoperative complications and survival situation were retrospective analyzed. Results (1) Clinicopathological characteristics:the median age of these patients was 58 years old(range: 39-63 years old). The median value of preoperative serum CA125 was 1 688 kU/L(range: 119-5 000 kU/L). The median diameter of metastatic tumors involved in pancreatic body or tail was 4.5 cm (range:3-10 cm). All the tumors from the 8 patients were confirmed to be high-grade serous carcinoma. Four patients were staged as International Federation of Gynecology and Obstetrics (FIGO)Ⅳ, and the other 4 patients were staged as FIGOⅢc. (2) Tumor metastases and the scope of cytoreductive surgeries:all of these 8 patients had widely disseminated ovarian cancer, with involvement of upper abdominal, middle abdominal and pelvic cavity. Each patient underwent extensive intra-abdominal cytoreductive surgeries, including hysterectomy, bilateral salpingo-oophorectomy, omentectomy, pelvic periton-ectomy, splenectomy, partial pancreatectomy. Each patient had cytoreductive surgeries of 9.6 different sites on average. Of all 8 patients who underwent partial pancreatectomy, 7 patients had pancreatic tails removed;the other 1 patient had pancreatic body and tail removed. The median volume of blood loss during surgery was 1 350 ml(range:300-3 500 ml), blood transfusion was performed in 7 patients with the median volume of 1 150 ml (range: 500-1 800 ml). (3) Residual diseases after cytoreductive surgeries: optimal cytoreduction was achieved in all patients, with microscopic residual disease in 3 patients, residual tumors diameter < 0.5 cm in 3 patients, and residual tumors diameter between 0.5 and 1 cm in 2 patients. (4) Postoperative complications: 4 patients suffered from complications including pancreatic leakage (2/8), intraperitoneal hemorrhage (1/8) and pancreatic pseudocyst accompanied by infection (1/8). These complications were treated successfully by conservative managements. (5) Survival situation: during the median follow-up duration of 17 months (ranged from 2 to 46 months), 5 patients were still alive until the end of follow-up, including 4 cases under treatment and 1 case survived 29 months without relapse after treatment. Three patients were respectively died in 5, 20 and 46 months after surgery. Conclusion There is a higher risk of postoperative complications of pancreas resection as part of primary cytoreductive surgery in advanced epithelial ovarian cancer, but the resection of pancreatic metastases and part of the pancreas is feasible and necessary.
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OBJECTIVE: Distal pancreatectomy with splenectomy may be required for optimal cytoreductive surgery in patients with epithelial ovarian cancer (EOC) metastasized to splenic hilum. This study evaluates the morbidity and treatment outcomes of the uncommon procedure in the management of advanced or recurrent EOC. METHODS: This study recruited 18 patients who underwent distal pancreatectomy with splenectomy during cytoreductive surgery of EOC. Their clinicopathological characteristics and follow-up data were retrospectively analyzed. RESULTS: All tumors were confirmed as high-grade serous carcinomas. The median diameter of metastatic tumors located in splenic hilum was 3.5 cm (range, 1 to 10 cm). Optimal cytoreduction was achieved in all patients. Eight patients (44.4%) suffered from postoperative complications. The morbidity associated with distal pancreatectomy and splenectomy included pancreatic leakage (22.2%), encapsulated effusion in the left upper quadrant (11.1%), intra-abdominal infection (11.1%), pleural effusion with or without pulmonary atelectasis (11.1%), intestinal obstruction (5.6%), pneumonia (5.6%), postoperative hemorrhage (5.6%), and pancreatic pseudocyst (5.6%). There was no perioperative mortality. The majority of complications were treated successfully with conservative management. During the median follow-up duration of 25 months, nine patients experienced recurrence, and three patients died of the disease. The 2-year progression-free survival and overall survival were 40.2% and 84.8%, respectively. CONCLUSION: The inclusion of distal pancreatectomy with splenectomy as part of cytoreduction for the management of ovarian cancer was associated with high morbidity; however, the majority of complications could be managed with conservative therapy.
Subject(s)
Adult , Aged , Female , Humans , Middle Aged , Cytoreduction Surgical Procedures , Disease-Free Survival , Neoplasms, Glandular and Epithelial/mortality , Ovarian Neoplasms/mortality , Pancreatectomy/adverse effects , Postoperative Complications/epidemiology , Splenectomy/adverse effects , Splenic Neoplasms/pathologyABSTRACT
Background and purpose:Risk of invasive cervical carcinoma (ICC) and its precancerous lesions following high risk human papillomavirus (hrHPV) infection may vary according to HPV types and geographic regions. Analyzing HPV-type distribution in cervical samples from local women aged 30 years and older, this study aimed to identify HPV types with higher risk of developing CIN2+, and to compare diagnostic performance for CIN2+using these types and type combinations. Methods:Cervical samples with histology follow-up from patients of a tertiary cancer center in Shanghai were collected for HPV genotyping by PCR-RDB. The risk associations of HPV types with CIN2+were estimated by logistic regression analysis, and ROC curves were plotted for diagnostic performance evaluation. Results:A total number of 413 specimens were obtained, including 38 CIN1, 184 CIN2/3, 126 ICC patients and 65 negative control people. The 4 most common HPV types in CIN2+were HPV16, 58, 33 and 18, in descending order. And only HPV16 (P<0.000 1), 58 (P=0.002), 33 (P=0.015) were signiifcantly associated with CIN2+lesions. Besides, the area under the ROC curve of the HPV16/18/33/58 test scored statistically higher than the HPV16/18 test did (P=0.006 6). Conclusion:A combined test of HPV16/18/33/58 may offer better performance for detecting CIN2+lesions in our geographic region.
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10.3969/j.issn.1007-3969.2013.05.009