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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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Objective To investigate the expressions of growth factor receptor binding protein 7 (GRB7) and human epidermal growth factor receptor 2 (HER2) in endometrial carcinoma and their clinical significances. Methods Immunohistochemistry was used to detect the expressions of GRB7 and HER2 in 52 endometrial carcinoma tissues, 38 endometrial atypical hyperplasia tissues and 30 normal endometrial tissues collected from patients in the Sixth People's Hospital of Shanghai Jiao Tong University from May 2015 to September 2017. The relationship between the expressions of GRB7 and HER2 and clinicopathological features of endometrial carcinoma patients was analyzed. Results The positive expression rates of GRB7 in endometrial carcinoma, endometrial atypical hyperplasia and normal endometrial tissues were 71.2％ (37/52), 39.5％(15/38), and 13.3％(2/30), respectively, and the difference was statistically significant (χ2=35.14, P<0.05). The positive expression rates of HER2 in endometrial carcinoma, endometrial atypical hyperplasia and normal endometrial tissues were 67.3％ (35/52), 34.2％ (13/38), and 10.0％ (3/30), respectively, and the difference was statistically significant (χ2= 29.360, P< 0.05). The positive expression rates of GRB7 in endometrial carcinoma patients with different clinical stages, histological grades and pathological types were statistically significant (all P<0.05). The positive expression rates of HER2 in endometrial carcinoma patients with different clinical stages, histological grades, lymph nodes metastasis and myometrial invasion were statistically significant (all P< 0.05). The expression of GRB7 in endometrial carcinoma was positively correlated with the expression of HER2 (r=0.375, P<0.05). Conclusion The high expressions of GRB7 and HER2 in endometrial carcinoma are closely related to the malignant degree of endometrial carcinoma.