| Part I:Clinical study of cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy to treat primary advanced/recurrent epithelial ovarian cancerObjective This study was to evaluate the efficacy and safety of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) to treat peritoneal carcinomatosis (PC) from primary advanced/recurrent epithelial ovarian cancer (EOC).Methods This study included 46 consecutive patients with primary advanced EOC (FIGO stage Ⅲc/Ⅳ, n= 16, group A) or recurrent EOC with PC (n= 30, group B), aged from 22 to 75 years old (median 57.5 years), treated by 50 CRS+HIPEC procedures, including 4 patients each receiving 2 CRS+HIPEC procedures due to tumor recurrence, from April 2004 to September 2014 in department of oncology, Zhongnan Hospital of Wuhan University. The patient information was systematically integrated into a prospectively established database and all of the patients were regularly followed-up. The primary endpoint was overall survival (OS) from the first treatment to disease-related death. The secondary endpoints were safety profiles.Results The median follow-up was 45.8 months (5.0-213.3), and 24 patients (52.2%) were deceased and 22 patients (47.8%) were still alive. The median OS was 57.5 months (95% CI 23.2-91.7) and the 1-,3-,5-year survival rates were 97.8%,65.2% and 56.5%, respectively. The median OS was 74.0 months (95% CI 8.5-139.5) for group A vs.57.5 months (95% CI 29.8-85.2) for group B (P= 0.68). The median OS for patients with PCI< 20 (n= 24) vs. PCI> 20 (n= 22) was 76.6 months (95% CI 56.5-96.7) vs.38.5 months (95% CI 24.2-52.8) (P= 0.01). The median OS for patients with CC0-1 vs. CC2-3 was 79.5 months (95% CI 64.8-94.2) vs.24.3 months (95% CI 13.9-34.7) (P= 0.00). The median OS for patients with postoperative chemotherapy cycles> 6 vs.< 6 was 74.0 months (95% CI 56.6-91.4) vs.32.3 months (95% CI 15.5-49.1) (P= 0.022). In the recurrent group, the median OS was 65.3 months (95% CI 42.6-88.9) for platinum-sensitive patients vs.20.0 months (95% CI 14.5-23.5) for platinum resistant patients (P= 0.05). There was no perioperative death. Postoperative adverse events occurred in 5 patients. Multivariate analysis revealed that CC0-1, and postoperative chemotherapy≥ 6 cycles were the independent factors for OS improvement.Conclusion For highly selected primary advanced/recurrent EOC PC, CRS+HIPEC could improve OS with acceptable safety profiles.Part II:Clinical study of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy in the treatment of primary peritoneal serous carcinoma Objective This study was to evaluate the efficacy and safety of cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) to treat primary peritoneal serous carcinoma (PPSC).Methods This retrospective study included 22 female patients from oncology department of Zhongnan Hospital Wuhan University from April 2007 to April 2014 with primary advanced PPSC (stage Ⅲ/Ⅳ, group A, n= 12) or recurrent PPSC (group B, n= 10) treated by CRS+HIPEC procedures. The primary endpoint was overall survival (OS), and the secondary endpoints were safety profiles.Results The median OS was 31.0 months (95% CI 22.3-38.7) and the 1-,3-,5-year survival rates were 100%,45.5% and 27.3%, respectively. The median OS was 31.0 months (95% CI 19.8-42.2) for group A vs.38.5 months (95% CI 9.6-67.4) for group B (P= 0.832, log rank test). The median OS for patients with PCI< 15 vs. PCI> 15 was 51.5 months (95% CI 34.9-68.1) vs.20.3 months (95% CI 12.6-28.0) (P= 0.000, log rank test). The median OS for patients with CC 0-1 vs. CC 2-3 was 38.5 months (95% CI 22.5-54.5) vs.23.5 months (95% CI 15.3-31.7) (P= 0.126, log rank test). The median preoperative and postoperative CA125 level was 387.9 U/mL (range,7.8-4881.0) and 213.8 U/mL (range,12.6-1970.1), respectively (P= 0.001). Univariate analysis identified that PCI< 15 as the only prognosis predicator (HR = 13.1,95% CI 2.7-63.4, P= 0.001). There was no perioperative death. SAE occurred in 2 patients (9.1%), including pneumonia and septicemia in 1 patient and anastomotic hemorrhage in 1 patient.Conclusion At a specialized peritoneal carcinomatosis treatment center, CRS+HIPEC could improve OS for selected PPSC patients, with acceptable perioperative safety profiles.Part III:Survival benefit of cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy for recurrent Epithelial Ovarian Cancer:A retrospective case control studyObjective This retrospective case control study was to evaluate the efficacy and safety of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) to treat recurrent epithelial ovarian cancer (ROC).Methods By the principle of main clinic-pathological feature matching, this study included 59 consecutive patients with recurrent EOC treated in Zhongnan Hospital of Wuhan University, from December 2006 to April 2015, including 28 patients treated with CRS+HIPEC in department of oncology (Study group) and 31 patients treated with CRS in department of gynaecological oncology (Control group). The primary endpoint was overall survival (OS) from the first recurrence after initial treatment with debulking surgery and systemic chemotherapy to disease-related death. The secondary endpoints were safety profiles.Results The median follow-up in Study and Control groups were 43.0 months (13.0～136.0) versus 46.0 months (18.0～181.0). The median OS was 30.0 months (95% CI 25.3-34.8) for Study group and 22.8 months (95% CI 18.2-27.4) for Control group (P= 0.029). The 1-,3-, and 5- year survival rates were 85.7% versus 71.0%,46.4% versus 35.5%, and 39.3% versus 25.8%, respectively, for Study versus Control groups. In subgroup of patients with PCI≤ 15, the median OS was 52.8 months (95% CI 0-108.3) for Study group and 22.8 months (95% CI 16.3-29.3) for Control group (P= 0.003). In subgroup of patients with CC0-1, the median OS was 52.8 months (95% CI 14.8-90.8) for Study group and 26.4 months (95% CI 19.5-33.3) for Control group (P= 0.005). The median OS for patients with postoperative adjuvant chemotherapy cycles≥ 6 were significantly longer than< 6 cycles of postoperative adjuvant chemotherapy in both Study and Control groups (P< 0.05). In Study group, the median OS was 30.0 months (95% CI 6.5-57.1) for platinum-sensitive patients versus 31.8 months (95% CI 25.5-34.5) for platinum resistant patients (P= 0.633). There was no perioperative death. Postoperative serious adverse events was 17.9% and 9.7%, respectively, for Study versus Control groups. Multivariate analysis revealed that CRS+HIPEC, CC0-1, and postoperative chemotherapy≥ 6 cycles were the independent factors for OS improvement.Conclusion Compared to CRS, CRS+HIPEC could improve OS with acceptable safety profiles for low PCI and CC0-1 recurrent EOC patients. |
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