Zhang 2018.
Study characteristics | ||
Methods | Single‐centre, retrospective study undertaken on women treated between January 2003 and December 2013, at the Department of Gynecology, Weifang Yidu Central Hospital, China | |
Participants | N = 200 women diagnosed with stage IIIC to IV invasive ovarian, fallopian tube or peritoneal high‐grade serous carcinoma, who were treated with platinum‐based NAC followed by IDS and adjuvant chemotherapy. Median age: 61 (range: 38 to 80) FIGO: IIIC – 169 (84.5%); IV – 31 (15.5%) Pre‐operative ascites
Median CA‐125 at diagnosis: 952 U/mL (range: 75 to 23,400) Median pre‐operative CA‐125: 572 (range: 43 to 986) Median CA‐125 decreasing kinetics (ratio of the initial serum CA‐125 level to the preoperative serum CA‐125 level): 2.3 (range: 0.8 to 30.2) ≤ 3 tumour sites: 50 (25%) > 3 tumour sites: 150 (75%) |
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Residual disease details | Median NACT cycles: 3 (range: 1 to 8) NAC was administrated intraperitoneally for 90 (45%) women and intravenously for 110 (55%) women Median adjuvant CT cycles: 5 (range: 3 to 7) 'Optimal' cytoreduction defined as RD < 1 cm (n = 156, 78%):
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Outcomes | Overall survival defined as interval between treatment initiation and death Median OS in participants with ascites regression: 32.1 Median OS in participants without ascites regression: 25.2 Multivariable Cox PH for OS adjusted for pre‐operative ascites, number of tumour sites, CA‐125 at diagnosis, CA‐125 decreasing kinetics:
Progression‐free survival defined as interval between the beginning of treatment and documented disease progression or death from any cause in women with no evidence of progression Median PFS in participants with ascites regression: 22.3 Median PFS in participants without ascites regression: 18 Multivariable Cox PH for PFS adjusted for pre‐operative ascites, number of tumour sites, number of NAC cycles, CA‐125 at diagnosis, CA‐125 decreasing kinetics:
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Risk of bias (QUIPS) | 1. Study participation (a‐f): low risk Adequate number of participants and description of target population. Baseline characteristics, eligibility criteria, sampling frame and period/place study took place presented clearly. 2. Study attrition (a‐e): unclear risk Unclear if patients with incomplete follow‐up were excluded before arriving at the stated sample size. Insufficient information to permit judgement. 3. Prognostic factor measurement (a‐f): low risk Valid and reliable measurement of RD Outcome level assessment: Outcome: overall survival 4. Outcome measurement (a‐c): low risk Valid and reliable measurement of outcome. OS defined as interval between treatment initiation and death. 5. Adjustment for other prognostic factors (a‐g): unclear risk Baseline CA‐125 and preoperative CA‐125 are likely to introduce multicollinearity. Model predicting OS adjusted for pre‐operative ascites, number of tumour sites, CA‐125 at diagnosis, CA‐125 decreasing kinetics 6. Statistical analysis and reporting (a‐d): unclear risk No conceptual framework; data driven based on P values of univariate associations Outcome: progression‐free survival 4. Outcome measurement (a‐c): low risk Valid and reliable measurement of outcome. PFS defined as interval between the beginning of treatment and documented disease progression or death from any cause in women with no evidence of progression. 5. Adjustment for other prognostic factors (a‐g): unclear risk Baseline CA‐125 and preoperative CA‐125 are likely to introduce multicollinearity. Model predicting PFS adjusted for age, preoperative ascites, FIGO stage, tumour sites, baseline CA‐125, preoperative CA‐125, number of NACT cycles and CA‐125 decreasing kinetics 6. Statistical analysis and reporting (a‐d): unclear risk No conceptual framework; data driven based on P values of univariate associations |
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Notes | Median follow‐up: 43.5 months Ascites regression defined as an ascites volume of less than 500 mL Inclusion criteria (i) Women histologically diagnosed as stage IIIc or IV invasive ovarian, fallopian tube or peritoneal high‐grade serous carcinoma; (ii) women treated with platinum‐based NAC followed by IDS and adjuvant chemotherapy; and (iii) women with an ascites volume of greater than or equal to 500 mL before NAC treatment as assessed by ultrasound examination Exclusion criteria (i) Fragile women who received slow‐release evacuation procedure before NAC due to intolerable abdominal distension; (ii) women with extra‐abdominal metastatic malignancy; and (iii) women whose preoperative serum cancer antigen 125 (CA‐125) levels were less than or equal to 35 U/ mL Treatment protocol A NAC regimen consisting of carbo‐platinum (area under the curves 5 to 6) and paclitaxel (135 to 175 mg/ m2) was administered every 3 weeks. IDS was performed approximately 2 to 4 weeks after the NAC regimen. The adjuvant chemotherapy (at least 3 to 4 cycles) was the same as NAC. The standard IDS included bilateral/unilateral salpingo‐oophorectomy, hysterectomy, appendectomy, pelvic/para‐aortic lymphadenectomy and omentectomy. Extensive upper abdominal surgery was defined as splenectomy, diaphragm stripping and/or resection, distal pancreatectomy, cholecystectomy, partial liver resection and partial gastrectomy. Other surgery procedures, such as large/small bowel resection and peritoneal resection, were performed as necessary. |