Hofstetter 2013.
Study characteristics | ||
Methods | Prospective multicentre study | |
Participants | 191 women with stage IIIA to IV primary ovarian cancer. Stage IIIa: 3, IIIb: 8, IIIc: 147, IV: 33 ECOG performance status (only available for 183 women) 0: 113, 1: 60; 2/3: 10 Age < 57: 98, > 57: 93 Histological subtypes; serous: 182, mixed serous:1, serous/clear cell: 4, undifferentiated: 4 Tumour grade 1/2: 51, 3: 140 |
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Residual disease details | All women underwent primary surgery. All women received postoperative intravenous or intraperitoneal platinum‐based chemotherapy. Women that received neoadjuvant chemotherapy were excluded Postoperative residual disease defined as
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Outcomes | Median follow‐up was 42 months 3‐year OS: HR of NMRD vs macroscopic RD: 2.95 (95% CI 1.87 to 4.67) HR adjusted for interval between surgery and start of chemotherapy, tumour stage, age and extent of surgery Morbidity Intraoperative complications included bladder injury (2), ureteral injury (1), intestinal injury (1), vascular injury (2), other operative injury (1). 9 of 185 women required blood transfusions. Postoperative complications comprised surgical site complications (35), medical complications (42), infectious complications (22) and reoperation's (22). Adjuvant chemotherapy
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Risk of bias (QUIPS) | 1. Study participation (a‐f): unclear risk Adequate number of participants and description of target population. Baseline characteristics, sampling frame and period/place study took place presented clearly. Though, inclusion criteria not detailed. 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 outcomes 5. Adjustment for other prognostic factors (a‐g): unclear risk Interval from primary surgery to chemotherapy (continuous) arbitrarily dichotomised along the median. Multivariate model predicting OS adjusted for interval from surgery to chemotherapy, FIGO stage, age and extent of surgery 6. Statistical analysis and reporting (a‐d): high risk No conceptual framework; variable selection strategy into multivariate model unclear. HRs for centre not included in the results for multivariate analysis. There were other factors that were also significant at univariate analysis but were not included in multivariate model. Outcome: progression‐free survival Not reported |
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Notes | The median time interval from primary surgery to the start of platinum‐based chemotherapy was 28 days (range: 4 to 128). Women who received the first cycle of chemotherapy less than 28 days after surgery had a significantly improved 3‐year survival rate of 70% as opposed to 60% in women with a later start of cytotoxic treatment. |