Tewari 2016.
Study characteristics | ||
Methods | Retrospective analysis | |
Participants | 1718 women with newly diagnosed International Federation of Gynecology and Obstetrics stage III and IV ovarian, peritoneal or fallopian tube carcinoma were included in the analysis
Median age (years): microscopic (58.5); optimal (60.1); suboptimal (60.2) Performance status ‐ frequency (%):
Top‐level FIGO stage: III: 1241 (72.2%); IV: 477 (27.8%) Histology: serous: 1477 (86%); mixed epithelial: 76 (4.4%); endometrioid: 56 (3.3%); clear‐cell/mucinous: 60 (3.5%); other: 24 (1.4%) Ascites: no: 346 (20.1%); yes: 1372 (79.9%) Progression‐free survival status: censored: 268 (15.6%); progression or death: 1450 (84.4%) Overall survival status: censored: 840 (48.9%); death: 878 (51.1%) USA |
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Residual disease details | Speciality of surgeon was not reported Primary cytoreductive surgery followed by platinum based chemotherapy Treatment arms: frequency (%)
Residual disease, n (%)
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Outcomes | Overall survival: HR adjusted for: TSIC = 15 days: ≤ 1 cm (AHR 1.41, 95% CI 0.77 to 2.58); > 1 cm (AHR 1.87, 95% CI 1.05 to 3.31) Residual = micro, 40 days:
Residual ≤ 1 cm, 40 days:
Residual > 1 cm, 40 days
Histology
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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 Definition of OS not provided but it usually has a standard definition 5. Adjustment for other prognostic factors (a‐g): low risk Arbitrary dichotomisation of time from surgery to chemotherapy. Multivariate model predicting OS adjusted for age, race, performance status, tumour grade, FIGO stage, histology, ascites, CA‐125, time from surgery to chemotherapy and interaction terms 6. Statistical analysis and reporting (a‐d): high risk No conceptual framework; unclear of variable selection criteria for multivariate analysis Outcome: progression‐free survival Not reported |
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Notes | At 15 days, time to initiation of chemotherapy does not increase the risk of death for any women, whereas at 40 days most women have an increased risk of death. This represents a change‐point in increasing time at which some women start to become affected negatively. |