Ataseven 2016.
Study characteristics | ||
Methods | Prospective cohort study | |
Participants | 326 consecutive women with FIGO IV Median age in the study was 61 years (range: 19 to 88 years) All 326 women presented with FIGO stage IV disease Histological cell type: high grade serous: 287 (88.0%), others: 39 (12.0%) Ascites: ≤ 500 mL: 149 (45.7%), > 500 mL: 177 (54.3%) Performance status: ECOG 0: 248 (76.1%), ECOG > 0: 78 (23.9%) Localization of metastasis:
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Residual disease details | Surgery was performed by accredited gynaecological oncologists Cohort 1 included 286 women who underwent primary debulking surgery Postoperative chemotherapy was administered in 92% (263/286) Cohort 2 included 40 women who underwent either no surgery or only diagnostic procedures without cytoreductive intention (NoCS ‐ no cytoreductive surgery) In cohort 2, platinum‐based chemotherapy was given to 87.5% (35/40) of women Residual disease for total cohort was noted as follows, n (%):
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Outcomes | Overall survival: HR adjusted for age, performance status, residual tumour, tumour stage and ascites NMRD: HR 1 SVRD: HR 1.50 (95% CI 1.01 to 2.23) LVRD (> 10 mm): HR 2.20 (95% CI 1.36 to 3.55) |
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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 5. Adjustment for other prognostic factors (a‐g): low risk HR for OS was adjusted for age, performance status, residual tumour, tumour stage and ascites in a multivariable Cox model 6. Statistical analysis and reporting (a‐d): high risk No conceptual framework; unclear of variable selection criteria in multivariate model Outcome: progression‐free survival Not reported |
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Notes | Follow‐up time: up to 4 years (mean: 46 months; median: 34 months; interquartile range: 12 to 70 months) In total, 28 women (8.6%) did not receive chemotherapy 30‐day mortality was observed in: 12/326 (3.68%) Median OS for all women was 50.3 months In cohort 1, complete resection was achieved in 54.9% (n = 157/286; RD0), cytoreduction to 1 mm to 10 mm in 30.7% (n = 88/286; RD1‐10) and bulky residual disease exceeding 10 mm in 14.3% (n = 41/286; RD > 10) Risk factors for residual disease after debulking surgery in women with EOC FIGO stage IV included:
Length of hospital stay not reported |