Lecointre 2020.
Study characteristics | ||
Methods | Retrospective, multicentre cohort study in 9 referral centres of France, constituting the FRANCOGYN study group | |
Participants | 501 women with histologically confirmed advanced epithelial ovarian cancer of stages III or IV according to the FIGO classification, diagnosed between January 2000 and June 2017. Participants were split into those with ≤ 4 NACT cycles and > 4 NACT cycles. Median age: ≤ 4 NACT cycles: 60.7 years; > 4 NACT cycles: 62.6 years BMI: < 25: 406 (81%); 25 to 30: 2 (1%); > 30: 93 (18%) White ethnicity: 246/284 (87%) Personal or familiar history of gynaecological cancer: 171 (34%) FIGO III: 409 (82%); FIGO IV: 92 (18%) Serous histology: 274/478 (57%) Pre‐operative CA‐125, U/mL: > 500: 302 (60%); ≤ 500: 199 (40%) Charlson index ≥ 1: 103/298 (35%) Tumour grade 1 to 2: 65 (13%); tumour grade 3: 248 (87%) |
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Residual disease details | The type of surgery performed was classified as complete (R0) when all visible tumours were removed (NMRD (referred to RD0 in study)) at the end of the intervention, R1 when it was ≤ 2.5 mm, R2 when it was more than > 2.5 mm but less than 2.5 cm NMRD: 346/471 (73%); RD > 0 cm to 2.5cm: 125/471 (27%) 30 participants had missing RD data |
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Outcomes | Median OS: 54.2 months
5‐year survival
≤ 4 cycles: 45.6%; > 4 cycles: 27.6%
10‐year survival
≤ 4 cycles: 26 %; > 4 cycles: 11% In multivariate Cox model controlling for number of NACT cycles (≤ 4, > 4); age (cat); Charlson index; FIGO; lymph node status (N+ vs N0); response to NACT; residual disease (RD > 0 cm to 2.5 cm vs NMRD) (adjusted HR 2.04 (95% CI 1.53 to 2.72)) Median PFS: 22.9 months 5‐year survival ≤ 4 cycles: 19.7%; > 4 cycles: 11.7% In multivariate Cox model controlling for number of NACT cycles (≤ 4, >4); age (cat); response to NACT; residual disease (RD > 0 cm to 2.5 cm vs NMRD) (adjusted HR 1.36 (95% CI 1.05 to 1.76)) |
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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): unclear risk Valid and reliable measurement of RD. 471 (94%) have RD data. Multicentre design may introduce heterogeneity in 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): high risk Multivariate Cox model for OS adjusted for number of NACT cycles (≤ 4, > 4); age (cat); Charlson index; FIGO; lymph node status (N+ vs N0); response to NACT; residual disease (RD > 0 cm to 2.5 cm vs RD 0 cm) Large missing data rate for Charlson index (40%) and response to NACT (24%) ‐ no methods discussed to handle missing data therefore assumed complete case analysis. 6. Statistical analysis and reporting (a‐d): unclear risk No conceptual framework; data driven based on P values of univariate associations. Unclear on reasons why the particular specific set of variables were selected for univariate screening. Although multivariate estimates for RD were presented in the text of results, they did not appear in the corresponding tables. Outcome: progression‐free survival 4. Outcome measurement (a‐c): low risk Valid and reliable measurement of outcome 5. Adjustment for other prognostic factors (a‐g): high risk Multivariate Cox model for PFS adjusted for number of NACT cycles (≤ 4, > 4); age (cat); response to NACT; residual disease (RD > 0 cm to 2.5 cm vs RD 0 cm) Large missing data rate for response to NACT (24%) ‐ no methods discussed to handle missing data therefore assumed complete case analysis. 6. Statistical analysis and reporting (a‐d): unclear risk No conceptual framework; data driven based on P values of univariate associations. Unclear on reasons why the particular specific set of variables were selected for univariate screening. Although multivariate estimates for RD were presented in the text of results, they did not appear in the corresponding tables. |
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Notes | Study reports n = 471 with RD data, but due to missing data from other variables in the multivariate model, the HR estimates for OS and PFS may not be based on complete case analysis and could be based on less, unless imputation was used (e.g. multiple imputation by chained equations). Median NACT cycles ≤4 cycles: median 4 (range 3 to 4); > 4 cycles: median 6 (range 5 to 8) NACT regime Platinum and taxane: 464 (93%); other platinum‐based: 37 (7%) Response to NACT: Complete response: 73/380 (19%); partial: 307/380 (81%) Time from diagnosis to IDS, months ≤ 4 NACT cycles: 3.8 (range 3.1 to 4.7); > 4 cycles: 5.9 (range 5.1 to 7.7) Operating duration, minutes ≤ 4 cycles: 328 (range 300 to 375); > 4 cycles: 360 (range 293 to 450) Blood transfusion: Yes: 44/77 (57%); no: 33/77 (43%) Intraoperative complications: Yes: 57/387 (15%); no: 330/387 (85%) |