Chang 2012a.
| Study characteristics | ||
| Methods | Retrospective review of medical records | |
| Participants | All women underwent primary cytoreductive surgery followed by platinum‐based chemotherapy. Consecutive women with stage IIIC and IV primary epithelial ovarian, fallopian tube or peritoneal cancer who underwent primary cytoreductive surgery at Ajou University Hospital between 1 January 2000 and 31 December 2011. Women received neoadjuvant chemotherapy, operated in other institution, stage IIIC due to nodal involvement were excluded N = 203 Median age was 54 years (range 30 to 78) Median BMI 23.3 (range 11.7 to 35.2) ASA 1 to 2: 114 (56.2%), 3 to 4: 80 (39.4%) Stage IIIC: 189 (93.1%), IV: 14(6.9%) Tumour grade 1: 26 (12.8%), grade 2: 72 (35.5%), grade 3: 100 (49.3%) Histological subtype: serous: 167 (82.3%), mucinous: 4 (2.0%), endometrioid: 5 (2.5%), clear cell: 9 (4.4%), mixed: 18 (8.9%) Median pre‐operative CA‐125: 603.8 (range 4.5 to 21,677) Ascites < 1000 mL (54.7%), > 1000 mL (45.3%) Carcinomatosis: yes (73.4), no (26.6%) Simple procedure (58.6%), radical procedure (41.4%). Cohort was divided into simple procedures and radical procedures group for statistical analysis. |
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| Residual disease details | Residual disease were defined:
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| Outcomes | Median follow‐up was 43 months (range of 1 to 124) Kaplan‐Meier Median unadjusted OS LVRD > 1 cm 37 months; SVRD 0.1 cm to 1 cm 46 months; NMRD 86 months Median unadjusted PFS LVRD > 1 cm 9 months; SVRD 0.1 cm to 1 cm 15 months; NMRD 35 months Multivariate analysis for OS: HR (LVRD > 1 cm vs NMRD) 3.24 (95% CI 1.90 to 5.53) HR (SVRD 0.1 cm to 1 cm vs NMRD): 2.22 (95% CI 1.25 to 3.94) Multivariate analysis for PFS: HR (LVRD > 1 cm vs NMRD): 3.40 (95% CI 2.00 to 5.77) HR (SVRD 0.1 cm to 1 cm vs NMRD): 2.20 (95% CI 1.26 to 3.84) HRs adjusted for age, FIGO stage and type of surgery (radical vs simple) Morbidity Operative time (minutes): simple: 235 (range 85 to 570), radical: 307 (range 150 to 810) Estimated blood loss: simple: 500 (range 200 to 4000), radical: 800 (range 300 to 7500) Intraoperative blood transfusion: simple (17.6%), radical (25.0%) Postoperative blood transfusion: simple (26.1%), radical (39.3%) Length of stay in ICU: simple: 0.8 (0 to 6), radical: 1.5 (0 to 6) Postoperative morbidity: simple (11.8%), radical (38.1%) Postoperative death < 30 days: simple = 0, radical = 1 |
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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 HR for OS was adjusted for stage (IV), surgical procedure, residual disease and age 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 4. Outcome measurement (a‐c): low risk Definition of PFS not provided but it usually has a standard definition. 5. Adjustment for other prognostic factors (a‐g): low risk HR for PFS was adjusted for stage (IV), surgical procedure, residual disease and age 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 |
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| Notes | Subgroup analysis for 139 women with peritoneal carcinomatosis, the median unadjusted OS LVRD > 1 cm 39 months, SVRD 0.1 cm to 1 cm 50 months, NMRD 86 months | |