Stoeckle 2014.
Study characteristics | ||
Methods | Single‐centre retrospective study | |
Participants | N = 118 women diagnosed with primary ovarian carcinoma, epithelial cell type (stages IIIC with carcinomatosis and IV) who were treated by NACT + late IDS (after 6 cycles) in the taxane/platinum period (1998 to 2010) Median age: 64 (range: 37 to 88) FIGO: IIIC – 82 (69%); IV – 36 (31%) Histology: serous – 111 (94%); non‐serous – 7 (6%) Had lymph node assessment: 105 (89%) Median node count: 32 (range: 4 to 81) Lymph node involvement
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Residual disease details | All women had sampling biopsy.
Median NACT cycles: 6 (range: 5 to 13) NACT regimen
All IDS performed by 2 surgeons (co‐authors on paper) with experience in ovarian cancer surgery Resection categories (other than peritoneal stripping)
Number of resection categories Median: 6 Range: 0 to 8 Standard surgery: 54 (46%) Extended surgery: 64 (54%) 'Optimal' cytoreduction defined as RD < 1 cm (n = 111, 94%)
* In multivariable analysis, it is NMRD vs RD > 0 cm |
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Outcomes | Overall survival defined as time from date of initial diagnosis to date of death of any cause Median OS: 42 months Median OS in no macroscopic RD group (RD 0 cm): 50 months Median OS in RD > 0: 38 months Multivariable Cox PH for OS adjusted for tumour grade, WHO performance status, ASA, bowel surgery (yes/no), FIGO stage: RD > 0 cm vs NMRD: HR 2.2 (95% CI 1.2 to 4.0), P = 0.01 Progression‐free survival (PFS) was calculated from the date of initial diagnosis to date of progression. Progression was defined as locoregional or metastatic recurrences after complete remission or progression of disease in women without complete remission. Median PFS: 17.2 months No multivariable analysis for PFS Death within 30 days of surgery: 2 (1.7%) |
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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. Overall survival defined as time from date of initial diagnosis to date of death of any cause. 5. Adjustment for other prognostic factors (a‐g): unclear risk Model predicting OS adjusted for tumour grade, WHO performance status, ASA, bowel surgery (yes/no), FIGO stage 6. Statistical analysis and reporting (a‐d): unclear risk No conceptual framework; data driven based on P values of univariate associations Outcome: progression‐free survival 4. Outcome measurement (a‐c): low risk Valid and reliable measurement of outcome. Progression was defined as locoregional or metastatic recurrences after complete remission or progression of disease in women without complete remission. 5. Adjustment for other prognostic factors (a‐g): high risk Model predicting PFS was not adjusted for any other prognostic factor 6. Statistical analysis and reporting (a‐d): high risk Model predicting PFS was not adjusted for any other prognostic factor |
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Notes | Median follow‐up: 37 months ASA score:
WHO performance status
At IDS, 96 (81%) presented with visible tumour. Median tumour size was 2 mm. Median length of hospital stay (all women): 10 (2 to 44) Median length of stay (women with complications): 16 (range: 7 to 44) Major morbidity was defined as a complication requiring a prolonged hospital stay (more than 10 days), re‐hospitalisation or reoperation (by surgery or interventional imaging) needing correction by major medication (e.g. prolonged IV antibiotics or blood transfusion (5 packed red blood cells), or causing death during the first postoperative month 21 women (18%) had major complications, for a total of 24 major complications
Rehospitalisation: 10 women Reoperation by surgery or imaging techniques: 8 women |