Eisenkop 2003.
| Study characteristics | ||
| Methods | This is a prospective study of women with FIGO stage IIIC ovarian cancer treated with primary cytoreductive surgery followed by platinum‐based chemotherapy between 1990 and 2002 at a single North American institution | |
| Participants | 408 consecutive women presenting with stage IIIC epithelial ovarian cancer form the study group The median age at study entry was 62.8 years (range: 24 to 91) All women presented with FIGO stage IIIC epithelial ovarian cancer: 408 (100%) Tumour cell type: serous: 239 (58.5%), unspecified adenocarcinoma: 98 (24%), endometrioid: 32 (8%), clear cell: 10 (2.5%), mucinous: 18 (4.5%), mixed: 9 (2%), transitional cell: 2 (0.5%) Tumour grade: 1: 21 (5%), 2: 82 (20%), 3: 304 (75%), unspecified: 1 woman Volume of ascites: none: 20 (5%), ≤ 1000 mL: 114(28%), > 1000 mL: 249(61%), not recorded: 24(6%) GOG performance score: 0: 17 (4%), 1: 88 (21.5%), 2: 177 (43.5%), 3: 59 (14.5%), 4: 2 (0.5%), unspecified: 65 (16%) Preoperative tumour volume: Location of the largest metastases: omentum and adjacent structures: 228 (56%), pelvis: 102 (25%), retroperitoneal lymph nodes: 34 (8%), diaphragm: 12 (3%), other (large bowel, small bowel, mesentery, etc): 32 (8%) Largest metastatic disease: < 10 cm: 104 (26%), > 10 cm: 302 (74%) |
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| Residual disease details | Residual disease was noted as follows:
Surgery was undertaken by a gynaecological oncologist and disease was assessed intraoperatively in each of the following 5 regions: the left and right upper abdominal quadrants, the pelvis, the retroperitoneum and the central abdomen. A specifically defined numerical rank of 0 to 3 was assigned to each of the 5 regions and the ranks for each of the 5 regions were summed to give a total score before cytoreduction. 'Optimal' cytoreduction was defined as complete cytoreduction with no visible residual disease. The authors have previously described in other publications how this can be achieved at different anatomical sites but recourse to bowel resection was routine as was pelvic and para‐aortic nodal dissection. Postoperative chemotherapy was platinum‐based: cisplatin (50 to 100 mg/m2) or carboplatin (300 to 400 mg/m2) given in combination therapy with either cyclophosphamide or paclitaxel every 3 weeks for a planned 6 to 8 cycles. |
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| Outcomes | Overall survival: HR adjusted for sum of rankings (a numerical ranking system was devised to reflect the continuum of progressively extensive tumour involvement for 5 anatomic regions) using a Cox model: SVRD vs NMRD: HR 2.32 (95% CI 1.20 to 5.37) LVRD (> 1 cm) vs NMRD HR: 2.98 (95% CI 1.74 to 5.23) Direct surgical morbidity and mortality Postoperative mortality occurred in 10 (2.5%) women Other morbidity including surgically related systemic morbidity such as chest infection, thromboembolic disease and cardiovascular events have not been reported Recovery The median length of hospital stay was 10 days |
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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. Survival was measured in months from the date of primary surgery to the time of death or last follow‐up appointment using life table analysis. 5. Adjustment for other prognostic factors (a‐g): high risk HR for OS was adjusted for residual disease and sum of rankings (a numerical ranking system was devised to reflect the continuum of progressively extensive tumour involvement for 5 anatomic regions) 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 | The median follow‐up interval was 32.8 months Survival was measured in months from the date of primary surgery to the time of death or last follow‐up appointment using life table analysis. Survival outcomes were analysed based on the numerical ranking of disease in each anatomical region, the sum of the ranking and the cytoreductive outcome. The median survival was 58.2 months (24% to 91%) and the estimated 5‐year survival was 49% Ranking of disease load 349 (85.5%) of women had ranking in all 5 designated regions. Ranking was not possible in the rest because lymph node dissection was deferred in 48 women (12%) or the pattern of spread was inconsistent with ranking criteria in 16 women (4%). On univariate analysis, categorisation of the sum of ranking scores (0 to 5 vs 6 to 10, vs ≥ 11), as well as ranking in the left upper abdominal quadrant and in the central abdomen were statistically important determinants of survival. Univariate analysis showed that any rank score over zero (any disease) in the left upper abdominal quadrant (P = 0.01) and in the central abdominal region (P = 0.04) adversely affected survival. An effect of the anatomical site of disease on survival was not confirmed on multivariate analysis. On multivariate analysis, survival was most influenced by the completeness of cytoreduction (P = 0.001), and less influenced by the categorised sum of rankings (P = 0.05). This study demonstrates that high rates of complete cytoreduction can be achieved within dedicated teams with suitable training. The independent effect of completeness of cytoreduction on survival is confirmed though the median length of follow‐up in the report is modest. |
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