Chi 2001.
| Study characteristics | ||
| Methods | Retrospective cohort study | |
| Participants | 282 women with stage III and IV epithelial ovarian cancer. Women with ovarian tumours of low‐malignant potential were excluded from this study. All women were treated between 1987 and 1994 at Memorial Sloan‐Kettering Cancer Center (MSKCC) The median age at study entry was 59 years with a range between 22 and 87 years 22 (8%) women had FIGO stage IIIA/IIIB, 194 (69%) had stage IIIC and 66 (23%) had stage IV disease Tumour cell type: serous 199 (71%), endometrioid: 46 (16%), clear cell: 19 (7%), mucinous: 10 (4%), mixed: 8 (3%) Tumour grade: 1: 13 (5%), 2: 69 (24%), 3: 184 (65%) Ascites: yes: 238 (84%), no: 43 (15%), unknown: 1 (1%) |
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| Residual disease details | Women were treated with primary surgery followed by chemotherapy Type of surgeon Residual disease was noted as follows:
The following types of chemotherapy were given to women in the study: cisplatin/cyclophosphamide: 143 (51%), carboplatin/cyclophosphamide: 65 (23%), carboplatin/paclitaxel: 31 (11%), cisplatin/paclitaxel 24 (8%), carboplatin: 7 (3%), cisplatin 1 (< 1%), none or unknown 10 (4%) Gynaecology oncologists from the academic institution surgically staged all women |
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| Outcomes | A multivariable analysis which included age, stage (IIIC and IV vs IIIA/IIIB), ascites (yes vs no) and residual disease (1 cm to 2cm and > 2 cm vs < 1 cm) was performed to evaluate important prognostic factors Overall survival: HR adjusted for prognostic categories (see above):
Direct surgical morbidity 8 women (2.83%) died within 1 month of surgery |
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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 Survival was calculated as the number of months from initial surgery to death or the date of last follow‐up 5. Adjustment for other prognostic factors (a‐g): low risk HR for OS was adjusted for residual disease, age, stage (IIIC and IV versus IIIA/IIIB) and ascites (yes versus no) 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 | Of the 295 women who were treated for FIGO stage III and IV epithelial ovarian cancer at this centre over the period of the study, 13 (5%) were lost to follow‐up, and the remaining 282 form the study group for this analysis Median follow‐up in the study was 32 months (range: 1 to 139 months) The chemotherapy was platinum‐based and when women who had initially had single agent therapy or combinations with cyclophosphamide recurred they were often given paclitaxel Survival was calculated as the number of months from initial surgery to death or the date of last follow‐up. 214 of the 282 (76%) women were dead from disease or other causes at the time of census. Multivariate analysis: Only women age at diagnosis (P = 0.001), presence of ascites (P = 0.001) and the size of residual disease after primary cytoreductive surgery (1 cm vs 1 cm to 2cm vs > 2 cm (P = 0.02 and 0.001, respectively)) retained prognostic significance Kaplan‐Meier curve Women with no more than 1 cm of residual disease after primary surgery have a 5‐year survival of 50% and a median survival of 55 months. There is no statistically significant difference in survival between those women with 1 cm to 2 cm of residual disease and those with greater than 2 cm residual (P = 0.40). This combined group of women have a 5‐year survival of 22% with a median survival of 28 months. Impact of residual tumour volume for FIGO stage III A subgroup analysis of the 216 women with stage III disease was done to examine the impact of size of residual disease on survival 56 of these women had up to 1 cm of residual disease and had 5‐year survival of 50% and median survival of 56 months 73 of these women had between 1 cm and 2cm of residual disease and had 5‐year survival of 28% and median survival of 31 months 87 of these women had greater than 2 cm of residual disease after surgery and had 5‐year survival of 21% and a median survival of 28 months The differences in survival are statistically significant between the women with up to 1 cm of residual disease and the women in the other 2 groups (P = 0.001). There is no statistically significant difference in survival between the women who had more than 1 cm residual disease. |
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