Chang 2012b.
Study characteristics | ||
Methods | Retrospective review of medical records | |
Participants | Consecutive women with stage IIIC 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 After primary surgery, all women received adjuvant chemotherapy consisting of cisplatin (75 mg/m2) or carboplatin (area under the curve; 5 to 7) and paclitaxel (135 mg/m2) based systemic combination chemotherapy (every 3 weeks for 6 to 9 cycles) Exclusion: primary cytoreduction at an outside institution, neoadjuvant chemotherapy, stage IIIC disease based on lymph node metastasis only or borderline malignancy N = 191 Median age was 54 years (range 30 to 78) Median BMI 23.2 (18.1 to 35.2) ASA 1 or 2: 107 (56.6%), 3 or 4: 74 (39.2%) Median pre‐op CA‐125 173.1 (range 4.5 to 21,677) Histological subtypes: serous: 155 (82%), mucinous: 4 (2.1%), endometrioid: 4 (2.1%), clear cell: 9 (4.8%), mixed: 17 (9.0%) Grade 1: 26 (13.8%), grade 2: 67 (35.4%), grade3: 5 (2.6%) Ascites < 1000 mL (57.7%), > 1000 mL (42.3%) Peritoneal carcinomatosis: yes:139 (73.5%), no: 50 (26.5%) Systematic lymphadenectomy (n = 135), no lymphadenectomy (n = 54) Lymphadenectomy; pelvic only (22.2%), pelvic and para‐aortic (77.8%) |
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Residual disease details | Residual disease were defined:
Overall surgical morbidity ‐ blood transfusion, deep vein thrombosis, sepsis, intestinal obstruction, ileus, lymphocyst or wound dehiscence was significantly higher in women who had lymphadenectomy |
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Outcomes |
Multivariate analysis for OS: SVRD 0.1 cm to 1 cm vs NMRD: HR 2.25 (95% CI 1.25 to 4.03) LVRD > 1 cm vs NMRD: HR 3.09 (95% CI 1.80 to 5.30) HRs adjusted for age, performance of radical surgery and performance of lymphadenectomy |
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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 residual disease, type of surgery, performance of lymphadenectomy 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 residual disease, type of surgery, performance of lymphadenectomy 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 | Systematic lymphadenectomy was performed in 135 (71.4%) of whom 105 had both pelvic and para‐aortic lymphadenectomy. The mean number of dissected pelvic and para‐aortic nodes were 25 (range 11 to 57) and 11 (range 3 to 35), respectively. 53.4% were found to have grossly enlarged lymph nodes during surgery. Of 135 women who underwent systematic lymphadenectomy, positive lymph nodes were found in 59%. The median unadjusted OS; lymphadenectomy 66 months, no lymphadenectomy 40 months. Subgroup analysis of NMRD: median OS 86 month versus no lymphadenectomy 46 months Of 189 women, tumour recurred in 110 women (58.2%) and 90 (47.6%) died of disease. 65 women with lymphadenectomy and 45 without lymphadenectomy had disease recurrence and there is no significant difference in the site of disease recurrence. |