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. 2022 Sep 26;2022(9):CD015048. doi: 10.1002/14651858.CD015048.pub2

Ataseven 2016.

Study characteristics
Methods Prospective cohort study
Participants 326 consecutive women with FIGO IV
Median age in the study was 61 years (range: 19 to 88 years)
All 326 women presented with FIGO stage IV disease
Histological cell type: high grade serous: 287 (88.0%), others: 39 (12.0%)
Ascites: ≤ 500 mL: 149 (45.7%), > 500 mL: 177 (54.3%)
Performance status: ECOG 0: 248 (76.1%), ECOG > 0: 78 (23.9%)
Localization of metastasis:
  • Pleural effusion/involvement: 134 (41.1%)

  • Abdominal wall: 133 (40.8%)

  • Extraregional lymph node: 63 (19.3%)

  • Liver: 45 (13.8%)

  • Spleen: 22 (6.7%)

  • Others: 19 (5.8%)


Germany
Residual disease details Surgery was performed by accredited gynaecological oncologists
Cohort 1 included 286 women who underwent primary debulking surgery
Postoperative chemotherapy was administered in 92% (263/286)
Cohort 2 included 40 women who underwent either no surgery or only diagnostic procedures without cytoreductive intention (NoCS ‐ no cytoreductive surgery)
In cohort 2, platinum‐based chemotherapy was given to 87.5% (35/40) of women
Residual disease for total cohort was noted as follows, n (%):
  • NMRD: 157 (48.2%)

  • SVRD: 88 (27.0%)

  • LVRD (> 10 mm): 41 (12.6%)

  • No cytoreduction: 40 (12.3%)

Outcomes Overall survival: HR adjusted for age, performance status, residual tumour, tumour stage and ascites
NMRD: HR 1
SVRD: HR 1.50 (95% CI 1.01 to 2.23)
LVRD (> 10 mm): HR 2.20 (95% CI 1.36 to 3.55)
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
5. Adjustment for other prognostic factors (a‐g): low risk
HR for OS was adjusted for age, performance status, residual tumour, tumour stage and ascites 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
Notes Follow‐up time: up to 4 years (mean: 46 months; median: 34 months; interquartile range: 12 to 70 months)
In total, 28 women (8.6%) did not receive chemotherapy
30‐day mortality was observed in: 12/326 (3.68%)
Median OS for all women was 50.3 months
In cohort 1, complete resection was achieved in 54.9% (n = 157/286; RD0), cytoreduction to 1 mm to 10 mm in 30.7% (n = 88/286; RD1‐10) and bulky residual disease exceeding 10 mm in 14.3% (n = 41/286; RD > 10)
Risk factors for residual disease after debulking surgery in women with EOC FIGO stage IV included:
  • Age (OR 1.85, 95% CI 1.13 to 3.03; P = 0.015)

  • Poor performance status (OR 3.46, 95% CI 1.67 to 7.18; P = 0.001)

  • Large volume ascites > 500 mL (OR 2.37, 95% CI 1.06 to 4.22; P = 0.035)

  • Presence of liver metastasis (OR 6.17, 95% CI 2.78 to 13.7; P < 0.001)


Length of hospital stay not reported