EORTC55971
Neoadjuvant Chemotherapy or Primary Surgery in Stage IIIC or IV Ovarian Cancer
Disease site
Ovary
Pubmed link
https://pubmed.ncbi.nlm.nih.gov/20818904/
Publication month/year
September 2010
Study question
Primary debulking surgery (PDS) followed chemotherapy vs neoadjuvant chemotherapy followed by interval debulking surgery (NACT/IDS) in women with advanced ovarian
Type of study
Randomised controlled trial (RCT)
Interventions compared
PDS vs NACT/IDS
Experimental arm (Intervention)
NACT/IDS
- x3 cycles chemotherapy (Platinum based)
- IDS
- x3 cycles chemotherapy (Platinum based)
Control arm
PDS
- PSD
- x6 cycles chemotherapy (Platinum based)
Chemotherapy: Paclitaxel (175 mg/m2, over 3 hrs) + Carboplatin (area under the curve of 6)
Other regimens: Cisplatin (75 mg/m2, every 3 weeks) or Carboplatin (area under the curve of 5)
Primary outcome
Overall survival (OS)
Secondary outcome
- Recurrence Free Survival (RFS)
- QoL
Inclusion criteria
- Biopsy-proven stage IIIC or IV invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian-tube carcinoma.
- OR fine-needle aspirate showing an adenocarcinoma with either a pelvic (ovarian) mass; metastases outside the pelvis measuring at least 2 cm in diameter; regional lymph-node metastasis or proof of stage IV disease
- CA125/CEA ratio > 25 – WHO perfrmance status 0-2
- Start treatment within 3 weeks of the biopsy or cytology
Exclusion criteria
Contraindication to PDS or NACT/IDS
Results
| PDS | NACT/IDS | |
|---|---|---|
| Recruited(n) | 336 | 334 |
| Received treatment(n) | 315 | 326 |
| Stage 3C | 257 (76.5%) | 253 (75.7%) |
| Stage 4 | 77(22.9%) | 81(24.3%) |
| Residual disease = 0 cm | 61(19.4%) | 151(51.2%) |
| Residual disease= 0-1 cm | 70(22.2%) | 87(29.5%) |
| Residual disease > 1cm | 167(53%) | 52(17.7%) |
| Surgery time (min, median) All | 165(10-720) | 180(30-560) |
| Surgical time (min, median) in zero residual | 312 | 194 |
| OS(median, months) | 29 | 30 |
| PFS(median, months) | 12 | 12 |
| Death ( < 28days treatment) | 2.5% | 0.7% |
| Grade 3/4 complications | 7.1% | 4.1% |
Conclusions
NACT/IDS is not inferior to PDS for patients with stage IIIC or IV ovarian carcinoma.
Study limitations
Variation in surgical quality & effort between recruiting centres
Additional resources
Metanalysis of CORUS & EORTC55971 (Link: https://pubmed.ncbi.nlm.nih.gov/30413383)
Reviewer name
Moiad Alazzam