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
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