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