112631-132

Chemotherapy or upfront surgery for newly diagnosed advanced ovarian cancer: Results from the MRC CHORUS trial.

Subcategory: 
Category: 
Gynecologic Cancer
Session Type and Session Title: 
Oral Abstract Session, Gynecologic Cancer
Abstract Number: 

5500

Citation: 

J Clin Oncol 31, 2013 (suppl; abstr 5500)

Author(s): 

Sean Kehoe, Jane Hook, Matthew Nankivell, Gordon C. Jayson, Henry Charles Kitchener, Tito Lopes, David Luesley, Timothy Perren, Selina Bannoo, Monica Mascarenhas, Stephen Dobbs, Sharadah Essapen, Jeremy Twigg, Jonathan Herod, W. Glenn McCluggage, Mahesh Parmar, Ann Marie Swart; School of Cancer Sciences, University of Birmingham, Birmingham, United Kingdom; MRC Clinical Trials Unit, London, United Kingdom; Medical Research Council Clinical Trials Unit, London, United Kingdom; Department of Medical Oncology, Christie Hospital and University of Manchester, Manchester Academic Health Sciences Centre, Manchester, United Kingdom; Academic Unit of Obstetrics and Gynaecology, University of Manchester, Manchester, United Kingdom; Royal Cornwall Hospitals NHS Foundation Trust, Truro, United Kingdom; Pan Birmingham Gynaecological Cancer Centre, City Hospital, Birmingham, United Kingdom; St James's Institute of Oncology, St. James's University Hospital, Leeds, United Kingdom; Department of Gynaecological Oncology, Belfast City Hospital, Belfast, Northern Ireland; Royal Surrey County Hospital, Guildford, United Kingdom; Department of Gynaecological Oncology, James Cook University Hospital, Middlesborough, United Kingdom; Department of Gynaecology, Liverpool Women's Hospital, Liverpool, United Kingdom; Department of Pathology, Belfast Health and Social Care Trust, Belfast, Northern Ireland


Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: First line treatment of advanced ovarian cancer (OC) is accepted to be primary surgery (PS) followed by adjuvant platinum-based chemotherapy (P-CT). However, the EORTC55971 trial suggested neoadjuvant chemotherapy (NACT) is an alternative, showing increased optimal debulking rates and reduced surgical complications without detriment to survival. CHORUS (CRUK 07/009) is the 2nd phase III randomized controlled trial to investigate timing of initial surgery in OC. Methods: Patients (pts) with clinical FIGO stage III-IV OC (pelvic mass, extrapelvic metastases and CA125/CEA ratio >25) were randomized to standard treatment (PS followed by 6 cycles P-CT) or NACT (3 cycles P-CT either side of surgery). CHORUS was designed to demonstrate non-inferiority of NACT, excluding a 6% absolute detriment in 3yr survival from 50% expected with PS (1-sided alpha 10%). Primary outcome was overall survival (OS) and secondary outcomes were progression free survival (PFS), toxicity and quality of life. Results: 550 women (276 PS, 274 NACT) were randomized from 74 centres (72 UK, 2 NZ) between Mar 2004 and Aug 2010. Baseline characteristics were well balanced: median age 65yrs, median tumor size 80mm, 25% FIGO stage IV, 19% WHO PS 2. Median follow-up was 3yrs, 410 pts have died. Treatment data are summarized in the Table. 3yr survival in the control arm was 32%. Intention to treat analysis showed a median OS of 22.8 months for PS vs 24.5 months for NACT (hazard ratio (HR) 0.87 in favor of NACT, 80% CI 0.76 – 0.98) and median PFS of 10.2 vs 11.7 months (HR 0.91, 0.81 – 1.02). OS results represent a 5% absolute benefit in 3yr survival for NACT to 37% and the upper 80% CI allows us to exclude a survival benefit for PS. Conclusions: NACT was associated with increased optimal debulking, less early mortality and similar survival in this poor prognosis group. CHORUS results are consistent with EORTC55971 and strengthen evidence that NACT is a viable alternative to PS. Clinical trial information: ISRCTN74802813.

PS
(n=276)
NACT
(n=274)
Treatment received Surgery 90% P-CT 92%
P-CT 76% Surgery 78%
Surgery + 6 cycles P-CT 64% 68%
Postop AEs (grade 3+)
Infection 6% 3%
Hemorrhage 3% 7%
VTE 2% 0%
Discharge within 14 days 74% 92%
Debulked to 0cm residual disease 15% 35%
12-month survival rate 70% 76%