P-0214 - Use of oxaliplatin-based chemotherapy in patients with metastatic colorectal cancer (mCRC): a post-hoc analysis of the GLUTOX study

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Benoit Samson
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors B. Samson1, R. Wierzbicki2, J. Maroun3, R. Letourneau4, E. Chen5, D. Charpentier6, F. Couture7, M. Vincent8, J. Lepine9, P. Whitlock10, K. Alloul11, F. Leblond11, W. Zhou11, P. Kavan12, P. Dube13, N. Aucoin14
  • 1Centre de Santé et de Services Sociaux Champlain Charles-Lemoyne, Greenfield Park/CA
  • 2RSM Durham Regional Cancer Centre, Oshawa/CA
  • 3The Ottawa Hospital Cancer Centre, Ottawa/CA
  • 4CHUM-Hopital St-Luc, Montreal/CA
  • 5Princess Margaret Hospital, Toronto/CA
  • 6CHUM-Hopital Notre-Dame, Montreal/CA
  • 7CHUQ Pavillon Hotel-Dieu De Quebec, Quebec City/CA
  • 8London Health Sciences Centre, London/CA
  • 9Centre Hospitalier Regional de Rimouski, Rimouski/CA
  • 10Dr. Leon Richard Oncology Centre, Moncton/CA
  • 11Sanofi Canada, Laval/CA
  • 12McGill University, Montreal/CA
  • 13Hopital Maisonneuve-Rosemont, Montreal/CA
  • 14Hopital de la Cite-de-la-Sante, Laval/CA

Abstract

Introduction

Oxaliplatin-based chemotherapy has significantly improved overall survival in first-line therapy for patients having CRC, either in adjuvant or metastatic settings. The objective of this post-hoc analysis conducted in mCRC patients of the GLUTOX study (Samson et al. Eur J Cancer 2013, 49(S2):S518) is to provide Canadian-based data on treatment patterns and efficacy.

Methods

The GLUTOX study was a Canadian, multicenter, randomized, open-label, phase III clinical trial with CRC patients treated in first-line with an oxaliplatin-based chemotherapy regimen either in adjuvant or metastatic settings. Adult oxaliplatin-naïve patients with ECOG ≤2 were included and patients were excluded if they were previously or currently diagnosed with a peripheral sensory neuropathy. Of the 200 patients enrolled in GLUTOX, 58 had mCRC. Efficacy, quality of life and safety data were analysed in the subgroup of mCRC patients.

Results

Patients with mCRC had a median age of 58 years (range of 33 to 75) and were mostly men (62.1%) and whites (96.6%). Primary tumor site was colon in 77.6% of patients. Patients were ECOG 0 (77.6%) and 1 (22.4%). Median duration of disease was 1.5 months (range 0.1 to 156.7). The oxaliplatin-based chemotherapy regimens were mFOLFOX6 (87.9%), FOLFOX4 (8.6%) and XELOX (3.4%) with 60.3% of patients receiving bevacizumab. Adverse events (35.1%) were the main reason for withdrawal from the study. A median of 10 cycles (range of 1 to 12) of oxaliplatin was received. 43.1% of patients had progressed during the study and the median progression-free survival was 638 days. 60.3%, 53.4% and 41.4% of patients reached respectively 8, 10 and 12 cycles of oxaliplatin-based chemotherapy regimen. Mean/median number of cycles received were 8.2/10 cycles. The overall/oxaliplatin median relative dose intensities (%) at cycles 8, 10 and 12 were respectively 100/100, 96/94 and 98/94. The overall response rate was 68.9%. On the FACT/GOG NTX-12 where a higher score indicates better QoL, a median increase of 3 points (range -6 to 29) from baseline to end of treatment was observed. At the 3 months follow-up visit, 48.2% of patients were receiving a chemotherapy regimen: FOLFOX (37.0%), 5FU/leucovorin (29.6%) and FOLFIRI (11.1%). 53.4% of patients reported grade 3/4 toxicities up to 30 days after the last oxaliplatin dose and the most frequent were neutropenia (29.3%), diarrhea (6.9%), peripheral neuropathy (6.9%) and febrile neutropenia (5.2%).

Conclusion

Oxaliplatin-based chemotherapy remains the most frequent choice worldwide in first-line for patients with CRC. Canadian mCRC patients had a higher response rate and a lower rate of grade 3/4 neutropenia, diarrhea and sensory toxicities compared to de Gramont et al. (J Clin Oncol 2000, 18:2938-2947). The Canadian mCRC patients analyzed in this post-hoc analysis had a 5 year younger median age and a better ECOG profile (0% vs 10% ECOG 2) than those studied by de Gramont et al. This Canadian multicenter post-hoc analysis is important as it provides insights of treatment patterns and progression-free survival.