P-0215 - Efficacy, safety and patient-reported outcomes of oxaliplatin-based chemotherapy in elderly patients with colorectal cancer (CRC): a post-hoc analys...

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Geriatric Oncology
Colon Cancer
Rectal Cancer
Presenter Benoit Samson
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors R. Letourneau1, H. Grassin2
  • 1CHUM-Hopital St-Luc, Montreal/CA
  • 2Sanofi Canada, Laval/CA

Abstract

Introduction

Oxaliplatin has significantly improved overall survival of adult patients having CRC. The objective of this post-hoc analysis from the GLUTOX study (Samson et al. Eur J Cancer 2013, 49(S2):S518) was to evaluate efficacy, safety and patient-reported outcomes of an oxaliplatin-based chemotherapy regimen in CRC patients of age ≥70 and <70 years old.

Methods

The GLUTOX study was a Canadian, multicenter, randomized, open-label, phase III clinical trial with 200 CRC patients treated with an oxaliplatin-based chemotherapy regimen either in adjuvant or metastatic settings. The GLUTOX trial randomized patients in 2 arms with or without glutamine, but this post-hoc analysis was done independently of the randomized treatment. 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. In this post-hoc analysis, efficacy, safety and patient-reported outcomes data were compared between patients ≥70 (elderly) and <70 (younger) years of age.

Results

37 patients were ≥70 years old (median = 72; range = 70-79) and 163 were <70 years old (median = 57; range = 29-69). Patients baseline and disease characteristics were similar between groups, except that in the elderly group there were more male patients (≥70 = 70.3%, <70 = 56.4%, p = 0.052) and the mean duration of disease was longer (≥70 = 8.91 ± 26.74, <70 = 2.85 ± 4.87 months, p = 0.015). Patients were mostly treated in adjuvant settings in both groups (≥70 = 59.5%, <70 = 73.6%, p = 0.99). Patients mostly used mFOLFOX6 (≥70 = 83.3%, <70 = 90.1%). Elderly patients received a median of 11 cycles (range = 1-12) of oxaliplatin compared to 10 cycles (range = 1-12) for younger patients (p = 0.35). Similar% of patients reached 8 (≥70 = 78.4%, <70 = 73.6%, p = 0.22), 10 (≥70 = 62.2%, <70 = 58.3%, p = 0.60) and 12 (≥70 = 51.4%, <70 = 41.7%, p = 0.27) cycles, with similar overall and oxaliplatin relative dose intensities. Best overall response was similar between groups (≥70 = 46.2%, <70 = 54.5%, p = 0.73) in the metastatic stratum. A median increase of 6 points (range: ≥70 = -1-26, <70 = -8-31) from baseline in the FACT/GOG NTX-12 score was observed in both groups. 59.5% of elderly and 55.2% of younger patients reported grade 3/4 toxicities up to 30 days after the last oxaliplatin dose. More neutropenia was reported in elderly (40.5%) than younger (22.1%) patients while less peripheral neuropathy observed in the elderly group (≥70 = 5.4%, <70 = 14.1%). Other frequent grade 3/4 toxicities reported were diarrhea (≥70 = 8.1%, <70 = 6.1%) and febrile neutropenia (≥70 = 5.4%, <70 = 3.7%).

Conclusion

In this post-hoc analysis, CRC patients aged ≥70 treated with an oxaliplatin-based chemotherapy regimen showed similar efficacy and patient reported outcomes results than patients <70 years of age, with more neutropenia but less peripheral neuropathy.