Three-month XELOX Regimen May Be Non-inferior to 6-month Regimen in Colorectal Cancer
An analysis suggested that a shorter, 3-month course of adjuvant chemotherapy for some patients with stage III colon cancer may yield comparable outcomes to the standard 6-month course.
|The following article features coverage from the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Click here to read more of Cancer Therapy Advisor's conference coverage.|
A preplanned pooled analysis of 6 global studies suggested that a shorter, 3-month course of adjuvant chemotherapy for some patients with stage III colon cancer may yield comparable outcomes to the standard 6-month course.1
This study (ClinicalTrials.gov Identifier: NCT01150045) from the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) Collaboration was presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
In patients with stage III colon cancer, oxaliplatin-based adjuvant therapy with FOLFOX or XELOX is the standard of care. Because oxaliplatin is associated with cumulative dose-dependent neurotoxicity, however, dose reductions are common.
The IDEA Collaboration was established to determine if a shorter duration of therapy without loss of efficacy would be of benefit to patients and health care resources.
A total of 12,834 patients with stage III disease were included.
Whether to use FOLFOX or XELOX was determined by the investigator. This was a non-inferiority study, which pre-specified that the upper limit of the hazard ratio (HR) for disease-free survival (DFS) should not exceed 1.12.
For higher than grade 2 neuropathy, the study showed a dramatic reduction in neurotoxicity in the 3-month treatment group (16% vs 3% for FOLFOX, 9% vs 3% for XELOX).
Three-year DFS was 74.6% for the 3-month group and 75.5% for the 6-month group. With an HR of 1.07, both treatment durations offered a similar efficacy. Yet the 95% confidence interval was 1.00 to 1.15, and the pre-specified non-inferiority was not met.
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The authors concluded that “while [non-inferiority] was not established for the overall cohort, [non-inferiority] of 3m [vs] 6m [oxaliplatin]-based adjuvant therapy was supported for XELOX.”
Read more of Cancer Therapy Advisor's coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.
- Shi Q, Sobrero AF, Shields AF, et al. Prospective pooled analysis of six phase III trials investigating the duration of adjuvant (adjuv) oxaliplatin-based therapy (3 vs 6 months) for patients (pts) with stage III colon cancer (CC): The IDEA (International Evaluation of Adjuvant chemotherapy) collaboration. J Clin Oncol. 2017;34(suppl; abstr LBA1).