|The following article features coverage from the ASCO Gastrointestinal Cancers Symposium 2022. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Adding oxaliplatin to fluoropyrimidine plus bevacizumab did not benefit older patients with metastatic colorectal cancer (mCRC), according to results of the phase 3 JCOG1018 RESPECT study.
The combination did not prolong progression-free survival (PFS), when compared with fluoropyrimidine plus bevacizumab, and was associated with greater toxicity.
These results were presented at the ASCO Gastrointestinal Cancers Symposium 2022 by Tetsuya Hamaguchi, MD, PhD, of Saitama Medical University International Medical Center in Japan.
“Fluoropyrimidine plus oxaliplatin with bevacizumab is one of the standard intensive initial therapies for these patients,” Dr Hamaguchi said. “However, because elderly patients are under-represented in clinical trials, the benefit of intensifying initial therapy is not clear in this group.”
The JCOG1018 RESPECT trial enrolled 251 patients with mCRC. They were randomly assigned to receive fluoropyrimidine plus bevacizumab with oxaliplatin (126 patients) or without oxaliplatin (125 patients). Patients received physician’s choice of fluoropyrimidine, which consisted of capecitabine or fluorouracil plus leucovorin.
The median age was 80 years in the no-oxaliplatin arm and 79 years in the oxaliplatin arm (overall range, 70-91 years). More than 90% of patients in each arm had a performance status of 0-1. The median number of metastatic sites was 2 in each arm (range, 1-5 in the no-oxaliplatin arm and 1-4 in the oxaliplatin arm).
The median PFS was 10.0 months in the oxaliplatin arm and 9.4 months in the no-oxaliplatin arm (hazard ratio [HR], 0.837; 95% CI, 0.673-1.042; P =.086).
The median overall survival was 19.7 months in the oxaliplatin arm and 21.3 months in the no-oxaliplatin arm (HR, 1.058; 95% CI, 0.808-1.386). The overall response rate was 47.7% and 29.5%, respectively.
Patients in the oxaliplatin arm experienced more frequent adverse events (AEs). Neutropenia was the most common hematologic grade 3-4 AE, occurring in 24% of patients in the oxaliplatin arm and 15% in the no-oxaliplatin arm.
The most common grade 2-4 non-hematologic AEs (in the oxaliplatin and no-oxaliplatin arms, respectively) were sensory neuropathy (57% and 15%), fatigue (32% and 21%), nausea (22% and 10%), and diarrhea (16% and 7%).
There were 3 treatment-related deaths in the oxaliplatin arm and 1 in the no-oxaliplatin arm.
As oxaliplatin was associated with more AEs and did not improve PFS, Dr Hamaguchi and colleagues concluded that fluoropyrimidine plus bevacizumab is the recommended initial treatment for elderly patients with mCRC.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Read more of Cancer Therapy Advisor’s coverage of ASCO GI 2022 by visiting the conference page.
Hamaguchi T, Takashima A, Mizusawa J, et al. A randomized phase III trial of mFOLFOX7 or CapeOX plus bevacizumab versus 5-FU/l-LV or capecitabine plus bevacizumab as initial therapy in elderly patients with metastatic colorectal cancer: JCOG1018 study (RESPECT). Presented at ASCO GI 2022; January 20-22, 2022. Abstract 10.