In a Japanese phase III trial (JCOG1018) reported in the Journal of Clinical Oncology, Takashima et al found that adding oxaliplatin to fluoropyrimidine/bevacizumab did not improve progression-free survival in the initial treatment of older patients with unresectable metastatic colorectal cancer.
Study Details
In the multicenter, open-label trial, 251 patients (aged 70–74) with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or aged ≥ 75 with an ECOG performance status of up to 2 were enrolled between September 2012 and March 2019. Patients were randomly assigned to receive fluoropyrimidine/bevacizumab with either fluorouracil plus calcium levofolinate (5-FU/l-LV) or capecitabine, selected before random assignment, plus bevacizumab with oxaliplatin (n = 126) or without oxaliplatin (n = 125). The primary endpoint was progression-free survival.
Key Findings
Median progression-free survival was 10.0 months (95% confidence interval [CI] = 9.0–11.2 months) in the oxaliplatin group vs 9.4 months (95% CI = 8.3–10.3 months) in the control group (hazard ratio [HR] = 0.84, 90.5% CI = 0.67–1.04, P = .086). Median progression-free survival for the oxaliplatin group vs the control group was 10 months vs 8.5 months (HR = 0.80, 95% CI = 0.57–1.13) among patients receiving 5-FU/l-LV and 10.0 vs 10.3 months (HR = 0.99, 95% CI = 0.67–1.46 ) among those receiving capecitabine. Median overall survival was 19.7 months (95% CI = 15.5–25.5 months) in the oxaliplatin group vs 21.3 months (95% CI = 18.7–24.3 months) in the control group (HR = 1.05, 95% CI = 0.81–1.37).
Grade ≥ 3 adverse events were reported in 69% of the oxaliplatin group vs 52% of the control group; the most common adverse events in both groups were neutropenia (24% vs 15%), hypertension (20% vs 15%), and anorexia (15% vs 7%). Treatment-related death occurred in three patients in the oxaliplatin group (from intracranial hemorrhage, interstitial pneumonia, and infectious pneumonia) and in one patient in the control group (from intracranial hemorrhage).
The investigators concluded: “No benefit of adding [oxaliplatin to fluoropyrimidine/bevacizumab plus bevacizumab] as first-line treatment was demonstrated in older patients with [metastatic colorectal cancer]. [Fluoropyrimidine/bevacizumab plus bevacizumab] is recommended for this population.”
Tetsuya Hamaguchi, MD, of the Department of Medical Oncology, Saitama Medical University, International Medical Center, Saitama, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by the National Cancer Research and Development Funds, Health and Labor Sciences Research Grant for Clinical Cancer Research, and others. For full disclosures of the study authors, visit ascopubs.org.
