Results of a phase 2 study indicate that mFOLFIRI was not superior to mFOLFOX in the second-line treatment of patients with biliary tract cancer.
Treatment with second-line chemotherapy is challenging after disease progression from first-line gemcitabine plus cisplatin in patients with locally advanced or metastatic biliary tract cancer. However, treatment with modified FOLFOX (mFOLFOX) was proved to be superior to active symptom control in the ABC-06 trial.1 Irinotecan (Camptosar) is an active drug used in the treatment of various gastrointestinal cancers.
Led by Jin Won Kim, MD, PhD, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea, a phase 2 study evaluated whether mFOLFIRI was superior to mFOLFOX in the second-line treatment of patients with biliary tract cancer.2 Study results were presented at this year’s annual meeting of the American Society of Clinical Oncology (ASCO).
Patients diagnosed with biliary tract cancer and had disease progression after receiving gemcitabine plus cisplatin were randomized 1:1 to mFOLFOX or mFOLFIRI. Randomization was stratified by tumor location (intrahepatic vs extrahepatic vs gallbladder vs ampulla of Vater) and Eastern Cooperative Oncology Group (ECOG) performance status (0-2). The primary end point was the overall survival (OS) rate at 6 months.
A total of 120 patients were enrolled in this study, 114 of whom received treatment, including 56 patients who received mFOLFOX and 58 patients who received mFOLFIRI. Patient median age was 63 years. Most (89.5%) patients had ECOG status of 0 or 1. Tumor location was intrahepatic in 47 patients (41.2%), extrahepatic in 27 patients (23.7%), gallbladder in 35 patients (30.7%), and ampulla of Vater in 5 patients (4.4%).
At a median follow-up duration of 25.8 months, the 6-month OS rates were 54.2% and 43.6% in those who received mFOLFOX and those in the mFOLFIRI group, respectively. Of 101 evaluable patients (mFOLFOX, N = 51; mFOLFIRI, N = 50), objective response rates were 5.9% and 66.7% in those with mFOLFOX and with mFOLFIRI, respectively; disease control rates were 4.0% and 64.4% with mFOLFOX and with mFOLFIRI, respectively.
Median progression-free survival rates were 2.8 months and 2.1 months with mFOLFOX and with mFOLFIRI, respectively (P = .887). Median OS rates were 6.3 months and 5.7 months with mFOLFOX and with mFOLFIRI, respectively (P = .472).
The most common grade 3 or 4 adverse events were neutropenia (25.0%) and aspartate transaminase or alanine transaminase elevation (16.1%) in the mFOLFOX group and neutropenia (25.9%) and anemia (17.2%) with the mFOLFIRI group. Peripheral neuropathy (37.5%) and thrombocytopenia (37.5%) occurred more frequently in the mFOLFOX group, and vomiting (19.0%) and cholangitis (10.3%) occurred more frequently with mFOLFIRI. No chemotherapy-related deaths were reported.
The investigators concluded that as second-line therapy for biliary tract cancer, the mFOLFIRI regimen was tolerable but not superior to mFOLFOX.
Source: Kim JW, et al. J Clin Oncol. 2020;38(15_suppl). Abstract 4603.
References
- Lamarca A, Palmer DH, Singh Wasan H, et al. ABC-06: a randomised phase III, multi-centre, open-label study of active symptom control (ASC) alone or ASC with oxaliplatin/5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced/metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy. J Clin Oncol. 2019;37(15_suppl):Abstract 4003.
- Kim JW, Suh KJ, Kim J-W, et al. A randomized phase II study of oxaliplatin/5-FU (mFOLFOX) versus irinotecan/5-FU (mFOLFIRI) chemotherapy in locally advanced or metastatic biliary tract cancer refractory to first-line gemcitabine/cisplatin chemotherapy. J Clin Oncol. 2020;38(15_suppl):Abstract 4603.