Abstract 4991
Background
There are very limited treatment options in metastatic colorectal cancer (mCRC) after progression on chemotherapy including fluoropyrimidine, oxaliplatin and irinotecan. This open label, multi-center, phase II study was conducted to investigate the combination of pemetrexed and erlotinib in patients who were refractory to previous chemotherapy for mCRC.
Methods
Patients were eligible if they had metastatic colorectal cancer that progressed to standard chemotherapy including fluoropyrimidine, oxaliplatin, and irinotecan. Each 21-day cycle consisted of intravenous pemetrexed at 500 mg/m2 on day 1 and daily oral erlotinib at 150 mg (reduced to 100 mg after the first 29 patients).
Results
Fifty patients were enrolled onto this phase II study. Twenty-seven patients (54%) had KRAS wild type tumors and 23 patients (46%) did KRAS mutant tumors. Forty-six patients were evaluable for response; twenty-seven patients (59%) had stable disease (SD) and 4 patients (9%) achieved prolonged SD for >6 months. No complete or partial responses were seen. The median progression-free survival was 2.5 months and the median overall survival was 7.3 months. Clinically significant grade 3 to 4 toxicities included diarrhea (6%), fatigue (6%), ileus (4%), skin rash (2%), and myalgia (2%); grade 3 or 4 toxicities were reduced with a lower starting dose of erlotinib.
Conclusions
The combination of pemetrexed and erlotinib seems to have limited activity in refractory mCRC patients. Further research for the regimen is not warranted without understanding predictive biomarkers.
Clinical trial identification
NCT02723578.
Legal entity responsible for the study
Joong Bae Ahn.
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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