A Phase II Study Alternating Erlotinib With Second-line mFOLFOX6 or FOLFIRI for Metastatic Colorectal Cancer
| Autor: | John M. Strother, Kerstin M Kampa-Schittenhelm, Matthew R. Kearney, Kendra Todd, Charles D. Lopez, Emerson Y. Chen, Jeff Donovan, Gina M. Vaccaro, Andrea Burt |
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| Rok vydání: | 2018 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Organoplatinum Compounds Colorectal cancer Leucovorin Phases of clinical research Neutropenia Irinotecan Disease-Free Survival 03 medical and health sciences Erlotinib Hydrochloride 0302 clinical medicine Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis Aged business.industry Combination chemotherapy General Medicine Middle Aged medicine.disease Oxaliplatin 030220 oncology & carcinogenesis FOLFIRI Camptothecin Female Erlotinib Fluorouracil business Colorectal Neoplasms medicine.drug |
| Zdroj: | Anticancer research. 39(1) |
| ISSN: | 1791-7530 |
| Popis: | Background Based on our pre-clinical data, we hypothesized that sequencing chemotherapy with erlotinib would increase the tumor response rate in patients with metastatic colorectal cancer. Patients and methods A phase II trial (planned n=58) using second-line therapy for metastatic colorectal cancer with either oxaliplatin-based (mFOLFOX6) or irinotecan-based (FOLFIRI) combination chemotherapy and 100 mg erlotinib daily on days 3-8 after each infusion (days 1 and 2) every 14 days. The primary endpoint was the response rate compared to the historical response rate. Results The FOLFIRI/erlotinib arm met the pre-specified response rate criteria of at least 10% to expand accrual to the intended sample size. The trial was halted after an interim safety analysis (n=11) due to excess grade 3 neutropenia, dose reductions and treatment delays. Grade 3 or 4 neutropenia was observed in 64% of patients. The response rate was 18%. Conclusion In second-line treatment for metastatic colorectal cancer, mFOLFOX6 or FOLFIRI with erlotinib in a sequence-dependent fashion is not feasible despite potential promising activity. |
| Databáze: | OpenAIRE |
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