A Phase II Study Alternating Erlotinib With Second-line mFOLFOX6 or FOLFIRI for Metastatic Colorectal Cancer.

Matthew R Kearney, Emerson Y Chen, Gina M Vaccaro, John Strother, Andrea Burt, Kendra Todd, Jeff Donovan, Kerstin M Kampa-Schittenhelm, Charles D Lopez

Journal: Anticancer research 2019;39(1):245-252

PMID: 30591465

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Abstract

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.

Address: Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, U.S.A.; Hematology Oncology of Salem, Salem, OR, U.S.A.; Department of Oncology, Hematology, Rheumatology, Clinical Immunology and Pulmonology, University Hospital Tübingen, Tübingen, Germany.; Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, U.S.A. [email protected].

DOI: 10.21873/anticanres.13104

Link outs

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https://medlineplus.gov/colorectalcancer.html

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https://assays.cancer.gov/CPTAC-802

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https://antibodies.cancer.gov/detail/CPTC-EGFR-8

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MeSH Terms: Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Colorectal Neoplasms, Disease-Free Survival, Erlotinib Hydrochloride, Female, Fluorouracil, Humans, Irinotecan, Leucovorin, Male, Middle Aged, Neoplasm Metastasis, Organoplatinum Compounds