Phase II trial of capecitabine plus erlotinib versus capecitabine alone in patients with advanced colorectal cancer

• Published in: Future oncology (London, England) Vol. 13; no. 9; pp. 777 - 786
• Main Authors: Vincent, Mark D, Breadner, Daniel, Soulieres, Denis, Kerr, Ian G, Sanatani, Michael, Kocha, Walter, Klimo, Peter, MacKenzie, Mary J, O'Connell, Anne, Whiston, Frances, Malpage, Anne S, Stitt, Larry, Welch, Stephen A
• Format: Journal Article
• Language: English
• Published: England Future Medicine Ltd 01.04.2017
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biomarkers, Tumor; Cancer therapies; capecitabine; Capecitabine - administration & dosage; Capecitabine - therapeutic use; Chemotherapy; Colorectal cancer; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - mortality; Colorectal Neoplasms - pathology; Combined Modality Therapy; Diarrhea; elderly; Epidermal growth factor; erlotinib; Erlotinib Hydrochloride - administration & dosage; Female; frail; Humans; Kaplan-Meier Estimate; Lung cancer; Male; Medical prognosis; Metastasis; Middle Aged; Mutation; Neoplasm Staging; Patients; primary tumor location; Proto-Oncogene Proteins p21(ras) - genetics; Targeted cancer therapy; Treatment Outcome; Tumor Burden; Tumors; capecitabine; primary tumor location; colorectal cancer; elderly; erlotinib; KRAS; frail
• ISSN: 1479-6694; 1744-8301
• DOI: 10.2217/fon-2016-0444

Capecitabine monotherapy as palliation for advanced colorectal cancer (CRC) is generally well tolerated. Adding erlotinib, an EGFR-tyrosine kinase inhibitor, might improve efficacy versus capecitabine alone. 82 patients received capecitabine alone (Arm 1) or capecitabine with erlotinib (Arm 2). Median time-to-progression (TTP) in Arm 1 was 7.9 months versus 9.2 in Arm 2. In -wild type (WT) patients TTP was 8.4 and 11.7 months in Arms 1 and 2, respectively. In -mutated patients TTP was 7.4 and 1.9 months in Arms 1 and 2, respectively (p = 0.023). Arm 2 -WT patients, left-sided primaries, had an overall survival of 16.0 versus 12.1 months in right-sided primaries. Adding erlotinib to capecitabine increased TTP by 3.2 months in -WT patients. This study suggests that erlotinib harms patients with -mutated advanced CRC while it may provide benefit to those with -WT CRC. Further study of EGFR-tyrosine kinase inhibitors in patients with left-sided -WT CRC is warranted.