Abstract
Purpose
To evaluate the efficacy and safety profile of the combination of panitumumab and irinotecan every 3 weeks in a phase II trial as second-line treatment in patients with advanced wild-type (WT) K-RAS colorectal cancer (CRC).
Methods
Fifty-three patients received 9 mg/kg of panitumumab followed by 350 mg/m2 of irinotecan every 21 days until disease progression, unacceptable toxicity or consent withdrawal.
Results
Median age of patients included was 67 years. All patients had previously received 5-fluorouracil, 84 % oxaliplatin and 8 % irinotecan as first-line treatment. Patients received a median of five infusions of panitumumab and irinotecan. On an intention-to-treat analysis, 12 patients (23 %) achieved partial responses and 22 patients (41 %) achieved disease stabilization. Median progression-free survival and overall survival were 4.5 and 15.1 months, respectively. The most frequent treatment-related severe toxicities per patient were diarrhoea (35.8 %), followed by skin rash (32.1 %), asthenia (18.9 %) and neutropenia (13.2 %). A significant association between clinical response and incidence and grade of skin toxicity was observed (p = 0.0032).
Conclusion
This study shows that the administration of panitumumab plus irinotecan every 3 weeks is safe, active and feasible as second-line treatment in patients with advanced WT K-RAS CRC.
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Acknowledgments
The authors thank the patients and the medical and nursing staff of all the participating institutions: Also, the authors acknowledge Inmaculada Ruiz de Mena from TTD Data Center and Marta Llorens and Xavier Núñez from TFS Trial Form Support for monitoring, statistics and data management. This research, including data collection, analysis and medical writing services, was funded by Amgen. The authors also thank Dr. Beatriz Gil-Alberdi from HealthCo (Madrid, Spain) for her assistance in the preparation of the manuscript. Supported by the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD), Madrid, Spain.
Conflict of interest
Alfredo Carrato, consultant or advisory role (Amgen, Merck Serono) and research funding (Amgen). Fernando Rivera, consultant or advisory role (Amgen) and research funding (Amgen). Enrique Aranda, consultant or advisory role (Roche and Merck Serono). All remaining authors have declared no conflict of interest.
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Study TTD-06-04; EudraCT: 2006-006363-24; clinicaltrials.gov identifier NCT00475293 registered on May 17, 2007.
On behalf of the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD).
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Carrato, A., Gómez, A., Escudero, P. et al. Panitumumab and irinotecan every 3 weeks is an active and convenient regimen for second-line treatment of patients with wild-type K-RAS metastatic colorectal cancer. Clin Transl Oncol 15, 705–711 (2013). https://doi.org/10.1007/s12094-012-0993-x
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DOI: https://doi.org/10.1007/s12094-012-0993-x