Background: Scientific data provide the evidence that secondary K-RAS mutations do not occur during anti-epidermal growth factor receptor therapy in colorectal cancer patients. This multicenter phase II prospective study aims to investigate the activity of a retreatment with a cetuximab-based therapy. Patients and methods: We enrolled 39 irinotecan-refractory patients who had a clinical benefit after a line of cetuximab- plus irinotecan-based therapy and then a progression of disease for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same cetuximab- plus irinotecan-based therapy. Results: Median number of therapeutic lines before accrual was 4. Median interval time between last cycle of first cetuximab-based therapy and first cycle of the retreatment was 6 months. Overall response rate was 53.8% with 19 partial responses (48.7%) and 2 complete responses (5.1%). Disease stabilization was obtained in 35.9% of patients and progression in four patients (10.2%). Median progression-free survival was 6.6 months. The correlation between skin toxicity during first cetuximab therapy and during cetuximab rechallenge was significant (P = 0.01). Conclusion: Rechallenge with the same cetuximab-based therapy may achieve a new important clinical benefit further delaying the progression of disease and improving the therapeutic options.

Cetuximab, Clinical trial, Colorectal neoplasms, Phase II, Retreatment
dx.doi.org/10.1093/annonc/mdr623, hdl.handle.net/1765/63979
Annals of Oncology
Erasmus School of Economics

Santini, D, Vincenzi, B, Addeo, R, Garufi, C, Masi, G, Scartozzi, M, … Tonini, G. (2012). Cetuximab rechallenge in metastatic colorectal cancer patients: How to come away from acquired resistance?. Annals of Oncology, 23(9), 2313–2318. doi:10.1093/annonc/mdr623