-In first line in combination with FOLFOX.
-In second line in combination with FOLFIRI in patients receiving first-line treatment with fluoropyrimidine-based chemotherapy (excluding irinotecan).
It has also revised the indication stating that panitumumab monotherapy is indicated for the treatment of mCRC patients with KRAS wild-type (wild-type) monotherapy after failure of chemotherapy regimens containing fluoropyrimidine, oxaliplatin and irinotecan.
Colorectal cancer is one of the most common tumors. According to the Spanish Society of Medical Oncology (SEOM), in Western countries is second in incidence (number of new cases per 100,000 inhabitants / year), behind lung cancer in men and breast cancer in women. Colorectal cancer accounts for approximately 10-15% of all cancers. In Spain there are a total of 21,000 patients with metastatic colorectal cancer.
Globally the annual incidence is about 1.2 million cases of colorectal cancer. This tumor accounts for over 630,000 deaths each year, so that is the third leading cause of cancer death in Western countries. The peak incidence is described in Japan, North America, parts of Europe, New Zealand and Australia, and the frequency is low in Africa and Southeast Asia.
"Metastatic colorectal cancer has a devastating impact on the lives of patients and families affected by this disease," said Professor Eduardo Diaz-Rubio, Chief of Medical Oncology at the Hospital San Carlos and founder of TTD (Group Gastrointestinal Cancer Treatment). Vectibix ® is a new option for these patients in an area where we have a limited number of targeted agents that have proven effective when used with chemotherapy "
"The extension of therapeutic indications panitumumab represents a promising advance for patients facing an aggressive disease with limited therapeutic options," said Roland Wandeler, CEO of Amgen. "It represents an important milestone for Amgen and underscores our commitment to develop drugs that make a real difference in the lives of patients."
Data from studies
Data from studies 20050203 (PRIME) and 20050181 (181) showed that the addition of panitumumab to FOLFOX or FOLFIRI chemotherapy improved progression free survival (PFS) compared to chemotherapy alone in the case of patients with KRAS mCRC. In addition, the overall response rate (ORR) achieved with panitumumab plus chemotherapy was superior to that obtained with chemotherapy alone.
Although numerical level was higher, the improvement in median overall survival (OS) did not reach statistical significance in the group treated with panitumumab in either of these two trials. Trials Amgen PRIME and 181 were the first phase 3 trials that prospectively analyzed the effect of an inhibitor of growth factor receptor (EGFR) as a function of KRAS status in patients with mCRC.
Adverse effects PRIME trial and 181 are some already known toxicities associated with EGFR therapy, such as rash, diarrhea and hypomagnesemia. The incidence of infusion-related reactions of grade 3/4 was approximately 1% in the treatment groups of the two trials. In patients with tumors with KRAS mutations, the results were worse in patients treated with panitumumab plus FOLFOX compared with those receiving the latter drug in isolation. The use of panitumumab should be limited to patients in whom there is a confirmed KRAS status (wild-type).
Jemal. Global Cancer Statistics. CA Cancer J Clin 2011; 61:69-90
Douillard, JE et al. Randomized, Phase 3 Study (PRIME) of Panitumumab with FOLFOX4 versus FOLFOX4 Alone as First-Line Treatment in Patients With Previously Untreated Metastatic Colorectal Cancer. J Clin Oncol 28. 2010.
Peeters, M et al. Randomized Phase III Study of Panitumumab With Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Compared With FOLFIRI Alone As Second-Line Treatment in Patients With Metastatic Colorectal Cancer. J Clin Oncol 28, 2010.
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