According to the results of a clinical trial presented at the 2015 Gastrointestinal Cancers Symposium in San Francisco, treatment of patients with metastatic colorectal cancer with a four-drug chemotherapy regimen plus Avastin® (bevacizumab) doubles survival when compared to a standard three drug regimen and Avastin.
According to estimates from the American Cancer Society, more than 102,000 new cases of colon cancer and about 40,000 new cases of rectal cancer were diagnosed in the United States in 2013. Together, the diseases were responsible for over 50,000 deaths. There is, however, good news about colorectal cancer in the United States: death rates associated with the disease have dropped during the past 15 years, and advances continue to be made in screening, prevention, and treatment. Unfortunately many individuals will fail initial therapy and develop metastatic disease. Continued development of drugs to treat metastatic colon cancer is necessary to further improve outcomes.
In the current study doctors from Italy treated patients with metastatic colon cancer under the age of 75 with either leucovorin, fluorouracil (5-FU), Camptosar® (irinotecan), Eloxatin® (oxaliplatin) (FOLFOXIRI), and Avastin or 12.4% with leucovorin-fluorouracil- Camptosar® (FOLFIRI)-Avastin and directly compared the outcomes.
The time to cancer progression was modestly improved from 9.7 months with FOLFIRI to 12.3 months with FOLFOXIRI. However, the number of patients surviving 5 years was significantly increased; doubling from 24.9% for FOLFOXIRI-Avastin compared to only12.4% for FOLFIRI-Avastin.
“FOLFOXIRI-Avastin doubles the estimated 5-year overall survival rate as compared to FOLFIRI-Avastin,” the lead investigator, Cremolini said during a press briefing that preceded the symposium. “FOLFOXIRI-Avastin represents a valuable option for the upfront treatment of metastatic colorectal cancer.” She added that the more intense regimen was also associated with increased toxicity, which was manageable. However, the regimen would not be suitable for patients older than 75 or those who are 70 to 75 and not in good health.
The two most widely used first-line chemotherapy regimens for metastatic colorectal cancer are FOLFIRI and FOLFOX (leucovorin-fluorouracil- Eloxatin®). Giving Avastin in addition to the chemotherapy has been shown to improve survival compared with chemotherapy alone.
This study clearly demonstrates that FOLFOXIRI-Avastin is a safe and effective option for patients with advanced colorectal cancer who can tolerate the regimen.
Reference: Cremolini C, Loupakis F, Masi G, et al. FOLFOXIRI plus bevacizumab (bev) versus FOLFIRI plus bev as first-line treatment of metastatic colorectal cancer (mCRC): Updated survival results of the phase III TRIBE trial by the GONO group. J Clin Oncol. 33, 2015 (suppl 3; abstr 657).
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