by Dr. C.H. Weaver M.D. updated 6/2019
According to the results of a randomized phase 3 clinical trial presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, the FOLFOXIRI plus Avastin (bevacizumab) treatment regimen may result in longer progression-free survival than FOLFOX plus Avastin.
FOLFOX, FOLFIRI, and FOLFOXIRI are all standard treatment regimens for advanced colo-rectal cancer. The addition of Avastin to each of them further improves their effectiveness.
Previous research has shown that FOLFOXIRI-Avastin improves overall survival in patients with metastatic colorectal cancer compared with FOLFIRI-Avastin. However, the FOLFOXIRI-based treatment is not recommended for all patients because of its side effects.
In the current clinical trial in 177 patients under the age of 70 with metastatic colorectal cancer and 3 or more baseline circulating tumor cells were treated with either FOLFOX or FOLFOXIRI plus Avastin every 2 weeks until disease progression, unacceptable toxicity, or patient withdraw from the study and directly compared.
FOLFOXIRI-Avastin treated patients survived on average without cancer progression slightly longer; an average of 12.4 months compared with 9.3 months with FOLFOX. The overall survival was 22.3 months for FOLFOXIRI compared with 17.6 months for FOLFOX.
A previous clinical trial presented at the 2015 Gastrointestinal Cancers Symposium in San Francisco, reported that the outcomes of patients with metastatic colorectal cancer treated with FOLFOXIRI plus Avastin® doubled survival when compared to the FOLFIRI three drug regimen and Avastin.
In that study doctors from Italy treated patients with metastatic colon cancer under the age of 75 with either FOLFOXIRI, and Avastin FOLFIRI-Avastin and directly compared the outcomes.
The time to cancer progression was also 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.
This study clearly demonstrates that FOLFOXIRI-Avastin is a safe and effective option for patients with advanced colorectal cancer who can tolerate the regimen. Patients however should be aware that colon cancer can increasingly be treated with precision cancer medicines based on genomic biomarker testing of their cancer or blood. Many patients can avoid chemotherapy and experience improved survival if they have certain biomarkers. Learn more here.
- Sastre J, Vieitez JM, Gomez-España MA, et al. Randomized phase III study comparing FOLFOX + bevacizumab versus folfoxiri + bevacizumab (BEV) as 1st line treatment in patients with metastatic colorectal cancer (mCRC) with ≥3 baseline circulating tumor cells (bCTCs). Presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 3507.
- Loupakis F, Cremolini C, Masi G, et al. Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. New Engl J Med. 2014; 371:1609-1618.
- Cremolini C, Loupakis F, Antoniotti C, et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study. Lancet. 2015;16(13):1306-1315.
- Sastre J, Maestro ML, Gómez-España A. Circulating tumor cell count is a prognostic factor in metastatic colorectal cancer patients receiving first-line chemotherapy plus bevacizumab: a Spanish Cooperative Group for the Treatment of Digestive Tumors Study. Oncologist. 2012;17(7):947-955.
- Gomez A, Vieitez JM, Gil S. Safety analysis of a phase III randomized trial comparing FOLFOX + bevacizumab vs FOLFOXIRI + bevacizumab as 1st line treatment in patients with metastatic colorectal cancer (mCRC) with ≥3 circulating tumor cells (CTCs) (VISNÚ-1 TTD TRIAL). J Clin Oncol. 2018;36(15_suppl):3536-3536.
- 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).