Metastatic colon cancer patients benefit from combination therapy14 Jan 2015
FOLFOXIRI chemotherapy in combination with bevacizumab is superior to the standard FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy with bevacizumab.
These are the updated results from an Italian phase 3 study of patients with metastatic colorectal cancer which showed that this combination doubled the 5-year overall survival rate. The study confirms findings from a previous, smaller phase 3 study which showed that FOLFOXIRI alone improved survival compared with FOLFIRI alone in the first-line treatment of metastatic colorectal cancer.
“This new approach offers a substantial survival improvement being a remarkable step forward in the treatment of this disease,” said presenting author Chiara Cremolini, MD, a medical oncologist at the Tuscan Tumor Institute in Pisa, Italy adding that “our results will encourage clinicians to adopt the FOLFOXIRI regimen with bevacizumab as an upfront therapy option for patients in otherwise good health.”
Clinical trial included 508 patients with advanced colorectal cancer
In the study, 508 patients with metastatic colorectal cancer were randomly assigned to initial (induction) therapy consisting of FOLFIRI plus bevacizumab or FOLFOXIRI plus bevacizumab. Up to six months (12 cycles) of induction therapy were planned, followed by maintenance treatment with bevacizumab in combination with less intensive chemotherapy, until the disease progressed. In about 80% of the patients, the cancer was not confined to the liver, and surgery was not feasible in most of them. Patients were followed for a median period of 48.1 months.
Promising clinical results with no added serious side effects
The median overall survival was significantly improved in the FOLFOXIRI plus bevacizumab group compared to the FOLFIRI plus bevacizumab group (29.8 vs. 25.8 months).
1 out of 4 patients (24.9%) in the FOLFOXIRI group were estimated to be alive five years after starting treatment, compared with 1 out of 8 patients (12.4%) in the FOLFIRI group.
While FOLFOXIRI increased the risks of diarrhea and low blood counts compared to FOLFIRI, serious adverse events were not increased. Dr Cremolini noted that, while many patients are able to tolerate FOLFOXIRI, it is an intensive regimen and should not be given to all patients, such as those older than 75 and those between 70 and 75 who are not in good general condition. Ongoing phase 2 trials are exploring strategies to shorten the duration of initial chemotherapy (from 6 to 4 months) and improve efficacy of the maintenance treatment.
Source: eCancer News