Bevacizumab + chemotherapy versus chemotherapy alone in elderly patients with untreated metastatic colorectal cancer: a randomized phase II trial - PRODIGE 20 study results

Abstract

BACKGROUND

Metastatic colorectal cancer frequently occurs in elderly patients. Bevacizumab in combination with front line chemotherapy is a standard treatment but some concern raised about tolerance of bevacizumab for these patients. The purpose of PRODIGE 20 was to evaluate tolerance and efficacy of bevacizumab according to specific endpoints in this population.

PATIENTS AND METHODS

Patients aged 75 and over were randomly assigned to bevacizumab + chemotherapy (BEV) versus chemotherapy (CT). LV5FU2, FOLFOX and FOLFIRI regimen were prescribed according to investigator's choice. The composite co-primary endpoint, assessed 4 months after randomization, was based on efficacy (tumor control and absence of decrease of the Spitzer QoL index) and safety (absence of severe cardiovascular toxicities and unexpected hospitalization). For each arm, the treatment will be consider as inefficient if 20% or less of the patients met the efficacy criteria and not safe if 40% or less met the safety criteria.

RESULTS

102 pts were randomized (51 BEV and 51 CT), median age was 80 years (range 75-91). Primary endpoint was met for efficacy in 50% and 58% and for safety in 61% and 71% of patients in BEV and CT respectively. Median progression-free survival was 9.7 months in BEV and 7.8 months in CT. Median overall survival (OS) was 21.7 months in BEV and 19.8 months in CT. The 36-months OS rate was 27% in BEV and 10.1% in CT. Severe toxicities grade 3/4 were mainly non hematologic toxicities (80.4% in BEV, 63.3% in CT).

CONCLUSION

Bevacizumab combined with chemotherapy was safe and efficient. Both arms met the primary safety and efficacy criteria.