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A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer
Cancer, 01/06/2012
Clinical Article
Wolff RA et al. – Enzastaurin combined with bevacizumab–based therapy is tolerable, but does not improve PFS during maintenance therapy in patients with MCRC compared with bevacizumab–based therapy alone.
Methods- Patients with locally advanced or MCRC and stable or responding disease after completing 6 cycles of first–line chemotherapy randomly received a loading dose of enzastaurin 1125 mg, followed by 500 mg/d subsequent doses or placebo
- Both arms received 5–fluorouracil/leucovorin (leucovorin 400 mg/m2 intravenously [IV], 5–fluorouracil 400–mg/m2 bolus, 5–fluorouracil 2400 mg/m2 IV) plus bevacizumab 5 mg/kg IV, every 2 weeks
- Primary endpoint was PFS, from randomization
- OS and PFS were also assessed from start of first–line therapy
- Enrollment was stopped, and final analysis was conducted after 73 PFS events
- 58 patients were randomized to enzastaurin and 59 to placebo
- For the enzastaurin and placebo arms, respectively, the median cycles received were 9 and 10, and the median PFS was 5.8 and 8.1 months (HR, 1.35; 95% CI, 0.84–2.16; P = .896)
- Median OS was not calculable because of high censoring (77.6% enzastaurin; 91.5% placebo)
- Median PFS from start of first–line therapy was 8.9 months for enzastaurin and 11.3 months for placebo (HR, 1.39; 95% CI, 0.86–2.23; P = .913)
- More enzastaurin patients developed thrombosis or embolism compared with placebo (15.8% and 1.7%; P = .008)
- One possibly enzastaurin–related death occurred because of arrhythmia
