Document Classification

Section Type: RESULTS

Text: Between March 3, 2008 and May 6, 2009, 171 patients were randomly assigned : 88 to the experimental group (group A), 42 to group B, and 41 to group C. PFS at 48 weeks was 29. 5 % (26 of 88 patients, 95 % CI 20. 0-39. 1) in group A, 35. 7 % (15 of 42, 21. 2-50. 2) in group B, and 61. 0 % (25 of 41, 46. 0-75. 9) in group C. Median PFS was 8. 2 months (95 % CI 7. 0-9. 6) in group A, 8. 2 months (5. 5-11. 7) in group B, and 16. 8 months (6. 0-26. 0) in group C. 45 (51 %) of 88 patients in group A stopped treatment for reasons other than progression compared with five (12 %) of 42 in group B and 15 (38 %) of 40 in group C. Grade 3 or worse adverse events were reported in 68 (77 %) of 88 patients in group A versus 25 (60 %) of 42 in group B and 28 (70 %) of 40 in group C. Serious adverse events were reported in 39 (44 %) of 88, 13 (31 %) of 42, and 18 (45 %) of 40 patients in groups A, B, and C, respectively.