Table 1 PFS and OS by the data cutoff dates (ITT population)

From: Randomized phase 3 study of lenalidomide versus chlorambucil as first-line therapy for older patients with chronic lymphocytic leukemia (the ORIGIN trial)

Endpoint

LEN

CHB

P-value

 

Median follow-up, months

N

Median, months (95% CI)

N

Median, months (95% CI)

HR (90% CI)

 

PFS

 18 February 2013

11.8

212

30.8 (18.7, NE)

215

23.0 (19.3, 29.2)

1.21 (0.88, 1.66)

0.323

 26 April 2013

12.6

225

30.8 (18.7, NE)

225

21.4 (19.3, 27.0)

1.00 (0.75, 1.34)

0.994

 31 March 2014

18.8

225

30.8 (18.7, NE)

225

21.4 (19.3, 25.1)

0.99 (0.76, 1.29)

0.967

OS

 18 February 2013

11.8

212

NE (NE, NE)

215

NE (NE, NE)

1.69 (1.06, 2.67)

0.060

 26 April 2013

12.6

225

NE (NE, NE)

225

NE (35.8, NE)

1.46 (0.95, 2.26)

0.149

 31 March 2014

18.8

225

NE (NE, NE)

225

44.0 (37.3, NE)

1.03 (0.73, 1.46)

0.883

  1. Abbreviations: CHB, chlorambucil; CI, confidence interval; HR, hazard ratio; ITT, intention-to-treat; LEN lenalidomide; NE, not estimable; OS, overall survival; PFS, progression-free survival.