Table 2

Efficacy measures for patients with non-squamous NSCLC by arm (Pemetrexed + BSC vs BSC)
Parameter Median PFS or OS time (95% CI)a, months HR 95% CIa 1-sided p-value
Pemetrexed/BSC (n = 28) BSC (n = 27)
Maintenance Phased
PFS 3.2 (2.9 to 6.1) 3.2 (2.2 to 4.3) 0.76b 0.42 to 1.37b 0.1815b
0.65c 0.35 to 1.20c 0.08465c
OS 12.2 (5.6 to 20.6) 11.8 (6.3 to 25.6) 1.13b 0.56 to 2.28b 0.36195b
0.95c 0.46 to 1.97c 0.4497c
Overall Study Period (induction + maintenance)e
PFS 6.2 (6.0 to 8.3) 6.0 (4.6 to 6.9) 0.71b 0.40 to 1.26b 0.12325b
0.60c 0.33 to 1.09c 0.0461c
OS 15.4 (8.4 to 23.7) 16.4 (9.1 to 28.5) 1.18b 0.59 to 2.38b 0.3188b
1.01c 0.49 to 2.08c 0.48985c

Abbreviations: BSC = best supportive care; CI = confidence interval; ECOG PS = Eastern Cooperative Oncology Group performance status; HR = hazard ratio; OS = overall survival; PFS = progression-free survival.

aTwo-sided 95% confidence interval.

bStratified for the best tumor response during the induction therapy.

cStratified for the best tumor response during the induction therapy and adjusted for sex, baseline disease stage (before induction therapy), and the ECOG PS score before the initiation of maintenance therapy.

dMaintenance phase was defined as visit 5 to the visit prior to the post-treatment phase (i.e. the data of progression or the start of a new anti-cancer therapy treatment).

eExploratory data analysis.

Mubarak et al.

Mubarak et al. BMC Cancer 2012 12:423   doi:10.1186/1471-2407-12-423

Open Data