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Table 2 Efficacy measures for patients with non-squamous NSCLC by arm (Pemetrexed + BSC vs BSC)

From: A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer

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 Phase d
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
  1. 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.
  2. aTwo-sided 95% confidence interval.
  3. bStratified for the best tumor response during the induction therapy.
  4. 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.
  5. 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).
  6. eExploratory data analysis.