Indirect Comparison Analysis to Evaluate the Clinical Effectiveness of Trastuzumab Emtansine (T-DM1) Versus Other Treatments for HER2-Positive Metastatic Breast Cancer (MBC) (original) (raw)

A395 months. Methods: In PRIME, 1183 patients with previously untreated mCRC were randomised. Using data from an exploratory analysis conducted when 80% of patients had died, NNTs (Bender. Encyclopedia of Biostatistics, Second Edition; Volume 6, pp3752-61) were retrospectively calculated in patients with KRAS/NRAS WT (n= 505; exons 2-4 assessed) mCRC overall and in the ECOG performance score 0/1 (n= 473) subgroup. ORR and PFS events were defined using RECIST. Results: In the overall KRAS/NRAS WT population, 59.3% vs 45.6% of patients receiving panitumumab+FOLFOX4 vs FOLFOX4 alone, respectively, achieved an OR; NNT(95% CI) in the ORR analysis was 7.3(4.5-19.9). In the ECOG 0/1 subgroup, 61.3% vs 46.4% of those receiving panitumumab+FOLFOX4 vs FOLFOX4 alone, respectively, had an OR; the NNT(95% CI) was 6.7(4.2-16.5). For the PFS overall population analysis, the HR(95% CI) was 0.74(0.62-0.90); HR(95% CI) for the ECOG 0/1 subgroup was 0.72(0.59-0.88). NNTs(95% CI) in the overall population at 6 and 12 months were 12.8(8.3-34.1) and 9.2(5.7-25.9), respectively; corresponding values for the ECOG 0/1 subgroup were 11.9(7.9-27.8) and 8.4(5.3-20.8). For the OS overall population analysis, the HR(95% CI) was 0.76(0.63-0.93); HR(95% CI) for the ECOG 0/1 subgroup was 0.74(0.60-0.90). NNTs(95% CI) in the overall population at 12 and 24 months were 16.

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