Abstract
8073 Background: A post hoc analysis of NSCLC (pts) ≥70 y in the pivotal E4599 trial found increased adverse events (AEs) and numerically decreased survival benefit associated with bevacizumab (BEV) vs pts <70 y. We evaluated the efficacy and safety of BEV by age in pts in a pooled dataset from the E4599 and PointBreak (PB) trials. Methods: Pts randomized to the PC (paclitaxel and carboplatin ) + BEV arms of E4599 and PB received P 200 mg/m2, C AUC 6, and BEV 15 mg/kg q3w for 6 (E4599) or 4 (PB) cycles; 1 pt in PB received 6 cycles. Eligible pts received maintenance BEV q3w until disease progression or unacceptable toxicity. Overall survival (OS), progression-free survival (PFS), and safety were assessed in pts grouped according to age (<65 y, 65–75 y, 70–75 y, <75 y, and ≥75 y). Pt-level data from the PC + BEV arms of E4599 and PB were pooled and compared with data from pts in the PC-alone arm of E4599. Results: PB and E4599 randomized 467 pts and 434 pts to PC + BEV, respectively. Baseline characteristics were balanced between age groups. OS and PFS hazard ratios (HRs) and increases in grade ≥3 AEs for the pooled pt cohort relative to E4599 PC-alone arm are shown (Table). Outcomes were similar in pts <70 y and ≥70 y, and data from the pooled population were similar to those seen in each individual trial (data not shown). Conclusions: In a pooled exploratory analysis of pt data from E4599 and PB, the statistically significant benefit associated with the addition of BEV to PC appeared consistent across all age groups <75y. Pts ≥75 y receiving BEV had a higher incidence of grade ≥3 AEs relative to PC alone with no statistically significant survival benefit, although an increase in grade ≥3 AEs was observed in all age groups. Clinical trial information: NCT00762034 and NCT00021060. [Table: see text]
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