Platinum-based combination chemotherapy in the treatment of older non-small cell lung cancer (NSCLC) patients (pts): Is there a role for Complete Geriatric Assessment (CGA)? Final results from the prospective multicenter NVALT-3 study

Abstract

e20547 Background: Nearly 50% of NSCLC pts are aged over 70 years, but only few receive combination chemotherapy. CGA is often advocated to assess the benefits and risks of chemotherapy in older pts. Methods: A total of 182 NSCLC pts ≥ 70 years with stage IIIb/IV disease were randomized to 4 cycles carboplatin/gemcitabine (CG) or carboplatin/paclitaxel (CP). Primary endpoint was change in QoL at week18. At baseline, CGA was performed with nine different tests. Toxicity (tox) was scored using NCI-CTC v2. Tox related outcomes were defined as all grade III/IV tox, SAEs, ≥ grade II neurological or neuropsychiatric (NP) tox and the ability to finish all cycles. Relationship of CGA and QoL scores with tox endpoints were investigated. Results: Median age was 74 yrs (70–87). PS was 0 in 30%, 1 in 54% and 2 in 17%. Median OS was 8.6 mo (95% CI, 7.2–10.2) for CG and 6.9 mo (95% CI, 5.6–10.0) for CP. Median PFS was 4.7 mo (95% CI, 3.9–5.8) for CG and 4.5 mo (95% CI, 4.1–5.3) for CP. One year survival was 29% (95% CI, 21–41%) for CG and 23% (95% CI, 16–35%) for CP. There was no difference in the change in global QoL between arms. Quality-adjusted survival curves were not different. PS was prognostic, but not different for both arms. Pts with better Activities of Daily Living (ADL), instrumental ADL, or physical functioning were more likely to finish all chemotherapy cycles. Pts with worse emotional or role functioning or Geriatric Depression Score were more likely to experience NP tox. None of the CGA or QoL summary scores were associated with the occurrence of the other tox endpoints at p< 0.01. Conclusions: Carboplatinum based combination chemotherapy in older NSCLC pts is feasible. The choice for adding paclitaxel or gemcitabine to carboplatin cannot be made based on effects on QoL. CGA predicts toxicity to a limited extent but does not add substantial information to PS. No significant financial relationships to disclose.