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W. Irvin



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    P2.03a - Poster Session with Presenters Present (ID 464)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03a-040 - Safety and Efficacy of Nab-Paclitaxel for 2nd Line Treatment of Elderly Patients with Stage IV Non-Small Cell Lung Cancer (ID 4209)

      14:30 - 14:30  |  Author(s): W. Irvin

      • Abstract

      Background:
      Retrospective analyses suggest benefit to 2[nd] line therapy in the fit elderly, but prospective data are lacking. Subgroup analysis of a phase III study of carboplatin and nab-paclitaxel for 1[st] line treatment of NSCLC showed superior survival in elderly patients.

      Methods:
      This is a phase II study for patients > 70 years of age with progression on a non-taxane 1[st] line doublet. Nab-paclitaxel 100mg/m[2] is administered intravenously, 3/4 weeks per cycle until progressive disease or intolerance. The primary endpoint is occurrence of ≥grade 3 treatment-related toxicities after 6 cycles or within 3 weeks if early treatment discontinuation occurred. Null hypothesis is a rate of 60% and alternative hypothesis is < 40%.

      Results:
      As of June 2016, 35/42 patients started treatment, and 31 completed. Median age is 75 (range 70 to 83). 51.4% are female. 8.6% have PS0, 68.6% PS1 and 22.9% PS2. 82.9% have adenocarcinoma, 14.3% SqCC, and 2.9% adenosquamous. 5.7% had EGFR, 28.6% kRAS. 33 patients had one prior treatment and 2 also received nivolumab. Of the 31 patients off treatment, median cycles received was 3 (range 1-22). 11/30 (37%) experienced the primary endpoint. When expanded to >=grade 3 toxicity at any time, this rose to 43% (13/30). The most common ≥G3 toxicities at any time point were fatigue (6/30), peripheral sensory neuropathy (4/30) and neutropenia (3/30). RR was 21% (1CR, 5PR, 16SD and 7PD of 29 patients evaluable). With a median FU of ongoing survivors (n=9) of 7.8 months, median progression free survival (PFS) was 5.2 months and median overall survival (OS) was 10.1 months. Figure 1



      Conclusion:
      These results demonstrate efficacy and safety of nab-paclitaxel for the 2[nd] line treatment of NSCLC in elderly patients and provide prospective data to support the treatment of fit elderly in 2[nd] line. Updated PFS, OS, geriatric assessment and quality of life data will be presented.