Abstract

The CAPITAL study, a randomized phase III trial, was conducted to compare carboplatin and nab-paclitaxel (nab-P/C) with docetaxel (D) for treating elderly patients with squamous-cell lung cancer. We performed a safety analysis for patients ≥75 and <75 years old from each treatment group, post-hoc analysis of the impact of second-line immune checkpoint inhibitors (ICI) on survival, and intra-cycle nab-paclitaxel skip status. The common adverse events (AEs) in the nab-P/C group were leucopenia, neutropenia, and anemia, while leucopenia, neutropenia, and febrile neutropenia were common in the D group. In the D group, there was a high frequency of AEs, particularly neutropenia for patients ≥75. In the nab-P/C group, the common AEs were anemia and thrombocytopenia for those patients. Thirty-eight percent (74/190) of the patients were transferred to the second-line ICI treatment, 36 and 38 patients from the nab-P/C and D groups, respectively. The overall survival of patients on ICI depended on their reason for discontinuing the first treatment. In both groups, improvement of overall survival was observed in patients with disease progression after first-line therapy. Median overall survival after discontinuation of nab-P/C was 321 d with ICI and 142 d without ICI; in the D group, it was 311 d with ICI and 256 d without ICI. However, no survival benefit was seen in patients who discontinued due to AEs. Their median overall survival after discontinuing nab-P/C was 224 d with ICI and 373 d without ICI; after discontinuing D, the median overall survival was 186.5 d with ICI and 154 d without ICI. In cycle one and two, 10%–30% of patients skipped taking nab-paclitaxel, and over 50% skipped taking it after cycle 3. Nab-P/C improved overall survival more than D in elderly patients with advanced or recurrent squamous cell lung cancer. ICI treatment did not improve the overall survival of patients in both groups, who discontinued the first line treatment due to AEs. Nab-P/C did not show a significant increase in toxicity in patients over 75 y of age. Many patients skipped nab-paclitaxel within cycles.

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