The combination of low-dose carboplatin with nab-paclitaxel and concurrent radiotherapy (RT) resulted in high response rates among patients aged 75 years and older with unresectable, advanced non-small cell lung cancer (NSCLC), according to the results of a phase 1 study presented at the 2020 World Conference on Lung Cancer in Singapore.
Low-dose carboplatin plus concurrent RT is standard treatment for patients with unresectable, locally advanced NSCLC; however, the number of daily infusions of carboplatin can be a barrier to its use. Weekly low-dose carboplatin plus paclitaxel with RT is also used, and it is believed that nab-paclitaxel may be a more effective radiosensitizer than paclitaxel. Therefore, the aim of this study was to evaluate the low-dose carboplatin/nab-paclitaxel combination plus RT among elderly patients with advanced NSCLC.
The phase 1 study included dose escalation and expansion portions. The study included 17 patients aged 75 years and older with unresectable stage III NSCLC treated with low-dose carboplatin plus nab-paclitaxel and RT. None of the patients had received prior systemic therapy. The primary endpoint of the expansion portion was treatment completion rate.
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At baseline, the median age was 81 years, and 15 patients were men. Twelve patients had an Eastern Oncology Cooperative Group (ECOG) performance status of 0; 5 had an ECOG performance status of 1. Thirteen patients were former or current smokers. Disease histology included 11 patients with adenocarcinoma, 4 with squamous cell carcinoma, and 2 with another histology.
The treatment completion rate was 100%. The response rate was 76.5%, all of which were partial responses. The median progression-free survival was 13.4 months.
Within the first 90 days, grade 3-4 adverse events included leukopenia (23.5%), neutropenia (17.6%), anemia (5.9%), and infection (5.9%). After 90 days, 1 death due to radiation pneumonitis was reported.
The authors concluded that “at the recommended dose, high treatment completion rate (100%) and promising efficacy were shown.” They noted that a phase 3 study was initiated in December 2020 to confirm these results.
Reference
Omori S, Harada H, Mori K, et al. Phase I study of carboplatin/nab-paclitaxel and concurrent TRT in elderly patients with unresectable locally advanced NSCLC. Presented at: 2020 World Conference on Lung Cancer Singapore; January 28-31, 2020.
