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.
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.
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.