nab-paclitaxel promising for Japanese NSCLC patients
medwireNews: Phase III trial results support the use of albumin-bound (nab-)paclitaxel plus carboplatin as a first-line treatment for Japanese patients with advanced non-small-cell lung cancer (NSCLC).
The findings, from an unplanned analysis of data from 149 Japanese participants of the CA031 study, should be considered "exploratory," the researchers say, but are "generally consistent" with the main trial results, which showed improved efficacy of nab-paclitaxel over solvent-based (sb-)paclitaxel.
Nab-paclitaxel can be given in saline without the need for antihistamines and corticosteroid treatment to prevent solvent-related hypersensitivity, explain Miyako Satouchi (Hyogo Cancer Center, Akashi City, Japan) and co-authors.
The original 1052 CA031 patients with untreated stage IIIB or IV NSCLC were randomly assigned to receive a 3-weekly cycle of carboplatin alongside nab-paclitaxel 100 mg/m2 weekly or sb-paclitaxel 200 mg/m2 every 3 weeks.
The overall response rate (ORR) for Japanese patients was 35% for those treated with nab-paclitaxel, showing a trend for a greater response compared with 27% for patients treated with sb-paclitaxel, giving a response rate ratio of 1.32.
The ORRs for the 11% of patients with squamous cell carcinoma were comparable between nab- and sb-paclitaxel, at 50% and 43%, respectively. For patients with nonsquamous cell carcinoma histology, the corresponding ORRs did not significantly differ, at 33% and 25%.
Nab-paclitaxel also showed better median progression-free survival (6.9 vs 5.6 months) and median overall survival (16.7 vs 15.9 months) compared with sb-paclitaxel but these differences did not reach statistical significance.
Safety data indicate that nab-paclitaxel was associated with an increased risk for grade 3 or higher anemia (32 vs 9%) and thrombocytopenia (14 vs 3%) compared with sb-paclitaxel.
However, the researchers note that nab-paclitaxel was also associated with a reduced risk for grade 2 or higher (18 vs 39%) and grade 3 or higher (3 vs 15%) sensory neuropathy, an often persistent symptom.
Furthermore, fewer nab-paclitaxel-treated patients halted treatment due to adverse events, at 21% versus 28% of sb-paclitaxel-treated patients.
Writing in Lung Cancer, Satouchi et al conclude: "The nab-[paclitaxel] treatment could be an alternative to sb-[paclitaxel] in the treatment of advanced NSCLC regardless of histology, and may have the potential for the treatment of [squamous cell carcinoma], where there is an unmet medical need."
medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2013
By Lynda Williams, Senior medwireNews Reporter