medwireNews: Nab-paclitaxel offers a similar survival benefit to docetaxel when given to previously treated patients with advanced non-small-cell lung cancer (NSCLC), show data from the phase 3 J-AXEL trial.
Isamu Okamoto (Kyushu University, Fukuoka, Japan) and co-investigators say nab-paclitaxel “should thus be considered a standard treatment option” for these patients.
They found that, during a median 15 months of follow-up, the mortality rate among 252 individuals with pretreated NSCLC randomly assigned to receive nab-paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 21-day cycle was 79.0%.
By comparison, the mortality rate was 84.9% among the 251 participants randomly assigned to receive docetaxel 60 mg/m2 on day 1 of each cycle.
Median overall survival times were not significantly different between the two arms, at 16.2 and 13.6 months with nab-paclitaxel and docetaxel, respectively, and the researchers report that the upper limit of the 95.2% confidence interval (1.07) was lower than the prespecified noninferiority margin of 1.25, “thus confirming the noninferiority of nab-paclitaxel.”
Median progression-free survival was, however, significantly longer with nab-paclitaxel than with docetaxel, at 4.2 versus 3.4 months and a hazard ratio of 0.76.
There was also a significant difference between the two groups in objective response rate, at 29.9% with nab-paclitaxel and 15.4% with docetaxel, and the team notes that this was consistent regardless of tumor histology.
Okamoto and co-authors report in the Journal of Thoracic Oncology that both groups received a median of four treatment cycles but there were fewer dose reductions with nab-paclitaxel than with docetaxel (27.3 vs 53.4%).
Conversely, more patients discontinued nab-paclitaxel because of adverse events or patient refusal due to toxicity than they did docetaxel (40.0 vs 31.3%).
The most common treatment-related adverse events of grade 3 or higher were leukopenia (25.7% of 245 patients in the nab-paclitaxel group vs 65.9% of 249 patients in the docetaxel group) and neutropenia (39.6 vs 83.1%).
Grade 3 or worse peripheral sensory neuropathy was more common with nab-paclitaxel than with docetaxel (9.8 vs 0.8%), whereas grade 3 or worse febrile neutropenia was less common (2.0 vs 22.1%). There were two treatment-related deaths in each group.
Okamoto et al conclude that their study demonstrates the “robust therapeutic efficacy of nab-paclitaxel for previously treated patients with advanced NSCLC regardless of histologic type.”
They note that nab-paclitaxel benefitted most patients subgroups assessed but say “questions about its efficacy remain for patients aged 75 years or older or for those with EGFR mutations.”
Nonetheless, they add that “[b]oth of these subgroups were small, and the data should therefore be interpreted with caution.”
The authors also advise caution regarding the generalizability of their results as the trial only included Japanese patients with NSCLC, who they say “usually experience a better survival compared with those of European descent.”
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