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The FDA approved nab-paclitaxel (Abraxane) plus carboplatin for patients with untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) in October 2012. This approval was based on an improvement in overall response rate (ORR) in the phase III CA031 trial that compared weekly nab-paclitaxel plus carboplatin with solvent-based (sb) paclitaxel plus carboplatin.
The most impressive activity was seen in patients with squamous histology, states H. Jack West, MD. In this population, the ORR was 41% with nab-paclitaxel compared with 24% for placebo (P
<.001). For the full population, the ORR with nab-paclitaxel was 33% versus 25% with sb-paclitaxel (P
In the study, a particularly strong advantage in overall survival (OS) was seen in elderly patients treated with nab-paclitaxel; however, this benefit may not be completely reproducible, West believes. For patients over the age of 70, the median OS was 19.9 months with nab-paclitaxel compared with 10.4 months for sb-paclitaxel (HR=0.583). West notes that the median age for newly diagnosed patients with NSCLC is 71, representing a significant population.
In order to cull out this benefit, West notes that a clinical trial is exploring nab-paclitaxel specifically in an elderly population. In addition to the benefits seen with the drug, nab-paclitaxel is fairly well tolerated, West notes. The leading cumulative toxicity is neuropathy, although in elderly patients fatigue and low blood counts can be a bigger concern. In general, West notes that he has rarely seen grade 3 neuropathy.
For patients who respond to nab-paclitaxel but experience fatigue, neuropathy, or cytopenias, a treatment holiday can be utilized to resolve these side effects. In many situations, following a break, patients will respond when rechallenged with nab-paclitaxel, West suggests.