Albumin-bound paclitaxel has favorable risk–benefit profile in NSCLC

Aug 29 2013

By Joanna Lyford, Senior medwireNews Reporter

Albumin-bound paclitaxel (nab-P) plus carboplatin is an effective and well-tolerated first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC), irrespective of histology, study results show.

Nab-P is an injectable formulation of paclitaxel that has a better therapeutic index than standard solvent-based paclitaxel and has been shown in preclinical models to deliver a 33% higher drug concentration to tumors.

In this study, Mark Socinski (University of Pittsburgh Cancer Institute, Pennsylvania) conducted a post-hoc analysis of a pivotal phase III clinical trial of nab-P in patients with advanced NSCLC.

Details of the trial have been reported elsewhere. Briefly, 1052 untreated patients with stage IIIB–IV NSCLC were randomly assigned to receive 100 mg/m²nab-P weekly and carboplatin at an area under the concentration-time curve (AUC) of 6 once every 3 weeks (nab-PC) or 200 mg/m² solvent-based paclitaxel plus carboplatin AUC 6 once every 3 weeks (sb-PC).

The primary analysis showed that nab-PC was superior to sb-PC with regard to objective overall response rate (ORR=33 vs 25%, response rate ratio[RRR]=1.313) and equivalent with regard to progression-free survival (median 6.3 vs 5.8 months) and overall survival (median 12.1 vs 11.2 months).

In the present analysis, Socinski’s group examined treatment outcomes by histologic subtype. Writing in the Annals of Oncology, they report that nab-PC was either equivalent or superior to sb-PC with regard to the study’s primary endpoint, ORR, across all histologic subtypes.

For nab-PC versus sb-PC, ORRs were 26% versus 27% (RRR=0.966) in patients with adenocarcinoma, 33% versus 15% (RRR=2.167) in patients with large cell carcinoma, and 24% versus 15% (RRR=1.593) in patients with not otherwise specified histology.

Nab-PC was equivalent to sb-PC with regard to overall survival, at 10.7 versus 9.5 months in patients with squamous cell carcinoma (HR=0.890) and 12.4 versus 10.6 months (HR=1.208) for patients with large cell carcinoma.

Finally, safety analyses within histologic subgroups were consistent with the overall population, with nab-PC versus sb-PC being associated with a lower frequency of grade 3/4 sensory neuropathy and arthralgia, and a higher frequency of thrombocytopenia and anemia.

“First-line nab-PC demonstrated a favorable risk–benefit profile in patients with NSCLC regardless of histology,” the authors conclude.

They summarize:“nab-PC should be considered among the first-line treatment options for patients with advanced NSCLC, particularly in patients with squamous cell carcinoma.”

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