Nab-paclitaxel in first-line treatment of advanced non-small-cell lung cancer

Abstract

Nanoparticle albumin-bound (nab-) paclitaxel is a solvent-free paclitaxel formulation that has been designed to reduce adverse reactions associated with conventional solvent-based paclitaxel formulations and to improve paclitaxel tumor penetration by exploiting the physiologic transport properties of albumin. In a recently reported phase 3 trial that compared nab-paclitaxel and solvent-based paclitaxel injection in combination with carboplatin as first-line treatment of advanced non– small-cell lung cancer (NSCLC), nab-paclitaxel was associated with a significantly greater overall response rate (ORR), the primary end point, and a reduced risk of neuropathy. The findings in this international trial, combined with the demonstration of paclitaxel efficacy in this setting, supported the recent approval of nab-paclitaxel combined with carboplatin as first-line treatment of advanced NSCLC. Subset analyses in the trial suggested some potential response and survival advantages with nab-paclitaxel treatment. Of 1,052 patients with nonresectable stage 3B or stage 4 NSCLC, 521 received a weekly nab-paclitaxel 100 mg/m infusion and 531 received conventional solventbased paclitaxel 200 mg/m every 3 weeks. All of the patients received carboplatin at area under the concentrationtime curve (AUC) 6 once every 3 weeks. Steroid/antihistamine premedication was required in the solvent-based paclitaxel group and was used at investigator discretion in the nab-paclitaxel group. Patients were to receive at least 6 cycles of treatment. The primary endpoint was ORR. The median age of the patients was 60 years in the nab-paclitaxel and solvent-based paclitaxel groups, with 14% and 15% of patients, respectively, being 70 years or older; 75% of patients in both groups were men, and 80% and 82% were white. Global geographic distribution was balanced, with most patients being from Russia (46% and 44%) and Ukraine (23% and 25%), followed by Japan (14% and 14%) and the United States (12% and 11%). ECOG performance status was 1 in 74% of the nabpaclitaxel group, and 78% of the solvent-based paclitaxel group. Histology consisted of adenocarcinoma in 49% and 50% of patients, and squamous cell carcinoma in 44% and 42%; and 79% of each group had stage IV disease. In