Safety and efficacy of weekly nab® paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer

SUMMARY: ABRAXANE® (Albumin-bound Paclitaxel or nab-Paclitaxel) is a solvent-free formulation of Paclitaxel with a superior therapeutic index and delivers higher concentrations of the drug’s active ingredient into the tumor cell. This is unlike solvent based taxanes such as TAXOL® (Paclitaxel) and TAXOTERE® (Docetaxel), which have delivery vehicles such as Cremaphor and Polysorbate 80 respectively. By virtue of being solvent free, ABRAXANE® can be administered over a shorter period of time without premedications and is associated with fewer side effects with possibly superior efficacy. In a phase III trial, 1052 treatment naive patients with Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC) were randomly assigned to receive ABRAXANE® 100 mg/m2 weekly and PARAPLATIN® (Carboplatin) at Area Under the Concentration-time curve (AUC) 6, once every 3 weeks (nab-PC) or TAXOL® 200mg/m2 plus PARAPLATIN® AUC 6 once every 3 weeks (sb-PC). Patients were stratified by disease (Stage IIIB vs IV), age (< 70 vs ≥ 70 years), sex (male vs female), histology (squamous vs adenocarcinoma vs others). The primary end point was Overall Response Rate (ORR). Secondary end points included Progression Free Survival (PFS) and Overall Survival (OS). In their original report, the authors concluded that the study met its primary end point and ABRAXANE® combination (nab-PC) significantly improved ORR compared to TAXOL® combination (sb-PC) and was also associated with less neuropathy. In a sub-set analysis of patients 70 years or older (N=156), those in the ABRAXANE® group had a significantly longer median OS compared to the TAXOL® group (19.9 vs 10.4 months, HR=0.58, P=0.009). The PFS in this elderly group trended in favor of ABRAXANE® (8 vs 6.8 months, P=0.13). This survival benefit was not seen in the younger patients. Elderly patients with NSCLC usually tend to have other co-morbidities and treatment can be challenging. With lower incidence of toxicities such as neuropathy, neutropenia and arthralgias, ABRAXANE® combination therapy can be a valuable option for the first line treatment of elderly patients with advanced NSCLC of all histologies. Socinski MA, Langer CJ, Okamoto I, et al. Ann Oncol. 2013;24:314-321