Nab-Paclitaxel plus gemcitabine significantly improved overall survival, progression-free survival, and response rate in patients with metastatic pancreatic adenocarcinoma. Combination treatment increases intra-tumoral gemcitabine levels attributable to a decrease in the primary gemcitabine metabolizing enzyme, cytidine deaminase. Based on these data, we planned to assess the efficacy and safety of combination with nab-PTX + gemcitabine in patients with non-small-cell lung cancer (NSCLC) previously treated with platinum based chemotherapy.
Patients with advanced NSCLC with progressive disease to platinum-based chemotherapy, ECOG performance status (PS) 0 or 1, and adequate kidney, liver and bone marrow function were eligible. Treatment consisted of nab-paclitaxel (100 mg/m2) + gemcitabine (1000 mg/m2) on days 1 and 8 of each 3-week cycle until progression disease or unacceptable toxicity. The primary endpoint was progression-free survival (PFS).
Of the 28 patients enrolled, 28 were evaluable for response and toxicity. The median age was 68 years (range 47–79), 23 male and 5 female. Histology subtypes were: adenocarcinoma 19 patients, squamous cell carcinoma 9 patients. Seventeen patients had ECOG PS 1 and 11 patients had PS 0. Twenty-four patients were 2nd line and 4 patients were 3rd line. The median number of cycles administered was 4(range 1–10). The overall response rate was 17.9%. The disease control rate was 67.9%. The median progression-free survival was 3.3 months (95% confidence interval [CI] = 1.6–4.7). Four patients (14.3%) had grade 3 anemia, 3 patients (10.7%) had grade 3 thrombocytopenia, 5 patients (17.9%) had grade 4 neutropenia. However, no patients developed febrile neutropenia. Remarkable non-hematologic toxicity was interstitial pneumonia with grade 3 in 4 patients (14.3%), neuropathy with grade 1 in 2 patients (7.1%) and infections with grade 3 in 2 patients (7.1%).
The efficacy of nab-Paclitaxel in combination with gemcitabine in advanced second or third-line NSCLC patients was limited and the high onset of interstitial pneumonia was unacceptable.
Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Has not received any funding
All authors have declared no conflicts of interest.