A phase II evaluation of the combination of paclitaxel protein-bound and carboplatin in the first-line treatment of advanced non-small cell lung cancer (NSCLC)

Abstract

7127 Background: Abraxane (A) is a cremophor free, albumin-bound nanoparticle of paclitaxel (P) approved for the treatment of metastatic breast cancer. Belani et al. (JCO 21: 2933–2939, 2003) reported that P 100 mg/m2 days 1, 8 and 15 q 28 days with C AUC 6 on day 1 led to a 32% response rate in 132 patients (pts) with NSCLC. The median time to progression (TTP) was 35 weeks (wks) for stage IIIB and 29 wks for stage IV. Methods: This study was designed to determine if substituting A for P at an identical dose would lead to an improved response rate, TTP or decreased toxicity. Results: Fifty-six pts with stage IIIB/IV NSCLC previously untreated with chemotherapy were enrolled. The median age was 66 (range 37 - 83); 37 were male and median ECOG performance status was 1 (range 0–2). Thirteen pts were stage IIIB. Metastases included bone (17), liver (7), brain (2) and lymph nodes (16). Currently a total of 239 cycles of therapy have been administered with a median of 4 (range 1–8) cycles per pt. In 194 (81%) full dose A was administered on days 1, 8 and 15. The table below shows toxicities compared to P: Seven pts (13%) experienced grade (G) 1 neuropathy and 3 pts (5%) experienced G 2 neuropathy. Five pts were inevaluable for response due to removal from study after <2 cycles of treatment (2 died from progressive disease, 2 because of toxicity - thrombocytopenia and neutropenia - and 1 refused). Of 51 evaluable pts 1 (2%) had a complete response and 23 patients (45%) achieved a partial response. Four of 10 evaluable stage IIIB pts obtained a PR. Twenty-one pts were stable for at least 12 weeks of whom twenty remain stable at 12–29 weeks and one progressed at 23 weeks. A total of 13 pts have progressed and 3 pts have died. The Kaplan-Meier estimate of median TTP is 23 wks and maximum follow up is 34 wks. Conclusions: We conclude that combining A and C is tolerable and active in the treatment of newly-diagnosed NSCLC and antitumor activity compares favorably to that of P/C. Further studies are warranted in this population. [Table: see text] [Table: see text]

Novel Cytotoxic Agents for Non-small Cell Lung Cancer

“…ABI-007 has been evaluated as a single agent for advanced NSCLC and demonstrated significant activity, with a response rate of 35% of 34 evaluable patients. 16,17…”

Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel, Carboplatin, and Bevacizumab in First-line Patients with Advanced Nonsquamous Non-small Cell Lung Cancer

“…Green et al 13 reported a response rate of 16% with nab-paclitaxel given as a single agent every 3 weeks in advanced NSCLC with a median survival of 11 months. nab-Paclitaxel has been evaluated in combination with carboplatin in the treatment of NSCLC utilizing both the weekly 14 and every 3-week 15 schedule of nab-paclitaxel. This phase II study was designed to evaluate the safety and antitumor activity of nab-paclitaxel combined with carboplatin and bevacizumab every 21 days in patients with advanced stage IIIB/IV NSCLC.…”

Phase I Trial of Nanoparticle Albumin-Bound Paclitaxel in Combination with Gemcitabine in Patients with Thoracic Malignancies

“…Phase II trials with single agent nab-paclitaxel and in combination with carboplatin have revealed significant activity in non-small cell lung cancer (NSCLC). [3][4][5][6] A phase III trial comparing carboplatin and paclitaxel versus carboplatin and nab-paclitaxel has been initiated in patients with advanced NSCLC.…”