ABSTRACT
Paclitaxel and platinum-based chemotherapy is considered to be a standard approach for locally advanced and metastatic non-small cell lung cancer [NSCLC]. In recent years, paclitaxel on a weekly schedule in combination with carboplatin has been widely used because it is associated with a lower incidence of neuropathy and myelosuppression. Otherwise, only a few studies are available in elderly patients with NSCLC. The aim of our study was to evaluate the efficacy and safety of weekly paclitaxel combined with carboplatin compared with the classic 3-weekly schedule of paclitaxel and carboplatin as initial therapy and the feasibility of subsequent maintenance therapy versus observation in elderly patients with locally advanced [stage IIIB] and metastatic [stage IV] NSCLC. Ninty patients >/=65 years with stage IIIB-IV NSCLC were randomly assigned to one of the following arms: arm1, paclitaxel 90 mg/m[2] weekly for 3 of 4 weeks with carboplatin [area under the curve /[AUC/] =6] on day 1 of each 4 week cycle; and arm 2, paclitaxel 200 mg/m[2] with carboplatin [AUC = 6] on day 1 of each 3-week. After four cycles of chemotherapy, those with objective response or stable disease were randomized to weekly paclitaxel [70 mg/ m[2], 3 of 4 weeks] or observation as maintenance therapy. Primary end point was response while second end points included survival and toxicity. Eighty-six patients were evaluable for response, overall responses were recorded in 42.9% in arm 1 versus 31.8% in arm 2; stable disease was 38.1% in arm 1 versus 27.3% in arm 2 and progressive disease was 19% in arm 1 versus 40.9% in arm 2. The median time to progression and median survival times were 7 months and 10.8 months in arm 1 versus 5.6 months and 9 months in arm 2, respectively. The 1-year survival rates were 47.6% in arm 1 versus 36.4% in arm 2. Grade 3/4 anemia was more common in arm 1 [23.8%] than arm 2 [9.1%]. Grade 3/4 neutropenia and febrile neutropenia occurred in 14.3% and 4.7% in arm 1 versus 22.7% and 9.1% in arm 2. Grade 2/3 neuropathy occurred in 4.7% in arm 1 versus 13.6% in arm 2. Efficacy was similar between the weekly regimen and the standard regimen of carboplatin and paclitaxel for elderly patients with advanced NSCLC and may be advantageous based on its favorable tolerability profile