Objective. Single-agent chemotherapy with a third-generation drug is recommended as standard treatment for elderly patients with advanced non-small cell lung cancer (NSCLC). However, the efficacy and safety of platinum-based combination chemotherapy for elderly patients aged 75 years and over with adequate organ function, is still controversial. We conducted the present phase I trial to determine the dose-limited toxicity (DLT), and recommended dose (RD), as well as the safety and efficacy of paclitaxel and carboplatin combination chemotherapy in elderly patients (≥75 years old) with advanced NSCLC.
Methods. Paclitaxel and carboplatin were given on day 1. Cycles were repeated every 21 days, for a maximum of 4 cycles. Dose levels 1 to 3 included paclitaxel 175, 175, 200 mg/m
2 and the carboplatin area under the curve (AUC) was 5, 6, 6, respectively. Three patients were initially enrolled at each dose level, and if one of them experienced a DLT, 3 additional patients were enrolled at the same dose level. Maximum-tolerated dose (MTD) was defined as the dose level at which 3 or more of 6 patients experienced a DLT. The RD was defined as 1 dose level below MTD.
Results. From December 2005 to November 2007, 10 patients were enrolled: 1 was excluded from the evaluation because of refusal of treatment. With regard to the toxicity, 5 patients had grade 3 to 4 neutropenia, and 1 had grade 3 thrombocytopenia. There was no DLT at any dose level, and dose level 3 was determined as the RD.
Conclusion. Full-dose paclitaxel and carboplatin combination chemotherapy for elderly patients 75 years old or older with advanced NSCLC was tolerable.
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