Comparison of docetaxel/cisplatin dosages of 75/60 and 60/60 mg/m(2) for the treatment of non-small cell lung cancer

• Published in: Experimental and therapeutic medicine Vol. 4; no. 2; pp. 317 - 322
• Main Authors: Kim, Kyu-Sik, Oh, In-Jae, Ban, Hee-Jung, Cho, Hyun-Ju, Kwon, Yong-Soo, Kim, Yu-Il, Lim, Sung-Chul, Na, Kook-Joo, Song, Sang-Yun, Choi, Song, Choi, Yoo-Duk, Kim, Young-Chul
• Format: Journal Article
• Language: English
• Published: Greece 01.08.2012
• ISSN: 1792-0981
• DOI: 10.3892/etm.2012.597

A combination of docetaxel (D) and cisplatin (P) is one of the standard regimens for the initial treatment of advanced non-small cell lung cancer (NSCLC). Yet, the toxicity of D administered at 75 mg/m(2) in three weekly doses to patients is a concern. The aim of this study was to assess the efficacy of a lower combination dose, 60 mg/m(2) of D and 60 mg/m(2) of cisplatin (P), as a treatment for NSCLC. In this randomized, phase III trial, we compared the response rates (RRs) and toxicity profiles of two combination regimens, D/P 75/60 vs. 60/60 mg/m(2), to patients with stage IIIB or IV NSCLC. A total of 132 patients were randomized to the 75/60 (n=65) or 60/60 (n=67) dosage group. Non-inferiority of 60/60 group compared to the 75/60 group was confirmed by the RR (38.5% for the 75/60 group and 40.3% for the 60/60 group, 95% confidence interval -14.8 to 18.5, meeting the predefined non-inferiority criterion). The dose reduction rate and incidence of grade 3-4 neutropenia were significantly higher in the 75/60 group. The incidence of neutropenia was significantly higher in those with the non-expressing genotype (GG) compared to the AG or AA genotypes of CYP3A5. We determined that DP 60/60 was not inferior to DP 75/60 in RR, and that the reduced combination dosage provides a better safety profile for patients.