title: Comparison of docetaxel/cisplatin dosages of 75/60 and 60/60 mg/m(2) for the treatment of non-small cell lung cancer.
abstract: 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.
authors.affiliation: Lung and Esophageal Cancer Clinic, Chonnam National University, Hwasun Hospital, Hwasun, Jeonnam; ; Departments of Internal Medicine.
authors.forename: Kyu-Sik
authors.initials: KS
authors.lastname: Kim
authors.forename: In-Jae
authors.initials: IJ
authors.lastname: Oh
authors.forename: Hee-Jung
authors.initials: HJ
authors.lastname: Ban
authors.forename: Hyun-Ju
authors.initials: HJ
authors.lastname: Cho
authors.forename: Yong-Soo
authors.initials: YS
authors.lastname: Kwon
authors.forename: Yu-Il
authors.initials: YI
authors.lastname: Kim
authors.forename: Sung-Chul
authors.initials: SC
authors.lastname: Lim
authors.forename: Kook-Joo
authors.initials: KJ
authors.lastname: Na
authors.forename: Sang-Yun
authors.initials: SY
authors.lastname: Song
authors.forename: Song
authors.initials: S
authors.lastname: Choi
authors.forename: Yoo-Duk
authors.initials: YD
authors.lastname: Choi
authors.forename: Young-Chul
authors.initials: YC
authors.lastname: Kim