Saad Amr Shafik, Ghali Ramy R, Shawki May Ahmed
Department of Clinical Oncology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
J Cancer Res Ther. 2017 Apr-Jun;13(2):198-203. doi: 10.4103/0973-1482.187287.
The use of cisplatin (Cis) versus carboplatin (Carb) in the treatment of advanced nonsmall cell lung cancer (NSCLC) is controversial. The aim of the study was to compare the safety and efficacy of Cis versus Carb in squamous NSCLC.
A prospective, randomized, controlled, open-label study was conducted on advanced squamous NSCLC patients who were randomly assigned to receive Cis (40 mg/m 2 [day 1 and day 8]) or Carb (area under the curve = 5 [day 1]) combined with gemcitabine [Gem] (1000 mg/m 2 [day 1 and day 8]) of a 3-week schedule for six cycles. Study objectives were a radiological response after three cycles and six cycles, 1-year progression-free survival (PFS), 1-year overall survival (OS), and quality of life (QOL) assessment using functional assessment of cancer therapy-lung at baseline, after three cycles, and after six cycles.
Statistical analysis was done using Statistical Package for Social Science version 15. A P < 0.05 was considered statistically significant.
Seventy-one patients were enrolled (Gem/Cis group [n = 36], Gem/Carb group [n = 35]). Response rates were comparable in both arms. Nonsignificant differences were found regarding 1-year PFS (P = 0.308) and 1-year OS (P = 0.929) between the two groups. Neutropenia was significantly higher in Gem/Carb group, while vomiting and ototoxicity were significantly higher in Gem/Cis group. The effect on QOL was similar in both groups.
Cis and Carb have similar efficacy, tolerability, and effect on QOL and both can be used as a first-line treatment of squamous NSCLC.
顺铂（Cis）与卡铂（Carb）在晚期非小细胞肺癌（NSCLC）治疗中的应用存在争议。本研究旨在比较Cis与Carb在鳞状NSCLC中的安全性和疗效。
对晚期鳞状NSCLC患者进行了一项前瞻性、随机、对照、开放标签研究，患者被随机分配接受Cis（40mg/m²[第1天和第8天]）或Carb（曲线下面积=5[第1天]）联合吉西他滨[Gem]（1000mg/m²[第1天和第8天]），每3周为一个周期，共六个周期。研究目标包括三个周期和六个周期后的放射学反应、1年无进展生存期（PFS）、1年总生存期（OS）以及在基线、三个周期后和六个周期后使用癌症治疗-肺癌功能评估进行生活质量（QOL）评估。
使用社会科学统计软件包第15版进行统计分析。P<0.05被认为具有统计学意义。
共纳入71例患者（吉西他滨/顺铂组[n = 36]，吉西他滨/卡铂组[n = 35]）。两组的缓解率相当。两组之间在1年PFS（P = 0.308）和1年OS（P = 0.929）方面未发现显著差异。吉西他滨/卡铂组的中性粒细胞减少症明显更高，而吉西他滨/顺铂组的呕吐和耳毒性明显更高。两组对QOL的影响相似。
顺铂和卡铂在疗效、耐受性和对QOL的影响方面相似，均可作为鳞状NSCLC的一线治疗药物。
