Nair Lekha Madhavan, Kumar R Rejnish, Thomachan Kainickal Cessal, Rafi Malu, George Preethi Sara, Krishna K M Jagathnath, Ramadas Kunnambath
Department of Radiation Oncology, Regional Cancer Centre, Trivandrum, Kerala, India.
Department of Cancer Epidemiology and Biostatistics, Regional Cancer Centre, Trivandrum, Kerala, India.
South Asian J Cancer. 2017 Apr-Jun;6(2):64-68. doi: 10.4103/2278-330X.208840.
Concurrent chemoradiation with 3 weekly cisplatin (100 mg/m) is the standard of care for locally advanced head and neck cancer. However, this regimen has been shown to be associated with lesser compliance and higher toxicities. Hence, there is a need to explore alternative concurrent cisplatin regimens.
The objective of this study was to compare the efficacy and toxicities of 3 weekly cisplatin (100 mg/m) with weekly cisplatin (40 mg/m) concurrently with radiation in patients with locally advanced head and neck cancer.
This phase IIb trial randomized 56 patients with Stage III and IV squamous cell carcinoma of oropharynx, hypopharynx, and larynx to Arm A or Arm B. Arm A received cisplatin 100 mg/m 3 weekly and Arm B received cisplatin 40 mg/m weekly concurrently with radiation. The primary end point was disease-free survival (DFS) and secondary end points were overall survival (OS) and acute toxicity. DFS and OS were estimated using Kaplan-Meier method, and log-rank test was used to assess the difference in these distributions with respect to treatment.
The 2-year DFS in Arm A and Arm B was 64.5% and 52.8%, respectively ( = 0.67). The OS at 2 years was 71% and 61.1% in Arm A and Arm B, respectively ( = 0.61). There were no significant differences in acute hematological, renal, or mucosal toxicities between the two arms.
This study showed a nonsignificant improvement in DFS and OS in the 3 weekly cisplatin arm over the weekly arm with comparable toxicities. The trial is registered with Clinical Trial Registry of India (CTRI registration number: CTRI/2013/05/003703, URL-http://ctri.nic.in).
每3周一次顺铂（100mg/m²）同步放化疗是局部晚期头颈癌的标准治疗方案。然而，该方案已被证明依从性较差且毒性较高。因此，有必要探索替代的顺铂同步治疗方案。
本研究的目的是比较每3周一次顺铂（100mg/m²）与每周一次顺铂（40mg/m²）同步放疗在局部晚期头颈癌患者中的疗效和毒性。
这项IIb期试验将56例口咽、下咽和喉的III期和IV期鳞状细胞癌患者随机分为A组或B组。A组接受每3周一次顺铂100mg/m²，B组接受每周一次顺铂40mg/m²同步放疗。主要终点是无病生存期（DFS），次要终点是总生存期（OS）和急性毒性。DFS和OS采用Kaplan-Meier法估计，对数秩检验用于评估这些分布在治疗方面的差异。
A组和B组的2年DFS分别为64.5%和52.8%（P = 0.67）。A组和B组的2年OS分别为71%和61.1%（P = 0.61）。两组之间的急性血液学、肾脏或黏膜毒性无显著差异。
本研究表明，每3周一次顺铂组在DFS和OS方面较每周一次顺铂组有不显著的改善，且毒性相当。该试验已在印度临床试验注册中心注册（CTRI注册号：CTRI/2013/05/003703，网址-http://ctri.nic.in）。
