一项2期随机研究，比较短程姑息性放疗与短程同步姑息性化疗加放疗在晚期不可切除头颈癌中的疗效。

A phase 2 randomized study to compare short course palliative radiotherapy with short course concurrent palliative chemotherapy plus radiotherapy in advanced and unresectable head and neck cancer.

作者信息

Kumar Arvind, Sharma Atul, Mohanti Bidhu Kalyan, Thakar Alok, Shukla Nootan Kumar, Thulkar Sanjay P, Sikka Kapil, Bhasker Suman, Singh Chirom Amit, Vishnubhatla Sreenivas

机构信息

Department of Medical Oncology, Dr BRA IRCH, All India Institute of Medical Sciences (AIIMS), New Delhi, India.

出版信息

Radiother Oncol. 2015 Oct;117(1):145-51. doi: 10.1016/j.radonc.2015.07.026. Epub 2015 Aug 21.

DOI:10.1016/j.radonc.2015.07.026

PMID:26303014

Abstract

BACKGROUND

Treatment of unresectable HNSCC is not well defined and has a poor outcome. This study has been designed to address the unmet needs of such groups of patients with primary end points of (a) proportion of patients eligible for radical treatment in each arm (b) loco-regional disease control at 6months between two arms.

MATERIALS AND METHODS

Locally advanced and unresectable HNSCC patients (except Nasopharynx and Larynx) unfit for radical treatment were randomized to arm A [short course RT alone (4Gy/#/day for 5days)] or arm B [RT as arm A+concurrent cisplatin at 6mg/m(2)/day IV bolus for 5days]. Those with at least PR were taken for further RT to complete biological equivalent dose of 70Gy, in both the arms. In arm B, concurrent CDDP at a dose of 40mg/m(2)/week was administered.

RESULTS

114 patients (57 in each arm) were randomized but 111 were analyzable. 15 (27.27%) patients in arm A and 28 (50%) patients in arm B had ⩾PR (p=0.01) however patients taken for FRT were 14 (25.45%) and 26 (46.42%) in arms A and B respectively (p=0.02). Locoregional control i.e. (CR+PR) at 6months was 16.36% in arm A versus 32.14% in arm B (p=0.15). Median PFS (arm A - 3.2months, arm B - 6.2months; p=0.02) and OS (arm A - 5.9months, arm B - 10.1months; p=0.03) was significantly more in arm B. There was relative improvement in quality of life for most parameters in arm B.

CONCLUSION

Concurrent low dose CTRT can be an effective treatment modality in advanced and incurable HNSCC. However, a larger phase III trial is required.

摘要

背景

不可切除的头颈部鳞状细胞癌（HNSCC）的治疗方法尚不明确，且预后较差。本研究旨在满足这类患者未被满足的需求，主要终点为：（a）每组中符合根治性治疗条件的患者比例；（b）两组在6个月时的局部区域疾病控制情况。

材料与方法

将局部晚期且不可切除的HNSCC患者（鼻咽和喉除外）中不适合根治性治疗的患者随机分为A组[单纯短程放疗（4Gy/次/天，共5天）]或B组[放疗方案同A组+顺铂同步化疗，6mg/m²/天，静脉推注，共5天]。两组中至少达到部分缓解（PR）的患者继续接受放疗，直至完成生物等效剂量70Gy。在B组中，同时给予剂量为40mg/m²/周的顺铂。

结果

114例患者（每组57例）被随机分组，但111例可进行分析。A组15例（27.27%）患者和B组28例（50%）患者达到⩾PR（p=0.01），然而，A组和B组分别有14例（25.45%）和26例（46.42%）患者接受了进一步放疗（p=0.02）。6个月时的局部区域控制率，即完全缓解（CR）+部分缓解（PR），A组为16.36%，B组为32.14%（p=0.15）。B组的中位无进展生存期（PFS）（A组-3.2个月，B组-6.2个月；p=0.02）和总生存期（OS）（A组-5.9个月，B组-10.1个月；p=0.03）明显更长。B组大多数参数的生活质量有相对改善。