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一项比较同步放化疗联合每周一次和顺铂每三周一次治疗局部晚期口咽癌的前瞻性随机研究。

A prospective randomized study comparing concurrent chemoradiation with weekly and 3 weekly cisplatin in locally advanced oropharyngeal carcinoma.

作者信息

Nanda R, Katke Aradhana, Suneetha N, Thejaswini B, Pasha Tanvir, Jagannath K P, Giri G V, Babu K Govind

机构信息

Department of Radiation Oncology, Kidwai Memorial Institute of Oncology, Bengaluru, Karnataka, India.

Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bengaluru, Karnataka, India.

出版信息

South Asian J Cancer. 2019 Jul-Sep;8(3):178-182. doi: 10.4103/sajc.sajc_270_18.

Abstract

INTRODUCTION

The chemotherapy schedules with cytotoxic dose or weekly regimes are still challenging, weighing the benefits versus toxicities. This prospective randomized study is an attempt to assess the efficacy of two schedules of cisplatin in management of locally advanced HNSCC.

OBJECTIVES

The objectives of this study was to evaluate tolerance, tumour response and toxicities of concurrent chemoradiation with cisplatin in weekly and three weekly regimes.

METHODS

Locally advanced oropharyngeal squamous cell carcinoma patients fit for concurrent chemoradiation with cisplatin 40 mg/m2 (weekly) and 100 mg/m2 (3 weekly) were randomized to Arm A and B concurrently with radiotherapy of 70Gy/35frs/7 weeks.

STATISTICAL ANALYSIS

Chi-square/ Fisher Exact test has been used to find the significance of study parameters on categorical scale between the groups. The statistical software SPSS 15.0 was used.

RESULTS

Between December 2010 and January 2013, 60 patients were enrolled. The median cycles of cisplatin in Arm-A was 5 and 2 in Arm-B. The complete response of 80.9% vs 75% and partial response of 14.3% vs 12.5% was observed in both arms respectively. There was no statistical difference in acute radiation and hematological toxicities between the two groups. With median follow up of 28 months, the 2 and 5 years overall survival was 55% and 58%; 41.6% and 32.3% in arms A and B respectively.

CONCLUSION

In our study of locally advanced oropharyngeal carcinoma treated with radical radiotherapy comparing concurrent chemotherapy with cisplatin weekly vs 3 weekly had no significant difference in overall response, complete response and acute toxicities.

摘要

引言

细胞毒性剂量化疗方案或每周化疗方案仍具有挑战性,需要权衡获益与毒性。这项前瞻性随机研究旨在评估两种顺铂方案治疗局部晚期头颈部鳞状细胞癌(HNSCC)的疗效。

目的

本研究的目的是评估顺铂每周方案和每三周方案同步放化疗的耐受性、肿瘤反应及毒性。

方法

适合顺铂40mg/m²(每周)和100mg/m²(每三周)同步放化疗的局部晚期口咽鳞状细胞癌患者被随机分为A组和B组,同时接受70Gy/35次/7周的放疗。

统计分析

采用卡方检验/费舍尔精确检验来确定两组间分类变量研究参数的显著性。使用统计软件SPSS 15.0。

结果

2010年12月至2013年1月,共纳入60例患者。A组顺铂的中位疗程为5个,B组为2个。两组分别观察到完全缓解率为80.9%对75%,部分缓解率为14.3%对12.5%。两组间急性放疗毒性和血液学毒性无统计学差异。中位随访28个月,A组和B组的2年和5年总生存率分别为55%和58%;41.6%和32.3%。

结论

在我们对局部晚期口咽癌行根治性放疗并比较顺铂每周与每三周同步化疗的研究中,总体反应、完全缓解率和急性毒性方面无显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1756/6699241/913035ae331a/SAJC-8-178-g001.jpg

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