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加速放疗联合96小时持续静脉输注紫杉醇治疗局部晚期头颈癌的初步试验最终报告

Final report of a pilot trial of accelerated radiotherapy plus concurrent 96-hour infusional paclitaxel for locally advanced head and neck cancer.

作者信息

Bucci Mary K, Rosenthal David I, Hershock Diane, Metz James, Devine Pamela, Kligerman Morton M, Machtay Mitchell

机构信息

Department of Radiation Oncology, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, USA.

出版信息

Am J Clin Oncol. 2004 Dec;27(6):595-602. doi: 10.1097/01.coc.0000135738.85334.ed.

DOI:10.1097/01.coc.0000135738.85334.ed
PMID:15577438
Abstract

Recent data show that accelerated radiotherapy (XRT) improves local-regional control (LRC) over standard-fractionation XRT. Concurrent chemoradiotherapy improves LRC and survival over XRT alone. This study assesses the feasibility, toxicity, and preliminary efficacy of concurrent 96-hour paclitaxel infusion with accelerated XRT. Eligible patients had stage IV squamous cell carcinoma of the head and neck, exclusive of nasopharynx cancer. Tumor had to be considered technically unresectable after evaluation by our multidisciplinary head/neck tumor board. XRT was given continuous course using an accelerated regimen with twice a day fractionation for the cone down (70-72 Gy/6 weeks). Chemotherapy consisted of 2 cycles of paclitaxel via 96-hour infusion during weeks 1 and 5 of XRT. The first 10 patients received doses of 40-120 mg/m2/cycle, and the subsequent 13 patients received 100 mg/m2/cycle. Twenty-three patients were studied. Median follow-up was 20.4 months (44.4 months for the 10 long-term survivors). Most (19/23) patients had reversible grade 3 acute mucositis. Median treatment time was 44 days, and all but 1 patient received both cycles of paclitaxel at their planned dose. The 3- and 4-year actuarial survival was 37%. Three- and 4-year LRC was 50%. Four patients (18%) developed distant metastases. Two patients (9%) developed severe esophageal strictures requiring permanent gastrostomy/tracheostomy, and 2 patients developed other late grade 3+ toxicities. Accelerated XRT plus concurrent 96-hour infusional paclitaxel as given in this study has intense but acceptable toxicity and is feasible. LRC and survival compare favorably with other aggressive regimens for this poor-prognosis population. Further study of accelerated XRT with concurrent chemotherapy is indicated.

摘要

近期数据显示,与标准分割放疗相比,加速放疗(XRT)可改善局部区域控制(LRC)。同步放化疗与单纯放疗相比,可改善LRC并提高生存率。本研究评估了同步96小时紫杉醇输注联合加速XRT的可行性、毒性及初步疗效。符合条件的患者为IV期头颈部鳞状细胞癌,不包括鼻咽癌。经我们的多学科头颈肿瘤委员会评估,肿瘤在技术上必须被认为无法切除。XRT采用加速方案连续疗程,缩野时每天两次分割照射(70 - 72 Gy/6周)。化疗包括在XRT的第1周和第5周通过96小时输注给予2个周期的紫杉醇。前10例患者每个周期的剂量为40 - 120 mg/m²,随后的13例患者每个周期的剂量为100 mg/m²。共研究了23例患者。中位随访时间为20.4个月(10例长期存活者为44.4个月)。大多数(19/23)患者出现可逆性3级急性黏膜炎。中位治疗时间为44天,除1例患者外,所有患者均按计划剂量接受了两个周期的紫杉醇治疗。3年和4年的精算生存率为37%。3年和4年的LRC为50%。4例患者(18%)发生远处转移。2例患者(9%)出现严重食管狭窄,需要永久性胃造口术/气管造口术,2例患者出现其他3级以上晚期毒性反应。本研究中给予的加速XRT联合同步96小时输注紫杉醇具有强烈但可接受的毒性,且是可行的。对于这一预后不良的人群,LRC和生存率与其他积极方案相比具有优势。有必要对加速XRT联合同步化疗进行进一步研究。

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