Aguilar-Ponce J, Granados-García M, Villavicencio V, Poitevin-Chacón A, Green D, Dueñas-González A, Herrera-Gómez A, Luna-Ortiz K, Alvarado A, Martínez-Said H, Castillo-Henkel C, Segura-Pacheco B, De la Garza J
Department of Medical Oncology, Instituto Nacional de Cancerología, Mexico City, DF, México.
Ann Oncol. 2004 Feb;15(2):301-6. doi: 10.1093/annonc/mdh071.
Concurrent chemoradiation is the current standard of treatment for patients with advanced unresectable head and neck squamous cell carcinoma (HNSCC). Due to the potent radiosensitizing properties of gemcitabine, we decided to assess its efficacy and toxicity with concurrent radiation in patients with advanced HNSCC.
From January 1997 to December 2001, 27 patients with locally advanced HNSCC (stage III, 37%; stage IV, 63%) were enrolled. All received a course of radiotherapy (70 Gy over 7 weeks) concurrent with weekly infusions of gemcitabine at 100 mg/m2 or 50 mg/m2.
All patients were assessable for toxicity and 26 for response. Severe mucositis (grade 3-4) was observed in 74% of patients (grade 4, 41%). Severe hematological toxicity was uncommon. Mild and moderate xerostomy was the most common late toxicity in 23 patients (85%). The median radiation dose delivered was 70 Gy (40-80 Gy), 25 patients (93%) received > or = 80% of the intended dose. Gemcitabine dose intensity was > or = 80% in only 13 (48%) patients. The rate of complete and partial responses were 61% and 27%, respectively, for an overall response rate of 88%. At a median follow-up of 13 months (range 6-62), the actuarial 3-year progression-free survival (PFS) and overall survival (OS) were 37% and 33%, respectively. The only variable associated with prolonged survival (P = 0.0001) was the degree of response. No difference was observed in response or toxicity with either gemcitabine 50 or 100 mg/m2.
The concurrent use of radiotherapy and gemcitabine is effective but produces manageable severe mucositis in a high percentage of patients.
同步放化疗是晚期不可切除头颈部鳞状细胞癌（HNSCC）患者当前的标准治疗方法。由于吉西他滨具有强大的放射增敏特性，我们决定评估其在晚期HNSCC患者同步放疗时的疗效和毒性。
1997年1月至2001年12月，纳入27例局部晚期HNSCC患者（Ⅲ期，37%；Ⅳ期，63%）。所有患者均接受一个疗程的放疗（7周内70 Gy），同时每周静脉输注100 mg/m²或50 mg/m²的吉西他滨。
所有患者均可评估毒性，26例可评估疗效。74%的患者出现严重黏膜炎（3 - 4级）（4级，41%）。严重血液学毒性不常见。23例患者（85%）中，轻度和中度口干是最常见的晚期毒性。所给予的中位放射剂量为70 Gy（40 - 80 Gy），25例患者（93%）接受了≥80%的预定剂量。仅13例患者（48%）的吉西他滨剂量强度≥80%。完全缓解率和部分缓解率分别为61%和27%，总缓解率为88%。中位随访13个月（范围6 - 62个月）时，3年无进展生存率（PFS）和总生存率（OS）的精算值分别为37%和33%。与生存期延长相关的唯一变量是缓解程度（P = 0.0001）。50 mg/m²或100 mg/m²的吉西他滨在疗效或毒性方面未观察到差异。
放疗与吉西他滨同步使用是有效的，但在高比例患者中会产生可控制的严重黏膜炎。
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