Dose escalation study of carbon ion radiotherapy for locally advanced head-and-neck cancer
Dose escalation study of carbon ion radiotherapy for locally advanced head-and-neck cancer
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DOI：
10.1016/j.ijrobp.2004.02.067
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发表时间：
2004-10-01
影响因子：
7
通讯作者：
Konno, A
中科院分区：
文献类型：
--
作者：
Mizoe, J;Tsujii, H;Konno, A
目的：在一项I/II期剂量递增临床试验中，评价碳离子放射治疗头颈部肿瘤的毒性和疗效。方法：1994年6月至1997年1月，36例局部晚期、经组织学证实、新发或复发的头颈部肿瘤患者接受碳离子治疗。进行了剂量递增研究，17例患者(A组)在6周内给予18次，19例患者(B组)在4周内给予16次。两组的资格和不合格标准是相同的。在仔细观察了至少3名接受相同剂量治疗的患者后，剂量以10%的增量递增。研究的终点是皮肤和粘膜的3级反应或肿瘤的局部控制。结果：随访时间从77个月到108个月，中位数90个月。A组2例，70.2GYE/18次/6周，I级皮肤急性反应。B组用52.8 Gye、57.6 Gye和64.0 Gye治疗4周，3级急性皮肤反应发生率分别为20%(115)、27%(2/11)和67%(2/3)。黏膜急性反应3级者仅1例。仅1例患者发生靠近肿瘤的粘膜2级晚期反应(浅表溃疡)。直到分析时，没有观察到其他2级或更大的晚期反应。急性肿瘤反应34例，其中完全缓解10例，部分缓解19例，无变化4例，进展1例。34例患者按Kaplan-Meier法计算，5年局控率为75%。5例恶性黑色素瘤5年局部控制率为100%，9例腺样囊性癌局部控制率为90%。8例唾液腺和4例耳的局部控制率在56个月和5年均为100%。结论：70.2 Gye至18次6周和64.0 Gye至16次4周的剂量分级方法在发病率和局部控制率方面具有相同的临床效果。结果显示，碳离子放射治疗对腺样囊性癌、恶性黑色素瘤等非鳞状细胞癌的局部控制有较好的疗效。从这项研究的结果可以得出结论，碳离子放射治疗将提供高的局部控制率，而不会对周围正常组织造成不可接受的损伤。(C)2004年爱思唯尔公司。
Purpose: To evaluate the toxicity and efficacy of carbon ion radiotherapy for head-and-neck cancer in a Phase I/II dose escalation clinical trial.Methods and Materials: Between June 1994 and January 1997, 36 patients with locally advanced, histologically proven, and new or recurrent cancer of the head and neck were treated with carbon ions. A dose escalation study was conducted, delivering 18 fractions through 6 weeks for 17 patients (Group A) and 16 fractions through 4 weeks for 19 patients (Group B). Eligibility and ineligibility criteria were the same in both groups. The dosages were escalated in increments of 10% after careful observation of at least 3 patients treated with the same dosages. The endpoints of the study were a Grade 3 reaction of the skin and the mucous membrane or local control of the tumors.Results: Follow-up time ranged from 77 to 108 months with a median of 90 months. Grade 3 acute reaction of the skin was detected in I of the 2 patients in Group A who were treated with 70.2 GyE/18 fractions/6 weeks. In Group B, Grade 3 acute skin reaction was detected in 20% (115), 27% (2/11), and 67% (2/3) patients treated with 52.8 GyE, 57.6 GyE, and 64.0 GyE through 16 fractions for 4 weeks, respectively. There was only 1 patient with a Grade 3 acute reaction of the mucous membrane. Only 1 patient developed a Grade 2 late reaction of the mucous membrane (superficial ulcer), which was located close to the tumor. No other Grade 2 or greater late reaction was noted until the time of analysis. Acute tumor reactions in 34 patients consisted of 10 patients of complete response 19 of partial response, 4 of no change, and 1 of progressive disease. Local control of 34 patients calculated by the Kaplan-Meier method was 75% at 5 years. Five years' local control of five malignant melanomas showed 100%, and that of 9 patients with adenoid cystic carcinoma was 90%. Also, local control of 8 patients of salivary glands and 4 patients of ears was 100% at 56 months and 5 years.Conclusions: The dose fractionation methods of 70.2 GyE through 18 fractions for 6 weeks and 64.0 GyE through 16 fractions for 4 weeks showed equal clinical outcome in terms of morbidity and local control. The outcome of carbon ion radiotherapy showed a specific effectiveness in local control of non-squamous cell carcinoma such as adenoid cystic carcinomas and malignant melanomas. From the results of this study, it can be concluded that carbon ion radiotherapy will deliver a high local control rate without unacceptable injuries to the surrounding normal tissues. (C) 2004 Elsevier Inc.