Miyamoto Tadaaki, Baba Masayuki, Sugane Toshio, Nakajima Mio, Yashiro Tomoyasu, Kagei Kennji, Hirasawa Naoki, Sugawara Toshiyuki, Yamamoto Naoyoshi, Koto Masashi, Ezawa Hidefumi, Kadono Kennoshuke, Tsujii Hirohiko, Mizoe Jun-etsu, Yoshikawa Kyosan, Kandatsu Susumu, Fujisawa Takehiko
Research Center Hospital for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
J Thorac Oncol. 2007 Oct;2(10):916-26. doi: 10.1097/JTO.0b013e3181560a68.
A phase I/II study was first conducted for the treatment of stage I non-small cell lung cancer (NSCLC) from 1994 to 1999 to determine the optimal dose. On the basis on the results, a phase II study using a regimen of four fractions during 1 week was performed. The purpose of the present study was to determine the local control and 5-year survival rates.
From December 2000 to November 2003, 79 patients with 80 primary lesions were treated. Using a fixed dose of 52.8 GyE for stage IA NSCLC and 60.0 GyE for stage IB NSCLC in four fractions during 1 week, the primary tumors were irradiated with carbon beams alone. The average age of the patients was 74.8 years. Sixty-two (78.5%) of these patients were medically inoperable. Local control and survival were determined using the Kaplan-Meier method. The data were statistically processed using the log-rank test.
All patients were observed for a minimum of 3 years or until death, with a median follow-up time of 38.6 months, ranging from 2.5 to 72.2 months. The local control rate for all patients was 90% (T1: 98%, T2: 80%). The patients' 5-year lung cancer-specific survival rate was 68% (IA: 87%, IB: 42%). The overall survival was 45% (IA: 62%, IB: 25%). Half of the deaths were attributable to intercurrent diseases. No toxic reactions in the lung greater than grade 3 were detected.
Carbon ion beam radiotherapy with a regimen of four fractions during 1 week has been proven as a valid alternative to surgery for stage I NSCLC and to offer particular benefits, especially for elderly and inoperable patients.
1994年至1999年首次开展了一项I/II期研究，用于治疗I期非小细胞肺癌（NSCLC）以确定最佳剂量。基于该结果，进行了一项在1周内分4次照射的II期研究。本研究的目的是确定局部控制率和5年生存率。
2000年12月至2003年11月，对79例有80个原发性病灶的患者进行了治疗。对于IA期NSCLC，采用固定剂量52.8 GyE，对于IB期NSCLC采用60.0 GyE，在1周内分4次照射，仅用碳离子束对原发性肿瘤进行照射。患者的平均年龄为74.8岁。其中62例（78.5%）患者因医学原因无法手术。采用Kaplan-Meier法确定局部控制率和生存率。数据采用对数秩检验进行统计学处理。
所有患者至少观察3年或直至死亡，中位随访时间为38.6个月，范围为2.5至72.2个月。所有患者的局部控制率为90%（T1：98%，T2：80%）。患者的5年肺癌特异性生存率为68%（IA期：87%，IB期：42%）。总生存率为45%（IA期：62%，IB期：25%）。一半的死亡归因于并发疾病。未检测到肺部大于3级的毒性反应。
对于I期NSCLC，1周内分4次照射的碳离子束放疗已被证明是一种有效的手术替代方案，尤其对老年和无法手术的患者具有特殊益处。
