Miyamoto Tadaaki, Baba Masayuki, Yamamoto Naoyoshi, Koto Masashi, Sugawara Toshiyuki, Yashiro Tomoyasu, Kadono Kennoshuke, Ezawa Hidefumi, Tsujii Hirohiko, Mizoe Jun-Etsu, Yoshikawa Kyosan, Kandatsu Susumu, Fujisawa Takehiko
Research Center Hospital for Charged Particle Therapy, National Institute of Radiological Sciences (NIRS), Chiba, Japan.
Int J Radiat Oncol Biol Phys. 2007 Mar 1;67(3):750-8. doi: 10.1016/j.ijrobp.2006.10.006.
A phase I/II study on carbon ion radiotherapy for Stage I non-small-cell lung cancer (NSCLC) was first conducted between 1994 and 1999 and determined the optimal dose. Second, a Phase II study using the optimal dose was performed. The purpose of the present study was to clarify the local control and 5-year survival rates.
Between April 1999 and December 2000, 50 patients with 51 primary lesions were treated. Using a fixed dose of 72 GyE in nine fractions over 3 weeks, the primary tumors were irradiated with carbon ion beams alone. The average age of the patients was 74.5 years. Thirty-three (66%) of these were medically inoperable. Local control and survival were determined by using the Kaplan-Meier method and the data were statistically processed by using the log-rank test.
All patients were observed for a minimum of 5 years or until death with a median follow-up time of 59.2 months (range, 6.0-83.0 months). The local control rate for all patients was 94.7%. The patients' 5-year cause-specific survival rate was 75.7% (IA: 89.4; IB: 55.1), and overall survival 50.0% (IA: 55.2; IB: 42.9). No toxic reactions in the lung greater than Grade 3 were detected.
Carbon ion radiotherapy, a new treatment modality with superior benefits in terms of quality of life and activity of daily living, 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年首次开展了一项关于I期非小细胞肺癌（NSCLC）碳离子放疗的I/II期研究，并确定了最佳剂量。其次，进行了一项使用最佳剂量的II期研究。本研究的目的是明确局部控制率和5年生存率。
1999年4月至2000年12月，对50例患有51个原发性病灶的患者进行了治疗。采用固定剂量72 GyE，分9次在3周内给予，仅用碳离子束照射原发性肿瘤。患者的平均年龄为74.5岁。其中33例（66%）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，并使用对数秩检验对数据进行统计学处理。
所有患者至少观察5年或直至死亡，中位随访时间为59.2个月（范围6.0 - 83.0个月）。所有患者的局部控制率为94.7%。患者的5年病因特异性生存率为75.7%（IA期：89.4%；IB期：55.1%），总生存率为50.0%（IA期：55.2%；IB期：42.9%）。未检测到大于3级的肺部毒性反应。
碳离子放疗作为一种在生活质量和日常生活活动方面具有显著优势的新治疗方式，已被证明是I期NSCLC手术的有效替代方法，尤其对老年和无法手术的患者具有特殊益处。
