Miyamoto Tadaaki, Yamamoto Naoyoshi, Nishimura Hideki, Koto Masashi, Tsujii Hirohiko, Mizoe Jun-etsu, Kamada Tadashi, Kato Hirotoshi, Yamada Shigeru, Morita Shinroku, Yoshikawa Kyosan, Kandatsu Susumu, Fujisawa Takehiko
Research Center Hospital for Charged Particle Therapy, National Institute of Radiological Sciences, 9-1 Anagawa, 4-chome, Inage-Ku, Chiba-shi 263-8555, Japan.
Radiother Oncol. 2003 Feb;66(2):127-40. doi: 10.1016/s0167-8140(02)00367-5.
Heavy ion radiotherapy is a promising modality because of its excellent dose localization and high biological effect on tumors. Using carbon beams, a dose escalation study was conducted for the treatment of stage I non-small cell lung cancer (NSCLC) to determine the optimal dose.
The first stage phase I/II trial using 18 fractions over 6 weeks for 47 patients and the second one using nine fractions over 3 weeks for 34 patients were conducted by the dose escalation method from 59.4 to 95.4 Gray equivalents (GyE) in incremental steps of 10% and from 68.4 to 79.2 GyE in 5% increments, respectively. The local control and survival rates were obtained using the Kaplan-Meier method.
Radiation pneumonitis at grade III occurred in three of 81 patients, but they fully recovered. This was not a dose-limiting factor. The local control rates in the first and second trials were 64% and 84%, respectively. The total recurrence rate in both trials was 23.2%. The infield local recurrence in the first trial was significantly dependent on carbon dose. The doses greater than 86.4 GyE at 18 fractions and 72 GyE at nine fractions achieved a local control of 90% and 95%, respectively. The 5 year overall and cause-specific survivals in 81 patients were 42% and 60%, respectively.
With our dose escalation study, the optimum safety and efficacy dose of carbon beams was determined. Carbon beam therapy attained almost the same results as surgery for stage I NSCLC although this was a I/II study.
重离子放射治疗因其出色的剂量定位和对肿瘤的高生物学效应而成为一种有前景的治疗方式。利用碳离子束,开展了一项针对I期非小细胞肺癌(NSCLC)治疗的剂量递增研究,以确定最佳剂量。
采用剂量递增法,对47例患者进行了为期6周、分18次照射的I/II期第一阶段试验,剂量从59.4至95.4戈瑞当量(GyE),以10%的增量递增;对34例患者进行了为期3周、分9次照射的第二阶段试验,剂量从68.4至79.2 GyE,以5%的增量递增。采用Kaplan-Meier法获得局部控制率和生存率。
81例患者中有3例发生III级放射性肺炎,但均完全康复。这并非剂量限制因素。第一阶段和第二阶段试验的局部控制率分别为64%和84%。两个试验的总复发率为23.2%。第一阶段试验中,瘤床局部复发显著依赖于碳离子剂量。18次照射时剂量大于86.4 GyE以及9次照射时剂量大于72 GyE分别实现了90%和95%的局部控制。81例患者的5年总生存率和病因特异性生存率分别为42%和60%。
通过我们的剂量递增研究,确定了碳离子束的最佳安全有效剂量。尽管这是一项I/II期研究,但碳离子束治疗I期NSCLC取得了与手术几乎相同的效果。