Kato Shingo, Ohno Tatsuya, Tsujii Hirohiko, Nakano Takashi, Mizoe Jun-Etsu, Kamada Tadashi, Miyamoto Tadaaki, Tsuji Hiroshi, Kato Hirotoshi, Yamada Shigeru, Kandatsu Susumu, Yoshikawa Kyosan, Ezawa Hidefumi, Suzuki Michiya
Research Center Hospital for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):388-97. doi: 10.1016/j.ijrobp.2005.12.050. Epub 2006 Apr 19.
To evaluate the toxicity and efficacy of carbon ion radiotherapy (CIRT) for locally advanced cervical cancer by two phase I/II clinical trials.
Between June 1995 and January 2000, 44 patients were treated with CIRT. Thirty patients had Stage IIIB disease, and 14 patients had Stage IVA disease. Median tumor size was 6.5 cm (range, 4.2-11.0 cm). The treatment consisted of 16 fractions of whole pelvic irradiation and 8 fractions of local boost. In the first study, the total dose ranged from 52.8 to 72.0 gray equivalents (GyE) (2.2-3.0 GyE per fraction). In the second study, the whole pelvic dose was fixed at 44.8 GyE, and an additional 24.0 or 28.0 GyE was given to the cervical tumor (total dose, 68.8 or 72.8 GyE).
No patient developed severe acute toxicity. In contrast, 8 patients developed major late gastrointestinal complications. The doses resulting in major complications were > or =60 GyE. All patients with major complications were surgically salvaged. The 5-year local control rate for patients in the first and second studies was 45% and 79%, respectively. When treated with > or =62.4 GyE, the local control was favorable even for the patients with stage IVA disease (69%) or for those with tumors > or =6.0 cm (64%).
In CIRT for advanced cervical cancer, the dose to the intestines should be limited to <60 GyE to avoid major complications. Although the number of patients in this study was small, the results support continued investigation to confirm therapeutic efficacy.
通过两项I/II期临床试验评估碳离子放射治疗（CIRT）对局部晚期宫颈癌的毒性和疗效。
1995年6月至2000年1月期间，44例患者接受了CIRT治疗。30例患者为IIIB期疾病，14例患者为IVA期疾病。肿瘤中位大小为6.5厘米（范围4.2 - 11.0厘米）。治疗包括16次全盆腔照射和8次局部加量照射。在第一项研究中，总剂量范围为52.8至72.0戈瑞当量（GyE）（每次分割2.2 - 3.0 GyE）。在第二项研究中，全盆腔剂量固定为44.8 GyE，宫颈肿瘤额外给予24.0或28.0 GyE（总剂量68.8或72.8 GyE）。
无患者发生严重急性毒性反应。相比之下，8例患者出现了严重的晚期胃肠道并发症。导致严重并发症的剂量≥60 GyE。所有发生严重并发症的患者均通过手术挽救。第一项和第二项研究中患者的5年局部控制率分别为45%和79%。当接受≥62.4 GyE治疗时，即使是IVA期疾病患者（69%）或肿瘤≥6.0厘米的患者（64%），局部控制情况也较好。
在晚期宫颈癌的CIRT治疗中，肠道剂量应限制在<60 GyE以避免严重并发症。尽管本研究中的患者数量较少，但结果支持继续开展研究以确认治疗效果。
