Nakano T, Suzuki M, Abe A, Suzuki Y, Morita S, Mizoe J, Sato S, Miyamoto T, Kamada T, Kato H, Tsujii H
Division of Radiation Medicine, Center of Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
Cancer J Sci Am. 1999 Nov-Dec;5(6):362-9.
The phase I/II clinical study of carbon beam therapy was undertaken for 31 cases of advanced cervical cancer of stages IIIB and IVA from June 1995 to November 1997. The main purpose was to determine clinically useful fraction doses without severe acute reaction of normal tissues and to assess tumor control dose levels achievable without significant normal tissue toxicity.
The treatment was given with four fixed fractions per week (24 fractions over 6 weeks) and was initiated with a fraction dose of 2.2 Gray equivalent (GyE), and the dose was increased as 2.4 GyE, 2.6 GyE, 2.8 GyE, and 3.0 GyE. Consequently, the total dose initiated was 52.8 GyE, to increase up to 72.0 GyE in 4.8-GyE increments in the dose-escalation fashion. Thirty patients with eligible advanced cervical cancers consisting of 27 squamous cell carcinomas and three adenocarcinomas were analyzed.
Acute response of normal tissues was less than with photon treatment until fraction doses of 2.8 GyE were administered, and patients finished treatment with comfortable conditions. Severe late complications occurred in the two patients who received more than 67.2 GyE. The 2-year cumulative survival rate and the local control rate of 27 patients with squamous cell carcinoma were 61.5% and 59.3%, respectively. According to stages, the 2-year survival rates of stage IIIB and IVA patients were 54.4% and 75.0%, respectively. The 2-year local control rates of stage IIIB and IVA patients were 52.6% and 75.0%, respectively.
These results indicated that the disease control seems to be relatively better for very advanced disease and with dose escalation treatment. Local control was not significantly correlated with total dose and tumor volume. The results of the present study, despite small numbers and short observation, suggest that an adequate fraction dose for pelvis fields is 2.8 to 3.0 GyE and that the carbon beam therapy might be advantageous for advanced cervical cancer.
1995年6月至1997年11月，对31例IIIB期和IVA期晚期宫颈癌患者进行了碳离子束治疗的I/II期临床研究。主要目的是确定在不引起正常组织严重急性反应的情况下临床上有用的分次剂量，并评估在不产生明显正常组织毒性的情况下可实现的肿瘤控制剂量水平。
治疗每周给予4次固定分次（6周共24次），起始分次剂量为2.2戈瑞当量（GyE），剂量依次增加为2.4 GyE、2.6 GyE、2.8 GyE和3.0 GyE。因此，起始总剂量为52.8 GyE，以4.8 GyE的增量按剂量递增方式增加至72.0 GyE。对30例符合条件的晚期宫颈癌患者进行了分析，其中包括27例鳞状细胞癌和3例腺癌。
在给予2.8 GyE分次剂量之前，正常组织的急性反应小于光子治疗，患者在舒适的状态下完成了治疗。接受超过67.2 GyE剂量的2例患者出现了严重的晚期并发症。27例鳞状细胞癌患者的2年累积生存率和局部控制率分别为61.5%和59.3%。按分期计算，IIIB期和IVA期患者的2年生存率分别为54.4%和75.0%。IIIB期和IVA期患者的2年局部控制率分别为52.6%和75.0%。
这些结果表明，对于非常晚期的疾病和剂量递增治疗，疾病控制似乎相对较好。局部控制与总剂量和肿瘤体积无显著相关性。本研究结果尽管样本量小且观察时间短，但表明盆腔野的合适分次剂量为2.8至3.0 GyE，碳离子束治疗可能对晚期宫颈癌有利。
