JRS-I LRA0401 和 LRB0402 日本横纹肌肉瘤研究组针对低风险胚胎性横纹肌肉瘤试验的结果。
Results of the JRS-I LRA0401 and LRB0402 Japan Rhabdomyosarcoma Study Group trials for low-risk embryonal rhabdomyosarcoma.
发表日期：2024 Aug 23
作者：
Hajime Hosoi, Mitsuru Miyachi, Satoshi Teramukai, Satomi Sakabayashi, Kunihiko Tsuchiya, Yasumichi Kuwahara, Rie Onodera, Kotone Matsuyama, Isao Yokota, Hiroshi Hojo, Hajime Okita, Jun-Ichi Hata, Minori Hamasaki, Masazumi Tsuneyoshi, Yoshinao Oda, Atsuko Nakazawa, Miho Kato, Tetsuya Takimoto, Keizo Horibe, Jun-Ichi Hara, Sachiyo Suita, Ryoji Hanada, Hidekazu Masaki, Miwako Nozaki, Hitoshi Ikeda, Seiji Kishimoto, Michio Kaneko, Akira Kawai, Yasuhide Morikawa
来源：
Experimental Hematology & Oncology
摘要：
在组间横纹肌肉瘤研究 IV 中，环磷酰胺总剂量增加至 26.4 g/m2 后，低风险横纹肌肉瘤患者的无失败生存率 (FFS) 有所改善。然而，这种剂量可能会增加某些患者发生不良事件的风险，包括不孕不育。 JRS-I LRA0401 和 LRB0402 方案旨在分别将环磷酰胺剂量减少至 9.6 g/m2 和 17.6 g/m2，而不降低 FFS 率。A 亚组患者接受八个周期（24 周）的长春新碱、放线菌素 D、和 1.2 g/m2/周期环磷酰胺。 B 亚组患者接受了 8 个周期（24 周）的长春新碱、放线菌素 D 和 2.2 g/m2/周期环磷酰胺治疗，随后接受 6 个周期（24 周）的长春新碱和放线菌素 D 治疗。两个亚组的 II/III 组患者均接受了放射治疗在A亚组（n = 12）中，3年FFS率为83%（95%置信区间[CI]，48-96），3年总生存（OS）率为100%。仅观察到 1 例孤立的局部复发 (8.3%)。没有出现意外的 4 级毒性，也没有死亡。 B 亚组 (n = 16) 中，3 年 FFS 和 OS 率分别为 88% (95% CI, 59-97) 和 94% (95% CI, 63-99)。没有意外的 4 级毒性，也没有死亡。对于低危 A 亚型横纹肌肉瘤患者，使用长春新碱、放线菌素 D 和较低剂量的环磷酰胺进行短期治疗，联合或不联合放疗（JRS-I LRA0401 方案），并适度减少环磷酰胺剂量用于低风险 B 亚组横纹肌肉瘤患者（JRS-I LRB0402 方案）不会损害 FFS。© 2024。作者获得日本临床肿瘤学会的独家许可。
Failure-free survival (FFS) rates of low-risk patients with rhabdomyosarcoma improved in Intergroup Rhabdomyosarcoma Study IV after the escalation of cyclophosphamide total dose to 26.4 g/m2. However, this dose may increase the risk of adverse events, including infertility, in some patients. The JRS-I LRA0401 and LRB0402 protocols aimed to reduce the cyclophosphamide dose to 9.6 g/m2 and 17.6 g/m2, respectively, without decreasing the FFS rates.Subgroup-A patients received eight cycles (24 weeks) of vincristine, actinomycin D, and 1.2 g/m2/cycle cyclophosphamide. Subgroup-B patients received eight cycles (24 weeks) of vincristine, actinomycin D, and 2.2 g/m2/cycle cyclophosphamide, followed by six cycles (24 weeks) of vincristine and actinomycin D. Group II/III patients in both subgroups received radiotherapy.In subgroup A (n = 12), the 3-year FFS rate was 83% (95% confidence interval [CI], 48-96), and the 3-year overall survival (OS) rate was 100%. Only one isolated local recurrence was observed (8.3%). There were no unexpected grade-4 toxicities and no deaths. In subgroup B (n = 16), the 3-year FFS and OS rates were 88% (95% CI, 59-97) and 94% (95% CI, 63-99), respectively. There were no unexpected grade 4 toxicities and no deaths.Shorter duration therapy using vincristine, actinomycin D, and lower dose cyclophosphamide with or without radiotherapy for patients with low-risk subgroup A rhabdomyosarcoma (JRS-I LRA0401 protocol) and moderate reduction of cyclophosphamide dose for patients with low-risk subgroup B rhabdomyosarcoma (JRS-I LRB0402 protocol) did not compromise FFS.© 2024. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.