Blayney Douglas W, LeBlanc Michael L, Grogan Thomas, Gaynor Ellen R, Chapman Robert A, Spiridonidis C Harris, Taylor Sarah A, Bearman Scott I, Miller Thomas P, Fisher Richard I
Wilshire Oncology Medical Group, Inc, Pasadena, CA, USA.
J Clin Oncol. 2003 Jul 1;21(13):2466-73. doi: 10.1200/JCO.2003.06.137.
To test the hypothesis that therapy of intermediate- and high-grade (excluding Burkitt lymphoblastic) lymphoma with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) could be safely dose-intensified with routine filgrastim support.
Eligible patients were those who were previously untreated and who had either bulky stage II, or stage III or IV lymphoma with working formulation histology D, E, F, G, H, or J; performance status < or = 2; and acceptable end organ function. No upper age limit was specified. Therapy was dose-intensified CHOP (CHOP-DI) with filgrastim support. Each course was repeated every 14 days for six planned courses.
Eighty-eight eligible patients were treated with CHOP-DI and had a median follow-up of 5.1 years on this phase II study, designated Southwest Oncology Group (SWOG) 9349. The progression-free survival was 51% at 2 years and 41% at 5 years. The overall survival was 60% at 5 years. Three fatal treatment-related events occurred. One patient with myelodysplastic syndrome was reported.
Treatment with CHOP-DI can be safely administered in the cooperative group setting and results in improved survival. Estimated overall survival at 5 years was 14% better than that of patients treated with standard-dose CHOP in an earlier SWOG study, although progression-free survival of 60% at 2 years-the prespecified end point-was not achieved. CHOP-DI, given every 2 weeks at escalated doses, is a strategy that should be tested in a future randomized clinical trial in lymphoma.
检验以下假设，即对于中高分级（不包括伯基特淋巴细胞性）淋巴瘤，使用环磷酰胺、多柔比星、长春新碱和泼尼松（CHOP方案）进行治疗时，在常规使用非格司亭支持的情况下可安全地增加剂量强度。
符合条件的患者为既往未接受过治疗，且患有大块型II期、III期或IV期淋巴瘤，组织学类型为工作分类D、E、F、G、H或J；体能状态≤2；且终末器官功能可接受。未设定年龄上限。治疗方案为在非格司亭支持下增加剂量强度的CHOP方案（CHOP-DI）。每14天重复一个疗程，共计划进行六个疗程。
88例符合条件的患者接受了CHOP-DI治疗，在这项名为西南肿瘤协作组（SWOG）9349的II期研究中，中位随访时间为5.1年。2年无进展生存率为51%，5年为41%。5年总生存率为60%。发生了3起致命的治疗相关事件。报告了1例患有骨髓增生异常综合征的患者。
CHOP-DI治疗可在协作组环境中安全实施，并能提高生存率。5年总生存率估计比早期SWOG研究中接受标准剂量CHOP治疗的患者高14%，尽管未达到2年60%的无进展生存率这一预先设定的终点。每2周给予递增剂量的CHOP-DI是一种应在未来淋巴瘤随机临床试验中进行检验的策略。
