THE THIRD INTERGROUP RHABDOMYOSARCOMA STUDY
THE THIRD INTERGROUP RHABDOMYOSARCOMA STUDY
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DOI：
10.1200/jco.1995.13.3.610
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发表时间：
1995-03-01
影响因子：
45.3
通讯作者：
MAURER, HM
中科院分区：
文献类型：
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作者：
CRIST, W;GEHAN, EA;MAURER, HM
目的：第三次组间横纹肌肉瘤研究（IRS-III，1984 年至 1991 年）的最终目标是通过比较基于风险的手术方案和多药化疗（有或没有放疗）的临床试验，改善横纹肌肉瘤儿童的治疗结果。 患者和方法： 1,062 名以前未接受治疗、手术后进入研究的合格患者被随机分组 或按临床组（I 至 IV）、组织学（不利或有利）和原发肿瘤部位分配治疗。初始缓解、无进展生存期 (PFS) 和生存期 (S) 是随机组之间以及 IRS-III 和 IRS-II（1978 年至 1984 年）治疗患者之间比较的终点。结果：IRS-III 的治疗总体结果显着优于 IRS-II（5 年 PFS，65% +/- 2% vs 55% +/- 2%；P < .001 通过分层测试）。 I 组组织学良好的肿瘤患者在接受 1 年长春新碱和放线菌素 (VA) 治疗方案后表现良好，而接受 VA 加环磷酰胺 (C) 治疗的可比组患者的情况也同样良好（5 年 PFS，83% +/- 3% vs 76% +/- 4%；P = 0.18）。对于 II 组组织学良好的肿瘤患者（不包括眼眶、头部和睾丸旁肿瘤），关于在 VA 中添加阿霉素 (ADR) 的益处尚无定论。 III 组肿瘤患者（不包括特殊骨盆、眼眶和其他选定的非脑膜旁头部部位的肿瘤患者）在 IRS-III 的强化治疗方案中比 IRS-II 中的脉冲 VAC 或 VAC-VADRC 治疗方案表现得更好（5 年 PFS 估计，62% +/- 3% vs 52% +/- 3%；P < .01）；然而，IRS-III 治疗组之间的结果没有显着差异。诊断时患有转移性疾病的患者（临床 IV 组）并没有从所评估的更复杂的治疗中显着受益 结论：使用基于风险的研究设计，对 IRS-III 中的大多数患者进行强化治疗，总体上显着改善了治疗结果。这种策略的最大收获是在活检后有肉眼残留肿瘤的患者（临床 III 组）中实现的。还可以在不影响生存的情况下减少对选定患者亚群的治疗。 (C) 1995 年美国临床肿瘤学会。
Purpose: The ultimate goal of the Third Intergroup Rhabdomyosarcomo Study (IRS-III, 1984 to 1991) was to improve treatment outcome in children with rhabdomyosarcoma through clinical trials comparing risk-based protocols of surgery and multiagent chemotherapy, with or without irradiation.Patients and Methods: One thousand sixty-two previously untreated, eligible patients who were entered onto the study after surgery were randomized or assigned to treatment by clinical group (I through IV), histology (unfavorable or favorable), and site of the primary tumor. Initial responses, progression-free survival (PFS), and survival (S) were the end points used in comparisons between randomized groups and between patients treated in IRS-lll and IRS-ll (1978 to 1984).Results: The overall outcome of therapy in IRS-III was significantly better than in IRS-II (5-year PFS, 65% +/- 2% v 55% +/- 2%; P < .001 by stratified testing). Patients with group I favorable-histology tumors fared as well on a 1-year regimen of vincristine and dactinomycin (VA), as did a comparable group treated with VA plus cyclophosphamide (C) (5-year PFS, 83% +/- 3% v 76% +/- 4%; P = .18). Results for patients with group II favoroble-histology tumors, excluding orbit, head, and paratesticular sires, were inconclusive regarding the benefit from addition of doxorubicin (ADR) to VA. Patients with group III tumors, excluding those in special pelvic, orbit, and other selected nonparameningeal head sites, fared much better on the more intensive regimens of IRS-lll than on pulsed VAC or VAC-VADRC in IRS-II (5-year PFS esti motes, 62% +/- 3% v 52% +/- 3%; P < .01); however, there were no significant differences in outcome among the groups treated in IRS-III. patients with metastatic disease at diagnosis (clinical group IV) did not benefit significantly from the more complex therapies evaluatedConclusion: Intensification of therapy for most patients in IRS-III, using a risk-based study design, significantly improved treatment outcome overall. The largest gain from this strategy was realized in patients with gross residual tumor after biopsy (clinical group III). It was also possible to decrease therapy for selected patient subsets without compromising survival. (C) 1995 by American Society of Clinical Oncology.