Standard chemotherapy compared with high-dose chemoradiotherapy for multiple myeloma: Final results of phase III US intergroup trial S9321
Standard chemotherapy compared with high-dose chemoradiotherapy for multiple myeloma: Final results of phase III US intergroup trial S9321
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DOI：
10.1200/jco.2005.04.5807
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发表时间：
2006-02-20
影响因子：
45.3
通讯作者：
Crowley, JC
中科院分区：
文献类型：
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作者：
Barlogie, B;Kyle, RA;Crowley, JC
目的 Intergroupe Francais du Myelome (IFM 90) 进行的一项前瞻性随机试验结果表明，与标准剂量治疗 (SDT) 相比，自体造血细胞支持的高剂量治疗 (HDT) 对多发性骨髓瘤 (MM) 患者具有更高的完全缓解率，并延长无进展生存期 (PFS) 和总生存期 (OS)。 1993 年，三个北美合作小组发起了一项前瞻性随机试验 (S9321)，比较 HDT（马法兰 [MEL] 140 mg/m(2) 加全身照射 12 Gy）与使用长春新碱、卡莫司汀、MEL、环磷酰胺和泼尼松方案的 SDT。两个治疗组的应答者 (>= 75%) 被随机分配接受干扰素 (IFN) 或不进行维持治疗。 结果 中位随访时间为 76 个月，两个研究组之间的应答率没有观察到差异（HDT，n = 261 名患者；SDT，In = 255 名患者）。同样，HDT 组和 SDT 组之间的 PFS 和 OS 持续时间没有差异，7 年估计 PFS 分别为 17% 和 16%，OS 分别为 37% 和 42%。在 242 名肿瘤缩小至少 75% 的患者中，随机分配接受 IFN 治疗的 121 名患者和随机分配不接受维持治疗的 121 名患者的 PFS 或 OS 没有观察到差异。在 157 名接受 SDT 复发的患者中，87 名接受了挽救性自体移植；他们的中位生存时间为 30 个月，仅略高于接受进一步 SDT 治疗的其余患者的生存时间（23 个月；P = .13）。 结论 S9321 中使用的 HDT 和 SDT 方案产生了可比较的缓解率以及 PFS 和 OS 持续时间。 IFN 维持治疗对任一臂肿瘤缩小≥ 75% 的患者均无益处。
Purpose Results of a prospective randomized trial conducted by the Intergroupe Francais du Myelome (IFM 90) indicated that autologous hematopoietic cell-supported high-dose therapy (HDT) effected higher complete response rates and extended progression-free survial (PFS) and overall survival (OS) compared with standard-dose therapies (SDT) for patients with multiple myeloma (MM).Patients and Methods In 1993, three North American cooperative groups launched a prospective randomized trial (S9321) comparing HDT (melphalan [MEL] 140 mg/m(2) plus total-body irradiation 12 Gy) with SDT using the vincristine, carmustine, MEL, cyclophosphamide, and prednisone regimen. Responders on both arms (>= 75%) were randomly assigned to interferon (IFN) or no maintenance treatment.Results With a median follow-up time of 76 months, no differences were observed in response rates between the two study arms (HDT, n = 261 patients; SDT, In = 255 patients). Similarly, PFS and OS durations did not differ between the HDT and SDT arms, with 7-year estimates of PFS of 17% and 16%, respectively, and OS of 37% and 42%, respectively. Of 242 patients achieving at least 75% tumor reduction, no difference was observed in PFS or OS among the 121 patients randomly assigned to IFN and the 121 patients randomly assigned to no maintenance therapy. Among 157 patients relapsing on SDT, 87 received a salvage autotransplantation; their median survival time of 30 months was only slightly better than the survival time of the remaining patients who were managed with further SDT (23 months; P = .13).Conclusion The HDT and SDT regimens used in S9321 yielded comparable response rates and PFS and OS durations. IFN maintenance therapy did not benefit patients who achieved >= 75% tumor reduction on either arm.