Vesole D H, Crowley J J, Catchatourian R, Stiff P J, Johnson D B, Cromer J, Salmon S E, Barlogie B
University of Arkansas for Medical Science, Little Rock, AR, USA.
J Clin Oncol. 1999 Jul;17(7):2173-9. doi: 10.1200/JCO.1999.17.7.2173.
To evaluate high-dose melphalan followed by autologous stem-cell transplantation in patients with refractory multiple myeloma.
Multiple myeloma patients with alkylating agent or vincristine/doxorubicin/dexamethasone-refractory disease were eligible for the phase II multi-institutional Southwest Oncology Group trial S8993. Patients up to age 70 years were enrolled between April 15, 1991, and May 1, 1996. Patients without prior stem-cell collection were primed with high-dose cyclophosphamide (HD-CTX; 6 g/m(2)) and granulocyte-macrophage colony-stimulating factor. After stem-cell procurement, patients received melphalan 200 mg/m(2) with autologous transplantation. Upon recovery from melphalan, patients were to receive interferon alfa-2b until relapse.
Seventy-two patients were enrolled onto S8993; five were ineligible and one received no therapy. Of the 66 assessable patients, 56 patients underwent the transplant procedure; 54 were assessable for response and 56 for toxicity. The response to HD-CTX (n = 37) included three complete remissions (CRs; 8%) and five partial remissions (PR; 14%); response to melphalan (n = 54) included 16 CRs (30%) and 19 PRs (35%), for an overall CR and >/= PR (n = 66; intent-to-treat) of 27% and 58%, respectively. Toxicities included six treatment-related deaths: two during HD-CTX and four during transplantation. The median progression-free survival (PFS) and overall survival (OS) durations on an intent-to-treat basis from transplant registration was 11 months and 19 months (95% confidence interval, 14 to 29 months), respectively. The 3-year actuarial PFS and OS rates were 25% and 31%, respectively.
High-dose therapy with melphalan 200 mg/m(2) is feasible with high response rates (58% overall) and an OS of 19 months in patients with refractory multiple myeloma.
评估大剂量美法仑联合自体干细胞移植治疗难治性多发性骨髓瘤患者的疗效。
对烷化剂或长春新碱/阿霉素/地塞米松难治性疾病的多发性骨髓瘤患者，符合II期多机构西南肿瘤协作组试验S8993的条件。1991年4月15日至1996年5月1日期间，纳入年龄在70岁及以下的患者。未进行过干细胞采集的患者，先接受大剂量环磷酰胺（HD-CTX；6 g/m²）和粒细胞-巨噬细胞集落刺激因子预处理。干细胞采集后，患者接受200 mg/m²美法仑自体移植。美法仑恢复后，患者接受α-2b干扰素治疗直至复发。
72例患者纳入S8993研究；5例不符合条件，1例未接受治疗。66例可评估患者中，56例患者接受了移植手术；54例可评估缓解情况，56例可评估毒性反应。HD-CTX（n = 37）的反应包括3例完全缓解（CR；8%）和5例部分缓解（PR；14%）；美法仑（n = 54）的反应包括16例CR（30%）和19例PR（35%），总体CR和≥PR（n = 66；意向性治疗）分别为27%和58%。毒性反应包括6例与治疗相关的死亡：HD-CTX期间2例，移植期间4例。从移植登记开始，意向性治疗的无进展生存期（PFS）和总生存期（OS）的中位数分别为11个月和19个月（95%置信区间，14至29个月）。3年精算PFS和OS率分别为25%和31%。
对于难治性多发性骨髓瘤患者，200 mg/m²美法仑大剂量治疗可行，缓解率高（总体为58%），OS为19个月。
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