Moreau P, Milpied N, Voillat L, Colombat P, Mahé B, Rapp M J, Moreau A, Dupas B, Bulabois C E, Juge-Morineau N, Harousseau J L
Department of Haematology, CHU Hôtel-Dieu, Nantes, France.
Bone Marrow Transplant. 1998 Jun;21(12):1193-6. doi: 10.1038/sj.bmt.1701272.
The aim of the present trial was to investigate the feasibility of high-dose therapy followed by autologous peripheral blood stem cell transplantation (PBSCT) as a component of front-line treatment in patients with disseminated intermediate- and high-grade non-Hodgkin's lymphoma (NHL) aged 61-65 years. From October 1993 to June 1996, 14 consecutive patients entered this single-center prospective pilot trial. Patients were five males and nine females, median age 63 (range 61-65). The first-line treatment consisted of three courses of CHOP therapy. Patients achieving either a partial response (PR) or a complete response (CR) after initial therapy were eligible for PBSCT, while those with refractory or progressive disease were not autografted but included in the feasibility study in an intent-to-treat analysis. Of the 14 patients, 11 achieved either a CR (one) or a PR (10) after three courses of CHOP while the three patients with no response were not autografted and subsequently died of progressive disease. PBSC collection was feasible in responding patients after G-CSF priming (10 microg/kg/day for 6 days). Conditioning therapy was the BEAM protocol. All patients engrafted after PBSCT. The median time to granulocyte (>0.5 x 10(9)/l) and platelet recovery (>25 x 10(9)/l) was 12 (range 9-18) and 13 days (range 7-22), respectively. No toxic deaths VOD or IP were observed. Four of the 11 responding patients relapsed 2, 7, 9 and 12 months after PBSCT, respectively, and all died from progressive disease. Overall, 7/14 patients are alive and free from disease, 16-43 months after initial diagnosis (median 28). The actuarial overall survival is 45.7 %, and the actuarial event-free survival is 50% at 3.5 years. This study shows the feasibility of high-dose therapy and PBSCT in patients with intermediate- or high-grade disseminated NHL aged 61-65 years. Such patients should not be excluded from trials evaluating the role of ASCT as part of initial treatment for disseminated and histologically aggressive NHL.
本试验的目的是研究大剂量治疗后行自体外周血干细胞移植（PBSCT）作为61 - 65岁播散性中高级非霍奇金淋巴瘤（NHL）一线治疗组成部分的可行性。1993年10月至1996年6月，14例连续患者进入该单中心前瞻性试验。患者中男性5例，女性9例，中位年龄63岁（范围61 - 65岁）。一线治疗包括三个疗程的CHOP方案。初始治疗后达到部分缓解（PR）或完全缓解（CR）的患者符合PBSCT条件，而难治性或疾病进展的患者不行自体移植，但纳入意向性分析的可行性研究。14例患者中，11例在三个疗程的CHOP治疗后达到CR（1例）或PR（10例），3例无反应的患者未行自体移植，随后死于疾病进展。在给予粒细胞集落刺激因子（G - CSF）动员（10μg/kg/天，共6天）后，有反应的患者可行PBSC采集。预处理方案为BEAM方案。所有患者在PBSCT后均实现造血重建。粒细胞（>0.5×10⁹/L）和血小板恢复（>25×10⁹/L）的中位时间分别为12天（范围9 - 18天）和13天（范围7 - 22天）。未观察到毒性死亡、肝静脉闭塞病（VOD）或感染相关并发症（IP）。11例有反应的患者中有4例分别在PBSCT后2、7、9和12个月复发，均死于疾病进展。总体而言，7/14例患者在初始诊断后16 - 43个月（中位28个月）存活且无疾病。3.5年时的精算总生存率为45.7%，精算无事件生存率为50%。本研究表明大剂量治疗和PBSCT在61 - 65岁中高级播散性NHL患者中是可行的。在评估自体干细胞移植（ASCT）作为播散性和组织学侵袭性NHL初始治疗一部分的作用的试验中，不应将此类患者排除在外。
