Martelli M, Vignetti M, Zinzani P L, Gherlinzoni F, Meloni G, Fiacchini M, De Sanctis V, Papa G, Martelli M F, Calabresi F, Tura S, Mandelli F
Dipartimento di Biopatologia Umana, Universita La Sapienza, Roma, Italy.
J Clin Oncol. 1996 Feb;14(2):534-42. doi: 10.1200/JCO.1996.14.2.534.
To evaluate, in a prospective multicentric study, the efficacy of a conventional salvage chemotherapy (dexamethasone, cisplatin, and cytarabine [DHAP]) versus high-dose chemotherapy (carmustine, etoposide, cytarabine, and cyclophosphamide [BEAC]) followed by autologous bone marrow transplantation (ABMT) in patients with aggressive non-Hodgkin's lymphoma (NHL) in clinical partial response (PR) after two thirds of a conventional front-line therapy.
From August 1988 to August 1991, 286 patients with aggressive NHL were randomized in seven Italian institutions to receive fluorouracil, methotrexate, cytarabine, cyclophosphamide, doxorubicin, vincristine, and prednisone (F-MACHOP) or methotrexate with leucovorin, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin (MACOP-B) as front-line therapy. Of the 286 patients enrolled onto the trial, 77 (27%) were considered in PR after two thirds of the front-line therapy, and 49 of 77 (64%) were randomized: 27 to receive DHAP chemotherapy and 22 to receive BEAC followed by ABMT.
The response after second-line treatment was as follows: in the DHAP group, four patients (15%) achieved a complete remission (CR), 12 (44%) remained in stable PR, and 11 (41%) showed progressive disease; in the ABMT group, three patients (14%) obtained a CR, 18 (82%) obtained a stable PR, and one (4%) progressed, with an overall response (CR + stable PR) of 59% and 96% (P < .001) in the DHAP and ABMT groups, respectively. The overall survival was 59% versus 73% and the progression-free survival (PFS) was 52% versus 73% in the DHAP and ABMT groups, respectively (P, not significant). The toxicity was mild, particularly in the ABMT group, and no treatment-related deaths occurred in either group.
Because of the small number of patients randomized, we were unable to determine whether ABMT or a standard salvage regimen (DHAP) is superior for PR patients. However, we confirmed that myeloablative treatment is a safe and well-tolerated procedure in this category of patients and this may enable us to evaluate its role as part of a front-line treatment in poor-risk NHL patients.
在一项前瞻性多中心研究中，评估传统挽救性化疗（地塞米松、顺铂和阿糖胞苷[DHAP]）与大剂量化疗（卡莫司汀、依托泊苷、阿糖胞苷和环磷酰胺[BEAC]）随后进行自体骨髓移植（ABMT），对接受三分之二传统一线治疗后处于临床部分缓解（PR）的侵袭性非霍奇金淋巴瘤（NHL）患者的疗效。
1988年8月至1991年8月，286例侵袭性NHL患者在意大利的7家机构中被随机分组，接受氟尿嘧啶、甲氨蝶呤、阿糖胞苷、环磷酰胺、多柔比星、长春新碱和泼尼松（F-MACHOP）或甲氨蝶呤联合亚叶酸钙、多柔比星、环磷酰胺、长春新碱、泼尼松和博来霉素（MACOP-B）作为一线治疗。在纳入该试验的286例患者中，77例（27%）在接受三分之二的一线治疗后被认为处于PR，其中49例（64%）被随机分组：27例接受DHAP化疗，22例接受BEAC治疗后进行ABMT。
二线治疗后的反应如下：在DHAP组中，4例患者（15%）达到完全缓解（CR），12例（44%）维持稳定的PR，11例（41%）疾病进展；在ABMT组中，3例患者（14%）获得CR，18例（82%）获得稳定的PR，1例（4%）疾病进展，DHAP组和ABMT组的总缓解率（CR + 稳定PR）分别为59%和96%（P <.001）。DHAP组和ABMT组的总生存率分别为59%和73%，无进展生存率（PFS）分别为52%和73%（P，无显著性差异）。毒性较轻，尤其是在ABMT组，两组均未发生与治疗相关的死亡。
由于随机分组的患者数量较少，我们无法确定ABMT或标准挽救方案（DHAP）对PR患者是否更优。然而，我们证实清髓性治疗在这类患者中是一种安全且耐受性良好的程序，这可能使我们能够评估其作为高危NHL患者一线治疗一部分的作用。
