Oyan Basak, Koc Yener, Ozdemir Evren, Kars Ayse, Turker Alev, Tekuzman Gulten, Kansu Emin
Section of Medical Oncology, Hematopoietic Stem Cell Transplantation Unit, Hacettepe University, Institute of Oncology, Ankara, Turkey.
Biol Blood Marrow Transplant. 2005 Sep;11(9):688-97. doi: 10.1016/j.bbmt.2005.05.014.
To achieve long-term disease-free survival, high-dose therapy and autologous stem cell transplantation (ASCT) is the current standard approach in patients with relapsed or refractory Hodgkin disease (HD) or non-Hodgkin lymphoma (NHL). Because chemosensitivity is a significant factor in determining transplantation eligibility, it is critical to select a salvage chemotherapy regimen that has the potential to induce a high response rate with low nonhematologic toxicity. In this phase II study, 49 patients with relapsed or refractory HD (n = 22) and NHL (n = 27) with a median age of 42 years were treated with an IIVP salvage regimen consisting of ifosfamide, idarubicin, and etoposide. Twenty-seven percent of the patients had primary refractory disease, whereas 22% and 51% had early and late relapses, respectively. As analyzed by intention to treat, 16 patients (33%) achieved complete remission and 21 patients (43%) achieved a partial response, leading to an overall response rate of 76% (63% in NHL and 91% in HD). In the univariate analysis, diagnosis (HD versus NHL), remission duration before the initiation of IIVP, disease bulk, increased lactate dehydrogenase, and the presence of "B" symptoms were significant factors affecting the response achieved by the IIVP regimen. Of 37 responders, 31 (84%) underwent high-dose therapy and transplantation. The probability of 4-year overall survival (OS) and event-free survival (EFS) in this group of patients who underwent ASCT was 67.7% and 49.1%, respectively. When compared with the patients who achieved a partial response, patients who achieved complete remission with the IIVP regimen had a significantly higher probability of 4-year EFS (67.3% versus 30%; P = .016) and 4-year OS (92.3% versus 39.2%; P = .003). In patients with HD, 4-year EFS and 4-year OS were 54.9% and 70.6%, respectively, without a significant difference with respect to the survival rates obtained in patients with NHL (43.6% and 63.6%, respectively). Common side effects observed during 102 cycles of therapy were grade 3 to 4 neutropenia (62%) and thrombocytopenia (58%). The IIVP regimen is a highly effective salvage regimen for patients with relapsed or refractory HD or NHL who are candidates for ASCT. Furthermore, the degree of response to IIVP predicts the posttransplantation outcome. However, close follow-up is necessary because of a high incidence of grade 3 to 4 hematologic toxicity.
为实现长期无病生存，大剂量化疗和自体干细胞移植（ASCT）是复发或难治性霍奇金淋巴瘤（HD）或非霍奇金淋巴瘤（NHL）患者目前的标准治疗方法。由于化疗敏感性是决定移植资格的重要因素，选择一种有可能诱导高缓解率且非血液学毒性低的挽救性化疗方案至关重要。在这项II期研究中，49例复发或难治性HD（n = 22）和NHL（n = 27）患者，中位年龄42岁，接受了由异环磷酰胺、伊达比星和依托泊苷组成的IIVP挽救方案治疗。27%的患者为原发性难治性疾病，而分别有22%和51%的患者为早期和晚期复发。按意向性分析，16例患者（33%）达到完全缓解，21例患者（43%）达到部分缓解，总缓解率为76%（NHL为63%，HD为91%）。单因素分析中，诊断（HD与NHL）、开始IIVP治疗前的缓解持续时间、疾病体积、乳酸脱氢酶升高以及“B”症状的存在是影响IIVP方案疗效的显著因素。37例缓解者中，31例（84%）接受了大剂量化疗和移植。这组接受ASCT的患者4年总生存（OS）率和无事件生存（EFS）率分别为67.7%和49.1%。与达到部分缓解的患者相比，采用IIVP方案达到完全缓解的患者4年EFS率（67.3%对30%；P = 0.016）和4年OS率（92.3%对39.2%；P = 0.003）显著更高。HD患者的4年EFS率和4年OS率分别为54.9%和70.6%，与NHL患者的生存率（分别为43.6%和63.6%）无显著差异。在102个治疗周期中观察到的常见副作用为3至4级中性粒细胞减少（62%）和血小板减少（58%）。IIVP方案对于适合ASCT的复发或难治性HD或NHL患者是一种高效的挽救方案。此外，对IIVP的反应程度可预测移植后的结果。然而，由于3至4级血液学毒性发生率高，密切随访是必要的。
