Department of Medical Oncology, Ankara University School of Medicine, Ankara, Turkey.
Med Oncol. 2010 Sep;27(3):942-5. doi: 10.1007/s12032-009-9313-x. Epub 2009 Sep 29.
In aggressive non-Hodgkin lymphoma (NHL), CHOP (cyclophosphamide, vincristine, doxorubicin, prednisolone) regimen has been standard for decades, and rituximab has increased response rates and survival in CD20 positive patients, recently. The aim of this prospective trial was to evaluate the long-term efficacy and toxicity of MINE as a consolidation treatment in aggressive NHL patients who had achieved CR or unproven CR after six cycles of CHOP in the first line setting. The primary end-point was disease-free-survival (DFS). Thirty-eight patients were enrolled between February 1992 and May 2000. All of the patients received two cycles of MINE (mesna 1.3 g/m(2), ifosfamide 1.3 g/m(2), etoposide 65 mg/m(2) on days 1-3, and mitoxantrone 12 mg/m(2) on day 1, every 3 weeks) following response to CHOP. Initial bulky disease sites were also applied radiotherapy. Male/female ratio was 1.53(23/15). Median age was 49(30-73). Most of the patients had advanced stage (84.2% for stage >3) and high IPI score (79% for IPI score >2). Sixty percent had diffuse large cell histology. Median follow-up time was 118 months (9-195). Actual mean dose intensity was 88%. There were seven febrile neutropenia episodes. Two patients had grade two neuropathy, one had grade three mucositis and another one had non-neutropenic pneumonia. There was no early toxic death. No serious late toxicity was observed during long-term follow-up. Five- and 10-year DFS rates were both 65.3%. DFS rate in the patients with more than two poor prognostic factors according to IPI score is remarkably high (88%). Five- and 10-year OS was 62.5 and 59%, respectively. MINE regimen seems to be effective as a consolidation regimen, especially, in intermediate/high risk patients and has low early and late toxicities, and it warrants to be evaluated in phase III randomised trials with rituximab in CD20 positive aggressive NHL patients.
在侵袭性非霍奇金淋巴瘤（NHL）中，CHOP（环磷酰胺、长春新碱、多柔比星、泼尼松）方案已被应用数十年，而利妥昔单抗最近增加了 CD20 阳性患者的缓解率和生存率。本前瞻性试验的目的是评估在一线治疗中，CHOP 治疗 6 周期后达到完全缓解或未证实完全缓解的侵袭性 NHL 患者中，MINE 作为巩固治疗的长期疗效和毒性。主要终点是无病生存（DFS）。1992 年 2 月至 2000 年 5 月期间共纳入 38 例患者。所有患者在 CHOP 治疗后对缓解情况进行评估，然后接受 2 个周期的 MINE（美司钠 1.3 g/m2、异环磷酰胺 1.3 g/m2、依托泊苷 65 mg/m2，第 1-3 天给药，米托蒽醌 12 mg/m2，第 1 天给药，每 3 周 1 次）。最初的大肿块病灶也接受了放射治疗。男女比例为 1.53（23/15）。中位年龄为 49（30-73）岁。大多数患者处于晚期（84.2%为 3 期以上）和高 IPI 评分（79%为 IPI 评分>2）。60%为弥漫性大细胞组织学。中位随访时间为 118 个月（9-195）。实际平均剂量强度为 88%。有 7 例发热性中性粒细胞减少症。2 例患者有 2 级神经病变，1 例有 3 级黏膜炎，另 1 例有非中性粒细胞性肺炎。没有早期毒性死亡。在长期随访中未观察到严重的迟发性毒性。5 年和 10 年的 DFS 率均为 65.3%。根据 IPI 评分，具有 2 个以上不良预后因素的患者的 DFS 率显著较高（88%）。5 年和 10 年的 OS 分别为 62.5%和 59%。MINE 方案作为巩固治疗方案似乎有效，尤其是在中高危患者中，且具有较低的早期和晚期毒性，值得在 CD20 阳性侵袭性 NHL 患者中与利妥昔单抗进行 III 期随机试验进行评估。
