Zallio Francesco, Tamiazzo Stefania, Monagheddu Chiara, Merli Francesco, Ilariucci Fiorella, Stelitano Caterina, Liberati Anna Marina, Mannina Donato, Vitolo Umberto, Angelucci Emanuele, Rota Scalabrini Delia, Vallisa Daniele, Bellei Monica, Bari Alessia, Ciccone Giovannino, Salvi Flavia, Levis Alessandro
Haematology Department, SS Antonio & Biagio and C. Arrigo Hospital, Alessandria, Italy.
Unity of Clinical Epidemiology, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino and CPO Piemonte, Torino, Italy.
Br J Haematol. 2016 Mar;172(6):879-88. doi: 10.1111/bjh.13904. Epub 2016 Jan 13.
Survival rates for elderly Hodgkin Lymphoma (HL) have not improved substantially in recent years, mainly because of a lack of prospective randomized studies, due to difficulties in enrolling patients. Between 2002 and 2006, 54 untreated HL patients, aged between 65 and 80 years and considered 'non-frail' according to a comprehensive geriatric evaluation, were enrolled into a phase III randomized trial to compare a reduced-intensity regimen (vinblastine, cyclophosphamide, procarbazine, prednisone, etoposide, mitoxantrone, bleomycin; VEPEMB) with standard ABVD (adriamycin, bleomycin, vinblastine, dacarbazine). Primary endpoint was progression-free survival (PFS). Seventeen patients were in early stage (I-IIA), while 37 were advanced stage. Median age was 72 years and median follow-up was 76 months. Five-year PFS rates were 48% vs. 70% [adjusted Hazard ratio (HR) = 2·19, 95% confidence interval (CI) = 0·94-5·10, P = 0·068] and 5-year overall survival (OS) rates were 63% vs. 77% (adjusted HR = 1·67, 95% CI = 0·69-4·03, P = 0·254) for VEPEMB compared to ABVD. Overall treatment-related mortality was 4%. World Health Organization grade 4 cardiac and lung toxicity occurred in four patients treated with ABVD versus no cases in the VEPEMB arm. Standard ABVD regimen resulted in better PFS and OS than the VEPEMB, although the differences were not statistically significant. The low toxicity of both treatments was probably attributable to stringent selection of patients based on a Comprehensive Geriatric Assessment that excluded frail patients.
近年来,老年霍奇金淋巴瘤(HL)的生存率并未显著提高,主要原因是由于患者入组困难,缺乏前瞻性随机研究。2002年至2006年期间,54例未经治疗的HL患者,年龄在65至80岁之间,根据综合老年评估被认为“非体弱”,被纳入一项III期随机试验,以比较低强度方案(长春花碱、环磷酰胺、丙卡巴肼、泼尼松、依托泊苷、米托蒽醌、博来霉素;VEPEMB)与标准ABVD方案(阿霉素、博来霉素、长春花碱、达卡巴嗪)。主要终点是无进展生存期(PFS)。17例患者处于早期(I-IIA期),37例为晚期。中位年龄为72岁,中位随访时间为76个月。与ABVD相比,VEPEMB的5年PFS率分别为48%和70%[调整后的风险比(HR)=2.19,95%置信区间(CI)=0.94-5.10,P=0.068],5年总生存率(OS)分别为63%和77%(调整后的HR=1.67,95%CI=0.69-4.03,P=0.254)。总体治疗相关死亡率为4%。接受ABVD治疗的4例患者发生了世界卫生组织4级心脏和肺部毒性,而VEPEMB组无病例发生。标准ABVD方案的PFS和OS优于VEPEMB,尽管差异无统计学意义。两种治疗的低毒性可能归因于基于综合老年评估对患者进行严格筛选,排除了体弱患者。