Kumar Lalit, Boya Rakesh Reddy, Pai Rohit, Harish P, Mookerjee Anjali, Sainath B, Patekar Mukesh Bhimrao, Sahoo Ranjit Kumar, Malik Prabhat Singh, Sharma O D, Gupta Ritu
Department of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.
Department of Laboratory Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.
Natl Med J India. 2016 Jul-Aug;29(4):192-199.
Survival of myeloma patients has improved considerably in the past decade. However, limited data are available on their long-term outcome. We analysed the data of 225 consecutive patients who underwent autologous stem cell transplantation (ASCT) at our centre.
Between April 1990 and December 2013, a total of 225 patients with multiple myeloma (median age 53 years, range 27-67 years, 69.3% men) underwent ASCT. High-dose melphalan 200 mg/m2 was used for conditioning. Before transplant, the patients received induction therapy with novel agents (thalidomide and dexamethasone, or lenalidomide and dexamethasone, or bortezomib and dexamethasone); or vincristine, doxorubicin, dexamethasone; or alkylating agents (vincristine, melphalan, cyclophosphamide and prednisolone; or melphalan and prednisolone). The response to transplant was evaluated using the European Bone Marrow Transplant criteria, and an intention-to-treat analysis was done.
Four-fifths (79.6%) of our patients had Durie Salmon Stage (DSS) IIIA and nearly a quarter (24%) of them had International Stage III disease. Before the transplant, 80.4% of patients had chemosensitive disease. The median interval from diagnosis to transplant was 10 months (range 2-128 months). Following ASCT, 197 (87.5%) patients responded. Complete response was obtained in 54.7%, very good partial response in 19% and partial response in 13.8%. At a median follow-up of 90 months (range 18-266 months), the median progression-free survival (PFS) and overall survival (OS) were 32 and 85.5 months, respectively. The estimated PFS and OS at 10 years were 29.7% and 43.6%, respectively. On multivariate analysis, the presence of extramedullary disease (HR 3.05, p < 0.001), and ISS III (HR 0.50, p < 0.02) predicted inferior OS. Extramedullary disease at diagnosis (HR 1.585, p < 0.03), and more than one regimen pre- transplant (HR 0.53, p < 0.02) predicted an inferior PFS. Complete response was a predictor of superior OS and PFS (p < 0.001).
Complete response following ASCT is associated with good long-term outcome. Alternative treatment strategies are needed to improve results in patients who fail to achieve CR post-transplant and in those with high-risk disease.
在过去十年中，骨髓瘤患者的生存率有了显著提高。然而，关于他们长期预后的数据有限。我们分析了在我们中心接受自体干细胞移植（ASCT）的225例连续患者的数据。
1990年4月至2013年12月期间，共有225例多发性骨髓瘤患者（中位年龄53岁，范围27 - 67岁，69.3%为男性）接受了ASCT。采用200mg/m²的大剂量美法仑进行预处理。移植前，患者接受新型药物（沙利度胺和地塞米松，或来那度胺和地塞米松，或硼替佐米和地塞米松）诱导治疗；或长春新碱、阿霉素、地塞米松；或烷化剂（长春新碱、美法仑、环磷酰胺和泼尼松龙；或美法仑和泼尼松龙）。根据欧洲骨髓移植标准评估移植反应，并进行意向性分析。
五分之四（79.6%）的患者为Durie Salmon分期（DSS）IIIA期，近四分之一（24%）为国际分期III期疾病。移植前，80.4%的患者患有化疗敏感疾病。从诊断到移植的中位间隔时间为10个月（范围2 - 128个月）。ASCT后，197例（87.5%）患者有反应。完全缓解率为54.7%，非常好的部分缓解率为19%，部分缓解率为13.8%。中位随访90个月（范围18 - 266个月）时，中位无进展生存期（PFS）和总生存期（OS）分别为32个月和85.5个月。10年时估计的PFS和OS分别为29.7%和43.6%。多因素分析显示，髓外疾病的存在（HR 3.05，p < 0.001）和国际分期III期（HR 0.50，p < 0.02）预示着较差的OS。诊断时的髓外疾病（HR 1.585，p < 0.03）和移植前使用超过一种方案（HR 并进行意向性分析。
五分之四（79.6%）的患者为Durie Salmon分期（DSS）IIIA期，近四分之一（24%）为国际分期III期疾病。移植前，80.4%的患者患有化疗敏感疾病。从诊断到移植的中位间隔时间为10个月（范围2 - 128个月）。ASCT后，197例（87.5%）患者有反应。完全缓解率为54.7%，非常好的部分缓解率为19%，部分缓解率为13.8%。中位随访90个月（范围18 - 266个月）时，中位无进展生存期（PFS）和总生存期（OS）分别为32个月和85.5个月。10年时估计的PFS和OS分别为29.7%和43.6%。多因素分析显示，髓外疾病的存在（HR 3.05，p < 0.001）和国际分期III期（HR 0.50，p < 0.02）预示着较差的OS。诊断时的髓外疾病（HR 1.585，p < 0.03）和移植前使用超过一种方案（HR 0.53，p < 0.0）预示着较差的PFS。完全缓解是较好的OS和PFS的预测因素（p < 0.001）。
ASCT后的完全缓解与良好的长期预后相关。对于移植后未达到CR的患者和高危疾病患者，需要替代治疗策略来改善治疗结果。
