Palandri Francesca, Castagnetti Fausto, Alimena Giuliana, Testoni Nicoletta, Breccia Massimo, Luatti Simona, Rege-Cambrin Giovanna, Stagno Fabio, Specchia Giorgina, Martino Bruno, Levato Luciano, Merante Serena, Liberati Anna Maria, Pane Fabrizio, Saglio Giuseppe, Alberti Daniele, Martinelli Giovanni, Baccarani Michele, Rosti Gianantonio
Department of Hematology/Oncology L. and A. Seràgnoli S.Orsola Malpighi Hospital, University of Bologna, Bologna, Italy.
Haematologica. 2009 Feb;94(2):205-12. doi: 10.3324/haematol.13529. Epub 2009 Jan 14.
Imatinib mesylate is the first line treatment for chronic myeloid leukemia. The advent of imatinib increased survival significantly in patients in an advanced phase of the disease. However, few long-term data on the outcome of these patients based on large, prospective and controlled trials are available.
A phase 2 multicenter trial of the use of imatinib 600 mg/daily in patients with accelerated phase chronic myeloid leukemia was sponsored and promoted by the Italian Cooperative Study Group on Chronic Myeloid Leukemia in 2001.
One hundred and eleven patients were enrolled; the median follow-up of the 41 living patients is 82 months (range, 73-87). One hundred and seven patients (96%) returned to chronic phase and 79 patients (71%) achieved a complete hematologic response. Cumulative best rates of major cytogenetic response and complete cytogenetic response were 30% and 21%, respectively. All responses were maintained for a minimum of 4 weeks. At last follow-up, four patients were alive in complete remission after allogeneic transplant, 16 patients (14%) had switched to a second generation tyrosine kinase inhibitor and 21 patients (19%) were alive on imatinib therapy. No late toxicities were observed. Progression-free survival and event-free survival rates were 36.5% and 15%, respectively, at 7 years. The median survival time was 37 months, and was significantly associated with the achievement of a complete hematologic response or a complete cytogenetic response.
Imatinib may induce durable responses, associated with prolonged survival, in patients with accelerated phase chronic myeloid leukemia.
甲磺酸伊马替尼是慢性髓性白血病的一线治疗药物。伊马替尼的出现显著提高了疾病晚期患者的生存率。然而，基于大型、前瞻性和对照试验的这些患者结局的长期数据很少。
2001年，意大利慢性髓性白血病合作研究组发起并推动了一项针对加速期慢性髓性白血病患者每日使用600毫克伊马替尼的2期多中心试验。
共纳入111例患者；41例存活患者的中位随访时间为82个月（范围73 - 87个月）。107例患者（96%）恢复到慢性期，79例患者（71%）获得完全血液学缓解。主要细胞遗传学缓解和完全细胞遗传学缓解的累积最佳率分别为30%和21%。所有缓解至少维持4周。在最后一次随访时，4例患者在异基因移植后处于完全缓解状态存活，16例患者（14%）已改用第二代酪氨酸激酶抑制剂，21例患者（19%）在接受伊马替尼治疗后存活。未观察到晚期毒性反应。7年时无进展生存率和无事件生存率分别为36.5%和15%。中位生存时间为37个月，与完全血液学缓解或完全细胞遗传学缓解的实现显著相关。
伊马替尼可能在加速期慢性髓性白血病患者中诱导持久缓解，并延长生存期。
