Ibrahim Ali, Moukalled Nour, Mahfouz Rami, El Cheikh Jean, Bazarbachi Ali, Abou Dalle Iman
Hematology-Oncology Division, Internal Medicine Department, American University of Beirut, Beirut, Lebanon.
Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA USA.
Clin Hematol Int. 2022 May 12;4(1-2):30-34. doi: 10.1007/s44228-022-00001-x. eCollection 2022 Jun.
The treatment of newly diagnosed chronic phase chronic myeloid leukemia (CML) with nilotinib has resulted in a higher rate of major molecular (MMR) and complete cytogenetic response (CCyR) at 12 months compared to imatinib but at a higher cumulative cost and increased risk of serious adverse events. To maintain long-term efficacy and minimize both toxicity and costs, we aimed at evaluating in a prospective single-center trial the efficacy and safety of a response-directed switch from nilotinib to imatinib after 12 months in patients newly diagnosed with chronic phase CML. Thirteen adult patients were enrolled. Twelve patients started on nilotinib 300 mg twice daily. Eleven patients completed one year of nilotinib and were switched to imatinib 400 mg daily as per protocol. At 3 months, all patients achieved a complete hematologic response, with 7 (58%) patients had early molecular response. At 12 months, all patients achieved CCyR, of whom 5 (42%) and 4 (33%) patients achieved MMR and MR4.5, respectively. Three (27%) patients switched back to nilotinib after 18, 24, and 51 months respectively: 1 patient because of loss of CCyR after 18 months, and 2 patients because of imatinib intolerance. At last follow-up, all patients ( = 12) were alive and in MMR, 6 (50%) of them in continuous MR4.5. These findings suggest that response directed switch from nilotinib to imatinib at 12 months is capable of maintaining long-term response, with manageable side effects. This approach warrants further exploration with larger prospective trials. Clinical trial registration: Clinicaltrials.gov identifier: NCT01316250, https://clinicaltrials.gov/ct2/results?cond=&term=NCT01316250&cntry=&state=&city=&dist=. .
与伊马替尼相比，用尼罗替尼治疗新诊断的慢性期慢性髓性白血病（CML）在12个月时主要分子反应（MMR）和完全细胞遗传学缓解（CCyR）率更高，但累积成本更高且严重不良事件风险增加。为了维持长期疗效并将毒性和成本降至最低，我们旨在通过一项前瞻性单中心试验评估新诊断的慢性期CML患者在12个月后从尼罗替尼转为伊马替尼的反应导向转换的疗效和安全性。招募了13名成年患者。12名患者开始每日两次服用300mg尼罗替尼。11名患者完成了一年的尼罗替尼治疗，并按照方案改为每日服用400mg伊马替尼。在3个月时，所有患者均达到完全血液学缓解，其中7名（58%）患者有早期分子反应。在12个月时，所有患者均达到CCyR，其中5名（42%）和4名（33%）患者分别达到MMR和MR4.5。3名（27%）患者分别在18、24和51个月后转回尼罗替尼：1名患者是因为18个月后失去CCyR，2名患者是因为伊马替尼不耐受。在最后一次随访时，所有患者（n = 12）均存活且处于MMR状态，其中6名（50%）处于持续MR4.5状态。这些发现表明，在12个月时从尼罗替尼转为伊马替尼的反应导向转换能够维持长期反应，且副作用可控。这种方法值得通过更大规模的前瞻性试验进一步探索。临床试验注册：Clinicaltrials.gov标识符：NCT01316250，https://clinicaltrials.gov/ct2/results?cond=&term=NCT01316250&cntry=&state=&city=&dist=. .
