Tipifarnib as maintenance therapy did not improve disease-free survival in patients with acute myelogenous leukemia at high risk of relapse: Results of the phase III randomized E2902 trial

被引：3

作者：

Luger, Selina M. ^{[1
]}

Wang, Victoria X. ^{[2
]}

Rowe, Jacob M. ^{[3
]}

Litzow, Mark R. ^{[4
]}

Paietta, Elisabeth ^{[5
]}

Ketterling, Rhett P. ^{[4
]}

Lazarus, Hillard ^{[6
]}

Rybka, Witold B. ^{[7
]}

Craig, Michael D. ^{[8
]}

Karp, Judith ^{[9
]}

Cooper, Brenda W. ^{[6
]}

Makary, Adel Z. ^{[10
]}

Kaminer, Lynne S. ^{[11
]}

Appelbaum, Frederick R. ^{[12
]}

Larson, Richard A. ^{[13
]}

Tallman, Martin S. ^{[14
,15
]}

机构：

[1] Univ Penn, Abramson Canc Ctr, Perelman Ctr Adv Med, South Tower,12th Floor, Philadelphia, PA 19104 USA

[2] Dana Farber Canc Inst, ECOG ACRIN Biostat Ctr, Boston, MA 02115 USA

[3] Rambam Med Ctr, Haifa, Israel

[4] Mayo Clin, Rochester, MN USA

[5] Montefiore Med Ctr, 111 E 210th St, Bronx, NY 10467 USA

[6] Case Western Reserve Univ, Cleveland, OH 44106 USA

[7] Penn State Hershey Canc Inst, Hershey, PA USA

[8] West Virginia Univ Healthcare, Morgantown, WV USA

[9] Johns Hopkins Univ, Baltimore, MD USA

[10] Geisinger Med Ctr, Danville, PA 17822 USA

[11] North Shore Hlth Syst Evanston Hosp, Evanston, IL USA

[12] Fred Hutchinson Canc Res Ctr, 1124 Columbia St, Seattle, WA 98104 USA

[13] Univ Chicago, Chicago, IL 60637 USA

[14] Northwestern Univ, Chicago, IL 60611 USA

[15] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA

来源：

LEUKEMIA RESEARCH | 2021年 / 111卷

关键词：

AML; Maintenance; Tipifarnib; ACUTE MYELOID-LEUKEMIA; FARNESYLTRANSFERASE INHIBITOR TIPIFARNIB; 1ST COMPLETE REMISSION; LOW-DOSE CYTARABINE; OLDER PATIENTS; GROUP-B; ADULTS; INTERLEUKIN-2; IMMUNOTHERAPY; DECITABINE;

D O I：

10.1016/j.leukres.2021.106736

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: Despite the achievement of complete remission with chemotherapy in patients with acute myeloid leukemia (AML), relapse is common and the majority of patients will die of their disease. Patients who achieve a remission after refractory or relapsed disease as well as elderly patients have a very high rate of relapse even if they achieve a complete remission. A phase 3 randomized ECOG-ACRIN-led intergroup study was conducted to determine whether post-remission therapy with the farnesyl transferase inhibitor, tipifarnib (R115777), improved the disease-free survival (DFS) of adult patients with AML in complete remission (CR), at high risk for relapse. Patients and methods: Adult patients with AML in remission after salvage therapy and/or over age 60 in first remission were enrolled in this study. They were randomly assigned to treatment with tipifarnib or observation (control). The primary objective was to compare the disease-free survival (DFS) between the two arms based on intention to treat, which includes all randomized patients. Results: One hundred and forty-four patients were enrolled on the study. Median DFS was 8.9 vs 5.3 months, for tipifarnib vs observation (one-sided p = 0.026) and did not cross the pre-specified boundary to call the study positive. For the 134 eligible patients, median DFS was 10.8 vs 5.3 months for those randomized to tipifarnib vs observation (one-sided p = 0.008). Moreover in an ad hoc evaluation of all women (n = 71) median DFS was 12.1 vs 3.9 months for tipifarnib vs observation (one-sided p = 0.0004) while median OS was 26.5 vs 8.4 months respectively (one-sided p = 0.001). Conclusion: This study was not able to demonstrate a benefit to tipifarnib as maintenance therapy in patients with AML in remission. While subsets of patients may indeed benefit, additional studies would be needed to elucidate that benefit which is unlikely given that other seemingly better options have since become available.

引用

页数：6

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