Multicenter Phase II Study of Lenalidomide in Relapsed or Recurrent Adult T-Cell Leukemia/Lymphoma: ATLL-002

被引：119

作者：

Ishida, Takashi ^{[1
]}

Fujiwara, Hiroshi ^{[2
]}

Nosaka, Kisato ^{[3
]}

Taira, Naoya ^{[4
]}

Abe, Yasunobu ^{[5
]}

Imaizumi, Yoshitaka ^{[6
]}

Moriuchi, Yukiyoshi ^{[7
]}

Jo, Tatsuro ^{[8
]}

Ishizawa, Kenichi ^{[9
]}

Tobinai, Kensei ^{[10
]}

Tsukasaki, Kunihiro ^{[12
]}

Ito, Shigeki ^{[13
]}

Yoshimitsu, Makoto ^{[14
]}

Otsuka, Maki ^{[15
]}

Ogura, Michinori ^{[16
]}

Midorikawa, Shuichi ^{[11
]}

Ruiz, Wanda ^{[11
]}

Ohtsu, Tomoko ^{[11
]}

机构：

[1] Nagoya City Univ, Grad Sch Med Sci, Nagoya, Aichi, Japan

[2] Ehime Univ Hosp, Toon, Ehime, Japan

[3] Kumamoto Univ Hosp, Kumamoto, Japan

[4] Heart Life Hosp, Okinawa, Japan

[5] Kyushu Canc Ctr, Fukuoka, Japan

[6] Nagasaki Univ Hosp, Nagasaki, Japan

[7] Sasebo City Gen Hosp, Nagasaki, Japan

[8] Japanese Red Cross Nagasaki Genbaku Hosp, Nagasaki, Japan

[9] Tohoku Univ Hosp, Sendai, Miyagi, Japan

[10] Natl Canc Ctr, Tokyo, Japan

[11] Celgene KK, Tokyo, Japan

[12] Natl Canc Ctr Hosp East, Chiba, Japan

[13] Iwate Med Univ, Morioka, Iwate, Japan

[14] Kagoshima Univ Hosp, Kagoshima, Japan

[15] Natl Hosp Org Kagoshima Med Ctr, Kagoshima, Japan

[16] Tokai Cent Hosp, Gifu, Japan

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2016年 / 34卷 / 34期

关键词：

SINGLE-AGENT LENALIDOMIDE; NON-HODGKIN-LYMPHOMA; MONOCLONAL-ANTIBODY KW-0761; NATURAL-KILLER-CELL; LEUKEMIA-LYMPHOMA; INTERFERON-ALPHA; IN-VIVO; RITUXIMAB; TRIAL; TRANSPLANTATION;

D O I：

10.1200/JCO.2016.67.7732

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose Few treatment options exist for adult T-cell leukemia/lymphoma (ATL), and the prognosis for this disease is poor. A phase I study of lenalidomide demonstrated preliminary antitumor activity in patients with relapsed ATL. The current phase II study evaluated the efficacy and safety of lenalidomide monotherapy in patients with relapsed or recurrent ATL. Patients and Methods Patients 20 years of age or older with acute, lymphoma, or unfavorable chronic subtype ATL, who had received one or more prior anti-ATL systemic chemotherapy and achieved stable disease or better on their last anti-ATL therapy with subsequent relapse or recurrence, were eligible. Patients received oral lenalidomide 25mg/d continuously until disease progression or unacceptable toxicity. The primary end point was overall response rate; secondary end points included safety, tumor control rate (stable disease or better), time to response, duration of response, time to progression, progression-free survival, and overall survival. Results Objective responses were noted in 11 of 26 patients (overall response rate, 42%; 95% CI, 23% to 63%), including four complete responses and one unconfirmed complete response. The tumor control rate was 73%. The median time to response and duration of response were 1.9 months and not estimable, respectively, and the median time to progression was 3.8 months. The median progression-free survival and overall survival were 3.8 and 20.3 months, respectively. The most frequent grade >= 3 adverse events were neutropenia (65%), leukopenia (38%), lymphopenia (38%), and thrombocytopenia (23%), which were all manageable and reversible. Conclusion Lenalidomide demonstrated clinically meaningful antitumor activity and an acceptable toxicity profile in patients with relapsed or recurrent aggressive ATL, hinting at its potential to become a treatment option. Further investigations of lenalidomide in ATL and other mature T-cell neoplasms are warranted. (C) 2016 by American Society of Clinical Oncology

引用

页码：4086 / +

页数：10

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