Mogamulizumab for relapsed adult T-cell leukemia-lymphoma: Updated follow-up analysis of phase I and II studies.
Mogamulizumab for relapsed adult T-cell leukemia-lymphoma: Updated follow-up analysis of phase I and II studies.
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DOI：
10.1111/cas.13343
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发表时间：
2017-10
期刊：
影响因子：
5.7
通讯作者：
Ueda R
中科院分区：
文献类型：
--
作者：
Ishida T;Utsunomiya A;Jo T;Yamamoto K;Kato K;Yoshida S;Takemoto S;Suzushima H;Kobayashi Y;Imaizumi Y;Yoshimura K;Kawamura K;Takahashi T;Tobinai K;Ueda R
本研究旨在阐明成人T细胞白血病-淋巴瘤(ATL)患者接受脱糖抗CCR4单抗莫古珠单抗的预后。本文更新了参加两项研究的ATL患者的无进展生存率(PFS)和总生存率(OS)，这两项研究分别是NCT00355472(复发性ATL和外周T细胞淋巴瘤患者使用MoGamulizumab的I期研究)和NCT00920790(复发性ATL的II期研究)。在I期研究的13名复发性侵袭性ATL患者中，4名(31%)存活了3年。在II期研究中，26名复发的侵袭性ATL患者的中位PFS为5.2个月，1年PFS为26%，而中位OS为14.4个月，3年OS为23%。对于没有皮疹或仅出现1级皮疹的患者，中位PFS为0.8个月，1年PFS为零，中位OS为6.0个月，3年OS为8%。相比之下，皮疹≥分级为2级的患者，中位PFS为11.7个月，1年PFS为50%，中位OS为25.6个月，3年OS为36%。因此，我们得出结论，莫伽珠单抗治疗可以改善一些复发性侵袭性ATL患者的PFS和OS，特别是那些出现皮疹作为中度免疫相关不良事件的患者。因此，有必要进行进一步的研究，以验证本观察结果，并澄清mogamulizumab活性所涉及的机制。
The present study sought to elucidate the prognosis of adult T‐cell leukemia–lymphoma (ATL) patients receiving mogamulizumab, a defucosylated anti‐CCR4 monoclonal antibody. Progression‐free survival (PFS) and overall survival (OS) of ATL patients enrolled in two studies are herein updated, namely NCT00355472 (phase I study of mogamulizumab in relapsed patients with ATL and peripheral T‐cell lymphoma) and NCT00920790 (phase II study for relapsed ATL). Of 13 patients with relapsed aggressive ATL in the phase I study, four (31%) survived >3 years. For 26 relapsed patients with aggressive ATL in the phase II study, median PFS was 5.2 months and 1‐year PFS was 26%, whereas median OS was 14.4 months, and 3‐year OS was 23%. For patients without a rash or who developed a grade 1 rash only, median PFS was 0.8 months, and 1‐year PFS was zero, with a median OS of 6.0 months, and 3‐year OS of 8%. In contrast, for patients who developed a rash ≥grade 2, median PFS was 11.7 months, and 1‐year PFS was 50%, with a median OS of 25.6 months, and 3‐year OS of 36%. Thus, we conclude that mogamulizumab monotherapy may improve PFS and OS in some patients with relapsed aggressive ATL, especially those who develop a skin rash as a moderate immune‐related adverse event. Therefore, further investigation is warranted to validate the present observations and to clarify the mechanisms involved in the activity of mogamulizumab.
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影响因子：
5.7
作者：
Ishitsuka K;Utsunomiya A;Katsuya H;Takeuchi S;Takatsuka Y;Hidaka M;Sakai T;Yoshimitsu M;Ishida T;Tamura K
通讯作者：
Tamura K
影响因子：
78.5
作者：
Bartlett, JB;Dredge, K;Dalgleish, AG
通讯作者：
Dalgleish, AG
DOI：
10.1056/nejmoa1505237
发表时间：
2015-11-05
期刊：
The New England journal of medicine
影响因子：
--
作者：
Ruan J;Martin P;Shah B;Schuster SJ;Smith SM;Furman RR;Christos P;Rodriguez A;Svoboda J;Lewis J;Katz O;Coleman M;Leonard JP
通讯作者：
Leonard JP
DOI：
10.1158/1078-0432.ccr-16-1022
发表时间：
2017-01-01
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
Sharma K;Janik JE;O'Mahony D;Stewart D;Pittaluga S;Stetler-Stevenson M;Jaffe ES;Raffeld M;Fleisher TA;Lee CC;Steinberg SM;Waldmann TA;Morris JC
通讯作者：
Morris JC
影响因子：
45.3
作者：
Katsuya, Hiroo;Yamanaka, Takeharu;Tamura, Kazuo
通讯作者：
Tamura, Kazuo