Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin

被引：34

作者：

Kim, Youn H. ^{[1
]}

Demierre, Marie-France ^{[2
]}

Kim, Ellen J. ^{[3
]}

Lerner, Adam ^{[2
]}

Rook, Alain H. ^{[3
]}

Duvic, Madeleine ^{[4
]}

Robak, Tadeusz ^{[5
]}

Samtsov, Alexey ^{[6
]}

McCulloch, William ^{[7
]}

Chen, Suephy C. ^{[8
,9
]}

Waksman, Joel ^{[10
]}

Nichols, Jean ^{[11
]}

Whittaker, Sean ^{[12
]}

机构：

[1] Stanford Canc Ctr, Stanford, CA USA

[2] Boston Med Ctr, Boston, MA USA

[3] Univ Penn, Philadelphia, PA 19104 USA

[4] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[5] Med Univ Lodz, Lodz, Poland

[6] Mil Med Acad, State Educ Inst Higher Profess Educ, St Petersburg, Russia

[7] Alba BioPharm Advisors Inc, Raleigh, NC USA

[8] VA Med Ctr, Decatur, GA USA

[9] Emory Univ, Atlanta, GA 30322 USA

[10] Brightech Int LLC, Somerset, NJ USA

[11] Celgene Corp, Summit, NJ USA

[12] Guys & St Thomas Hosp, London SE1 9RT, England

来源：

LEUKEMIA & LYMPHOMA | 2013年 / 54卷 / 02期

关键词：

Cutaneous T-cell lymphoma; pruritus; romidepsin; QUALITY-OF-LIFE; DENILEUKIN DIFTITOX; MYCOSIS-FUNGOIDES; SEZARY-SYNDROME; TRIAL; MULTICENTER; VORINOSTAT; PHASE-2; ANALOG;

D O I：

10.3109/10428194.2012.711829

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Patients with cutaneous T-cell lymphoma (CTCL) frequently experience severe pruritus that can significantly impact their quality of life. Romidepsin is approved by the US Food and Drug Administration (FDA) for the treatment of patients with CTCL who have received at least one prior systemic therapy, with a reported objective response rate of 34%. In a phase 2 study of romidepsin in patients with CTCL (GPI-04-0001), clinically meaningful reduction in pruritus (CMRP) was evaluated as an indicator of clinical benefit by using a patient-assessed visual analog scale. To determine the effect of romidepsin alone, confounding pruritus treatments including steroids and antihistamines were prohibited. At baseline, 76% of patients reported moderate-to-severe pruritus; 43% of these patients experienced CMRP, including 11 who did not achieve an objective response. Median time to CMRP was 1.8 months, and median duration of CMRP was 5.6 months. Study results suggest that the clinical benefit of romidepsin may extend beyond objective responses.

引用

页码：284 / 289

页数：6

共 26 条

[1]

[Anonymous], 1 WORLD C CUT LYMPH

[2]

[Anonymous], 1 WORLD C CUT LYMPH

[3]

[Anonymous], 1 WORLD C CUT LYMPH

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