Phase II Trial of Pembrolizumab Plus Gemcitabine, Vinorelbine, and Liposomal Doxorubicin as Second-Line Therapy for Relapsed or Refractory Classical Hodgkin Lymphoma

被引：140

作者：

Moskowitz, Alison J. ^{[1
]}

Shah, Gunjan ^{[2
]}

Schoeder, Heiko ^{[1
]}

Ganesan, Nivetha ^{[1
]}

Drill, Esther ^{[3
]}

Hancock, Helen ^{[1
]}

Davey, Theresa ^{[1
]}

Perez, Leslie ^{[1
]}

Ryu, Sunyoung ^{[1
]}

Sohail, Samia ^{[1
]}

Santarosa, Alayna ^{[1
]}

Galasso, Natasha ^{[1
]}

Neuman, Rachel ^{[1
]}

Liotta, Brielle ^{[1
]}

Blouin, William ^{[1
]}

Kumar, Anita ^{[1
]}

Lahoud, Oscar ^{[1
]}

Batlevi, Connie L. ^{[1
]}

Hamlin, Paul ^{[1
]}

Straus, David J. ^{[1
]}

Rodriguez-Rivera, Ildefonso ^{[1
]}

Owens, Colette ^{[1
]}

Caron, Philip ^{[1
]}

Intlekofer, Andrew M. ^{[1
]}

Hamilton, Audrey ^{[1
]}

Horwitz, Steven M. ^{[1
]}

Falchi, Lorenzo ^{[1
]}

Joffe, Erel ^{[1
]}

Johnson, William ^{[1
]}

Lee, Christina ^{[1
]}

Palomba, M. Lia ^{[1
]}

Noy, Ariela ^{[1
]}

Matasar, Matthew J. ^{[1
]}

Pongas, Georgios ^{[4
]}

Salles, Gilles ^{[1
]}

Vardhana, Santosha ^{[1
]}

Sanin, Beatriz Wills ^{[1
]}

von Keudell, Gottfried ^{[1
]}

Yahalom, Joachim ^{[1
]}

Dogan, Ahmet ^{[1
]}

Zelenetz, Andrew D. ^{[1
]}

Moskowitz, Craig H. ^{[4
]}

机构：

[1] Mem Sloan Kettering Canc Ctr, 530 East 74th St, New York, NY 10021 USA

[2] Mem Sloan Kettering Canc Ctr, Bone Marrow Transplant Serv, New York, NY USA

[3] Mem Sloan Kettering Canc Ctr, Biostatist, New York, NY USA

[4] Univ Miami Hlth Syst, Sylvester Comprehens Canc Ctr, Miami, FL USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2021年 / 39卷 / 28期

关键词：

STEM-CELL TRANSPLANTATION; POSITRON-EMISSION-TOMOGRAPHY; HIGH-DOSE CHEMOTHERAPY; BRENTUXIMAB VEDOTIN; FDG-PET; SALVAGE REGIMEN; DISEASE; INTERIM; INTENSIFICATION; MULTICENTER;

D O I：

10.1200/JCO.21.01056

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PURPOSEWe conducted a phase II study evaluating pembrolizumab plus gemcitabine, vinorelbine, and liposomal doxorubicin (pembro-GVD) as second-line therapy for relapsed or refractory (rel/ref) classical Hodgkin lymphoma (cHL) (ClinicalTrials.gov identifier: NCT03618550).METHODSTransplant eligible patients with rel/ref cHL following first-line therapy were treated with two to four cycles of pembrolizumab (200 mg intravenous [IV], day 1), gemcitabine (1,000 mg/m(2) IV, days 1 and 8), vinorelbine (20 mg/m(2) IV, days 1 and 8), and liposomal doxorubicin (15 mg/m(2), days 1 and 8), given on 21-day cycles. The primary end point was complete response (CR) following up to four cycles of pembro-GVD. Patients who achieved CR by labeled fluorodeoxyglucose-positron emission tomography (Deauville <= 3) after two or four cycles proceeded to high-dose therapy and autologous hematopoietic cell transplantation (HDT/AHCT). HDT/AHCT was carried out according to institutional standards, and brentuximab vedotin maintenance was allowed following HDT/AHCT.RESULTSOf 39 patients enrolled, 41% had primary ref disease and 38% relapsed within 1 year of frontline treatment. 31 patients received two cycles of pembro-GVD, and eight received four cycles. Most adverse events were grade 1 or two, whereas few were grade 3 and included transaminitis (n = 4), neutropenia (n = 4), mucositis (n = 2), thyroiditis (n = 1), and rash (n = 1). Of 38 evaluable patients, overall and CR rates after pembro-GVD were 100% and 95%, respectively. Thirty-six (95%) patients proceeded to HDT/AHCT, two received pre-HDT/AHCT involved site radiation, and 13 (33%) received post-HDT/AHCT brentuximab vedotin maintenance. All 36 transplanted patients are in remission at a median post-transplant follow-up of 13.5 months (range: 2.66-27.06 months).CONCLUSIONSecond-line therapy with pembro-GVD is a highly effective and well-tolerated regimen that can efficiently bridge patients with rel/ref cHL to HDT/AHCT.

引用

页码：3109 / +

页数：11

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