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Clinical Trials: Targeted Therapy

Safety and Efficacy of Vorinostat Plus Sirolimus or Everolimus in Patients with Relapsed Refractory Hodgkin Lymphoma

Filip Janku, Haeseong Park, S. Greg Call, Kiran Madwani, Yasuhiro Oki, Vivek Subbiah, David S. Hong, Aung Naing, Vivianne M. Velez-Bravo, Tamara G. Barnes, Fredrick B. Hagemeister, Gerald S. Falchook, Daniel D. Karp, Jennifer J. Wheler, Sarina A. Piha-Paul, Ignacio Garrido-Laguna, Elizabeth J. Shpall, Luis E. Fayad, Sattva S. Neelapu, Funda Meric-Bernstam, Razelle Kurzrock and Michelle A. Fanale
Filip Janku
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • ORCID record for Filip Janku
  • For correspondence: fjanku@mdanderson.org
Haeseong Park
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
2Department of Internal Medicine (Division of Oncology), Washington University School of Medicine, St. Louis, Missouri.
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S. Greg Call
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Kiran Madwani
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Yasuhiro Oki
3Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Vivek Subbiah
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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  • ORCID record for Vivek Subbiah
David S. Hong
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Aung Naing
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Vivianne M. Velez-Bravo
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Tamara G. Barnes
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Fredrick B. Hagemeister
3Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Gerald S. Falchook
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Daniel D. Karp
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Jennifer J. Wheler
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Sarina A. Piha-Paul
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Ignacio Garrido-Laguna
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Elizabeth J. Shpall
4Department of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Luis E. Fayad
3Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Sattva S. Neelapu
3Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Funda Meric-Bernstam
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Razelle Kurzrock
1Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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Michelle A. Fanale
3Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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DOI: 10.1158/1078-0432.CCR-20-1215 Published November 2020
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Abstract

Purpose: Preclinical and early clinical data suggested that combining histone deacetylase (HDAC) and mTOR inhibitors can synergistically inhibit Hodgkin lymphoma.

Patients and Methods: During the dose-escalation study (ClinicalTrials.gov number: NCT01087554) with the HDAC inhibitor vorinostat and the mTOR inhibitor sirolimus (V+S), a patient with Hodgkin lymphoma refractory to nine prior therapies demonstrated a partial response (PR) lasting for 18.5 months, which promoted additional enrollment of patients with Hodgkin lymphoma as well as exploration of an alternative combination of vorinostat and mTOR inhibitor everolimus (V+E).

Results: A total of 40 patients with refractory Hodgkin lymphoma received V+S (n = 22) or V+E (n = 18). Patients received a median of five prior therapies, including brentuximab (n = 39), autologous stem cell transplantation (n = 26), and allogeneic stem cell transplantation (n = 12). The most frequent grade ≥3 treatment-related adverse event was thrombocytopenia in 55% and 67% of patients treated with V+S and V+E, respectively. Complete response was reported in 6 (27%) patients treated with V+S and 2 (11%) patients treated with V+E, and PR was reported in 6 patients (27%) treated with V+S and 4 (22%) patients treated with V+E (objective response rate of 55% and 33%, respectively). In summary, combined HDAC and mTOR inhibition had encouraging activity in heavily pretreated patients with relapsed/refractory Hodgkin lymphoma and warrants further investigation.

Conclusions: Combined HDAC and mTOR inhibition has salutary activity in patients with relapsed refractory Hodgkin lymphoma and warrants further investigation.

This article is featured in Highlights of This Issue, p. 5541

Footnotes

  • Note: Supplementary data for this article are available at Clinical Cancer Research Online (http://clincancerres.aacrjournals.org/).

  • ClinicalTrials.gov Identifier: NCT01087554.

  • Clin Cancer Res 2020;26:5579–87

  • Received March 31, 2020.
  • Revision received July 25, 2020.
  • Accepted August 24, 2020.
  • Published first October 14, 2020.
  • ©2020 American Association for Cancer Research.
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Clinical Cancer Research: 26 (21)
November 2020
Volume 26, Issue 21
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Safety and Efficacy of Vorinostat Plus Sirolimus or Everolimus in Patients with Relapsed Refractory Hodgkin Lymphoma
Filip Janku, Haeseong Park, S. Greg Call, Kiran Madwani, Yasuhiro Oki, Vivek Subbiah, David S. Hong, Aung Naing, Vivianne M. Velez-Bravo, Tamara G. Barnes, Fredrick B. Hagemeister, Gerald S. Falchook, Daniel D. Karp, Jennifer J. Wheler, Sarina A. Piha-Paul, Ignacio Garrido-Laguna, Elizabeth J. Shpall, Luis E. Fayad, Sattva S. Neelapu, Funda Meric-Bernstam, Razelle Kurzrock and Michelle A. Fanale
Clin Cancer Res November 1 2020 (26) (21) 5579-5587; DOI: 10.1158/1078-0432.CCR-20-1215

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Safety and Efficacy of Vorinostat Plus Sirolimus or Everolimus in Patients with Relapsed Refractory Hodgkin Lymphoma
Filip Janku, Haeseong Park, S. Greg Call, Kiran Madwani, Yasuhiro Oki, Vivek Subbiah, David S. Hong, Aung Naing, Vivianne M. Velez-Bravo, Tamara G. Barnes, Fredrick B. Hagemeister, Gerald S. Falchook, Daniel D. Karp, Jennifer J. Wheler, Sarina A. Piha-Paul, Ignacio Garrido-Laguna, Elizabeth J. Shpall, Luis E. Fayad, Sattva S. Neelapu, Funda Meric-Bernstam, Razelle Kurzrock and Michelle A. Fanale
Clin Cancer Res November 1 2020 (26) (21) 5579-5587; DOI: 10.1158/1078-0432.CCR-20-1215
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