Gemcitabine Plus Liposomal Doxorubicin for Relapsed Refractory T‐cell Lymphomas

Waller, Allyson; Lundberg, Jordan; Porter, Kyle; Hwang, Sook Yeon; Hastings, Justin; Haverkos, Bradley M.; Brammer, Jonathan E.; Fabbro, Stephanie K.; William, Basem M.; Dotson, Emily; Porcu, Pierluigi

doi:10.1002/hon.2439_166

Cited by 1 publication

(1 citation statement)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Subsequently, a phase II trial of LD 20 mg/m 2 every 2 weeks for 8 cycles followed by bexarotene reported an ORR of 41% at 16 weeks (18). LD has also been evaluated in patients with TCL, including PTCL, in combination with gemcitabine with modest results (19).…”

Section: Introductionmentioning

confidence: 99%

Romidepsin Plus Liposomal Doxorubicin Is Safe and Effective in Patients with Relapsed or Refractory T-Cell Lymphoma: Results of a Phase I Dose-Escalation Study

Yang

et al. 2020

Clinical Cancer Research

View full text Add to dashboard Cite

Purpose: The histone deacetylase (HDAC) inhibitor romidepsin and the anthracycline liposomal doxorubicin (LD) have modest single-agent activity in cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). We investigated the safety and efficacy of the combination of these two agents in CTCL and PTCL.Patients and Methods: Using CTCL cell lines and primary CTCL tumor cells, we demonstrated synergistic antitumor activity with romidepsin plus doxorubicin. We then conducted a phase I dose-escalation study of the romidepsin/LD combination in relapsed/refractory CTCL and PTCL. The primary objective was to determine the MTD of romidepsin in combination with LD at 20 mg/m 2 i.v., once every 28 days.Results: Eleven patients with CTCL and 12 patients with PTCL were treated. The MTD of romidepsin was determined to be 12 mg/m 2 . Grade 3/4 hematologic toxicities included thrombo-cytopenia (17%), anemia (13%), and neutropenia (9%). The most frequent treatment-related nonhematologic adverse events were fatigue (48%), nausea (48%), vomiting (35%), and anorexia (30%). Among 21 evaluable patients, the overall response rate was 70% [1 complete response (CR), 6 partial responses (PR)] in CTCL and 27% (3 CR, 0 PR) in PTCL. Of the patients with CTCL, 8 of 10 had skin response, including 6 patients (60%) achieving skin involvement less than 10% of their body surface area at time of best response.Conclusions: Romidepsin plus LD demonstrated an acceptable safety profile and promising clinical efficacy with deep skin responses in relapsed/refractory CTCL. Thus, this combination could be considered as a bridge to skin-directed treatment or allogeneic hematopoietic cell transplantation in patients with aggressive CTCL.

show abstract

Section: Introductionmentioning

confidence: 99%