What question did this study set out to answer?

To confirm the therapeutic efficacy and safety profile of romidepsin in patients with treatment-refractory cutaneous T-cell lymphoma.

August 9, 2010Journal of Clinical Oncology

Final Results From a Multicenter, International, Pivotal Study of Romidepsin in Refractory Cutaneous T-Cell Lymphoma

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Authors

SWSean WhittakerGuy's Hospital MDMarie‐France DemierreBoston University EKEllen J. KimUniversity of Pennsylvania

Discussion

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Implication

Phase II trial demonstrates durable responses to romidepsin in refractory cutaneous T-cell lymphoma, indicating its value as an effective systemic therapy.

Key Points

To confirm the therapeutic efficacy and safety profile of romidepsin in patients with treatment-refractory cutaneous T-cell lymphoma.
Conducted an international, single-arm, open-label phase II trial in 96 patients with stage IB to IVA refractory CTCL who had received ≥1 prior systemic therapy.
Administered intravenous romidepsin at 14 mg/m² on days 1, 8, and 15 every 28 days, assessing composite tumor burden across skin, lymph nodes, and blood.
The primary endpoint objective response rate was 34% (33/96) overall, with 6 complete responses, and 38% (26/68) among patients with advanced-stage disease (≥ stage IIB).
Median time to response was 2 months, and median duration of response was 15 months.
Clinically meaningful reduction in pruritus occurred in 43% of evaluable patients (28/65) with a median duration of 6 months; drug-related adverse events were primarily mild gastrointestinal symptoms, asthenia, and reversible ECG changes.

Cite This Study

Whittaker et al. (2010) studied this question.

synapsesocial.com/papers/6a7147b4ce524a4339c4db0c https://doi.org/10.1200/jco.2010.28.9066

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Implication

Phase II trial demonstrates durable responses to romidepsin in refractory cutaneous T-cell lymphoma, indicating its value as an effective systemic therapy.

Final Results From a Multicenter, International, Pivotal Study of Romidepsin in Refractory Cutaneous T-Cell Lymphoma

Discussion

Member takes

Implication

Key Points

Cite This Study

Final Results From a Multicenter, International, Pivotal Study of Romidepsin in Refractory Cutaneous T-Cell Lymphoma

Discussion

Member takes

Implication

Key Points

Cite This Study

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