Utility of 18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma

Steven Horwitz, B. Coiffier, F. Foss, H. M. Prince, L. Sokol, M. Greenwood, D. Caballero, F. Morschhauser, L. Pinter-Brown, S. P. Iyer, A. Shustov, J. Nichols, J. Balser, B. Balser, B. Pro

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

Background: For patients with peripheral T-cell lymphoma (PTCL), the value of 18fluoro-deoxyglucose positron emission tomography (FDG-PET) scans for assessing prognosis and response to treatment remains unclear. The utility of FDG-PET, in addition to conventional radiology, was examined as a planned exploratory end point in the pivotal phase 2 trial of romidepsin for the treatment of relapsed/refractory PTCL. Patients and methods: Patients received romidepsin at a dose of 14 mg/m2 on days 1, 8, and 15 of 28-day cycles. The primary end point was the rate of confirmed/unconfirmed complete response (CR/CRu) as assessed by International Workshop Criteria (IWC) using conventional radiology. For the exploratory PET end point, patients with at least baseline FDG-PET scans were assessed by IWC + PET criteria. Results: Of 130 patients, 110 had baseline FDG-PET scans, and 105 were PET positive at baseline. The use of IWC + PET criteria increased the objective response rate to 30% compared with 26% by conventional radiology. Durations of response were well differentiated by both conventional radiology response criteria [CR/CRu versus partial response (PR), P = 0.0001] and PET status (negative versus positive, P < 0.0001). Patients who achieved CR/CRu had prolonged progression-free survival (PFS, median 25.9 months) compared with other response groups (P = 0.0007). Patients who achieved PR or stable disease (SD) had similar PFS (median 7.2 and 6.3 months, respectively, P = 0.6427). When grouping PR and SD patients by PET status, patients with PET-negative versus PET-positive disease had a median PFS of 18.2 versus 7.1 months (P = 0.0923). Conclusion(s): Routine use of FDG-PET does not obviate conventional staging, but may aid in determining prognosis and refine response assessments for patients with PTCL, particularly for those who do not achieve CR/CRu by conventional staging. The optimal way to incorporate FDG-PET scans for patients with PTCL remains to be determined. Trial registration: NCT00426764.

Original languageEnglish (US)
Pages (from-to)774-779
Number of pages6
JournalAnnals of Oncology
Volume26
Issue number4
DOIs
StatePublished - Apr 1 2015

Keywords

  • Histone deacetylase inhibitor
  • Peripheral t-cell lymphoma
  • Positron emission tomography
  • Radiology
  • Romidepsin

ASJC Scopus subject areas

  • Hematology
  • Oncology

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