title: 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.
abstract: BACKGROUND
  For patients with peripheral T-cell lymphoma (PTCL), the value of (18)fluoro-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.
  
  
  METHODS
  Patients received romidepsin at a dose of 14 mg/m(2) 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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT00426764.
authors.affiliation: Lymphoma Division, Memorial Sloan-Kettering Cancer Center, New York, USA. Electronic address: horwitzs@mskcc.org.
authors.forename: S
authors.initials: S
authors.lastname: Horwitz
authors.affiliation: Department of Hematology, Hospices Civils de Lyon, Lyon, France.
authors.forename: B
authors.initials: B
authors.lastname: Coiffier
authors.affiliation: Hematology Department, Yale Cancer Center, New Haven, USA.
authors.forename: F
authors.initials: F
authors.lastname: Foss
authors.affiliation: Division of Cancer Medicine, Department of Haematology, Peter MacCallum Cancer Centre and University of Melbourne, Australia.
authors.forename: H M
authors.initials: HM
authors.lastname: Prince
authors.affiliation: Department of Malignant Hematology, Moffitt Cancer Center, Tampa, USA.
authors.forename: L
authors.initials: L
authors.lastname: Sokol
authors.affiliation: Department of Haematology, Royal North Shore Hospital, Sydney, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Greenwood
authors.affiliation: Hematology Department, Hospital Universitario de Salamanca, Salamanca, Spain.
authors.forename: D
authors.initials: D
authors.lastname: Caballero
authors.affiliation: Department of Hematology, Hôpital Claude Huriez, CHU de Lille, France.
authors.forename: F
authors.initials: F
authors.lastname: Morschhauser
authors.affiliation: Division of Hematology-Oncology, UCLA Medical Center, Los Angeles.
authors.forename: L
authors.initials: L
authors.lastname: Pinter-Brown
authors.affiliation: Malignant Hematology, Houston Methodist Cancer Center, Houston.
authors.forename: S P
authors.initials: SP
authors.lastname: Iyer
authors.affiliation: Division of Hematology, University of Washington, Seattle.
authors.forename: A
authors.initials: A
authors.lastname: Shustov
authors.affiliation: JNichols LLC, Swampscott.
authors.forename: J
authors.initials: J
authors.lastname: Nichols
authors.affiliation: Veristat, LLC, Holliston.
authors.forename: J
authors.initials: J
authors.lastname: Balser
authors.affiliation: Veristat, LLC, Holliston.
authors.forename: B
authors.initials: B
authors.lastname: Balser
authors.affiliation: Division of Hematology, Thomas Jefferson University, Philadelphia, USA.
authors.forename: B
authors.initials: B
authors.lastname: Pro
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D047630:Depsipeptides / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D019788:Fluorodeoxyglucose F18 / Q000493:pharmacokinetics*; D005500:Follow-Up Studies; D006801:Humans; D016411:Lymphoma, T-Cell, Peripheral / Q000000981:diagnostic imaging* / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D049268:Positron-Emission Tomography / Q000706:statistics & numerical data*; D011379:Prognosis; D011446:Prospective Studies; D019275:Radiopharmaceuticals / Q000493:pharmacokinetics; D012074:Remission Induction; D015996:Survival Rate; D014018:Tissue Distribution
chemical_list: D000903:Antibiotics, Antineoplastic; D047630:Depsipeptides; D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18; C087123:romidepsin
keywords: histone deacetylase inhibitor; peripheral T-cell lymphoma; positron emission tomography; radiology; romidepsin