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Utility of (18)fluoro-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
- Source :
- Annals of Oncology, Annals of Oncology, Elsevier, 2015, 26 (4), pp.774-779. ⟨10.1093/annonc/mdv010⟩, Annals of Oncology, 2015, 26 (4), pp.774-779. ⟨10.1093/annonc/mdv010⟩
- Publication Year :
- 2015
- Publisher :
- HAL CCSD, 2015.
-
Abstract
- International audience; 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.PATIENTS AND 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.TRIAL REGISTRATION: NCT00426764.
- Subjects :
- 0303 health sciences
medicine.diagnostic_test
business.industry
[SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging
Phases of clinical research
[SDV.CAN]Life Sciences [q-bio]/Cancer
[SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology
Hematology
3. Good health
Romidepsin
03 medical and health sciences
0302 clinical medicine
Oncology
Refractory
Positron emission tomography
030220 oncology & carcinogenesis
medicine
Clinical endpoint
Radiation treatment planning
Nuclear medicine
business
Prospective cohort study
Survival rate
030304 developmental biology
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 09237534 and 15698041
- Database :
- OpenAIRE
- Journal :
- Annals of Oncology, Annals of Oncology, Elsevier, 2015, 26 (4), pp.774-779. ⟨10.1093/annonc/mdv010⟩, Annals of Oncology, 2015, 26 (4), pp.774-779. ⟨10.1093/annonc/mdv010⟩
- Accession number :
- edsair.doi.dedup.....1b4a201f100cf4d3fad528bca7409a14