End-of-treatment PET/CT predicts PFS and OS in DLBCL after first-line treatment: results from GOYA
Language English Country United States Media print
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
33651099
PubMed Central
PMC7948296
DOI
10.1182/bloodadvances.2020002690
PII: S2473-9529(21)00150-6
Knihovny.cz E-resources
- MeSH
- Lymphoma, Large B-Cell, Diffuse * diagnostic imaging drug therapy MeSH
- Progression-Free Survival MeSH
- Humans MeSH
- Positron Emission Tomography Computed Tomography * MeSH
- Positron-Emission Tomography MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Retrospective Studies MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
GOYA was a randomized phase 3 study comparing obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) vs standard-of-care rituximab plus CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). This retrospective analysis of GOYA aimed to assess the association between progression-free survival (PFS) and overall survival (OS) with positron emission tomography (PET)-based complete response (CR) status. Overall, 1418 patients were randomly assigned to receive 8 21-day cycles of obinutuzumab (n = 706) or rituximab (n = 712) plus 6 or 8 cycles of CHOP. Patients received a mandatory fluoro-2-deoxy-d-glucose-PET/computed tomography scan at baseline and end of treatment. After a median follow-up of 29 months, the numbers of independent review committee-assessed PFS and OS events in the entire cohort were 416 (29.3%) and 252 (17.8%), respectively. End-of-treatment PET CR was highly prognostic for PFS and OS according to Lugano 2014 criteria (PFS: hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.19-0.38; P < .0001; OS: HR, 0.12; 95% CI, 0.08-0.17; P < .0001), irrespective of international prognostic index score and cell of origin. In conclusion, the results from this prospectively acquired large cohort corroborated previously published data from smaller sample sizes showing that end-of-treatment PET CR is an independent predictor of PFS and OS and a promising prognostic marker in DLBCL. Long-term survival analysis confirmed the robustness of these data over time. Additional meta-analyses including other prospective studies are necessary to support the substitution of PET CR for PFS as an effective and practical surrogate end point. This trial was registered at www.clinicaltrials.gov as #NCT01287741.
BC Cancer Center for Lymphoid Cancer and the University of British Columbia Vancouver BC Canada
Cross Cancer Institute University of Alberta Edmonton AB Canada
Department of Radiology and Medical Imaging University of Virginia Charlottesville VA
Department of Translational and Precision Medicine Sapienza University Rome Italy
F Hoffmann La Roche Ltd Basel Switzerland
Fudan University Shanghai Cancer Center Shanghai China
Istituto Nazionale Tumori Fondazione G Pascale IRCCS Naples Italy
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ClinicalTrials.gov
NCT01287741
