First-line immunochemotherapy for follicular lymphoma in the GALLIUM study: Prognostic value of PET-CT status after long-term follow-up.

Authors

null

Tina Nielsen

F. Hoffmann-La Roche Ltd., Basel, Switzerland

Tina Nielsen , Sally Barrington , Michel Meignan , Deniz Sahin , Andrea Knapp , Anastasiia Kinkolykh , Michael Herold , Wolfgang Hiddemann , Robert Marcus , Judith Trotman

Organizations

F. Hoffmann-La Roche Ltd., Basel, Switzerland, King’s College London and Guys’& St Thomas PET Imaging Centre, School of Biomedical Engineering and Imaging Sciences, King’s College London, London, United Kingdom, Service de Médecine Nucléaire, Hôpital Henri Mondor and Université Paris Est Créteil, Créteil, France, Consultant to F. Hoffmann-La Roche Ltd., via GCE Solutions-an IQVIA business, Basel, Switzerland, HELIOS-Klinikum Erfurt, Erfurt, Germany, Department of Medicine III, Ludwig-Maximilians-University Hospital Munich, Munich, Germany, HCA Healthcare, London, United Kingdom, Hematology Department, Concord Repatriation General Hospital, University of Sydney, Concord, Australia

Research Funding

Pharmaceutical/Biotech Company
GALLIUM was sponsored by F. Hoffmann-La Roche Ltd. Third-party medical writing assistance, under the direction of Judith Trotman, was provided by Aisling Lynch and Katie Smith of Gardiner-Caldwell Communications, and was funded by F. Hoffmann-La Roche Ltd

Background: The prognostic value of 18F-fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) response assessment following first-line immunochemotherapy for advanced-stage symptomatic follicular lymphoma (FL) was previously demonstrated for patients (pts) enrolled in the Phase III GALLIUM study (NCT01332968; Trotman et al. ICML 2017). Here, we evaluated the association between PET complete metabolic response (CMR) and survival after longer follow-up in this patient population. Methods: In the GALLIUM study, 1202 pts with previously untreated FL were randomized 1:1 to induction therapy of 1000mg obinutuzumab (G; Days 1, 8, 15 of Cycle 1 then Day 1 of subsequent cycles) or 375mg/m2 rituximab (R; Day 1 of each cycle), in combination with chemotherapy (CHOP, CVP, or bendamustine) (Marcus et al. New Engl J Med 2017). PET-CT scans were mandatory, where available, at baseline and end-of-induction (EOI) for the first 170 pts enrolled, and optional thereafter. For this response analysis, the Lugano 2014 criteria were applied by an independent review committee (IRC) (Cheson et al. J Clin Oncol 2014). Associations between EOI PET complete metabolic response (PET-CMR) status and progression-free survival (PFS) and overall survival (OS) were evaluated, with hazard ratios (HR) stratified according to chemotherapy regimen and FL International Prognostic Index. Results: Of the 609 pts with a baseline PET scan, 595 (98%) had detectable lesions. Of these, 519 pts had an EOI PET evaluable by Lugano 2014 criteria. At EOI, per IRC assessment, 450/595 (76%) pts had achieved CMR. Pts with non-available scans were considered as non-responders and were excluded from the landmark (LM) analyses. Pts who died or progressed (CT-based progression assessment) before or at EOI were excluded from the PFS LM analysis; pts who died before EOI were excluded from the OS LM analysis. After a median follow-up of 76.5 months, EOI PET status was highly prognostic for both longer investigator-assessed PFS (non-CMR vs CMR: HR 3.40; 95% CI: 2.33–4.97; p < 0.0001) and longer OS (HR 3.34; 95% CI: 1.81–6.17; p < 0.0001). Six-year investigator-assessed PFS from EOI was 62.6% (95% CI: 57.0–67.6) for CMR pts compared with 23.4% (95% CI: 12.2–36.7) for non-CMR pts; the corresponding OS was 91.3% (95% CI: 88.1–93.6) vs 79.6% (95% CI: 68.0–87.4). Conclusions: With more than 6 years of follow-up, this analysis confirms that after first-line chemoimmunotherapy for FL, achieving CMR on PET-CT is an early and strong predictor of increased PFS and OS. Clinical trial information: NCT01332968.

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies

Sub Track

Chronic Lymphocytic Leukemia (CLL) and Hairy Cell

Clinical Trial Registration Number

NCT01332968

Citation

J Clin Oncol 38: 2020 (suppl; abstr 8025)

DOI

10.1200/JCO.2020.38.15_suppl.8025

Abstract #

8025

Poster Bd #

358

Abstract Disclosures