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. 2023 Apr;12(7):8211-8217.
doi: 10.1002/cam4.5628. Epub 2023 Feb 17.

Is local review of positron emission tomography scans sufficient in diffuse large B-cell lymphoma clinical trials? A CALGB 50303 analysis

Pallawi Torka  1 , Levi D Pederson  2 , Michael V Knopp  3 , David Poon  3 , Jun Zhang  3 , Brad S Kahl  4 , Howard R Higley  5 , Gary Kelloff  6 , Jonathan W Friedberg  7 , Lawrence H Schwartz  8 , Wyndham H Wilson  9 , John P Leonard  10 , Nancy L Bartlett  4 , Heiko Schöder  11 , Amy S Ruppert  12
Affiliations

Is local review of positron emission tomography scans sufficient in diffuse large B-cell lymphoma clinical trials? A CALGB 50303 analysis

Pallawi Torka et al. Cancer Med. 2023 Apr.

Abstract

Background: Quantitative methods of Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) interpretation, including the percent change in FDG uptake from baseline (ΔSUV), are under investigation in lymphoma to overcome challenges associated with visual scoring systems (VSS) such as the Deauville 5-point scale (5-PS).

Methods: In CALGB 50303, patients with DLBCL received frontline R-CHOP or DA-EPOCH-R, and although there were no significant associations between interim PET responses assessed centrally after cycle 2 (iPET) using 5-PS with progression-free survival (PFS) or overall survival (OS), there were significant associations between central determinations of iPET ∆SUV with PFS/OS. In this patient cohort, we retrospectively compared local vs central iPET readings and evaluated associations between local imaging data and survival outcomes.

Results: Agreement between local and central review was moderate (kappa = 0.53) for VSS and high (kappa = 0.81) for ∆SUV categories (<66% vs. ≥66%). ∆SUV ≥66% at iPET was significantly associated with PFS (p = 0.03) and OS (p = 0.002), but VSS was not. Associations with PFS/OS when applying local review vs central review were comparable.

Conclusions: These data suggest that local PET interpretation for response determination may be acceptable in clinical trials. Our findings also highlight limitations of VSS and call for incorporation of more objective measures of response assessment in clinical trials.

Keywords: Deauville 5-PS; International Harmonization Project criteria; interim PET; visual scoring system; ΔSUV.

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Conflict of interest statement

Pallawi Torka: Consulting advice: TG therapeutics, ADC therapeutics, Genentech, Kura Oncology. Brad S. Kahl: Consulting advice: Genentech, MTEM, MEI, Pharmacyclics, ADCT, Abbvie, Kite, BMS, Beigene, AstraZeneca, TG therapeutics, Epizyme, Takeda, Hutchmed, Genmab. Research Support: Genentech, AstraZeneca, Beigene. Howard R Higley: HRH was a former employee (now retired) of CCS Associates, a contract research organization supporting the NCI and FNIH, when the work described in this manuscript was performed. At that time, he had no further conflicts or disclosures to report. Lawrence H. Schwartz: DSMB/endpoint committee payable to institution: Merck, BMS, Regeneron. Research support: JNJ. Patents planned, issued or pending: Image segmentation licensed to Varian, payable to institution. John P. Leonard: Consulting advice: Abbvie, Astellas, AstraZeneca, Bayer, Beigene, BMS, Calithera, Constellation, Eisai, Lilly, Epizyme, Genmab, Grail, Incyte, Janssen, Karyopharm, Merck, Mustang Bio, Pfizer, Roche/Genentech, Second Genome, Sutro. Research support: Genentech, Janssen. Amy S. Ruppert: ASR is currently employed by Eli Lilly and Company, though contributions to the work described in this manuscript occurred during employment with The Ohio State University which ended as of January 2022; served on an independent DSMB for Telios Pharma. Levi D. Pederson, Michael V. Knopp, David Poon, Jun Zhang, Gary Kelloff, Jonathan W. Friedberg, Wyndham H. Wilson, Nancy L. Bartlett and Heiko Schöder: none.

Figures

FIGURE 1
FIGURE 1
Progression free survival (PFS) and Overall survival (OS) landmarked at iPET, according to iPET status by IHPC (negative/positive) (A and B) and by prespecified ΔSUV groups (C and D) using local PET interpretation.
See this image and copyright information in PMC

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