TY - JOUR
T1 - Comparative assessment of standard and immune response criteria for evaluation of response to PD-1 monotherapy in unresectable HCC
AU - Lewis, Sara
AU - Cedillo, Mario A.
AU - Lee, Karen M.
AU - Bane, Octavia
AU - Hectors, Stefanie
AU - Ma, Weiping
AU - Wang, Pei
AU - Stocker, Daniel
AU - Morris, Darrell V.
AU - Pinato, David
AU - Sung, Max
AU - Marron, Thomas
AU - Schwartz, Myron
AU - Taouli, Bachir
N1 - Funding Information:
Stefanie Hectors: Employment at Regeneron Pharmaceuticals. David Pinato: Lecture fees (ViiV Healthcare, EISAI, BMS, Roche, Bayer Healthcare), travel expenses (BMS, MSD and Bayer Healthcare), consulting fees (Mina Therapeutics, EISAI, Roche, Astra Zeneca, DaVolterra) research funding to institution (MSD, BMS, Biognosys). Thomas Marron: Advisory boards and/or DSMBs (Boehringer Ingelheim, BMS, AstraZeneca, Genentech, Celldex, and Regeneron), research grant support (BMS, Regeneron and Boehringer Ingelheim). Bachir Taouli: Grant/research support (Bayer, Takeda, Regeneron, Siemens, Echosens). The remaining authors (SL, MAC, KML, OB, WM, PW, DS, DVM, MS, and MS) have no relevant disclosures.
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2022/3
Y1 - 2022/3
N2 - Purpose: To assess response to programmed death-1 (PD-1) monotherapy (nivolumab) in hepatocellular carcinoma (HCC) patients using RECIST1.1, modified RECIST (mRECIST), and immune RECIST (iRECIST). A secondary objective was to identify clinicolaboratory and imaging variables predictive of progressive disease (PD) and overall survival (OS). Methods: Patients with HCC treated with nivolumab at a single institution from 5/2016 to 12/2019 with MRI or CT performed ≥ 4 weeks post treatment were retrospectively assessed. Patients who received concurrent locoregional, radiation, or other systemic therapies were excluded. Response was assessed by 2 observers in consensus using RECIST1.1, mRECIST, and iRECIST at 3/6/9/12-month time points. Time to progression (TTP) and OS were recorded. Clinicolaboratory and imaging variables were evaluated as predictors of PD and OS using uni-/multivariable and Cox regression analyses. Results: Fifty-eight patients (42M/16F) were included. 118 target lesions (TL) were identified before treatment. Baseline mean TL size was 49.1 ± 43.5 mm (range 10–189 mm) for RECIST1.1/iRECIST and 46.3 ± 42.3 mm (range 10–189 mm) for mRECIST. Objective response rate (ORR) was 21% for mRECIST/iRECIST/RECIST1.1, with no cases of pseudoprogression. Median OS and median TTP were 717 days and 127 days for RECIST1.1/mRECIST/iRECIST-iUPD (unconfirmed PD). Older age, MELD/Child–Pugh scores, AFP, prior transarterial radioembolization (TARE), and larger TL size were predictive of PD and/or poor OS using mRECIST/iRECIST. The strongest predictor of PD (HR = 2.49, 95% CI 1.29–4.81, p = 0.007) was TARE. The strongest predictor of poor OS was PD by mRECIST/iRECIST at 3 months (HR = 2.26, 95% CI 1.00–5.10, p = 0.05) with borderline significance. Conclusion: Our results show ORR of 21%, equivalent for mRECIST, iRECIST, and RECIST1.1 in patients with advanced HCC clinically treated with nivolumab.
AB - Purpose: To assess response to programmed death-1 (PD-1) monotherapy (nivolumab) in hepatocellular carcinoma (HCC) patients using RECIST1.1, modified RECIST (mRECIST), and immune RECIST (iRECIST). A secondary objective was to identify clinicolaboratory and imaging variables predictive of progressive disease (PD) and overall survival (OS). Methods: Patients with HCC treated with nivolumab at a single institution from 5/2016 to 12/2019 with MRI or CT performed ≥ 4 weeks post treatment were retrospectively assessed. Patients who received concurrent locoregional, radiation, or other systemic therapies were excluded. Response was assessed by 2 observers in consensus using RECIST1.1, mRECIST, and iRECIST at 3/6/9/12-month time points. Time to progression (TTP) and OS were recorded. Clinicolaboratory and imaging variables were evaluated as predictors of PD and OS using uni-/multivariable and Cox regression analyses. Results: Fifty-eight patients (42M/16F) were included. 118 target lesions (TL) were identified before treatment. Baseline mean TL size was 49.1 ± 43.5 mm (range 10–189 mm) for RECIST1.1/iRECIST and 46.3 ± 42.3 mm (range 10–189 mm) for mRECIST. Objective response rate (ORR) was 21% for mRECIST/iRECIST/RECIST1.1, with no cases of pseudoprogression. Median OS and median TTP were 717 days and 127 days for RECIST1.1/mRECIST/iRECIST-iUPD (unconfirmed PD). Older age, MELD/Child–Pugh scores, AFP, prior transarterial radioembolization (TARE), and larger TL size were predictive of PD and/or poor OS using mRECIST/iRECIST. The strongest predictor of PD (HR = 2.49, 95% CI 1.29–4.81, p = 0.007) was TARE. The strongest predictor of poor OS was PD by mRECIST/iRECIST at 3 months (HR = 2.26, 95% CI 1.00–5.10, p = 0.05) with borderline significance. Conclusion: Our results show ORR of 21%, equivalent for mRECIST, iRECIST, and RECIST1.1 in patients with advanced HCC clinically treated with nivolumab.
KW - Check point blockade
KW - Computed tomography
KW - Hepatocellular carcinoma
KW - Immunotherapy
KW - Magnetic resonance imaging
KW - Response to therapy
UR - http://www.scopus.com/inward/record.url?scp=85122086942&partnerID=8YFLogxK
U2 - 10.1007/s00261-021-03386-0
DO - 10.1007/s00261-021-03386-0
M3 - Article
C2 - 34964909
AN - SCOPUS:85122086942
VL - 47
SP - 969
EP - 980
JO - Abdominal Radiology
JF - Abdominal Radiology
SN - 2366-004X
IS - 3
ER -