Impact of corticosteroid therapy on the outcomes of hepatocellular carcinoma treated with immune checkpoint inhibitor therapy

David J Pinato; Ahmed Kaseb; Yinghong Wang; Anwaar Saeed; David Szafron; Tomi Jun; Sirish Dharmapuri; Abdul Rafeh Naqash; Mahvish Muzaffar; Musharraf Navaid; Uqba Khan; ChiehJu Lee; Anushi Bulumulle; Bo Yu; Sonal Paul; Petros Fessas; Neil Nimkar; Dominik Bettinger; Hannah Hildebrand; Tiziana Pressiani; Yehia I Abugabal; Nicola Personeni; Yi-Hsiang Huang; Jingky Lozano-Kuehne; Lorenza Rimassa; Celina Ang; Thomas U Marron

doi:10.1136/jitc-2020-000726

Impact of corticosteroid therapy on the outcomes of hepatocellular carcinoma treated with immune checkpoint inhibitor therapy

David J Pinato, Ahmed Kaseb, Yinghong Wang, Anwaar Saeed, David Szafron, Tomi Jun, Sirish Dharmapuri, Abdul Rafeh Naqash, Mahvish Muzaffar, Musharraf Navaid, Uqba Khan, ChiehJu Lee, Anushi Bulumulle, Bo Yu, Sonal Paul, Petros Fessas, Neil Nimkar, Dominik Bettinger, Hannah Hildebrand, Tiziana PressianiYehia I Abugabal, Nicola Personeni, Yi-Hsiang Huang, Jingky Lozano-Kuehne, Lorenza Rimassa, Celina Ang, Thomas U Marron

Istituto Clinico Humanitas

Research output: Contribution to journal › Article › peer-review

Abstract

The impact of corticosteroid therapy (CT) on efficacy of immune checkpoint inhibitors (ICI) is undefined in hepatocellular carcinoma (HCC). We evaluated whether CT administered at baseline (bCT) or concurrently with ICI (cCT) influences overall (OS), progression-free survival (PFS) and overall response rates (ORR) in 341 patients collected across 3 continents. Of 304 eligible patients, 78 (26%) received >10 mg prednisone equivalent daily either as bCT (n=14, 5%) or cCT (n=64, 21%). Indications for CT included procedure/prophylaxis (n=37, 47%), management of immune-related adverse event (n=27, 35%), cancer-related symptoms (n=8, 10%) or comorbidities (n=6, 8%). Neither overall CT, bCT nor cCT predicted for worse OS, PFS nor ORR in univariable and multivariable analyses (p>0.05). CT for cancer-related indications predicted for shorter PFS (p<0.001) and was associated with refractoriness to ICI (75% vs 33%, p=0.05) compared with cancer-unrelated indications. This is the first study to demonstrate that neither bCT nor cCT influence response and OS following ICI in HCC. Worse outcomes in CT recipients for cancer-related indications appear driven by the poor prognosis associated with symptomatic HCC.

Original language	English
Journal	J. Immunother. Cancer
Volume	8
Issue number	2
DOIs	https://doi.org/10.1136/jitc-2020-000726
Publication status	Published - Oct 2020

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Pinato, D. J., Kaseb, A., Wang, Y., Saeed, A., Szafron, D., Jun, T., Dharmapuri, S., Naqash, A. R., Muzaffar, M., Navaid, M., Khan, U., Lee, C., Bulumulle, A., Yu, B., Paul, S., Fessas, P., Nimkar, N., Bettinger, D., Hildebrand, H., ... Marron, T. U. (2020). Impact of corticosteroid therapy on the outcomes of hepatocellular carcinoma treated with immune checkpoint inhibitor therapy. J. Immunother. Cancer, 8(2). https://doi.org/10.1136/jitc-2020-000726

Impact of corticosteroid therapy on the outcomes of hepatocellular carcinoma treated with immune checkpoint inhibitor therapy. / Pinato, David J; Kaseb, Ahmed; Wang, Yinghong; Saeed, Anwaar; Szafron, David; Jun, Tomi; Dharmapuri, Sirish; Naqash, Abdul Rafeh; Muzaffar, Mahvish; Navaid, Musharraf; Khan, Uqba; Lee, ChiehJu; Bulumulle, Anushi; Yu, Bo; Paul, Sonal; Fessas, Petros; Nimkar, Neil; Bettinger, Dominik; Hildebrand, Hannah; Pressiani, Tiziana; Abugabal, Yehia I; Personeni, Nicola; Huang, Yi-Hsiang; Lozano-Kuehne, Jingky; Rimassa, Lorenza; Ang, Celina; Marron, Thomas U.

In: J. Immunother. Cancer, Vol. 8, No. 2, 10.2020.

Research output: Contribution to journal › Article › peer-review

Pinato, DJ, Kaseb, A, Wang, Y, Saeed, A, Szafron, D, Jun, T, Dharmapuri, S, Naqash, AR, Muzaffar, M, Navaid, M, Khan, U, Lee, C, Bulumulle, A, Yu, B, Paul, S, Fessas, P, Nimkar, N, Bettinger, D, Hildebrand, H, Pressiani, T, Abugabal, YI, Personeni, N, Huang, Y-H, Lozano-Kuehne, J, Rimassa, L, Ang, C & Marron, TU 2020, 'Impact of corticosteroid therapy on the outcomes of hepatocellular carcinoma treated with immune checkpoint inhibitor therapy', J. Immunother. Cancer, vol. 8, no. 2. https://doi.org/10.1136/jitc-2020-000726

Pinato, David J ; Kaseb, Ahmed ; Wang, Yinghong ; Saeed, Anwaar ; Szafron, David ; Jun, Tomi ; Dharmapuri, Sirish ; Naqash, Abdul Rafeh ; Muzaffar, Mahvish ; Navaid, Musharraf ; Khan, Uqba ; Lee, ChiehJu ; Bulumulle, Anushi ; Yu, Bo ; Paul, Sonal ; Fessas, Petros ; Nimkar, Neil ; Bettinger, Dominik ; Hildebrand, Hannah ; Pressiani, Tiziana ; Abugabal, Yehia I ; Personeni, Nicola ; Huang, Yi-Hsiang ; Lozano-Kuehne, Jingky ; Rimassa, Lorenza ; Ang, Celina ; Marron, Thomas U. / Impact of corticosteroid therapy on the outcomes of hepatocellular carcinoma treated with immune checkpoint inhibitor therapy. In: J. Immunother. Cancer. 2020 ; Vol. 8, No. 2.

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abstract = "The impact of corticosteroid therapy (CT) on efficacy of immune checkpoint inhibitors (ICI) is undefined in hepatocellular carcinoma (HCC). We evaluated whether CT administered at baseline (bCT) or concurrently with ICI (cCT) influences overall (OS), progression-free survival (PFS) and overall response rates (ORR) in 341 patients collected across 3 continents. Of 304 eligible patients, 78 (26%) received >10 mg prednisone equivalent daily either as bCT (n=14, 5%) or cCT (n=64, 21%). Indications for CT included procedure/prophylaxis (n=37, 47%), management of immune-related adverse event (n=27, 35%), cancer-related symptoms (n=8, 10%) or comorbidities (n=6, 8%). Neither overall CT, bCT nor cCT predicted for worse OS, PFS nor ORR in univariable and multivariable analyses (p>0.05). CT for cancer-related indications predicted for shorter PFS (p<0.001) and was associated with refractoriness to ICI (75% vs 33%, p=0.05) compared with cancer-unrelated indications. This is the first study to demonstrate that neither bCT nor cCT influence response and OS following ICI in HCC. Worse outcomes in CT recipients for cancer-related indications appear driven by the poor prognosis associated with symptomatic HCC.",

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AU - Pinato, David J

AU - Kaseb, Ahmed

AU - Wang, Yinghong

AU - Saeed, Anwaar

AU - Szafron, David

AU - Jun, Tomi

AU - Dharmapuri, Sirish

AU - Naqash, Abdul Rafeh

AU - Muzaffar, Mahvish

AU - Navaid, Musharraf

AU - Khan, Uqba

AU - Lee, ChiehJu

AU - Bulumulle, Anushi

AU - Yu, Bo

AU - Paul, Sonal

AU - Fessas, Petros

AU - Nimkar, Neil

AU - Bettinger, Dominik

AU - Hildebrand, Hannah

AU - Pressiani, Tiziana

AU - Abugabal, Yehia I

AU - Personeni, Nicola

AU - Huang, Yi-Hsiang

AU - Lozano-Kuehne, Jingky

AU - Rimassa, Lorenza

AU - Ang, Celina

AU - Marron, Thomas U

PY - 2020/10

Y1 - 2020/10

N2 - The impact of corticosteroid therapy (CT) on efficacy of immune checkpoint inhibitors (ICI) is undefined in hepatocellular carcinoma (HCC). We evaluated whether CT administered at baseline (bCT) or concurrently with ICI (cCT) influences overall (OS), progression-free survival (PFS) and overall response rates (ORR) in 341 patients collected across 3 continents. Of 304 eligible patients, 78 (26%) received >10 mg prednisone equivalent daily either as bCT (n=14, 5%) or cCT (n=64, 21%). Indications for CT included procedure/prophylaxis (n=37, 47%), management of immune-related adverse event (n=27, 35%), cancer-related symptoms (n=8, 10%) or comorbidities (n=6, 8%). Neither overall CT, bCT nor cCT predicted for worse OS, PFS nor ORR in univariable and multivariable analyses (p>0.05). CT for cancer-related indications predicted for shorter PFS (p<0.001) and was associated with refractoriness to ICI (75% vs 33%, p=0.05) compared with cancer-unrelated indications. This is the first study to demonstrate that neither bCT nor cCT influence response and OS following ICI in HCC. Worse outcomes in CT recipients for cancer-related indications appear driven by the poor prognosis associated with symptomatic HCC.

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