Background: Atezolizumab plus bevacizumab has recently been approved as a new first-line standard of care for patients with unresectable hepatocellular carcinoma (HCC). Objective: We performed a real-world study to evaluate the impact of the IMbrave150 trial inclusion criteria on the safety and efficacy of treatment outside of clinical trials. Methods: We analyzed patients treated with atezolizumab plus bevacizumab for unresectable HCC from four different countries. No specific inclusion and exclusion criteria were applied, except for the absence of previous systemic therapies for HCC. The entire population was split into two groups according to concordance with the inclusion criteria as reported in the IMbrave150 trial in 'IMbrave150-in' and 'IMbrave150-out' patients, and safety and efficacy in the two groups of patients were evaluated. Results: Overall, 766 patients were included in the analysis: 561/766 (73%) in the 'IMbrave150-in' group and 205/766 (27%) in the 'IMbrave150-out' group. Median overall survival (OS) and median progression-free survival (PFS) were 16.3 versus 14.3 months (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.35-0.65; p < 0.0001] and 8.3 versus 6.0 months (HR 0.79, 95% CI 0.63-0.99; p = 0.0431) in 'IMbrave150-in' and 'IMbrave150-out' patients, respectively. Multivariate analysis confirmed that patients included in the 'IMbrave150-in' group had significantly longer OS compared with patients included in the 'IMbrave150-out' group (HR 0.76, 95% CI 0.47-0.97; p = 0.0195). In 'IMbrave150-in' patients, the albumin-bilirubin (ALBI) grade was not associated with OS, whereas in 'IMbrave150-out' patients, those with ALBI grade 1 reported a significant benefit in terms of OS compared with those with ALBI grade 2 (16.7 vs. 5.9 months; HR 4.40, 95% CI 2.40-8.08; p > 0.0001). No statistically significant differences were reported in the 'IMbrave150-in' and 'IMbrave150-out' groups in terms of safety profile. Conclusion: Adherence to the IMbrave150 trial inclusion criteria favorably impacts the prognosis of patients receiving atezolizumab plus bevacizumab. Among patients who did not meet the IMbrave150 inclusion criteria, those with ALBI grade 1 could benefit from the treatment.

Real-World Data for Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: How Does Adherence to the IMbrave150 Trial Inclusion Criteria Impact Prognosis?

Masi, Gianluca;Vivaldi, Caterina;
2023-01-01

Abstract

Background: Atezolizumab plus bevacizumab has recently been approved as a new first-line standard of care for patients with unresectable hepatocellular carcinoma (HCC). Objective: We performed a real-world study to evaluate the impact of the IMbrave150 trial inclusion criteria on the safety and efficacy of treatment outside of clinical trials. Methods: We analyzed patients treated with atezolizumab plus bevacizumab for unresectable HCC from four different countries. No specific inclusion and exclusion criteria were applied, except for the absence of previous systemic therapies for HCC. The entire population was split into two groups according to concordance with the inclusion criteria as reported in the IMbrave150 trial in 'IMbrave150-in' and 'IMbrave150-out' patients, and safety and efficacy in the two groups of patients were evaluated. Results: Overall, 766 patients were included in the analysis: 561/766 (73%) in the 'IMbrave150-in' group and 205/766 (27%) in the 'IMbrave150-out' group. Median overall survival (OS) and median progression-free survival (PFS) were 16.3 versus 14.3 months (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.35-0.65; p < 0.0001] and 8.3 versus 6.0 months (HR 0.79, 95% CI 0.63-0.99; p = 0.0431) in 'IMbrave150-in' and 'IMbrave150-out' patients, respectively. Multivariate analysis confirmed that patients included in the 'IMbrave150-in' group had significantly longer OS compared with patients included in the 'IMbrave150-out' group (HR 0.76, 95% CI 0.47-0.97; p = 0.0195). In 'IMbrave150-in' patients, the albumin-bilirubin (ALBI) grade was not associated with OS, whereas in 'IMbrave150-out' patients, those with ALBI grade 1 reported a significant benefit in terms of OS compared with those with ALBI grade 2 (16.7 vs. 5.9 months; HR 4.40, 95% CI 2.40-8.08; p > 0.0001). No statistically significant differences were reported in the 'IMbrave150-in' and 'IMbrave150-out' groups in terms of safety profile. Conclusion: Adherence to the IMbrave150 trial inclusion criteria favorably impacts the prognosis of patients receiving atezolizumab plus bevacizumab. Among patients who did not meet the IMbrave150 inclusion criteria, those with ALBI grade 1 could benefit from the treatment.
2023
Rimini, Margherita; Persano, Mara; Tada, Toshifumi; Suda, Goki; Shimose, Shigeo; Kudo, Masatoshi; Cheon, Jaekyung; Finkelmeier, Fabian; Lim, Ho Yeong; Presa, José; Masi, Gianluca; Yoo, Changhoon; Lonardi, Sara; Piscaglia, Fabio; Kumada, Takashi; Sakamoto, Naoya; Iwamoto, Hideki; Aoki, Tomoko; Chon, Hong Jae; Himmelsbach, Vera; Pressiani, Tiziana; Montes, Margarida; Vivaldi, Caterina; Soldà, Caterina; Hiraoka, Atsushi; Sho, Takuya; Niizeki, Takashi; Nishida, Naoshi; Steup, Christoph; Hirooka, Masashi; Kariyama, Kazuya; Tani, Joji; Atsukawa, Masanori; Takaguchi, Koichi; Itobayashi, Ei; Fukunishi, Shinya; Tsuji, Kunihiko; Ishikawa, Toru; Tajiri, Kazuto; Ochi, Hironori; Yasuda, Satoshi; Toyoda, Hidenori; Ogawa, Chikara; Nishimura, Takashi; Hatanaka, Takeshi; Kakizaki, Satoru; Shimada, Noritomo; Kawata, Kazuhito; Tada, Fujimasa; Ohama, Hideko; Nouso, Kazuhiro; Morishita, Asahiro; Tsutsui, Akemi; Nagano, Takuya; Itokawa, Norio; Okubo, Tomomi; Arai, Taeang; Imai, Michitaka; Kosaka, Hisashi; Naganuma, Atsushi; Koizumi, Yohei; Nakamura, Shinichiro; Kaibori, Masaki; Iijima, Hiroko; Hiasa, Yoichi; Burgio, Valentina; Rimassa, Lorenza; Scartozzi, Mario; Cascinu, Stefano; Casadei-Gardini, Andrea
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11568/1170186
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