Regorafenib versus cabozantinb as second-line treatment after sorafenib for unresectable hepatocellular carcinoma: matching-adjusted indirect comparison analysis

Journal of Cancer Research and Clinical Oncology - Tập 147 - Trang 3665-3671 - 2021
Andrea Casadei-Gardini1,2, Lorenza Rimassa3,4, Margherita Rimini5, Changhoon Yoo6, Baek-Yeol Ryoo6, Sara Lonardi7,8, Gianluca Masi9,10, Hyung-Don Kim6, Caterina Vivaldi9,10, Min-Hee Ryu6, Mario Domenico Rizzato8, Francesca Salani9,10, Yeonghak Bang6, Antonio Pellino8,11, Silvia Catanese9,10, Valentina Burgio2, Stefano Cascinu12,2, Alessandro Cucchetti13,14
1School of Medicine, Vita-Salute San Raffaele University, Milan, Italy
2Unit of Oncology, Università Vita-Salute, IRCCS-San Raffaele Scientific Institute, Milan, Italy
3Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
4Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
5Department of Oncology and Hematology, Division of Oncology, University of Modena and Reggio Emilia, Modena, Italy
6Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KOREA
7Early Phase Clinical Trial Unit, Department of Oncology, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy
8Medical Oncology Unit 1, Department of Oncology, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy
9Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy
10Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy
11Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy
12School of Medicine, Vita Salute San Raffaele University, Milan, Italy
13Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy
14General and Oncologic Surgery, Morgagni-Pierantoni Hospital, AUSL Romagna, Forlì, Italy

Tóm tắt

Recently, three published phase III trials highlighted the superiority of investigational drugs compared to placebo, thus leading to their approval in the second-line setting. We report here a MAIC of second-line MKI options for patients with HCC previously treated with sorafenib using individual real-world data of regorafenib and aggregate data of second-line cabozantinib from the CELESTIAL trial. Data from 278 patients who received regorafenib as second-line therapy after sorafenib failure for unresectable HCC were used as IPD. Data inclusion were adapted to those reported in the CELESTIAL trial in the subset of patients who received sorafenib as the only prior therapy. Survival medians and rates were obtained from Kaplan–Meier curves, and differences between regorafenib and cabozantinib groups were explored through Cox regression adjusted for weights originating from MAIC. The median OS of the weighted regorafenib group was 11.1 months (IQR: 5.6–16.4) and 11.3 (IQR: 6.7–22.4) for cabozantinib; HR 0.83 (95%CI 0.62–1.09). The median PFS of the weighted regorafenib group was 3.0 months (IQR: 1.9–4.8) and 5.5 (IQR: 2.3–9.3) for cabozantinib; HR 0.50 (95%CI 0.41–0.62). In the subgroup who received prior sorafenib for < 3 months, the median OS of the regorafenib group was 6.5 months (IQR: 4.7–10.9) and 9.5 months (IQR: 5.9–18.2) for cabozantinib; HR 0.68 (95%CI 0.39–1.16). In the subgroup receiving prior sorafenib for 3 to < 6 months, the median OS of the regorafenib group was 8.0 months (IQR: 4.2–15.2) and 11.5 (IQR: 6.5–23.9) for cabozantinib; HR 0.66 (95%CI 0.42–1.02). In the subgroup receiving prior sorafenib for ≥ 6 months, the median OS of the regorafenib group was 13.4 (IQR: 8.1–46.5) and 12.3 (IQR: 6.6–22.9) for cabozantinib; HR 0.89 (95%CI 0.52–1.51). Our results confirmed no differences between regorafenib and cabozantinib in terms of OS. However, in earlier progressors on prior sorafenib a larger benefit might be expected from cabozantinib treatment.

Tài liệu tham khảo

Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, Cicin I, Merle P, Chen Y, Park JW, Blanc JF, Bolondi L, Klümpen HJ, Chan SL, Zagonel V, Pressiani T, Ryu MH, Venook AP, Hessel C, Borgman-Hagey AE, Schwab G, Kelley RK (2018) Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med 379(1):54–63 Bi F, Qin S, Gu S et al (2020) Donafenib versus sorafenib as first-line therapy in advanced hepatocellular carcinoma: An open-label, randomized, multicenter phase II/III trial. J ClinOncol 38:4506–4506 Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Breder V, Gerolami R, Masi G, Ross PJ, Song T, Bronowicki JP, Ollivier-Hourmand I, Kudo M, Cheng AL, Llovet JM, Finn RS, LeBerre MA, Baumhauer A, Meinhardt G, Han G, RESORCE Investigators (2017) Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 389(10064):56–66 Cainap C, Qin S, Huang WT, Chung IJ, Pan H, Cheng Y et al (2015) Linifanib versus sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J ClinOncol 33:172–179 Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z (2009) Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol 10(1):25–34 Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL, IMbrave150 Investigators (2020) Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 382(20):1894–1905 Guyot P, Ades AE, Ouwens MJ, Welton NJ (2012) Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. BMC Med Res Methodol 1(12):9 Johnson PJ, Qin S, Park JW, Poon RT, Raoul JL, Philip PA et al (2013) Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J ClinOncol 31:3517–3524 Kelley RK, Ryoo BY, Merle P, Park JW, Bolondi L, Chan SL, Lim HY, Baron AD, Parnis F, Knox J, Cattan S, Yau T, Lougheed JC, Milwee S, El-Khoueiry AB, Cheng AL, Meyer T, Abou-Alfa GK (2020) Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial. ESMO Open 5(4):e000714 Kelley RK, Mollon P, Blanc JF, Daniele B, Yau T, Cheng AL, Valcheva V, Marteau F, Guerra I, Abou-Alfa GK (2020) Comparative efficacy of cabozantinib and regorafenib for advanced hepatocellular carcinoma. AdvTher 37(6):2678–2695 Koeberle D, Dufour JF, Demeter G, Li Q, Ribi K, Samaras P et al (2016) Sorafenib with or without everolimus in patients with advanced hepatocellular carcinoma (HCC): a randomized multicenter. Clin Trial. https://doi.org/10.1093/annonc/mdw054 Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL (2018) Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet 391:1163–1173 Li Q, Qin S, Gu S et al (2020) Apatinib as second-line therapy in Chinese patients with advanced hepatocellular carcinoma: A randomized, placebo-controlled, double-blind, phase III study. J ClinOncol 38:4507–4507 Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J (2008) SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 359(4):378–390 Llovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C et al (2013) Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J ClinOncol 31:3509–3516 Merle P, Blanc JF, Phelip JM, Pelletier G, Bronowicki JP, Touchefeu Y, Pageaux G, Gerolami R, Habersetzer F, Nguyen-Khac E, Casadei-Gardini A, Borbath I, Tran A, Wege H, Saad AS, Colombo M, Abergel A, Richou C, Waked I, Yee NS, Molé A, Attali P, Le Boulicaut J, Vasseur B, RELIVE Investigators (2019) Doxorubicin-loaded nanoparticles for patients with advanced hepatocellular carcinoma after sorafenib treatment failure (RELIVE): a phase 3 randomised controlled trial. Lancet GastroenterolHepatol. 4(6):454–465 Ren Z, Fan J, Xu J et al (2020) LBA2 - Sintilimab plus bevacizumab biosimilar vs sorafenib as first-line treatment for advanced hepatocellular carcinoma (ORIENT-32). Ann Oncol 31(suppl_6): S1287-S1318 Rimassa L, Assenat E, Peck-Radosavljevic M, Pracht M, Zagonel V, Mathurin P, RotaCaremoli E, Porta C, Daniele B, Bolondi L, Mazzaferro V, Harris W, Damjanov N, Pastorelli D, Reig M, Knox J, Negri F, Trojan J, LópezLópez C, Personeni N, Decaens T, Dupuy M, Sieghart W, Abbadessa G, Schwartz B, Lamar M, Goldberg T, Shuster D, Santoro A, Bruix J (2018) Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study. Lancet Oncol 19(5):682–693 Signorovitch JE, Sikirica V, Erder MH, Xie J, Lu M, Hodgkins PS, Betts KA, Wu EQ (2012) Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health. 15(6):940–947. https://doi.org/10.1016/j.jval.2012.05.004 Trojan J, Mollon P, Daniele B et al (2020) 1146 -Comparative efficacy of cabozantinib and ramucirumab after sorafenib for patients with advanced hepatocellular carcinoma and AFP ≥ 400 ng/mL. Hepatology 72(suppl_1):691A-692A Zhu AX, Kang YK, Yen CJ, Finn RS, Galle PR, Llovet JM, Assenat E, Brandi G, Pracht M, Lim HY, Rau KM, Motomura K, Ohno I, Merle P, Daniele B, Shin DB, Gerken G, Borg C, Hiriart JB, Okusaka T, Morimoto M, Hsu Y, Abada PB, Kudo M, REACH-2 study investigators (2019) Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 20(2):282–296 (1985) The Will Rogers phenomenon--additional evidence. N Engl J Med 313(20):1291–2
Thông tin
Thông tin xuất bản

Journal of Cancer Research and Clinical Oncology

Tập 147

3665-3671

Thông tin tác giả