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 Burgio12, Stefano Cascinu13,12, Alessandro Cucchetti14,15. 1. School of Medicine, Vita-Salute San Raffaele University, Milan, Italy. casadeigardini@gmail.com. 2. Unit of Oncology, Università Vita-Salute, IRCCS-San Raffaele Scientific Institute, via Olgettina 70, 20132, Milan, Milano, Italy. casadeigardini@gmail.com. 3. Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy. 4. Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy. 5. Department of Oncology and Hematology, Division of Oncology, University of Modena and Reggio Emilia, 4121, Modena, Italy. 6. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 7. Early Phase Clinical Trial Unit, Department of Oncology, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy. 8. Medical Oncology Unit 1, Department of Oncology, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. 9. Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy. 10. Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 11. Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. 12. Unit of Oncology, Università Vita-Salute, IRCCS-San Raffaele Scientific Institute, via Olgettina 70, 20132, Milan, Milano, Italy. 13. School of Medicine, Vita-Salute San Raffaele University, Milan, Italy. 14. Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Bologna, Italy. 15. General and Oncologic Surgery, Morgagni-Pierantoni Hospital, Ausl Romagna, Forlì, Italy.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.
Authors: James E Signorovitch; Vanja Sikirica; M Haim Erder; Jipan Xie; Mei Lu; Paul S Hodgkins; Keith A Betts; Eric Q Wu Journal: Value Health Date: 2012 Sep-Oct Impact factor: 5.725
Authors: Xavier Adhoute; Marie De Matharel; Laurent Mineur; Guillaume Pénaranda; Dann Ouizeman; Clemence Toullec; Albert Tran; Paul Castellani; Armelle Rollet; Valérie Oules; Hervé Perrier; Si Nafa Si Ahmed; Marc Bourliere; Rodolphe Anty Journal: World J Gastrointest Oncol Date: 2022-08-15