Objective Response by mRECIST is an Independent Prognostic Factor for overall Survival in Hepatocellular Carcinoma in SILIUS Trial

How to cite: Kudo, M.; Ueshima, K.; Chiba, Y.; Ogasawara, S.; Obi, S.; Izumi, N.; Aikata, H.; Nagano, H.; Hatano, E.; Sasaki, Y.; Hino, K.; Kumada, T.; Yamamoto, K.; Imai, Y.; Iwadou, S.; Ogawa, C.; Okusaka, T.; Kanai, F.; Arai, Y. Objective Response by mRECIST is an Independent Prognostic Factor for overall Survival in Hepatocellular Carcinoma in SILIUS Trial. Preprints 2019, 2019070075. https://doi.org/10.20944/preprints201907.0075.v1 Kudo, M.; Ueshima, K.; Chiba, Y.; Ogasawara, S.; Obi, S.; Izumi, N.; Aikata, H.; Nagano, H.; Hatano, E.; Sasaki, Y.; Hino, K.; Kumada, T.; Yamamoto, K.; Imai, Y.; Iwadou, S.; Ogawa, C.; Okusaka, T.; Kanai, F.; Arai, Y. Objective Response by mRECIST is an Independent Prognostic Factor for overall Survival in Hepatocellular Carcinoma in SILIUS Trial. Preprints 2019, 2019070075. https://doi.org/10.20944/preprints201907.0075.v1

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MDPI and ACS Style

Kudo, M.; Ueshima, K.; Chiba, Y.; Ogasawara, S.; Obi, S.; Izumi, N.; Aikata, H.; Nagano, H.; Hatano, E.; Sasaki, Y.; Hino, K.; Kumada, T.; Yamamoto, K.; Imai, Y.; Iwadou, S.; Ogawa, C.; Okusaka, T.; Kanai, F.; Arai, Y. Objective Response by mRECIST is an Independent Prognostic Factor for overall Survival in Hepatocellular Carcinoma in SILIUS Trial. Preprints 2019, 2019070075. https://doi.org/10.20944/preprints201907.0075.v1

APA Style

Kudo, M., Ueshima, K., Chiba, Y., Ogasawara, S., Obi, S., Izumi, N., Aikata, H., Nagano, H., Hatano, E., Sasaki, Y., Hino, K., Kumada, T., Yamamoto, K., Imai, Y., Iwadou, S., Ogawa, C., Okusaka, T., Kanai, F., & Arai, Y. (2019). Objective Response by mRECIST is an Independent Prognostic Factor for overall Survival in Hepatocellular Carcinoma in SILIUS Trial. Preprints. https://doi.org/10.20944/preprints201907.0075.v1

Chicago/Turabian Style

Kudo, M., Fumihiko Kanai and Yasuaki Arai. 2019 "Objective Response by mRECIST is an Independent Prognostic Factor for overall Survival in Hepatocellular Carcinoma in SILIUS Trial" Preprints. https://doi.org/10.20944/preprints201907.0075.v1

Abstract

Background In SILIUS (NCT01214343), combination of sorafenib and hepatic arterial infusion chemotherapy did not significantly improve overall survival in patients with advanced hepatocellular carcinoma (HCC) compared with sorafenib alone. In this study, we explored the relationship between objective response by mRECIST and overall survival (OS) in the sorafenib group, in the combination group and in all patients in the SILIUS trial. Methods Association between objective response and OS in patients treated with sorafenib (n=103), combination (n=102) and all patients (n=205) were analyzed. The median OS of responders was compared with that of non-responders. Landmark analyses were performed according to objective response at several fixed time points, as sensitivity analyses, and the effect on OS was evaluated by Cox regression analysis with objective response as a time-dependent covariate, with other prognostic factors was performed. Results In the sorafenib group, OS of responders (n = 18) was significantly better than that of non-responders (n = 78) (p < 0.0001), where median OS was 27.2 (95% CI, 16.0–not reached) months for responders and 8.9 (95% CI, 6.5–12.6) months for non-responders. HRs from landmark analyses at 4, 6, and 8 months were 0.45 (p=0.0330), 0.37 (p=0.0053), and 0.36 (p=0.0083), respectively. Objective response was an independent predictor of OS based on unstratified Cox regression analyses. In the all patients and the combination group, similar results were obtained. Conclusion In the SILIUS trial, objective response was an independent prognostic factor for OS in patients with HCC.

Keywords

hepatocellular carcinoma; objective response; modified RECIST; sorafenib; hepatic arterial infusion chemotherapy

Subject

Medicine and Pharmacology, Gastroenterology and Hepatology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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