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タイトル: Phase II clinical trial of sorafenib plus interferon-alpha treatment for patients with metastatic renal cell carcinoma in Japan
著者: Eto, Masatoshi
Kawano, Yoshiaki
Hirao, Yoshihiko
Mita, Koji
Arai, Yoichi
Tsukamoto, Taiji
Hashine, Katsuyoshi
Matsubara, Akio
Fujioka, Tomoaki
Kimura, Go
Shinohara, Nobuo
Tatsugami, Katsunori
Hinotsu, Shiro
Naito, Seiji
著者名の別形: 樋之津, 史郎
キーワード: Sorafenib
Interferon-alpha
Renal cell carcinoma
発行日: 9-Oct-2015
出版者: BioMed Central Ltd.
誌名: BMC Cancer
巻: 15
論文番号: 667
抄録: Background: To improve antitumor effects against metastatic renal cell carcinoma (mRCC), use of molecular target-based drugs in sequential or combination therapy has been advocated. In combination therapy, interferon (IFN)-aα amplified the effect of sorafenib in our murine model (J Urol 184:2549, 2010), and cytokine-treated mRCC patients in Japan had good prognoses (Eur Urol 57:317, 2010). We thus conducted a phase II clinical trial of sorafenib plus IFN-aα for untreated mRCC patients in Japan. Methods: In this multicenter, prospective study, provisionally registered patients with histologically confirmed metastatic clear cell RCC received natural IFN-aα (3 dosages of 3 million U per week) for 2 weeks. Only IFN-aα-tolerant patients were registered to this trial, and treated additionally with oral sorafenib (400 mg, bid). The primary end point of the study was rate of response (CR + PR) to sorafenib plus IFN-aα treatment assessed using RECIST v1.0. The secondary end points were disease control rate (CR + PR + SD), progression free survival (PFS), overall survival (OS), and safety of the combined treatment. PFS and OS curves were plotted using the Kaplan-Meier method. Results: From July 2009 to July 2012, a total of 53 untreated patients were provisionally registered, and 51 patients were finally registered. Rate of Response to the combined therapy of sorafenib plus IFN-aα was 26.2 % (11/42) (CR 1, PR 10). The median PFS was 10.1 months (95 % CI, 6.4 to 18.5 months), and the median OS has not been reached yet. The combined therapy increased neither the incidence of adverse effects (AE) nor the incidence of unexpected AE. A limitation was that a relatively high number of patients (9 patients) were excluded for eligibility criteria violations. Conclusion: Our data have demonstrated that sorafenib plus IFN-aα treatment is safe and effective for untreated mRCC patients. Trial registration:UMIN000002466 , 9th September, 2009
著作権等: © 2015 Eto et al. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
URI: http://hdl.handle.net/2433/212504
DOI(出版社版): 10.1186/s12885-015-1675-1
出現コレクション:学術雑誌掲載論文等

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