MP69-19 EXTENDED ANALYSES OF PHASE II CLINICAL TRIAL OF SORAFENIB PLUS INTERFERON-ALPHA TREATMENT FOR PATIENTS WITH METASTATIC RENAL CELL CARCINOMA IN JAPAN (2015)

You have accessJournal of UrologyKidney Cancer: Advanced II1 Apr 2015MP69-19 EXTENDED ANALYSES OF PHASE II CLINICAL TRIAL OF SORAFENIB PLUS INTERFERON-ALPHA TREATMENT FOR PATIENTS WITH METASTATIC RENAL CELL CARCINOMA IN JAPAN Masatoshi Eto, Yoshiaki Kawano, Yoshihiko Hirao, Koji Mita, Yoichi Arai, Taiji Tsukamoto, Katsuyoshi Hashine, Akio Matsubara, Tomoaki Fujioka, Go Kimura, Nobuo Shinohara, Katsunori Tatsugami, Shiro Hinotsu, and Seiji Naito Masatoshi EtoMasatoshi Eto More articles by this author , Yoshiaki KawanoYoshiaki Kawano More articles by this author , Yoshihiko HiraoYoshihiko Hirao More articles by this author , Koji MitaKoji Mita More articles by this author , Yoichi AraiYoichi Arai More articles by this author , Taiji TsukamotoTaiji Tsukamoto More articles by this author , Katsuyoshi HashineKatsuyoshi Hashine More articles by this author , Akio MatsubaraAkio Matsubara More articles by this author , Tomoaki FujiokaTomoaki Fujioka More articles by this author , Go KimuraGo Kimura More articles by this author , Nobuo ShinoharaNobuo Shinohara More articles by this author , Katsunori TatsugamiKatsunori Tatsugami More articles by this author , Shiro HinotsuShiro Hinotsu More articles by this author , and Seiji NaitoSeiji Naito More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2523AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To improve the antitumor effects of molecular target-based drugs, sequential or combination therapy with these drugs has been advocated. In combination therapy, we reported mechanistic analyses of the additional effect of interferon (IFN)-α on sorafenib in our murine model (J Urol 184:2549, 2010). Furthermore, we have recently reported good results of a phase II clinical trial of sorafenib plus IFN-α for untreated mRCC patients in Japan (ESMO 2013, abstract #2793, manuscript submitted). In this study, we have further performed subgroup analyses to clarify who would benefit from the combined therapy. METHODS In this multicenter, prospective study (Registration identification number: UMIN000002466), from July 2009 to July 2012, 53 provisionally registered patients with histologically confirmed clear cell mRCC, measurable disease, age > 20 years, ECOG PS 0-1 and adequate organ function received 3 dosages of 3 million U per week of natural IFN-α treatment for 2 weeks. Then, 51 patients tolerable to IFN-α treatment were finally registered to this trial, and oral administration of sorafenib (400mg, bid) was added to IFN-α treatment. Nine patients were excluded because of violation of eligibility criteria. The primary end point of the study was to evaluate response rate (CR + PR) of sorafenib plus IFN-α treatment for mRCC patients using RECIST v1.0. The secondary end point was to evaluate disease control rate (CR + PR + SD), progression free survival (PFS), OS, and safety of the combined treatment. Subgroup analyses using MSKCC criteria, metastatic sites, and a sum of the longest diameter (LD) for all target lesions were also performed. RESULTS Response rate of the combined therapy 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. In MSKCC criteria, the median PFS in favorable risk group was 19.1 months, whereas that in intermediate risk group was 9.3 months. ECOG PS of all patients with objective responses was 0. Regarding metastatic sites, no statistical difference in PFS was observed between patients with lung metastases only and those with metastases in multiple organs. However, patients with bulky metastases (a sum of the LD; > 70mm) in the liver tended to show progressive disease. CONCLUSIONS We have shown patients' profile who would benefit from the sorafenib plus IFN-α treatment. We believe that our results are useful when we consider the first line treatment for mRCC patients. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e874 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Masatoshi Eto More articles by this author Yoshiaki Kawano More articles by this author Yoshihiko Hirao More articles by this author Koji Mita More articles by this author Yoichi Arai More articles by this author Taiji Tsukamoto More articles by this author Katsuyoshi Hashine More articles by this author Akio Matsubara More articles by this author Tomoaki Fujioka More articles by this author Go Kimura More articles by this author Nobuo Shinohara More articles by this author Katsunori Tatsugami More articles by this author Shiro Hinotsu More articles by this author Seiji Naito More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...