Enzalutamide + androgen deprivation therapy (ADT) versus flutamide + ADT in Japanese men with castration‐resistant prostate cancer: AFTERCAB study

The objective of the study is to compare the efficacy and safety of alternative androgen therapy (AAT) with enzalutamide + androgen deprivation therapy (ADT) and flutamide + ADT in the treatment of Japanese men with metastatic or nonmetastatic castration‐resistant prostate cancer (CRPC) who progressed despite combined androgen blockade (CAB) with bicalutamide + ADT. AAT treatment sequence was also investigated.

[1]  T. Deguchi,et al.  Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: the OCUU-CRPC study , 2019, International Journal of Clinical Oncology.

[2]  A. Villers,et al.  ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer , 2019, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[3]  M. Stockler,et al.  Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. , 2019, The New England journal of medicine.

[4]  T. Nakatani,et al.  Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: study protocol for a multicenter randomized phase II trial (the OCUU-CRPC study) , 2019, BMC Cancer.

[5]  H. Akaza,et al.  Combined androgen blockade achieved better oncological outcome in androgen deprivation therapy for prostate cancer: Analysis of community‐based multi‐institutional database across Japan using propensity score matching , 2018, Cancer medicine.

[6]  Y. Kakehi,et al.  Evidenced‐based clinical practice guideline for prostate cancer (summary: Japanese Urological Association, 2016 edition) , 2017, International journal of urology : official journal of the Japanese Urological Association.

[7]  H. Miyake,et al.  Impact of Prior Use of an Androgen Receptor‐Axis‐Targeted (ARAT) Agent With or Without Subsequent Taxane Therapy on the Efficacy of Another ARAT Agent in Patients With Metastatic Castration‐Resistant Prostate Cancer , 2017, Clinical genitourinary cancer.

[8]  M. Yao,et al.  Predictors of poor response to secondary alternative antiandrogen therapy with flutamide in metastatic castration-resistant prostate cancer. , 2016, Japanese journal of clinical oncology.

[9]  Y. Ohashi,et al.  A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer , 2016, International Journal of Clinical Oncology.

[10]  F. Saad,et al.  Enzalutamide in metastatic prostate cancer before chemotherapy. , 2014, The New England journal of medicine.

[11]  J. Carles,et al.  Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): results of phase III PREVAIL study. , 2014, Clinical advances in hematology & oncology : H&O.

[12]  Kurt Miller,et al.  Increased survival with enzalutamide in prostate cancer after chemotherapy. , 2012, The New England journal of medicine.

[13]  E. Higashihara,et al.  Alternative antiandrogen therapy in patients with castration‐resistant prostate cancer: A single‐center experience , 2010, International journal of urology : official journal of the Japanese Urological Association.

[14]  K. Izumi,et al.  Adrenal androgen levels as predictors of outcome in castration‐resistant prostate cancer patients treated with combined androgen blockade using flutamide as a second‐line anti‐androgen , 2010, International journal of urology : official journal of the Japanese Urological Association.

[15]  M. Okada,et al.  [New response evaluation criteria in solid tumours-revised RECIST guideline (version 1.1)]. , 2009, Gan to kagaku ryoho. Cancer & chemotherapy.

[16]  H. Akaza,et al.  Combined androgen blockade with bicalutamide for advanced prostate cancer , 2009, Cancer.

[17]  H. Scher,et al.  Development of a Second-Generation Antiandrogen for Treatment of Advanced Prostate Cancer , 2009, Science.

[18]  Tomohiko Ichikawa,et al.  Alternative nonsteroidal antiandrogen therapy for advanced prostate cancer that relapsed after initial maximum androgen blockade. , 2008, The Journal of urology.

[19]  Susan Halabi,et al.  Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[20]  K. Nishimura,et al.  Effects of flutamide as a second‐line agent for maximum androgen blockade of hormone refractory prostate cancer , 2007, International journal of urology : official journal of the Japanese Urological Association.

[21]  Y. Mizutani,et al.  Clinical efficacy of alternative antiandrogen therapy in Japanese men with relapsed prostate cancer after first‐line hormonal therapy , 2007, International journal of urology : official journal of the Japanese Urological Association.

[22]  H. Akaza,et al.  Efficacy of primary hormonal therapy for patients with localized and locally advanced prostate cancer: A retrospective multicenter study , 2006, International journal of urology : official journal of the Japanese Urological Association.

[23]  H. Miyake,et al.  Clinical outcome of maximum androgen blockade using flutamide as second‐line hormonal therapy for hormone‐refractory prostate cancer , 2005, BJU international.

[24]  K. Fujikawa,et al.  Prostate–Specific Antigen Levels and Clinical Response to Flutamide as the Second Hormone Therapy for Hormone–Refractory Prostate Carcinoma , 2000, European Urology.

[25]  Tosiya Sato,et al.  On the variance estimator for the Mantel-Haenszel risk difference , 1989 .

[26]  D. Schoenfeld,et al.  Sample-size formula for the proportional-hazards regression model. , 1983, Biometrics.

[27]  渡辺祐一 新しい効果判定基準RECIST (Response Evaluation Criteria in Solid Tumors) 総論 肺がん, がんの化学療法 (前篇) , 2001 .