Docetaxel‐based chemotherapy combined with dexamethasone 1 mg daily oral administration for castration‐resistant prostate cancer: Long‐term outcomes

• Published in: International journal of urology 2019-08, Vol.26 (8), p.797-803
• Main Authors: Tanaka, Nobumichi, Nishimura, Kazuo, Okajima, Eijiro, Ina, Kenji, Ogawa, Osamu, Nagata, Hirohiko, Akakura, Koichiro, Fujimoto, Kiyohide, Gotoh, Momokazu, Teramukai, Satoshi, Hirao, Yoshihiko
• Format: Article
• Language: English
• Subjects: Castration; castration‐resistant prostate cancer; Chemotherapy; Dexamethasone; docetaxel; Metastases; Metastasis; Multivariate analysis; Oral administration; Prostate cancer; Survival; Survival analysis
• ISSN: 0919-8172; 1442-2042
• DOI: 10.1111/iju.14009

Objectives To report long‐term outcome survival analysis of docetaxel‐based chemotherapy combined with dexamethasone in castration‐resistant prostate cancer patients (Japan‐Multinational Trial Organization Pca10‐01 trial). Methods The Japan‐Multinational Trial Organization Pca10‐01 phase II trial was a multicenter, prospective single‐arm, phase II trial both in non‐metastatic and metastatic castration‐resistant prostate cancer patients that was organized by The Japan‐Multinational Trial Organization. Patients received 75 mg/m2 of docetaxel (every 21 days) and 0.5 mg of dexamethasone orally twice a day continuing throughout the treatment period. The primary end‐point of this additional analysis was overall survival. Secondary end‐points were progression‐free survival and safety. Results Between January 2011 and February 2014, a total of 76 chemotherapy‐naïve castration‐resistant prostate cancer patients were enrolled. The median overall survival time was 42.5 months. The median overall survival time of M1 patients was 40.5 months (M0: not reached). The median progression‐free survival time was 13.2 months (M0: 15.7 months and M1: 12.3 months). The multivariate analysis predicting overall survival of M1 patients showed that time to castration‐resistant prostate cancer (≥20 months) was an independent parameter (hazard ratio 0.39, P = 0.023). Regarding the safety analysis, 36 out of 74 patients (48.6%) suffered from any grade of adverse events after the protocol treatment, and 18 patients (24.3%) had grade ≥3 adverse events. Conclusions Docetaxel‐based chemotherapy combined with dexamethasone can achieve excellent survival efficacy not only in M0 castration‐resistant prostate cancer patients, but also in M1 castration‐resistant prostate cancer patients.