The efficacy and safety of docetaxel-based chemotherapy combined with dexamethasone 1 mg daily oral administration: JMTO Pca 10-01 phase II trial

Tanaka, Nobumichi; Nishimura, Kazuo; Okajima, Eijiro; Ina, Kenji; Ogawa, Osamu; Nagata, Hirohiko; Akakura, Koichiro; Fujimoto, Kiyohide; Gotoh, Momokazu; Teramukai, Satoshi; Hirao, Yoshihiko

doi:10.1093/jjco/hyw193

Cited by 11 publications

(15 citation statements)

References 17 publications

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“…One reason is good efficacy of this combination. The prostate‐specific antigen response in this study (all patients, 76.8%; M0, 81.3%; M1, 75.5%) was higher than that in the Japanese phase II trial (44.4%) and TAX 327 phase III trial (45%) . Dexamethasone replacement instead of prednisolone seems to be a good partner for docetaxel.…”

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confidence: 57%

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

Yuasa

2019

Int J of Urology

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13 Yao A, Sejima T, Iwamoto H et al. High neutrophil-to-lymphocyte ratio predicts poor clinical outcome in patients with castration-resistant prostate cancer treated with docetaxel chemotherapy. Int. J. Urol. 2015; 22: 827-33. 14 Fukuta F, Kitamura H, Yanase M et al. Efficacy and safety of docetaxel and prednisolone for castration-resistant prostate cancer: a multi-institutional retrospective study in Japan. Jpn. J. Clin. Oncol. 2015; 45: 682-7. 15 Yamashita S, Kohjimoto Y, Iguchi T et al. Prognostic factors and risk stratification in patients with castration-resistant prostate cancer receiving docetaxelbased chemotherapy. BMC Urol. 2016; 16: 13. 16 Armstrong AJ, Garrett-Mayer E, Ou Yang YC et al. Prostate-specific antigen and pain surrogacy analysis in metastatic hormone-refractory prostate cancer.

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confidence: 57%

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

Yuasa

2019

Int J of Urology

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“…There have been no studies to confirm the efficacy and safety of the 75 mg/m 2 dose in Japanese patients. To investigate the efficacy and safety of the combination therapy of docetaxel (75 mg/m 2 ) and dexamethasone (1 mg), we carried out a prospective phase II trial (JMTO Pca 10‐01 phase II trial) . We also confirmed a novel PSA response and acceptable safety profile regarding adverse events compared with the Japanese phase II study.…”

Section: Introductionmentioning

confidence: 75%

“…The main objective of the JMTO Pca 10‐01 phase II trial was to confirm the equivalence of efficacy and safety of docetaxel‐based chemotherapy (75 mg/m 2 ) with a low dose of dexamethasone (1 mg) compared with the Japanese phase II trial . The PSA response (all patients: 76.8%, M0: 81.3%, and M1: 75.5%) was significantly higher than that in the Japanese phase II trial (44.4%, 95% CI 27.9–61.9).…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2019

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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/m 2 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-na€ ıve 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.

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“…Azapeptides have been modified and tested to obstruct gama-SM protein. Another gama-SM protein inhibitor, peptide-based, have also been considered with the knowledge that its chemical composition is very advantageous for various combination therapies (68, 69). Additionally, boronic acid-based inhibitors have been determined to constrain the destruction of gama-SM substrates and its effects on gama-SM protein secretion and progression of xenografts in vivo (70, 71).…”

Section: Targeting Hsp70 and Gama-sm: A Possible Therapy For Pcamentioning

confidence: 99%

Hsp70 and gama-Semino protein as possible prognostic marker of prostate cancer

et al. 2018

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In the United States, Prostate Cancer (PCa) is the leading cause of cancer-related mortality in men. PCa resulted in abnormal growth and function of prostate gland such as secretion of high level of gamma-seminoprotein (gama-SM)/Prostate-Specific Antigen (PSA) which could be detected in the blood. Beside gama-SM protein, the levels of heat shock proteins (Hsp70) were also observed significantly high. Therefore, gama-SM and Hsp70 are unique proteins with high potential for PCa therapeutics and diagnostics. High level of Hsp70 suppresses apoptosis, thus allowing PCa cells to exist; however, depletion of Hsp70 induces apoptosis in PCa cells. Gama-SM is the most prominent biomarker for PCa screening; however, its accuracy is still questionable. Thus, a more suitable streamline biomarker for PCa screening is urgently needed. Hsp70 and gama-SM proteins could be used as a revolutionary biomarker for PCa, and could help to identify possible therapeutic target(s). In this review article we will discuss the relationship between the Hsp70 and gama-SM proteins with PCa, their potential as a dual biomarker, and the possibility for both proteins being used as therapeutic targets.

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The efficacy and safety of docetaxel-based chemotherapy combined with dexamethasone 1 mg daily oral administration: JMTO Pca 10-01 phase II trial

Abstract: The present study showed a significantly high PSA response compared with previous reports. Most patients tolerated the protocol treatment well, whereas hematotoxicity was often observed.

Cited by 11 publications

References 17 publications

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

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

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

Hsp70 and gama-Semino protein as possible prognostic marker of prostate cancer

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