Goserelin Acetate with or without Antiandrogen or Estrogen in the Treatment of Patients with Advanced Prostate Cancer: A Multicenter, Randomized, Controlled Trial in Japan

Kotake, Toshihiko; Usami, Michiyuki; Akaza, Hideyuki; Koiso, K; Homtna, Y.; Kawabe, Kazuki; Aso, Yoshio; Orikasa, Seiichi; Shimazaki, Jun; Isaka, Shigeo; Yoshida, Osamu; Hirao, Yoshihiko; Okajima, Eigoro; Naito, Seiji; Kumazawa, J; Kanetake, Hiroshi; Saito, Yutaka; Ohi, Yasuyo; Ohashi, Yasuo

doi:10.1093/jjco/29.11.562

Cited by 28 publications

(17 citation statements)

References 24 publications

(33 reference statements)

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“…Applications of such systems include vaccination [2,[6][7][8] and drug delivery [9][10][11][12][13], for periods of up to 6 months. Understanding the surface and the bulk chemical composition of such microspheres can provide significant insight into the production process and may also contribute to an understanding of the involvement of micro and nanostructure in drug release.…”

Section: Introductionmentioning

confidence: 99%

Chemical and spatial analysis of protein loaded PLGA microspheres for drug delivery applications

Rafati

Boussahel

Shakesheff

et al. 2012

Journal of Controlled Release

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Polymer microspheres for controlled release of therapeutic protein from within an implantable scaffold were produced and analysed using complimentary techniques to probe the surface and bulk chemistry of the microspheres. Time of Flight - Secondary Ion Mass Spectrometry (ToF-SIMS) surface analysis revealed a thin discontinuous film of polyvinyl alcohol (PVA) surfactant (circa 4.5 nm thick) at the surface which was readily removed under sputtering with C(60). Atomic Force Microscopy (AFM) imaging of microspheres before and after sputtering confirmed that the PVA layer was removed after sputtering revealing poly(lactic-co-glycolic) acid(PLGA). Scanning electron microscopy showed the spheres to be smooth with some shallow and generally circular depressions, often with pores in their central region. The occurrence of the protein at the surface was limited to areas surrounding these surface pores. This surface protein distribution is believed to be related to a burst release of the protein on dissolution. Analysis of the bulk properties of the microspheres by confocal Raman mapping revealed the 3D distribution of the protein showing large voids within the pores. Protein was found to be adsorbed at the interface with the PLGA oil phase following deposition on evaporation of the solvent. Protein was also observed concentrated within pores measuring approximately 2 μm across. The presence of protein in large voids and concentrated pores was further scrutinised by ToF-SIMS of sectioned microspheres. This paper demonstrates that important information for optimisation of such complex bioformulations, including an understanding of the release profile can be revealed by complementary surface and bulk analysis allowing optimisation of the therapeutic effect of such formulations.

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Section: Introductionmentioning

confidence: 99%

Chemical and spatial analysis of protein loaded PLGA microspheres for drug delivery applications

Rafati

Boussahel

Shakesheff

et al. 2012

Journal of Controlled Release

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“…Neither of the steroidal antiandrogen studies showed an improvement in overall survival (OS) with combination therapy compared with LHRH-A alone. 6,7 The use of the nonsteroidal antiandrogen flutamide combined with an LHRH-A was studied in 161 Japanese patients. 8 In this unblinded study, combination therapy was superior to LHRH-A monotherapy in terms of reduction of prostate-specific antigen (PSA) level and time to PSA progression.…”

Section: Introductionmentioning

confidence: 99%

Bicalutamide 80 mg combined with a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A monotherapy in advanced prostate cancer: findings from a phase III randomized, double-blind, multicenter trial in Japanese patients

Usami

Akaza

Arai

et al. 2007

Prostate Cancer Prostatic Dis

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To compare combination therapy with bicalutamide 80 mg and a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A alone in Japanese men with untreated advanced prostate cancer. A total of 205 patients with stage C/D prostate cancer were randomized to either LHRH-A þ once-daily oral bicalutamide 80 mg or placebo. Primary study variables have been reported previously. Secondary variables included: time to achieve prostate-specific antigenp4 ng/ ml, time-to-treatment failure (TTTF), time-to-disease progression (TTP), overall survival (OS), adverse events and adverse drug reactions. Following combination therapy with bicalutamide 80 mg, there were significant (Po0.001) advantages over LHRH-A alone in terms of TTTF and TTP, but the difference in the interim OS was not statistically significant. First-line combination therapy with bicalutamide 80 mg in Japanese patients with advanced prostate cancer offers significant benefits over LHRH-A alone, with respect to TTTF and TTP. Follow-up for OS continues.

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“…The median number of PSA evaluations within 12 months after radiotherapy was 4 (range, [1][2][3][4][5][6][7][8][9][10][11][12] in all 84 patients. Median follow-up of all patients was 26.9 months (range, 2.7-77.3 months), and all patients without clinical failure had at least 1 year of follow-up.…”

Section: Methodsmentioning

confidence: 99%

“…Androgen ablation is an effective treatment approach for prostate cancer and has been used as one of the primary treatments for localized disease or palliative treatment for systemic disease (1,2). In Japan in particular, androgen ablation has frequently been used because most Japanese patients with prostate cancer have had high-risk disease and hormonal therapy is frequently preferred as the primary therapy (3,4).…”

Section: Introductionmentioning

confidence: 99%

External Beam Radiotherapy for Clinically Localized Hormone-Refractory Prostate Cancer: Clinical Significance of Nadir Prostate-Specific Antigen Value Within 12 Months

Ogawa

Nakamura

Sasaki³

et al. 2009

International Journal of Radiation Oncology*Biology*Physics

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Goserelin Acetate with or without Antiandrogen or Estrogen in the Treatment of Patients with Advanced Prostate Cancer: A Multicenter, Randomized, Controlled Trial in Japan

Abstract: Neither short- nor long-term combined androgen blockade had a survival advantage over goserelin acetate alone.

Cited by 28 publications

References 24 publications

Chemical and spatial analysis of protein loaded PLGA microspheres for drug delivery applications

Chemical and spatial analysis of protein loaded PLGA microspheres for drug delivery applications

Bicalutamide 80 mg combined with a luteinizing hormone-releasing hormone agonist (LHRH-A) versus LHRH-A monotherapy in advanced prostate cancer: findings from a phase III randomized, double-blind, multicenter trial in Japanese patients

External Beam Radiotherapy for Clinically Localized Hormone-Refractory Prostate Cancer: Clinical Significance of Nadir Prostate-Specific Antigen Value Within 12 Months

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