Casodex scientific update |
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Int J Urol. 2007 Mar;14(3):264-7.
ishimura K, Arichi N, Tokugawa S, Yoshioka I, Kishikawa H, Ichikawa Y
Department of Urology, Hyogo Prefectural Nishinomiya Hospital, 13-9 Rokutanji-cho, Nishinomiya 662-0918, Japan.
Effects of flutamide as a second-line agent for maximum androgen blockade of hormone refractory prostate cancer.
We analyzed clinical effects of flutamide as a second-line agent for maximum androgen blockade (MAB) in patients with relapsing prostate cancer who received bicalutamide as the first-line MAB agent. This study included 13 patients with progressive prostate cancer who had relapsed after first-line MAB, with bicalutamide at 80 mg/day. After checking for antiandrogen withdrawal syndrome, they were given flutamide at 375 mg/day as second-line MAB. The effectiveness of that therapy was evaluated by changes in prostatic specific antigen (PSA) levels, with response defined as a decrease of greater than 50% from the start of therapy. We also compared several factors between responders and non-responders. Nine (69.2%) of the 13 patients showed a decrease in PSA levels, of whom five (38.5%) had a greater than 50% decrease and were defined as responders. The median duration of PSA response was 11.0 months (range 5-20 months). Patients who had a longer duration of response to first-line MAB had a significantly greater response to second-line MAB. For advanced prostate cancer patients who progressed on first-line MAB with bicalutamide, flutamide administration as a second-line antiandrogen was found to be relatively effective, especially for those who showed a longer duration of response to the first-line MAB. Our results confirm previous findings that MAB using flutamide is an effective second-line hormonal therapy.
Gan To Kagaku Ryoho. 2007 Apr;34(4):589-95.
Nishimura S, Arai Y, Usami M, Kanetake H, Naito S, Akaza H.
Kyoto University, Graduate School of Economics.
[Cost-effectiveness analysis of maximum androgen blockade for Japanese men with advanced prostate cancer][Article in Japanese]
Like other countries, Japan is facing the problem of rising medical costs associated with aging of the population, and therefore the cost-effectiveness of medicines has become increasingly important. Maximum androgen blockade (MAB) therapy, which is being widely used for advanced prostate cancer, has proved useful in clinical studies but it requires the additional use of an anti-androgen in contrast with luteinizing hormone releasing hormone agonist (LHRHa) monotherapy, raising a concern about the increase medical costs. Thus, based on the results of a Japanese Phase III study of bicalutamide we performed a cost-effectiveness analysis. We constructed a Markov model to express the changes in prognosis following MAB therapy and LHRHa monotherapy for advanced prostate cancer and the cost and effectiveness (survival) were simulated. As a result, the expected costs of MAB therapy and LHRHa monotherapy were 5,240,000 yen and 3,660,000 yen, respectively, with expected survival durations of 7.45 and 6.44 years. The incremental cost-effectiveness ratio for MAB therapy was 1,560,000 yen/life-year saved, lower than the established threshold (6,000,000 yen/life-year saved), and a sensitivity analysis confirmed the robustness of this result. Therefore, the incremental cost of bicalutamide was considered worth it in view of the therapeutic effect, suggesting that MAB therapy is a highly cost-effective therapy.
Ann Urol (Paris). 2006 Dec;40 Suppl 2:S49-52.
Haddad E.
Clinique Hartmann, 26, boulevard Victor-Hugo, 92200 Neuilly-sur-Seine, France.
[Management of gynecomastia induced by bicalutamide][Article in French]
Adjuvant bicalutamide monotherapy after radical prostatectomy improves the overall survival in patients with locally advanced prostate cancer. The main adverse event of the nonsteroidal antiandrogen is the development of gynecomastia against which prophylactic breast irradiation can be administered. Therapeutic local radiotherapy using a very small number of fractions is a well-tolerated management option. Symptom improvement is observed in about half of the patients. Radiotherapy-related adverse effects are often mild (erythema, skin irritation) and transient. Tamoxifen has been also shown to be effective in prevention and treatment of gynecomastia induced by adjuvant therapy by bicalutamide in two-third of patients. Long-term safety of this prophylactic and therapeutic approach needs to be investigated through appropriate trials. Further evaluation of the optimal dose and duration of treatment with tamoxifen in this setting is required.
Urologe A. 2006 Sep 20;
Altwein JE, Ebert T.
Urologische Abteilung, Krankenhaus Barmherzige Bruder, Akademisches Lehrkrankenhaus, Technische Universitat, Romanstrasse 93, 80639, Munchen, Deutschland.
[Local recurrence of prostate cancer: hormone therapy.][Article in German]
BACKGROUND: The majority of patients receive HT after biochemical progression despite primary therapy of prostate cancer with curative intent. It is difficult to differentiate at a low rise in PSA level, e.g.,
Prostate Cancer Prostatic Dis. 2005 Feb 01.
Saltzstein D, Sieber P, Morris T, Gallo J.
1Urology San Antonio Research PA, Pasteur Medical Plaza, San Antonio, Texas, USA.
Prevention and management of bicalutamide-induced gynecomastia and breast pain: randomized endocrinologic and clinical studies with tamoxifen and anastrozole.
A randomized, double-blind, placebo-controlled multicenter trial involving 107 men receiving bicalutamide ('Casodex') 150 mg/day therapy following radical therapy for prostate cancer assessed tamoxifen ('Nolvadex') 20 mg/day and anastrozole ('Arimidex') 1 mg/day for the prophylaxis and treatment of gynecomastia/breast pain. Tamoxifen, but not anastrozole, significantly reduced the incidence of gynecomastia/breast pain when used prophylactically and therapeutically. Serum testosterone levels increased with tamoxifen relative to placebo but prostate-specific antigen levels declined in all treatment groups. Further studies are needed to define the optimum tamoxifen dose and to assess any impact on cancer control. The use of tamoxifen in this setting remains to be investigated.Prostate Cancer and Prostatic Diseases advance online publication, 1 February 2005; doi:10.1038/sj.pcan.4500782.
Prostate Cancer Prostatic Dis. 2005 Feb 15.
Sugiono M, Winkler MH, Okeke AA, Benney M, Gillatt DA.
1Bristol Urological Institute, Southmead Hospital, UK.
Bicalutamide vs cyproterone acetate in preventing flare with LHRH analogue therapy for prostate cancer-a pilot study.
Objective: To evaluate the efficacy of bicalutamide vs cyproterone acetate in preventing PSA flare (as a surrogate for tumour flare) for patients requiring luteinizing hormone-releasing hormone (LHRH) analogue therapy for prostate cancer.Patients and Methods: In this pilot study, 40 men were randomized 1 : 1 to bicalutamide 50 mg o.d. or cyproterone acetate 100 mg t.i.d. 5 days prior to goserelin acetate and continued for 21 days thereafter. PSA, luteinizing hormone (LH), follicle-stimulating hormone (FSH) and testosterone were obtained before treatment and on days 6, 8, 10, 16, 21 and 28. Primary end point was PSA. Hormone profile and clinical features including urinary symptoms and bone pain were secondary end points.Results: Both groups were equally matched apart from serum creatinine and ALP. The speed and magnitude of the percentage change in median PSA from baseline was increased for the CPA group but there was no statistically significant difference in the two groups. Although those receiving bicalutamide all showed a testosterone peak, this remained within the normal range. No difference in the frequency of drug-specific adverse events was found. None of the patients died or developed cord compression during the study period.Conclusion: Bicalutamide is able to suppress the initial PSA surge as effectively as cyproterone acetate albeit slightly delayed. A statement whether bicalutamide is equally good at preventing clinical flare cannot be made and should be assessed in an appropriately powered study.Prostate Cancer and Prostatic Diseases advance online publication, 15 February 2005;
doi:10.1038/sj.pcan.4500784.
J Clin Oncol. 2005 Feb 1;23(4):808-15.
Boccardo F, Rubagotti A, Battaglia M, Di Tonno P, Selvaggi FP, Conti G, Comeri G, Bertaccini A, Martorana G, Galassi P, Zattoni F, Macchiarella A, Siragusa A, Muscas G, Durand F, Potenzoni D, Manganelli A, Ferraris V, Montefiore F.
University and National Cancer Research Institute, University of Genoa, Genoa, Italy.
Evaluation of tamoxifen and anastrozole in the prevention of gynecomastia and breast pain induced by bicalutamide monotherapy of prostate cancer.
PURPOSE: To determine whether tamoxifen or anastrozole prevents gynecomastia and breast pain caused by bicalutamide (150 mg) without compromising efficacy, safety, or sexual functioning. PATIENTS AND METHODS: A double-blind, placebo-controlled trial was performed in patients with localized, locally advanced, or biochemically recurrent prostate cancer. Patients (N = 114) were randomly assigned to either bicalutamide (150 mg/d) plus placebo or in combination with tamoxifen (20 mg/d) or anastrozole (1 mg/d) for 48 weeks. Gynecomastia, breast pain, prostate-specific antigen (PSA), sexual functioning, and serum levels of hormones were assessed. RESULTS: Gynecomastia developed in 73% of patients in the bicalutamide group, 10% of patients in the bicalutamide-tamoxifen group, and 51% of patients in the bicalutamide-anastrozole group (P < .001); breast pain developed in 39%, 6%, and 27% of patients, respectively (P = .006). Baseline PSA level decreased by > or = 50% in 97%, 97%, and 83% of patients in the bicalutamide, bicalutamide-tamoxifen, and bicalutamide-anastrozole groups, respectively (P = .07); and adverse events were reported in 37%, 35%, and 69% of patients, respectively (P = .004). There were no major differences among treatments in sexual functioning parameters from baseline to month 6. Elevated testosterone levels occurred in each group; however, free testosterone levels remained unchanged in the bicalutamide-tamoxifen group because of increased sex hormone-binding globulin levels. CONCLUSION: Anastrozole did not significantly reduce the incidence of bicalutamide-induced gynecomastia and breast pain. In contrast, tamoxifen was effective, without increasing adverse events, at least in the short-term follow-up. These data support the need for a larger study to determine any effect on mortality.
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Drug category:Anti-cancer drugs
 Casodex scientific update
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