Randomised Study of Casodex 50 Mg Monotherapy vs Orchidectomy in the Treatment of Metastatic Prostate Cancer

Iversen, Peter; Tveter, Kjell J.; Varenhorst, Eberhard

doi:10.3109/00365599609180896

Cited by 44 publications

(43 citation statements)

References 16 publications

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“…26,27,35,36,39,44,46 This measure, specifically validated on advanced metastatic prostate patients, consists of 30 questions addressing 10 relevant do- 31 the Functional Living Index-Cancer, 45 the Southwest Oncology Group questionnaire (SWOG), 29 and the Functional Assessment of Cancer Therapy. 32 Nevertheless, some trials reported limited information about the nature of the HRQOL measure used while others created ad hoc measures without giving any information about the developmental process.…”

Section: Hrqol Assessment Methodologymentioning

confidence: 99%

“…There was partial consensus on the benefits of bicalutamide on some HRQOL domains, though most of these studies gave either limited details on compliance at baseline or did not report compliance data, thus hampering a robust conclusion regarding the impact of bicalutamide on HRQOL. 26,35,36,44,46 Iversen et al 36 reported that sexual interest was greater in patients treated with bicalutamide at one month; pain and bed disability outcomes improved more in the orchidectomy group at one and three months. Emotional well being and social functioning improved more in patients randomized to orchidectomy at three and six months after entry, respectively.…”

Section: Clinical Impact Of Medical Treatment Modalities On Patient Hmentioning

confidence: 99%

“…Publications cited in Table 1 Related publications dealing with the same trial Porter et al 25 Porter and McEwan 60 Kaisary et al 35 Cleary et al 51 Bales and Chodak et al 61 Tyrrell et al 62 Chodak et al 26 Bales and Chodak 61 Tyrrell et al 62 Schellhammer et al 27 Schellhammer et al 63 Soloway et al 57 Schellhammer et al 64 Iversen et al 36 Cleary et al 51 Bales and Chodak et al 61 Tyrrell et al 62 da Silva et al 37 Denis et al 58 Rosendahl et al 65 Tannock et al 28 Bloomfield et al 66 Osoba et al 52 Pummer et al 38 Pummer 56 Tyrrell et al 44 Tyrrell 62 Moinpour et al 29 Eisenberger et al 59 Iversen et al 46 Tyrrell et al 62 Duncan et al 31 Pickles et al 67 Fossa et al 40 de Reijke et al 68 clinical significance of the results and give a comprehensive picture of the impact of the medical treatment on patient HRQOL. Other reports appeared to be redundant and/or did not cross reference with other publications.…”

Section: Table 5 Related Publicationsmentioning

confidence: 99%

“…[47][48][49] Bicalutamide, the therapy against which most treatment comparisons were made, was used in seven trials. 26,27,35,36,39,44,46 Radiotherapy was limited to four RCTs. 25,31,42,47 The majority of the trials involved metastatic prostate carcinoma patients aged 65-75 years.…”

Section: Demographics and Trial Designsmentioning

confidence: 99%

“…Ten RCTs were carried out in North America, [25][26][27][28][29][30][31][32][33][34] nine were carried out in Europe, [35][36][37][38][39][40][41][42][43] three enrolled patients from different continents, 44 -46 and three were carried out in Japan. [47][48][49] Bicalutamide, the therapy against which most treatment comparisons were made, was used in seven trials.…”

Section: Demographics and Trial Designsmentioning

confidence: 99%

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Health related quality of life in prostate carcinoma patients

Efficace

Bottomley

Andel

2003

Cancer

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Extensive lattice‐Boltzmann simulations were performed to obtain the drag force for random arrays of monodisperse and bidisperse spheres. For the monodisperse systems, 35 different combinations of the Reynolds number Re (up to Re = 1,000) and packing fraction ϕ were studied, whereas for the bidisperse systems we also varied the diameter ratio (from 1:1.5 to 1:4) and composition, which brings the total number of different systems that we considered to 150. For monodisperse systems, the data was found to be markedly different from the Ergun equation and consistent with a correlation, based on similar type of simulations up to Re = 120. For bidisperse systems, it was found that the correction of the monodisperse drag force for bidispersity, which was derived for the limit Re = 0, also applies for higher‐Reynolds numbers. On the basis of the data, a new drag law is suggested for general polydisperse systems, which is on average within 10% of the simulation data for Reynolds numbers up to 1,000, and diameter ratios up to 1:4. © 2007 American Institute of Chemical Engineers AIChE J, 2007.

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Section: Hrqol Assessment Methodologymentioning

confidence: 99%

Section: Clinical Impact Of Medical Treatment Modalities On Patient Hmentioning

confidence: 99%

Section: Table 5 Related Publicationsmentioning

confidence: 99%

Section: Demographics and Trial Designsmentioning

confidence: 99%

Section: Demographics and Trial Designsmentioning

confidence: 99%

See 3 more Smart Citations

Health related quality of life in prostate carcinoma patients

Efficace

Bottomley

Andel

2003

Cancer

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Bicalutamide (Casodex®) in the treatment of prostate cancer: History of clinical development

1998

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BACKGROUND Bicalutamide (Casodex®) is a new nonsteroidal antiandrogen developed for use in patients with prostate cancer. The efficacy and tolerability of bicalutamide as monotherapy and as combination therapy for patients with advanced prostate cancer have been evaluated in randomized clinical trials. Clinical trials are currently in progress to further evaluate bicalutamide as monotherapy in patients with advanced stages of disease and as adjuvant or first‐line therapy in patients with early‐stage disease. METHODS A review of published trials of bicalutamide focusing on dose‐ranging investigations, phase II and phase III monotherapy trials, a phase III trial of combined androgen blockade, and a safety overview. RESULTS In dose‐ranging trials, bicalutamide doses of 10‐200 elicited biochemical, objective, and subjective responses; higher bicalutamide doses (up to 600 mg) have also been evaluated. A 50‐mg daily dose of bicalutamide was initially evaluated as monotherapy in phase II and phase III trials; in subsequent trials, a 150‐mg daily dose was investigated. A 150‐mg daily dose is considered to provide equivalent survival outcome compared with castration in patients with locally advanced prostate cancer, whereas the benefits of a better quality of life and better palliation with the 150‐mg daily bicalutamide dose relative to castration in patients with metastatic disease needs to be balanced against the small shortfall (median difference, 42 days) in survival. In combination with a luteinizing hormone‐releasing hormone agonist analogue (LHRH‐A), a 50‐mg daily dose of bicalutamide has equivalent efficacy to a corresponding flutamide (250 mg three times daily) combination regimen. Treatment with the bicalutamide combination regimen resulted in a longer median survival than with the flutamide combination regimen. Bicalutamide is well tolerated when used as monotherapy or in combination with a LHRH‐A. The benefits of bicalutamide as monotherapy include retention of libido and sexual potency and as combination therapy a lower incidence of diarrhea relative to flutamide. CONCLUSIONS A 50‐mg daily dose of bicalutamide is sufficient when given in combination with an agent, such as a LHRH‐A, that lowers serum testosterone, but higher doses of bicalutamide may be needed when the drug is given as monotherapy. Bicalutamide, 50‐mg daily, is a logical first choice for antiandrogen therapy when used in combination with an LHRH‐A for the treatment of patients with advanced prostate cancer. Bicalutamide 150‐mg daily is considered an effective monotherapy for use in patients with locally advanced disease. Additional clinical trials are currently in progress to further evaluate bicalutamide as a monotherapy for advanced prostate cancer and to assess its value as adjuvant or first‐line therapy for early‐stage prostate cancer. Prostate 34:61–72, 1998. © 1998 Wiley‐Liss, Inc.

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Bicalutamide dosages used in the treatment of prostate cancer

Kolvenbag

Nash

1999

Prostate

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BACKGROUND Androgen deprivation is often used for the treatment of patients with prostate cancer. Androgen deprivation can be achieved by surgical castration or medical castration, with or without using an antiandrogen. Each of these treatments may be used alone, or an antiandrogen may be used alongside castration to produce combined androgen blockade therapy. METHODS The nonsteroidal antiandrogen, bicalutamide (Casodex®), has been evaluated as a component in combined androgen blockade and as monotherapy. We review the arguments that indicate why a 50‐mg once‐daily dose of bicalutamide is appropriate in combined androgen blockade, while ongoing clinical trials evaluate 150‐mg once‐daily as monotherapy in the treatment of prostate cancer. RESULTS The choice of the 50‐mg dose of bicalutamide when used in combined androgen blockade is supported by four main arguments. First, bicalutamide 50 mg is at least equivalent to, if not better than, flutamide 750 mg in terms of receptor affinity, potency, and favorable plasma concentration profile. Second, the reduction in testosterone concentrations produced by medical or surgical castration decreases the potential competition between bicalutamide and testosterone for androgen receptors in prostate cells, allowing the use of a lower dose of antiandrogen in combined androgen blockade than is necessary in monotherapy. Third, bicalutamide 50 mg has an excellent tolerability profile. Fourth, at the 50‐mg dose, bicalutamide plus luteinizing hormone‐releasing hormone analogue was equivalent to flutamide plus luteinizing hormone‐releasing hormone analogue, although there was a trend towards longer survival with bicalutamide. Furthermore, investigations of higher doses of bicalutamide have justified evaluation of bicalutamide 150 mg as monotherapy. First, pharmacodynamic studies reveal an increasing prostate‐specific antigen response with increasing dose, which appears to plateau at a dose of around 150–200 mg. Second, in an analysis with 31% mortality, bicalutamide 150 mg appeared to have equivalent efficacy compared with castration in terms of survival in patients with nonmetastatic prostate cancer. CONCLUSIONS On the basis of available data, bicalutamide 50 mg is an appropriate dose to use in combined androgen blockade, while 150 mg is being evaluated in ongoing clinical trials as a suitable dose for monotherapy. Prostate 39:47–53, 1999. © 1999 Wiley‐Liss, Inc.

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Randomised Study of Casodex 50 Mg Monotherapy vs Orchidectomy in the Treatment of Metastatic Prostate Cancer

Cited by 44 publications

References 16 publications

Health related quality of life in prostate carcinoma patients

Health related quality of life in prostate carcinoma patients

Bicalutamide (Casodex®) in the treatment of prostate cancer: History of clinical development

Bicalutamide dosages used in the treatment of prostate cancer

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