A multicenter phase III comparison of docetaxel (D) + prednisone (P) and mitoxantrone (MTZ) + P in patients with hormone-refractory prostate cancer (HRPC)

Eisenberger, Mario A.; Wit, Ronald de; Berry, W.; Bodrogi, I.; Płużańska, A; N., Kim; Оудард, С.; Christine, Tamara; James, Nicholas D.; Tannock, I.

doi:10.1200/jco.2004.22.14_suppl.4

Cited by 28 publications

(17 citation statements)

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“…In addition to the main publication of the trial, 27 there were two abstracts, 35,36 an approval package 37 and an approval summary 34 The median number of cycles received by the 3-weekly docetaxel group was 9.5 (range 1-11), the median number received by the group receiving weekly docetaxel (6-week cycle) was 4 (range 1-6) and the median for the mitoxantrone group was 5 (range 1-11). The planned treatment was delivered to 98% patients in the 3-weekly docetaxel group, 96% in the weekly docetaxel group and 99% in the mitoxantrone group.…”

Section: Docetaxel Plus Prednisone Versus Mitoxantrone Plus Prednisonementioning

confidence: 99%

A systematic review and economic model of the clinical effectiveness and cost-effectiveness of docetaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer

Collins¹,

Fenwick²,

Trowman³

et al. 2007

Health Technol Assess

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Section: Docetaxel Plus Prednisone Versus Mitoxantrone Plus Prednisonementioning

confidence: 99%

A systematic review and economic model of the clinical effectiveness and cost-effectiveness of docetaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer

Collins¹,

Fenwick²,

Trowman³

et al. 2007

Health Technol Assess

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“…Recently, a survival benefit for treatment with docetaxel-containing chemotherapy was demonstrated in two large phase III clinical trials (Eisenberger et al, 2004;Petrylak et al, 2004). Patients were treated for a fixed number of cycles and their total treatment lasted 30 and 36 weeks in these two studies.…”

mentioning

confidence: 99%

Multiple cycles of intermittent chemotherapy in metastatic androgen-independent prostate cancer

et al. 2004

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Recently, completed phase III studies demonstrated a survival benefit for a fixed number of cycles of docetaxel-containing chemotherapy treatment of androgen-independent prostate cancer (AIPC). Management of patients who respond well to initial chemotherapy for AIPC remains ill-defined. We previously reported that in a select group of such patients, retreatment with the same regimen was feasible and was associated with quality of life gains. Here, we report that multiple cycles of such intermittent chemotherapy are feasible. We prospectively tested intermittent chemotherapy in eight AIPC patients responding to calcitriol plus docetaxel who reached a serum prostate-specific antigen (PSA) o4 ng ml À1 (22% of the 37 patients who were initially treated with this regimen). Chemotherapy was suspended until a rise in PSA X50% and 1 ng ml À1 . The median duration of the first treatment holiday was 20 weeks (13 -74 weeks) and all patients retained sensitivity to retreatment. Four patients were eligible for a second chemotherapy holiday, and the median duration was 21 weeks (17 -28 weeks). Two patients elected to take a third chemotherapy holiday, which lasted 10 and 28 weeks. The median time to treatment failure was 26.5 months (95% CI 23.6 -29.4 months), and the median survival is 41 months (95% CI 33.7 -48.3 months). Multiple cycles of intermittent chemotherapy interrupted by clinically meaningful treatment holidays are feasible in a subset of AIPC patients treated with this docetaxel-containing regimen. Intermittent chemotherapy for AIPC is feasible and deserves further study.

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“…With the use of PSA velocity as a surrogate marker being increasingly accepted, such findings may assume greater significance (Carter et al, 2003;D'Amico et al, 2003;Rini et al, 2003). The lower response rate in this study particularly in comparison to newer data from taxanes based studies (Eisenberger et al, 2004;Petrylak et al, 2004) may in part be explained by the fact that the patients in this study were resistant to corticosteroids and oestrogens as well as to androgen deprivation.…”

Section: Discussionmentioning

confidence: 58%

“…More recently, the presentation of two large randomised phase III trials comparing mitoxantrone and docetaxel showed a significant survival advantage in favour of docetaxel (Eisenberger et al, 2004;Petrylak et al, 2004).…”

mentioning

confidence: 99%

Chlorambucil and lomustine (CL56) in absolute hormone refractory prostate cancer: re-induction of endocrine sensitivity an unexpected finding

et al. 2004

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The management of androgen independent prostate cancer is increasingly disputed. Diethylstilbestrol and steroids have useful second-line activity in its management. The value of chemotherapy still remains contentious. This paper reports a phase 2 study of two orally active chemotherapy drugs in patients who are absolutely hormone refractory having failed primary androgen blockade and combined oestrogens and corticosteroids. In total, 37 patients who were biochemically castrate with absolute hormone refractory prostate cancer and performance status of 0 -3 were enrolled. Therapy consisted of chlorambucil 1 mg kg À1 given as 6 mg a day until the total dose was reached and lomustine 2 mg kg À1 given every 56 days (CL56). During this time all hormone therapy was stopped. One patient normalised his PSA with a further two having a greater than 50% decline leading to an objective response rate of 10%. The median time to progression was 3.6 months with an overall survival of 7.1 months. The median survival of this group of patients from first becoming androgen independent was 23.5 months. Eight of 17 (47%) patients who were subsequently rechallenged with hormonal therapy following failure of chemotherapy had a further PSA reduction, three (17%) of which were 450%. The median progression-free interval for the eight patients was 4 months. In conclusion, CL56 has a low objective response rate in the management of absolute hormone refractory prostate cancer. Toxicity was mild. Re-induction of hormone sensitivity following failure of chemotherapy was an unexpected finding that requires further study.

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A multicenter phase III comparison of docetaxel (D) + prednisone (P) and mitoxantrone (MTZ) + P in patients with hormone-refractory prostate cancer (HRPC)

Cited by 28 publications

References 0 publications

A systematic review and economic model of the clinical effectiveness and cost-effectiveness of docetaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer

A systematic review and economic model of the clinical effectiveness and cost-effectiveness of docetaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer

Multiple cycles of intermittent chemotherapy in metastatic androgen-independent prostate cancer

Chlorambucil and lomustine (CL56) in absolute hormone refractory prostate cancer: re-induction of endocrine sensitivity an unexpected finding

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