Hydrocortisone With or Without Mitoxantrone in Men With Hormone-Refractory Prostate Cancer: Results of the Cancer and Leukemia Group B 9182 Study

Abstract

M+H generated more frequent responses and a delay in both time to treatment failure and disease progression compared with hydrocortisone alone. In addition, there was a possible benefit of M+H with respect to pain control over hydrocortisone alone. No improvement in survival was observed. Although M+H could be viewed as a palliative option for patients with HRPC, new drugs and novel strategies are needed to improve survival for this disease.

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

“…In the recent preliminary analysis of a randomised trial comparing dexamethasone alone to dexamethasone and diethylstilbestrol (Shamash et al, 2004), 51% had a PSA response to dexamethasone. This is higher than the PSA response to hydrocortisone -21% (Dawson et al, 1995;Kantoff et al, 1999), or prednisone -17% (Dowling et al, 2001;Berry et al, 2002). One explanation for this may be that receptors other than the androgen receptor may be more important than previously appreciated in determining prostate cancer responses.…”

A systematic review of the effectiveness of docetaxel and mitoxantrone for the treatment of metastatic hormone-refractory prostate cancer

“…Of the seven RCTs included, three used docetaxel compared with mitoxantrone plus prednisone (Petrylak et al, 2004;Tannock et al, 2004;Oudard et al, 2005), three used mitoxantrone plus a corticosteroid compared with a corticosteroid (used as active supportive care) (Tannock et al, 1996;Kantoff et al, 1999;Berry et al, 2002) and one used mitoxantrone plus prednisone compared with mitoxantrone plus prednisone plus clodronate (Ernst et al, 2003). There were no trials comparing docetaxel plus prednisolone/prednisone or mitoxantrone plus a corticosteroid with other Figure 1 Process of study selection.…”

“…Other outcomes could not be pooled because they were measured differently in the three RCTs. However, in the two studies that measured health-related quality of life and pain response, the mitoxantrone groups had statistically significant improvements compared with the corticosteroid groups for several of the quality of life and pain items assessed (Tannock et al, 1996;Kantoff et al, 1999). High losses to follow-up for these outcomes dictate that these results should be interpreted cautiously.…”

“…Two of these compared mitoxantrone plus prednisone with prednisone (5 mg twice daily) (Tannock et al, 1996;Berry et al, 2002), whereas one compared mitoxantrone plus hydrocortisone with hydrocortisone (40 mg given in two divided doses daily) (Kantoff et al, 1999). One of the RCTs included 120 men with asymptomatic mHRPC (Berry et al, 2002); another included 161 men with symptomatic mHRPC, with symptoms including pain and disease progression (Tannock et al, 1996); while the third study included all men with progressive mHRPC (n ¼ 242) (Kantoff et al, 1999). One RCT allowed patients to crossover during the trial, this resulted in 50 out of 81 patients randomised to prednisone to receive additional mitoxantrone (Tannock et al, 1996); the other two RCTs did not allow crossovers.…”

Mitoxantrone, vinorelbine and prednisone (MVD) in the treatment of metastatic hormonoresistant prostate cancer — a phase II trial

“…9,10 Recently, advances have been made in understanding the biology of hormone-refractory prostate carcinoma, which is elucidating potential targets for new drugs. 11 Vinorelbine is a new semisynthetic vinca-alkaloid derivative with antimicrotubular activity that has shown to be highly effective in small-cell lung cancer compared with vinblastine and vindesine 12,13 and in hormonedependent tumours such as breast cancer.…”