title: Randomized comparison of goserelin acetate versus mitomycin C plus goserelin acetate in previously untreated prostate cancer patients with bone metastases.
abstract: In a prospective trial conducted by the Gruppo Onco Urologico Piemontese, newly diagnosed prostate cancer patients with bone metastases were randomized to receive goserelin (3.6 mg subcutaneously every 4 weeks) or goserelin plus mitomycin at 14 mg/m2 i.v. every 6 weeks. Treatment was planned to be continued until progression. The study was interrupted because of inadequate accrual rate when 63 patients had been recruited. A long-term follow-up (median, 47 months), performed to counterbalance the limited number of patients included, revealed no difference in time to progression and overall survival between the study treatments. However, 56.5% of assessable patients allocated to the chemotherapy arm presented a > or =90% reduction of prostate-specific antigen levels compared with 36.3% in the goserelin group, and previously elevated levels normalized in 73.9% versus 45.4%. Non-progressing patients received 5-7 cycles of mitomycin C with acceptable toxicity, but the cytotoxic treatment was interrupted early in all cases within the first year due to cumulative myelotoxicity. In conclusion, the results, although inconclusive, fail to support a clear advantage in terms of cost/benefit of chemotherapy plus hormone therapy over hormone treatment alone in advanced prostate cancer with bone involvement.
authors.affiliation: Dipartimento di Scienze Cliniche e Biologiche, Università di Torino, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Fontana
authors.forename: O
authors.initials: O
authors.lastname: Bertetto
authors.forename: G
authors.initials: G
authors.lastname: Fasolis
authors.forename: A
authors.initials: A
authors.lastname: Berruti
authors.forename: R
authors.initials: R
authors.lastname: Tarabuzzi
authors.forename: G
authors.initials: G
authors.lastname: Pagani
authors.forename: T
authors.initials: T
authors.lastname: Buniva
authors.forename: R
authors.initials: R
authors.lastname: Zolfanelli
authors.forename: S
authors.initials: S
authors.lastname: Pallotti
authors.forename: L
authors.initials: L
authors.lastname: Frezzotti
authors.forename: C
authors.initials: C
authors.lastname: Bumma
authors.forename: S R
authors.initials: SR
authors.lastname: Rossetti
authors.forename: L
authors.initials: L
authors.lastname: Dogliotti
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000556:secondary; D018450:Disease Progression; D018572:Disease-Free Survival; D017273:Goserelin / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000627:therapeutic use*; D009376:Neoplasms, Hormone-Dependent / Q000097:blood / Q000188:drug therapy*; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D018931:Antineoplastic Agents, Hormonal; D017273:Goserelin; D016685:Mitomycin; D017430:Prostate-Specific Antigen