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Phase III trial of cyclophosphamide versus cyclophosphamide, doxorubicin, and methotrexate in hormone-refractory prostatic cancer. A Hoosier Oncology Group study
Phase III trial of cyclophosphamide versus cyclophosphamide, doxorubicin, and methotrexate in hormone-refractory prostatic cancer. A Hoosier Oncology Group study
- Source :
- Cancer. 70(10)
- Publication Year :
- 1992
-
Abstract
- BACKGROUND Between August 1984 and November 1989, the Hoosier Oncology Group conducted a Phase III study comparing cyclophosphamide (CTX) with cyclophosphamide, doxorubicin, and methotrexate (CAM) in patients with hormone-refractory metastatic prostatic cancer to determine whether the addition of doxorubicin and methotrexate to the cyclophosphamide regimen conferred any survival advantage. METHODS One hundred three patients were registered and randomized, 99 were evaluable for response, and all were evaluable for survival results. All had histologically confirmed metastatic prostatic cancer and had not responded to hormonal therapy. Fifty-three patients received CTX alone, and 50 received CAM. Seventy-one patients (69%) had evaluable disease, and 32 (31%) had measurable disease. RESULTS There were no complete responses and only four (13%) partial responses in the patients with measurable disease. There was no difference in overall survival time between the two treatment arms in either patients with a Karnofsky performance status (KPS) of 80-100 (median survival, 9.0 versus 9.5 months; P = 0.93) or in those with a KPS of 50-70 (median survival, 5.0 versus 6.0 months; P = 0.51). There was no difference in overall time to progression between the two treatment arms (median time to progression; 4.4 versus 6.2 months; P = 0.07). Toxicity was tolerable in both regimens. CONCLUSIONS It was concluded that there was no survival advantage to CAM over CTX alone. New chemotherapeutic agents with greater activity against prostatic cancer must be identified.
- Subjects :
- Oncology
Male
Cancer Research
medicine.medical_specialty
Neoplasms, Hormone-Dependent
Cyclophosphamide
medicine.medical_treatment
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Carcinoma
medicine
Humans
Aged
Chemotherapy
business.industry
Remission Induction
Cancer
Prostatic Neoplasms
Evaluable Disease
Middle Aged
medicine.disease
Survival Analysis
Regimen
Methotrexate
Doxorubicin
Hormonal therapy
business
medicine.drug
Subjects
Details
- ISSN :
- 0008543X
- Volume :
- 70
- Issue :
- 10
- Database :
- OpenAIRE
- Journal :
- Cancer
- Accession number :
- edsair.doi.dedup.....3e3b5635cc16ad43dc8a371669456dfe