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GENITOURINARY : PROSTATE CANCER
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Regimen/Number Of Patients |
Drug Dose and Route |
Leukopenia/ Neutropenia Toxicity |
Anemia Toxicity |
Other Grade III-IV Toxicities |
Emetogenic Potential |
Consequences of Adverse Event(s) |
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Docetaxel-Estramustine (Sinibaldi VJ, et al. Cancer. 2002;94:1457-65)
N = 40
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Estramustine 280 mg PO every 6 hours for 5 doses; first dose 12 hours befor: Docetaxel 70 mg/m2 IV over 1 hour on day 1 Repeat cycle every 21 days Appropriate premedications listed in Section 2, Commonly Used Premedication Regimens |
Neutropenia Grade III 30% Grade IV 45%
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Grade III 2.5%
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Febrile Neutropenia (Grade IV) 5% fatigue (Grade III) 70% Diarrhea (Grade III) 7.5% Hyperglycemia (Grade III) 10% Local Skin Reaction (Grade III) 7.5% Nail Changes (Grade III) 7.5% CHF (Grade IV) 2.5% |
level 2 |
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Docetaxel Estramustine Low-Dose Hydrocortisone (Savarese DM, et al. J Clin Oncol. 2001;19:2509-16)
N = 46 |
Estramustine 10 mg/kg/d PO (3 divided doses) days 1-5 on an empty stomach Docetaxel 70 mg/m2 IVover 1 hour day 2 Hydrocortisone 30 mg PO every morning and mg every evening continuously Repeat estramustine/docetaxel cycles Every 21 day
Notes: Standard premedications administered. Study did not routinely administer antithrombotic prophylaxis. |
Leukopenia Grade III 57% Grade IV 4% Neutropenia Grade III 26% Grade IV 30% |
Grade III 13% |
Infection (site unknown) 24% Thrombocytopenia 20% Hyperglycemia 18% Hypocalcemia (Grade III) 2% Phlebitis/Thrombosis 6% Edema 22% Malaise/Fatigue/Asthenia 24% Stomatitis/Esophagitis (Grade III) 6% Nausea (Grade III) 4% Vomiting (Grade IV) 2% Diarrhea 6% Anorexia 4% Hepatic 22% Dyspnea 22% Dysrhythmias(Grade III) 2% Ischemia (Grade III) 7% BUN/SCr (Grade III) 9% Renal Failure (Grade IV) 2% Neurologic (Grade III) 8% |
Days 1-5― level 2 |
No episodes efebrile neutropenia Docetaxel dose reduction required in 6 patients: 2 = Transaminase elevation 1 = Thrombocytopenia 1 = Diarrhea 1 = Dysphagia/ mucositis 1 = Lethargy paresthesias Duration of neutropenia short (< 1 week) Docetaxel discontinued in 2 patients: 1 = Acute hypertension during infusion 24% of patients withdrew from study due to low-grade toxicities (fatigue/asthenia) |
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GENITOURINARY : PROSTATE CANCER (continued ) : Page 2
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|
Regimen/Number Of Patients |
Drug Dose and Route |
Leukopenia/ Neutropenia Toxicity |
Anemia Toxicity |
Other Grade III-IV Toxicities |
Emetogenic Potential |
Consequences of Adverse Event(s) |
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Estramustine Vinblastine (Hudes G, et al. J Clin Oncol. 1999;17:3160-66)
N = 95
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Estramustine 200 mg/m2 PO tid days 1-42 Vinblastine 4 mg/m2 IV weekly for 6 weeks, begin day 1 Repeat cycle every 8 weeks |
Grade III 7% Grade IV 1% |
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Neutropenic Infection 7% Thrombocytopenia* 1% Nausea* 28% Leg Edema* 12% Fatigue* 16% Neurologic* 12% Constipation* 3% Cardiac* 5%
*Grade II-IV toxicity |
Day 1-42― level 2 |
Dose reduced in 30% of patients |
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Mitoxantrone Prednisone (Tannock IF, et al. J Clin Oncol. 1996;14:1756-64)
N = 80 |
Mitoxantrone 12 mg/m2 IV day 1 Prednisone 5 mg PO bid continuously Repeat cycle every 2 1 days |
Neutropenia Grade III 32% Grade IV 13% |
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Neutropenic Sepsis 1% Thrombocytopenia 5% Nausea/Vomiting <1% |
Day 1― level 3 |
Dose reduced in 25% of patients, and increased in 45% of patients 5 patients developed cardiac abnormalities, 2 symptomatic with CHF |