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GENITOURINARY : TESTICULAR 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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BEP (Nichols CR, et al, J Clin Oncol . 1998;16;1287-93)
N= 141
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Bleomycin 30 units IV days 2, 9, 16 Etoposide 100 mg/m2/d IV days 1-5 Cisplatin 20 mg/m2/d IV days 1-5 Repeat cycle every 21 days X 4 cycles Appropriate premedications listed in Section2, Commonly Used Premedication Regimens |
Hematologic Grade III 39% Grade IV 34%
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Neutropenic Infection * 5% Nausea /Vomiting* 7% Neurologic * 7% Respiratory* 5 % Hepatic * 3% Respiratory Failure* 1 %
* Grade III-V toxicity |
Days 1-5- Level 5 Days 9,16- Level 2 |
Overall treatment-related mortality 4% Septic mortality 2% Pulmonary toxicity leading to discontinuation of bleomycin 3.5% G-CSF added to protocol in 1991; G-CSF 5 mcg/kg Days 7, 9-14, and 16-17 |
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Carboplatin Etoposide (Bhatia S, et al, J Clin Oncol. 2000;18:3346-51)
N=65
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Carboplatin 700 mg/m2 IV over 30 minutes days -6, -5, -4 Etoposide 750 mg/m2 IV (undiluted 20mg/ml0 over 2 hours days -6, -5, -4 Stem cell support day 0 G-CSF 5 mcg/kg/d starting day 0 until hematologic recovery (AGC ≥ 2000/mm2 x 2 days) |
Median day to ANC > 500 (PBSC) (bone Marrow)
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Neutropenic Fever 51 % Diarrhea 29 % Serum Creatinine 2 mg/dL. 9% Median Platelet Count 20,000/mm2 days (PBSC) days (bone marrow) Mucositis 29% |
Days -6, -5, -4 level 5
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1 patient required hemodialysis No treatment-related mortality |
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EP (Motzer RJ, et al, J Clin Oncol. 1995;13:2700-04)
N= 50 |
Etoposide 100 mg/m2/d IV days 1-5 Cisplatin 20 mg/m2/d IV days 1-5 Repeat cycle every 21 days |
Neutropenia (grade unknown) at day 21 24% |
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Neutropenic Sepsis 10 % Nausea/Vomiting * 44 % Thromboembolism 2 %
Grade I – II toxicity |
Day 1-5- Level 5 |
One week dose delay prior to Second cycle 24% 10% of patients hospitalized with febrile neutropenia |
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Paclitaxel Gemcitabine Hinton S, et al, J Clin Oncol. 2002;20:1859-63)
N= 28
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Paclitaxel 110 mg/m2 IV over 1 hour Days 1, 8, 15 followed by Gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, 15 Repeat cycle every 28 days Appropriate premedications listed in Section 2, Commonly Used Premedication Regimens
Note: Study included one patient with ovarian germ cell cancer. |
Leukopenia Grade III 59% Grade IV 7% Neutropenia Grade III 30% Grade IV 26%
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Grade III 11 % |
Febrile Neutropenia (Grade III) 4 % Fever (Grade III) 4% Inner Ear/ Hearing (Grade III) 4% Fatigue (Grade III) 7% Nausea (Grade III) 4%? Vomiting (Grade III) 4% Diarrhea (Grade III) 4% Pruritis (Grade III) 4% Thrombocytopenia (Grade III) 33% Dyspnea (Grade III) 7% Ventricular Arrhythmia (Grade III) 4% Rash/ Desquamation (Grade III) 4% Neuropathy- Sensory (Grade III) 4% |
Days 1, 8, 15 - level 3 |
Filgrastim was permitted For patients with an ANC < 500 for more than 5 days, neutropenic fever, or documented infections while neutropenic No patient stopped Therapy because of toxicity
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GENITOURINARY : TESTICULAR 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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VinBlastine Ifosfamide Cisplatin (Miller KD, et al. J Clin Oncol . 1997;15:1427-31)
N= 24
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Vinblastine 0.11 mg/kg IV days 1, 2 Ifosfamide 1200 mg/m2/d IV days 1-5 (with mesna uroprotection) Cisplatin 20 mg/m2/d IV days 1-5 Repeat cycle every 21 days
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Days 1- 5- Level 5 |
Toxicity data reported on 17 patients : 89 % neutropenic fever requiring antibiotics 59% required RBC transfusion 35% required platelet transfusion 1 therapy- related death due to CNS toxicity |
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VIP (Nichols CR, et al, J Clin Oncol, 1998;16:1287-93)
N= 145
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Etoposide 75 mg/m2/d IV days 1-5 Ifosfamide 1200 mg/m2/d IV days 1-5 Cisplatin 20 mg/m2/d IV days 1-5 Mesna 120 mg/m2 IV 15 minutes prior to Ifosfamide, then 1200 mg/m2/d IV continuous infusion days 1-5 Repeat cycle every 21 days
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Hematologic Grade III 28% Grade IV 60% Grade V 1 %
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Neutropenic infection * 6% Nausea/Vomiting * 9 % Neurological * 8% Respiratory * 4% Hepatic * 3% Renal * 5% Cerebral Hemorrhage * < 1%
* Grade III-V toxicity |
Days 1-5 – Level 5 |
Overall treatment-related mortality 3% G-CSF addea to protocol In 1991; G-CSF dose of 2.5 mcg/kg days 7-16
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