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GYNECOLOGY: OVARIAN 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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Carbo – Tax (Neijt JP, et al, Semin Oncol, 1997; 24: S15:36-39
N= 71
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Paclitaxel 175 mg/m2 IV over 3 hrs, day 1, followed by Carboplatin dose targeted by the Calvert equation to AUC of 5, IV day 1 Repeat cycle every 21 days Appropriate premedications listed in Section 2, Commonly Used Premedicaiton Regimens |
Neutropenia Grade III 31 % Grade IV 45%
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Nausea / Vomiting (Grade III) 16% Neurotoxicity (Grade III) 1% Thrombocytopenia 4%
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Day 1 – level 5 |
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Cisplatin (Muggia FM, et al, J Clin Oncol , 2000;18:106-115)
N= 200 |
Cisplatin 100 mg/m2 IV day 1 Repeat cycle every 21 days |
Neutropenia Grade III 36% Grade IV 12% |
Grade III 11% Grade IV < 1% |
Fever < 1% Thrombocytopenia 4% Gastrointestinal 33 % Renal 4% Neurologic 11 % Cardiovascular 2% |
Day 1 – Level 5 |
Treatment was discontinued due to toxicity in 12% of patients |
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Cisplatin + Paclitaxel (Markman M, et al, J Clin Oncol. 2001;19:1001-07
N= 227 |
Paclitaxel 135 mg/m2 IV continuous infusion over 24 hours day 1, followed by Cisplatin 75 mg/m2 IV day 2 Repeat cycle every 21 days Appropriate premedications listed in Section 2, Commonly Used Premedicaiton Regimens |
Neutropenia Grade III 49% Grade IV 13% |
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Infection 2% Fever 2% Thrombocytopenia 3% Other Hematologic 88 % Gastrointestinal 17 % Cardiovascular 3% Neurologic 9 % Metabolic 2% Creatinine Clearance 2% Allergic Reaction 2% Fatigue (Grade III) 1% |
Day 1 – Level 2 Day 2 – Level 5 |
2 treatment-related mortalities |
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Docetaxel (Verschraegen CF, et al J Clin Oncol, 2000;18:2733-39 ) N=32
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Docetaxel 100 mg/m2 IV over 1 hour day 1 Repeat cycle every 21 days Appropriate premedications listed in Section 2, Commonly Used Premedicaiton Regimens |
Granulocytopenia Grade III 6% Grade IV 72%
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Grade III 32% |
Febrile Neutropenia 33% Thrombocytopenia (Grade III) 6% |
Day 1- Level 2 |
No septic deaths Growth factors required For 72% of patients after first cycle
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Docetaxel Carboplatin (Vasey PA, et al. Br J Cancer. 2001;84:170-78)
N= 139 922 patients in Recommended dosage) |
Docetaxel 75 mg/m2 IV over 1 hour day 1, Followed by Carboplatin AUC of 5 (via CrDETA)or AUC of 6 ( if CrCl calculated using Cockroft and Gault formula) IV day 1 Repeat cycle every 21 days Appropriate premedicatios listed in Section 2, Commonly Used Premedication Regimens |
Neutropenia Grade III 9 % Grade IV 77 % Leukopenia Grade III 59 % Grade IV 5%
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Grade III-IV 14% |
Febrile Neutropenia (Grade IV) 3% Neutropenia > 7 days (Grade IV) 14% Thrombocytopenia 14% Nausea (Grade III) 5% Vomiting (Grade III) 5% Fatigue (Grade III) 5%
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Day 1 – Level 5 |
Dose reductions secondary to febrile neutropenia 6% |
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GYNECOLOGY : OVARIAN 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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Liposomal Doxorubicin (Gordon AN, et al. J Clin Oncol, 2001;19:3312-22)
N= 239
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Pegylated liposomal Doxorubicin 50 mg/m2 IV over 1 hour day 1 Repeat cycle every 28 days
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Neutropenia 12% Leukopenia 10% |
Grade III-IV 5% |
Thrombocytopenia Alopecia 1% Palmar- Plantar Erythrodysesthesia (PPE) 23% Stomatitis 8% |
Day 1 – Level 3 |
57% of patients had a delayed, interrupted, or reduced dose of pegylated liposomal doxorubicin (primarily related to PPE) PPE leading to discontinuation of therapy occurred in 4% of patients Growth factors added to therapy in 4.6 % of patients Erythropoietin was added to therapy in 6% of patients 18% of patients withdrew from the study secondary to adverse events |
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Paclitaxel ( Trimble EL, et al, J Clin Oncol. 1993; 11:2405-10)
N= 917
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Paclitaxel 135 mg/m2 IV Over3 or24 hrs, day 1 Repeat cycle every 21 days Appropriate premedications listed in Section 2, Commonly Used Premedicaiton Regimens
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Leukopenia Grade III - IV 78%
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Neutropenic Fever 33% Infection 12 % Cardiac 2% Thrombocytopenia 8 % Vomiting 7% Mucositis 1% Neurologic 2%
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Day 1 – Level 2 |
Dose reduction 12% Delay of cycle by more than 1 week 29% Death 2%
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Topotecan (Bookman MA, et al, J Clin Oncol. 1998;16:3345-52)
N= 139
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Topotecan 15 mg/m2 / d IV over 30 min, days 1- 5 Repeat cycle every 21 days |
Grade III 15% Grade IV 82%
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Grade III-IV 49% |
Neutropenic Fever 18% (after these advers effects, G-CSF was given ) Sepsis 9% Nausea 7% Vomiting 4% Fatigue 5% Thrombocytopenia 52% Severe Bleeding < 1%
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Days 1-5- Level 2 |
Dose reduction 8% of courses Delay > 1 week 7% of courses Transfusion 22% of courses Withdrawal due to toxicity 4% of patients |