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GYNECOLOGY :CERVICAL 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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Cisplatin (Bonomi P, et al, J Clin Oncol 1985; 3: 1079-85)
N= 180 |
Cisplatin 100 mg/m2 IV day 1 Repeat cycle every 21 days |
Leukopenia Grade III 6% Grade IV <1%
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Thrombocytopenia 1 % Nephrotoxicity (SCr > 2.0 Or BUN . 40 ) 14% Nausea/ Vomiting * 74% -83% Hearing Loss (clinical ) * 12% Neurotoxicity * 7%
* Grade unknown |
Day 1 – level 5 |
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Cisplatin 5-Fluorouracil Pelvic Radiation (Peters WA, et al, J Clin Oncol . 2000;18:1606-13)
N= 127 |
Radiation therapy 1.7 Gy/d on days 1-5 of each week, for a total of 29 fractions (49.3 Gy) Cisplatin 70 mg/m2 IV over 2 hours day 1 5-Fluorouracil 1000 mg/m2/d IV continuous infusion days 1-4 2 nd cycle began on day 22, the 3 rd and 4 th chemotherapy cycles scheduled after com- pletion of RT, to begin on days 43 and 64 |
Leukopenia Grade III 33% Grade IV 2.5% Granulocytopenia Grade III 19.6% Grade IV 9% |
Grade III-IV 3.3% |
Infection (Grade III) 0.8% Diarrhea 9.8% Nausea (Grade III) 14% Small Bowel Obstruction (Grade IV) 1.6 % Stomatitis 2.4 % Vomiting 12.3 %
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Day 1 – level 5 Days 2-4- level 2 Radiation therapy days: intermediate risk |
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Cisplatin 5- Fluorouracil Hydroxyurea (Rose PG, et al, N Engl J Med. 1999;340: 1144-53)
N= 173 |
Cisplatin 50 mg/m2 IV day 1, 29 5-Fluorouracil 1000 mg/m2/d IV continuous infusion days 1-4 and 29-32 Hydroxyurea 2000 mg/m2 PO Twice weekly two hours before Fradiotherapy at weeks 1-6 Radiation Therapy (see article )
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Leukopenia Grade III 41% Grade IV 5%
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Thrombocytopenia 4% Gastrointestinal 18% Genitourinary 2% Cutaneous 5% Neurologic 1 % Cardiovascular (Grade III) 2% Fatigue (Grade III) 1% Pain (Grade III) 1 % Weight Loss (Grade III) 2% |
Days 1& 29 level 5 Days 2-4, 30-32- level 2 Days with just Hydroxyurea - level 1 |
The median treatment delay was 10 days There were no toxic deaths |
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Cisplatin Ifosfamide (Bloss JD, et al, J Clin Oncol. 2002;20;1832-37)
N= 146
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Cisplatin 50 mg/m2 IV day 1 Ifosfamide 5000 mg/m2 IV continuous Infusion over 24 hours day 1 Mesna 6000 mg/m2 IV continuous infusion over 36 hours, starting on day 1 with The ifosfamide Repeat cycle every 21 days. |
Leukopenia Grade III 42% Grade IV 42% Neutropenia Grade III 25% Grade IV 56%
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Grade III 21% Grade IV 1.4 % |
Sepsis (Grade IV) < 1 % Thrombocytopenia 16% Nausea / Vomiting 15% Gastrointestinal 2 % Central Neurotoxicity 10% Renal (Grade III) 2 % Weight loss (Grade III) 3 % |
Day 1- level 5 |
No treatment-related Deaths |
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GYNECOLOGY: CERVICAL 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) |
|
Cisplatin – Vinorelbine (Pignata S, et al, J Clin. Oncol. 1999;17:765-60)
N= 50
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Cisplatin 80 mg/m2 IV day 1 Vinorelbine 25 mg/m2 IV days 1, 8 * Repeat cycle every 21 days. Administer vinorelbine immediately after cisplatin on day 1 |
Neutropenia Grade III* 52% Grade IV* 4 % Leukopenia Grade III 24% Grade IV 0%
per cycle
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Grade III 8% Grade IV 2 % |
Nausea / Vomiting (Grade III) 6% Peripheral Neuropathy (Grade III) 2 % Alopecia (Grade III) 4% |
Day 1 – level 5 Dat 8 – level 1 |
No dose reduction, delay, or discontinuation due to toxicity 50% (n=25) of patients randomly received G-CSF; all other patients received it only if experiencing grade IVneutropenia (n = 1) |
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Cisplatin (weekly) and XRT (Keys HM, et al. N Engl J Med. 1999;340:1154-61)
N= 183
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Cisplatin 40 mg/m2 IV each week During XRT (not to exceed 70 mg/wk) x 6 doses maximum XRT 1.8 – 2.0 Gy daily, 5 days per week for a total of 45 Gy, followed by local brachytherapy and hysterectomy |
Leukopenia Grade III 18% Grade IV 3 %
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Gastrointestinal 14% |
Level 4 |
35% of patients had Grade III-IV toxicity |
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Mitomycin – C Cisplatin (Wagenaar HC, et al, Eur J Cancer . 2001;37:1624-28)
N= 33
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Mitomycin –C 6 mg/m2 IV day 1, followed by Cisplatin 50 mg/m2 IV over 1 hours day 1 Repeat cycle every 28 days
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WHO Toxicity: WBC Grade III 6 % |
WHO Toxicity: Hemoglobin Grade III 3 %
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WHO Toxicity: Nausea / Vomiting 26% Diarrhea (Grade III) 6% Allergy (Grade IV) 3% Alopecia (Grade III) 3 %
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Day 1 – level 5 |
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Paclitaxel – Cisplatin (Rose PG, et al, J Clin Oncol, 1999;17:2676-80)
N= 44
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Paclitaxel 135 mg/m2 IV 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 Premedication Regimens |
Neutropenia Grade III 16% Grade IV 61% Leukopenia Grade III 32% Grade IV 32%
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Grade III 23% Grade IV 2 % |
Neutropenic Fever 28% Fever 5% Thrombocytopenia 18% Neurologic 7% Cardiac (Grade IV) 7% Pulmonary 7% Dehydration 2% Electrolyte Abnormalities 7% Pneumonia 2% Infection (Grade IV) 2% Renal (Grade III) 2% Nausea / Vomiting 32% Diarrhea 7% Stomatitis 5% |
Day 1- level 2 Day 2- level 5 |
Infectious mortality 5% Dose reduction of paclitaxel due to neutropenia in 27% of patients Dose reduction of cisplatin due to toxicity In 20% of patients |