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LUNG CANCER : NON-SMALL-CELL
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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) |
|
Carboplatin– Paclitaxel (Schiller JH, et al. N Engl J Med. 2002;346:92-8)
N= 293
|
Carboplatin dose targeted by the Calvert equation to AUC of 6, IV day 1 paclitaxel 225 mg/m2 IV over 3 hours day 1 Repeat cycle every 21 days Appropriate premedications listed in Section 2, Commonly Used Premedication Regimens |
Neutropenia Grade III 20% Grade IV 43%
|
Grade III 9 % Grade IV 1 %
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Infection 5% Thrombocytopenia 10 % Nausea (Grade III) 9 % Vomiting 8 % Diarrhea 2 % Cardiac Toxicity 2 % Renal Toxicity 1 % Neuropathy (Grade III) 10 % Weakness 15 % Hypersensitivity Reactions 2 % |
Day 1 – Level 5 |
4 % had febrile neutropenia (Grade IV) 1 % had fatal infection |
|
Cisplatin-Docetaxel (Schiller JH, et al. N Engl J Med. 2002;346:92-8)
N= 297
|
Cisplatin 75 mg/m2 IV day 1 Docetaxel 75 mg/m2 IV day 1 Repeat cycle every 21 days Appropriate premedications listed in Section 2, Commonly Used Premedication Regimens |
Neutropenia Grade III 21% Grade IV 48%
|
Grade III 13 % Grade IV 1 %
|
Infection 7 % Thrombocytopenia 3 % Nausea (Grade III) 24 % Vomiting 21 % Diarrhea 10 % Cardiac Toxicity 3 % Renal Toxicity (Grade III) 3 % Neuropathy (Grade III) 5 % Weakness 16 % Hypersensitivity Reactions 7 % |
Day 1 – Level 5 |
% had febrile neutropenia (Grade IV) 2 % had fatal infection |
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Cisplatin-Gemcitabine (Schiller JH, et al. N Engl J Med. 2002;346:92-8)
N= 293
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Cisplatin 100 mg/m2 IV day 1 Gemcitabine 1000 mg/m2 IV days 1, 8, 15 Repeat cycle every 28 days
|
Neutropenia Grade III 24 % Grade IV 39 %
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Grade III 27 % Grade IV 1 %
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Febrile Neutropenia, (Grade IV) 3% Infection 6 % Thrombocytopenia 50 % Nausea (Grade III) 37 % Vomiting 35 % Diarrhea 3 % Cardiac Toxicity 4 % Renal Toxicity 8% Neuropathy (Grade III) 9 % Weakness (Grade III) 1 % |
Day 1- Level 5 Days 8, 15- Level 2 |
% had fetal infection
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Cisplatin-Paclitaxel (Schiller JH, et al. N Engl J Med. 2002;346:92-8)
N= 300
|
Paclitaxel 135 mg/m2 IV over 24 hours day 1 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 18 % Grade IV 57 %
|
Grade III 12 % Grade IV 1 %
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Febrile Neutropenia (Grade IV) 14 % Infection 8 % Thrombocytopenia 6 % Nausea (Grade III) 25 % Vomiting 24 % Diarrhea 7 % Cardiac Toxicity 2 % Renal Toxicity (GradeIII) 3 % Neuropathy (Grade III) 5 % Weakness 14 % Hypersensitivity Reactions 3 % |
Day 1 – Level 2 Day 2 – Level 5 |
2 % had fatal infection |
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LUNG CANCER : NON-SMALL-CELL (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 ( Kelly K, et al. J. Clin Oncol 2001;19:3210-18)
N= 202
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Cisplatin 100 mg/m2 IV day 1 Vinorelbine 30 mg/m2 IV days 1, 8, 15, 22 Repeat cycle every 28 days
|
Leukopenia Grade III 35 % Grade IV 15 %
Neutropenia Grade III 27 % Grade IV 49 %
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Grade III 17 %
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Thrombocytopenia (Grade III) 4 % Nausea (Grade III) 18 % Neuropathy (Grade III) 3 % Vomiting (Grade III) 12 % Dehydration (Grade III) 6% Fatigue (Grade III) 11% Hyponatremia (Grade III)7% Respiratory Infection (with neutropenia ) (Grade III) 5 %
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Day 1 – Level 5 Days 8, 15, 22- level 1 |
28% of patients discontinued therapy due to toxicity No patient developed Grade IV febrile neutropenia Grade III-IV infection with Grade III-IV neutropenia occurred in 10 patients 8 patients died of toxicity
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Docetaxel (Hainsworth JD, et al, Cancer . 2000;89:328-33)
N= 39
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Docetaxel 36 mg/m2 IV over 1 hours days 1, 8,15, 22, 29, 36 Repeat cycle every 8 weeks Appropriate premedications listed in Section 2, Commonly Used Premedication Regimens
Note : Gegimen used for elderly or Poor –risk patients
|
Leukopenia Grade III 8 %
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Grade III 13 %
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Fatigue/ Asthenia 10 % Nausea / Emesis 10 % Skin Toxicity 3 % Neuropathy 3 % Hypersensitivity Reactions 3 % Alopecia 13%
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Day 1, 8, 15, 22, 29, 36 Level 2
|
13% of patients required RBC transfusions
|
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EP (Klastersky J, et al, J Clin Oncol. 1990;8:1556-62)
N= 114
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Etoposide 100 mg/m2 /d IV days 1 – 3 Cisplatin 120 mg/m2 IV days 1 Repeat cycle every 21-28 days
|
Leukopenia Grade III-IV 34%
|
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Infection * 5 % Thrombocytopenia* 15 % Nausea /Vomiting* 77 % Diarrhea * 11 % Bleeding * 3% Polyneuropathy 2 % Renal Dysfunction * 10% Hypoacusia * 7% Alopecia * 60%
* Grade II-IV toxicity |
Day 1 – Level 5 Days 2, 3- Level 2 |
Toxic mortality 4 % Dose delayed in 6% of patients Dose decreased in 6% of patients |
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G + V (Frasci G, et al, J Clin Oncol. 2000;18:2529-36)
N= 60 |
Gemcitabine 1200 mg/m2 IV days 1, 8 Vinorelbine 30 mg/m2 IV days 1, 8 Repeat cycle every 21 days
Note; Regimen used for elderly patients . |
Neutropenia Grade III 30% Grade IV 8.3%
|
Grade III 6.7% |
Thrombocytopenia 13.3 % Vomiting 15 % Fatigue (Grade III) 5 %
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Day 1, 8- Level 2
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Therapy stopped early secondary to toxicity in 12% of patients 2 toxic deaths |
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LUNG CANCER : NON-SMALL-CELL (continued ) : Page 3
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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) |
|
Paclitaxel (Ranson M, et al, J Natl Cancer Inst. 2000;92:1074-80)
N= 78
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Paclitaxel 200 mg/m2 IV over 3 hours days 1 Repeat cycle every 21 days Appropriate premedicaitons listed in Section 2, Commonly Used Premedication Regimens |
Leukopenia Grade III-IV 9% Neutropenia Grade III-IV 34%
|
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Infection 10 % Nausea / Vomiting 5 % Diarrhea 4% Mucositis 1 % Arthralgia/Myalgia 22 % Asthenia 14 % Peripheral Neuropathy 5% Alopecia 76 % Cardiovascular 1 %
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Day 1- Level 2
|
Dose reductions for hematologic and non- hematologic toxicity in 32% of paclitaxel- treated patien |
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Vinorelbine (Le Chevalier T, et al, J Clin Oncol. 1994;12:360-67)
N= 206 |
Vinorelbine 30 mg/m2 IV weekly |
Neutropenia Grade III-IV 53.2% |
|
Sepsis 3.4% Nausea/Vomiting (Grade II-IV) 12% Neurologic 9 % Diarrhea (Grade II-IV) 4% Alopecia (Grade II-IV) 14% |
Day 1 – Level 1 |
Toxic mortality 1% Hospitalization for sepsis 3% Dose intensity 83% Discontinued treatment secondary to treatmeant-related toxicity or patient refusal 8 % |