81378
document
Cisplatin plus etoposide with and without ifosfamide in extensive small-cell lung cancer : a Hoosier Oncology Group study . PURPOSE To determine whether the addition of ifosfamide to cisplatin plus etoposide improves the response rate , time to disease progression , or overall survival in previously untreated patients with extensive-stage small-cell carcinoma of the lung ( SCLC ) . PATIENTS AND METHODS Patients with extensive SCLC with a Karnofsky performance score ( KPS ) > or = 50 and adequate renal function and bone marrow reserve were eligible . Patients with CNS metastases were eligible and received concurrent whole-brain radiotherapy . Patients were randomized to receive cisplatin ( 20 mg/m2 ) plus etoposide ( 100 mg/m2 ) ( VP ) both given intravenously ( i.v . ) on days 1 to 4 or cisplatin ( 20 mg/m2 ) , ifosfamide ( 1.2 g/m2 ) , and etoposide ( 75 mg/m2 ) ( VIP ) all given i.v . on days 1 to 4 . Cycles were repeated every 3 weeks for four cycles . RESULTS From May 1989 through March 1993 , 171 patients were randomized ( 84 to VP and 87 to VIP ) . The median follow-up duration is 26 months . All patients were assessable for survival ; 163 were fully assessable for response and 162 for toxicity . Myelosuppression was greater with VIP . Objective responses were observed in 55 of 82 ( 67 % ) and 59 of 81 ( 73 % ) assessable patients treated with VP and VIP , respectively ( difference not significant ) . The difference in the median time to progression was statistically different ( P = .039 ) . The median survival times on VP and VIP were 7.3 months and 9.0 months , respectively ( P = .045 for survival curves by stratified log-rank test ) with 2-year survival rates of 5 % versus 13 % , respectively . CONCLUSION VIP combination chemotherapy is associated with an improved time to progression and overall survival over VP therapy in patients with extensive SCLC .
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Intervention_Pharmacological
Cisplatin plus etoposide
81380
Intervention_Pharmacological
ifosfamide
81381
Intervention_Pharmacological
ifosfamide
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Intervention_Pharmacological
cisplatin plus etoposide
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
etoposide
81385
Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
ifosfamide
81387
Intervention_Pharmacological
etoposide
81388
Outcome_Other
response rate
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Outcome_Other
time to disease progression
81390
Outcome_Mortality
overall survival
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Outcome_Mortality
survival
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Outcome_Other
assessable for response
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Outcome_Other
toxicity
81394
Outcome_Physical
Myelosuppression
81395
Outcome_Other
greater
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Outcome_Other
Objective responses
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Outcome_Other
median time to progression
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Outcome_Mortality
median survival times
81399
Outcome_Mortality
2-year survival rates
81400
Outcome_Other
time to progression
81401
Outcome_Mortality
overall survival
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Participant_Condition
lung cancer
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Participant_Condition
small-cell carcinoma of the lung ( SCLC )
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Participant_Sample-size
171
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Participant_Sample-size
163
81406
Participant_Sample-size
162