Premium
A randomized trial to compare intravenous and oral etoposide in combination with cisplatin for the treatment of small cell lung cancer
Author(s) -
Johnson David H.,
Ruckdeschel John C.,
Keller James H.,
Lyman Gary H.,
Kallas Gerald J.,
Macdonald John,
Deconti Ronald C.,
Lee Jeannette,
Scott Ringenberg Q.,
Patterson William P.,
Lazarus Hillard M.,
Lokich Jacob
Publication year - 1991
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19910101)67:1+<245::aid-cncr2820671306>3.0.co;2-z
Subject(s) - medicine , etoposide , regimen , neutropenia , gastroenterology , population , randomization , surgery , febrile neutropenia , chemotherapy , randomized controlled trial , environmental health
In a randomized multi‐center study, 83 patients with small cell lung cancer were randomly assigned to treatment with cisplatin 100 mg/m 2 intravenously (IV) day 1 and etoposide 120 mg/m 2 IV days 1, 2, and 3 or cisplatin 100 mg/m 2 IV day 1 and etoposide 120 mg/m 2 IV day 1 and 240 mg/m 2 orally days 2 and 3. Both regimens were repeated every 4 weeks. Prior to randomization, patients were stratified by extent of disease, performance status, and gender. A total of 41 patients were randomly assigned to the parenteral treatment only regimen, and 42 patients received cisplatin and IV/oral etoposide therapy. Both treatment arms were comparable regarding patient characteristics. Limited disease (LD) patients constituted 52% and 49% of the patient population for the oral and IV etoposide regimens, respectively. The overall complete response (CR) and partial response (PR) rate was 50% (95% confidence interval [CI] 35% to 65%) for the oral etoposide regimen and 59% (95% CI 44% to 74%) for the IV etoposide regimen ( P = 0.438). For both regimens, 55% of the LD patients achieved either CR or PR. Time to progression and survival were comparable for both treatment arms. Hematologic toxicity was comparable in both treatment arms, with 80% of patients experiencing grade 3 or 4 neutropenia or thrombocytopenia. Moderate to severe anemia and weight loss were more predominant with the IV than with the oral regimen.