title: A randomized trial to compare intravenous and oral etoposide in combination with cisplatin for the treatment of small cell lung cancer.
abstract: In a randomized multi-center study, 83 patients with small cell lung cancer were randomly assigned to treatment with cisplatin 100 mg/m2 intravenously (IV) day 1 and etoposide 120 mg/m2 IV days 1, 2, and 3 or cisplatin 100 mg/m2 IV day 1 and etoposide 120 mg/m2 IV day 1 and 240 mg/m2 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.
authors.affiliation: Division of Medical Oncology, Vanderbilt University, Nashville, Tennessee.
authors.forename: D H
authors.initials: DH
authors.lastname: Johnson
authors.forename: J C
authors.initials: JC
authors.lastname: Ruckdeschel
authors.forename: J H
authors.initials: JH
authors.lastname: Keller
authors.forename: G H
authors.initials: GH
authors.lastname: Lyman
authors.forename: G J
authors.initials: GJ
authors.lastname: Kallas
authors.forename: J
authors.initials: J
authors.lastname: Macdonald
authors.forename: R C
authors.initials: RC
authors.lastname: DeConti
authors.forename: J
authors.initials: J
authors.lastname: Lee
authors.forename: Q S
authors.initials: QS
authors.lastname: Ringenberg
authors.forename: W P
authors.initials: WP
authors.lastname: Patterson
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D016001:Confidence Intervals; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage* / Q000633:toxicity; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction
chemical_list: D005047:Etoposide; D002945:Cisplatin