title: Phase II study of area under the plasma-concentration-versus-time curve-based carboplatin plus standard-dose intravenous etoposide in elderly patients with small-cell lung cancer.
abstract: OBJECTIVE
  The target area under the plasma-concentration-versus-time curve (AUC)-based dosing of carboplatin using Calvert's formula is expected to result in more acceptable toxicity and greater efficacy in elderly patients with small-cell lung cancer (SCLC) than the body surface area-based dosing strategy. This phase II study was designed to determine the toxicity and efficacy of carboplatin based on Calvert's formula plus the standard dose of intravenous etoposide for elderly patients with SCLC.
  
  
  METHODS
  Carboplatin, dosed to a target AUC of 5 x (24-hour creatinine clearance + 25), was given intravenously on day 1 and etoposide 100 mg/m(2) was given intravenously on days 1, 2, and 3. Patients aged >/= 70 years old with a performance status of 0 to 2 were eligible.
  
  
  RESULTS
  Thirty-six patients were enrolled onto the study. The patient characteristics were as follows: median age, 73 years; limited disease (LD), 16 patients; and extensive disease (ED), 20 patients. Grades 3 and 4 leukopenia occurred in 57% and 3% of patients, and grades 3 and 4 thrombocytopenia occurred in 40% and 11% of patients, respectively. There was one treatment-related death due to hemoptysis. Other toxicities were relatively mild. There were two complete responses and 25 partial responses, for a response rate of 75%. The median survival time was 10.8 months (LD, 11.6 months; ED, 10.1 months), and the 1-year survival rate was 47%.
  
  
  CONCLUSIONS
  This carboplatin/etoposide combination chemotherapy is an active and relatively nontoxic regimen in elderly patients with SCLC, which suggests that the combination may be suitable for randomized controlled trials.
authors.affiliation: Yokohama Municipal Citizen's Hospital, Yokohama, Kanagawa, Japan. scyooka@alles.or.jp
authors.forename: H
authors.initials: H
authors.lastname: Okamoto
authors.forename: K
authors.initials: K
authors.lastname: Watanabe
authors.forename: Y
authors.initials: Y
authors.lastname: Nishiwaki
authors.forename: K
authors.initials: K
authors.lastname: Mori
authors.forename: Y
authors.initials: Y
authors.lastname: Kurita
authors.forename: I
authors.initials: I
authors.lastname: Hayashi
authors.forename: M
authors.initials: M
authors.lastname: Masutani
authors.forename: K
authors.initials: K
authors.lastname: Nakata
authors.forename: S
authors.initials: S
authors.lastname: Tsuchiya
authors.forename: H
authors.initials: H
authors.lastname: Isobe
authors.forename: N
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000378:metabolism* / Q000401:mortality; D004305:Dose-Response Relationship, Drug; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D008297:Male; D015999:Multivariate Analysis; D015996:Survival Rate; D013997:Time Factors
chemical_list: D005047:Etoposide; D016190:Carboplatin