title: Randomized double-blind placebo-controlled trial of cisplatin and etoposide plus megestrol acetate/placebo in extensive-stage small-cell lung cancer: a North Central Cancer Treatment Group study.
abstract: OBJECTIVE
  Megestrol acetate has been reported to improve appetite and quality of life and to decrease nausea and vomiting in patients with cancer anorexia/cachexia. The present trial was formulated to evaluate the impact of megestrol acetate on quality of life, toxicity, response, and survival in individuals with extensive-stage small-cell lung cancer who received concomitant chemotherapy.
  
  
  METHODS
  Patients were randomized to receive megestrol acetate 800 mg/d orally or placebo. In addition, all patients were scheduled to receive a maximum of four cycles of cisplatin and etoposide chemotherapy. Quality of life was self-assessed at entry onto study, with every cycle of chemotherapy, and 4 months thereafter with a linear visual analog scale. Toxicity was evaluated by patient questionnaire and investigator reports.
  
  
  RESULTS
  A total of 243 eligible patients were randomized. Those who received megestrol acetate had increased nonfluid weight gain (P = .004) and significantly less nausea (P = .0002) and vomiting (P = .02). Significant thromboembolic phenomena occurred more often in patients who received megestrol acetate versus placebo (9% v 2%, P = .01). Patients who received megestrol acetate had more edema (30% v 20%, P = .002), an inferior response rate to chemotherapy (68% v 80%, P = .03), and a trend for inferior survival duration (median, 8.2 v 10.0 months, P = .49). These findings may have been influenced by a poorer quality of life of the megestrol acetate group at study initiation. There were no significant changes in quality of life scores over time between either of the study arms.
  
  
  CONCLUSIONS
  Megestrol acetate cannot be routinely recommended for all patients with small-cell lung cancer at the time of chemotherapy initiation. Rather, its therapeutic ratio may be more favorable for patients with problematic cancer anorexia/cachexia.
authors.affiliation: Mayo Clinic, Rochester, MN 55905, USA.
authors.forename: K M
authors.initials: KM
authors.lastname: Rowland
authors.forename: C L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: E G
authors.initials: EG
authors.lastname: Shaw
authors.forename: A W
authors.initials: AW
authors.lastname: Maksymiuk
authors.forename: S A
authors.initials: SA
authors.lastname: Kuross
authors.forename: S H
authors.initials: SH
authors.lastname: Jung
authors.forename: J W
authors.initials: JW
authors.lastname: Kugler
authors.forename: L K
authors.initials: LK
authors.lastname: Tschetter
authors.forename: C
authors.initials: C
authors.lastname: Ghosh
authors.forename: P L
authors.initials: PL
authors.lastname: Schaefer
authors.forename: D
authors.initials: D
authors.lastname: Owen
authors.forename: J H
authors.initials: JH
authors.lastname: Washburn
authors.forename: T A
authors.initials: TA
authors.lastname: Webb
authors.forename: J A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: J R
authors.initials: JR
authors.lastname: Jett
mesh_terms: D000855:Anorexia / Q000209:etiology / Q000517:prevention & control; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001853:Bone Marrow / Q000187:drug effects; D002100:Cachexia / Q000209:etiology / Q000517:prevention & control; D018288:Carcinoma, Small Cell / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008535:Megestrol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019290:Megestrol Acetate; D010147:Pain Measurement; D011788:Quality of Life; D016019:Survival Analysis; D015996:Survival Rate; D013923:Thromboembolism / Q000139:chemically induced
chemical_list: D005047:Etoposide; D008535:Megestrol; D002945:Cisplatin; D019290:Megestrol Acetate