title: Prospective randomized phase III trial of etoposide/cisplatin versus high-dose epirubicin/cisplatin in small-cell lung cancer.
abstract: High-dose epirubicin plus cisplatin was compared with the reference regimen of etoposide/cisplatin in small-cell lung cancer (SCLC). Four hundred two previously untreated patients with SCLC were randomized to receive etoposide 100 mg/m(2) on days 1-3 and cisplatin 100 mg/m(2) on day 1 or epirubicin 100 mg/m(2) and cisplatin 100 mg/m(2) on day 1 every 21 days for a total of 6 cycles. Patients were stratified according to treatment center and extent of disease (limited disease, n = 207; extensive disease, n = 195). Patients with limited disease were treated with thoracic radiation therapy after completion of chemotherapy, and those who exhibited a complete response were advised to receive prophylactic cranial irradiation. The primary endpoint was survival, and secondary endpoints were time to progression (TTP), response, toxicity, and costs. Patient characteristics were generally well balanced in the 2 arms, even though more patients in the epirubicin/cisplatin arm had > 5% weight loss and poor Karnofsky performance index compared with the etoposide/cisplatin arm. One hundred thirty-four patients (66.3%) in the etoposide/cisplatin arm and 126 (63.0%) in the epirubicin/cisplatin arm received all 6 planned cycles of chemotherapy. Response rate, TTP, and survival did not differ significantly between the 2 arms. Grade 3/4 neutropenia and toxic deaths occurred more frequently in the etoposide/cisplatin arm. Epirubicin/cisplatin showed a similar activity with a slightly lower toxicity profile than the reference regimen of etoposide/cisplatin. The epirubicin/cisplatin regimen may be recommended in the treatment of SCLC.
authors.affiliation: Hospital Universitario Miguel Servet, Zaragosa, Madrid Spain. aartalc@salud.aragob.es
authors.forename: Angel
authors.initials: A
authors.lastname: Artal-Cortés
authors.forename: Jose
authors.initials: J
authors.lastname: Gomez-Codina
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Gonzalez-Larriba
authors.forename: Isidoro
authors.initials: I
authors.lastname: Barneto
authors.forename: Alfredo
authors.initials: A
authors.lastname: Carrato
authors.forename: Dolores
authors.initials: D
authors.lastname: Isla
authors.forename: Carlos
authors.initials: C
authors.lastname: Camps
authors.forename: Carlos
authors.initials: C
authors.lastname: Garcia-Giron
authors.forename: Albert
authors.initials: A
authors.lastname: Font
authors.forename: Alfredo
authors.initials: A
authors.lastname: Meana
authors.forename: Maria
authors.initials: M
authors.lastname: Lomas
authors.forename: Catalina
authors.initials: C
authors.lastname: Vadell
authors.forename: Antonio
authors.initials: A
authors.lastname: Arrivi
authors.forename: Carmen
authors.initials: C
authors.lastname: Alonso
authors.forename: Immaculada
authors.initials: I
authors.lastname: Maestu
authors.forename: Joaquin
authors.initials: J
authors.lastname: Campbell
authors.forename: Rafael
authors.initials: R
authors.lastname: Rosell
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D016371:Cranial Irradiation; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D017707:Erythrocyte Transfusion / Q000706:statistics & numerical data; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D008297:Male; D008875:Middle Aged; D017713:Platelet Transfusion / Q000706:statistics & numerical data; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant
chemical_list: D000900:Anti-Bacterial Agents; D015251:Epirubicin; D005047:Etoposide; D002945:Cisplatin