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A randomized Phase III trial of etoposide, epirubicin, and cisplatin versus 5‐fluorouracil, epirubicin, and cisplatin in the treatment of patients with advanced gastric carcinoma
Author(s) -
İçli Fikri,
Çelik İsmail,
Aykan Faruk,
Üner Aytuǧ,
Demirkazik Ahmet,
Özet Ahmet,
Özgüroǧlu Mustafa,
Taş Faruk,
Akbulut Hakan,
Firat Dinçer
Publication year - 1998
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/(sici)1097-0142(19981215)83:12<2475::aid-cncr10>3.0.co;2-h
Subject(s) - epirubicin , medicine , cisplatin , etoposide , fluorouracil , oncology , chemotherapy , gastric carcinoma , randomized controlled trial , cancer , cyclophosphamide
BACKGROUND Gastric carcinoma is a substantial health problem in Turkey, and the majority of patients present with inoperable disease. The aim of this randomized trial was to assess the activity of 5‐fluorouracil versus etoposide when combined with epirubicin plus cisplatin in patients with advanced gastric carcinoma (AGC). METHODS In this prospective, randomized, multicenter Phase III study, previously untreated patients with histopathologically proven AGC enrolled after giving informed consent. Patients were allocated to receive either EEP (etoposide 120 mg/m 2 , epirubicin 30 mg/m 2 , and cisplatin 40 mg/m 2 on Days 1 and 8) or FEP (5‐fluorouracil 600 mg/m 2 , epirubicin 60 mg/m 2 , and cisplatin 80 mg/m 2 on Day 1), and the regimens were to be repeated every fourth week. RESULTS Of a total of 131 eligible patients, 64 were in the EEP group and 67 were in the FEP group. The objective response (complete + partial) rates for evaluable patients (n = 118) were comparable ( P = 0.63) in the EEP (20.3%, 12/59) and FEP (15.3%, 9/59) groups, respectively. Actuarial analyses revealed comparable median progression free survival (6 vs. 7 months, P > 0.05) and overall survival (6 vs. 5 months, P > 0.05) duration in the EEP and FEP groups. Both regimens were well tolerated. The most common toxicity was Grade 1‐2 nausea with or without vomiting. No chemotherapy‐related death occurred. CONCLUSIONS The current study resulted in inadequate response rates for EEP and FEP regimens. Neither combination, as used at the doses and schedules in this study, can be recommended as standard treatment for patients with AGC. Cancer 1998;83:2475‐2480. © 1998 American Cancer Society.