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Treatment of patients with advanced gastric carcinoma with a 5‐fluorouracil‐based or a cisplatin‐based regimen
Author(s) -
Barone Carlo,
Corsi Domenico C.,
Pozzo Carmelo,
Cassano Alessandra,
Fontana Tecla,
Noviello Maria R.,
Landriscina Matteo,
Colloca Giuseppe,
Astone Antonio
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(19980415)82:8<1460::aid-cncr5>3.0.co;2-d
Subject(s) - medicine , epirubicin , regimen , etoposide , cisplatin , gastroenterology , fluorouracil , performance status , confidence interval , chemotherapy , bolus (digestion) , surgery , cyclophosphamide
BACKGROUND Although many drug combination therapies have been proposed, there is no standard therapy for patients with advanced gastric carcinoma. The superiority of combination therapy over monochemotherapy has not been demonstrated convincingly. To explore the role of monochemotherapy, the authors evaluated 5‐fluorouracil (5‐FU), modulated by 6S‐leucovorin (6S‐LV) and a cisplatin‐containing regimen, which was comprised of epirubicin, etoposide, and cisplatin with the addition of the reversal agent lonidamine (EEP‐L). METHODS After stratification according to performance status (PS) and resection of the primary tumor, 72 patients with advanced gastric carcinoma were randomized to 2 parallel Phase II trials with 5‐FU/6S‐LV and EEP‐L, respectively. Thirty‐six patients in Study A received bolus 6S‐LV, 100 mg/m 2 , followed by bolus 5‐FU, 370 mg/m 2 , on Days 1‐5 and 36 others in Study B received epirubicin, 30 mg/m 2 , on Days 1 and 5; etoposide, 100 mg/m 2 , on Days 1, 3, and 5; cisplatin, 30 mg/m 2 , on Days 2 and 4; and lonidamine, 150 mg/day. RESULTS There were 6 partial responses (18.2%) (95% confidence interval [CI] ± 13.2) in Study A and 7 partial responses (21.9%) (95% CI ± 14.3) in Study B. Partial responses were more frequent in patients with resected tumors or with an Eastern Cooperative Oncology Group PS of 0‐1. The median duration of response was 8.8 and 8.3 months, respectively, in Study A and Study B. The median survival reached 8 months in Study A and 9 months in Study B. In the whole population of patients survival was significantly higher in patients with a PS of 0‐1 ( P < 0.05). Patients with a PS of 0‐1 and a resected tumor had the significantly longest survival both in EEP‐L treated patients and in all evaluable patients in the two studies. The most frequent World Health Organization Grade 3‐4 toxic effects were gastrointestinal in Study A and hematologic in Study B. No treatment‐related death was observed. CONCLUSIONS The efficacy of 5‐FU, modulated with 6S‐LV, is moderate in patients with advanced gastric carcinoma, similar to cisplatin‐containing regimens. PS and other prognostic factors could influence the response rate, which does not appear to be a reliable parameter for evaluating the outcome of chemotherapy trials. Cancer 1998;82:1460‐7. © 1998 American Cancer Society.