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Bimonthly high dose leucovorin and 5‐fluorouracil 48‐hour infusion with interferon‐alpha‐2a in patients with advanced colorectal carcinoma
Author(s) -
Tournigand Christophe,
Louvet Christophe,
de Gramont Aimery,
Lucchi Elisabeth,
Seitz JeanFrançois,
Mal Frédéric,
Raymond Eric,
Cady Jean,
Carola Elisabeth,
Krulik Marcel
Publication year - 1997
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(19970315)79:6<1094::aid-cncr6>3.0.co;2-g
Subject(s) - medicine , fluorouracil , alpha interferon , colorectal cancer , alpha (finance) , oncology , interferon alfa , carcinoma , gastroenterology , chemotherapy , interferon , surgery , cancer , immunology , patient satisfaction , construct validity
BACKGROUND The rationale for the modulation of 5‐fluorouracil (5‐FU) with interferon‐alpha (IFN) is inhibition of 5‐FU catabolism and 5‐FU resistance. Clinical trials have shown debatable results when IFN is given in high doses with 5‐FU used as a bolus alone or in combination with leucovorin (LV). A first‐line Phase II study was performed in 50 patients with metastatic colorectal carcinoma who were given a bimonthly combination of high dose LV, a high dose 48‐hour infusion of 5‐FU, and a low dose of IFN. METHODS The regimen was comprised of a 2‐hour infusion of LV, 500 mg/m 2 , on each of 2 consecutive days, and a 48‐hour infusion of 5‐FU, 1.5 to 2 g/m 2 /24 hours, starting after Day 1 of LV treatment every 2 weeks until there was evidence of disease progression. IFN was administered subcutaneously three times weekly at a dose of 3 MU (body surface area [BSA] < 1.75 m 2 ) or 4.5 MU (BSA ≥ 1.75 m 2 ). RESULTS World Health Organization toxicity Grade 3‐4 occurred in 21 patients (42%): diarrhea in 6%, mucositis in 12%, neutropenia in 30%, and alopecia in 8%. The overall response rate was 44%; 1 patient had a complete response (2%), 21 had partial responses (42%), 23 had stable disease (46%), and 5 had disease progression (10%). The median progression free survival was 9 months, and median survival was 25 months. CONCLUSIONS Bimonthly high dose LV, a high dose 48‐hour infusion of 5‐FU, and a low dose of IFN had good activity in patients with advanced colorectal carcinoma. However, as in other schedules of LV and 5‐FU, IFN induces high grade toxicity. Cancer 1997; 79:1094‐9. © 1997 American Cancer Society.