Eight-hour infusion versus bolus injection of doxorubicin in the EAP regimen in patients with advanced gastric cancer: a prospective randomised trial.
Ann Oncol
; 11(3): 343-8, 2000 Mar.
Article
en En
| MEDLINE
| ID: mdl-10811503
ABSTRACT
BACKGROUND:
Doxorubicin (40 mg/m2/cycle), etoposide (360 mg/m2/cycle) and cisplatin (80 mg/m2/cycle) comprise an efficient regimen in patients with advanced gastric cancer (AGC). However, its excessive hematological toxicity led doctors to avoid using the combination. Doxorubicin is the main cause of myelotoxicity in the EAP regimen. The aim of this study was to compare an eight-hour infusion of doxorubicin (arm A) with intravenous injection of doxorubicin (arm B) in the EAP regimen with respect to toxicity, objective responses, time to progression (TTP) and survival in patients with AGC. PATIENTS ANDMETHODS:
One-hundred twenty chemotherapy-naïve patients with measurable AGC were randomised between September 1994 and August 1998. Sixty patients in arm A and sixty patients in arm B were considered as fully evaluable. The arms were well balanced for age, sex distribution, previous therapy, histological grade and performance status. One-hundred eighty cycles were applied in arm A (median 2) and 201 in arm B (median 4).RESULTS:
No difference was detected (P = 0.28) in the response rate of arm A 20% (CR 3; PR 9; 95% CI 10-30) and B 28% (CR 3; PR 14; 95% CI 17-40). But there was a significant difference in PD (P = 0.005) between arm A (51%) and arm B (36%). TTP (P = 0.01) and survival (P = 0.02) analyses detected an advantage for arm B vs. arm A. Grades 3-4 toxicity were as follows (arms A%/B%) anemia 8/10, leukopenia 24/26, thrombocytopenia 6/16 (significance, P = 0.05), nausea/vomiting 5/8, diarrhea 6/2, mucositis 8/5. Apart from the trombocytopenia, there was no significant difference in toxicity grades 3-4 between the two arms. Four treatment-related deaths occurred, two in each arm.CONCLUSIONS:
Bolus injection of doxorubicin is superior to eight-hour doxorubicin infusion in the EAP regimen in terms of survival, TTP and PD without being significantly more toxic.
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Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
3_ND
/
4_TD
/
6_ODS3_enfermedades_notrasmisibles
Problema de salud:
3_diarrhea
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4_diarrhoeal_infections
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6_digestive_diseases
/
6_stomach_cancer
Asunto principal:
Neoplasias Gástricas
/
Protocolos de Quimioterapia Combinada Antineoplásica
/
Doxorrubicina
Tipo de estudio:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Límite:
Adult
/
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Ann Oncol
Asunto de la revista:
NEOPLASIAS
Año:
2000
Tipo del documento:
Article