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Titolo:
TOPOTECAN, A NEW ACTIVE-DRUG IN THE 2ND-LINE TREATMENT OF SMALL-CELL LUNG-CANCER - A PHASE-II STUDY IN PATIENTS WITH REFRACTORY AND SENSITIVE DISEASE
Autore:
ARDIZZONI A; HANSEN H; DOMBERNOWSKY P; GAMUCCI T; KAPLAN S; POSTMUS P; GIACCONE G; SCHAEFER B; WANDERS J; VERWEIJ J;
Indirizzi:
IST NAZL RIC CANC,DEPT MED ONCOL 1,LARGO ROSANNA BENZI 10 I-16132 GENOA ITALY
Titolo Testata:
Journal of clinical oncology
fascicolo: 5, volume: 15, anno: 1997,
pagine: 2090 - 2096
SICI:
0732-183X(1997)15:5<2090:TANAIT>2.0.ZU;2-Z
Fonte:
ISI
Lingua:
ENG
Soggetto:
TREATED PATIENTS; TOPOISOMERASE-I; CHEMOTHERAPY; CAMPTOTHECIN; IDARUBICIN; ETOPOSIDE; TRIALS; AGENT;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
24
Recensione:
Indirizzi per estratti:
Citazione:
A. Ardizzoni et al., "TOPOTECAN, A NEW ACTIVE-DRUG IN THE 2ND-LINE TREATMENT OF SMALL-CELL LUNG-CANCER - A PHASE-II STUDY IN PATIENTS WITH REFRACTORY AND SENSITIVE DISEASE", Journal of clinical oncology, 15(5), 1997, pp. 2090-2096

Abstract

Purpose: To assess activity and toxicity of topotecon in previously treated small-cell lung cancer (SCLC) patients. Patients and Methods: Patients with measurable SCLC, progressive after one first-line regimen, were eligible for the study. Two groups of patients were selected: (1) patients who failed first-line treatment less than or equal to 3 months from chemotherapy discontinuation (refractory group); and (2) patients who responded to first-line treatment and progressed greater than 3 months after chemotherapy discontinuation (sensitive group). Topotecan was administered as a 30-minute daily infusion at a dose of 1.5 mg/m(2) for 5 consecutive days, every 3 weeks. Results: One hundred onepatients were entered onto the study and 403 courses were administered. Ninety-two patients (47 refractory and 45 sensitive) were eligible and assessable for response. Among refractory patients, there were twopartial responses (PRs) and one complete response (CR), for an overall response rate of 6.4% (95% confidence interval [CI], 1.3% to 17.6%),whereas in the sensitive group, there were 11 PRs and six CRs, for anoverall response rate of 37.8% (95% CI, 23.8% to 53.5%). Overall median duration of response was 7.6 months. Median survival was 5.4 months; median survival of refractory patients was 4.7 months, whereas that of sensitive patients was 6.9 months (P=.002). Median survival of responding patients was 12.5 months. Toxicity was mainly hematologic. Leukopenia, although short-lived, was universal, with grade III and IV neutropenia occurring in 28% and 46.8% of cycles, respectively. Nonhematological toxicity was mild. Fatigue/malaise was reported in 39.3% of cycles and transient elevation of liver enzymes in 17%. Conclusion: Topotecan has significant activity in SCLC, particularly in patients sensitive to prior chemotherapy, with predictable and manageable toxicity. The incorporation of topotecan in combination chemotherapy regimens for future treatment of SCLC is warranted. (C) 1997 by American Society of Clinical Oncology.

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Documento generato il 02/04/20 alle ore 21:43:55