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Titolo:
PHASE I-II AND PHARMACOKINETIC STUDY OF A NEW FOTEMUSTINE SCHEDULE INADVANCED NON-SMALL-CELL LUNG-CANCER
Autore:
LECESNE A; CHABOT G; BERILLE J; LUCAS C; BAUD M; GOUYETTE A; MARTY M; LECHEVALIER T;
Indirizzi:
INST GUSTAVE ROUSSY,SERV MED B F-94805 VILLEJUIF FRANCE INST GUSTAVE ROUSSY,CLIN PHARMACOL LAB,INSERM,U140 VILLEJUIF FRANCE INST GUSTAVE ROUSSY,CLIN PHARMACOL LAB,CNRS,URA 147 VILLEJUIF FRANCE INST RECH INT SERVIER F-92400 COURBEVOIE FRANCE HOP ST LOUIS,DEPT MED F-75010 PARIS FRANCE
Titolo Testata:
Lung cancer
fascicolo: 1, volume: 13, anno: 1995,
pagine: 69 - 78
SICI:
0169-5002(1995)13:1<69:PIAPSO>2.0.ZU;2-9
Fonte:
ISI
Lingua:
ENG
Soggetto:
RANDOMIZED TRIAL; NITROSOUREA; CHEMOTHERAPY; CISPLATIN; VINDESINE;
Keywords:
FOTEMUSTINE; PHASE I-II; PHARMACOKINETICS; NON-SMALL CELL LUNG CANCER;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
20
Recensione:
Indirizzi per estratti:
Citazione:
A. Lecesne et al., "PHASE I-II AND PHARMACOKINETIC STUDY OF A NEW FOTEMUSTINE SCHEDULE INADVANCED NON-SMALL-CELL LUNG-CANCER", Lung cancer, 13(1), 1995, pp. 69-78

Abstract

Fotemustine, a new nitrosourea derivative has already demonstrated activity in non-small cell lung cancer (NSCLC). In order to improve its therapeutic index, we designed a protocol in which Fotemustine was delivered with dose escalation on 3 consecutive days as induction therapyfollowed by a 5-week rest period. Maintenance therapy consisted of 100 mg/m(2) once every 3 weeks. Pharmacokinetic data were assessed during this Phase I-II study and reported here, Patients and methods: Nineteen patients with metastatic (17) or locally advanced (2) NSCLC were included in the present study. Ten of those with metastatic disease hadbrain metastases and 15 had previously received chemotherapy. Fotemustine was given at 50 mg/m(2) on day 1-2-3 (group 1: four patients), 75mg/m(2) on day 1-2-3 (group 2: 16 patients including two who had already received 50 mg/m(2)) and 100 mg/m(2) on day 1-2-3 (group 3: one patient). Results: The maximal tolerated dose was 75 mg/m(2) on day 1-2-3 (total cumulated dose 225 mg/m(2)). At this dose level, we observed 25% of Grade 3-4 neutropenia and 31% of Grade 3-4 thrombocytopenia. One patient died of pulmonary infection during aplasia. No other significant toxicity occurred. Of the 17 evaluable patients, one obtained a PR lasting 6 months in group 2 and 1 PR lasting 3 months in group 3. Nosignificant difference was noted in the AUC between days 1, 2 or 3 inany of the seven patients in whom a pharmacokinetic study of Fotemustine was performed. Conclusion: Administered on 3 consecutive days, Fotemustine seems to be less effective and more toxic than other schedules tested in NSCLC. Despite the quality of the two responses observed, this protocol has been discontinued and the standard administration ondays 1 and 8 remains the schedule of choice in NSCLC.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/11/20 alle ore 04:22:20