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Titolo:
Phase I-II study of 5-fluorouracil, recombinant interferon alpha 2a, and cisplatin in combination with external beam radiation therapy followed by surgery in patients with locally advanced carcinoma of the esophagus
Autore:
Damle, S; Beitler, JJ; Haynes, H; Camacho, M; Wolf, E; Wadler, S;
Indirizzi:
Montefiore Med Ctr, Dept Oncol, Bronx, NY 10467 USA Montefiore Med Ctr Bronx NY USA 10467 tr, Dept Oncol, Bronx, NY 10467 USA Albert Einstein Med Ctr, Bronx, NY 10467 USA Albert Einstein Med Ctr Bronx NY USA 10467 n Med Ctr, Bronx, NY 10467 USA Montefiore Med Ctr, Dept Radiat Oncol, Bronx, NY 10467 USA Montefiore Med Ctr Bronx NY USA 10467 t Radiat Oncol, Bronx, NY 10467 USA Montefiore Med Ctr, Dept Cardiothorac Surg, Bronx, NY 10467 USA MontefioreMed Ctr Bronx NY USA 10467 diothorac Surg, Bronx, NY 10467 USA Montefiore Med Ctr, Dept Radiol, Bronx, NY 10467 USA Montefiore Med Ctr Bronx NY USA 10467 r, Dept Radiol, Bronx, NY 10467 USA
Titolo Testata:
AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS
fascicolo: 4, volume: 22, anno: 1999,
pagine: 391 - 395
SICI:
0277-3732(199908)22:4<391:PISO5R>2.0.ZU;2-F
Fonte:
ISI
Lingua:
ENG
Soggetto:
SQUAMOUS-CELL CARCINOMA; CLINICAL-TRIAL; CANCER; CHEMOTHERAPY; RADIOTHERAPY; CHEMORADIOTHERAPY; LUNG;
Keywords:
multimodality therapy; esophageal carcinoma; interferon alpha 2a;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
26
Recensione:
Indirizzi per estratti:
Indirizzo: Wadler, S Montefiore Med Ctr, Dept Oncol, 111 E 210th St, Bronx, NY 10467 USA Montefiore Med Ctr 111 E 210th St Bronx NY USA 10467 Y 10467 USA
Citazione:
S. Damle et al., "Phase I-II study of 5-fluorouracil, recombinant interferon alpha 2a, and cisplatin in combination with external beam radiation therapy followed by surgery in patients with locally advanced carcinoma of the esophagus", AM J CL ONC, 22(4), 1999, pp. 391-395

Abstract

Multimodality therapy has been demonstrated to be superior to external beam radiation therapy and possibly surgery alone for the treatment of carcinoma of the esophagus. The combination of 5-fluorouracil (5-FU), cisplatin, and recombinant interferon alpha 2 alpha (IFN) has yielded 65% response rates in metastatic and regionally advanced carcinoma of the esophagus. A phaseI-II study was performed to assess the feasibility of combining 5-FU, IFN,and cisplatin with external beam radiation therapy followed by surgery in potentially resectable patients. Eligibility included biopsy-proven stage II-III squamous cell or adenocarcinoma of the esophagus with no prior therapy. External beam radiation therapy was administered concurrently with chemotherapy beginning on day 1, 5 days per week, twice a day with 1.5 Gy/fraction to a total dose of 45 Gy. 5-FU was administered at 750 mg/m(2) on days 1, 8, 15, 22, and 29 after the administration of IFN and cisplatin. IFN was given at a dose of 6 million units subcutaneously three times per week beginning on day 1. Dose levels I, II, and III of cisplatin were 25, 30, and 35mg/m(2) administered on days 1, 8, 15, 22, and 29. The sequence of administration was IFN followed by cisplatin followed immediately by 5-FU. Dose escalation between patient cohorts occurred if 0/3 or less than or equal to 1/6 patients had dose-limiting toxicity, i.e., grade II-III toxicity attributable to cisplatin. A phase II trial was planned using the maximum tolerated dose of cisplatin determined from the phase I trial. Patients who successfully completed therapy underwent thoracic exploration to resect residual disease. Twelve patients were enrolled; all were eligible. The demographics of the population were median age, 60 years (range, 44-77) nine male and three female patients, nine squamous cell carcinoma, one adenocarcinoma, and two adenosquamous histology; stage II:III, 2:10. Grade 3-4 toxicities included granulocytopenia (12 patients), thrombocytopenia (six), anemia (three),infection (six), diarrhea (two), mucositis (two), and renal and hepatic toxicities tone). Five patients had a clinical complete response, among whom four underwent surgery. At surgery, one patient had no evidence of residualdisease and three patients had microscopic disease only. Two patients had progressive disease and five could not complete the therapy because of toxicities. Two patients are alive and disease free at 25 and 23 months, respectively. This regimen, though active, demonstrated an unfavorable toxicity profile and cannot be recommended for further study.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 01/12/20 alle ore 10:07:11