A phase II trial of interferon alpha‐2A, 5‐fluorouracil, and cisplatin in patients with advanced esophageal carcinoma Journal Article
| Authors: | Ilson, D. H.; Sirott, M.; Saltz, L.; Heelan, R.; Huang, Y.; Keresztes, R.; Kelsen, D. P. |
| Article Title: | A phase II trial of interferon alpha‐2A, 5‐fluorouracil, and cisplatin in patients with advanced esophageal carcinoma |
| Abstract: | Background. The combination of 5‐fluorouracil (5‐FU) and cisplatin has moderate antitumor activity in the treatment of metastatic epidermoid carcinoma of the esophagus. The authors have recently shown activity for the combination of 5‐FU and interferon‐alpha 2a (IFN‐alpha) in both esophageal epidermoid and adenocarcinoma. A Phase II trial, therefore, was undertaken to evaluate the antitumor activity of the three‐drug combination of IFN‐alpha, 5‐FU, and cisplatin in unresectable or metastatic esophageal carcinoma. Methods. Twenty‐seven patients with locally advanced or metastatic carcinoma of the esophagus were treated. No prior chemotherapy was allowed. Twelve patients had epidermoid carcinoma (44%) and 15 patients had adenocarcinoma (56%). Patients received IFN‐alpha at a dose of 3 × 106 units/day given daily by subcutaneous injection on days 1 to 28,5‐FU at a dose of 750 mg/m2/day for 5 days by continuous intravenous infusion on days 1 to 5, and cisplatin at a dose of 100 mg/m2 on day 1. Treatment was recycled every 28 days, and after the first three cycles, cisplatin was administered only on alternate cycles. Twenty‐seven patients completed a median of 4 cycles (range, 1–13 cycles), and 26 patients were evaluable for response. Results. Major responses were observed in 13 patients (50%, 95% confidence intervals, 31–69%), including two complete responses (8%). The response proportion in epidermoid carcinoma (8 of 11 patients, 73%) was higher than the response proportion in adenocarcinoma (5 of 15 patients, 33%). The median duration of response was 29 weeks (range, 11–74 weeks), similar in epidermoid carcinoma and adenocarcinoma. Toxicity was moderately severe but manageable with dose attenuations. Grade 3/4 hematologic toxicity was observed in 41% of patients and grade 3/4 nonhematologic toxicity was observed in 26% of patients. IFN‐alpha was reduced to either a 3‐ or 5‐day a week schedule because of fatigue and/or myelosuppression in 12 patients (44%). There were two treatment‐related deaths (7%). Conclusions. In this Phase II trial, the combination of IFN‐alpha, 5‐FU, and cisplatin had substantial antitumor activity in esophageal carcinoma with apparently greater antitumor activity in epidermoid carcinoma than adenocarcinoma. A larger confirmatory trial comparing this treatment to conventional 5‐FU and cisplatin is warranted for epidermoid carcinoma. In future chemotherapy trials, the response assessment for epidermoid and adenocarcinoma should continue to be stratified. Copyright © 1995 American Cancer Society |
| Keywords: | adult; clinical article; aged; clinical trial; fatigue; squamous cell carcinoma; carcinoma, squamous cell; cisplatin; fluorouracil; advanced cancer; cancer combination chemotherapy; liver neoplasms; combined modality therapy; neurotoxicity; adenocarcinoma; nephrotoxicity; phase 2 clinical trial; bone marrow suppression; gastrointestinal symptom; antineoplastic combined chemotherapy protocols; antineoplastic activity; death; drug response; remission induction; injections, subcutaneous; infusions, intravenous; esophagus carcinoma; esophageal neoplasms; esophagectomy; esophageal cancer; intravenous drug administration; metastatic; hematologic diseases; middle age; recombinant alpha2a interferon; unresectable; interferon alfa-2a; subcutaneous drug administration; human; male; female; priority journal; article; support, non-u.s. gov't; interferon‐alpha |
| Journal Title: | Cancer |
| Volume: | 75 |
| Issue: | 9 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 1995-05-01 |
| Start Page: | 2197 |
| End Page: | 2202 |
| Language: | English |
| DOI: | 10.1002/1097-0142(19950501)75:9<2197::aid-cncr2820750902>3.0.co;2-s |
| PUBMED: | 7712428 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 28 August 2018 -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work