Phase II clinical trial of 13-cis-retinoic acid and interferon-α-2a in patients with advanced esophageal carcinoma Journal Article
| Authors: | Enzinger, P. C.; Ilson, D. H.; Saltz, L. B.; Martin, L. K.; Kelsen, D. P. |
| Article Title: | Phase II clinical trial of 13-cis-retinoic acid and interferon-α-2a in patients with advanced esophageal carcinoma |
| Abstract: | BACKGROUND. Interferon in combination with 5-fluorouracil has been shown to be active in squamous cell carcinoma (SCC) and adenocarcinoma (AC) of the esophagus. 13-cis-retinoic acid (CRA) has chemopreventive activity in SCC of the head and neck, and, in combination with interferon, has antitumor activity in SCC of the skin and cervix. METHODS. The activity and toxicity of CRA and interferon-α-2a (IFN) in patients with advanced esophageal carcinoma was evaluated in a Phase II single institution thai. Patients had unresectable or metastatic AC or SCC of the esophagus. One prior chemotherapy regimen was allowed. IFN was given by daily subcutaneous injection at a dose of 3 million U and CRA was taken orally at a dose of 1 mg/kg/day in 2 divided doses. Treatment was given in cycles of 4 weeks and continued until documented disease progression. RESULTS. Of the 19 patients entered, 15 were evaluable for response and toxicity. One patient was evaluable for response only and one patient was evaluable for toxicity only. Evaluable patients were predominantly male (15 patients), and had AC (13 patients). All had AICC Stage IV disease and 12 were pretreated. Patients completed an average of two cycles of therapy (range, one to six cycles) prior to progression of disease. National Cancer Institute Common Toxicity Criteria Grade 3/4 toxicity was notable for nausea (25%) and fatigue (31%). No major objective responses were recorded. Eleven patients with AC and 3 patients with SCC had rapid progression of disease. One patient with AC was found to have a minor response for 22 weeks and 1 patient with AC had stable disease for 45 weeks. CONCLUSIONS. This regimen had no significant activity in patients with advanced AC of the esophagus. Further evaluation of IFN plus CRA, using this dose and schedule, is not recommended. In comparison with prior trials of this therapy, a surprising amount of severe nausea and fatigue was observed in this trial. |
| Keywords: | adult; cancer chemotherapy; clinical article; treatment outcome; aged; middle aged; clinical trial; carcinoma, squamous cell; advanced cancer; drug efficacy; adenocarcinoma; phase 2 clinical trial; bone marrow suppression; antineoplastic combined chemotherapy protocols; drug screening; drug response; isotretinoin; esophagus carcinoma; esophageal neoplasms; drug induced disease; oral drug administration; esophageal carcinoma; interferon-α; recombinant alpha2a interferon; cheilitis; 13-cis-retinoic acid; interferon alfa-2a; subcutaneous drug administration; humans; human; male; female; priority journal; article |
| Journal Title: | Cancer |
| Volume: | 85 |
| Issue: | 6 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 1999-03-15 |
| Start Page: | 1213 |
| End Page: | 1237 |
| Language: | English |
| DOI: | 10.1002/(sici)1097-0142(19990315)85:6<1213::aid-cncr1>3.0.co;2-n |
| PUBMED: | 10189124 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 16 August 2016 -- Source: Scopus |
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