Phase II study of interferon gamma in malignant carcinoid tumors (E9292): A trial of the eastern cooperative oncology group

Keith Stuart; Donna E. Levy; Tom Anderson; Constantine A. Axiotis; Janice P. Dutcher; Andrew Eisenberg; John K. Erban; Al Bowen Benson

doi:10.1023/B:DRUG.0000006177.46798.1f

Phase II study of interferon gamma in malignant carcinoid tumors (E9292): A trial of the eastern cooperative oncology group

Keith Stuart^*, Donna E. Levy, Tom Anderson, Constantine A. Axiotis, Janice P. Dutcher, Andrew Eisenberg, John K. Erban, Al Bowen Benson

^*Corresponding author for this work

Medicine, Hematology Oncology Division

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

Abstract

Purpose: To determine the safety and efficacy of treatment with gamma interferon (IFNγ) in patients with metastatic carcinoid tumor. Patients and methods: 51 patients were enrolled on this Phase II Eastern Cooperative Oncology Group (ECOG) study. Seventy five percent of them had hormonally active tumors. Treatment consisted of IFNγ subcutaneously at a daily dose of 0.1 mg/m². Patents were evaluated for toxicity weekly for the first month and monthly thereafter; response was determined radiologically every 8 weeks. Results: Patients received treatment with IFNγ for a median of 17. 9 weeks (range 2-175). Toxicity was generally mild and expected: 61% experienced noninfected fever and 21% developed granulocytopenia. Three patients (6%) had a partial response; there were no complete responses. Median time to progression was 5.5 months (95% confidence interval 3.9-11.1). The 1-year progression free rate was 28% (13.4-43.4%). Median survival was 42 months, with a 1-year survival rate of 67% (53.3-80%). Discussion: This Phase II study demonstrated that therapy with IFNγ in patients with metastatic carcinoid tumor was well-tolerated, but did not produce significant antitumor effects. The overall results were somewhat comparable to those previously seen with alpha interferons as well as cytotoxic drugs.

Original language	English (US)
Pages (from-to)	75-81
Number of pages	7
Journal	Investigational New Drugs
Volume	22
Issue number	1
DOIs	https://doi.org/10.1023/B:DRUG.0000006177.46798.1f
State	Published - Jan 2004

Funding

This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, M.D.) and supported in part by P ublic Health Service Grants CA23318, CA21115, CA80775, CA13650, CA07190 and from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Keywords

Carcinoid
Interferon

ASJC Scopus subject areas

Pharmacology (medical)
Oncology
Pharmacology

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10.1023/B:DRUG.0000006177.46798.1f

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title = "Phase II study of interferon gamma in malignant carcinoid tumors (E9292): A trial of the eastern cooperative oncology group",

abstract = "Purpose: To determine the safety and efficacy of treatment with gamma interferon (IFNγ) in patients with metastatic carcinoid tumor. Patients and methods: 51 patients were enrolled on this Phase II Eastern Cooperative Oncology Group (ECOG) study. Seventy five percent of them had hormonally active tumors. Treatment consisted of IFNγ subcutaneously at a daily dose of 0.1 mg/m2. Patents were evaluated for toxicity weekly for the first month and monthly thereafter; response was determined radiologically every 8 weeks. Results: Patients received treatment with IFNγ for a median of 17. 9 weeks (range 2-175). Toxicity was generally mild and expected: 61% experienced noninfected fever and 21% developed granulocytopenia. Three patients (6%) had a partial response; there were no complete responses. Median time to progression was 5.5 months (95% confidence interval 3.9-11.1). The 1-year progression free rate was 28% (13.4-43.4%). Median survival was 42 months, with a 1-year survival rate of 67% (53.3-80%). Discussion: This Phase II study demonstrated that therapy with IFNγ in patients with metastatic carcinoid tumor was well-tolerated, but did not produce significant antitumor effects. The overall results were somewhat comparable to those previously seen with alpha interferons as well as cytotoxic drugs.",

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note = "Funding Information: This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, M.D.) and supported in part by P ublic Health Service Grants CA23318, CA21115, CA80775, CA13650, CA07190 and from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.",

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doi = "10.1023/B:DRUG.0000006177.46798.1f",

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AU - Anderson, Tom

AU - Axiotis, Constantine A.

AU - Dutcher, Janice P.

AU - Eisenberg, Andrew

AU - Erban, John K.

AU - Benson, Al Bowen

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PY - 2004/1

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N2 - Purpose: To determine the safety and efficacy of treatment with gamma interferon (IFNγ) in patients with metastatic carcinoid tumor. Patients and methods: 51 patients were enrolled on this Phase II Eastern Cooperative Oncology Group (ECOG) study. Seventy five percent of them had hormonally active tumors. Treatment consisted of IFNγ subcutaneously at a daily dose of 0.1 mg/m2. Patents were evaluated for toxicity weekly for the first month and monthly thereafter; response was determined radiologically every 8 weeks. Results: Patients received treatment with IFNγ for a median of 17. 9 weeks (range 2-175). Toxicity was generally mild and expected: 61% experienced noninfected fever and 21% developed granulocytopenia. Three patients (6%) had a partial response; there were no complete responses. Median time to progression was 5.5 months (95% confidence interval 3.9-11.1). The 1-year progression free rate was 28% (13.4-43.4%). Median survival was 42 months, with a 1-year survival rate of 67% (53.3-80%). Discussion: This Phase II study demonstrated that therapy with IFNγ in patients with metastatic carcinoid tumor was well-tolerated, but did not produce significant antitumor effects. The overall results were somewhat comparable to those previously seen with alpha interferons as well as cytotoxic drugs.

AB - Purpose: To determine the safety and efficacy of treatment with gamma interferon (IFNγ) in patients with metastatic carcinoid tumor. Patients and methods: 51 patients were enrolled on this Phase II Eastern Cooperative Oncology Group (ECOG) study. Seventy five percent of them had hormonally active tumors. Treatment consisted of IFNγ subcutaneously at a daily dose of 0.1 mg/m2. Patents were evaluated for toxicity weekly for the first month and monthly thereafter; response was determined radiologically every 8 weeks. Results: Patients received treatment with IFNγ for a median of 17. 9 weeks (range 2-175). Toxicity was generally mild and expected: 61% experienced noninfected fever and 21% developed granulocytopenia. Three patients (6%) had a partial response; there were no complete responses. Median time to progression was 5.5 months (95% confidence interval 3.9-11.1). The 1-year progression free rate was 28% (13.4-43.4%). Median survival was 42 months, with a 1-year survival rate of 67% (53.3-80%). Discussion: This Phase II study demonstrated that therapy with IFNγ in patients with metastatic carcinoid tumor was well-tolerated, but did not produce significant antitumor effects. The overall results were somewhat comparable to those previously seen with alpha interferons as well as cytotoxic drugs.

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Phase II study of interferon gamma in malignant carcinoid tumors (E9292): A trial of the eastern cooperative oncology group

Abstract

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Keywords

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