ECOG phase II trial of graded-dose peginterferon a-2b in patients with metastatic melanoma overexpressing basic fibroblast growth factor (E2602)

Ronald S. Go, Sandra J. Lee, Donghoon Shin, Steven M. Callister, Dean A. Jobe, Robert M. Conry, Ahmad A. Tarhini, John M. Kirkwood

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Abstract

Purpose: We investigated the use of graded-dose peginterferon a-2b (Peg-IFN) in patients with stage IV melanoma overexpressing basic fibroblast growth factor (FGF-2). The primary objective was suppression of plasma FGF-2 to within reference range (<7.5 pg/mL). Experimental Design: Plasma FGF-2 was measured at baseline (step 1), and patients with concentrations of 15 pg/mL or more were eligible for study treatment (step 2). Peg-IFN was given weekly at a starting dose of 0.5 μg/kg/wk with increment every 3 weeks based on serial FGF-2 concentrations. Results: Two hundred seven patients entered step 1;45 (22%) overexpressed FGF-2 (median - 22 pg/dL). Twenty-nine eligible patients entered step 2 and received treatment. Patients' median age was 64 years (range, 29-84 years). Most had more than two prior therapies. FGF-2 decreased in 28 (97%) patients, with suppression to reference range in 10 (35%). Median time to FGF-2 suppression was 30 days. The best clinical responses were partial response (7%) and stable disease (17%). Median progression-free survival (PFS) and overall survival (OS) were 2.0 and 9.7 months, respectively. Patients who achieved FGF-2 suppression were more likely than those who did not to have a response or stable disease (P - 0.03). VEGF concentrations decreased in 27 patients (93%) during treatment and paralleled those of FGF-2 over time. We found no compensatory increase in VEGF among those with FGF-2 suppression. Conclusions: Graded-dose Peg-IFN suppresses FGF-2 in patients with metastatic melanoma who overexpress FGF-2. Over one third of patients had complete suppression of plasma FGF-2, which correlated with clinical response to this therapy.

Original languageEnglish (US)
Pages (from-to)6597-6604
Number of pages8
JournalClinical Cancer Research
Volume19
Issue number23
DOIs
StatePublished - Dec 1 2013
Externally publishedYes

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Fibroblast Growth Factor 2
Melanoma
Vascular Endothelial Growth Factor A
Reference Values
Therapeutics
Disease-Free Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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ECOG phase II trial of graded-dose peginterferon a-2b in patients with metastatic melanoma overexpressing basic fibroblast growth factor (E2602). / Go, Ronald S.; Lee, Sandra J.; Shin, Donghoon; Callister, Steven M.; Jobe, Dean A.; Conry, Robert M.; Tarhini, Ahmad A.; Kirkwood, John M.

In: Clinical Cancer Research, Vol. 19, No. 23, 01.12.2013, p. 6597-6604.

Research output: Contribution to journalArticle

Go, Ronald S. ; Lee, Sandra J. ; Shin, Donghoon ; Callister, Steven M. ; Jobe, Dean A. ; Conry, Robert M. ; Tarhini, Ahmad A. ; Kirkwood, John M. / ECOG phase II trial of graded-dose peginterferon a-2b in patients with metastatic melanoma overexpressing basic fibroblast growth factor (E2602). In: Clinical Cancer Research. 2013 ; Vol. 19, No. 23. pp. 6597-6604.
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abstract = "Purpose: We investigated the use of graded-dose peginterferon a-2b (Peg-IFN) in patients with stage IV melanoma overexpressing basic fibroblast growth factor (FGF-2). The primary objective was suppression of plasma FGF-2 to within reference range (<7.5 pg/mL). Experimental Design: Plasma FGF-2 was measured at baseline (step 1), and patients with concentrations of 15 pg/mL or more were eligible for study treatment (step 2). Peg-IFN was given weekly at a starting dose of 0.5 μg/kg/wk with increment every 3 weeks based on serial FGF-2 concentrations. Results: Two hundred seven patients entered step 1;45 (22{\%}) overexpressed FGF-2 (median - 22 pg/dL). Twenty-nine eligible patients entered step 2 and received treatment. Patients' median age was 64 years (range, 29-84 years). Most had more than two prior therapies. FGF-2 decreased in 28 (97{\%}) patients, with suppression to reference range in 10 (35{\%}). Median time to FGF-2 suppression was 30 days. The best clinical responses were partial response (7{\%}) and stable disease (17{\%}). Median progression-free survival (PFS) and overall survival (OS) were 2.0 and 9.7 months, respectively. Patients who achieved FGF-2 suppression were more likely than those who did not to have a response or stable disease (P - 0.03). VEGF concentrations decreased in 27 patients (93{\%}) during treatment and paralleled those of FGF-2 over time. We found no compensatory increase in VEGF among those with FGF-2 suppression. Conclusions: Graded-dose Peg-IFN suppresses FGF-2 in patients with metastatic melanoma who overexpress FGF-2. Over one third of patients had complete suppression of plasma FGF-2, which correlated with clinical response to this therapy.",
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AU - Go, Ronald S.

AU - Lee, Sandra J.

AU - Shin, Donghoon

AU - Callister, Steven M.

AU - Jobe, Dean A.

AU - Conry, Robert M.

AU - Tarhini, Ahmad A.

AU - Kirkwood, John M.

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Y1 - 2013/12/1

N2 - Purpose: We investigated the use of graded-dose peginterferon a-2b (Peg-IFN) in patients with stage IV melanoma overexpressing basic fibroblast growth factor (FGF-2). The primary objective was suppression of plasma FGF-2 to within reference range (<7.5 pg/mL). Experimental Design: Plasma FGF-2 was measured at baseline (step 1), and patients with concentrations of 15 pg/mL or more were eligible for study treatment (step 2). Peg-IFN was given weekly at a starting dose of 0.5 μg/kg/wk with increment every 3 weeks based on serial FGF-2 concentrations. Results: Two hundred seven patients entered step 1;45 (22%) overexpressed FGF-2 (median - 22 pg/dL). Twenty-nine eligible patients entered step 2 and received treatment. Patients' median age was 64 years (range, 29-84 years). Most had more than two prior therapies. FGF-2 decreased in 28 (97%) patients, with suppression to reference range in 10 (35%). Median time to FGF-2 suppression was 30 days. The best clinical responses were partial response (7%) and stable disease (17%). Median progression-free survival (PFS) and overall survival (OS) were 2.0 and 9.7 months, respectively. Patients who achieved FGF-2 suppression were more likely than those who did not to have a response or stable disease (P - 0.03). VEGF concentrations decreased in 27 patients (93%) during treatment and paralleled those of FGF-2 over time. We found no compensatory increase in VEGF among those with FGF-2 suppression. Conclusions: Graded-dose Peg-IFN suppresses FGF-2 in patients with metastatic melanoma who overexpress FGF-2. Over one third of patients had complete suppression of plasma FGF-2, which correlated with clinical response to this therapy.

AB - Purpose: We investigated the use of graded-dose peginterferon a-2b (Peg-IFN) in patients with stage IV melanoma overexpressing basic fibroblast growth factor (FGF-2). The primary objective was suppression of plasma FGF-2 to within reference range (<7.5 pg/mL). Experimental Design: Plasma FGF-2 was measured at baseline (step 1), and patients with concentrations of 15 pg/mL or more were eligible for study treatment (step 2). Peg-IFN was given weekly at a starting dose of 0.5 μg/kg/wk with increment every 3 weeks based on serial FGF-2 concentrations. Results: Two hundred seven patients entered step 1;45 (22%) overexpressed FGF-2 (median - 22 pg/dL). Twenty-nine eligible patients entered step 2 and received treatment. Patients' median age was 64 years (range, 29-84 years). Most had more than two prior therapies. FGF-2 decreased in 28 (97%) patients, with suppression to reference range in 10 (35%). Median time to FGF-2 suppression was 30 days. The best clinical responses were partial response (7%) and stable disease (17%). Median progression-free survival (PFS) and overall survival (OS) were 2.0 and 9.7 months, respectively. Patients who achieved FGF-2 suppression were more likely than those who did not to have a response or stable disease (P - 0.03). VEGF concentrations decreased in 27 patients (93%) during treatment and paralleled those of FGF-2 over time. We found no compensatory increase in VEGF among those with FGF-2 suppression. Conclusions: Graded-dose Peg-IFN suppresses FGF-2 in patients with metastatic melanoma who overexpress FGF-2. Over one third of patients had complete suppression of plasma FGF-2, which correlated with clinical response to this therapy.

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