The feasibility of adjuvant interferon α-2b in children with high-risk melanoma

Fariba Navid, Wayne L. Furman, Martin Fleming, Bhaskar N. Rao, Sandra Kovach, Catherine A. Billups, Alvida M. Cain, Rex Amonette, Jesse J. Jenkins, Alberto S. Pappo

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Abstract

BACKGROUND. It has been shown that induction high-dose interferon α-2b (IFN-α-2b) followed by maintenance therapy improves recurrence-free survival in adults with high-risk, resected melanoma. In this study, the feasibility and toxicity of this regimen were evaluated in newly diagnosed pediatric patients with Stage III melanoma involving regional lymph nodes. METHODS. Fifteen patients age ≤ 18 years with newly diagnosed Stage III melanoma were enrolled on an institutional protocol. Patients were treated with wide local excision, sentinel lymph node biopsy, lymph node dissection, and adjuvant biotherapy, consisting of induction therapy with 20 million IU?m 2 per day IFN-α-2b intravenously 5 times per week for 4 weeks followed by maintenance therapy with IFN-α-2b 10 million IU/m2 per day subcutaneously 3 times per week for 48 weeks. Patients were monitored for toxicity and tumor recurrence. RESULTS. All patients completed induction therapy, and nine patients completed maintenance therapy. Three patients currently are receiving maintenance, 2 patients developed recurrent disease on maintenance therapy, and 1 patient stopped maintenance therapy 5 weeks early. During induction therapy, Grade 3-4 toxicities included 14 episodes of neutropenia in 11 patients, 3 episodes of leukopenia in 2 patients, and 6 episodes of liver transaminase elevations in 5 patients. Dose modifications were required in four patients. During maintenance therapy, Grade 3-4 toxicities included 23 episodes of neutropenia in 10 patients and 2 episodes of liver transaminase elevations in 2 patients. Three patients required dose modifications. All toxicities were reversible with interruption or dose modification of therapy, and no patients were taken off study due to toxicity. CONCLUSIONS. High dose IFN-α-2b for 4 weeks followed by a lower dose maintenance phase for 48 weeks was feasible in children with Stage III melanoma and was associated with tolerable toxicity.

Original languageEnglish (US)
Pages (from-to)780-787
Number of pages8
JournalCancer
Volume103
Issue number4
DOIs
StatePublished - Feb 15 2005

Fingerprint

Interferons
Melanoma
Therapeutics
Transaminases
Neutropenia
Maintenance
Recurrence
Sentinel Lymph Node Biopsy
Biological Therapy
Liver
Leukopenia
Lymph Node Excision

All Science Journal Classification (ASJC) codes

  • Cancer Research
  • Oncology

Cite this

Navid, F., Furman, W. L., Fleming, M., Rao, B. N., Kovach, S., Billups, C. A., ... Pappo, A. S. (2005). The feasibility of adjuvant interferon α-2b in children with high-risk melanoma. Cancer, 103(4), 780-787. https://doi.org/10.1002/cncr.20860

The feasibility of adjuvant interferon α-2b in children with high-risk melanoma. / Navid, Fariba; Furman, Wayne L.; Fleming, Martin; Rao, Bhaskar N.; Kovach, Sandra; Billups, Catherine A.; Cain, Alvida M.; Amonette, Rex; Jenkins, Jesse J.; Pappo, Alberto S.

In: Cancer, Vol. 103, No. 4, 15.02.2005, p. 780-787.

Research output: Contribution to journalArticle

Navid, F, Furman, WL, Fleming, M, Rao, BN, Kovach, S, Billups, CA, Cain, AM, Amonette, R, Jenkins, JJ & Pappo, AS 2005, 'The feasibility of adjuvant interferon α-2b in children with high-risk melanoma', Cancer, vol. 103, no. 4, pp. 780-787. https://doi.org/10.1002/cncr.20860
Navid F, Furman WL, Fleming M, Rao BN, Kovach S, Billups CA et al. The feasibility of adjuvant interferon α-2b in children with high-risk melanoma. Cancer. 2005 Feb 15;103(4):780-787. https://doi.org/10.1002/cncr.20860
Navid, Fariba ; Furman, Wayne L. ; Fleming, Martin ; Rao, Bhaskar N. ; Kovach, Sandra ; Billups, Catherine A. ; Cain, Alvida M. ; Amonette, Rex ; Jenkins, Jesse J. ; Pappo, Alberto S. / The feasibility of adjuvant interferon α-2b in children with high-risk melanoma. In: Cancer. 2005 ; Vol. 103, No. 4. pp. 780-787.
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abstract = "BACKGROUND. It has been shown that induction high-dose interferon α-2b (IFN-α-2b) followed by maintenance therapy improves recurrence-free survival in adults with high-risk, resected melanoma. In this study, the feasibility and toxicity of this regimen were evaluated in newly diagnosed pediatric patients with Stage III melanoma involving regional lymph nodes. METHODS. Fifteen patients age ≤ 18 years with newly diagnosed Stage III melanoma were enrolled on an institutional protocol. Patients were treated with wide local excision, sentinel lymph node biopsy, lymph node dissection, and adjuvant biotherapy, consisting of induction therapy with 20 million IU?m 2 per day IFN-α-2b intravenously 5 times per week for 4 weeks followed by maintenance therapy with IFN-α-2b 10 million IU/m2 per day subcutaneously 3 times per week for 48 weeks. Patients were monitored for toxicity and tumor recurrence. RESULTS. All patients completed induction therapy, and nine patients completed maintenance therapy. Three patients currently are receiving maintenance, 2 patients developed recurrent disease on maintenance therapy, and 1 patient stopped maintenance therapy 5 weeks early. During induction therapy, Grade 3-4 toxicities included 14 episodes of neutropenia in 11 patients, 3 episodes of leukopenia in 2 patients, and 6 episodes of liver transaminase elevations in 5 patients. Dose modifications were required in four patients. During maintenance therapy, Grade 3-4 toxicities included 23 episodes of neutropenia in 10 patients and 2 episodes of liver transaminase elevations in 2 patients. Three patients required dose modifications. All toxicities were reversible with interruption or dose modification of therapy, and no patients were taken off study due to toxicity. CONCLUSIONS. High dose IFN-α-2b for 4 weeks followed by a lower dose maintenance phase for 48 weeks was feasible in children with Stage III melanoma and was associated with tolerable toxicity.",
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AU - Navid, Fariba

AU - Furman, Wayne L.

AU - Fleming, Martin

AU - Rao, Bhaskar N.

AU - Kovach, Sandra

AU - Billups, Catherine A.

AU - Cain, Alvida M.

AU - Amonette, Rex

AU - Jenkins, Jesse J.

AU - Pappo, Alberto S.

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N2 - BACKGROUND. It has been shown that induction high-dose interferon α-2b (IFN-α-2b) followed by maintenance therapy improves recurrence-free survival in adults with high-risk, resected melanoma. In this study, the feasibility and toxicity of this regimen were evaluated in newly diagnosed pediatric patients with Stage III melanoma involving regional lymph nodes. METHODS. Fifteen patients age ≤ 18 years with newly diagnosed Stage III melanoma were enrolled on an institutional protocol. Patients were treated with wide local excision, sentinel lymph node biopsy, lymph node dissection, and adjuvant biotherapy, consisting of induction therapy with 20 million IU?m 2 per day IFN-α-2b intravenously 5 times per week for 4 weeks followed by maintenance therapy with IFN-α-2b 10 million IU/m2 per day subcutaneously 3 times per week for 48 weeks. Patients were monitored for toxicity and tumor recurrence. RESULTS. All patients completed induction therapy, and nine patients completed maintenance therapy. Three patients currently are receiving maintenance, 2 patients developed recurrent disease on maintenance therapy, and 1 patient stopped maintenance therapy 5 weeks early. During induction therapy, Grade 3-4 toxicities included 14 episodes of neutropenia in 11 patients, 3 episodes of leukopenia in 2 patients, and 6 episodes of liver transaminase elevations in 5 patients. Dose modifications were required in four patients. During maintenance therapy, Grade 3-4 toxicities included 23 episodes of neutropenia in 10 patients and 2 episodes of liver transaminase elevations in 2 patients. Three patients required dose modifications. All toxicities were reversible with interruption or dose modification of therapy, and no patients were taken off study due to toxicity. CONCLUSIONS. High dose IFN-α-2b for 4 weeks followed by a lower dose maintenance phase for 48 weeks was feasible in children with Stage III melanoma and was associated with tolerable toxicity.

AB - BACKGROUND. It has been shown that induction high-dose interferon α-2b (IFN-α-2b) followed by maintenance therapy improves recurrence-free survival in adults with high-risk, resected melanoma. In this study, the feasibility and toxicity of this regimen were evaluated in newly diagnosed pediatric patients with Stage III melanoma involving regional lymph nodes. METHODS. Fifteen patients age ≤ 18 years with newly diagnosed Stage III melanoma were enrolled on an institutional protocol. Patients were treated with wide local excision, sentinel lymph node biopsy, lymph node dissection, and adjuvant biotherapy, consisting of induction therapy with 20 million IU?m 2 per day IFN-α-2b intravenously 5 times per week for 4 weeks followed by maintenance therapy with IFN-α-2b 10 million IU/m2 per day subcutaneously 3 times per week for 48 weeks. Patients were monitored for toxicity and tumor recurrence. RESULTS. All patients completed induction therapy, and nine patients completed maintenance therapy. Three patients currently are receiving maintenance, 2 patients developed recurrent disease on maintenance therapy, and 1 patient stopped maintenance therapy 5 weeks early. During induction therapy, Grade 3-4 toxicities included 14 episodes of neutropenia in 11 patients, 3 episodes of leukopenia in 2 patients, and 6 episodes of liver transaminase elevations in 5 patients. Dose modifications were required in four patients. During maintenance therapy, Grade 3-4 toxicities included 23 episodes of neutropenia in 10 patients and 2 episodes of liver transaminase elevations in 2 patients. Three patients required dose modifications. All toxicities were reversible with interruption or dose modification of therapy, and no patients were taken off study due to toxicity. CONCLUSIONS. High dose IFN-α-2b for 4 weeks followed by a lower dose maintenance phase for 48 weeks was feasible in children with Stage III melanoma and was associated with tolerable toxicity.

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