A Phase II Trial of Vinorelbine Tartrate in Patients with Disseminated Malignant Melanoma and One Prior Systemic Therapy: A Southwest Oncology Group Study

Robert P. Whitehead, James Moon, S. Spence McCachren, Evan M Hersh, Wolfram E. Samlowski, J. Thaddeus Beck, Nerses S. Tchekmedyian, Vernon K. Sondak

Research output: Contribution to journalArticle

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Abstract

BACKGROUND. Single-agent chemotherapy with dacarbazine continues to be the standard of care for the treatment of metastatic melanoma. However, there is a large population of patients who have failed first-line therapy and might benefit from additional treatment. In the current study, the authors evaluated the antitumor effects and toxicity of vinorelbine therapy in patients who had failed one prior systemic therapy. METHODS. Patients were required to have a histologic diagnosis of melanoma and be of Stage IV with measurable disease, a Southwest Oncology Group (SWOG) performance status (PS) of 0-2, no evidence of brain metastases, and adequate bone marrow and liver function. Treatment was comprised of vinorelbine given at a dose of 30 mg/m2/week by intravenous bolus. RESULTS. Twenty-four patients were registered to the study, 3 of whom were determined to be ineligible. The 21 eligible patients had a median age of 58 years with a SWOG PS of 0 in 7 patients, 1 in 13 patients, and 2 in 1 patient. There were no complete or partial responses observed, for a response rate of 0 of the 21 patients studied (95% confidence interval [95% CI], 0-16%); the study closed after the first stage of accrual. The estimated median progression-free survival was 2 months (95% CI, 1.5-3.3 months) and the estimated median overall survival was 6 months (95% CI, 3.7-8.3 months). There was one death due to febrile neutropenia reported, with six patients experiencing one or more Grade 4 toxicities, including neutropenia/granulocytopenia, leukopenia, dyspnea, and fatigue. CONCLUSIONS. Despite impressive preclinical activity against melanoma, vinorelbine does not appear to have enough clinical activity to be of interest in previously treated patients with disseminated melanoma. The progression-free and overall survival results noted in previously treated patients in the current study were similar to results reported in prior SWOG Phase II trials in untreated patients. The group of previously treated patients may be used to evaluate new agents for the treatment of disseminated melanoma.

Original languageEnglish (US)
Pages (from-to)1699-1704
Number of pages6
JournalCancer
Volume100
Issue number8
DOIs
StatePublished - Apr 15 2004

Fingerprint

Melanoma
Therapeutics
Confidence Intervals
vinorelbine
Disease-Free Survival
Febrile Neutropenia
Dacarbazine
Agranulocytosis
Leukopenia
Standard of Care
Neutropenia
Dyspnea
Fatigue
Bone Marrow
Neoplasm Metastasis
Drug Therapy

Keywords

  • Disseminated melanoma
  • Phase II trial
  • Previously treated patients
  • Southwest Oncology Group
  • Toxicity
  • Vinorelbine

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A Phase II Trial of Vinorelbine Tartrate in Patients with Disseminated Malignant Melanoma and One Prior Systemic Therapy : A Southwest Oncology Group Study. / Whitehead, Robert P.; Moon, James; McCachren, S. Spence; Hersh, Evan M; Samlowski, Wolfram E.; Beck, J. Thaddeus; Tchekmedyian, Nerses S.; Sondak, Vernon K.

In: Cancer, Vol. 100, No. 8, 15.04.2004, p. 1699-1704.

Research output: Contribution to journalArticle

Whitehead, RP, Moon, J, McCachren, SS, Hersh, EM, Samlowski, WE, Beck, JT, Tchekmedyian, NS & Sondak, VK 2004, 'A Phase II Trial of Vinorelbine Tartrate in Patients with Disseminated Malignant Melanoma and One Prior Systemic Therapy: A Southwest Oncology Group Study', Cancer, vol. 100, no. 8, pp. 1699-1704. https://doi.org/10.1002/cncr.20183
Whitehead, Robert P. ; Moon, James ; McCachren, S. Spence ; Hersh, Evan M ; Samlowski, Wolfram E. ; Beck, J. Thaddeus ; Tchekmedyian, Nerses S. ; Sondak, Vernon K. / A Phase II Trial of Vinorelbine Tartrate in Patients with Disseminated Malignant Melanoma and One Prior Systemic Therapy : A Southwest Oncology Group Study. In: Cancer. 2004 ; Vol. 100, No. 8. pp. 1699-1704.
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title = "A Phase II Trial of Vinorelbine Tartrate in Patients with Disseminated Malignant Melanoma and One Prior Systemic Therapy: A Southwest Oncology Group Study",
abstract = "BACKGROUND. Single-agent chemotherapy with dacarbazine continues to be the standard of care for the treatment of metastatic melanoma. However, there is a large population of patients who have failed first-line therapy and might benefit from additional treatment. In the current study, the authors evaluated the antitumor effects and toxicity of vinorelbine therapy in patients who had failed one prior systemic therapy. METHODS. Patients were required to have a histologic diagnosis of melanoma and be of Stage IV with measurable disease, a Southwest Oncology Group (SWOG) performance status (PS) of 0-2, no evidence of brain metastases, and adequate bone marrow and liver function. Treatment was comprised of vinorelbine given at a dose of 30 mg/m2/week by intravenous bolus. RESULTS. Twenty-four patients were registered to the study, 3 of whom were determined to be ineligible. The 21 eligible patients had a median age of 58 years with a SWOG PS of 0 in 7 patients, 1 in 13 patients, and 2 in 1 patient. There were no complete or partial responses observed, for a response rate of 0 of the 21 patients studied (95{\%} confidence interval [95{\%} CI], 0-16{\%}); the study closed after the first stage of accrual. The estimated median progression-free survival was 2 months (95{\%} CI, 1.5-3.3 months) and the estimated median overall survival was 6 months (95{\%} CI, 3.7-8.3 months). There was one death due to febrile neutropenia reported, with six patients experiencing one or more Grade 4 toxicities, including neutropenia/granulocytopenia, leukopenia, dyspnea, and fatigue. CONCLUSIONS. Despite impressive preclinical activity against melanoma, vinorelbine does not appear to have enough clinical activity to be of interest in previously treated patients with disseminated melanoma. The progression-free and overall survival results noted in previously treated patients in the current study were similar to results reported in prior SWOG Phase II trials in untreated patients. The group of previously treated patients may be used to evaluate new agents for the treatment of disseminated melanoma.",
keywords = "Disseminated melanoma, Phase II trial, Previously treated patients, Southwest Oncology Group, Toxicity, Vinorelbine",
author = "Whitehead, {Robert P.} and James Moon and McCachren, {S. Spence} and Hersh, {Evan M} and Samlowski, {Wolfram E.} and Beck, {J. Thaddeus} and Tchekmedyian, {Nerses S.} and Sondak, {Vernon K.}",
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T1 - A Phase II Trial of Vinorelbine Tartrate in Patients with Disseminated Malignant Melanoma and One Prior Systemic Therapy

T2 - A Southwest Oncology Group Study

AU - Whitehead, Robert P.

AU - Moon, James

AU - McCachren, S. Spence

AU - Hersh, Evan M

AU - Samlowski, Wolfram E.

AU - Beck, J. Thaddeus

AU - Tchekmedyian, Nerses S.

AU - Sondak, Vernon K.

PY - 2004/4/15

Y1 - 2004/4/15

N2 - BACKGROUND. Single-agent chemotherapy with dacarbazine continues to be the standard of care for the treatment of metastatic melanoma. However, there is a large population of patients who have failed first-line therapy and might benefit from additional treatment. In the current study, the authors evaluated the antitumor effects and toxicity of vinorelbine therapy in patients who had failed one prior systemic therapy. METHODS. Patients were required to have a histologic diagnosis of melanoma and be of Stage IV with measurable disease, a Southwest Oncology Group (SWOG) performance status (PS) of 0-2, no evidence of brain metastases, and adequate bone marrow and liver function. Treatment was comprised of vinorelbine given at a dose of 30 mg/m2/week by intravenous bolus. RESULTS. Twenty-four patients were registered to the study, 3 of whom were determined to be ineligible. The 21 eligible patients had a median age of 58 years with a SWOG PS of 0 in 7 patients, 1 in 13 patients, and 2 in 1 patient. There were no complete or partial responses observed, for a response rate of 0 of the 21 patients studied (95% confidence interval [95% CI], 0-16%); the study closed after the first stage of accrual. The estimated median progression-free survival was 2 months (95% CI, 1.5-3.3 months) and the estimated median overall survival was 6 months (95% CI, 3.7-8.3 months). There was one death due to febrile neutropenia reported, with six patients experiencing one or more Grade 4 toxicities, including neutropenia/granulocytopenia, leukopenia, dyspnea, and fatigue. CONCLUSIONS. Despite impressive preclinical activity against melanoma, vinorelbine does not appear to have enough clinical activity to be of interest in previously treated patients with disseminated melanoma. The progression-free and overall survival results noted in previously treated patients in the current study were similar to results reported in prior SWOG Phase II trials in untreated patients. The group of previously treated patients may be used to evaluate new agents for the treatment of disseminated melanoma.

AB - BACKGROUND. Single-agent chemotherapy with dacarbazine continues to be the standard of care for the treatment of metastatic melanoma. However, there is a large population of patients who have failed first-line therapy and might benefit from additional treatment. In the current study, the authors evaluated the antitumor effects and toxicity of vinorelbine therapy in patients who had failed one prior systemic therapy. METHODS. Patients were required to have a histologic diagnosis of melanoma and be of Stage IV with measurable disease, a Southwest Oncology Group (SWOG) performance status (PS) of 0-2, no evidence of brain metastases, and adequate bone marrow and liver function. Treatment was comprised of vinorelbine given at a dose of 30 mg/m2/week by intravenous bolus. RESULTS. Twenty-four patients were registered to the study, 3 of whom were determined to be ineligible. The 21 eligible patients had a median age of 58 years with a SWOG PS of 0 in 7 patients, 1 in 13 patients, and 2 in 1 patient. There were no complete or partial responses observed, for a response rate of 0 of the 21 patients studied (95% confidence interval [95% CI], 0-16%); the study closed after the first stage of accrual. The estimated median progression-free survival was 2 months (95% CI, 1.5-3.3 months) and the estimated median overall survival was 6 months (95% CI, 3.7-8.3 months). There was one death due to febrile neutropenia reported, with six patients experiencing one or more Grade 4 toxicities, including neutropenia/granulocytopenia, leukopenia, dyspnea, and fatigue. CONCLUSIONS. Despite impressive preclinical activity against melanoma, vinorelbine does not appear to have enough clinical activity to be of interest in previously treated patients with disseminated melanoma. The progression-free and overall survival results noted in previously treated patients in the current study were similar to results reported in prior SWOG Phase II trials in untreated patients. The group of previously treated patients may be used to evaluate new agents for the treatment of disseminated melanoma.

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KW - Phase II trial

KW - Previously treated patients

KW - Southwest Oncology Group

KW - Toxicity

KW - Vinorelbine

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