A phase II study of high-dose paclitaxel in patients with advanced neuroendocrine tumors

Stephen Maxted Ansell, Henry Clement Pitot, Patrick A. Burch, Larry K. Kvols, Michelle R. Mahoney, Joseph Rubin

Research output: Contribution to journalArticle

92 Citations (Scopus)

Abstract

BACKGROUND. New agents with antitumor activity in patients with neuroendocrine tumors are sorely needed. A Phase II study of high-dose paclitaxel in patients with metastatic carcinoid and islet cell tumors was performed at the Mayo Clinic. Granulocyte-colony-stimulating factor (GCSF) also was administered to ameliorate neutropenia. METHODS. Twenty-four patients (14 with carcinoid tumors, 9 with islet cell tumors, and 1 with an anaplastic tumor) were enrolled on this Phase II study of paclitaxel given as a 24-hour continuous infusion at a dose of 250 mg/m2 every 3 weeks plus GCSF at a dose of 5 μg/kg/day subcutaneously, beginning 24 hours after the completion of the paclitaxel dose and continuing until the absolute neutrophil count was > 10,000/μL. RESULTS. All 24 patients were evaluable for analysis. The overall response rate was 8% (95% confidence interval [95% CI], 0-0.11). At last follow-up all patients except 1 had developed disease progression, with an estimated median time to disease progression of 3.2 months (95% CI, 1.6-6.0 months). The estimated median survival was 1.5 years (95% CI, 1.0-1.8 years). Hematologic toxicity was significant with 12 of 24 patients developing Grade 4 (according to the National Cancer Institute Common Toxicity Criteria scale) neutropenia; however, there were no septic deaths reported. There were 17 episodes of Grade 4 neutropenia in these 12 patients and the duration of these events ranged from 2-5 days. More common nonhematologic toxicities included arthralgia (21 patients), anorexia (15 patients), nausea (15 patients), diarrhea (12 patients), and allergic reactions (2 patients). CONCLUSIONS. Given the lack of antitumor activity of paclitaxel and the significant hematologic toxicity observed despite the use of GCSF support in the current study cohort of patients with neuroendocrine tumors, further studies of this combination in this particular patient population are not recommended.

Original languageEnglish (US)
Pages (from-to)1543-1548
Number of pages6
JournalCancer
Volume91
Issue number8
DOIs
StatePublished - Apr 15 2001

Fingerprint

Neuroendocrine Tumors
Paclitaxel
Granulocyte Colony-Stimulating Factor
Neutropenia
Islet Cell Adenoma
Carcinoid Tumor
Confidence Intervals
Disease Progression
National Cancer Institute (U.S.)
Arthralgia
Anorexia
Antineoplastic Agents
Nausea
Diarrhea

Keywords

  • Carcinoid tumor
  • Islet cell tumor
  • Neuroendocrine tumors
  • Paclitaxel

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A phase II study of high-dose paclitaxel in patients with advanced neuroendocrine tumors. / Ansell, Stephen Maxted; Pitot, Henry Clement; Burch, Patrick A.; Kvols, Larry K.; Mahoney, Michelle R.; Rubin, Joseph.

In: Cancer, Vol. 91, No. 8, 15.04.2001, p. 1543-1548.

Research output: Contribution to journalArticle

Ansell, Stephen Maxted ; Pitot, Henry Clement ; Burch, Patrick A. ; Kvols, Larry K. ; Mahoney, Michelle R. ; Rubin, Joseph. / A phase II study of high-dose paclitaxel in patients with advanced neuroendocrine tumors. In: Cancer. 2001 ; Vol. 91, No. 8. pp. 1543-1548.
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AU - Rubin, Joseph

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N2 - BACKGROUND. New agents with antitumor activity in patients with neuroendocrine tumors are sorely needed. A Phase II study of high-dose paclitaxel in patients with metastatic carcinoid and islet cell tumors was performed at the Mayo Clinic. Granulocyte-colony-stimulating factor (GCSF) also was administered to ameliorate neutropenia. METHODS. Twenty-four patients (14 with carcinoid tumors, 9 with islet cell tumors, and 1 with an anaplastic tumor) were enrolled on this Phase II study of paclitaxel given as a 24-hour continuous infusion at a dose of 250 mg/m2 every 3 weeks plus GCSF at a dose of 5 μg/kg/day subcutaneously, beginning 24 hours after the completion of the paclitaxel dose and continuing until the absolute neutrophil count was > 10,000/μL. RESULTS. All 24 patients were evaluable for analysis. The overall response rate was 8% (95% confidence interval [95% CI], 0-0.11). At last follow-up all patients except 1 had developed disease progression, with an estimated median time to disease progression of 3.2 months (95% CI, 1.6-6.0 months). The estimated median survival was 1.5 years (95% CI, 1.0-1.8 years). Hematologic toxicity was significant with 12 of 24 patients developing Grade 4 (according to the National Cancer Institute Common Toxicity Criteria scale) neutropenia; however, there were no septic deaths reported. There were 17 episodes of Grade 4 neutropenia in these 12 patients and the duration of these events ranged from 2-5 days. More common nonhematologic toxicities included arthralgia (21 patients), anorexia (15 patients), nausea (15 patients), diarrhea (12 patients), and allergic reactions (2 patients). CONCLUSIONS. Given the lack of antitumor activity of paclitaxel and the significant hematologic toxicity observed despite the use of GCSF support in the current study cohort of patients with neuroendocrine tumors, further studies of this combination in this particular patient population are not recommended.

AB - BACKGROUND. New agents with antitumor activity in patients with neuroendocrine tumors are sorely needed. A Phase II study of high-dose paclitaxel in patients with metastatic carcinoid and islet cell tumors was performed at the Mayo Clinic. Granulocyte-colony-stimulating factor (GCSF) also was administered to ameliorate neutropenia. METHODS. Twenty-four patients (14 with carcinoid tumors, 9 with islet cell tumors, and 1 with an anaplastic tumor) were enrolled on this Phase II study of paclitaxel given as a 24-hour continuous infusion at a dose of 250 mg/m2 every 3 weeks plus GCSF at a dose of 5 μg/kg/day subcutaneously, beginning 24 hours after the completion of the paclitaxel dose and continuing until the absolute neutrophil count was > 10,000/μL. RESULTS. All 24 patients were evaluable for analysis. The overall response rate was 8% (95% confidence interval [95% CI], 0-0.11). At last follow-up all patients except 1 had developed disease progression, with an estimated median time to disease progression of 3.2 months (95% CI, 1.6-6.0 months). The estimated median survival was 1.5 years (95% CI, 1.0-1.8 years). Hematologic toxicity was significant with 12 of 24 patients developing Grade 4 (according to the National Cancer Institute Common Toxicity Criteria scale) neutropenia; however, there were no septic deaths reported. There were 17 episodes of Grade 4 neutropenia in these 12 patients and the duration of these events ranged from 2-5 days. More common nonhematologic toxicities included arthralgia (21 patients), anorexia (15 patients), nausea (15 patients), diarrhea (12 patients), and allergic reactions (2 patients). CONCLUSIONS. Given the lack of antitumor activity of paclitaxel and the significant hematologic toxicity observed despite the use of GCSF support in the current study cohort of patients with neuroendocrine tumors, further studies of this combination in this particular patient population are not recommended.

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