A phase II trial of etoposide, leucovorin, 5-FU, and interferon alpha 2b (ELFI) + G-CSF for patients with pancreatic adenocarcinoma

A Southwest Oncology Group study (SWOG 9413)

John S. Macdonald, Joth L. Jacobson, Manuel Modiano, Dennis F. Moore, David R Gandara, Louis E. Schroder, Robert A. Chapman

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background. Chemotherapeutic treatments using combinations of etoposide, leucovorin and 5-FU (ELF) have shown activity in the treatment of gastrointestinal malignancies. Interferon alpha 2b is known to have antiproliferative effects on several cell lines and has well documented in vitro evidence of synergism with 5-FU. It was postulated that the combination of ELF and interferon alpha 2b would improve response rates and survival in patients with pancreas cancer. Methods. Fifty-five eligible patients with locally-advanced or metastatic pancreatic adenocarcinoma received a regimen consisting of: IV leucovorin at 300 mg/m2/day on Days 1-3 (of 28-day cycle), IV etoposide at 80 mg/m2/day on Days 1-3, IV 5-FU at 500 mg/m2/day on Days 1-3, subcutaneous interferon alpha 2b at 3 million units TIW, and subcutaneous G-CSF at 5 μg/kg/day on Days 4-14 (or until WBC exceeds 10,000/μl). Patients with no evidence of disease progression continued on treatment for a total of 6 cycles. Results. Complete response was demonstrated in 1 patient, partial response in 5 patients (11% confirmed response rate). The median survival was 5 months, and the six-month survival rate was 40%. Ten patients completed all 6 cycles of treatment. Toxicity-related dose delays and reductions were necessary for most patients. Conclusions. Although the combination of ELF and interferon alpha 2b (ELFI) has modest activity in pancreatic cancer, it is a toxic and complex regimen that is not superior to other currently available approaches for the chemotherapeutic management of pancreatic cancer. ELFI cannot be recommended as a standard therapy.

Original languageEnglish (US)
Pages (from-to)269-273
Number of pages5
JournalInvestigational New Drugs
Volume18
Issue number3
DOIs
StatePublished - 2000

Fingerprint

interferon alfa-2b
Leucovorin
Granulocyte Colony-Stimulating Factor
Etoposide
Fluorouracil
Adenocarcinoma
Pancreatic Neoplasms
Survival Rate
Therapeutics
Poisons
Disease Progression

Keywords

  • 5-fluorouracil
  • Combination chemotherapy
  • Etoposide
  • Interferon alpha
  • Pancreatic cancer

ASJC Scopus subject areas

  • Molecular Medicine
  • Pharmacology

Cite this

A phase II trial of etoposide, leucovorin, 5-FU, and interferon alpha 2b (ELFI) + G-CSF for patients with pancreatic adenocarcinoma : A Southwest Oncology Group study (SWOG 9413). / Macdonald, John S.; Jacobson, Joth L.; Modiano, Manuel; Moore, Dennis F.; Gandara, David R; Schroder, Louis E.; Chapman, Robert A.

In: Investigational New Drugs, Vol. 18, No. 3, 2000, p. 269-273.

Research output: Contribution to journalArticle

Macdonald, John S. ; Jacobson, Joth L. ; Modiano, Manuel ; Moore, Dennis F. ; Gandara, David R ; Schroder, Louis E. ; Chapman, Robert A. / A phase II trial of etoposide, leucovorin, 5-FU, and interferon alpha 2b (ELFI) + G-CSF for patients with pancreatic adenocarcinoma : A Southwest Oncology Group study (SWOG 9413). In: Investigational New Drugs. 2000 ; Vol. 18, No. 3. pp. 269-273.
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abstract = "Background. Chemotherapeutic treatments using combinations of etoposide, leucovorin and 5-FU (ELF) have shown activity in the treatment of gastrointestinal malignancies. Interferon alpha 2b is known to have antiproliferative effects on several cell lines and has well documented in vitro evidence of synergism with 5-FU. It was postulated that the combination of ELF and interferon alpha 2b would improve response rates and survival in patients with pancreas cancer. Methods. Fifty-five eligible patients with locally-advanced or metastatic pancreatic adenocarcinoma received a regimen consisting of: IV leucovorin at 300 mg/m2/day on Days 1-3 (of 28-day cycle), IV etoposide at 80 mg/m2/day on Days 1-3, IV 5-FU at 500 mg/m2/day on Days 1-3, subcutaneous interferon alpha 2b at 3 million units TIW, and subcutaneous G-CSF at 5 μg/kg/day on Days 4-14 (or until WBC exceeds 10,000/μl). Patients with no evidence of disease progression continued on treatment for a total of 6 cycles. Results. Complete response was demonstrated in 1 patient, partial response in 5 patients (11{\%} confirmed response rate). The median survival was 5 months, and the six-month survival rate was 40{\%}. Ten patients completed all 6 cycles of treatment. Toxicity-related dose delays and reductions were necessary for most patients. Conclusions. Although the combination of ELF and interferon alpha 2b (ELFI) has modest activity in pancreatic cancer, it is a toxic and complex regimen that is not superior to other currently available approaches for the chemotherapeutic management of pancreatic cancer. ELFI cannot be recommended as a standard therapy.",
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T1 - A phase II trial of etoposide, leucovorin, 5-FU, and interferon alpha 2b (ELFI) + G-CSF for patients with pancreatic adenocarcinoma

T2 - A Southwest Oncology Group study (SWOG 9413)

AU - Macdonald, John S.

AU - Jacobson, Joth L.

AU - Modiano, Manuel

AU - Moore, Dennis F.

AU - Gandara, David R

AU - Schroder, Louis E.

AU - Chapman, Robert A.

PY - 2000

Y1 - 2000

N2 - Background. Chemotherapeutic treatments using combinations of etoposide, leucovorin and 5-FU (ELF) have shown activity in the treatment of gastrointestinal malignancies. Interferon alpha 2b is known to have antiproliferative effects on several cell lines and has well documented in vitro evidence of synergism with 5-FU. It was postulated that the combination of ELF and interferon alpha 2b would improve response rates and survival in patients with pancreas cancer. Methods. Fifty-five eligible patients with locally-advanced or metastatic pancreatic adenocarcinoma received a regimen consisting of: IV leucovorin at 300 mg/m2/day on Days 1-3 (of 28-day cycle), IV etoposide at 80 mg/m2/day on Days 1-3, IV 5-FU at 500 mg/m2/day on Days 1-3, subcutaneous interferon alpha 2b at 3 million units TIW, and subcutaneous G-CSF at 5 μg/kg/day on Days 4-14 (or until WBC exceeds 10,000/μl). Patients with no evidence of disease progression continued on treatment for a total of 6 cycles. Results. Complete response was demonstrated in 1 patient, partial response in 5 patients (11% confirmed response rate). The median survival was 5 months, and the six-month survival rate was 40%. Ten patients completed all 6 cycles of treatment. Toxicity-related dose delays and reductions were necessary for most patients. Conclusions. Although the combination of ELF and interferon alpha 2b (ELFI) has modest activity in pancreatic cancer, it is a toxic and complex regimen that is not superior to other currently available approaches for the chemotherapeutic management of pancreatic cancer. ELFI cannot be recommended as a standard therapy.

AB - Background. Chemotherapeutic treatments using combinations of etoposide, leucovorin and 5-FU (ELF) have shown activity in the treatment of gastrointestinal malignancies. Interferon alpha 2b is known to have antiproliferative effects on several cell lines and has well documented in vitro evidence of synergism with 5-FU. It was postulated that the combination of ELF and interferon alpha 2b would improve response rates and survival in patients with pancreas cancer. Methods. Fifty-five eligible patients with locally-advanced or metastatic pancreatic adenocarcinoma received a regimen consisting of: IV leucovorin at 300 mg/m2/day on Days 1-3 (of 28-day cycle), IV etoposide at 80 mg/m2/day on Days 1-3, IV 5-FU at 500 mg/m2/day on Days 1-3, subcutaneous interferon alpha 2b at 3 million units TIW, and subcutaneous G-CSF at 5 μg/kg/day on Days 4-14 (or until WBC exceeds 10,000/μl). Patients with no evidence of disease progression continued on treatment for a total of 6 cycles. Results. Complete response was demonstrated in 1 patient, partial response in 5 patients (11% confirmed response rate). The median survival was 5 months, and the six-month survival rate was 40%. Ten patients completed all 6 cycles of treatment. Toxicity-related dose delays and reductions were necessary for most patients. Conclusions. Although the combination of ELF and interferon alpha 2b (ELFI) has modest activity in pancreatic cancer, it is a toxic and complex regimen that is not superior to other currently available approaches for the chemotherapeutic management of pancreatic cancer. ELFI cannot be recommended as a standard therapy.

KW - 5-fluorouracil

KW - Combination chemotherapy

KW - Etoposide

KW - Interferon alpha

KW - Pancreatic cancer

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