A phase II study of mitomycin C, cisplatin and protracted infusional 5-fluorouracil in advanced pancreatic carcinoma: efficacy and low toxicity

Russell David Petty, M. C. Nicolson, T. S. Sinclair, S. Skaria, Leslie Samuel, M. Koruth, Aberdeen Pancreatic Cancer Focus Group

Research output: Contribution to journalArticle

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Abstract

Background: The effective treatment of unresectable pancreatic carcinoma represents a formidable challenge. There is a need to develop systemic therapies which combine efficacy with acceptable toxicity. The current 'gold standard' gemcitabine gives an objective response rate of the order of 20% and median survival up to 6 months. Here we have evaluated the efficacy and toxicity of mitomycin C, cisplatin and protracted infusional 5-fluorouracil (MCF).

Patients and methods: Forty-five patients with locally advanced (13 patients) or metastatic (32 patients) pancreatic carcinoma were treated with mitomycin C7 mg/m(2) 6 weekly, cisplatin 60 mg/m(2) 3 weekly and protracted venous infusion 5-FU 300 mg/m(2)/day. Patients were evaluated for response after three cycles and received six cycles in total in the absence of progressive disease or poor tolerance. Median age was 62 (45-75) years; 41 patients were World Health Organization performance status 0-1.

Results: Treatment was well tolerated with 36 (84%) patients completing three or more cycles. Grade 3 or 4 toxicities were uncommon: anaemia in three patients (7%), mucositis in two (5%), nausea and vomiting in three (7%) and diarrhoea in one (1%). An objective response was seen in 21 (46%) patients. There was one complete response. The median survival overall was 7.1 months and 10.5 months in responders. The median duration of response was 4.3 months. One-year survival was 29%, 2-year survival was 18%.

Conclusions: MCF combines efficacy with low toxicity in the treatment of advanced pancreatic carcinoma. The efficacy is at least comparable and may be superior to single-agent gemcitabine and MCF may therefore provide a cost-effective alternative.

Original languageEnglish
Pages (from-to)1100-1105
Number of pages6
JournalAnnals of Oncology
Volume14
Issue number7
DOIs
Publication statusPublished - Jul 2003

Keywords

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols
  • Carcinoma
  • Cisplatin
  • Female
  • Fluorouracil
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Mitomycins
  • Pancreatic Neoplasms
  • Survival Analysis
  • Treatment Outcome

Cite this

Petty, R. D., Nicolson, M. C., Sinclair, T. S., Skaria, S., Samuel, L., Koruth, M., & Aberdeen Pancreatic Cancer Focus Group (2003). A phase II study of mitomycin C, cisplatin and protracted infusional 5-fluorouracil in advanced pancreatic carcinoma: efficacy and low toxicity. Annals of Oncology, 14(7), 1100-1105. https://doi.org/10.1093/annonc/mdg278

A phase II study of mitomycin C, cisplatin and protracted infusional 5-fluorouracil in advanced pancreatic carcinoma : efficacy and low toxicity. / Petty, Russell David; Nicolson, M. C.; Sinclair, T. S.; Skaria, S.; Samuel, Leslie; Koruth, M.; Aberdeen Pancreatic Cancer Focus Group.

In: Annals of Oncology, Vol. 14, No. 7, 07.2003, p. 1100-1105.

Research output: Contribution to journalArticle

Petty, RD, Nicolson, MC, Sinclair, TS, Skaria, S, Samuel, L, Koruth, M & Aberdeen Pancreatic Cancer Focus Group 2003, 'A phase II study of mitomycin C, cisplatin and protracted infusional 5-fluorouracil in advanced pancreatic carcinoma: efficacy and low toxicity' Annals of Oncology, vol. 14, no. 7, pp. 1100-1105. https://doi.org/10.1093/annonc/mdg278
Petty, Russell David ; Nicolson, M. C. ; Sinclair, T. S. ; Skaria, S. ; Samuel, Leslie ; Koruth, M. ; Aberdeen Pancreatic Cancer Focus Group. / A phase II study of mitomycin C, cisplatin and protracted infusional 5-fluorouracil in advanced pancreatic carcinoma : efficacy and low toxicity. In: Annals of Oncology. 2003 ; Vol. 14, No. 7. pp. 1100-1105.
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abstract = "Background: The effective treatment of unresectable pancreatic carcinoma represents a formidable challenge. There is a need to develop systemic therapies which combine efficacy with acceptable toxicity. The current 'gold standard' gemcitabine gives an objective response rate of the order of 20{\%} and median survival up to 6 months. Here we have evaluated the efficacy and toxicity of mitomycin C, cisplatin and protracted infusional 5-fluorouracil (MCF).Patients and methods: Forty-five patients with locally advanced (13 patients) or metastatic (32 patients) pancreatic carcinoma were treated with mitomycin C7 mg/m(2) 6 weekly, cisplatin 60 mg/m(2) 3 weekly and protracted venous infusion 5-FU 300 mg/m(2)/day. Patients were evaluated for response after three cycles and received six cycles in total in the absence of progressive disease or poor tolerance. Median age was 62 (45-75) years; 41 patients were World Health Organization performance status 0-1.Results: Treatment was well tolerated with 36 (84{\%}) patients completing three or more cycles. Grade 3 or 4 toxicities were uncommon: anaemia in three patients (7{\%}), mucositis in two (5{\%}), nausea and vomiting in three (7{\%}) and diarrhoea in one (1{\%}). An objective response was seen in 21 (46{\%}) patients. There was one complete response. The median survival overall was 7.1 months and 10.5 months in responders. The median duration of response was 4.3 months. One-year survival was 29{\%}, 2-year survival was 18{\%}.Conclusions: MCF combines efficacy with low toxicity in the treatment of advanced pancreatic carcinoma. The efficacy is at least comparable and may be superior to single-agent gemcitabine and MCF may therefore provide a cost-effective alternative.",
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T1 - A phase II study of mitomycin C, cisplatin and protracted infusional 5-fluorouracil in advanced pancreatic carcinoma

T2 - efficacy and low toxicity

AU - Petty, Russell David

AU - Nicolson, M. C.

AU - Sinclair, T. S.

AU - Skaria, S.

AU - Samuel, Leslie

AU - Koruth, M.

AU - Aberdeen Pancreatic Cancer Focus Group

PY - 2003/7

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N2 - Background: The effective treatment of unresectable pancreatic carcinoma represents a formidable challenge. There is a need to develop systemic therapies which combine efficacy with acceptable toxicity. The current 'gold standard' gemcitabine gives an objective response rate of the order of 20% and median survival up to 6 months. Here we have evaluated the efficacy and toxicity of mitomycin C, cisplatin and protracted infusional 5-fluorouracil (MCF).Patients and methods: Forty-five patients with locally advanced (13 patients) or metastatic (32 patients) pancreatic carcinoma were treated with mitomycin C7 mg/m(2) 6 weekly, cisplatin 60 mg/m(2) 3 weekly and protracted venous infusion 5-FU 300 mg/m(2)/day. Patients were evaluated for response after three cycles and received six cycles in total in the absence of progressive disease or poor tolerance. Median age was 62 (45-75) years; 41 patients were World Health Organization performance status 0-1.Results: Treatment was well tolerated with 36 (84%) patients completing three or more cycles. Grade 3 or 4 toxicities were uncommon: anaemia in three patients (7%), mucositis in two (5%), nausea and vomiting in three (7%) and diarrhoea in one (1%). An objective response was seen in 21 (46%) patients. There was one complete response. The median survival overall was 7.1 months and 10.5 months in responders. The median duration of response was 4.3 months. One-year survival was 29%, 2-year survival was 18%.Conclusions: MCF combines efficacy with low toxicity in the treatment of advanced pancreatic carcinoma. The efficacy is at least comparable and may be superior to single-agent gemcitabine and MCF may therefore provide a cost-effective alternative.

AB - Background: The effective treatment of unresectable pancreatic carcinoma represents a formidable challenge. There is a need to develop systemic therapies which combine efficacy with acceptable toxicity. The current 'gold standard' gemcitabine gives an objective response rate of the order of 20% and median survival up to 6 months. Here we have evaluated the efficacy and toxicity of mitomycin C, cisplatin and protracted infusional 5-fluorouracil (MCF).Patients and methods: Forty-five patients with locally advanced (13 patients) or metastatic (32 patients) pancreatic carcinoma were treated with mitomycin C7 mg/m(2) 6 weekly, cisplatin 60 mg/m(2) 3 weekly and protracted venous infusion 5-FU 300 mg/m(2)/day. Patients were evaluated for response after three cycles and received six cycles in total in the absence of progressive disease or poor tolerance. Median age was 62 (45-75) years; 41 patients were World Health Organization performance status 0-1.Results: Treatment was well tolerated with 36 (84%) patients completing three or more cycles. Grade 3 or 4 toxicities were uncommon: anaemia in three patients (7%), mucositis in two (5%), nausea and vomiting in three (7%) and diarrhoea in one (1%). An objective response was seen in 21 (46%) patients. There was one complete response. The median survival overall was 7.1 months and 10.5 months in responders. The median duration of response was 4.3 months. One-year survival was 29%, 2-year survival was 18%.Conclusions: MCF combines efficacy with low toxicity in the treatment of advanced pancreatic carcinoma. The efficacy is at least comparable and may be superior to single-agent gemcitabine and MCF may therefore provide a cost-effective alternative.

KW - Aged

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Carcinoma

KW - Cisplatin

KW - Female

KW - Fluorouracil

KW - Humans

KW - Infusions, Intravenous

KW - Male

KW - Middle Aged

KW - Mitomycins

KW - Pancreatic Neoplasms

KW - Survival Analysis

KW - Treatment Outcome

U2 - 10.1093/annonc/mdg278

DO - 10.1093/annonc/mdg278

M3 - Article

VL - 14

SP - 1100

EP - 1105

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 7

ER -