Dose-intense PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) in advanced pancreatic adenocarcinoma

M. Reni, S. Cereda, E. Bonetto, M. G. Viganò, P. Passoni, A. Zerbi, G. Balzano, R. Nicoletti, C. Staudacher, V. Di Carlo

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Abstract

Background: PEFG regimen (cisplatin and epirubicin 40 mg/m 2 day 1, gemcitabine 600 mg/m 2 days 1 and 8, 5-fluorouracil (FU) 200 mg/m 2/day continuous infusion) significantly improved the outcome of patients with advanced pancreatic adenocarcinoma (PA) with respect to standard gemcitabine in a previous phase III trial. This regimen was subsequently modified in a dose-finding study by increasing dose intensity of cisplatin and epirubicin (both at 30 mg/m 2 every 14 days) and of gemcitabine (at 800 mg/m 2 every 14 days). Results of a consecutive series treated by dose-intense PEFG regimen are herewith reported. Material and methods: Dose-intense PEFG was administered to chemotherapy-naive patients with stages III-IV PA, <75 years, performance status (PS) > 50, till progressive disease or for a maximum of 6 months. Results: Between January 2004 and June 2005, 49 (31 or 63% metastatic) patients, median age 62 years, median PS 80, were treated with dose-intense PEFG. Partial response and stable disease was observed in 24 (49%) and 16 (33%) patients, respectively; 31 patients were progression-free at 6 months (PFS-6 = 63%). Median survival was 10.5 months and 1-year overall survival (OS) was 48% (95% confidence interval: 33-61%). Main grade 3-4 toxicity was: neutropenia in 26% of patients, stomatitis and fatigue in 8%, anaemia, diarrhoea, nausea/vomit in 6%, febrile neutropenia and thrombocytopaenia in 4%, hand-foot syndrome in 2%. Conclusion: When compared with 84 patients treated by classical PEFG at the same institution, dose-intense PEFG was not inferior in terms of PFS-6 (63 versus 57%), 1-year OS (48 versus 42%) and response rate (49 versus 49%); it allowed to increase dose intensity for gemcitabine by 32%, for cisplatin and epirubicin by 36% (FU reduced by 3%), to significantly reduce grade 3-4 hematological toxicity (neutropenia: 26 versus 86%; P <0.00001; thrombocytopaenia: 4 versus 58%; P <0.00001) and to reduce by one-third the number of outpatient accesses. The new PEFG schedule appears more suitable for clinical use and should be preferred as a basis for further development of therapeutic strategies against pancreatic cancer.

Original languageEnglish
Pages (from-to)361-367
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume59
Issue number3
DOIs
Publication statusPublished - Mar 2007

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gemcitabine
Epirubicin
Fluorouracil
Cisplatin
Adenocarcinoma
Toxicity
Chemotherapy
Neutropenia
Survival
Hand-Foot Syndrome
Febrile Neutropenia
Fatigue of materials
Stomatitis
Pancreatic Neoplasms
Nausea
Fatigue
Anemia
Diarrhea
Appointments and Schedules
Outpatients

Keywords

  • Chemotherapy
  • Dose-intense PEFG
  • Pancreatic cancer
  • PEFG regimen

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology

Cite this

Dose-intense PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) in advanced pancreatic adenocarcinoma. / Reni, M.; Cereda, S.; Bonetto, E.; Viganò, M. G.; Passoni, P.; Zerbi, A.; Balzano, G.; Nicoletti, R.; Staudacher, C.; Di Carlo, V.

In: Cancer Chemotherapy and Pharmacology, Vol. 59, No. 3, 03.2007, p. 361-367.

Research output: Contribution to journalArticle

Reni, M. ; Cereda, S. ; Bonetto, E. ; Viganò, M. G. ; Passoni, P. ; Zerbi, A. ; Balzano, G. ; Nicoletti, R. ; Staudacher, C. ; Di Carlo, V. / Dose-intense PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) in advanced pancreatic adenocarcinoma. In: Cancer Chemotherapy and Pharmacology. 2007 ; Vol. 59, No. 3. pp. 361-367.
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title = "Dose-intense PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) in advanced pancreatic adenocarcinoma",
abstract = "Background: PEFG regimen (cisplatin and epirubicin 40 mg/m 2 day 1, gemcitabine 600 mg/m 2 days 1 and 8, 5-fluorouracil (FU) 200 mg/m 2/day continuous infusion) significantly improved the outcome of patients with advanced pancreatic adenocarcinoma (PA) with respect to standard gemcitabine in a previous phase III trial. This regimen was subsequently modified in a dose-finding study by increasing dose intensity of cisplatin and epirubicin (both at 30 mg/m 2 every 14 days) and of gemcitabine (at 800 mg/m 2 every 14 days). Results of a consecutive series treated by dose-intense PEFG regimen are herewith reported. Material and methods: Dose-intense PEFG was administered to chemotherapy-naive patients with stages III-IV PA, <75 years, performance status (PS) > 50, till progressive disease or for a maximum of 6 months. Results: Between January 2004 and June 2005, 49 (31 or 63{\%} metastatic) patients, median age 62 years, median PS 80, were treated with dose-intense PEFG. Partial response and stable disease was observed in 24 (49{\%}) and 16 (33{\%}) patients, respectively; 31 patients were progression-free at 6 months (PFS-6 = 63{\%}). Median survival was 10.5 months and 1-year overall survival (OS) was 48{\%} (95{\%} confidence interval: 33-61{\%}). Main grade 3-4 toxicity was: neutropenia in 26{\%} of patients, stomatitis and fatigue in 8{\%}, anaemia, diarrhoea, nausea/vomit in 6{\%}, febrile neutropenia and thrombocytopaenia in 4{\%}, hand-foot syndrome in 2{\%}. Conclusion: When compared with 84 patients treated by classical PEFG at the same institution, dose-intense PEFG was not inferior in terms of PFS-6 (63 versus 57{\%}), 1-year OS (48 versus 42{\%}) and response rate (49 versus 49{\%}); it allowed to increase dose intensity for gemcitabine by 32{\%}, for cisplatin and epirubicin by 36{\%} (FU reduced by 3{\%}), to significantly reduce grade 3-4 hematological toxicity (neutropenia: 26 versus 86{\%}; P <0.00001; thrombocytopaenia: 4 versus 58{\%}; P <0.00001) and to reduce by one-third the number of outpatient accesses. The new PEFG schedule appears more suitable for clinical use and should be preferred as a basis for further development of therapeutic strategies against pancreatic cancer.",
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author = "M. Reni and S. Cereda and E. Bonetto and Vigan{\`o}, {M. G.} and P. Passoni and A. Zerbi and G. Balzano and R. Nicoletti and C. Staudacher and {Di Carlo}, V.",
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T1 - Dose-intense PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) in advanced pancreatic adenocarcinoma

AU - Reni, M.

AU - Cereda, S.

AU - Bonetto, E.

AU - Viganò, M. G.

AU - Passoni, P.

AU - Zerbi, A.

AU - Balzano, G.

AU - Nicoletti, R.

AU - Staudacher, C.

AU - Di Carlo, V.

PY - 2007/3

Y1 - 2007/3

N2 - Background: PEFG regimen (cisplatin and epirubicin 40 mg/m 2 day 1, gemcitabine 600 mg/m 2 days 1 and 8, 5-fluorouracil (FU) 200 mg/m 2/day continuous infusion) significantly improved the outcome of patients with advanced pancreatic adenocarcinoma (PA) with respect to standard gemcitabine in a previous phase III trial. This regimen was subsequently modified in a dose-finding study by increasing dose intensity of cisplatin and epirubicin (both at 30 mg/m 2 every 14 days) and of gemcitabine (at 800 mg/m 2 every 14 days). Results of a consecutive series treated by dose-intense PEFG regimen are herewith reported. Material and methods: Dose-intense PEFG was administered to chemotherapy-naive patients with stages III-IV PA, <75 years, performance status (PS) > 50, till progressive disease or for a maximum of 6 months. Results: Between January 2004 and June 2005, 49 (31 or 63% metastatic) patients, median age 62 years, median PS 80, were treated with dose-intense PEFG. Partial response and stable disease was observed in 24 (49%) and 16 (33%) patients, respectively; 31 patients were progression-free at 6 months (PFS-6 = 63%). Median survival was 10.5 months and 1-year overall survival (OS) was 48% (95% confidence interval: 33-61%). Main grade 3-4 toxicity was: neutropenia in 26% of patients, stomatitis and fatigue in 8%, anaemia, diarrhoea, nausea/vomit in 6%, febrile neutropenia and thrombocytopaenia in 4%, hand-foot syndrome in 2%. Conclusion: When compared with 84 patients treated by classical PEFG at the same institution, dose-intense PEFG was not inferior in terms of PFS-6 (63 versus 57%), 1-year OS (48 versus 42%) and response rate (49 versus 49%); it allowed to increase dose intensity for gemcitabine by 32%, for cisplatin and epirubicin by 36% (FU reduced by 3%), to significantly reduce grade 3-4 hematological toxicity (neutropenia: 26 versus 86%; P <0.00001; thrombocytopaenia: 4 versus 58%; P <0.00001) and to reduce by one-third the number of outpatient accesses. The new PEFG schedule appears more suitable for clinical use and should be preferred as a basis for further development of therapeutic strategies against pancreatic cancer.

AB - Background: PEFG regimen (cisplatin and epirubicin 40 mg/m 2 day 1, gemcitabine 600 mg/m 2 days 1 and 8, 5-fluorouracil (FU) 200 mg/m 2/day continuous infusion) significantly improved the outcome of patients with advanced pancreatic adenocarcinoma (PA) with respect to standard gemcitabine in a previous phase III trial. This regimen was subsequently modified in a dose-finding study by increasing dose intensity of cisplatin and epirubicin (both at 30 mg/m 2 every 14 days) and of gemcitabine (at 800 mg/m 2 every 14 days). Results of a consecutive series treated by dose-intense PEFG regimen are herewith reported. Material and methods: Dose-intense PEFG was administered to chemotherapy-naive patients with stages III-IV PA, <75 years, performance status (PS) > 50, till progressive disease or for a maximum of 6 months. Results: Between January 2004 and June 2005, 49 (31 or 63% metastatic) patients, median age 62 years, median PS 80, were treated with dose-intense PEFG. Partial response and stable disease was observed in 24 (49%) and 16 (33%) patients, respectively; 31 patients were progression-free at 6 months (PFS-6 = 63%). Median survival was 10.5 months and 1-year overall survival (OS) was 48% (95% confidence interval: 33-61%). Main grade 3-4 toxicity was: neutropenia in 26% of patients, stomatitis and fatigue in 8%, anaemia, diarrhoea, nausea/vomit in 6%, febrile neutropenia and thrombocytopaenia in 4%, hand-foot syndrome in 2%. Conclusion: When compared with 84 patients treated by classical PEFG at the same institution, dose-intense PEFG was not inferior in terms of PFS-6 (63 versus 57%), 1-year OS (48 versus 42%) and response rate (49 versus 49%); it allowed to increase dose intensity for gemcitabine by 32%, for cisplatin and epirubicin by 36% (FU reduced by 3%), to significantly reduce grade 3-4 hematological toxicity (neutropenia: 26 versus 86%; P <0.00001; thrombocytopaenia: 4 versus 58%; P <0.00001) and to reduce by one-third the number of outpatient accesses. The new PEFG schedule appears more suitable for clinical use and should be preferred as a basis for further development of therapeutic strategies against pancreatic cancer.

KW - Chemotherapy

KW - Dose-intense PEFG

KW - Pancreatic cancer

KW - PEFG regimen

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