Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma

Moh'D Khushman, Naomi Dempsey, Jennifer Cudris Maldonado, Arturo Loaiza-Bonilla, Michel Velez, Lauren Carcas, Daniel Dammrich, Jorge Hurtado-Cordovi, Ritesh Parajuli, Terri Pollack, Ana P. Harwood, Jessica Macintyre, Ching Wei D Tzeng, Jaime R Merchan, Maria H Restrepo, Ikechukwu I. Akunyili, Afonso Ribeiro, Govindarajan Narayanan, Lorraine Portelance, Danny Sleeman & 3 others Joe Levi, Caio M S Rocha Lima, Peter Hosein

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Abstract

Background The efficacy of FOLFIRINOX for metastatic pancreatic cancer has led to its use in patients with earlier stages of disease. This study retrospectively analyzed a cohort of patients with locally-advanced pancreatic cancer (LAPC) treated with FOLFIRINOX. Methods Between 2008 and 2013, 51 treatment-naïve patients with LAPC at a single institution received first-line FOLFIRINOX with neoadjuvant intent, at the full dose as described in the PRODIGE 4/ACCORD 11 study. Combined chemoradiation was administered for those who remained unresectable after maximum response to chemotherapy. The primary outcome measure was overall survival (OS), and secondary outcomes were progression-free survival (PFS) and margin-negative (R0) resection rate, and toxicity profile. Results A total of 429 cycles of FOLFIRINOX were given with a median of 8 cycles (range 2-29) per patient; 66% of cycles were full dose. After chemotherapy, 27 (53%) received chemoradiation. The median OS was 35.4 months (95% CI 25.8-45). Ten (4 borderline resectable and 6 unresectable) patients had successful R0 resections; those who had R0 resections had a significantly longer survival than those who did not (3-year OS rate 67% versus 21%, log rank p = 0.042). Increasing number of full-dose cycles was significantly associated with increased survival. The toxicity profile was similar to previous reports of this regimen. Conclusions FOLFIRINOX is feasible as neoadjuvant therapy for LAPC. Although the R0 resection rate was only 20%, the median OS of almost 3 years appears promising. Dose intensity and duration were associated with increased survival in this study, arguing against dose attenuated versions of this regimen.

Original languageEnglish (US)
Pages (from-to)667-673
Number of pages7
JournalPancreatology
Volume15
Issue number6
DOIs
StatePublished - 2015

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Adenocarcinoma
Pancreatic Neoplasms
Survival
Drug Therapy
Neoadjuvant Therapy
Disease-Free Survival
Survival Rate
Outcome Assessment (Health Care)
Therapeutics

Keywords

  • Borderline resectable pancreatic cancer
  • Chemotherapy
  • FOLFIRINOX
  • Locally advanced pancreatic cancer
  • Neoadjuvant
  • Pancreatic adenocarcinoma

ASJC Scopus subject areas

  • Endocrinology
  • Endocrinology, Diabetes and Metabolism
  • Hepatology

Cite this

Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma. / Khushman, Moh'D; Dempsey, Naomi; Cudris Maldonado, Jennifer; Loaiza-Bonilla, Arturo; Velez, Michel; Carcas, Lauren; Dammrich, Daniel; Hurtado-Cordovi, Jorge; Parajuli, Ritesh; Pollack, Terri; Harwood, Ana P.; Macintyre, Jessica; Tzeng, Ching Wei D; Merchan, Jaime R; Restrepo, Maria H; Akunyili, Ikechukwu I.; Ribeiro, Afonso; Narayanan, Govindarajan; Portelance, Lorraine; Sleeman, Danny; Levi, Joe; Rocha Lima, Caio M S; Hosein, Peter.

In: Pancreatology, Vol. 15, No. 6, 2015, p. 667-673.

Research output: Contribution to journalArticle

Khushman, MD, Dempsey, N, Cudris Maldonado, J, Loaiza-Bonilla, A, Velez, M, Carcas, L, Dammrich, D, Hurtado-Cordovi, J, Parajuli, R, Pollack, T, Harwood, AP, Macintyre, J, Tzeng, CWD, Merchan, JR, Restrepo, MH, Akunyili, II, Ribeiro, A, Narayanan, G, Portelance, L, Sleeman, D, Levi, J, Rocha Lima, CMS & Hosein, P 2015, 'Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma', Pancreatology, vol. 15, no. 6, pp. 667-673. https://doi.org/10.1016/j.pan.2015.08.010
Khushman, Moh'D ; Dempsey, Naomi ; Cudris Maldonado, Jennifer ; Loaiza-Bonilla, Arturo ; Velez, Michel ; Carcas, Lauren ; Dammrich, Daniel ; Hurtado-Cordovi, Jorge ; Parajuli, Ritesh ; Pollack, Terri ; Harwood, Ana P. ; Macintyre, Jessica ; Tzeng, Ching Wei D ; Merchan, Jaime R ; Restrepo, Maria H ; Akunyili, Ikechukwu I. ; Ribeiro, Afonso ; Narayanan, Govindarajan ; Portelance, Lorraine ; Sleeman, Danny ; Levi, Joe ; Rocha Lima, Caio M S ; Hosein, Peter. / Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma. In: Pancreatology. 2015 ; Vol. 15, No. 6. pp. 667-673.
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title = "Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma",
abstract = "Background The efficacy of FOLFIRINOX for metastatic pancreatic cancer has led to its use in patients with earlier stages of disease. This study retrospectively analyzed a cohort of patients with locally-advanced pancreatic cancer (LAPC) treated with FOLFIRINOX. Methods Between 2008 and 2013, 51 treatment-na{\"i}ve patients with LAPC at a single institution received first-line FOLFIRINOX with neoadjuvant intent, at the full dose as described in the PRODIGE 4/ACCORD 11 study. Combined chemoradiation was administered for those who remained unresectable after maximum response to chemotherapy. The primary outcome measure was overall survival (OS), and secondary outcomes were progression-free survival (PFS) and margin-negative (R0) resection rate, and toxicity profile. Results A total of 429 cycles of FOLFIRINOX were given with a median of 8 cycles (range 2-29) per patient; 66{\%} of cycles were full dose. After chemotherapy, 27 (53{\%}) received chemoradiation. The median OS was 35.4 months (95{\%} CI 25.8-45). Ten (4 borderline resectable and 6 unresectable) patients had successful R0 resections; those who had R0 resections had a significantly longer survival than those who did not (3-year OS rate 67{\%} versus 21{\%}, log rank p = 0.042). Increasing number of full-dose cycles was significantly associated with increased survival. The toxicity profile was similar to previous reports of this regimen. Conclusions FOLFIRINOX is feasible as neoadjuvant therapy for LAPC. Although the R0 resection rate was only 20{\%}, the median OS of almost 3 years appears promising. Dose intensity and duration were associated with increased survival in this study, arguing against dose attenuated versions of this regimen.",
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author = "Moh'D Khushman and Naomi Dempsey and {Cudris Maldonado}, Jennifer and Arturo Loaiza-Bonilla and Michel Velez and Lauren Carcas and Daniel Dammrich and Jorge Hurtado-Cordovi and Ritesh Parajuli and Terri Pollack and Harwood, {Ana P.} and Jessica Macintyre and Tzeng, {Ching Wei D} and Merchan, {Jaime R} and Restrepo, {Maria H} and Akunyili, {Ikechukwu I.} and Afonso Ribeiro and Govindarajan Narayanan and Lorraine Portelance and Danny Sleeman and Joe Levi and {Rocha Lima}, {Caio M S} and Peter Hosein",
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T1 - Full dose neoadjuvant FOLFIRINOX is associated with prolonged survival in patients with locally advanced pancreatic adenocarcinoma

AU - Khushman, Moh'D

AU - Dempsey, Naomi

AU - Cudris Maldonado, Jennifer

AU - Loaiza-Bonilla, Arturo

AU - Velez, Michel

AU - Carcas, Lauren

AU - Dammrich, Daniel

AU - Hurtado-Cordovi, Jorge

AU - Parajuli, Ritesh

AU - Pollack, Terri

AU - Harwood, Ana P.

AU - Macintyre, Jessica

AU - Tzeng, Ching Wei D

AU - Merchan, Jaime R

AU - Restrepo, Maria H

AU - Akunyili, Ikechukwu I.

AU - Ribeiro, Afonso

AU - Narayanan, Govindarajan

AU - Portelance, Lorraine

AU - Sleeman, Danny

AU - Levi, Joe

AU - Rocha Lima, Caio M S

AU - Hosein, Peter

PY - 2015

Y1 - 2015

N2 - Background The efficacy of FOLFIRINOX for metastatic pancreatic cancer has led to its use in patients with earlier stages of disease. This study retrospectively analyzed a cohort of patients with locally-advanced pancreatic cancer (LAPC) treated with FOLFIRINOX. Methods Between 2008 and 2013, 51 treatment-naïve patients with LAPC at a single institution received first-line FOLFIRINOX with neoadjuvant intent, at the full dose as described in the PRODIGE 4/ACCORD 11 study. Combined chemoradiation was administered for those who remained unresectable after maximum response to chemotherapy. The primary outcome measure was overall survival (OS), and secondary outcomes were progression-free survival (PFS) and margin-negative (R0) resection rate, and toxicity profile. Results A total of 429 cycles of FOLFIRINOX were given with a median of 8 cycles (range 2-29) per patient; 66% of cycles were full dose. After chemotherapy, 27 (53%) received chemoradiation. The median OS was 35.4 months (95% CI 25.8-45). Ten (4 borderline resectable and 6 unresectable) patients had successful R0 resections; those who had R0 resections had a significantly longer survival than those who did not (3-year OS rate 67% versus 21%, log rank p = 0.042). Increasing number of full-dose cycles was significantly associated with increased survival. The toxicity profile was similar to previous reports of this regimen. Conclusions FOLFIRINOX is feasible as neoadjuvant therapy for LAPC. Although the R0 resection rate was only 20%, the median OS of almost 3 years appears promising. Dose intensity and duration were associated with increased survival in this study, arguing against dose attenuated versions of this regimen.

AB - Background The efficacy of FOLFIRINOX for metastatic pancreatic cancer has led to its use in patients with earlier stages of disease. This study retrospectively analyzed a cohort of patients with locally-advanced pancreatic cancer (LAPC) treated with FOLFIRINOX. Methods Between 2008 and 2013, 51 treatment-naïve patients with LAPC at a single institution received first-line FOLFIRINOX with neoadjuvant intent, at the full dose as described in the PRODIGE 4/ACCORD 11 study. Combined chemoradiation was administered for those who remained unresectable after maximum response to chemotherapy. The primary outcome measure was overall survival (OS), and secondary outcomes were progression-free survival (PFS) and margin-negative (R0) resection rate, and toxicity profile. Results A total of 429 cycles of FOLFIRINOX were given with a median of 8 cycles (range 2-29) per patient; 66% of cycles were full dose. After chemotherapy, 27 (53%) received chemoradiation. The median OS was 35.4 months (95% CI 25.8-45). Ten (4 borderline resectable and 6 unresectable) patients had successful R0 resections; those who had R0 resections had a significantly longer survival than those who did not (3-year OS rate 67% versus 21%, log rank p = 0.042). Increasing number of full-dose cycles was significantly associated with increased survival. The toxicity profile was similar to previous reports of this regimen. Conclusions FOLFIRINOX is feasible as neoadjuvant therapy for LAPC. Although the R0 resection rate was only 20%, the median OS of almost 3 years appears promising. Dose intensity and duration were associated with increased survival in this study, arguing against dose attenuated versions of this regimen.

KW - Borderline resectable pancreatic cancer

KW - Chemotherapy

KW - FOLFIRINOX

KW - Locally advanced pancreatic cancer

KW - Neoadjuvant

KW - Pancreatic adenocarcinoma

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