A phase II study of adjuvant gemcitabine plus docetaxel followed by concurrent chemoradation in resected pancreaticobiliary carcinoma

May Cho, Andrea Wang-Gillam, Robert Myerson, Feng Gao, Steven Strasberg, Joel Picus, Steven Sorscher, Chloe Fournier, Gayathri Nagaraj, Parag Parikh, Rama Suresh, David Linehan, Benjamin R. Tan

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objectives Adjuvant gemcitabine with or without chemoradiation is a standard therapeutic option for patients with resected pancreatic cancer. The feasibility and toxicity of gemcitabine with docetaxel before and after 5-fluorouracil (5FU)-based chemoradiation in the adjuvant pancreatic and biliary cancer setting were investigated. Methods After a curative-intent resection, eligible patients with pancreaticobiliary cancers were treated with two cycles of gemcitabine and docetaxel followed by 5FU-based chemoradiation. Four weeks after completing chemoradiation, two cycles of gemcitabine and docetaxel were administered. The primary endpoint was the incidence of severe toxicities. Secondary endpoints included disease-free survival (DFS) and overall survival (OS). Results Fifty patients with pancreaticobiliary cancers were enrolled. Twenty-nine patients had pancreatic cancer whereas 21 patients had biliary tract or ampullary cancers. There was one death as a result of pneumonia, and 15% of patients experienced grade 3 or greater non-haematological toxicities. The median DFS and OS for patients with pancreatic cancer were 9.6 and 17 months, respectively, and for those with resected biliary tract cancer were 12 and 23 months, respectively. Conclusions This combination of gemcitabine and docetaxel with chemoradiation is feasible and tolerable in the adjuvant setting. Future studies utilizing a different gemcitabine/taxane combination and schedule may be appropriate in the adjuvant treatment of both pancreatic cancer and biliary tumours.

Original languageEnglish (US)
Pages (from-to)587-593
Number of pages7
JournalHPB
Volume17
Issue number7
DOIs
StatePublished - Jul 1 2015
Externally publishedYes

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docetaxel
gemcitabine
Pancreatic Neoplasms
Carcinoma
Biliary Tract Neoplasms
Fluorouracil
Disease-Free Survival
Neoplasms
Survival
Biliary Tract
Pneumonia
Appointments and Schedules

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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A phase II study of adjuvant gemcitabine plus docetaxel followed by concurrent chemoradation in resected pancreaticobiliary carcinoma. / Cho, May; Wang-Gillam, Andrea; Myerson, Robert; Gao, Feng; Strasberg, Steven; Picus, Joel; Sorscher, Steven; Fournier, Chloe; Nagaraj, Gayathri; Parikh, Parag; Suresh, Rama; Linehan, David; Tan, Benjamin R.

In: HPB, Vol. 17, No. 7, 01.07.2015, p. 587-593.

Research output: Contribution to journalArticle

Cho, M, Wang-Gillam, A, Myerson, R, Gao, F, Strasberg, S, Picus, J, Sorscher, S, Fournier, C, Nagaraj, G, Parikh, P, Suresh, R, Linehan, D & Tan, BR 2015, 'A phase II study of adjuvant gemcitabine plus docetaxel followed by concurrent chemoradation in resected pancreaticobiliary carcinoma', HPB, vol. 17, no. 7, pp. 587-593. https://doi.org/10.1111/hpb.12413
Cho, May ; Wang-Gillam, Andrea ; Myerson, Robert ; Gao, Feng ; Strasberg, Steven ; Picus, Joel ; Sorscher, Steven ; Fournier, Chloe ; Nagaraj, Gayathri ; Parikh, Parag ; Suresh, Rama ; Linehan, David ; Tan, Benjamin R. / A phase II study of adjuvant gemcitabine plus docetaxel followed by concurrent chemoradation in resected pancreaticobiliary carcinoma. In: HPB. 2015 ; Vol. 17, No. 7. pp. 587-593.
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T1 - A phase II study of adjuvant gemcitabine plus docetaxel followed by concurrent chemoradation in resected pancreaticobiliary carcinoma

AU - Cho, May

AU - Wang-Gillam, Andrea

AU - Myerson, Robert

AU - Gao, Feng

AU - Strasberg, Steven

AU - Picus, Joel

AU - Sorscher, Steven

AU - Fournier, Chloe

AU - Nagaraj, Gayathri

AU - Parikh, Parag

AU - Suresh, Rama

AU - Linehan, David

AU - Tan, Benjamin R.

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N2 - Objectives Adjuvant gemcitabine with or without chemoradiation is a standard therapeutic option for patients with resected pancreatic cancer. The feasibility and toxicity of gemcitabine with docetaxel before and after 5-fluorouracil (5FU)-based chemoradiation in the adjuvant pancreatic and biliary cancer setting were investigated. Methods After a curative-intent resection, eligible patients with pancreaticobiliary cancers were treated with two cycles of gemcitabine and docetaxel followed by 5FU-based chemoradiation. Four weeks after completing chemoradiation, two cycles of gemcitabine and docetaxel were administered. The primary endpoint was the incidence of severe toxicities. Secondary endpoints included disease-free survival (DFS) and overall survival (OS). Results Fifty patients with pancreaticobiliary cancers were enrolled. Twenty-nine patients had pancreatic cancer whereas 21 patients had biliary tract or ampullary cancers. There was one death as a result of pneumonia, and 15% of patients experienced grade 3 or greater non-haematological toxicities. The median DFS and OS for patients with pancreatic cancer were 9.6 and 17 months, respectively, and for those with resected biliary tract cancer were 12 and 23 months, respectively. Conclusions This combination of gemcitabine and docetaxel with chemoradiation is feasible and tolerable in the adjuvant setting. Future studies utilizing a different gemcitabine/taxane combination and schedule may be appropriate in the adjuvant treatment of both pancreatic cancer and biliary tumours.

AB - Objectives Adjuvant gemcitabine with or without chemoradiation is a standard therapeutic option for patients with resected pancreatic cancer. The feasibility and toxicity of gemcitabine with docetaxel before and after 5-fluorouracil (5FU)-based chemoradiation in the adjuvant pancreatic and biliary cancer setting were investigated. Methods After a curative-intent resection, eligible patients with pancreaticobiliary cancers were treated with two cycles of gemcitabine and docetaxel followed by 5FU-based chemoradiation. Four weeks after completing chemoradiation, two cycles of gemcitabine and docetaxel were administered. The primary endpoint was the incidence of severe toxicities. Secondary endpoints included disease-free survival (DFS) and overall survival (OS). Results Fifty patients with pancreaticobiliary cancers were enrolled. Twenty-nine patients had pancreatic cancer whereas 21 patients had biliary tract or ampullary cancers. There was one death as a result of pneumonia, and 15% of patients experienced grade 3 or greater non-haematological toxicities. The median DFS and OS for patients with pancreatic cancer were 9.6 and 17 months, respectively, and for those with resected biliary tract cancer were 12 and 23 months, respectively. Conclusions This combination of gemcitabine and docetaxel with chemoradiation is feasible and tolerable in the adjuvant setting. Future studies utilizing a different gemcitabine/taxane combination and schedule may be appropriate in the adjuvant treatment of both pancreatic cancer and biliary tumours.

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