Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer

A multicenter phase II trial

William Small, Jordan Berlin, Gary M. Freedman, Theodore Lawrence, Mark S. Talamonti, Mary F. Mulcahy, A. Bapsi Chakravarthy, Andre A. Konski, Mark M. Zalupski, Philip A. Philip, Timothy J. Kinsella, Nipun Merchant, John P. Hoffman, Al B. Benson, Steven Nicol, Rong M. Xu, John F. Gill, Cornelius J. McGinn

Research output: Contribution to journalArticle

122 Citations (Scopus)

Abstract

Purpose: Gemcitabine is effective in the treatment of pancreatic cancer and is a potent radiosensitizer. This study assessed safety and efficacy of full-dose gemcitabine administered before and during concurrent three-dimensional conformal radiation (3D-CRT) in patients with nonmetastatic pancreatic cancer. Patients and Methods: During cycles 1 and 3, patients received gemcitabine at 1,000 mg/m2 on days 1 and 8 of each 21-day cycle. Cycle 2 included the same dose of gemcitabine on days 1, 8, and 15 of a 28-day cycle with concurrent 3D-CRT at 36 Gy, administered in 15 fractions of 2.4 Gy, over 3 weeks. Resectable patients underwent surgery 4 to 6 weeks after treatment. The primary objective was evaluation of toxicity. Tumor response, CA 19-9, and 1-year survival were also assessed. Results: Forty-one patients enrolled at six institutions between April 2002 and October 2003. Among the 39 treated patients, the most common toxicities were grade 3 neutropenia (12.8%), grade 3 nausea (10.3%), and grade 3 vomiting (10.3%). The response rate was 5.1% and disease control rate was 84.6%. Mean post-treatment CA 19-9 levels (228 ± 347 U/mL) were significantly (P = .006) reduced compared with pretreatment levels (1,241 ± 2,124 U/mL). Thirteen (81%) of 16 patients initially judged resectable, three (33%) of nine borderline-resectable patients, and one (7%) of 14 unresectable patients underwent resection after therapy. One-year survival rates were 73% for all patients, 94% for resectable patients, 76% for borderline-resectable patients, and 47% for unresectable patients. Conclusion: Full-dose gemcitabine with concurrent radiotherapy was well tolerated and active. Evaluation of this regimen in a larger, randomized trial for patients with resectable or borderline-resectable disease may be warranted.

Original languageEnglish (US)
Pages (from-to)942-947
Number of pages6
JournalJournal of Clinical Oncology
Volume26
Issue number6
DOIs
StatePublished - Feb 20 2008
Externally publishedYes

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gemcitabine
Pancreatic Neoplasms
Radiotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer : A multicenter phase II trial. / Small, William; Berlin, Jordan; Freedman, Gary M.; Lawrence, Theodore; Talamonti, Mark S.; Mulcahy, Mary F.; Chakravarthy, A. Bapsi; Konski, Andre A.; Zalupski, Mark M.; Philip, Philip A.; Kinsella, Timothy J.; Merchant, Nipun; Hoffman, John P.; Benson, Al B.; Nicol, Steven; Xu, Rong M.; Gill, John F.; McGinn, Cornelius J.

In: Journal of Clinical Oncology, Vol. 26, No. 6, 20.02.2008, p. 942-947.

Research output: Contribution to journalArticle

Small, W, Berlin, J, Freedman, GM, Lawrence, T, Talamonti, MS, Mulcahy, MF, Chakravarthy, AB, Konski, AA, Zalupski, MM, Philip, PA, Kinsella, TJ, Merchant, N, Hoffman, JP, Benson, AB, Nicol, S, Xu, RM, Gill, JF & McGinn, CJ 2008, 'Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer: A multicenter phase II trial', Journal of Clinical Oncology, vol. 26, no. 6, pp. 942-947. https://doi.org/10.1200/JCO.2007.13.9014
Small, William ; Berlin, Jordan ; Freedman, Gary M. ; Lawrence, Theodore ; Talamonti, Mark S. ; Mulcahy, Mary F. ; Chakravarthy, A. Bapsi ; Konski, Andre A. ; Zalupski, Mark M. ; Philip, Philip A. ; Kinsella, Timothy J. ; Merchant, Nipun ; Hoffman, John P. ; Benson, Al B. ; Nicol, Steven ; Xu, Rong M. ; Gill, John F. ; McGinn, Cornelius J. / Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer : A multicenter phase II trial. In: Journal of Clinical Oncology. 2008 ; Vol. 26, No. 6. pp. 942-947.
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abstract = "Purpose: Gemcitabine is effective in the treatment of pancreatic cancer and is a potent radiosensitizer. This study assessed safety and efficacy of full-dose gemcitabine administered before and during concurrent three-dimensional conformal radiation (3D-CRT) in patients with nonmetastatic pancreatic cancer. Patients and Methods: During cycles 1 and 3, patients received gemcitabine at 1,000 mg/m2 on days 1 and 8 of each 21-day cycle. Cycle 2 included the same dose of gemcitabine on days 1, 8, and 15 of a 28-day cycle with concurrent 3D-CRT at 36 Gy, administered in 15 fractions of 2.4 Gy, over 3 weeks. Resectable patients underwent surgery 4 to 6 weeks after treatment. The primary objective was evaluation of toxicity. Tumor response, CA 19-9, and 1-year survival were also assessed. Results: Forty-one patients enrolled at six institutions between April 2002 and October 2003. Among the 39 treated patients, the most common toxicities were grade 3 neutropenia (12.8{\%}), grade 3 nausea (10.3{\%}), and grade 3 vomiting (10.3{\%}). The response rate was 5.1{\%} and disease control rate was 84.6{\%}. Mean post-treatment CA 19-9 levels (228 ± 347 U/mL) were significantly (P = .006) reduced compared with pretreatment levels (1,241 ± 2,124 U/mL). Thirteen (81{\%}) of 16 patients initially judged resectable, three (33{\%}) of nine borderline-resectable patients, and one (7{\%}) of 14 unresectable patients underwent resection after therapy. One-year survival rates were 73{\%} for all patients, 94{\%} for resectable patients, 76{\%} for borderline-resectable patients, and 47{\%} for unresectable patients. Conclusion: Full-dose gemcitabine with concurrent radiotherapy was well tolerated and active. Evaluation of this regimen in a larger, randomized trial for patients with resectable or borderline-resectable disease may be warranted.",
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T2 - A multicenter phase II trial

AU - Small, William

AU - Berlin, Jordan

AU - Freedman, Gary M.

AU - Lawrence, Theodore

AU - Talamonti, Mark S.

AU - Mulcahy, Mary F.

AU - Chakravarthy, A. Bapsi

AU - Konski, Andre A.

AU - Zalupski, Mark M.

AU - Philip, Philip A.

AU - Kinsella, Timothy J.

AU - Merchant, Nipun

AU - Hoffman, John P.

AU - Benson, Al B.

AU - Nicol, Steven

AU - Xu, Rong M.

AU - Gill, John F.

AU - McGinn, Cornelius J.

PY - 2008/2/20

Y1 - 2008/2/20

N2 - Purpose: Gemcitabine is effective in the treatment of pancreatic cancer and is a potent radiosensitizer. This study assessed safety and efficacy of full-dose gemcitabine administered before and during concurrent three-dimensional conformal radiation (3D-CRT) in patients with nonmetastatic pancreatic cancer. Patients and Methods: During cycles 1 and 3, patients received gemcitabine at 1,000 mg/m2 on days 1 and 8 of each 21-day cycle. Cycle 2 included the same dose of gemcitabine on days 1, 8, and 15 of a 28-day cycle with concurrent 3D-CRT at 36 Gy, administered in 15 fractions of 2.4 Gy, over 3 weeks. Resectable patients underwent surgery 4 to 6 weeks after treatment. The primary objective was evaluation of toxicity. Tumor response, CA 19-9, and 1-year survival were also assessed. Results: Forty-one patients enrolled at six institutions between April 2002 and October 2003. Among the 39 treated patients, the most common toxicities were grade 3 neutropenia (12.8%), grade 3 nausea (10.3%), and grade 3 vomiting (10.3%). The response rate was 5.1% and disease control rate was 84.6%. Mean post-treatment CA 19-9 levels (228 ± 347 U/mL) were significantly (P = .006) reduced compared with pretreatment levels (1,241 ± 2,124 U/mL). Thirteen (81%) of 16 patients initially judged resectable, three (33%) of nine borderline-resectable patients, and one (7%) of 14 unresectable patients underwent resection after therapy. One-year survival rates were 73% for all patients, 94% for resectable patients, 76% for borderline-resectable patients, and 47% for unresectable patients. Conclusion: Full-dose gemcitabine with concurrent radiotherapy was well tolerated and active. Evaluation of this regimen in a larger, randomized trial for patients with resectable or borderline-resectable disease may be warranted.

AB - Purpose: Gemcitabine is effective in the treatment of pancreatic cancer and is a potent radiosensitizer. This study assessed safety and efficacy of full-dose gemcitabine administered before and during concurrent three-dimensional conformal radiation (3D-CRT) in patients with nonmetastatic pancreatic cancer. Patients and Methods: During cycles 1 and 3, patients received gemcitabine at 1,000 mg/m2 on days 1 and 8 of each 21-day cycle. Cycle 2 included the same dose of gemcitabine on days 1, 8, and 15 of a 28-day cycle with concurrent 3D-CRT at 36 Gy, administered in 15 fractions of 2.4 Gy, over 3 weeks. Resectable patients underwent surgery 4 to 6 weeks after treatment. The primary objective was evaluation of toxicity. Tumor response, CA 19-9, and 1-year survival were also assessed. Results: Forty-one patients enrolled at six institutions between April 2002 and October 2003. Among the 39 treated patients, the most common toxicities were grade 3 neutropenia (12.8%), grade 3 nausea (10.3%), and grade 3 vomiting (10.3%). The response rate was 5.1% and disease control rate was 84.6%. Mean post-treatment CA 19-9 levels (228 ± 347 U/mL) were significantly (P = .006) reduced compared with pretreatment levels (1,241 ± 2,124 U/mL). Thirteen (81%) of 16 patients initially judged resectable, three (33%) of nine borderline-resectable patients, and one (7%) of 14 unresectable patients underwent resection after therapy. One-year survival rates were 73% for all patients, 94% for resectable patients, 76% for borderline-resectable patients, and 47% for unresectable patients. Conclusion: Full-dose gemcitabine with concurrent radiotherapy was well tolerated and active. Evaluation of this regimen in a larger, randomized trial for patients with resectable or borderline-resectable disease may be warranted.

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