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 language | English (US) |
|---|---|
| Pages (from-to) | 942-947 |
| Number of pages | 6 |
| Journal | Journal of Clinical Oncology |
| Volume | 26 |
| Issue number | 6 |
| DOIs | |
| State | Published - Feb 20 2008 |
| Externally published | Yes |
Fingerprint
ASJC Scopus subject areas
- Cancer Research
- Oncology
- Medicine(all)
Cite this
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 journal › Article
}
TY - JOUR
T1 - Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer
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.
UR - http://www.scopus.com/inward/record.url?scp=39749174027&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=39749174027&partnerID=8YFLogxK
U2 - 10.1200/JCO.2007.13.9014
DO - 10.1200/JCO.2007.13.9014
M3 - Article
VL - 26
SP - 942
EP - 947
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 6
ER -