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 B Merchant; John P Hoffman; Al B Benson; Steven Nicol; Rong M Xu; John F Gill; Cornelius J McGinn

doi:10.1200/JCO.2007.13.9014

Back

Full-Dose Gemcitabine With Concurrent Radiation Therapy in Patients With Nonmetastatic Pancreatic Cancer: A Multicenter Phase II Trial

Journal article

Peer reviewed

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, …

Journal of clinical oncology, Vol.26(6), pp.942-947

2008-02-20

DOI: https://doi.org/10.1200/JCO.2007.13.9014

PMID: 18281668

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.

Metrics

6 Record Views

115 Times Cited - Web of Science

See more details

InCites Highlights

These are selected metrics from InCites Benchmarking & Analytics tool, related to this output

Collaboration types: Domestic collaboration
Citation topics: 1 Clinical & Life Sciences; 1.151 Pancreas & Gall Bladder Disorders; 1.151.395 Pancreatic Cancer
Web Of Science research areas: Oncology
ESI research areas: Clinical Medicine

UN Sustainable Development Goals (SDGs)

This output has contributed to the advancement of the following goals:

Source: InCites

Details

Title: Full-Dose Gemcitabine With Concurrent Radiation Therapy in Patients With Nonmetastatic Pancreatic Cancer: A Multicenter Phase II Trial
Creators: William Small - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Jordan Berlin - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Gary M Freedman - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Theodore Lawrence - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Mark S Talamonti - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Mary F Mulcahy - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
A. Bapsi Chakravarthy - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Andre A Konski - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Mark M Zalupski - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Philip A Philip - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Timothy J Kinsella - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Nipun B Merchant - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
John P Hoffman - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Al B Benson - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Steven Nicol - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Rong M Xu - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
John F Gill - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Cornelius J McGinn - From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Vanderbilt University Medical Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Maine Medical Center, Portland, ME; Karmanos Cancer Institute, Detroit, MI; University Hospitals Case Medical Center, Cleveland, OH; and Eli Lilly & Co, Indianapolis, IN
Publication Details: Journal of clinical oncology, Vol.26(6), pp.942-947
Academic Unit: Miller School of Medicine; UMMG Department of Surgery; UMMG Dept of Surgery - Div of Surgical Oncology
Language: English
Resource Type: Journal article
PMID: 18281668
Record Identifier: 991031599753402976