Phase 2 multi‐institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma

BACKGROUND This phase 2 multi‐institutional study was designed to determine whether gemcitabine (GEM) with fractionated stereotactic body radiotherapy (SBRT) results in acceptable late grade 2 to 4 gastrointestinal toxicity when compared with a prior trial of GEM with single‐fraction SBRT in patient...

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Bibliographic Details
Published in:Cancer 2015-04, Vol.121 (7), p.1128-1137
Main Authors: Herman, Joseph M., Chang, Daniel T., Goodman, Karyn A., Dholakia, Avani S., Raman, Siva P., Hacker‐Prietz, Amy, Iacobuzio‐Donahue, Christine A., Griffith, Mary E., Pawlik, Timothy M., Pai, Jonathan S., O'Reilly, Eileen, Fisher, George A., Wild, Aaron T., Rosati, Lauren M., Zheng, Lei, Wolfgang, Christopher L., Laheru, Daniel A., Columbo, Laurie A., Sugar, Elizabeth A., Koong, Albert C.
Format: Article
Language:English
Subjects:
Adenocarcinoma - mortality
Adenocarcinoma - pathology
Adenocarcinoma - therapy
Adult
Aged
Aged, 80 and over
chemoradiation
Combined Modality Therapy
Deoxycytidine - analogs & derivatives
Deoxycytidine - therapeutic use
Disease Progression
Dose Fractionation
Female
Follow-Up Studies
Humans
locally advanced
Male
Middle Aged
Neoplasm Staging
Original
pancreatic cancer
Pancreatic Neoplasms - mortality
Pancreatic Neoplasms - pathology
Pancreatic Neoplasms - therapy
positron emission tomography
Prognosis
Prospective Studies
Quality of Life
Radiosurgery
stereotactic body radiotherapy
Survival Rate
unresectable
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Summary:BACKGROUND This phase 2 multi‐institutional study was designed to determine whether gemcitabine (GEM) with fractionated stereotactic body radiotherapy (SBRT) results in acceptable late grade 2 to 4 gastrointestinal toxicity when compared with a prior trial of GEM with single‐fraction SBRT in patients with locally advanced pancreatic cancer (LAPC). METHODS A total of 49 patients with LAPC received up to 3 doses of GEM (1000 mg/m2) followed by a 1‐week break and SBRT (33.0 gray [Gy] in 5 fractions). After SBRT, patients continued to receive GEM until disease progression or toxicity. Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ‐C30) and pancreatic cancer‐specific QLQ‐PAN26 module before SBRT and at 4 weeks and 4 months after SBRT. RESULTS The median follow‐up was 13.9 months (range, 3.9‐45.2 months). The median age of the patients was 67 years and 84% had tumors of the pancreatic head. Rates of acute and late (primary endpoint) grade ≥2 gastritis, fistula, enteritis, or ulcer toxicities were 2% and 11%, respectively. QLQ‐C30 global quality of life scores remained stable from baseline to after SBRT (67 at baseline, median change of 0 at both follow‐ups; P>.05 for both). Patients reported a significant improvement in pancreatic pain (P = .001) 4 weeks after SBRT on the QLQ‐PAN26 questionnaire. The median plasma carbohydrate antigen 19‐9 (CA 19‐9) level was reduced after SBRT (median time after SBRT, 4.2 weeks; 220 U/mL vs 62 U/mL [P
ISSN:0008-543X
1097-0142
DOI:10.1002/cncr.29161