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

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.

Cancer, 2015-04, Vol.121 (7), p.1128-1137 [Periódico revisado por pares]

United States: BlackWell Publishing Ltd

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Título:
Phase 2 multi‐institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma
Autor: 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.
Assuntos: 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
É parte de: Cancer, 2015-04, Vol.121 (7), p.1128-1137
Notas: Presented at the 48th Annual Meeting of the American Society of Clinical Oncology; June 1‐5, 2012; Chicago, IL and the American Society of Radiation Oncology 2013 Annual Meeting; September 22‐25, 2013; Atlanta, GA.
Presented at the 48th Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2012; Chicago, IL and the American Society of Radiation Oncology 2013 Annual Meeting; September 22-25, 2013; Atlanta, GA.
Descrição: 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<.001]). The median overall survival was 13.9 months (95% confidence interval, 10.2 months‐16.7 months). Freedom from local disease progression at 1 year was 78%. Four patients (8%) underwent margin‐negative and lymph node‐negative surgical resections. CONCLUSIONS Fractionated SBRT with GEM results in minimal acute and late gastrointestinal toxicity. Future studies should incorporate SBRT with more aggressive multiagent chemotherapy. Cancer 2015;121:1128–1137. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. To the authors' knowledge, the current study is the first prospective multi‐institutional trial evaluating the role of stereotactic body radiotherapy in patients with locally advanced pancreatic cancer. The results suggest that fractionated stereotactic body radiotherapy with gemcitabine achieves favorable toxicity, quality of life, and preliminary efficacy compared with historical data.
Editor: United States: BlackWell Publishing Ltd
Idioma: Inglês

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

United States: BlackWell Publishing Ltd

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