Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma Journal Article
| Authors: | Herman, J. M.; Chang, D. T.; Goodman, K. A.; Dholakia, A. S.; Raman, S. P.; Hacker-Prietz, A.; Iacobuzio-Donahue, C. A.; Griffith, M. E.; Pawlik, T. M.; Pai, J. S.; O'reilly, E.; Fisher, G. A.; Wild, A. T.; Rosati, L. M.; Zheng, L.; Wolfgang, C. L.; Laheru, D. A.; Columbo, L. A.; Sugar, E. A.; Koong, A. C. |
| Article Title: | Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma |
| Abstract: | 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. |
| Keywords: | adult; clinical article; controlled study; treatment response; aged; constipation; fatigue; neutropenia; advanced cancer; cancer growth; diarrhea; gastrointestinal hemorrhage; systemic therapy; conference paper; gemcitabine; positron emission tomography; antineoplastic agent; anorexia; protein blood level; quality of life; controlled clinical trial; phase 2 clinical trial; anemia; blood toxicity; nausea; thrombocytopenia; dehydration; ca 19-9 antigen; weight reduction; cancer pain; abdominal pain; alanine aminotransferase blood level; aspartate aminotransferase blood level; lymphocytopenia; gastrointestinal toxicity; radiation dose fractionation; digestive system ulcer; multicenter study; pancreas adenocarcinoma; enteritis; therapy effect; heartburn; locally advanced; pancreatic cancer; stereotactic body radiotherapy; inoperable cancer; stereotactic body radiation therapy; dyspepsia; chemoradiation; linear accelerator; cyberknife; duodenum ulcer; volumetric modulated arc therapy; gastritis; digestive system fistula; unresectable; human; male; female; priority journal; radiotherapy unit |
| Journal Title: | Cancer |
| Volume: | 121 |
| Issue: | 7 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 2015-04-01 |
| Start Page: | 1128 |
| End Page: | 1137 |
| Language: | English |
| DOI: | 10.1002/cncr.29161 |
| PROVIDER: | scopus |
| PMCID: | PMC4368473 |
| PUBMED: | 25538019 |
| DOI/URL: | |
| Notes: | Export Date: 4 May 2015 -- Source: Scopus |
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