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Showing content from https://pubmed.ncbi.nlm.nih.gov/25538019/ below:

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

Clinical Trial

. 2015 Apr 1;121(7):1128-37. doi: 10.1002/cncr.29161. Epub 2014 Dec 23. Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma Daniel T Chang, Karyn A Goodman, Avani S Dholakia, Siva P Raman, Amy Hacker-Prietz, Christine A Iacobuzio-Donahue, Mary E Griffith, Timothy M Pawlik, Jonathan S Pai, Eileen O'Reilly, George A Fisher, Aaron T Wild, Lauren M Rosati, Lei Zheng, Christopher L Wolfgang, Daniel A Laheru, Laurie A Columbo, Elizabeth A Sugar, Albert C Koong

Affiliations

Affiliation

¹ Department of Radiation Oncology & Molecular Radiation Sciences, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.

PMID: 25538019
PMCID: PMC4368473
DOI: 10.1002/cncr.29161

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Clinical Trial

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

Joseph M Herman et al. Cancer. 2015.

. 2015 Apr 1;121(7):1128-37. doi: 10.1002/cncr.29161. Epub 2014 Dec 23. Authors Joseph M Herman¹, Daniel T Chang, Karyn A Goodman, Avani S Dholakia, Siva P Raman, Amy Hacker-Prietz, Christine A Iacobuzio-Donahue, Mary E Griffith, Timothy M Pawlik, Jonathan S Pai, Eileen O'Reilly, George A Fisher, Aaron T Wild, Lauren M Rosati, Lei Zheng, Christopher L Wolfgang, Daniel A Laheru, Laurie A Columbo, Elizabeth A Sugar, Albert C Koong Affiliation

¹ Department of Radiation Oncology & Molecular Radiation Sciences, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.

PMID: 25538019
PMCID: PMC4368473
DOI: 10.1002/cncr.29161

Item in Clipboard

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/m(2)) 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.

Keywords: chemoradiation; locally advanced; pancreatic cancer; positron emission tomography; stereotactic body radiotherapy; unresectable.

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Figures
Figure 1

Consolidated Standards Of Reporting Trials…

Figure 1

Consolidated Standards Of Reporting Trials (CONSORT) flow diagram showing enrollment and outcomes is…

Figure 1

Consolidated Standards Of Reporting Trials (CONSORT) flow diagram showing enrollment and outcomes is shown.

Figure 2

Kaplan-Meier estimates of the survival…

Figure 2

Kaplan-Meier estimates of the survival function for (A) overall survival and (B) progression-free…

Figure 2

Kaplan-Meier estimates of the survival function for (A) overall survival and (B) progression-free survival are shown. The 95% confidence intervals are included as dotted lines.