{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T01:58:07Z","timestamp":1760234287862,"version":"build-2065373602"},"reference-count":22,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2021,4,29]],"date-time":"2021-04-29T00:00:00Z","timestamp":1619654400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>We developed and implemented an objective toxicity scoring system to be used during endoscopic evaluation of the upper gastrointestinal (GI) tract in order to directly assess changes in toxicity during the radiation treatment of pancreatic cancer. We assessed and validated the upper GI toxicity of 19 locally advanced pancreatic cancer trial patients undergoing stereotactic body radiation therapy (SBRT). Wilcoxon-signed rank tests were used to compare pre- and post-SBRT scores. Comparison of the toxicity scores measured before and after SBRT revealed a mild increase in toxicity in the stomach and duodenum (p &lt; 0.005), with no cases of severe toxicity observed. Kappa and AC1 statistics analysis were used to evaluate interobserver agreement. Our toxicity scoring system was reliable in determining GI toxicity with a good overall interobserver agreement for pre-treatment scores (stomach, \u03ba = 0.71, p &lt; 0.005; duodenum, \u03ba = 0.88, p &lt; 0.005) and post-treatment scores (stomach, \u03ba = 0.71, p &lt; 0.005; duodenum, \u03ba = 0.76, p &lt; 0.005). The AC1 statistics yielded similar results. With future usage, we hope this scoring system will be a useful tool for objectively and reliably assessing changes in GI toxicity during the treatment of pancreatic cancer and for GI toxicity assessments and comparisons during radiation therapy research trials.<\/jats:p>","DOI":"10.3390\/cancers13092136","type":"journal-article","created":{"date-parts":[[2021,4,29]],"date-time":"2021-04-29T04:30:11Z","timestamp":1619670611000},"page":"2136","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development of an Objective Scoring System for Endoscopic Assessment of Radiation-Induced Upper Gastrointestinal Toxicity"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6398-4789","authenticated-orcid":false,"given":"Daniel","family":"Lin","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shalini","family":"Moningi","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Brigham and Women\u2019s Hospital, 75 Francis St, Boston, MA 02115, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2283-4765","authenticated-orcid":false,"given":"Joseph","family":"Abi Jaoude","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ben S.","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Nutrition, Division of Internal Medicine, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irina M.","family":"Cazacu","sequence":"additional","affiliation":[{"name":"Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy of Craiova, Strada Petru Rares 2, Craiova 200349, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1521-0495","authenticated-orcid":false,"given":"Ramez","family":"Kouzy","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6350-2206","authenticated-orcid":false,"given":"Graciela M.","family":"Nogueras Gonzalez","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Division of Basic Sciences, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6924-2794","authenticated-orcid":false,"given":"Phonthep","family":"Angsuwatcharakon","sequence":"additional","affiliation":[{"name":"Department of Anatomy, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph M.","family":"Herman","sequence":"additional","affiliation":[{"name":"Department of Radiation Medicine, Northwell Health Cancer Institute, 450 Lakeville Road, New Hyde Park, NY 11042, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manoop S.","family":"Bhutani","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Nutrition, Division of Internal Medicine, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8052-3316","authenticated-orcid":false,"given":"Cullen M.","family":"Taniguchi","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,4,29]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"7","DOI":"10.3322\/caac.21551","article-title":"Cancer statistics, 2019","volume":"69","author":"Siegel","year":"2019","journal-title":"CA Cancer J. Clin."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1806","DOI":"10.1200\/JCO.2008.17.7188","article-title":"DPC4 gene status of the primary carcinoma correlates with patterns of failure in patients with pancreatic cancer","volume":"27","author":"Fu","year":"2009","journal-title":"J. Clin. Oncol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1028","DOI":"10.6004\/jnccn.2017.0131","article-title":"Pancreatic Adenocarcinoma, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology","volume":"15","author":"Tempero","year":"2017","journal-title":"J. Natl. Compr. Cancer Netw."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"626","DOI":"10.1111\/1754-9485.12084","article-title":"The use of fiducial markers in image-guided radiotherapy for gastric cancer: Gastric cancer fiducial IGRT","volume":"57","author":"Sia","year":"2013","journal-title":"J. Med. Imaging Radiat. Oncol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"659","DOI":"10.1016\/j.gie.2018.10.047","article-title":"EUS-guided fiducial placement for GI malignancies: A systematic review and meta-analysis","volume":"89","author":"Coronel","year":"2019","journal-title":"Gastrointest. Endosc."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"693","DOI":"10.1016\/j.adro.2018.07.008","article-title":"Dose escalation for locally advanced pancreatic cancer: How high can we go?","volume":"3","author":"Colbert","year":"2018","journal-title":"Adv. Radiat. Oncol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1420","DOI":"10.1016\/j.ijrobp.2009.09.075","article-title":"A Dosimetric Model of Duodenal Toxicity After Stereotactic Body Radiotherapy for Pancreatic Cancer","volume":"78","author":"Murphy","year":"2010","journal-title":"Int. J. Radiat. Oncol. Biol. Phys."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1016\/j.adro.2017.02.004","article-title":"Dose escalation with an IMRT technique in 15 to 28 fractions is better tolerated than standard doses of 3DCRT for LAPC","volume":"2","author":"Colbert","year":"2017","journal-title":"Adv. Radiat. Oncol."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Zhang, S., Liang, F., and Tannock, I. (2016). Use and misuse of common terminology criteria for adverse events in cancer clinical trials. BMC Cancer, 16.","DOI":"10.1186\/s12885-016-2408-9"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"240","DOI":"10.1093\/jnci\/djm324","article-title":"Is There Room for Improvement in Adverse Event Reporting in the Era of Targeted Therapies?","volume":"100","author":"Edgerly","year":"2008","journal-title":"J. Natl. Cancer Inst."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"457","DOI":"10.1001\/jamaoncol.2018.6205","article-title":"Investigating Potential Bias in Patient-Reported Outcomes in Open-label Cancer Trials","volume":"5","author":"Roydhouse","year":"2019","journal-title":"JAMA Oncol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"65577","DOI":"10.18632\/oncotarget.11576","article-title":"The use of and adherence to CTCAE v3.0 in cancer clinical trial publications","volume":"7","author":"Zhang","year":"2016","journal-title":"Oncotarget"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1297","DOI":"10.1007\/s11136-008-9379-5","article-title":"Prospects and challenges in using patient-reported outcomes in clinical practice","volume":"17","author":"Fung","year":"2008","journal-title":"Qual. Life Res."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1016\/j.ijosm.2018.03.003","article-title":"The challenges and opportunities of using patient reported outcome measures (PROMs) in clinical practice","volume":"28","author":"Fleischmann","year":"2018","journal-title":"Int. J. Osteopath. Med."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"2352","DOI":"10.1245\/s10434-014-4274-5","article-title":"The Role of Stereotactic Body Radiation Therapy for Pancreatic Cancer: A Single-Institution Experience","volume":"22","author":"Moningi","year":"2015","journal-title":"Ann. Surg. Oncol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1128","DOI":"10.1002\/cncr.29161","article-title":"Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma: SBRT for Unresectable Pancreatic Cancer","volume":"121","author":"Herman","year":"2015","journal-title":"Cancer"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"808","DOI":"10.1080\/02841860600908954","article-title":"Stereotactic Body Radiation Therapy (SBRT) for lung metastases","volume":"45","author":"Okunieff","year":"2006","journal-title":"Acta Oncol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1461","DOI":"10.1586\/14737140.2014.952286","article-title":"Stereotactic body radiation therapy in pancreatic cancer: The new frontier","volume":"14","author":"Moningi","year":"2014","journal-title":"Expert Rev. Anticancer Ther."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"256","DOI":"10.1016\/j.semradonc.2017.02.005","article-title":"Integration of Stereotactic Body Radiation Therapy into the Multidisciplinary Management of Pancreatic Cancer","volume":"27","author":"Rosati","year":"2017","journal-title":"Semin. Radiat. Oncol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1097\/COC.0000000000000472","article-title":"Dose Escalation in Stereotactic Body Radiation Therapy for Pancreatic Cancer: A Meta-Analysis","volume":"42","author":"Zaorsky","year":"2019","journal-title":"Am. J. Clin. Oncol."},{"key":"ref_21","first-page":"236","article-title":"The tolerance of gastrointestinal organs to stereotactic body radiation therapy: What do we know so far?","volume":"5","author":"Thomas","year":"2014","journal-title":"J. Gastrointest. Oncol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"684","DOI":"10.1111\/j.0006-341X.2004.00218.x","article-title":"Dose-Finding Based on Efficacy\u2013Toxicity Trade-Offs","volume":"60","author":"Thall","year":"2004","journal-title":"Biometrics"}],"container-title":["Cancers"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6694\/13\/9\/2136\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T05:55:02Z","timestamp":1760162102000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6694\/13\/9\/2136"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,29]]},"references-count":22,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2021,5]]}},"alternative-id":["cancers13092136"],"URL":"https:\/\/doi.org\/10.3390\/cancers13092136","relation":{},"ISSN":["2072-6694"],"issn-type":[{"type":"electronic","value":"2072-6694"}],"subject":[],"published":{"date-parts":[[2021,4,29]]}}}