Short-term safety of adjuvant chemoradiotherapy after local resection for patients with high-risk submucosal invasive rectal cancer: a single-arm, multicenter phase II trial.

Abstract

BACKGROUND:

Surgery is recommended for patients with high-risk submucosal invasive rectal cancer (SM-RC) after local resection but affects the quality of life due to stoma placement or impaired anal function; therefore, alternative treatment approaches are needed to prevent local metastasis. The purpose of this study was to assess the short-term safety of adjuvant chemoradiotherapy with capecitabine in patients with high-risk submucosal invasive rectal cancer after local resection.

METHODS:

This single-arm, multicenter, phase II trial included patients undergoing local resection for high-risk submucosal invasive rectal cancer within 12 weeks prior to enrollment. High-risk submucosal invasive rectal cancer was defined as the presence of at least one of the following factors: poor differentiation of adenocarcinoma, submucosal invasion depth > 1 mm, presence of lymphovascular invasion and grade-2 or -3 tumour budding. Protocol treatment comprised 45.0 Gy radiotherapy with conventional fractionation and 1650 mg/m2 capecitabine given twice daily until radiotherapy completion. The primary endpoint was treatment completion rate with an expected rate of 95% and a threshold of 80%.

RESULTS:

Twenty-nine patients from six institutions were enrolled between May 2015 and February 2018. One patient was ineligible. Twenty-three patients completed treatment, with a completion rate of 82% (80% confidence interval, 69-91%); the remaining five patients completed treatment with protocol deviation. The median relative dose intensity of capecitabine was 100% (range, 58-100%). Common adverse events included radiation dermatitis (54%), anal pain (39%) and anal mucositis (29%). No grade-3 or higher adverse events were reported.

CONCLUSIONS:

Adjuvant chemoradiotherapy using capecitabine demonstrated acceptable short-term safety profiles in patients with high-risk submucosal invasive rectal cancer after local resection.

• Authors: Masaaki Noguchi, Kohei Shitara, Akihito Kawazoe, Daisuke Yamamoto, Yasumasa Takii, Yutaka Saito, Toshihiko Sato, Takahiro Horimatsu, Hideki Ishikawa, Yoshinori Ito, Masaaki Ito, Hiroaki Ikematsu
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 51 Issue 5 Pg. 707-712 (Apr 30 2021) ISSN: 1465-3621 [Electronic] England
• PMID: 33558891 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: © The Author(s) 2021. Published by Oxford University Press.

Topics

• Adult
• Aged
• Aged, 80 and over
• Chemoradiotherapy, Adjuvant (adverse effects, methods)
• Female
• Humans
• Male
• Middle Aged
• Neoplasm Staging
• Quality of Life
• Rectal Neoplasms (drug therapy, pathology, surgery)
• Young Adult