Abstract 89P
Background
Surgery is recommended for patients with high-risk submucosal invasive rectal cancer (SM-RC) after local resection. However, surgery affect patient’s quality of life due to stoma placement and impaired anal function. Thus, alternative treatments to prevent local metastasis are anticipated. This study assessed the safety of adjuvant chemoradiotherapy with capecitabine for patients with high-risk SM-RC after local resection.
Methods
This single-arm, multicenter, phase II trial enrolled patients with high-risk SM-RC who underwent local resection within 12 weeks prior to enrollment. High-risk SM-RC was defined as the presence of at least one of the following factors: poor differentiation of adenocarcinoma, ≥ 1mm of submucosal invasion, presence of lymphovascular invasion, and grade 2 or 3 of tumor budding. Protocol treatment included 45.0 Gy radiotherapy with conventional fractionation and 825 mg/m2 capecitabine administered twice daily until the completion of radiotherapy. The primary endpoint was treatment completion rate, with an expected rate of 95% and a threshold of 80%. This study was registered with the University Hospital Medical Information Network, number UMIN000016785.
Results
A total of 29 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; range, 69%–91%). The remaining five patients also completed treatment with protocol deviation from the planned treatment schedule. The mean relative dose intensity of capecitabine was 89% (range, 58%–100%). The most common adverse events were 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 manageable safety in patients with high-risk SM-RC after local resection.
Clinical trial identification
UMIN000016785.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
The National Cancer Center Research and Development Fund (25‐A‐12) to Dr Saito.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
87P - Negative to positive lymph node ratio-prognostic marker of survival in node positive rectal cancer
Presenter: Pavan Jonnada
Session: Poster display session
Resources:
Abstract
88P - The Sidra LUMC advanced colon cancer NGS cohort
Presenter: Wouter Hendrickx
Session: Poster display session
Resources:
Abstract
90P - High MICB expression confers prognostic benefit in colorectal cancer
Presenter: Shanchao Yu
Session: Poster display session
Resources:
Abstract
91P - Adjuvant therapy for high-risk stage II or stage III colon adenocarcinoma: A propensity score-matched, nationwide, population-based cohort study
Presenter: Chien-Hsin Chen
Session: Poster display session
Resources:
Abstract
92P - Prospective randomized controlled study comparing primary surgery versus neoadjuvant chemotherapy followed by surgery in gastric carcinoma
Presenter: Vipin Goel
Session: Poster display session
Resources:
Abstract
93P - Biomarker selection of liver metastatic colorectal patients for anti-EGFR monoclonal antibodies: A machine learning analysis
Presenter: Yijiao Chen
Session: Poster display session
Resources:
Abstract
94P - NORTH/HGCSG1003: North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer: Final analysis
Presenter: Michio Nakamura
Session: Poster display session
Resources:
Abstract
95P - Anatomical resections improve relapse-free survival in patients with KRAS/NRAS/BRAF- mutated colorectal liver metastases
Presenter: Ye Wei
Session: Poster display session
Resources:
Abstract
96P - Incidence, characteristics and prognosis in colorectal cancer with CNS metastases
Presenter: Nicola Taylor
Session: Poster display session
Resources:
Abstract
97P - The role of adjuvant chemotherapy according to the status of surgical margin in rectal cancer
Presenter: Jong Hoon Lee
Session: Poster display session
Resources:
Abstract