New published article: Bastian et al., 2025

Congratulations to Dr. Bastian and colleagues on the publication of their article on the results of a Phase Ib clinical trial investigating neoadjuvant therapy combined with radiotherapy in the treatment of rectal cancer in the journal Clinical Colorectal Cancer. We are delighted to have contributed to the success of this article!

Treatment of 𝐥𝐨𝐜𝐚𝐥𝐥𝐲 𝐚𝐝𝐯𝐚𝐧𝐜𝐞𝐝 𝐡𝐢𝐠𝐡-𝐫𝐢𝐬𝐤 𝐫𝐞𝐜𝐭𝐚𝐥 𝐜𝐚𝐧𝐜𝐞𝐫 is based on 𝐥𝐨𝐧𝐠-𝐭𝐞𝐫𝐦 𝐜𝐡𝐞𝐦𝐨𝐫𝐚𝐝𝐢𝐨𝐭𝐡𝐞𝐫𝐚𝐩𝐲 (CRT). 𝐍𝐞𝐨𝐚𝐝𝐣𝐮𝐯𝐚𝐧𝐭 𝐭𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬, such as tyrosine kinase inhibitors, can improve outcomes. In this 𝐩𝐡𝐚𝐬𝐞 𝐈𝐛 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥, the authors investigated the clinical effects of 𝐚𝐝𝐝𝐢𝐧𝐠 𝐫𝐞𝐠𝐨𝐫𝐚𝐟𝐞𝐧𝐢𝐛, a multi-enzyme tyrosine kinase inhibitor, to long-term 𝐜𝐚𝐩𝐞𝐜𝐢𝐭𝐚𝐛𝐢𝐧𝐞-𝐛𝐚𝐬𝐞𝐝 𝐂𝐑𝐓. The primary endpoint of the study was pathological response after treatment.

In this cohort of 25 patients, the addition of regorafenib 80 mg to long-term CRT treatment in these patients with locally advanced rectal cancer achieved 𝐜𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐨𝐫 𝐧𝐞𝐚𝐫-𝐜𝐨𝐦𝐩𝐥𝐞𝐭𝐞 𝐩𝐚𝐭𝐡𝐨𝐥𝐨𝐠𝐲 𝐫𝐞𝐠𝐫𝐞𝐬𝐬𝐢𝐨𝐧. All patients underwent surgical treatment. 𝐓𝐨𝐱𝐢𝐜𝐢𝐭𝐲 𝐰𝐚𝐬 𝐦𝐚𝐧𝐚𝐠𝐞𝐚𝐛𝐥𝐞 and post-operative complications were as expected (35.3%).

As regorafenib and capecitabine share common toxicities and radiotherapy increases intestinal toxicity, this study showed that 𝐫𝐞𝐠𝐨𝐫𝐚𝐟𝐞𝐧𝐢𝐛 𝐚𝐭 𝐚 𝐝𝐨𝐬𝐞 𝐨𝐟 𝟖𝟎 𝐦𝐠 could be used as neoadjuvant therapy with CRT 𝐰𝐢𝐭𝐡𝐨𝐮𝐭 𝐚𝐝𝐝𝐢𝐧𝐠 𝐚𝐝𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 𝐭𝐨𝐱𝐢𝐜𝐢𝐭𝐲.