Post by Laura Moolenaar

After nearly 10 years, we are proud to share that the results of the TESAR trial have been published in The Lancet Gastroenterology & Hepatology. The 𝗧𝗘𝗦𝗔𝗥 𝘁𝗿𝗶𝗮𝗹 is the first multicentre phase III randomised controlled trial comparing adjuvant chemoradiotherapy with completion total mesorectal excision (cTME) after local excision of high-risk pT1 and low-risk pT2 rectal cancer. Between 2015 and 2024, 202 patients were enrolled across 25 hospitals in the Netherlands and France. As loss of equipoise hampered patient accrual, randomisation was halted before reaching the target sample size of 302 patients and the trial was converted to a patient-preference design. The present publication reports outcomes prior to this transition. 𝗞𝗲𝘆 𝗳𝗶𝗻𝗱𝗶𝗻𝗴𝘀 1. Non-inferiority for 3-year locoregional recurrence could not formally be demonstrated. Estimated 3-year LR rates were 5.0% after adjuvant chemoradiotherapy vs 1.1% after cTME, corresponding to a difference of 3.9% (90% CI, 0.0 to 9.4; non-inferiority margin: 7%; P=0.16).  2. However, adjuvant chemoradiotherapy resulted in low rates of unsalvageable locoregional recurrence (1.1% after 3 years) and substantially reduced treatment-related morbidity and stoma rates.  3. Quality-of-life outcomes were comparable or favoured adjuvant chemoradiotherapy across nearly all domains.   𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝗰𝗲 These findings challenge cTME as the standard of care for patients with locally excised high-risk pT1 and low-risk pT2 rectal cancer and support implementation of adjuvant chemoradiotherapy. Longer follow-up will be essential to determine the long-term oncological outcomes. This study would not have been possible without the incredible commitment of patients, investigators, sponsors and in particular co-authors: Mahsoem Ali Theo Aufenacker Geerard Beets Robbert Bosker Tineke Buffart Pim Burger Evelien Dekker Quentin Denost Pascal Doornebosch Peter van Duijvendijk Hans Fabry debby geijsen Michael Gerhards Helma WMU van Grevenstein Brechtje Grotenhuis - Van Berkel Christiaan Hoff Jeroen Leijtens MD F.E.B.S. (Coloproctology) Koen Peeters Apollo Pronk George Van der Schelling colin sietses Anke Smits Boudewijn T. Anthony van de Ven Emiel Verdaasdonk Ronald Vuylsteke Erik van Westreenen Hans Wilt de David Zimmerman Marilyne Lange Nicole C.T. van Grieken Barbara Bastiaansen Roel Hompes Corrie Marijnen Marcel G.W. Dijkgraaf, PhD Leon M.G. Moons Pieter Tanis Chris Cunningham Jurriaan Tuynman KWF Kankerbestrijding The full article can be found here: https://lnkd.in/e-UD3NnT