Key clinical point: Three months of induction therapy with modified folinic acid-fluorouracil-oxaliplatin 6 (mFOLFOX6)/capecitabine-oxaliplatin (CAPOX) downstaged early-stage I/IIA rectal cancer in the majority of selected patients, allowing a well-tolerated organ-preserving surgery.
Major finding: Induction therapy with mFOLFOX6/CAPOX followed by transanal excision surgery (TES) downstaged tumors to ypT0/T1 cN0 in 57% of patients, with 79% (90% CI 69%-88%) of overall patients achieving organ preservation with no unexpected toxicities.
Study details : Findings are from the phase 2 NEO trial including 58 patients with clinical T1-T3abN0 low- or mid-rectal adenocarcinoma with no unfavorable histologic characteristics who were treated with 3 months of chemotherapy (mFOLFOX6/CAPOX), of which 56 proceeded to TES.
Disclosures: This study was supported by the Canadian Cancer Society . Some authors declared receiving honoraria or research funding from or serving as consultants or advisors or on speakers’ bureau for various sources.
Source: Kennecke HF et al. Neoadjuvant chemotherapy, excision, and observation for early rectal cancer: The phase II NEO trial (CCTG CO.28) primary end point results. J Clin Oncol. 2022 (Aug 18). Doi: 10.1200/JCO.22.00184