27 Jul It has the potential to change the treatment paradigm for many patients with rectal cancer
This study represents an attempt to investigate, in a multi-institutional setting, the feasibility of rectal preservation in a number of LARC patients who develop a cCR after a novel neoadjuvant therapy protocol. The study design is innovative because it compares 3-year DFS in a group of LARC patients treated according to a protocol incorporating TNT and NOM, to a similar group of historical controls treated according to the standard CRT, TME and ACT protocol. The studies published thus far on the safety of NOM in LARC patients have compared the survival of a selected group of patients with a cCR and NOM, to a selected group of patients with a pCR after TME. While these reports provide an estimate of the safety of NOM, they do not provide accurate information on the impact of selective use of NOM on outcomes in the entire LARC population. Our study will be the first to determine the proportion of patients with LARC who will be candidates for NOM, and the impact of NOM on 3-year DFS in the entire LARC population.
There is now conclusive evidence that tumor response to chemotherapy and radiation requires time, and that some tumors achieve a maximal response only after several months. However, in the studies on NOM published to date, tumor response was assessed a few weeks after completing the standard neoadjuvant protocol. It is possible that many patients who were considered non-responders early on, and were therefore not offered NOM, might actually have been complete responders given a longer observation period.