Rectal Cancer, Complete Healing for 1 in 4 Even Without Surgery

One in four patients with mid-low rectal carcinoma locally advanced cancer heals completely even without surgery. This is what the authors of the No-Cut study are convinced of, the results of which were presented at the Esmo 2024 Congress underway in Barcelona. The researchers of the study – promoted and carried out by the Niguarda Hospital in Milan – have demonstrated that preserving the integrity of the rectum, guaranteeing the same levels of safety and healing given by the traditional surgical approach, is possible.

The study, conducted from 2018 to 2024, involved radiotherapists, medical oncologists, surgeons, radiologists, endoscopists, pathologists, biologists, pharmacists, study coordinators, administrators and researchers in 4 institutions in Italy: the Niguarda Hospital in Milan (promoter), the European Institute of Oncology (IEO) in Milan, the Veneto Oncology Institute (IOV) in Padua and the Papa Giovanni XXIII Hospital in Bergamo. Oncologist Alessio Amatu from Niguarda illustrated the data at the presidential symposium ‘Eyes to The Future’: “The translational objectives of genomics and transcriptomics, presented for the first time at the Esmo congress, concern the predictive value of circulating tumor DNA (ctDNA, liquid biopsy) and tumor RNA and are also significant and indicative because they are able to predict the clinical response”.

In locally advanced rectal cancer, one of the most commonly used treatment strategies currently involves surgical removal of the disease. In particular, until 2017, cases of locally advanced medium-low rectal cancer were always treated with chemo-radiotherapy and rectal surgery, followed by precautionary (adjuvant) post-surgical chemotherapy to reduce the risk of recurrence. With the No-Cut study, researchers instead wanted to investigate the effectiveness of a treatment path that could preserve the integrity of the rectum while ensuring the same levels of healing and safety as surgery. The protocol involved the preventive administration of a more intense therapy, consisting of an initial phase of chemotherapy followed by a second phase enhanced with radiotherapy. Subsequently, if complete clinical remission of the disease was highlighted during the instrumental clinical reassessment (with rectal examination, nuclear magnetic resonance imaging, rectal echoendoscopy and biopsy), the patient could avoid rectal surgery and instead be subjected to active surveillance with close checks over time.

In the study, 180 people have been treated and studied over the years and the clinical result was that one in four people achieved complete clinical remission that has been maintained over time. A characteristic that has allowed them to avoid rectal surgery and colostomy, significantly improving their quality of life. In addition, within the No-Cut study, some multiomic biomarkers were studied (radiological and pathological characteristics, ‘radiopathomics’; DNA of the tumor and circulating in the blood, ‘genomics and liquid biopsy’; RNA of the tumor, ‘transcriptomics’), with the aim of identifying a priori in which cases it was possible to avoid rectal surgery or those who, not achieving complete clinical remission, could benefit from new therapies in the future.

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“The main objective of the study – comments Salvatore Siena, director of Oncology at the Niguarda Hospital in Milan and principal investigator of No-Cut – is very innovative and relevant for the development of non-surgical therapy for locally advanced rectal cancer: it is a matter of verifying whether avoiding surgery (Non-Operative Management, Nom) affects the rate of tumor metastasis. The main objective has been achieved and is positive, because following Nom the survival of patients at a distance of 30 months was 97%, and free from metastasis. A result that is much more favorable than expected”.

The No-Cut study is funded by grant IG-20685 from Fondazione Airc Ets, by Fondazione Oncologia Niguarda Ets and by the Divisional Fund of the Falck Oncology Complex Structure of Niguarda.