Rectal cancer: 25% of patients can be cured without surgery
In Italy, there are more than 14,000 cases per year and approximately 5,000 deaths. The results of the NO-CUT clinical study change and improve clinical practice
Key points
Rectal cancer affects 700,000 people worldwide every year, and 340,000 of these die from the disease. In Italy, there are more than 14,000 cases per year and about 5,000 deaths. These numbers alone make us understand the urgency of finding new treatments and the importance of the results obtained from the Italian clinical trial NO-CUT, which modify and improve the clinical practice of therapy for rectal cancer: in one out of four people, in fact, thanks to the NO-CUT protocol it has been possible to achieve complete remission of the tumour without surgery. The results of the study, coordinated by researchers from Niguarda Hospital and the University of Milan, with the support of the Airc Foundation for Cancer Research, have just been published in the scientific journal The Lancet Oncology.
Instead of surgery, careful follow-up
In short, this new study demonstrates that when preoperative therapies eliminate malignancies, "surgery can give way to careful follow-up, thus offering the possibility of recovery without the need for surgery," explains Salvatore Siena, director of Falck Oncology at Niguarda Hospital in Milan, full professor of Medical Oncology in the Department of Oncology and Haemato-Oncology (DIPO) at the University of Milan, and senior author of the NO-CUT study. 'Overall,' adds Siena, 'we can say that the approach validated by the NO-CUT clinical trial represents significant progress for people with rectal cancer and is a milestone in oncology. Indeed, the data from the NO-CUT trial show that when preoperative therapies eliminate the tumour, surgery can give way to careful follow-up, thus offering the possibility of recovery without the need for surgery. The results have indeed confirmed the safety of this strategy, which has become an established option in the treatment guidelines for rectal cancer'.
The study and its objectives
The study involved 180 patients with locally advanced rectal cancer who were treated with total neoadjuvant therapy, i.e. with four administrations of medical oncological therapy followed by radio- and chemotherapy. Of these, those who achieved a complete clinical response, i.e. about 25%, were able to avoid rectal surgery without an increased risk of developing metastases in other organs. "In the NO-CUT study," warns Gianluca Vago, Director of the Department of Oncology and Haemato-Oncology (DIPO) at the University of Milan, "there is an important translational component: doctors and researchers used advanced diagnostic tools, such as the analysis of circulating tumour DNA (with the so-called liquid biopsy) and of the transcription characteristics of individual tumours. The aim was to identify patients who can benefit from neoadjuvant therapy and the non-surgical approach, or those who, not benefiting at all, can be started on surgery immediately, avoiding ineffective treatments. This study highlights the very high value of our country's research, which is able to change clinical practice to the benefit of patients'.
The alternative to traditional therapy
Locally advanced rectal carcinomas, i.e. excluding the early and metastatic stages, account for about one third of all new cases. To date, cure is possible with a multimodal therapy comprising radiotherapy, medical oncological therapy and rectal surgery. The latter, thanks to the results of the recently published NO-CUT study, can be avoided in a quarter of cases without compromising the possibility of cure. The study, designed in 2017 and open to patient enrolment from 2018 to 2024, is sponsored by Niguarda Hospital and the University of Milan and was conducted in four cancer centres: niguarda itself (principal investigator Salvatore Siena), the European Institute of Oncology in Milan (principal investigator Maria Giulia Zampino), the Istituto Oncologico Veneto in Padua (principal investigator Francesca Bergamo), and the Papa Giovanni XXIII Hospital in Bergamo (principal investigator Stefania Mosconi). The IFOM - Molecular Oncology Foundation Institute, the Mario Negri Institute for Pharmacological Research, the Candiolo Institute and the University of Turin contributed to the translational studies and statistics. NO-CUT was funded by the AIRC Foundation for Cancer Research ETS, the Niguarda Oncology Foundation ETS, and the Niguarda Hospital.
