Study with Polish scientists among the 12 most important in the world. Prof. Rutkowski: “Melanoma disappears in 60% of people”
This study has been selected as one of the twelve most important clinical trials in the world conducted this year in oncology. It concerns patients with melanoma, but it shows a new trend in cancer treatment: the use of immunotherapy before surgery. – The effects are excellent, such results are almost unheard of in oncology today – says Prof. Piotr Rutkowski from the National Institute of Oncology, who participated in the study.
The study concerned melanoma patients with lymph node metastases. It was designed by scientists from the Netherlands and Australia, but scientists from the National Institute of Oncology participated in it from the beginning: Prof. Piotr Rutkowski and Dr. Joanna Płaczke. – This study was cleverly designed by scientists, using drugs that are already used in oncological treatment, but they were administered in a different way. What’s more, it was a non-commercial study, i.e. created by scientists, not sponsored by pharmaceutical companies. Our colleagues contacted us immediately, and proposed us as one of the centers conducting the study. Its organization was difficult because it required good cooperation between the surgeon and the oncologist at a very early stage, even before the surgery – explains Prof. Piotr Rutkowski, head of the Clinic of Soft Tissue, Bone and Melanoma Cancers
The immune system learns about cancer
Currently, patients with this stage of melanoma have their lymph nodes removed and then receive immunotherapy for a year. – In this study, two cycles of immunotherapy were administered before surgery: so that the immune system would be stimulated, so that it would recognize the cancer cells and “learn” them while the cancer is still there. Then the cancerous lymph nodes were removed. The cells of the immune system were already “learned,” so even if cancer cells appeared, they would be quickly eliminated – emphasizes Prof. Rutkowski.
As part of the clinical trial, patients were classified into two groups: the first received double immunotherapy (two drugs: nivolumab and ipilimumab) for 6 weeks before surgery. Patients from the second group underwent surgery and then received immunotherapy (one drug) for 12 months. – It turned out that 60% of patients who received preoperative immunotherapy had complete pathological remission, i.e. the melanoma disappeared. These patients did not receive any treatment after surgery. After a year, it turned out that the results of treatment in this group were 25% better than in patients who received immunotherapy after surgery. 96% of patients also had no trace of the disease after a year and a half – adds Prof. Rutkowski.
Although in this case it is not yet possible to be certain of recovery, there is a good chance that in many patients the disease will not return.
– We have observations from previous studies that in such a situation the cancer did not recur; I think it will be the same here. This is the first study to prove the effects of preoperative immunotherapy in melanoma in a large group of patients. This is an amazing effect, today in oncology such results are rare – emphasizes Prof. Rutkowski.
A breakthrough in treatment
The breakthrough nature of the study also lies in the fact that significantly better results were achieved not thanks to the emergence of new drugs, but by shifting the use of immunotherapy already used in melanoma to preoperative treatment.
Importantly, the administration of immunotherapy before surgery is short (6 weeks), so it does not postpone the surgical procedure, so there is no risk of the cancer spreading. – This is one of the first studies to prove that preoperative treatment is more effective than postoperative treatment when it comes to immunotherapy.
This concerns melanoma, but similar reports on the effectiveness of immunotherapy before surgery are also available in lung cancer, squamous cell carcinoma of the skin, and similar studies are planned for bladder cancer. Another study showed that in the case of patients with rectal cancer who have DNA repair gene disorders, immunotherapy before surgery makes surgery unnecessary at all, because the cancer simply disappears – emphasizes Prof. Rutkowski.
Change in the patient treatment program in Poland?
A study on the use of dual immunotherapy in melanoma was published in the prestigious New England Journal of Medicine. It was chosen as one of the twelve most important clinical trials in oncology this year in the world.
The treatment is more effective than the current standard, and at the same time shorter, so it does not expose the patient to the side effects of drugs or frequent hospital stays, it is also cost-effective, which is why experts will want to change the way this group of patients is treated in Poland. – We will apply as the Polish Oncological Society to change the drug program for melanoma patients in this area: this concerns about ¼ of patients with metastases to lymph nodes. Many people who will receive such treatment will have much better effects, which is why we want it to be used in Polish patients – emphasizes Prof. Rutkowski.
This study also shows how important non-commercial trials are in oncology: designed by scientists, they often change the standards of treatment.
