Treatment of skin cancer
Neuruppin, 29 June 2022
According to an international clinical trial involving the MHB, immunotherapy of malignant melanomas may serve to avoid surgery and subsequent chemo and/or radiotherapy. Findings are based on biostatistics from Neuruppin.
Dr. Katarzyna Jóźwiak, statistician at the MHB (Brandenburg Medical School) Institute of Biostatistics and Registry Research, played a significant role in the evaluation of the PRADO study: “Results of our clinical trial indicate that melanoma patients with positive response to immunotherapy may avoid surgery and subsequent chemotherapy and/or radiotherapy. Spared from the side effects of surgery and subsequent treatment, they will nevertheless have a high probability of relapse-free survival and a better quality of life. This is indeed good news for the patients concerned.”
The PRADO study is a phase-2 study enrolling 99 stage III melanoma patients who prior to surgery received neoadjuvant immunotherapy with Ipilimumbab and Nivolumab to activate the body’s immune response. The term neoadjuvant (or preoperative) therapy is used in oncology to describe a therapy applied prior to planned surgery with the aim to reduce tumour size, improve the initial situation, make a tumour operable or render major surgery unnecessary.
In 61% of patients, tumours showed a strong response to this type of immunotherapy so that the usual surgical lymph node dissection and subsequent systemic therapy with or without synchronous radiotherapy were avoided. The patients concerned attained 93% probability of relapse-free survival after 24 months and in addition a clearly improved quality of life compared to patients with lymph node dissection and systemic chemo or radiotherapy and the potentially severe long-term effects involved. No regression occurred in these patients, and they felt better. However, since skin cancer may come back even after two years, the trial is scheduled to continue, with a larger number of patients to receive immunotherapy in a second phase.
Michael Hauptmann, MHB professor and director of the MHB Institute of Biostatistics and Registry Research, describes the findings on the application of immunotherapy as a first move towards safe and personalized de-escalation in the treatment of selected stage-III melanoma patients.
The trial headed by researchers at the Amsterdam Antoni van Leeuwenhoek Institute included patients from the Netherlands and Australia. Results were presented at the June meeting of ASCO (American Society of Clinical Oncology) in Chicago and simultaneously published in the renowned journal Nature Medicine (see here).