Dr François CHERIFI, Head of Medical Oncology at the Centre Baclesse, presented his PROMENADE study: "PembROlizuMab for early ER-low/HER2- breast caNcer, reAlworlD frEnch cohort" at a mini-oral atESMO 2024 in Barcelona. The ESMO Congress is a major annual international event in the field of oncology. It provides a platform for the presentation of the latest research, treatment innovations and discussions on best practices in cancer care.
"PROMENADE": study of a rare cancer
This study focused on a group of 114 women with triple-negative breast cancer expressing low levels of hormone receptors, a rare subpopulation in this type of cancer. It was carried out in 12 CLCCs (Centres de Lutte contre le Cancer) in France, including the Centre Baclesse.
The study focused on a subgroup of this cancer, with very low hormone receptor expression (between 1 and 9%), representing less than 10% of cases.
The aim of the study was to assess whether adding a drug called Pembrolizumab, which stimulates the immune system (or immunotherapy), to the usual neoadjuvant chemotherapy before surgery improved patient outcomes.
In France, the use of Pembrolizumab in combination with neoadjuvant chemotherapy (prior to surgery) in this indication has been authorized for early access since March 2022, thanks to the KEYNOTE-522 trial. This trial demonstrated a significant increase in the total disappearance of cancer cells at the time of surgery, known as pathological complete response (pCR), and progression-free survival in patients with high-risk early triple-negative breast cancer.
Different criteria in different countries
The criteria for defining hormone receptor expression levels vary between France and the USA. In the USA, we consider a cancer to be triple-negative if hormone receptor expression is strictly below 1%, but in France our limit for defining triple-negative breast cancer is hormone receptor expression below 10%.
In France, a breast cancer is considered "ER-low" if it has between 1% and 9% expression of hormone receptors. We therefore apply a higher tolerance for hormone receptors than other countries. Previous studies have also been based solely on patients with hormone receptor expression levels strictly below 1%.
Promising results
The "PROMENADE" study shows a high rate of complete disappearance of cancer cells during surgery after treatment with immunotherapy for patients with low hormone receptor expression.
The results of the study therefore show that combining Pembrolizumab with chemotherapy brings significant benefits for women with this type of cancer. This could lead to a reconsideration of treatment practices, particularly in the United States, where this type of patient does not yet have access to immunotherapy.
They also provide food for thought about the criteria for referral to immunotherapy in these rare breast cancers. They also prove that the use of immunotherapy in France for ER-Low breast cancers is justified and beneficial for patients.
"The results of the PROMENADE study support our current practice of using immunotherapy in this rare subgroup. It is important to pursue more fundamental studies to better identify patients who can benefit from these innovative treatments", emphasizes Dr. François CHERIFI.
"Being selected for an oral presentation at ESMO is an important mark of recognition. The selection process is competitive, as many researchers submit their work. The evaluation committees rigorously examine the quality, originality, and potential impact of the studies, which makes the selection process demanding. This oral presentation at the ESMO congress is a testament to the quality of Dr. CHERIFI's work, highlighting innovative research recognized by international experts and illustrating the excellence of the Baclesse Center in the field of oncology," explains Dr. George EMILE, medical oncologist and head of the SEIN unit at the Baclesse Center.
What is triple-negative breast cancer?
Triple-negative breast cancer differs from other, more frequently encountered breast cancers in that it has none of the 3 main receptors, namely :
- The estrogen receptor (ER or RO)
- The progesterone receptor (PR)
- The HER2 receptor
RH: For Hormone Receptors, grouping together estrogen and progesterone receptors.
