Professor Dr Dana Stănculeanu is a distinguished Romanian oncologist with many years of experience in clinical work and research. “At this stage of my life and career I consider young doctors to be my most important ‘project’. I support their ideas and encourage them to express their opinions and fight for their ideals and make use of the knowledge from my generation,” she said in a talk with us. Together with Dr Elena Dumitrescu, professor Dr Stănculeanu also works with Mediately in creating oncology tools and supports cooperation in medical digitalisation.
What are currently the most important challenges in treating breast cancer in Romania? Do you have all the treatments needed available, or what are you still missing if any?
According to Globocan, the incidence of breast cancer in 2020 in Romania was around 12% and the mortality rate was close to 8%, a trend present also in the rest of Europe. The main issues in Romania related to the diagnosis of breast cancer in its early stages are a lack of awareness about the risk factors which may contribute to the development of the disease. This is accompanied by a lack of systematic national screening programmes, which should be implemented on a mandatory basis - starting with self-palpation of breasts, up to ultrasound examination and mammography, depending on the risk profile of each patient. As for the treatment of breast cancer, this pathological area receives reimbursement both for targeted therapy and immunotherapy. The therapeutic alternatives are very similar to those in the rest of Europe. On the other hand, speaking of a customized treatment linked with the molecular profile of each patient, there can be multiple therapeutic alternatives, but not all of them are reimbursed or available in Romania.
The main issues in Romania related to the diagnosis of breast cancer in its early stages are a lack of awareness about the risk factors.
The most important study at this year's oncology congresses was DESTINY-BreastO4. What is the clinical perspective of conjugated antibodies in adjuvant treatment? It seems that there is another entity beside HER-2 + and - breast cancer.
Unequivocally, trastuzumab deuxtecan has proved its efficacy in treating metastatic breast cancer with low HER-2 expression, with notable results both for progression-free survival (PFS) and overall survival (OS). Clearly, this molecular subtype related to a low HER -2 status (defined with a 1+ scoring at immunohistochemistry (IHC) or 2+ in IHC and negative in-situ hybridization) must be considered as a separate entity and further researched for future therapeutic approaches, including adjuvant therapy.
CDK4/6 inhibitors are now also very interesting drugs from a clinical perspective. The results of the MAINTAIN study are very interesting for continuing treatment with CDK4/6i. How do you view these results in clinical practice?
The MAINTAIN study showed a significant improvement in the progression-free survival (PFS) interval of the disease in patients with metastatic breast cancer and positive hormone receptors/HER-2 negative who received ribociclib as a medication after the progression of the disease post-treatment with another CDK 4/6 inhibitor. In fact, the study validates a practice already encountered in Romania, as clinical protocol allows the continuation of the treatment based on the clinical benefit. Treatment with a CDK 4/6 inhibitor can be continued even after the progression of the disease, especially in patients with a good performance status, prolonging this patient group’s survival but in the meantime helping them maintain a good quality of life. Also, I should mention a rule which applies to the majority of tumour locations: never switch too early. You must not switch treatment after the first progression of the disease, especially if it is not significant and the general status of the patient is satisfactory. Moreover, the post progression therapeutic alternatives after CDK 4/6 inhibitors are limited. PIK3CA mutation can be tested - a mutation which could be shown in 20 to 30% of patients with breast cancer, a therapeutic option for these patients is targeted therapy with alpelisib, which is available as a programme but partially co-paid by eligible patients.
Triple negative breast cancer - how do you view clinical challenges and research achievements?
Until recently, the therapeutic options in Romania for triple negative breast cancer were limited. Last year we received reimbursement for both atezolizumab in association with nab-paclitaxel for the treatment of unresectable advanced local or metastatic triple negative breast cancer in patients with tumours with a PDL-1 expression (>=1%) never treated for a metastatic disease previously, and olaparib for patients showing germinal mutations of the BRCA 1/2 gene and previously treated with a combination of anthracycline plus taxane in a (neo)adjuvant or metastatic context. The treatment of triple negative breast cancer without a BRCA 1/2 mutation and with a negative PDL-1 status is still a challenge.
Immunotherapy in breast cancer - how do you view the latest results and where do you see its place?
Over the years, immunotherapy has improved the survival rate of HER-2 + breast cancer patients through the treatment with monoclonal antibodies such as trastuzumab, pertuzumab and, recently, margetuximab, along with antibody-drug conjugated trastuzumab emtansine and trastuzumab deruxtecan. Immune-control check-point inhibitors have shown a promising efficacy in treating triple negative breast cancer, for example atezolizumab and pembrolizumab. But despite the success of immunotherapy, some patients do not respond to it or they experience adverse reactions. I strongly consider that immunotherapy in breast cancer and the main mechanisms of resistance to treatment need to be further explored.
Immune-control check-point inhibitors have shown a promising efficacy in treating triple negative breast cancer, for example atezolizumab and pembrolizumab.
Immunotherapy is still the new kid on the block in oncology, being used in almost every field, including solid cancers. In your opinion, what is its future outlook, how do you view monotherapy and combinations in clinical practice, what do you expect?
Our knowledge about the relationship between cancer and the immune system has improved significantly in the last decades. In recent years, the success of immunotherapy in treating cancer, including monoclonal antibodies, vaccines against cancer and immune-control check-points inhibitors have revolutionized anti-neoplasm therapy. Nevertheless, challenges remain. Customized combined therapies will be the next strategy in oncology, and rigorous research of the interaction between tumour and the tumoral microenvironment is needed.
How do you view the use of immunotherapy in earlier stages and adjuvant settings?
Immunotherapy is an important finding for the systemic treatment of patients with advanced neoplasms. Still, we know only a limited amount about their efficacy and safety in adjuvant settings. I believe that more studies are needed to demonstrate the efficacy and safety of immunotherapy in adjuvant therapy.
One of the main challenges in immunotherapy are adverse events (AEs), very new for many doctors, especially in primary levels of healthcare. How do you see possible solutions to manage AEs? You are also collaborating on an AE management tool, where do you see its uses?
The management of immune-related adverse events post immunotherapy treatment is still a challenge in Romania, and the approach towards them should be realized in a multidisciplinary way, with close collaboration between different specialists, depending on the location of the shown toxicity.
It was a pleasure for me to collaborate with Dr Elena Dumitrescu in developing the digital tool for the management of immune-related adverse events. I am also a supporter of medical digitalization, and I encourage the use of adjuvant tools. Of course, if they are based on established therapeutic guidelines. For an oncology specialist it is quite a challenge in their practice to be able to access all possible medical resources, especially since their time is very limited.
The National Society of Medical Oncologists from Romania (SNOMR) has also identified the need and created a scientific event called “Management of Adverse Events Associated with Cancer Immunotherapy”, an event which was held on 17 September in a hybrid format. This event aims to improve the management of immunotherapy-associated adverse effects by sharing the expertise of specialists, information about recent updates regarding the therapies reimbursed in Romania and validation of the current practices within the tumour board or a multidisciplinary team with different medical specializations.
For an oncology specialist it is quite a challenge in their practice to be able to access all possible medical resources, especially since their time is very limited.
How do you view the role of digitalisation in oncology?
I strongly believe that collaboration is the key and I am glad that this path has been opened, creating awareness about the need for medical digitalization and for partnership in innovation. This year, during the National Forum of Young Oncologists, an event supported by SNOMR, the first session targeting the synergy between technology and medicine was held, called “Onco-Innovation Startup Hub”. Six startups, including Mediately, shared details of innovative med-tech solutions. We will continue this innovative tradition. We invite all interested physicians to join us and to register on our society’s platform.
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On which projects and studies are you currently working? What are some of your personal goals?
I am coordinating 9 PhD students developing various projects that you’ll find out about soon. At this stage of my life and career I consider young doctors to be the most important “project”. I am a supporter of young people and I support their ideas and encourage them to express their opinions and fight for their ideals, to make use of the knowledge from my generation the best they can. By the way, SNOMR supports young oncologists in their professional development with financial support for publishing their original scientific works in high-impact medical journals and in the near future also through the development of grants for original ideas, student exchange programs within national and international centres, and mentorship programmes. I invite all these young doctors to become members of SNOMR and to register on our platform