В статье представлены результаты голосования I Cанкт-Петербургского международного консенсуса по диагностике и лечению рака молочной железы «Белые ночи 2024», посвященного наиболее актуальным и спорным вопросам диагностики, хирургической тактики, лучевой терапии и системного лечения данной категории пациентов. Под председательством член-корреспондента РАН, профессора Владимира Федоровича Семиглазова в международном консенсусе приняли участие 38 экспертов в области диагностики и лечения рака молочной железы (РМЖ), проголосовавших в ходе прямого эфира по 32 вопросам, разделенным на блоки раннего и метастатического РМЖ. Проведение II Cанкт-Петербургского международного консенсуса по диагностике и лечению РМЖ «Белые ночи 2025» запланировано со 2 по 5 июля 2025 года.

В данном разделе указаны критерии оценки клинической значимости применения дорогостоящей противоопухолевой лекарственной терапии в соответствии со шкалой, разработанной экспертной группой (см. стр. 7). В тексте они обозначены, как магнитуда клинической значимости (МКЗ).

В данном разделе указаны критерии оценки клинической значимости применения дорогостоящей противоопухолевой лекарственной терапии в соответствии со шкалой, разработанной экспертной группой (см. стр. 7). В тексте они обозначены, как магнитуда клинической значимости (МКЗ).

Gastric cancer is an important medical and social problem all over the world. The aggressiveness of the course of this disease is reflected by the high figures of one-year mortality, which is due to both high neglect at the time of diagnosis and unsatisfactory results of surgical treatment of even a localized tumor process, which from a biological point of view casts doubt on the possibility of performing a “radical” operation for this type of malignant tumor. Currently, the “gold standard” has become the conduct of perioperative chemotherapy according to the FLOT scheme for locally advanced stages of gastric cancer, esophagogastric junction and esophagogastric junction and lower esophagus. A further promising direction for improving perioperative chemotherapy is the investigation of immune checkpoint inhibitors (pembrolizumab, atezolizumab and durvalumab) in combination with cytostatics. Today, there are still a number of unresolved issues, including the need to continue such aggressive treatment in the postoperative period with an unsatisfactory pathomorphological response from the tumor. Performing the entire volume of chemotherapy is a difficult task, due to the toxicity of this type of treatment and the weakened condition of the patient after extensive surgery. The significance of the pathomorphological regression of the tumor after neoadjuvant chemotherapy is also unclear. Only 10–15% of patients achieve a complete pathomorphological response. The standard postoperative practice is to carry out the same preoperative chemotherapy regimen, regardless of sensitivity to it. The search for prognostic markers will help to individualize the treatment strategy of such patients and protect patients from excessive toxicity with unjustified continuation of chemotherapy.

In recent years, approaches to the pharmacological treatment of non-small cell lung cancer (NSCLC) have significantly evolved due to a deeper understanding of tumor biology and, consequently, the active development of personalized medicine and the introduction of targeted therapies. The identification of activating mutations, including ALK gene rearrangements, enables long-term objective control, which is particularly crucial in young patients with extensive metastatic disease and brain metastases (BM). The high rate of central nervous system (CNS) metastases characteristic of ALK-positive NSCLC underscores the importance of selecting therapeutic agents with high intracranial activity. Lorlatinib, a third-generation ALK tyrosine kinase inhibitor (TKI), is capable of crossing the blood-brain barrier and effectively suppressing resistance mutations that may develop during treatment with crizotinib or second-generation TKIs. Initially, lorlatinib was used in the second-line and subsequent lines of therapy; however, updated results from the CROWN study have demonstrated its unprecedented efficacy as a first-line treatment, including in patients with BM. Currently, lorlatinib is approved in the Russian Federation for the treatment of ALK-positive advanced NSCLC in both previously treated patients and as a first-line therapy. This paper presents a clinical case of a 49-yearold patient with advanced ALK-positive NSCLC and brain metastases. Following the diagnostic phase, which included videoassisted thoracoscopy and morphological verification, the patient underwent a course of chemotherapy with cisplatin and pemetrexed. Subsequently, based on the results of molecular genetic testing, lorlatinib was initiated at a dose of 100 mg/day. Within a month, a significant regression of CNS metastases was observed. Therapy was accompanied by minimal side effects, including hypercholesterolemia and elevated liver enzymes, which were successfully managed with lipid-lowering agents and physical activity. During targeted therapy, the patient has maintained stable disease for 26 months, showing a strong clinical response without the need for dose reduction. This case report highlights the efficacy and tolerability of lorlatinib in the treatment of ALK-positive NSCLC with BM and underscores its potential in clinical practice.

Currently, tumour tissue biopsy to determine RAS/BRAF gene alterations, assess microsatellite instability status, and determine HER‑2/neu gene amplification/hyperexpression is the gold standard of diagnosis and allows the selection of optimal molecularly targeted therapy when considering treatment strategies for patients with metastatic colorectal cancer. However, biopsy does not fully reflect the existing intratumoural heterogeneity and clonal evolution of tumour cells, which can often be the cause of therapeutic failures. In recent years, liquid biopsy has attracted increasing attention as an additional and potentially alternative non-invasive tool for molecular tumour profiling. Assessment of circulating tumour DNA allows changes in the genetic status of the tumour to be monitored and the «burden» of disease to be measured dynamically in real time. Advances in liquid biopsy technology have led to promising new strategies for the management of patients with metastatic colorectal cancer in late-line therapy. The standard drug arsenal in this group of patients is limited to either repeat administration of previously effective therapy or regorafenib and the combination of trifluridine/tipiracil with bevacizumab, which are characterized by limited clinical activity. However, thanks to the discovery of the NeoRAS wild-type phenomenon and the rechallenge strategy of anti-EGFR monoclonal antibodies based on the study of clonal selection and evolution of tumour cells, the administration of epidermal growth factor inhibitors in a molecularly selected by liquid biopsy population is accompanied by good tolerability and efficacy. Numerous clinical studies are ongoing to further understand the mechanisms of tumour resistance and to develop new evidence-based treatment approaches in order to realise the concept of personalised medicine.

Gastric cancer (GC) is one of the most aggressive and unfavorably ongoing malignant neoplasms, occupying the fifth and fourth places in the structure of oncological morbidity and mortality, respectively. Overexpression of the human epidermal growth factor receptor 2 (HER2-neu) is detected in about 20% of patients with advanced GC, which made it possible to successfully use trastuzumab in combination with chemotherapy (CT) in this cohort of patients. The development of resistance to trastuzumab is a serious problem that requires research and development of new therapy targeted to blockHER2-neu. Trastuzumab deruxtecan is an antibody–drug conjugate consisting of an antibody to the HER2-neu receptor and a topoisomerase inhibitor linked by a cleavable tetrapeptide-based linker. The drug has proven its effectiveness as a monotherapy for the treatment of patients with metastatic or locally advanced HER2-positive gastric adenocarcinoma or cardio esophageal junction in the 2nd and subsequent lines of treatment. In the above clinical case a 57-year-old patient with CEС adenocarcinoma with metastatic liver damage, distant lymphnodes and the presence of HER2-neu overexpression is presented. After the standard first-line drug treatment according to the XELOX scheme with trastuzumab, the patient underwent surgical treatment followed by postoperative chemotherapy according to the FOLFOX scheme in combination with trastuzumab. Given the negative dynamics, the next step was 3 injections of nivolumab immunotherapy, which eventually led to the development of autoimmune hepatitis and rapid progression of the disease. Almost the last hope for the patient was the introduction of trastuzumab deruxtecan, which allowed for an objective response, as well as an improvement in the patient’s clinical condition, which led to the achievement of the longest possible progression-free survival (PFS).

At present, cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors such as palbociclib, ribociclib, and abemaciclib are widely used for the first-line treatment of locally advanced or metastatic breast cancer. However, direct comparisons of these treatment options in randomized studies have not been conducted.Aim of the work is to gather and analyze published data on the comparative effectiveness of CDK4/6 inhibitors in combination with aromatase inhibitors in postmenopausal patients with HR+/HER2– locally advanced or metastatic breast cancer. A systematic review of publications presenting results from original studies on the impact of CDK4/6 inhibitor therapy in combination with aromatase inhibitors on the survival of patients was performed. Nineteen studies with original data on progression-free survival and overall survival were identified. None of the studies found significant differences between different CDK4/6 inhibitors and aromatase inhibitors in terms of progression-free survival. A statistically significant superiority of ribociclib over palbociclib in terms of overall survival was observed in a single matching-adjusted indirect comparison, while seven other studies of various types (real-world data studies, matching-adjusted indirect comparisons, and meta-analyses) did not find significant differences between the investigated drugs in terms of overall survival.Currently, there is no compelling evidence of the superiority of one CDK4/6 inhibitor over others. The decision on the preference for a specific drug within the class can only be made after conducting direct randomized comparison trials, or accumulating sufficient real-world data on the use of palbociclib, ribociclib, and abemaciclib.

Melanoma of the skin is one of the most aggressive cancers. Until recently, metastatic melanoma was associated with an extremely negative prognosis: the median overall survival for this category of patients was no more than 7–8 months. Thanks to the improvement of therapeutic approaches, it was possible to achieve a significant increase in the life expectancy of patients with an unresectable and metastatic process. Currently, several targeted and immunotherapy options are available for the treatment of metastatic or unresectable skin melanoma. These therapeutic approaches have thoroughly taken a leading place in everyday clinical practice and have made it possible to change the natural history of this disease: today about 30–60% of patients can survive 5 years or more. There are 3 immune response checkpoint inhibitors related to PD-1 receptor blockers registered in our country: pembrolizumab, nivolumab and the Russian-made prolgolimab. In this article, we describe a clinical case of effective treatment of a patient with generalized melanoma of the skin using the domestic drug prolgolimab. The article also provides a brief description of the main studies on domestic immunotherapy molecules and their indirect comparison with foreign analogues.

Introduction . Despite the registered standard treatment option for patients who underwent radical resection for metachronous metastases of colorectal cancer (CRC), the feasibility of adjuvant chemotherapy (ACT) for all patients seems controversial. Due to studies demonstrating improved disease-free survival rates with postoperative chemotherapy vs observation, it would seem that there is reasonable expectation of improved overall survival (OS) rates, which, however, were not statistically different between groups. This article presents the interim results of our own study. Aim . To analyse the efficacy of ACT vs dynamic observation in patients who underwent surgery for metachronous metastases of colorectal cancer. Materials and methods . It was a prospective-retrospective, non-randomized, non-inferiority study. A total of 120 patients were recruited between June 2008 and September 2022. The ACT group included 71 patients. All patients received only oxaliplatin-based chemotherapy regimens; the dynamic observation group included 49 patients. Results . The interim analysis showed that the median disease-free survival (mDFS) in the ACT group (n = 71) was 20.9 months (13.7–28.3) vs 24.4 months in the dynamic observation group (n = 49) (11.1–37.7), HR: 0.76 (95% CI: 0.45–1.29), p = 0.29. Two-year disease-free survival (DFS) rates were 46.6% in the post-surgery chemotherapy (CT) group (n = 50) and 55.5% in the experimental group (n = 31), HR: 0.69 (95% CI: 0.39–1.2), p = 0.21. Conclusion . ACT has not improved the long-term treatment outcomes in patients who underwent radical resection for metachronous metastases of CRC.

Расширение арсенала лекарственных препаратов для лечения метастатического рака молочной железы (мРМЖ) определяет необходимость оптимизации существующих подходов к выстраиванию наиболее эффективной линейности терапии. С появлением в клинической практике новых коньюгатов моноклональных антител, нацеленных на определенный рецептор, совмещенных с цитостатиком, поставило этот вопрос в отношении терапии пациентов тройным негативным (ТН) и HER2-low РМЖ. В статье представлен обзор основных исследований эффективности сацитузумаба говитекана и трастузумаба дерукстекана в контексте последней версии клинических рекомендаций по лечению данных вариантов метастатического рака молочной железы. Накопление практического опыта и обобщение его в исследованиях реальной клинической практики позволят клиническим онкологам окончательно сформировать стратегию последовательного применения вновь появляющихся конъюгатов.

Adjuvant endocrine therapy is an integral component of treatment for resectable luminal breast cancer. Tamoxifen or aromatase inhibitors monotherapy has been the standard of practice for many years. However, recent studies have shown that the addition of ovarian suppression statistically significantly increases survival rates in patients at high risk for recurrence and with poor prognosis factors. In this literature review, we summarized recent data regarding the role of ovarian suppression in adjuvant therapy for hormone-positive breast cancer. Suppression of ovarian function was most effective in young patients (< 35 years) in the premenopausal stage when adverse prognostic factors were present (indications for (neo)adjuvant CT, G3, etc.) The authors noted that using of aromatase inhibitors instead of tamoxifen in this subgroup significantly reduced the risk of breast cancer recurrence. Ovarian suppression, especially in combination with aromatase inhibitors, was accompanied by an increase in the incidence of adverse side effects, particularly osteoporosis and bone fractures, which can be reduced by prescribing adequate accompanying therapy with OMA. The optimal duration of ovarian function suppression has also not been determined, but a two-year course seems optimal, given the results of large clinical trials. In the protocols performed, there was no significant effect of temporary ovarian suppression on the likelihood of subsequent pregnancy.

Malignant glomus tumor is an extremely rare, aggressive neoplasm, which is contain from modified glomus body’s cells. The correct morphological diagnosis is difficult, and requires careful differential diagnosis between neuroendocrine tumors, pericytic tumors, smooth muscle neoplasms. The literature describes only sporadic clinical observations, a series of cases and the results of a small number of retrospective studies. Due to the rarity of nosology, the optimal treatment strategy for this disease has not been developed. Most cases, surgical treatment is used in a locally common process. Cases of metastasis of a malignant glomus tumor are extremely rare. There is no consensus on the tactics of systemic treatment to date. In this article, we present a clinical case of achieving stabilization of the tumor process after 5 courses of chemotherapy with doxorubicin, ifosfamide in a 49-year-old patient with a malignant glomus tumor of the soft tissues of the left forearm with metastatic lesion of the tissues of the anterior chest wall on the left with spread to the left small pectoral muscle, 3rd rib and pleural cavity, with metastatic lesion lung parenchyma.

The Russian consensus on prevention, diagnostic and treatment of gastric cancer was prepared on the initiative of the Moscow clinical scientific center named after A. S. Loginov according to the Delphi method. Its aim was to clarify and consolidate the opinions of specialists on the most relevant issues of prevention, diagnosis and treatment of gastric cancer. An interdisciplinary approach was provided by the participation of leading gastroenterologists, oncologists and surgeons.

Non-small cell lung cancer (NSCLC) that occupies a leading place in the pattern of cancer incidence and mortality is a highly heterogeneous group of diseases. The presence of a wide spectrum of NSCLC driver mutations has led to a fundamentally different understanding of the treatment strategy for this cohort of patients and a significant improvement in long-term oncological outcomes, even in the metastatic process. Chromosomal rearrangements involving the anaplastic lymphoma kinase (ALK) gene loci on chromosome 2 are found in approximately 3–5% of patients with metastatic NSCLC (mNSCLC) and in most cases are associated not only with a number of specific clinical features, but also with high sensitivity to targeted therapy with tyrosine kinase inhibitors (TKI). Crizotinib was the first approved ALK inhibitor, but although most patients achieved response within the first two years after start of the treatment, disease progression occurred often due to intracranial injury. The development of second-(ceritinib, alectinib), brigatinib and third-generation (lorlatinib) drugs has led to a statistically significant improvement in progression-free survival (PFS) rates, as well as control over intracranial manifestations of the disease and a change in the initial treatment strategy for these patients. In addition, new-generations of TKIs were developed to solve the problem of acquired resistance, as well as to achieve the best outcomes in the presence of such unfavourable factors as the presence of a TP53 mutation and/or ALK inhibitor low-sensitive translocation variants of the intracellular kinase domain of EML4 (echinoderm microtubule‐associated protein‐like 4)‐ALK (anaplastic lymphoma kinase) protein. Thus, advances in the therapeutic options for ALK-positive mNSCLC has completely changed the course of the disease, resulting in a significant increase in overall survival (OS) rates not only with the sequential use of different generation TKIs, but also with the choice of the most effective first-line option. In this article, we present an analysis of data on the efficacy and toxicity of lorlatinib, a third-generation TKI, in the first-line treatment for ALK+ mNSCLC.

Given the rapid expansion of indications for immune checkpoint inhibitors therapy in the clinical practice of oncologists, as well as the emergence of new drugs with similar mechanisms of action, knowledge of rare immune-related adverse events is extremely important for physicians, both in terms of their early detection and optimisation of treatment tactics. Despite their rarity, the spectrum of rheumatological manifestations is quite broad, which requires the continued detailed accumulation and analysis of clinical material. The present clinical observation convincingly demonstrates that when prescribing immune checkpoint inhibitors in case of symptoms suspicious of Sjögren's syndrome, a thorough history and a complete examination, including specialized diagnostic tests to evaluate salivary and lacrimal gland function, should be performed. The differential diagnosis of Sjögren's syndrome with other nosologies requires serum autoantibody testing and salivary gland biopsy. Prompt referral of the patient to a rheumatologist is critical, to avoid delay in making a correct diagnosis. Early diagnosis and timely treatment of toxic reactions are the key to successful anti-tumour therapy. Achieving this goal requires close collaboration between multidisciplinary physicians, the patient, and the patient's family.

Objective. To evaluate the alterations of Global longitudinsl strain (GLS) and it’s value for prediction of cardiotoxicity of low to moderate cumulative doses of anthracyclines. Methods. Forty-nine women 50 ± 10 years old with breast cancer, treated with anthracyclines (cumulative dose of 251 ± 60 mg/m2) were enrolled in the study. Echocardiography with GLS measurement was performed at baseline, at the end of anthracycline treatment, then every 3 months during 1 year. Cardiotoxicity was defined as a decline in left ventricular ejection fraction (LVEF) of at least 10 % to ≤ 53 %. Results. There was a significant increase in mean LVESV and LVEDV and decrease of GLS (р < 0,05) but not LVEF at 3 month post anthracycline treatment. Cardiotoxicity was detected in 8 patients (16 %) with moderate baseline risk. Absolute ≥ 4 % reduction of GLS during follow-up, GLS andpercent of it’s reduction from baseline to 3 month post-anthracycline were predictive of cardiotoxicity (AUC = 0,822 and 0,870, respectively). The reduction in GLS of >12,5 % from baseline at 3 month post anthracyclines was predictive of cardiotoxicity with sensitivity of 80 % and specificity of 95 %. Conclusions. GLS and its reduction from baseline has shown predictive value for development of cardiotoxicity in patients with moderate risk treated with low-to moderate cumulative doses of antracyclines. Additional echocardiography with GLS assessment at 3–6 month after completion of anthracycline treatment may be recommended irrespective of cardiotoxicity risk.