Control of cell cycle progression plays a significant role in tumor development. The cyclin-dependent kinase (CDK) family governs cell cycle progression, and the activations of CDK4 and CDK6 allow cells to transit from G1 phase to S phase to start mitosis. Overactivation of CDK4/6 is closely related to tumor progression, thus CDK4/6 can be used as a potential target of oncotherapy. CDK4/6 inhibitors can not only arrest the tumor cells at G1 phase to prevent tumor overgrowth, but also affect the tumor microenvironment and enhance immune activity. Trilaciclib is a small-molecule CDK4/6 inhibitor, which is highly efficient, selective and reversible. Trilaciclib administrated before chemotherapy can temporarily block the hematopoietic stem cells and progenitor cells in bone marrow at G1 phase to reduce the cytotoxic damage caused by chemotherapy, thus protecting bone marrow and the immune system. Trilaciclib was first approved by FDA in the United States in February 2021 for extensive stage small cell lung cancer (ES-SCLC) before platinum/etoposide or topotecan chemotherapy to reduce the incidences of myelosuppression in adult patients. In July 2022, National Medical Products Administration (NMPA) also approved the administration of trilaciclib in patients with ES-SCLC who had not previously received systemic chemotherapy. In addition, the positive effects of trilaciclib on overall survival (OS) were observed in patients with triple-negative breast cancer (TNBC) treated with chemotherapy. Other clinical studies related to trilaciclib were still ongoing. This review summarizes the anti-tumor mechanisms of trilaciclib and the relative preclinical and clinical studies, aiming to provide further reference for clinical application and future research.

Chemotherapy-induced myelosupression (CIM) is the most common toxicity of chemotherapy drugs. Usually, more than 80% of chemotherapy drugs lead to myelosuppression, and CIM is usually characterized by neutropenia, thrombocytopenia and erythrocytopenia. Dose reduction and delayed administration of chemotherapy drugs by CIM seriously reduce the life quality of patients and the overall anti-tumor effect of chemotherapy. As the first drug approved for bone marrow protection, trilaciclib is a highly effective, selective and reversible cyclin-dependent kinase (CDK) 4/6 inhibitor, which can temporarily block cell cycle of hematopoietic stem/progenitor cells and immune cells in G1 phase, so as to reduce the damage caused by chemotherapy and protect bone marrow protection. In April 2021, trilaciclib was approved by FDA as a myelo preservation in the United States. In July 2022, trilaciclib was approved by the National Medical Products Administration for marketing in China, and the first indication of trilaciclib in China was for patients with extensive stage small-cell lung cancer. In this review, the mechanisms of action, pharmacokinetics, drug interaction mechanism, clinical evaluation, safety and other related research progress of trilaciclib are systematically reviewed, aiming to provide further reference and basis for clinical practice.

Lung cancer is one of the most common cancers worldwide. As reported in 2020, there were approximately 2.2 million new cases of lung cancer worldwide, accounting for 11.4% of newly diagnosed malignant tumors. Additionally, there were 1.8 million deaths resulting from lung cancer in 2020, representing about 18% of all cancer-related deaths globally. Lung cancer remains the leading cause of cancer-associated morbidity and mortality in China. Despite the increasing popularity of immunotherapy and targeted therapy, chemotherapy remains one of the most dominant treatment modalities for lung cancer (particularly for small-cell lung cancer). However, chemotherapeutic drugs in clinical practice lack specificity and kill normal cells while killing tumor cells, especially cells that are relatively active in proliferation or metabolism. Chemotherapy-induced myelosuppression (CIM) is the most common dose-limiting and potentially fatal complication in cancer therapy and a key factor affecting the course and dose of chemotherapy, and nearly 90% of chemotherapeutic drugs may be associated with myelosuppression. Myelosuppression is the biggest obstacle to cancer chemotherapy. Myelosuppression seriously affects the life quality of cancer patients, reduces patient compliance, delays treatment, and even threatens the lives of patients, which we should pay attention to in clinical practice. At present, the main treatment regimens for bone marrow suppression are those follows, such as drugs promoting neutrophils, red blood cells, thrombopoietic drugs and blood transfusion. As the world's first approved CDK4/6 inhibitor with full myeloprotection, the use of trilaciclib before chemotherapy is effective in reducing the incidences of CIM. This review aims to summarize the relevant research progress in recent years from the mechanism of bone marrow suppression, related treatment measures of bone marrow suppression after chemotherapy for lung cancer, and provides further ideas and clinical basis for clinical application, monitoring and management of CIM.

Chemotherapy still plays pivotal roles in the comprehensive treatment of tumors. Chemotherapy-induced myelosuppression (CIM) is the most common adverse event of chemotherapy, which has posed serious impacts on the anti-tumor efficacy of chemotherapy and the quality of patients' lives, and also resulted in increased treatment burden of patients and more medical resources at the same time. Trilaciclib is a highly potent, selective, reversible cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Clinical data showed that trilaciclib could temporarily arrest bone marrow cells in G1 phase to reduce the incidences of CIM and the proportion of chemotherapy dose adjustment and delay, increasing the tolerance of chemotherapy and reducing the economic burden. This article systematically elaborates on the CIM-caused hazards, clinical prevention, and current status of treatment of CIM, as well as the roles of trilaciclib in the prevention of CIM and its economic value, aiming to provide scientific reference for patients to select reasonable prevention and therapeutic treatment regimens of CIM.

Small cell lung cancer (SCLC) is characterized by a high degree of malignancy, with poor prognosis and high-growth fraction. About two-thirds of patients have developed distant metastasis at the time of diagnosis with rapid disease progression and high recurrence rates. Currently, topotecan-based chemotherapy remains the standard second-line treatment of SCLC with unfavorable disease remission, and less than one-fourth of patients have benefited from its efficacy. Chemotherapy-induced myelosuppression (CIM) is the most common toxicity in cancer chemotherapy, and severe CIM will reduce the dose intensity and anti-tumor efficacy of chemotherapy. Trilaciclib is a short-acting intravenous cyclin-dependent kinase 4/6 (CDK4/6) inhibitor administered prior to chemotherapy to preserve hematopoietic stem and progenitor cells and immune system function during chemotherapy, which has been approved by NMPA for prevention of CIM in SCLC in July 2022. Previous results showed that trilaciclib yielded favorable bone marrow protection during chemotherapy, but its anti-tumor effects in second-line treatment of SCLC have not been determined. This paper reports a case of a patient with advanced small-cell lung cancer with multiple metastases who obtained progression-free survival time of more than 1 year using trilaciclib combined with topotecan as second-line treatment.

Small-cell lung cancer (SCLC) is one of the most malignant subtypes of lung cancer with rapid tumor progression and a poor prognosis, and also one of the malignancies most difficult to cure in clinical practice. Currently, platinum-based chemotherapy remains the first-line standard treatment for extensive-stage small cell lung cancer (ES-SCLC). Full-dose chemotherapy is warranted for the best efficacy, and the effective rate of first-line treatment is 60%~80% (full-dose), while chemotherapy-induced myelosuppression (CIM) is the main reason hindering adequate chemotherapy. Granulocyte colony-stimulating factor (G-CSF) is commonly used to deal with neutropenia in clinical practice, while this traditional treatment may even cause the depletion of bone marrow hematopoietic reserve function and damage to the normal bone marrow hematopoietic function of patients. Currently, trilaciclib has been approved for the prevention of myelosuppression in ES-SCLC, which can protect hematopoietic stem cells/progenitor cells (HSPCs) fundamentally. In this paper, we report a case of a patient with ES-SCLC treated in our department receiving bone marrow protection with trilaciclib combined with chemotherapy, aiming to provide reference and basis for further research.

Immunotherapy combined with chemotherapy has been established as the standard first-line treatment in advanced esophageal cancer (EC). Myelosuppression is the most common side effects of chemotherapy, and severe myelosuppression often leads to prolonged cycles of chemotherapy and reduced doses of chemotherapy, thereby reducing the intensity and potential anti-tumor efficacy of chemotherapy. At present, granulocyte-stimulating factor (G-CSF) is widely used to stimulate the differentiation of bone marrow hematopoietic progenitor cells to treat chemotherapy-induced myelosuppression (CIM). Trilaciclib is a short-acting and reversible CDK4/6 inhibitor, which can provide systemic protection of bone marrow hematopoiesis, and was approved by NMPA in July 2022 for the prophylactic treatment of myelosuppression in extensive-stage small cell lung cancer (ES-SCLC). However, trilaciclib has not been widely used in clinical practice. Therefore, this paper reports a case of one patient with advanced EC who was treated by trilaciclib to prevent CIM in our department, aiming to provide further reference and basis for further investigation.

The investigation shows that malignant tumor is one of the major diseases threatening human health and life safety. In recent years, the cancer prevalence and mortality rate remain high, making anti-tumor drug research a hot field of drug research and development. For a better understanding of the industry development situation and to grasp the latest development of antitumor drug patent applications, Derwent Innovations Index was used for mining and analysis on the patent document against cancer drugs. At the same time, we complemented public patent data in recent years, as well as the overall intelligence information updates, statistics, analysis, and visualization, in order to provide information reference and decision support for the research and development of anti-tumor drugs and medicine.

Molecular targeted therapy has become a research hotspot in the field of cancer therapy in recent years. Regorafenib belongs to the multi-target tyrosine kinase inhibitor class of antitumor drug developed by Bayer company, which was approved by NMPA in March 2017. This article introduces the status of regorafenib-related Chinese patent applications and focuses on combing and analyzing the development context of patent technology, in order to provide reference for the drug R&D and patent portfolio for relevant domestic pharmaceutical companies.

Non-alcoholic fatty liver disease (NAFLD) is a common chronic metabolic disease characterized by the accumulation of fat in the liver. The onset and progression of NAFLD are associated with a variety of metabolic abnormalities, including obesity, diabetes mellitus, and hyperlipidemia. Due to its high prevalence and risk worldwide, NAFLD has become an important issue in public health. However, to date, treatments for NAFLD are very limited, with no relevant drugs approved for marketing in Europe, America, or China and clinical trials of new drugs have gained no progress in recent years. This paper reviews the therapeutic targets, clinical research progress of new drugs, and new treatment strategies for NAFLD, in addition to summarizing the reasons for the high failure rate of NASH clinical trials and proposing corresponding solutions, aiming at providing ideas and reference for new drug development.

Tumor therapy has always been the focus of study. Due to the variability of tumor cells, the complexity of the tumor microenvironment and other factors, the problems such as multidrug resistance of tumors, reduced drug delivery efficiency are obtained. In recent years, increasing attention has been paid to biomimetic vectors, in which cancer cell membrane (CCM) is a new type of nano-carrier with the characteristics of homologous targeting, immune escape and penetrating biological barrier. Using CCM as a bionic carrier to coat different types of nanoparticles (NPs) can achieve effective tumor targeting and advantages in tumor therapy. This review introduces the biomimetic vector of CCM, briefly describes the preparation process of NPs coated with CCM, summarizes the research of CCM in tumor drug delivery and tumor vaccine, and discusses the future development prospects of CCM.

To analyze the pattern, characteristics and causes of protocol violation in anti-tumor drug clinical trials from the perspective of ethical review. The number and categories of violation projects were retrospectively analyzed and compared in different departments and the area of clinical trials (domestic or international). The impact of protocol violation on clinical trials carried out in our hospital from 2018 to 2021 was also analyzed. From 2018 to 2021, 1256 protocol violation cases occurred in clinical trials of anti-tumor drugs carried out in our hospital. The number of continuous protocol violations (318, 25.32%) was the largest, and the number of researchers' failure to cooperate with supervision/audit (6, 0.50%) was the fewest. The difference in the number of protocol violation between internal and surgical, domestic and global clinical trials were both statistically significant (P<0.01). The proportion of protocol violations affecting the safety, rights of subjects and trials results were 5.81%, 4.78% and 5.41%, respectively. Various protocol violations may occur during clinical trials of anti-tumor drugs. In order to improve the quality of clinical trials, it can be effectively avoided by strengthening quality control and conducting targeted training for the research team and subjects.