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On April 17, the "Project for Enhancing Precision Treatment Capabilities for Solid Tumors – Integrated Symposium on Cancer Supportive Care" was successfully held in Jinan.This conference featured specialized lectures and discussion sessions on how to address bone marrow suppression and nausea/vomiting in cancer treatment. Leading experts in the field engaged in in-depth exchanges and discussions, jointly promoting the vigorous development of supportive cancer care and helping patients achieve the core goal of high-quality long-term survival.
Opening Remarks of the Conference
At the beginning of the conference,Professor Yu Jinming, Chairman of CSCOAs the host, he delivered a speech and extended sincere greetings to the attending guests. Chairman Yu Jinming pointed out that, under the medical development pattern where the survival period of cancer patients has significantly lengthened and cancer treatment has entered the era of chronic disease management, the coordinated development of cancer supportive care cannot be overlooked. Currently, there are still many unmet clinical needs in this field, and Qilu Pharmaceutical Co., Ltd. has set an outstanding example for the industry with its forward-looking layout, pipeline planning, and deep integration of multidisciplinary industry-academia-research collaboration. Chairman Yu Jinming concluded by stating that medical progress has never been a journey for lone travelers but rather a crystallization of the wisdom of countless individuals; only by breaking down disciplinary barriers and integrating superior resources can we write a new chapter in patient-centered cancer supportive diagnosis and treatment.
Professor Ma Jun, Supervisor of CSCO Supervisory BoardIn his speech, he pointed out that supportive therapy plays a crucial role in achieving high-quality long-term survival for patients. Professor Ma Jun, drawing from his personal experiences, elaborated on the firm belief that "all difficulties can be overcome with the patient at heart," earnestly encouraging young medical professionals to inherit and promote the spirit of kindness, innovation, responsibility, and service, collectively helping patients achieve a meaningful extension of life.
Professor Zhang Li from the Sun Yat-sen University Cancer CenterIn his speech, he emphasized that tumor supportive care should be patient-centered, and clinical practice needs to balance the tumor with the overall state of the human body. Professor Zhang Li called for the clinical community to recognize the academic value of supportive care to achieve comprehensive benefits for patients.
Finally, Professor Hongming Pan from Sir Run Run Shaw Hospital, Zhejiang UniversityIn his speech, the significance of this conference was affirmed. Professor Pan Hongming expressed that clinical practice should adopt a dual approach of anti-tumor treatment and supportive care to fulfill the original mission of oncology medical workers.
CSCO Research Fund Launch Ceremony
In order to further promote the vigorous development of China's oncology事业, the Beijing CSCO Clinical Oncology Research Foundation and Qilu Pharmaceutical Co., Ltd. have sincerely collaborated to jointly launch the "CSCO-Qilu Oncology Hematology Research Fund Project".Under the joint launch by Chairman Jinming Yu, Professor Jun Ma, Professor Li Zhang, Professor Hongming Pan, Mr. Yong Tian, and Mr. Wen Xu, this project has officially set sail!
Chapter One
Professor Zhang Zhen from the Tumor Hospital Affiliated to Fudan University, Professor Li Li from the Tumor Hospital Affiliated to Guangxi Medical UniversityHost this session.
Dr. Wang MengIntroduction to Qilu Pharmaceutical's Oncology Support Pipeline. Qilu Pharmaceutical has more than ten products in the oncology support treatment category, covering various therapeutic areas such as increasing white blood cells, increasing platelets, antiemetic, and bone metastasis treatment. Among them, Romiplostim N01, as a new generation of long-acting thrombopoietin receptor agonist (TPO-RA), provides a better new option in the field of cancer treatment-induced thrombocytopenia (CTIT).
Results from a Phase II clinical trial evaluating the efficacy and safety of N01 (a romiplostim biosimilar) in patients with CTIT indicate that the response rate of N01 reached 90%, with a significantly higher treatment response rate (no dose adjustment due to thrombocytopenia in two consecutive chemotherapy cycles) compared to placebo (73.3% vs. 40.9%). Currently, the Phase III clinical trial for the treatment and prevention of CTIT using N01 is being conducted systematically across major clinical centers.
The above achievements fully demonstrate Qilu Pharmaceutical's continuous exploration and innovation capabilities in the field of cancer supportive care, providing a solid guarantee for cancer supportive treatment.
Professor Ming Hou from Qilu Hospital of Shandong University, Professor Qingyuan Zhang from the Tumor Hospital Affiliated to Harbin Medical UniversityHost of This Session.
Professor Donglu Zhao from the Harbin Hematology and Oncology Research InstituteDelivered a wonderful presentation titled "The Importance of Standardized Management of CTIT in the Context of the Precision Medicine Era."
With the significant improvement in survival rates of cancer patients, cancer treatment has entered the era of chronic disease management, making the long-term management of adverse reactions a key component. While targeted therapy and immunotherapy have enhanced patients' quality of life, they have also increased the incidence of CTIT due to different mechanisms of action. CTIT not only reduces relative dose intensity but also significantly impacts treatment outcomes and patient survival. Therefore, in this new era of cancer management, there is an urgent need for safer, more convenient, and effective CTIT treatments. The emergence of the next-generation TPO-RA, Romiplostim N01, brings new hope for the treatment of CTIT.
At the mechanism of action level, romiplostim acts on the natural binding site, enabling comprehensive and efficient activation of downstream signaling pathways, promoting the proliferation, differentiation, and maturation of megakaryocytes, demonstrating a powerful platelet-boosting effect.
Compared with recombinant human thrombopoietin (rhTPO), romiplostim demonstrates multiple advantages: its molecular structure shares no homology with human endogenous TPO, avoiding immunogenic reactions and eliminating the risk of neutralizing antibody production; a once-weekly subcutaneous injection regimen significantly enhances treatment convenience, reduces adverse effects such as pain and infection caused by frequent injections, and provides ideal compliance assurance for long-term management; its unique mechanism of action prevents spontaneous platelet aggregation, effectively controlling the risk of thrombosis; high-quality evidence with robust support: results from the Phase II clinical study (N01) of romiplostim indicate that CTIT treatment initiated at a dose of 2 μg/kg resulted in 90.0% of patients achieving a platelet count ≥100×10^9/L after one cycle of chemotherapy.9/L or at least 30×10 higher than baseline9/L. In tumor patients who experienced CTIT in the previous cycle, administration of a prophylactic dose of 1-2 μg/kg effectively increased platelet levels in 68.3% of patients, ensuring the successful completion of two cycles of chemotherapy without any chemotherapy regimen adjustments due to thrombocytopenia (chemotherapy delay ≥4 days, chemotherapy dose reduction ≥15%, or chemotherapy termination), and without the need for salvage therapy. The incidence of adverse events was low, with good tolerability, and overall safety was controllable.
As a long-acting TPO-RA, romiplostim also demonstrates multiple advantages over short-acting oral TPO-RAs. The once-weekly subcutaneous administration provides continuous and stable platelet production, reducing dosing frequency while effectively improving patient compliance. Romiplostim is not affected by food or drug interactions, imposing no strict restrictions on the type or timing of food intake. From a pharmacokinetic perspective, romiplostim is recycled by endothelial cells and cleared by the reticuloendothelial system without undergoing hepatic or renal metabolism, thus having no adverse effects on liver function. In clinical evidence-based studies, romiplostim has also demonstrated favorable hepatic safety in the treatment of CTIT, with no liver-related adverse events reported.
Based on the existing evidence, Romiplostim N01 provides a solution for CTIT management that balances efficacy and safety through its innovative mechanism of action, optimized dosing regimen, and superior evidence-based medical data.
Professor Ma Ji from Shandong Cancer HospitalSystematically expounded the diagnosis and treatment strategies of CTIT related to radiotherapy and chemotherapy for solid tumors through a question-and-answer format, from both basic research and clinical practice aspects.
1. Can Romiplostim be used concurrently with chemotherapy? Yes.
Professor Ma Ji pointed out that the theory and clinical practice of megakaryocyte differentiation and maturation jointly demonstrate the feasibility of using romiplostim concurrently with chemotherapy, without concern for the impact of chemotherapy on megakaryocyte proliferation.
2. It is still unclear whether increasing the initial dose of Romiplostim can enhance its efficacy.
For CTIT patients, individualized dose adjustment strategies may be further explored through clinical research in the future.
3. Can the therapeutic efficacy of Romiplostim be improved when combined with other platelet-increasing drugs? The potential is worth expecting.
Despite the current lack of publicly available research data, the significant efficacy advantage of single-agent romiplostim makes this direction urgently in need of clinical validation.
4. Can different TPO-RA drugs be interchangeable? Mechanism-supported, clinically effective.
Basic research shows that the mechanisms of action of different TPO receptor agonists are complementary. Clinical data indicate that among patients who switch medications due to insufficient efficacy, adverse reactions, or mode of administration, 60% still achieve a platelet response. This provides flexibility for the dynamic adjustment of treatment regimens.
5. Is the thrombosis risk higher with Romiplostim? The risk is lower.
Meta-analysis shows that the incidence of thrombosis with romiplostim is significantly lower than that with eltrombopag.
6. Other effects of TPO? Future is promising.
Studies show that romiplostim not only significantly reduces the level of anti-platelet antibodies but also promotes the recovery of hematopoietic function in patients with CTIT after hematopoietic stem cell transplantation (HSCT). Additionally, rhTPO is expected to become an effective strategy for alleviating radiation injury.
In the summary, Professor Ma Ji provided an in-depth and comprehensive introduction to the mechanisms and application prospects of TPO-RAs. Based on the pathogenesis of thrombocytopenia related to radiotherapy and chemotherapy, he proposed corresponding treatment decision recommendations. He specifically mentioned the ongoing study by Professor Hou Ming's team at Qilu Hospital of Shandong University, which compares the efficacy of Romiplostim N01 with rhTPO in treating refractory CTIT. The results of this study are expected to provide higher quality evidence-based medical evidence for clinical decision-making.
InProfessor Wang Linlin from Shandong Cancer HospitalIn the discussion session hosted,Professor Zhou Jun from Peking University Cancer Hospital, Professor Yan Hua from Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Professor Shi Yan from Qilu Hospital of Shandong University, Professor Guan Shanghui from Qilu Hospital of Shandong UniversityDiscussions were held on the formulation of bone marrow protection strategies in clinical practice and the experience with the clinical application of Romiplostim N01.
Experts unanimously recognized the significant advantages of Romiplostim N01 in the prevention and treatment of thrombocytopenia, while also delving into the mechanisms of thrombocytopenia caused by different treatment methods and their coping strategies, emphasizing the importance of personalized treatment and prevention. Experts called for strengthening relevant clinical research to provide higher-level evidence-based medical proof, promoting the optimization of clinical practice.
This section is byProfessor Hu Man from Shandong Cancer Hospital, Professor Ying Jier from Hanggang Campus of Cancer Hospital Affiliated to University of Chinese Academy of SciencesHost.
Professor Yang Liu from Zhejiang Provincial People's HospitalIntroduction to the Construction of the Bone Marrow Suppression Planning and Management Discipline in the Zhejiang Provincial People's Hospital for Tumor Supportive Care.
This project focuses on intelligent and information-based construction, aiming to achieve full-process management of bone marrow suppression. It ensures that patients can complete chemotherapy with full dosage and full course while improving medical services, increasing patient satisfaction, reducing medical costs, and ultimately enhancing patient survival benefits. The project has achieved certain phased results, significantly improving diagnostic quality and patient satisfaction while reducing medical costs.
Professor Yang Liu concluded at the end, "In the future, all parties in healthcare and pharmaceuticals will continue to work together to continuously promote the improvement and perfection of the project."
Professor Peng Zhi from Peking University Cancer HospitalShared profound insights on "Zero CINV" management.
Professor Peng Zhi stated that chemotherapy-induced nausea and vomiting (CINV) has always been a tough challenge for patients, and achieving "zero CINV" is the ultimate goal of CINV prevention and treatment. However, reaching this goal faces multiple challenges such as limited effectiveness of antiemetic treatments, difficulty in controlling some CINV cases, poor compliance with guideline implementation, and insufficient patient awareness. In view of this, strengthening the standardized management of CINV has become a top priority.
Against this backdrop, Qilu Pharmaceutical's Aprepitant Submicron Emulsion was approved in August 2022 as the first domestically produced generic to pass evaluation in China. The NCCN guidelines include Aprepitant Submicron Emulsion as a Class I evidence recommendation for the prevention of acute and delayed vomiting. Authoritative guidelines and expert consensus in China have added recommendations for its use in outpatient and day chemotherapy settings. With its advantages of short administration time and high safety, Aprepitant Injection can be considered a preferred option for patients undergoing day or outpatient chemotherapy.
Finally, Professor Peng Zhi suggested a three-step approach based on the guidelines to strengthen the standardized management of CINV. Efforts should focus on optimizing the guidelines, implementing the guidelines, and formulating personalized treatment decisions. At the same time, vigorous education campaigns on the prevention and treatment of CINV should be carried out for both medical staff and patients to promote advancements in CINV management.
Under the guidance of Professor Ying Jier,Professor Dongyuan Zhu from Shandong Cancer Hospital, Professor Jundong Zhou from Suzhou Municipal Hospital, Professor Zhaoxia Liu from the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Professor Hairong Liu from the First Affiliated Hospital of Shandong First Medical UniversityActive discussions were held on the management of informatization projects and the creation of wards such as "vomiting-free," "pain-free," and "bone marrow suppression-free." The professors unanimously emphasized the importance of supportive care, affirmed the intelligent management experience of Zhejiang Provincial People's Hospital, and shared their perspectives on cancer supportive care from different angles. Key points included personalized treatment, multidisciplinary collaboration, risk assessment, stratified prevention, multimodal patient education, and comprehensive management, all aimed at enhancing the treatment experience and survival prognosis of patients through integrated measures in clinical practice.
Meeting Summary
Professor Pan Hongming said in the conference summary that the development of cancer supportive care needs to be advanced from multiple dimensions. By accelerating the research and development of new drugs and clinical trials, improving the construction of guideline systems, promoting basic projects, strengthening hospital management support, and deepening international exchange and cooperation, the level of cancer diagnosis and treatment will be further enhanced, significantly improving patients' quality of life.
Finally, Professor Hou Ming once again expressed sincere thanks to the experts and peers present. He pointed out that supportive care has evolved from the initial simple pain relief to become a vast systematic project encompassing support for cytopenia, functions of major organs, mental health, analgesic nutrition, and more. We should keep up with the cutting-edge international development trends, leverage technological innovation, and promote China's supportive care system to achieve higher-quality development and realize new breakthroughs.