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preface
On December 15, a team led by Professor Zhang Li of the Department of Internal Medicine of the Cancer Center of Sun Yat-sen University published an article entitled "Multicenter, double-blind randomized controlled phase 3 clinical trial of olanzapine combined with triple antiemetic regimen for the prevention of nausea and vomiting caused by multi-day chemotherapy of highly emetogenic drugs" in the Lancet sub-journal eClinicalMedicine (impact factor = 17.
033) (click to read the original article to view the original link).
For a long time, nausea and vomiting caused by hyperemetogenic chemotherapy have been an important adverse reaction
that plagues the treatment of tumor patients.
Many patients refuse treatment
for fear of nausea and vomiting caused by chemotherapy.
Therefore, a large number of clinical studies have been carried out at home and abroad to control nausea and vomiting caused by chemotherapy, and relevant diagnosis and treatment guidelines
have also been established.
However, previous studies and guidelines have focused on the control of nausea and vomiting caused by single-day chemotherapy, and there has been a lack of strong evidence-based medical evidence at home and abroad on how to choose an antiemetic regimen for patients who need to receive a multi-day high-emetogenic chemotherapy regimen.
This double-blind, double-mimic, randomized controlled, phase III clinical study conducted by Professor Li's team specifically targeted patients receiving multi-day chemotherapy with highly emetogenic drugs, and enrolled 349 patients with malignant solid tumors who planned to receive a chemotherapy regimen containing cisplatin (3-day total dose≥ 75mg/m2) for 3 days, and were randomly divided into 1:1 to receive oral olanzapine or placebo plus triple antiemetic therapy (including fosapitant, ondansetron and dexamethasone).
。 The results showed that the proportion of patients who achieved complete remission throughout the observation period was significantly higher in the olanzapine group than in the placebo group (69% vs.
58%, P = 0.
031).
Throughout the observation period, more patients did not develop nausea in the olanzapine group than in the placebo group (72% vs.
60%, P = 0.
021).
In almost all subgroups, complete response and nausea-free benefit
were observed in the olanzapine group compared with placebo.
This study is currently the world's first large-scale III randomized controlled study
in patients receiving multi-day hyperemetogenic chemotherapy.
This study provides new evidence-based medical evidence for the prevention of CINV in such patients, and this treatment regimen will surely become the recommended antiemetic strategy for multi-day chemotherapy patients for clinical use
.
It is worth mentioning that Professor Zhang's team also carried out a translational study of chemotherapy-induced nausea and vomiting in this study, which prospectively collected blood samples from enrolled patients and determined the plasma p substance and 5-HT concentration of biomarkers related to baseline vomiting for translational analysis
.
It was found that higher baseline plasma 5-HT concentrations were associated with
a higher risk of chemotherapy-induced nausea and vomiting (CINV).
The results of this translational study also provide a new idea
for the next step to find people at high risk of nausea and vomiting.
Professor Zhang Li and Professor Huang Yan are the co-corresponding authors of the paper; Deputy Chief Physician Zhao Yuanyuan, Chief Physician Yang Yunpeng, Deputy Chief Physician Gao Fangfang (Henan Cancer Hospital), Director Hu Changlu (First Affiliated Hospital of University of Science and Technology of China), and Director Zhong Diansheng (Tianjin Medical University) are co-first authors
of the paper.
Investigator profile
Corresponding author
Professor Li Zhang
Director of the Department of Internal Medicine, Sun Yat-sen University Cancer Hospital, doctoral supervisor, chief expert of lung cancer
Chairman of the Cancer Rehabilitation and Palliative Care Professional Committee of the Chinese Anti-Cancer Association
Vice Chairman of Clinical Trial Professional Committee of Chinese Anti-Cancer Association
Standing Director of Chinese Society of Clinical Oncology (CSCO).
Chairman-designate of the CSCO-Immunotherapy Expert Committee
Honorary Chairman of the Chemotherapy Professional Committee of Guangdong Anti-Cancer Association
Vice Chairman of the Lung Cancer Professional Committee of Guangdong Anti-Cancer Association
Chairman of the Precision Medicine Professional Committee of Guangdong Clinical Medical Association
Leading Medical Talents of Guangdong Province, Outstanding Talents of the "Special Support Program" (Nanyue Baijie)
The person in charge of the precision research project of the diagnosis and treatment standards and application plans of lung cancer of the National Key R&D Program "Precision Medicine Research"
Co-corresponding author
Professor Huang Yan
Chief physician and doctoral supervisor of the Department of Internal Medicine, Sun Yat-sen University Cancer Hospital
Youth Director of Chinese Anti-Cancer Association
Chairman of the Cancer Rehabilitation and Palliative Care Professional Committee of Guangdong Anti-Cancer Association
Vice Chairman of the Chemotherapy Professional Committee of Guangdong Anti-Cancer Association
First author
Zhao Yuanyuan Deputy Chief Physician
Deputy Chief Physician and Master Supervisor of Department of Internal Medicine, Cancer Center of Sun Yat-sen University
Member of Palliative Care Professional Committee of Chinese Anti-Cancer Association
Member of Cancer Rehabilitation and Palliative Care Professional Committee of Guangdong Anti-Cancer Association
Member of the Standing Committee of the Youth Committee of the Cancer Rehabilitation and Palliative Care Professional Committee of Guangdong Anti-Cancer Association
Member of the Standing Committee of the Youth Committee of the Chemotherapy Professional Committee of Guangdong Anti-Cancer Association
Co-first author
Yang Yunpeng Chief Physician
Chief physician and attending professor of the Department of Internal Medicine, Cancer Center of Sun Yat-sen University
Vice Chairman/Secretary General of the CSCO Neurological Oncology Expert Committee
Member of the Standing Committee of the CSCO Immunotherapy Expert Committee
Member of the CSCO Young Experts Committee
Member of the CSCO Vascular Targeting Expert Committee
Chairman of the Youth Committee of the Chemotherapy Committee of Guangdong Anti-Cancer Association
Reviewed: Faline
Typesetting: Faline
Execution: Uni
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