Fudan Cancer Team’s Research on Preventing Nausea and Vomiting During Cancer Immunotherapy Published in an International Journal
As cancer treatment enters a new era of immunity, traditional antiemetic regimens using corticosteroids for a long time often fall into the dilemma of "antiemetic" and "preservation of immunity". Zhang Jian, chief physician of the Phase I ward of Fudan University Shanghai Cancer Center, led 28 centers across the country to jointly complete a national multi-center investigator-initiated clinical study (IIT), achieving breakthrough results and solving this clinical pain point. Relevant results were recently officially published in the international oncology journal "Journal of Clinical Oncology" (JCO, impact factor 44.7), providing a new Chinese evidence-based program for global tumor supportive care, and is expected to rewrite the clinical standardization diagnosis and treatment model.
It is reported that this phase III clinical study initiated by the researcher included a total of 644 clinical cases, with Professor Meng Yanchun and Dr. Liu Yingying as the co-first authors. This study has previously completed an oral report at the 2026 American Society of Clinical Oncology (ASCO) annual meeting, and was published online in a rapid communication format three months ago. It was officially published this time and was recognized by the industry as a landmark achievement with the value of changing clinical practice. It was also invited to be highlighted at the Antiemetic Research Group meeting of the International Association for Supportive Care of Cancer, which increased the international voice of Fudan Oncology in the field of tumor supportive care. This is also the Fudan Oncology Team’s systemic treatment plan that once again topped JCO’s original IIT clinical research results after the “ABC” plan for triple-negative breast cancer brain metastasis.
Antiemetic treatment encounters corticosteroid dilemma, and a team is formed to solve the problem
Currently, new anti-tumor therapies such as immune checkpoint inhibitors and antibody-drug conjugates have been widely used in the treatment of solid tumors. Most of them are combined with highly emetogenic chemotherapy regimens, and strong anti-emetic intervention needs to be carried out simultaneously in clinical practice. According to the current international NCCN antiemetic guidelines, the standard quadruple antiemetic regimen of highly emetogenic chemotherapy requires the use of dexamethasone for four consecutive days, with a dose of 12 mg on the first day and 8 mg daily on the second to fourth days. However, more and more clinical evidence confirms that short-term glucocorticoid exposure can also inhibit human T cell function, hinder antigen presentation, and directly weaken the effect of anti-tumor immunotherapy. At the same time, adverse reactions such as insomnia, anxiety, hyperglycemia, and increased risk of infection caused by dexamethasone will continue to accumulate with multiple cycles of treatment, seriously affecting the quality of life of cancer patients during treatment. "How to reduce or even exempt the use of corticosteroids while ensuring the antiemetic effect has become a core clinical problem that needs to be overcome in the era of immunotherapy." Director Zhang Jian formed a research team to tackle this clinical difficulty.
In order to solve this dilemma, Professor Zhang Jian led the team to lead the DESCEND multi-center, randomized, open-label, phase III non-inferiority clinical trial to explore a more accurate and safer new corticosteroid-free and corticosteroid-reduced antiemetic solution. The study divided 644 adult patients who received highly emetogenic chemotherapy into three groups at a ratio of 1:1:1. They adopted a standard four-day corticosteroid antiemetic regimen, a single-dose reduction corticosteroid regimen on the first day, and a full-course corticosteroid-free exemption regimen. The primary endpoint of the study was set as the overall complete response rate from 0 to 120 hours after chemotherapy, that is, the proportion of effective control without vomiting and without the use of rescue drugs.
Rigorous clinical trial data showed that the antiemetic efficacy of the three groups of patients was balanced and all met clinical expectations. The overall complete response rate was 72.4% in the standard regimen group, 72.2% in the dexamethasone reduction regimen group, and 70.1% in the complete corticosteroid-free regimen group. Statistical analysis showed that the difference in effectiveness between the reduced dose regimen and the standard regimen was -0.2%, and the difference between the exemption regimen and the standard regimen was -2.2%. Both comparisons met the preset non-inferiority margin, and the non-inferiority test results were both statistically significant. In terms of secondary efficacy indicators such as antiemetic control in the acute phase, delayed phase, and complete protection rate, there was no significant statistical difference between the three groups of data, confirming that the efficacy of the corticosteroid-reducing and corticosteroid-free regimens was not inferior to the traditional standard regimen.
Zhang Jian pointed out that the advantages of the new solution are particularly prominent in terms of safety and quality of life benefits. "Compared with the traditional standard protocol, the incidence and severity of corticosteroid-related adverse reactions such as anxiety, hiccups, indigestion, and insomnia among patients in the corticosteroid reduction group and the full exemption group were significantly reduced. The differences in many indicators are highly statistically significant, effectively avoiding the treatment burden caused by long-term corticosteroid intervention and greatly improving the patient treatment experience." Zhang Jian said.
National multi-center phase III clinical trial results form the "China Plan"
Based on solid evidence-based data, the DESCEND study identified two core benefit groups and established a hierarchical and accurate clinical corticosteroid management system. For patients receiving chemotherapy combined with immunotherapy, the reduction plan of 6 mg of corticosteroids on the first day compresses the traditional four-day corticosteroid treatment course to a single day and halve the dose. On the basis of ensuring the anti-emetic effect throughout the course, it minimizes the interference of corticosteroids on the body's immune function and completely breaks the patient's treatment dilemma of choosing between "controlling vomiting" and "preserving immunity". For people with contraindications such as diabetes, glaucoma, mental illness, or past intolerance to the adverse effects of corticosteroids, the full-course corticosteroid-free antiemetic program provides a safe and reliable new alternative. The study also suggests that the corticosteroid-free regimen has a slightly weaker nausea control effect in the delayed period of 1 to 3 days in the initial treatment. However, on the fifth to seventh days of treatment, the quality of life recovery level of patients with all regimens tends to be the same, reaching about 80%. Clinical practice can be flexibly optimized through backup rescue drugs, non-drug intervention, etc. to adapt to the individual needs of different patients.
From attacking refractory tumor lesions to optimizing the supportive treatment system, the oncology team continues to delve into clinical pain points and produce original results. Zhang Jian said: "In the future, the team will continue to focus on the field of precise supportive treatment of tumors. On the one hand, it will further verify the corticosteroid reduction and discontinuation strategy in the population of highly emetogenic chemotherapy combined with immunotherapy in a prospective cohort and consolidate the evidence for clinical application; on the other hand, it will optimize the dosage of olanzapine and combine it with acupuncture and other non-pharmacological intervention methods to make up for the shortcomings of early control of corticosteroid-free antiemetic programs; at the same time, it will explore dynamic adjustment programs based on the patient's individual treatment response and build a full-course personalized antiemetic diagnosis and treatment system."
The official publication of the DESCEND study marks the official farewell to the traditional extensive model of "uniform dose, fixed course of treatment" in the anti-emetic management of highly emetogenic chemotherapy in domestic tumors, and has entered a new stage of personalized precision of "precise stratification and precise treatment". This result not only provides clinicians with authoritative evidence-based basis for optimizing antiemetic programs, but also effectively improves the safety and comfort of cancer patients' treatment through innovative strategies to reduce toxicity and preserve efficacy, and contributes an original Chinese program of great clinical value to the global field of supportive cancer treatment.