Points to consider when developing drugs for dry eye syndrome

Changes in both the social environment (e.g., the increased use of electronic media) and the atmospheric environment (e.g., air pollution and dust) have contributed to an increasing incidence of eye disease and an increased need for eye care. Notably, the signs and symptoms of dry eye syndrome can impact the daily quality of life for various age groups, including the elderly, and usually requires active treatment. The symptoms of dry eye syndrome include tear film instability, hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities. As treatments for dry eye are being developed, a standardized guideline is needed to increase the efficiency of drug development and improve the quality of clinical trial data. In this paper, we present general considerations for the pharmaceutical industry and clinical trial investigators designing clinical trials focused on the development of drugs to treat dry eye syndrome.

Magnetic resonance imaging features of syringobulbia in small breed dogs

Syringobulbia is a rare neurological disorder characterized by a fluid-filled cavity in the brainstem. In this study, clinical signs, features on magnetic resonance imaging (MRI), and the diseases present concurrently with syringobulbia were investigated in 33 small breed dogs. Most dogs (97%) had concurrent syringomyelia, and some dogs (24%) presented with vestibular or cranial nerve symptoms associated with the medulla oblongata. MRIs revealed slit-like, bulbous, and vertical linear shapes of the cavities on T2-weighted hyperintense and T1-weighted hypointense signals similar to the cerebrospinal fluid. Chiari-like malformations were identified in all dogs. This study highlights the association of syringobulbia with syringomyelia and Chiari-like malformations in small breed dogs with or without brainstem-associated clinical signs.

A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

Purpose@#Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. @*Materials and Methods@#Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. @*Results@#Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250–0.890; P=0.020). @*Conclusions@#After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.

The effect of COVID-19 pandemic on the length of stay and outcomes in the emergency department

Objective@#This study aimed to evaluate the change in length of stay (LOS) in the emergency department (ED) and outcomes during the coronavirus disease 2019 (COVID-19) pandemic. @*Methods@#This is a single-center, retrospective observational study. We compared ED LOS and outcomes in patients aged ≥19 years who presented to the ED of Soonchunhyang University Bucheon Hospital, a single tertiary university hospital, between January and December in 2018, 2019, and 2020. We included patients who were diagnosed with fever, pneumonia, and sepsis in the ED, based on the International Statistical Classification of Diseases and Related Health Problems 10th Revision. We also compared the LOS and outcomes of overall ED patients in 2019 (before COVID-19) and in 2020 (after COVID-19). @*Results@#A total of 5,061 patients with fever, pneumonia, and sepsis were analyzed. The LOS in the ED in 2020 significantly increased compared with 2018 and 2019 (177.0±115.0 minutes in 2018, 154.0±85.0 minutes in 2019, and 208.0±239.0 minutes in 2020). The proportion of patients who were transferred to other hospitals in 2020 (2.1%) increased compared with 2018 (0.8%) and 2019 (0.7%). Intensive care unit admission significantly increased in 2020 (13.7%) compared with 2019 (10.3%). Among all ED patients, ED LOS in 2020 was longer than in 2019, particularly in patients who were admitted and then transferred to another hospital. Intensive care unit admission (4.4% vs. 5.0%), transfer rate (0.7% vs. 0.9%), and ED mortality (0.6% vs. 0.7%) also significantly increased. @*Conclusion@#The ED LOS, time to intensive care unit admissions, time to transfer to other hospitals, and ED mortality significantly increased during the COVID-19 pandemic.

Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform

Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.

Do Obliquity and Position of the Oblique Lumbar Interbody Fusion Cage Influence the Degree of Indirect Decompression of Foraminal Stenosis?

Objective@#: Oblique lumbar interbody fusion (OLIF) is a surgical technique that utilizes a large interbody cage to indirectly decompress neural elements. The position of the cage relative to the vertebral body could affect the degree of foraminal decompression. Previous studies determined the position of the cage using plain radiographs, with conflicting results regarding the influence of the position of the cage to the degree of neural foramen decompression. Because of the cage obliquity, computed tomography (CT) has better accuracy than plain radiograph for the measurement of the obliquely inserted cage. The objective of this study is to find the correlation between the position of the OLIF cage with the degree of indirect decompression of foraminal stenosis using CT and magnetic resonance imaging (MRI). @*Methods@#: We review imaging of 46 patients who underwent OLIF from L2-L5 for 68 levels. Segmental lordosis (SL) was measured in a plain radiograph. The positions of the cage were measured in CT. Spinal canal cross-sectional area (SCSA), and foraminal crosssectional area (FSCA) measurements using MRI were taken into consideration. @*Results@#: Patients’ mean age was 69.7 years. SL increases 3.0±5.1 degrees. Significant increases in SCSA (33.3%), FCSA (43.7% on the left and 45.0% on the right foramen) were found (p<0.001). Multiple linear regression analysis shows putting the cage in the more posterior position correlated with more increase of FSCA and decreases SL correction. The position of the cage does not affect the degree of the central spinal canal decompression. Obliquity of the cage does not result in different degrees of foraminal decompression between right and left side neural foramen. @*Conclusion@#: Cage position near the posterior part of the vertebral body increases the decompression effect of the neural foramen while putting the cage in the more anterior position correlated with increases SL.

Emergency medicine residents’ needs assessment for education and training using nationwide survey

Objective@#This study was conducted to identify the needs assessment for education and training of emergency medicine (EM) residents. @*Methods@#The results of a national survey of EM residents of the Korean Society of Emergency Medicine in 2019 were used. Education was one of the five categories in the survey. The preferred learning methods and their perceived importance and ability to perform in nine competencies were assessed. The Borich’s needs assessment model was used to analyze their needs. @*Results@#Among 591 EM residents, 382 responded, and 371 responses were finally analyzed. Regarding the learning methods, junior residents preferred in-hospital conferences, staff lectures, internet resources, and textbooks. Overall, medical knowledge and procedural skills were the most important, and research was less important to recognize. Medical knowledge showed the highest rank in the needs assessment in all years, and ethics and professionalism showed the lowest ranks. The needs for procedural skills were higher in junior years but lower in senior years. @*Conclusion@#These results will form the basis for the design of training programs to meet the educational needs of EM residents for each grade. Furthermore, an analysis of the educational needs should be done periodically according to the changes and demands of the times.

Effects of Action Observation Training and Mirror Therapy on the Electroencephalograms of Stroke Patients

Purpose@#This study examined the effectiveness of action observation training (AOT) and mirror therapy in improving the electroencephalograms (EEG) of stroke patients. @*Methods@#Patients were allocated randomly to three groups: an action observation training with activity (AOTA) group (n=12), a mirror therapy with activity (MTA) group (n=11), and an AOT-only group (n=12). All groups received conventional physiotherapy in five 60-minute sessions over six weeks. The AOTA, MTA, and AOT groups practiced AOTA, MTA, and AOT, respectively, in three 30-minute sessions over six weeks. The differences between the pre- and post-treatment EEGs were assessed using a paired t-test. Comparisons between the groups were performed using one-way ANOVA. @*Results@#The participants in the AOTA and MTA groups showed significant improvement in the EEG. AOTA improved the alpha waves of the prefrontal, temporal, and parietal lobes significantly (p<0.05). MTA improved the alpha waves of the temporal lobe significantly (p<0.05). AOT did not result in significant improvement @*Conclusion@#AOTA and MTA improve stroke patients’ EEGs. Mirror neuron activation combined with conventional stroke physiotherapy promotes motor recovery and functioning. The effect is enhanced when the actions are executed after observation. Further research into mirror neuron activation will be needed to develop methods to improve the EEGs of stroke patients.

Outcomes and Biomarkers of Immune Checkpoint Inhibitor Therapy in Patients with Refractory Head and Neck Squamous Cell Carcinoma: KCSG HN18-12 / Journal of the Korean Cancer Association, 대한암학회지

Purpose@#This study was conducted to determine the effectiveness of immune checkpoint inhibitors (ICIs) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after platinum-containing chemotherapy. We also identified clinical biomarkers which may be predictive of patient prognosis. @*Materials and Methods@#We analyzed 125 patients with R/M HNSCC who received ICIs, retrospectively. Overall response rate (ORR) was the primary study outcome. Overall survival (OS) and progression-free survival (PFS) were the secondary study outcomes. @*Results@#The patients received anti–programmed cell death protein-1 (PD-1) (n=73, 58%), anti–programmed death-ligand 1 (PD-L1) (n=24, 19%), or a combination of anti–PD-1/PD-L1 and anti–cytotoxic T-lymphocyte antigen 4 (n=28, 22%). The median age was 57 years (range, 37 to 87). The location of the primary tumor was in the oral cavity in 28% of the cases, followed by oropharynx (27%), hypopharynx (20%), and larynx (12%). The ORR was 15% (19/125). With 12.3 months of median follow-up, median PFS was 2.7 months. Median OS was 10.8 months. A neutrophil-to-lymphocyte ratio (NLR) > 4 was significantly associated with poor response to ICIs (odds ratio, 0.30; p=0.022). A sum of the target lesions > 40 mm (hazard ratio [HR], 1.53; p=0.046] and a NLR > 4 (HR, 1.75; p=0.009) were considered to be predictive markers of short PFS. A poor performance status (HR, 4.79; p 40 mm (HR, 1.93; p=0.025), and an NLR > 4 (HR, 3.36; p < 0.001) were the significant predictors for poor survival. @*Conclusion@#ICIs exhibited favorable antitumor activity in R/M HNSCC. Clinically, our findings can be used to recognize patients benefit from receiving ICI.

Effects of Action Observation Training and Mirror Therapy on the Electroencephalograms of Stroke Patients

Purpose@#This study examined the effectiveness of action observation training (AOT) and mirror therapy in improving the electroencephalograms (EEG) of stroke patients. @*Methods@#Patients were allocated randomly to three groups: an action observation training with activity (AOTA) group (n=12), a mirror therapy with activity (MTA) group (n=11), and an AOT-only group (n=12). All groups received conventional physiotherapy in five 60-minute sessions over six weeks. The AOTA, MTA, and AOT groups practiced AOTA, MTA, and AOT, respectively, in three 30-minute sessions over six weeks. The differences between the pre- and post-treatment EEGs were assessed using a paired t-test. Comparisons between the groups were performed using one-way ANOVA. @*Results@#The participants in the AOTA and MTA groups showed significant improvement in the EEG. AOTA improved the alpha waves of the prefrontal, temporal, and parietal lobes significantly (p<0.05). MTA improved the alpha waves of the temporal lobe significantly (p<0.05). AOT did not result in significant improvement @*Conclusion@#AOTA and MTA improve stroke patients’ EEGs. Mirror neuron activation combined with conventional stroke physiotherapy promotes motor recovery and functioning. The effect is enhanced when the actions are executed after observation. Further research into mirror neuron activation will be needed to develop methods to improve the EEGs of stroke patients.

Outcomes and Biomarkers of Immune Checkpoint Inhibitor Therapy in Patients with Refractory Head and Neck Squamous Cell Carcinoma: KCSG HN18-12 / Journal of the Korean Cancer Association, 대한암학회지

Purpose@#This study was conducted to determine the effectiveness of immune checkpoint inhibitors (ICIs) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after platinum-containing chemotherapy. We also identified clinical biomarkers which may be predictive of patient prognosis. @*Materials and Methods@#We analyzed 125 patients with R/M HNSCC who received ICIs, retrospectively. Overall response rate (ORR) was the primary study outcome. Overall survival (OS) and progression-free survival (PFS) were the secondary study outcomes. @*Results@#The patients received anti–programmed cell death protein-1 (PD-1) (n=73, 58%), anti–programmed death-ligand 1 (PD-L1) (n=24, 19%), or a combination of anti–PD-1/PD-L1 and anti–cytotoxic T-lymphocyte antigen 4 (n=28, 22%). The median age was 57 years (range, 37 to 87). The location of the primary tumor was in the oral cavity in 28% of the cases, followed by oropharynx (27%), hypopharynx (20%), and larynx (12%). The ORR was 15% (19/125). With 12.3 months of median follow-up, median PFS was 2.7 months. Median OS was 10.8 months. A neutrophil-to-lymphocyte ratio (NLR) > 4 was significantly associated with poor response to ICIs (odds ratio, 0.30; p=0.022). A sum of the target lesions > 40 mm (hazard ratio [HR], 1.53; p=0.046] and a NLR > 4 (HR, 1.75; p=0.009) were considered to be predictive markers of short PFS. A poor performance status (HR, 4.79; p 40 mm (HR, 1.93; p=0.025), and an NLR > 4 (HR, 3.36; p < 0.001) were the significant predictors for poor survival. @*Conclusion@#ICIs exhibited favorable antitumor activity in R/M HNSCC. Clinically, our findings can be used to recognize patients benefit from receiving ICI.

Follistatin Mitigates Myofibroblast Differentiation and Collagen Synthesis of Fibroblasts from Scar Tissue around Injured Flexor Tendons

How many emergency medicine residents reselect their specialty if they could?

Objective@#The 2019 Korean Emergency Medicine Residents Survey (KEMRS) is the first survey by the Korean Society of Emergency Medicine (KSEM) on the comprehensive satisfaction of their residents. Satisfaction is important not only for the personal well-being of the residents but also for patient safety. @*Methods@#A total of 622 emergency medicine residents were surveyed, using both a paper and email questionnaire from May to August of 2019. Factors related to satisfaction were analyzed. @*Results@#Of the responders, 66% said they would reapply for the emergency specialty and 51% said that they would reselect the same training hospital. The group of residents who said they would choose emergency medicine again felt that their expectations had been met and that they were comfortable with the choice of the specialty. They felt that the factors of satisfaction with their shift schedule and personal health played a more important role in their reselection of the training hospital than the workload. @*Conclusion@#The satisfaction levels of the Korean emergency residents were low. Thus, training hospitals should provide a reasonable working environment to increase their satisfaction. Also, it is important to create an environment where residents can feel rewarded and proud of the work they do.

Long-term treatment outcomes of children and adolescents with lymphoblastic lymphoma treated with various regimens:a single-center analysis

Background@#Lymphoblastic lymphoma (LBL) is the second most common subtype of pediatric non-Hodgkin lymphoma. Modified treatments derived from the LSA2-L2 regimen resulted in encouraging survival, but toxicities and long-term sequelae have been problematic. At present, the acute lymphoblastic leukemia (ALL)-type protocol has demonstrated efficacy in LBL. We analyzed the outcomes of children and adolescents with LBL treated with various regimens. @*Methods@#From 1991‒2018, this study enrolled 63 patients diagnosed with LBL at Asan Medical Center. Medical records were retrospectively analyzed. @*Results@#Among 63 patients, most patients (38.1%) presented with stage IV at diagnosis, and two had central nervous system (CNS) involvement. At a median follow-up of 160 months, the 5-year event free survival (EFS), overall survival (OS), and relapse free survival (RFS) were 68.8%, 79.3%, and 71.3%, respectively. Among 61 patients who received chemotherapy, 27 patients (44.3%) received the NY protocol, and 14 (23.0%) received the ALL-type protocol. There was no significant difference in 5-yr OS (85.2%/78.6%), EFS (73.5%/78.6%), and RFS (73.5%/78.6%) between the NY and ALL protocol groups, regardless of immunophenotype. Thirteen patients (21.3%) received prophylactic cranial radiotherapy with no difference in the incidence of CNS relapse based on irradiation. @*Conclusion@#This study showed no difference in outcome between the NY and ALL-type protocols, regardless of stage or immunophenotype. In addition to improving the effectiveness of treatment, it is necessary to continuously appraise the appropriate chemotherapy regimen, considering toxicities and long-term prognosis, for pediatric LBL.

How many emergency medicine residents reselect their specialty if they could?

Objective@#The 2019 Korean Emergency Medicine Residents Survey (KEMRS) is the first survey by the Korean Society of Emergency Medicine (KSEM) on the comprehensive satisfaction of their residents. Satisfaction is important not only for the personal well-being of the residents but also for patient safety. @*Methods@#A total of 622 emergency medicine residents were surveyed, using both a paper and email questionnaire from May to August of 2019. Factors related to satisfaction were analyzed. @*Results@#Of the responders, 66% said they would reapply for the emergency specialty and 51% said that they would reselect the same training hospital. The group of residents who said they would choose emergency medicine again felt that their expectations had been met and that they were comfortable with the choice of the specialty. They felt that the factors of satisfaction with their shift schedule and personal health played a more important role in their reselection of the training hospital than the workload. @*Conclusion@#The satisfaction levels of the Korean emergency residents were low. Thus, training hospitals should provide a reasonable working environment to increase their satisfaction. Also, it is important to create an environment where residents can feel rewarded and proud of the work they do.

How Do Oroxylin A and Spinosin Exert Their Activities on Cognitive Function?

Flavonoids are mainly contained in the vegetables and medicinal herbs. Until now, over 5,000 kinds of flavonoid have been identified and their biological activities have been reported. Among them, we are interested in oroxylin A and spinosin because of their specific structures having bulky group at C-6 of ring A. Oroxylin A is contained in the Scutellaria baicalensis and exhibits cognitive enhancing activity as a GABAA receptor antagonist, which is different from those of mainly contained in the S. baicalenis, baicalein or wogonin. Spinosin is isolated from Zizyphus jujuba var. spinosa and mainly studied as a hypnotic or anxiolytic agent because of traditional knowledge about its original herb. As far as we know, the cognitive function of spinosin was first identified by our group. In this review, we discuss how such flavonoids exert their pharmacological activities associated with cognitive function based on the receptor binding study and behavioral studies. Traditional knowledge and reverse pharmacology may be addressed in the research field of phytochemical pharmacology and useful to unveil the secret of phytochemicals.

The Two Cases of Multifocal Fixed Drug Eruption Caused by Diclofenac / 대한피부과학회지

Fixed drug eruption (FDE) is a drug-induced disorder that may appear as patches or bullae. It recurs at the same sites as those involved in exposure to the same drug (causative drug). We encountered two cases of generalized FDE, and both patients had a history of diclofenac exposure before the onset of skin lesions. In the first case, an 82-year-old female patient presented with multiple erythematous patches on the trunk and lower extremities. In the second case, a 71-year-old male patient developed multiple bullae on violaceous patches on the trunk and extremities. The findings of histopathologic examinations were indicative of the diagnosis of FDEs. Although diclofenac is commonly used as a non-steroidal inflammatory drug, diclofenac-induced generalized FDE occurs rarely and has not been reported in Korea. With reuse of causative drugs, the size and number of lesions tend to increase. Therefore, early diagnosis of FDE is important, and avoidance of repeated exposure to drugs should be educated.

Comparison of the characteristics and injury severity of passengers in motor vehicle accidents between urban and rural cities in South Korea

Objective@#To analyze motor vehicle accidents in two different traffic environments and compare differences in severity between both regions. @*Methods@#Injury data were collected by the Emergency Medicine and Traffic Accident Research Team as part of the Korean In-Depth Accident Study. Patients admitted to emergency medical centers located in Wonju, Gangwon province (population 345,143, rural, group A) and Bucheon, Gyeonggi province (population 870,735, urban, group B) between January 2011 and December 2017 were included for analysis. Injury severity was classified into four categories based on Injury Severity Score (ISS): minor (1≤ <9), moderate (9≤ <15), major (15≤ <25), and critical (≥25). @*Results@#Overall, 1,807 patients were included (group A, 1,484; group B, 323). There was a higher proportion of daytime accidents, accidents involving larger cars, passenger injuries, and accidents involving lack of seat belt use in group A than in group B. The mean ISS value was 8.98 in group A and 4.62 in group B (P<0.001). Minor (20.4% vs. 10.8%) and major/critical (15.7% vs. 5.0%) injuries were more frequent in group A than group B (P<0.001). Patient ratios (A/B) for each ISS classification were 0.76 (minor), 1.89 (moderate), 3.43 (major), and 2.77 (critical). The factors showing a significant relationship with severity were driver’s seat (P=0.037) and no seat belt (P<0.001). @*Conclusion@#Patients in a rural city who visited the emergency room owing to motor vehicle accidents had more severe injuries than those in an urban city.

Real-World Experience of Nivolumab in Non-small Cell Lung Cancer in Korea / Journal of the Korean Cancer Association, 대한암학회지

Purpose@#The introduction of immune checkpoint inhibitors represents a major advance in the treatment of lung cancer, allowing sustained recovery in a significant proportion of patients. Nivolumab is a monoclonal anti–programmed death cell protein 1 antibody licensed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. In this study, we describe the demographic and clinical outcomes of patients with advanced NSCLC treated with nivolumab in the Korean expanded access program. @*Materials and Methods@#Previously treated patients with advanced non-squamous and squamous NSCLC patients received nivolumab at 3 mg/kg every 2 weeks up to 36 months. Efficacy data including investigator-assessed tumor response, progression data, survival, and safety data were collected. @*Results@#Two hundred ninety-nine patients were treated across 36 Korean centers. The objective response rate and disease control rate were 18% and 49%, respectively; the median progression-free survival was 2.1 months (95% confidence interval [CI], 1.87 to 3.45), and the overall survival (OS) was 13.2 months (95% CI, 10.6 to 18.9). Patients with smoking history and patients who experienced immune-related adverse events showed a prolonged OS. Cox regression analysis identified smoking history, presence of immune-related adverse events as positive factors associated with OS, while liver metastasis was a negative factor associated with OS. The safety profile was generally comparable to previously reported data. @*Conclusion@#This real-world analysis supports the use of nivolumab for pretreated NSCLC patients, including those with an older age.

Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting / Journal of the Korean Cancer Association, 대한암학회지

Purpose@#The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highly-emetogenic chemotherapy (HEC)–induced nausea and vomiting. @*Materials and Methods@#Patients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by gender, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6. @*Results@#A total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], −7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, −2.3%; 95% CI, −13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, −7.9 to 15.5), respectively. FLIE total score ≥ 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups. @*Conclusion@#In all aspects of efficacy, safety and QOL, RAD is non-inferior to PAD for the control of CINV in cancer patients receiving HEC.