Choosing the right adjuvant therapy for stage III-IVA endometrial cancer: A comparative analysis of chemoradiotherapy and chemotherapy.

OBJECTIVE: The optimal adjuvant treatment for patients with locally advanced endometrial cancer (EC) remains debatable. We comparatively analyzed recurrence patterns and survival outcomes in patients with stage III-IVA EC treated with adjuvant chemotherapy (CT) exclusively or combined with radiotherapy (CRT). METHODS: We retrospectively analyzed 184 patients treated for stage III-IVA EC at 2 tertiary institutions between 2010 and 2021. All patients underwent standard primary surgery and received either CT alone (n = 89) or CRT (n = 95) as an adjuvant treatment. We compared the failure patterns, recurrence-free survival (RFS), and overall survival (OS) between the CT and CRT groups. RESULTS: The median follow-up period was 54.8 months. Most patients underwent pelvic (94.6%) or para-aortic (75.5%) lymphadenectomies. The 5-year RFS was 69.2% with CRT versus 56.3% with CT (P = 0.038), and 5-year OS was 86.1% versus 78.9% (P = 0.357). Pelvic and para-aortic recurrence rates were significantly higher in the CT group (pelvic: 29.2%; para-aortic: 20.2%) than in the CRT group (pelvic: 10.5%; para-aortic: 6.3%). The CRT group showed a higher rate of distant recurrence (CRT, 23.2% vs. CT, 14.6%) however, the 5-year cumulative incidence of distant recurrence was not significantly different between the two groups (CRT, 28% vs. CT, 35%). CONCLUSIONS: This study highlights the potential benefits of adjuvant CRT in patients with stage III-IVA EC. The incorporation of molecular classification is necessary to derive optimal personalized adjuvant treatment strategies for this patient population.

Machine learning models to identify low adherence to influenza vaccination among Korean adults with cardiovascular disease.

BACKGROUND: Annual influenza vaccination is an important public health measure to prevent influenza infections and is strongly recommended for cardiovascular disease (CVD) patients, especially in the current coronavirus disease 2019 (COVID-19) pandemic. The aim of this study is to develop a machine learning model to identify Korean adult CVD patients with low adherence to influenza vaccination METHODS: Adults with CVD (n = 815) from a nationally representative dataset of the Fifth Korea National Health and Nutrition Examination Survey (KNHANES V) were analyzed. Among these adults, 500 (61.4%) had answered "yes" to whether they had received seasonal influenza vaccinations in the past 12 months. The classification process was performed using the logistic regression (LR), random forest (RF), support vector machine (SVM), and extreme gradient boosting (XGB) machine learning techniques. Because the Ministry of Health and Welfare in Korea offers free influenza immunization for the elderly, separate models were developed for the < 65 and ≥ 65 age groups. RESULTS: The accuracy of machine learning models using 16 variables as predictors of low influenza vaccination adherence was compared; for the ≥ 65 age group, XGB (84.7%) and RF (84.7%) have the best accuracies, followed by LR (82.7%) and SVM (77.6%). For the < 65 age group, SVM has the best accuracy (68.4%), followed by RF (64.9%), LR (63.2%), and XGB (61.4%). CONCLUSIONS: The machine leaning models show comparable performance in classifying adult CVD patients with low adherence to influenza vaccination.

A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities.

BACKGROUND: The efficacy of epidermal growth factor (EGF) receptor (EGFR) inhibitors in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC), or colorectal cancer (CRC) has been demonstrated. However, dermatological reactions to these inhibitors can cause significant physical and psychosocial discomfort. The objective of the present study was to evaluate the efficacy of EGF ointment for EGFR inhibitor-related skin adverse events (ERSEs). MATERIALS AND METHODS: This placebo-controlled, double-blind, multicenter, pilot phase III trial enrolled patients with NSCLC, PC, or CRC treated with EGFR inhibitors. Patients with grade ≥2 ERSEs were included. Patients were randomized to three treatment arms: arm 1, placebo; arm 2, 1 ppm of EGF ointment; and arm 3, 20 ppm of EGF ointment. Patients applied ointment to their skin lesions twice daily. RESULTS: Efficacy evaluation was available for 80 patients (9 for PC, 28 for NSCLC, and 43 for CRC). Responses were 44.4% in arm 1, 61.5% in arm 2, and 77.8% in arm 3. There was a linear correlation between EGF concentrations and responses (p = .012). Quality of life (QoL) was assessed for 74 patients. Maximum changes in composite scores by Skindex-16 after treatment were significantly different among arms (mean ± SD: -5.2 ± 8.6 for arm 1, -11.7 ± 14.2 for arm 2, and - 18.6 ± 17.7 for arm 3; p = .008). EGF arms showed significant improvement in emotions (p = .005) and functioning (p = .044) scores over the placebo arm. CONCLUSION: EGF ointment is effective for managing ERSEs. It can also improve patients' QoL compared with placebo. Clinical trial identification number. NCT02284139 IMPLICATIONS FOR PRACTICE: Patients with non-small cell lung cancer, pancreatic cancer, or colorectal cancer who are treated with epidermal growth factor (EGF) receptor (EGFR) inhibitors may experience dermatologic reactions to their treatment. This study investigated the benefit of an EGF ointment in the treatment of these adverse events and observed the ointment to be effective in managing EGFR inhibitor-related skin adverse events.

Prediction scoring system based on clinicohematologic parameters for cervical cancer patients undergoing chemoradiation.

OBJECTIVE: A scoring system based on clinicohematologic parameters in cervical cancer patients receiving chemoradiation has not been reported to date. The aim of this study was to determine the prognostic value of clinicohematologic parameters in patients with cervical cancer undergoing chemoradiation and to develop a prediction scoring system based on these results. METHODS: A total of 107 patients who received definitive chemoradiation for cervical cancer were enrolled in this study. The clinical data and hematologic parameters were retrospectively reviewed, and their prognostic value in predicting survival was analyzed. The neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and lymphocyte-to-monocyte ratio (LMR) and the changes in these hematologic parameters (ΔNLR, ΔPLR, and ΔLMR) between pre- and post-treatment were calculated to determine the specific value of these parameters for predicting patient survival. RESULTS: The median follow-up time was 39.9 (range 2.7-114.6) months. The 3-year overall survival rate and progression-free survival rate were 80.9% (95% CI 72.7 to 90.0) and 53.4% (95% CI 44.1 to 64.8), respectively. The median progression-free survival was 67.5 months and the median overall survival was not reached. According to multivariable analysis, a ΔNLR≥0 was significantly associated with decreased progression-free survival (HR=2.91, 95% CI 1.43 to 5.94) and overall survival (HR=3.13, 95% CI 1.18 to 8.27). In addition, age (age <58.5 years; progression-free survival: HR=2.55, 95% CI 1.38 to 4.70; overall survival: HR=4.49, 95% CI 1.78 to 11.33) and the International Federation of Gynecology and Obstetrics (FIGO) stage (Ⅲ-Ⅳ; progression-free survival: HR=2.49, 95% CI 1.40 to 4.43; overall survival: HR=3.02, 95% CI 1.32 to 6.90) were identified as predictors of poor survival. CONCLUSIONS: Both the age and FIGO stage, as clinical parameters, and the ΔNLR, as a hematologic parameter, were independent prognostic factors for survival for cervical cancer patients treated with chemoradiation. Based on these results, we developed a risk score-based classification system for predicting survival.

Fibroblast growth factor receptor 3 (FGFR3) aberrations in muscle-invasive urothelial carcinoma.

BACKGROUND: Recent studies suggest that FGFR3 is a potential therapeutic target in urothelial carcinoma (UC). The purpose of this study was to evaluate the rates and types of FGFR3 aberrations in patients with muscle-invasive UC who received radical resection. METHODS: We analyzed surgical tumor samples from 74 UC patients who had received radical cystectomy (n = 40) or ureteronephrectomy (n = 34). Ion AmpliSeq Cancer Hotspot Panel v2 and nCounter Copy Number Variation Assay were used to detect FGFR3 aberrations. RESULTS: Fifty-four patients (73%) had high-grade tumors, and 62% had lymph node involvement. Sixteen patients (22%) harbored FGFR3 alterations, the most common of which was FGFR3 mutations (n = 13): Y373C (n = 3), N532D (n = 3), R248C (n = 2), S249C (n = 1), G370C (n = 1), S657S (n = 1), A797P (n = 1), and 746_747insG (n = 1). Three additional patients had a FGFR3-TACC3 rearrangement. The frequency of FGFR3 aberrations was higher in bladder UC (25%) than in UC of the renal pelvis and ureter (18%) but the difference was not statistically significant (P = 0.444). Genes that were co-aberrant with FGFR3 included APC (88%), PDGFRA (81%), RET (69%), and TP53 (69%). CONCLUSIONS: We report the frequency and types of FGFR3 aberrations in Korean patients with UC. Patients with FGFR3 mutations or FGFR3-TACC3 fusion may constitute potential candidates for a novel FGFR-targeted therapy in the perioperative setting.

Prevalence of and Factors Associated with Sarcopenia in Korean Cancer Survivors: Based on Data Obtained by the Korea National Health and Nutrition Examination Survey (KNHANES) 2008-2011.

Using a representative dataset from the Korea National Health and Nutrition Examination Survey (KNHANES) from 2008 to 2011, we analyzed anthropometric and dual-energy X-ray absorptiometry (DXA)-determined body composition findings for 493 cancer survivors (mean age a61.1 ± 12.6 years; 35.7% male). A much higher proportion of men (30.1%) than women (0.6%) met the criteria of sarcopenia. Subjects with a history of lung cancer, genitourinary cancer, or gastric cancer were prone to develop sarcopenia (31.6%, 26.3%, and 21.4%, respectively). Furthermore, sarcopenia was more prevalent among elderly (≥65 years; P < 0.001), those with a lower BMI level (<23 kg/m2; P < 0.001), heavy drinker (P = 0.012), or smoker (P < 0.001), and those with inadequate intakes of protein (P = 0.017) and vitamin A (P = 0.024). Multivariable logistic analyses revealed sarcopenia was significantly associated with male gender (odds ratio [OR], 68.14; 95% CI, 15.52-299.13), a BMI of <23 kg/m2 (OR 35.93, 95% CI, 8.24-156.67), and inadequate protein intake (OR 3.07, 95% CI, 1.30-7.22); these factors are significant predictors of sarcopenia in Korean cancer survivors.

The Predictive Value of Tumor Size, Volume, and Markers During Radiation Therapy in Patients With Cervical Cancer.

OBJECTIVES: We investigated the prognostic significance of changes in primary tumor volume and serum squamous cell carcinoma antigen (SCC-ag) levels during radiation therapy (RT) in patients with cervical cancer. METHODS: We conducted a review of 40 patients treated with RT. All patients received external beam RT and intracavitary brachytherapy. The primary tumor volume and squamous cell carcinoma antigen levels were measured pre-RT and mid-RT. Overall survival (OS) and progression free survival (PFS) were estimated, and possible prognostic factors for survival were analyzed. RESULTS: The correlation coefficient between primary tumor volume reduction rate (pTVRR) and serum squamous cell carcinoma antigen reduction rate in all patients was 0.550 (P < 0.001). In univariate analysis, stage more than II (P <0.001), pre-RT pTV of 55 cm or more (P = 0.05), mid-RT tumor size of 4 cm or more (P = 0.004), and pTVRR of 90% or less (P = 0.031) were significant unfavorable prognostic factors for PFS, whereas stage (P = 0.009) was the only significant prognostic factor for OS. Multivariable analysis revealed that none of these factors were independently associated with PFS or OS. CONCLUSIONS: There was a significant correlation between pTVRR and squamous cell carcinoma antigen reduction rate. Our findings indicate that the tumor parameters such as pre-RT pTV, mid-RT tumor size, and pTVRR are associated with PFS in women with cervical cancer.

Evaluation of sarcopenia in small-cell lung cancer patients by routine chest CT.

BACKGROUND: Single cross-sectional area of muscle at the third lumbar vertebra (L3MA) is gold standard to estimate skeletal muscle mass (SMM), and L3 muscle index (L3MI, L3MA/height(2)) is used to determine sarcopenia. The purposes of this study were to evaluate the relationship between SMM indices determined by routine chest CT and L3MI in patients with small-cell lung cancer (SCLC) and to suggest chest CT-derived diagnostic criteria for sarcopenia. METHODS: Area of pectoralis muscles at the aortic arch (PMA) and at L1 (L1MA) was retrospectively measured on chest CT images of 90 consecutive SCLC patients. Pearson's correlation and multiple linear regression analysis were used to assess relationships between L3MI determined by PET/CT and pectoralis muscle index (PMI) and L1 muscle index (L1MI) determined by chest CT. RESULTS: The correlation between L1MI and L3MI was stronger than that between PMI and L3MI (r = 0.851 vs. r = 0.447, p < 0.001). Multivariable regression analysis showed that L1MI was the only significant predictor of L3MI; L3MI = 0.963 × L1MI + 10.336 (R (2)  = 0.689, p < 0.001) for male and L3MI = 0.772 × L1MI + 16.518 (R (2)  = 0.777, p < 0.001) for female. Using this relationship, estimated cutoffs of L1MI for sarcopenia were 46 cm(2)/m(2) for male and 29 cm(2)/m(2) for female (L3MI cutoffs for sarcopenia are 55 cm(2)/m(2) for male and 39 cm(2)/m(2) for female). The sensitivity and specificity of L1MI cutoffs to determine sarcopenia were 98.2 and 100 %, respectively. CONCLUSIONS: Chest CT-determined L1MI is highly correlated with L3MI in SCLC patients. L1MI, as determined by chest CT, could be used to determine the presence of sarcopenia with suggested cutoffs of 46 cm(2)/m(2) for men and 29 cm(2)/m(2) for women.

Opioid rotation versus combination for cancer patients with chronic uncontrolled pain: a randomized study.

BACKGROUND: For cancer patients with inadequate pain relief, a switch to an alternative opioid is the preferred option for symptomatic improvement. However, multiple opioids are often simultaneously administered for anecdotal reasons. This prospective study evaluated pain response to either opioid rotation or combination in patients with uncontrolled cancer pain. METHODS: Patients suffering with uncontrolled cancer pain despite dose titration were randomly assigned to opioid rotation group or opioid combination group. Patients answered a questionnaire that included items on pain severity (0 to 10) and interferences at baseline and after one week. RESULTS: Of the 50 patients registered, 39 patients answered the questionnaire after one week of treatment. After one week, the mean pain scores were significantly improved in both groups. Ten patients (42%) in the rotation group and 16 patients (62%) in the combination group reported that they achieved relief from pain (p = 0.08). The incidence of adverse events was similar in both groups, but fewer patients experienced constipation with opioid rotation than with combination (17% vs. 42%, respectively; p = 0.05). The frequency of rescue analgesics (50% vs. 69%; p = 0.17) and dose modification (29% vs. 38%; p = 0.49) were similar in the rotation and combination groups. CONCLUSIONS: For patients with chronic uncontrolled cancer pain, both opioid rotation and combination strategies appear to provide significant relief of pain and improved patient satisfaction. TRIAL REGISTRATION: This study was registered in advance to ClinicalTrials.gov (no. NCT00478101).

A rare presentation of catamenial hemoptysis as a solitary pulmonary nodule.

Thoracic endometriosis is a rare disorder characterized by the presence of functioning endometrial tissue within the pleura, lung parenchyma, or the airways. We report a case of catamenial hemoptysis with a rare presentation, that is, as a solitary pulmonary nodule with an internal cavity and surrounding ground glass opacity.

Epidermal growth factor receptor (EGFR) exon 20 mutations in non-small-cell lung cancer and resistance to EGFR-tyrosine kinase inhibitors.

INTRODUCTION: In patients with non-small cell lung cancer (NSCLC), the predictive value of rare epidermal growth factor receptor (EGFR) exon 20 mutations in determining a patient's response to EGFR tyrosine kinase inhibitor (TKI) treatment is unclear. PATIENTS AND METHODS: We reviewed data for NSCLC patients harboring EGFR exon 20 mutations from two hospitals in Korea. EGFR mutations were analyzed using directional sequencing. RESULTS: We identified eight patients carrying EGFR exon 20 mutations, seven of whom had insertional mutations. Three patients carried previously unreported insertional mutations. Among six patients who were treated with EGFR TKI, one showed stable disease and three showed primary resistance. Response evaluations were not performed for the other two patients because of their clinical deterioration. CONCLUSIONS: EGFR exon 20 insertional mutations, including three that were previously unreported, were associated with the poor response of patients to TKI treatment.

Clinical significance of Ki-67 and p53 expression in curatively resected non-small cell lung cancer.

The aim of this study is to explore the association of Ki-67 and p53 expression with prognosis in non-small cell lung cancer (NSCLC) patients who underwent curative resection. We retrospectively identified 116 consecutive patients with stages I-III NSCLC who underwent curative resection at a single center from January 2007 to December 2012. Ki-67 and p53 expression was assessed by immunohistochemistry. Data on clinicopathologic features and survival were collected retrospectively. Ki-67 expression in 109 samples and p53 expression in 115 patients were analyzed. According to the results, 108 patients (99 %) showed at least some expression of Ki-67. The median Ki-67 expression level was 30 %. Positive p53 expression was observed in 91 (79 %) patients. Higher Ki-67 expression (>40 %) was significantly more frequent in male (26 vs. 4 % in female, p=0.002), ever-smoker (31 vs. 10 % in never-smoker, p=0.024), and non-adenocarcinoma (30 vs. 11 % of adenocarcinoma, p=0.012) patients. In univariable analysis, median disease-free survival (DFS) was shorter with higher Ki-67 expression (16.1 vs. 61.9 months in those with lower Ki-67 expression, p=0.005), and p53 expression did not show an association with DFS. Among 42 patients with stage I NSCLC who did not receive adjuvant chemotherapy, DFS was significantly worse in patients with higher Ki-67 expression (2-year DFS rate 57 vs. 88 %, p=0.018). In a Cox regression model, higher Ki-67 expression (>40 %) was a significant independent prognostic factor associated with poorer DFS (HR 2.9, 95 % CI 1.3-6.2) along with TNM stage and age. Higher Ki-67 expression (>40 %) showed an independent association with shorter DFS in NSCLC patients who underwent curative resection.

Matched-pair analysis comparing the outcomes of T cell/histiocyte-rich large B cell lymphoma and diffuse large B cell lymphoma in patients treated with rituximab-CHOP.

BACKGROUND: T cell/histiocyte-rich large B cell lymphoma (THRLBCL) is a rare morphological variant of diffuse large B cell lymphoma (DLBCL), accounting for 1-3% of all DLBCLs. However, its impact on treatment outcome and prognosis is still not clearly defined. METHODS: We compared the clinical outcomes between THRLBCL and DLBCL, not otherwise specified (NOS), in patients treated with rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). RESULTS: Data from 11 patients with THRLBCL were matched to 33 patients with DLBCL-NOS. Patients were matched by five established prognostic factors of the International Prognostic Index, including age, Ann Arbor stage, Eastern Cooperative Oncology Group performance status, serum lactate dehydrogenase level and the number of extranodal involvement. There was no significant difference in the complete response rate to R-CHOP between THRLBCL (91%, 10/11) and DLBCL-NOS (97%, 32/33; p = 0.442). The 3-year event-free survival rate was 81% for both THRLBCL and DLBCL-NOS (p = 0.813). The 3-year overall survival rates were 75 and 81%, respectively (p = 0.719). CONCLUSIONS: The treatment outcomes of THRLBCL are similar to those of DLBCL-NOS. The addition of rituximab to CHOP seems to be helpful for the management of THRLBCL, as it is for DLBCL-NOS.

Positive correlation between baseline PET or PET/CT findings and clinical parameters in multiple myeloma patients.

Recently, positron emission tomography (PET) has been incorporated into a series of prospective studies as a predictor of outcomes in multiple myeloma (MM), and the number of (18)F-fluorodeoxuglucose (FDG)-avid focal lesions (FLs) and the intensity of tumor metabolism have been designated as important surrogate markers for predicting prognosis. Here, we compared initial clinical characteristics of MM patients with baseline PET parameters: the number of FLs and the maximum standardized uptake value (SUVmax). A total of 59 patients diagnosed with MM between August 2004 and February 2012 were reviewed. At diagnosis, 23 patients (40.0%) had ≤3 FLs, 11 patients (18.6%) 4-9 FLs, and 25 patients (42.4%) ≥10 FLs. The median SUVmax was 5.3 (range 0-24.3), and 40 patients (67.8%) showed a SUVmax >4. No clinical characteristics were significantly different between groups with a SUVmax ≤4 and a SUVmax >4. However, there were significant differences in several clinical indices between the FLs ≤3 and FLs >3 groups; elevated ß2-microglobulin, elevated lactate dehydrogenase, anemia and more advanced disease by the Durie-Salmon stage corresponded to FLs >3 at baseline PET. Adverse baseline PET findings are positively correlated with prognostically relevant clinical parameters. Regarding PET parameters, FLs are more likely to be well correlated with disease aggressiveness and pathophysiology compared to SUVmax.

Thoraco-abdominal CT examinations for evaluating cause of cardiac arrest and complications of chest compression in resuscitated patients.

The objective of the study is to describe the causes of cardiac arrest and complications of cardiopulmonary resuscitation (CPR) on thoraco-abdominal CT examinations for resuscitated patients in our institution. We evaluated the causes of cardiac arrest on thoraco-abdominal CT scans, which was compared with the final diagnosis (determined by consensus of two emergency physicians based on the clinical, imaging, and laboratory findings). Additionally, we evaluated the complications of CPR on thoraco-abdominal CT scans. From March 2005 to August 2011, 82 patients underwent CT of the thorax (n=77) and abdomen (n=23) within 24 h after CPR. Final diagnosis was as follows: cardiac (n=29), respiratory (n=28), metabolic (n=11), exsanguination (n=5), cerebral (n=2), sepsis (n=1), and indeterminate (n=6). In 25 patients (30 %), thoraco-abdominal CT scans made the role either as a definitive study (n=22) or as a supportive test (n=3) for the diagnosis. In particular, CT was critical in diagnosis of many respiratory causes (64 %) and all exsanguinations. The most common complications following CPR were skeletal chest injuries (n=48), followed by lung contusion (n=45). Thoraco-abdominal CT examinations are helpful for the diagnosis of cause of cardiac arrest and complications of CPR.

The value of chest CT for prediction of breast tumor size: comparison with pathology measurement.

BACKGROUND: Little information is available on the use of chest computed tomography (CT) to predict breast tumor size in breast cancer, despite the fact that chest CT examinations are being increasingly used. The purpose of this study was to evaluate the value of chest CT for predicting breast tumor size using pathology measurements as reference standards. METHODS: Tumor sizes (defined as greatest diameter) were retrospectively measured on the preoperative chest CT images of 285 patients with surgically proven unifocal, invasive breast carcinoma. Greatest tumor diameters as determined by chest CT and pathologic examinations were compared by linear regression and Spearman's rho correlation analysis. Concordance between CT and pathology results was defined as a diameter difference of <5 mm. Subgroup analyses were also performed with respect to tumor size (<20 mm or ≥20 mm) and histological subtype (invasive ductal carcinoma(IDC) or non-IDC). RESULTS: CT and pathology measured diameters were found to be linearly related (size at pathology = 1.086 × CT determined tumor size - 1.141; Spearman's rho correlation coefficient = 0.84, P<0.001). Most tumors (n = 228, 80.0%) were concordant by chest CT and pathology, but 36 tumors (12.7%) were underestimated by CT (average underestimation, 11 mm; range, 6-36 mm) and 21 tumors (7.4%) were overestimated (average overestimation by CT, 10 mm; range, 6-19 mm). The concordance rate between the two sets of measurements was greater for tumor of <20 mm and for IDC (P<0.001 and P = 0.011, respectively). CONCLUSIONS: Tumor size by chest CT is well correlated with pathology determined tumor size in breast cancer patients, and the diameters of the majority of tumors by chest CT and pathology differed by <5 mm. In addition, the concordance rate was higher for breast tumors of <20 mm and for tumors of the IDC histologic subtype.

Unique perception of clinical trials by Korean cancer patients.

BACKGROUND: In the past few years, the number of clinical trials has increased rapidly in East Asia, especially for gastric and hepatobiliary cancer that are prevalent in Asian populations. However, the actual degree of understanding or perceptions of clinical trials by cancer patients in East Asian countries have seldom been studied. METHODS: Between July 1st and November 30th of 2011, we conducted a prospective study to survey cancer patients regarding their awareness of, and willingness to participate in, a clinical trial. Patients with gastrointestinal/hepatobiliary cancer who visited the Hematology-Oncology outpatient clinic at Samsung Medical Center (SMC) were enrolled. A total of 21 questions were asked including four questions which used the Visual analogue scale (VAS) score. RESULTS: In this survey study, 1,000 patients were asked to participate and 675 patients consented to participate (67.5%). The awareness of clinical trials was substantially higher in patients who had a higher level of education (p<0.001), were married (p=0.004), and had a higher economic status (p=0.001). However, the willingness to participate in a clinical trial was not affected by the level of education or economic status of patients. The most influential factors for patient willingness to participate were a physician recommendation (n=181, 26.8%), limited treatment options (n=178, 26.4%), and expectations of effectiveness of new anti-cancer drugs (n=142, 21.0%). Patients with previous experience in clinical trials had a greater willingness to participate in clinical trials compared to patients without previous experience (p<0.001). CONCLUSIONS: This large patient cohort survey study showed that Korean cancer patients are more aware of clinical trials, but awareness did not translate into willingness to participate.

Efficacy and Safety of Trastuzumab Biosimilar (CT-P6) Compared With Reference Trastuzumab in Patients With HER2-positive Advanced Gastric Cancer: A Retrospective Analysis.

OBJECTIVES: Treatment with trastuzumab and chemotherapy significantly improves the outcome in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). CT-P6 (trastuzumab-pkrb; Herzuma) is a trastuzumab biosimilar approved for the treatment of HER2-positive gastric cancer. In this study, we aimed to compare the efficacy and safety of CT-P6 and reference trastuzumab as first-line treatment for HER2-positive AGC. MATERIALS AND METHODS: The medical records of 102 patients with HER2-positive AGC treated with first-line trastuzumab-based chemotherapy were retrospectively reviewed. These patients were treated with either reference trastuzumab (n=72) or a biosimilar (n=30). Treatment outcomes, such as objective response rate, progression-free survival (PFS), and overall survival (OS), were compared between the reference and biosimilar groups. RESULTS: The objective response rate of both groups (52.8% and 56.8% in the reference and biosimilar groups, respectively) were comparable (P=0.72). No statistically significant difference was observed with the reference versus biosimilar trastuzumab for PFS (median PFS, 6.9 vs. 5.4 mo; P=0.98) or OS (median OS, 12.3 mo vs. not reached; P=0.42). Safety profiles were similar between the 2 groups. CONCLUSIONS: Biosimilar trastuzumab showed equivalent outcome to reference trastuzumab, with similar adverse events. Biosimilar trastuzumab can suitably and safely replace trastuzumab as a reference for the treatment of HER2-positive AGC.

Enfortumab vedotin-related pneumonitis is more common than expected and could lead to acute respiratory failure.

PURPOSE: To analyse the incidence of pneumonitis related to enfortumab vedotin (EV) in patients with metastatic urothelial cell carcinoma (mUC). METHODS: Patients with mUC who participated in two EV clinical trials in South Korea were analysed for the incidence and clinical course of EV-related pneumonitis through retrospective, independent review. The clinical characteristics and radiologic attributes of potential pneumonitis were identified and reviewed by the participating investigators and pulmonologists. RESULTS: Between October 2018 and January 2020, 64 patients were enrolled in the EV-201 and EV-301 trials across eight institutions in South Korea and were treated with EV. Among them, 18 (28.1%) developed all-grade EV-related pneumonitis, from which 2 (11.1%) patients died. The median time between the last dosing of immunotherapy and the start of EV was 5.6 weeks (range, 0.71-143.1). The median time from the start of EV treatment to the onset of pneumonitis was 13 weeks (range, 2.7-51.0). Of the patients who developed pneumonitis, 7 (38.9%) were clinically asymptomatic. The most common radiologic finding was organising pneumonia (66.7%). CONCLUSIONS: Although we could not rule out the relationship with prior immunotherapy administration, EV-related pneumonitis occurred in approximately 25% of the patients who had received EV in two prospective clinical trials, from which two died. Clinicians should closely monitor patients who have experienced immunotherapy treatment failure for the development of pneumonitis. A delay between initiating EV after termination of immunotherapy should be considered with caution.

Comparison of the Data of a Next-Generation Sequencing Panel from K-MASTER Project with That of Orthogonal Methods for Detecting Targetable Genetic Alterations.

PURPOSE: K-MASTER project is a Korean national precision medicine platform that screened actionable mutations by analyzing next-generation sequencing (NGS) of solid tumor patients. We compared gene analyses between NGS panel from the K-MASTER project and orthogonal methods. MATERIALS AND METHODS: Colorectal, breast, non-small cell lung, and gastric cancer patients were included. We compared NGS results from K-MASTER projects with those of non-NGS orthogonal methods (KRAS, NRAS, and BRAF mutations in colorectal cancer [CRC]; epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK] fusion, and reactive oxygen species 1 [ROS1] fusion in non-small cell lung cancer [NSCLC], and Erb-B2 receptor tyrosine kinase 2 (ERBB2) positivity in breast and gastric cancers). RESULTS: In the CRC cohort (n=225), the sensitivity and specificity of NGS were 87.4% and 79.3% (KRAS); 88.9% and 98.9% (NRAS); and 77.8% and 100.0% (BRAF), respectively. In the NSCLC cohort (n=109), the sensitivity and specificity of NGS for EGFR were 86.2% and 97.5%, respectively. The concordance rate for ALK fusion was 100%, but ROS1 fusion was positive in only one of three cases that were positive in orthogonal tests. In the breast cancer cohort (n=260), ERBB2 amplification was detected in 45 by NGS. Compared with orthogonal methods that integrated immunohistochemistry and in situ hybridization, sensitivity and specificity were 53.7% and 99.4%, respectively. In the gastric cancer cohort (n=64), ERBB2 amplification was detected in six by NGS. Compared with orthogonal methods, sensitivity and specificity were 62.5% and 98.2%, respectively. CONCLUSION: The results of the K-MASTER NGS panel and orthogonal methods showed a different degree of agreement for each genetic alteration, but generally showed a high agreement rate.