ABSTRACT
Purpose@#We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials. @*Materials and Methods@#Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations. @*Results@#Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations. @*Conclusion@#This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.
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Purpose@#We evaluated the efficacy and safety of pembrolizumab in patients with recurrent gynecologic cancers in real-world practice. @*Materials and Methods@#We conducted a retrospective, single-institution study of patients with recurrent gynecologic malignancies treated with pembrolizumab. The primary endpoints were the objective response rate (ORR) and safety. @*Results@#Thirty-one patients treated with pembrolizumab were included. The primary disease sites were the uterine cervix (n=18), ovaries (n=8), and uterine corpus (n=5). Fifteen of the 31 patients (48%) had an Eastern Cooperative Oncology Group performance status of ≥2. The median number of prior chemotherapy lines was 2 (range, 1–6), and 14 of 31 patients (45%) had received ≥ 3 prior lines of chemotherapy. The overall ORR was 22.6%: specifically, 22.3% (4 of 18 patients), 12.5% (1 of 8 patients), and 40% (2 of 5 patients) for cervical, ovarian, and endometrial cancers, respectively. During a median follow-up of 4.7 months (range, 0.2–35.3), the median time to response was 1.9 months (range, 1.4–5.7). The median duration of response was not reached (range, 8.8-not reached).The median progression-free survival was 2.5 months (95% confidence interval, 1.7-not reached). Adverse events occurred in 20 patients (64.5%), and only 3 (9.7%) were grade ≥3. There was one case of suspicious treatment-related mortality, apart from which most adverse events were manageable. @*Conclusion@#In real-world practice, pembrolizumab was feasible and effective in heavily treated recurrent gynecologic cancer patients with poor performance status who may not be eligible for enrollment in clinical trials.
ABSTRACT
When conventional treatments of malignant pleural effusion, such as repeated thoracentesis, closed thoracotomy and pleurodesis by instilled sclerosing agents, are ineffective, there are few alternative therapies available. Our case involves a 47-year-old woman with uterine cervical carcinoma suffering from malignant pleural effusion. She presented with a chief complaint of severe dyspnea, and was classified as an Eastern Cooperative Oncology Group (ECOG) performance status of 4. Her underlying cervical carcinoma progressed despite various systemic chemotherapy regimens. In addition, pleural effusion persisted in spite of 4 weeks of drainage through the thoracotomy tube and talc pleurodesis. Under such circumstances, we attempted intrapleural chemotherapy with cisplatin plus cytarabine, which resulted in significant decrease of the pleural effusion. No serious systemic toxicities, including myelosuppression, were observed. As a result, the patient's dyspnea was relieved, and her ECOG performance status improved from 4 to 2. However, the thoracotomy tube was not removed due to subsequent iatrogenic pneumothorax. Pleural effusion did not recur for the 4 weeks leading up to her death.
Subject(s)
Female , Humans , Middle Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Cisplatin/administration & dosage , Cytarabine/administration & dosage , Fatal Outcome , Pleural Effusion, Malignant/drug therapy , Treatment OutcomeABSTRACT
BACKGROUND: The primary mediastinal lymphoma (PML) is defined as the non-Hodgkin's lymphoma that presents primarily within the mediastinum, and primary mediastinal diffuse large B cell lymphoma (PMLBL) is defined as primary mediastinal lymphoma of which histology shows diffuse large B cell lymphoma. There is no available clinical study yet about the clinical characteristics and treatment outcome of PMLBL in Korea. Here the authors report our experience of 21 cases of PML including 11 cases of PMLBL. METHODS: The authors reviewed retrospectively medical records of 21 cases with PML from January 1992 to January 2003, and analyzed clinical characteristics, response to induction therapy, and survival. The authors subsequently performed subset analysis in 11 cases with PMLBL. Median follow-up period was 16 months (range, 4~80 months). RESULTS: Male to female ratio was 8:13 and the median age of 21 PML cases was 33.5 years. Of 21 PML cases, histology of most cases was diffuse large B cell lymphoma (11/21) and lymphoblastic lymphoma (8/21). Cell lineage was B cell in 13 cases (61.9%). Thirteen cases (62.0%) were in stage I and II. Initial induction therapy was chemotherapy alone in 19 cases, combined chemoradiotherapy in 1 case and no treatment in remaining 1 case. Response rate to initial therapy was 70% in 20 PML cases (complete response [CR] 50%, partial response 20%) with CR of 50% in 10 PMLBL. Median progression-free survival and overall survival for 11 PMLBL cases were 11 months and 16 months, respectively. CONCLUSION: Incidence of PML showed slight predominance in female and in relatively young age with median age of less than 40 years. Most patients presented with a chief complaint of superior vena cava syndrome including dyspnea. The most common histology of PML was diffuse large B cell lymphoma. PMLBL represented low complete response rate to conventional chemotherapy, low progression-free and overall survival rates compared with peripheral diffuse large B cell lymphoma by historical review.
Subject(s)
Female , Humans , Male , Cell Lineage , Chemoradiotherapy , Disease-Free Survival , Drug Therapy , Dyspnea , Follow-Up Studies , Incidence , Korea , Lymphoma , Lymphoma, B-Cell , Lymphoma, Non-Hodgkin , Mediastinum , Medical Records , Precursor Cell Lymphoblastic Leukemia-Lymphoma , Retrospective Studies , Superior Vena Cava Syndrome , Survival Rate , Treatment OutcomeABSTRACT
Acute mesenteric ischemia leading to massive bowel infarction following cardiac surgery particularly coronary artery bypass graft (CABG), is reported to be a very rare but serious life-threatening complication. In this case, a 55-year-old female underwent CABG and complained of abdominal pain on the first postoperative day, which was thought to be nonspecifically related to the operation wound. In the further hospital course, the patient was found to have extensive acute mesenteric infarction due to thromboembolism of superior mesenteric artery. This is a valuable educational case, since only high index of suspicion does not delay making a diagnosis especially in the patients with risk factors of acute mesenteric ischemia after cardiac surgery requiring cardiopulmonary bypass. On suspicion of acute mesenteric ischemia, an aggressive diagnostic and therapeutic approach should be performed immediately.
Subject(s)
Female , Humans , Middle Aged , Abdominal Pain , Cardiopulmonary Bypass , Coronary Artery Bypass , Coronary Vessels , Diagnosis , Infarction , Ischemia , Mesenteric Artery, Superior , Mesentery , Risk Factors , Thoracic Surgery , Thromboembolism , Transplants , Wounds and InjuriesABSTRACT
Infective endocarditis is still one of the important fatal diseases especially when it is accompanied with systemic embolic manifestations. So, this is often misdiagnosised because of a variability of systemic embolic manifestations. We experienced a case of infective endocarditis with pulmonic embolic manifestations whose illness was initially diagnosed as recurrent pneumonia. She was a 20-yrs-old girl with ventricular septal defect and treated as community acquired pneumonia. But transesophageal echocardiography revealed a vegetation on right ventricular free wall. So, she was diagnosed as having infective endocarditis and treated effectively with appropriate antibiotic therapy and discharged with improvement of symptoms. This a first case of infective endocarditis with ventricular septal defect who have a vegetation on right ventricular free wall in korea. Therefore, we report this case with brief review of related literatures.
Subject(s)
Female , Humans , Diagnostic Errors , Echocardiography, Transesophageal , Endocarditis , Heart Septal Defects, Ventricular , Korea , Pneumonia , Pulmonary EmbolismABSTRACT
BACKGROUND: Non-diabetic renal diseases are accompanied in 9-66% of type 2 diabetic patients and some clinical and laboratory findings are known as predictors of these non-diabetic renal disease. In Korea, however, there have been few studies on the clinical and pathologic findings of non-diabetic renal disease in diabetic patients. The purpose of this study was to explore the clinical, laboratory, and pathologic features of non-diabetic renal disease and to clarify the factors that could predict non-diabetic renal disease in type 2 diabetic patients. METHODS: The medical records of type 2 diabetic patients who were over 20 years old and underwent renal biopsy between January, 1994 and December, 2003, were retrospectively reviewed. RESULTS: A total of 56 patients were enrolled. Persistent hematuria (25.0%) was the leading reason for renal biopsy in type 2 diabetic patients, followed by sudden onset of nephrotic-range proteinuria (23.2 %), short duration (<10 years) of DM (23.2%), rapid deterioration of renal function (17.9%), and absence of diabetic retinopathy (8.9%). Renal biopsy revealed diabetic nephropathy (DN) in 20 patients (35.7%), non-diabetic renal disease (NDRD) in 33 patients (58.9%), and NDRD with concomitant DN in 3 patients (5.4%). The most common NDRD was membranous nephropathy, accompanied in 9 patients (16.1 %), followed by minimal change disease (10.7%), focal segmental glomerulosclerosis (8.9%). When the patients were divided into DN (20 patients) and NDRD (36 patients) groups, NDRD group had significantly shorter duration of DM, more patients with hematuria, and less patients with DM retinopathy. In contrast, there were no differences in age, sex, blood pressure, blood urea nitrogen, serum creatinine, albumin, and total cholesterol levels, 24 hr urinary protein and albumin excretion, creatinine clearance, and proportion of patients with DM neuropathy between the two groups. CONCLUSION: There were significant differences in the duration of DM, the presence of hematuria, and the presence of retinopathy between DN and NDRD groups. Therefore, we must consider NDRD in type II DM patients with short duration of DM, hematuria or without retinopathy.
Subject(s)
Humans , Young Adult , Biopsy , Blood Pressure , Blood Urea Nitrogen , Cholesterol , Creatinine , Diabetic Nephropathies , Diabetic Retinopathy , Glomerulonephritis, Membranous , Glomerulosclerosis, Focal Segmental , Hematuria , Korea , Medical Records , Nephrosis, Lipoid , Proteinuria , Retrospective StudiesABSTRACT
This report attempts to explain the (i) implications of comorbidity for research and practice in the fieldo of oncology, (ii) the approach for dosing of anti-cancer drugs in the presence of comorbidity, as an example of its clinical application, and finally (iii) the dosing guidelines for the anticancer drugs clinically active in gastric cancer in the presence of renal or liver dysfunction. This has resulted from the idea of approaching comorbidity in a systematic way and of integrating it with oncologic decisions. Various methods have been used to assess comorbidity. However, significant work remains to be done to analyze how various diseases combine to influence the oncologic outcome. The main end-point explored so far has been mortality, but a largely open challenge remains to correlate comorbidity with treatment tolerance and functional and quality of life, as well as to integrate it in clinical decision-making. Cancer chemotherapy in comorbidity should be considered as an example of the need for dose optimization in individual patients, and it should be determined by considering the basic principles of the pharmacokinetics and the pharmacodynamics of the agents. This review analyzes the available data on the pharmacokinetics and the toxicities of anti-cancer agents in the comorbidity population.
Subject(s)
Humans , Comorbidity , Drug Therapy , Liver Diseases , Mortality , Pharmacokinetics , Quality of Life , Stomach NeoplasmsABSTRACT
PURPOSE: Among the many biological characteristics of cancer, matrix metalloproteinases(MMPs) are essential for tumor invasion and metastasis. The correction of the imbalance between MMPs and tissue inhibitors of matrix metalloproteinase (TIMP) has been suggested as a possible goal for the control of invasive phenotype of the cancer. To test the possible inhibition of MMP-9 in ex vivo model and the selection of the patients who are sensitive to MMP inhibitory (MMPI) treatment, we evaluated IC50 of the gabexate mesylate (Foy) against MMP-9 and compared them to the clinical parameters and patients survivals. MATERIALS AND METHODS: Thirty-four paired normal and gastric cancer tissues were tested for the IC50 of the gabexate mesylate. MMP-9 activity was measured by zymography. RESULTS: MMP-9 expression (percent of sample band density to control band) (p=0.04) and IC50 (p=0.02) of cancer tissues were significantly higher than those of normal tissues. Cancer tissue IC50 was higher than that of normal tissues in cases when the tumor mass diameter was longer than 5 cm (p=0.03) as well as in higher T-stage (p=0.04), lymph node metastasis (p=0.04) and in advanced stages (p=0.04). There was a tendency of increased IC50 of diffuse and mixed type than that of intestinal type (diffuse & mixed: 11.0+-20.8 mg/ml, intestinal: 2.7+-3.9 mg/ml; p 0.07), in spite of no difference in MMP-9 expression (diffuse & mixed: 40.3+49.2%, intestinal: 51.0+-58.0%). In early gastric cancer (EGC), there was no difference in IC50 between normal and cancer tissues whereas cancer tissue IC50 was higher than that of normal tissue in advanced gastric cancer (p 0.02). There was a tendency of increment of ICo in cancer tissues of advanced gastric cancer than that of EGC whereas no difference was found in MMP-9 expression between these types of cancers. Poor prognosis was found in high IC50 patients in curatively resected patients (p=0.04). In multivariate analysis, high IC50 was suggested as a possible independent prognostic factor. CONCLUSION: We could differentiate the high risk patients using IC50 of gabexate mesylate in ex vivo model. This model can be applied in detecting patients with poor prognosis and patients who can have a possible benefit with MMPI treatment.
Subject(s)
Humans , Gabexate , Inhibitory Concentration 50 , Lymph Nodes , Matrix Metalloproteinases , MMPI , Multivariate Analysis , Neoplasm Metastasis , Patient Selection , Phenotype , Population Characteristics , Prognosis , Stomach NeoplasmsABSTRACT
No abstract available.