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.

PURPOSE: This randomized phase III study was designed to compare the efficacy and safety of irinotecan plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC). MATERIALS AND METHODS: Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8+cisplatin 70 mg/m2 intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival. RESULTS: A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were no significant differences between IP and EP arms for the median overall survival (10.9 months vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 months vs. 5.8 months, p=0.115). However, there was a significant difference in response rate (62.4% vs. 48.2%, p=0.006). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 months vs. 10.1 months, p=0.036), < 65 years old (12.7 months vs. 11.3 months, p=0.024), and Eastern Cooperative Oncology Group performance status 0/1 (12.4 months vs. 10.9 months, p=0.040) patient groups. The severity of treatment-related adverse events such as grade 3/4 anemia, nausea and diarrhea was more frequent in patients treated with IP. CONCLUSION: The IP chemotherapy did not significantly improve the survival compared with EP chemotherapy in Korean patients with extensive-disease SCLC.
Anemia ; Arm ; Cisplatin* ; Diarrhea ; Disease Progression ; Disease-Free Survival ; Drug Therapy ; Etoposide* ; Humans ; Lung Neoplasms ; Male ; Nausea ; Small Cell Lung Carcinoma*

BACKGROUND/AIMS: This study was to evaluate the clinical significance of infusion-related reaction (IRR) of rituximab in diffuse large B-cell lymphoma (DLBCL) patients who received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone) as a first-line chemotherapy. METHODS: The medical records of 326 patients diagnosed with DLBCL were re trospectively analyzed. Both doctor's progress records and nursing records were reviewed. IRR was graded according to the National Cancer Institute Common Terminology Criteria. RESULTS: IRR was not associated with overall survival (OS) or progression-free survival (PFS) of DLBCL patients as compared to those who did not have IRR (OS: median 78.0 months vs. 69.0 months, p = 0.700; PFS: median 65.4 months vs. 64.0 months, p = 0.901). IRR grade did not affect OS or PFS. B symptoms was independently associated with IRR (hazard ratio [HR], 1.850; 95% confidence interval [CI], 1.041 to 3.290; p = 0.036). Further, bone marrow involvement was independently associated with re-IRR (HR, 4.904; 95% CI, 0.767 to 3.118; p = 0.029). CONCLUSIONS Our study shows that IRR of rituximab is not associated with OS or PFS of DLBCL patients who received R-CHOP. Furthermore, our study suggests a need for more careful observation for IRR in patients with B symptoms or bone marrow involvement.

PURPOSE: We investigated the effects of proteinuria and renal insufficiency on all-cause mortality in patients with colorectal cancer, with special emphasis on cancer staging and cancer-related deaths. MATERIALS AND METHODS: We retrospectively studied a cohort of patients with colorectal cancer. In protocol 1, patients were classified into four groups based on the operability of cancer and proteinuria: group 1, early-stage cancer patients (colorectal cancer stage < or =3) without proteinuria; group 2, early-stage cancer patients with proteinuria; group 3, advanced-stage cancer patients without proteinuria (colorectal cancer stage=4); and group 4, advanced-stage cancer patients with proteinuria. In protocol 2, patients were classified into four similar groups based on cancer staging and renal insufficiency (eGFR <60 mL/min/1.73 m2). Between January 1, 1998 and December 31, 2009, 3379 patients were enrolled in this cohort and followed until May 1, 2012 or until death. RESULTS: The number of patients with proteinuria was 495 (14.6%). The prevalence of proteinuria was higher in advanced-stage cancer (n=151, 22.3%) than in early-stage cancer patients (n=344, 12.7%). After adjusting for age, gender and other clinical variables, the proteinuric, early-stage cancer group was shown to be associated with an adjusted hazard ratio of 1.67 and a 95% confidence interval of 1.38-2.01, compared with non-proteinuric early-stage cancer patients. However, renal insufficiency was not associated with colorectal cancer mortality. CONCLUSION: Proteinuria is an important risk factor for cancer mortality, especially in relatively early colorectal cancer.
Aged ; Colorectal Neoplasms/complications/*mortality/pathology ; Female ; Humans ; Male ; Middle Aged ; Neoplasm Staging ; Prevalence ; Proteinuria/*complications/epidemiology ; Renal Insufficiency/complications ; Retrospective Studies ; Risk Factors

PURPOSE: To evaluate the outcomes and prognostic factors of postoperative radiotherapy (PORT) for patients with pathological stage III non-small-cell lung cancer (NSCLC) at a single institution. MATERIALS AND METHODS: From 2000 to 2007, 88 patients diagnosed as having pathologic stage III NSCLC after curative resection were treated with PORT. There were 80 patients with pathologic stage IIIA and eight patients with pathologic stage IIIB in the AJCC 6th staging system. The majority of patients (n=83) had pathologic N2 disease, and 56 patients had single station mediastinal LN metastasis. PORT was administered using conventional technique (n=76) or three-dimensional conformal technique (n=12). The median radiation dose was 54 Gy (range, 30.6 to 63 Gy). Thirty-six patients received chemotherapy. Radiation pneumonitis was graded by the Radiation Therapy Oncology Group system, and other treatment-related toxicities were assessed by CTCAE v 3.0. RESULTS: Median survival was 54 months (range, 26 to 77 months). The 5-year overall survival (OS) and disease free survival (DFS) rates were 45% and 38%, respectively. The number of metastatic lymph nodes was associated with overall survival (hazard ratio, 1.037; p-value=0.040). The 5-year locoregional recurrence free survival (LRFS) and distant metastasis free survival (DMFS) rates were 88% and 48%, respectively. Multiple stations of mediastinal lymph node metastasis was associated with decreased DFS and DMFS rates (p-value=0.0014 and 0.0044, respectively). Fifty-one relapses occurred at the following sites: 10 loco-regional, 41 distant metastasis. Grade 2 radiation pneumonitis was seen in three patients, and symptoms were well tolerated with anti-tussive medication. Grade 2 radiation esophagitis was seen in 11 patients. There were no grade 3 or more severe complications associated with PORT. CONCLUSION: Our retrospective data show that PORT for pathological stage III NSCLC is a safe and feasible treatment and could improve loco-regional control. The number of metastatic lymph nodes and stations of mediastinal lymph node metastasis were analyzed as prognostic factors. Furthermore, efforts are needed to reduce distant metastasis, which is a major failure pattern of advanced stage NSCLC.
Disease-Free Survival ; Esophagitis ; Humans ; Lung ; Lung Neoplasms ; Lymph Nodes ; Neoplasm Metastasis ; Radiation Pneumonitis ; Recurrence ; Retrospective Studies

PURPOSE: To investigate the role of radiotherapy for squamous cell carcinomas of the external auditory canal and middle ear. MATERIALS AND METHODS: A series of 35 patients who were treated at a single institution from 1981 through 2007 were retrospectively analyzed. Thirteen patients were treated by radiotherapy alone; four by surgery only and 18 by a combination of surgery and radiotherapy. The total radiation dose ranged from 39~70 Gy (median, 66 Gy) in 13~35 fractions for radiotherapy alone and 44~70 Gy (median, 61.2 Gy) in 22~37 fractions for the combined therapy. Clinical end-points were the cause of specific survival (CSS) and local relapse-free survival (LRFS). The median follow-up time was 2.8 years (range, 0.2~14.6 years). RESULTS: The 3-year CSS and LRFS rate was 80% and 63%, respectively. Based on a univariate analysis, performance status and residual disease after treatment had a significant impact on CSS; performance status and histologic grade for LRFS. Patients treated by radiotherapy alone had more residual disease following the course of treatment compared to patients treated with the combined therapy; 69% vs. 28%, respectively. CONCLUSION: Our results suggest that radiation alone was not an inferior treatment modality for CSS compared to the combined therapy for squamous cell carcinoma of the external auditory canal and middle ear. However, local failure after radiotherapy is the main issue that will require further improvement to gain optimal local control.
Carcinoma, Squamous Cell ; Ear Canal ; Ear, Middle ; Follow-Up Studies ; Humans ; Retrospective Studies

BACKGROUND: The reference values of laboratory should review regularly to maintain good quality of practice. This is the second report of studies on reference values of Korea Association of Health Promotion (KAHP). The first one was reported in 2002 in Journal of Laboratory Medicine and Quality Assurance in Korea. The aim of this study is to know the changes of reference values for the past five years. METHODS: The way to analyze the data this time was essentially the same as the previous one (Indirect Method). The data from January to December, 2007 were collected. They totalled 5,133,327 test results from approximately 140 thousands individuals who visited for health checkup. The data were statistically analyzed with Minitab version 15.1.20.0 for Gaussian distribution using Anderson-Darling test. The trimming process repeated for the outliers, the results lying outside of +/-3SD, and as much as four times in certain test items, though, none of the tests showed Gaussian distribution. Subsequently, the reference values of most tests were defined in the ranges from the point of lowest 2.5% to the point of highest 97.5% and others were those, below 95 percentiles according to CLSI C28-A3 guideline. RESULTS: The reference ranges of 56 test items were either set as before or adjusted with new values, and compared. CONCLUSIONS: Comparing to the previous reference values (2002), the tests for liver function showed the lower upper values and the tests for diabetes and lipids showed higher upper values. Others were changed minimally with no significance.
Deception ; Health Promotion ; Korea ; Liver ; Normal Distribution ; Reference Values

PURPOSE: The aim of this study was to evaluate the efficacy and safety of a herbal formula that mainly consists of Cornus officinalis for treating erectile dysfunction. MATERIALS AND METHODS: Eighty patients suffering with erectile dysfunction were enrolled in this randomized, double-blinded, placebo-controlled study. The average duration of erectile dysfunction of the herbal formula group(n=40) vs. the placebo group(n=40) were 19.33+/-18.13 months vs. 19.33+/-25.62 months, respectively. The safety variables we examined were the history, physical examination, vital signs, EKG, clinical laboratory tests and hormonal tests. Efficacy assessments included the International Index of Erectile Function(IIEF), the sexual encounter profile(SEP) diary and Global Assessment Questions(GAQ). RESULTS: No significant changes in the laboratory values, hormone tests and blood pressure were observed in both groups. In comparison with the placebo group(6.57+/-11.72), the herbal formula group experienced a significant improvement of the IIEF(11.13+/-11.83)(p<0.05). When the herbal formula and placebo groups were divided by age and the IIEF score (age: 50 years and IIEF: 42) and then compared, the low IIEF group(IIEFor=50) of the herbal formula group significantly improved their IIEF score(p<0.05). The herbal formula group significantly improved their GAQ score(p<0.05). The herbal formula was well tolerated. The common adverse events were headache(2.5%) and nausea(5%). CONCLUSIONS: In conclusion, the herbal formula that mainly consists Cornus officinalis was not only effective at improving erectile function, but it was also safe for the treatment of erectile dysfunction.
Blood Pressure ; Cornus* ; Electrocardiography ; Erectile Dysfunction* ; Humans ; Male ; Physical Examination ; Treatment Outcome ; Vital Signs

BACKGROUND: Since highly active antiretroviral therapy has lengthened the life span of individuals infected with human immunodeficiency virus (HIV), the importance of malignancy associated with HIV has been increased. The relative frequencies of malignancies in HIV infected patients may vary in different race and region. The aim of this study is to determine the prevalence and characteristics of malignancies in patients with HIV infection in South Korea. MATERIALS AND METHODS: To identify HIV patients with malignancy, we reviewed the electronic database of pathological reports for all HIV-infected patients seen from January 1986 to December 2005 at the Seoul National University Hospital. We retrospectively reviewed the medical records of them. RESULTS: Among 850 patients infected with HIV, 33 episodes of malignant diseases were diagnosed in 32 patients (3.76%). Thirty were males, and median age was 46 years (range 29-70). At the time of the diagnosis of malignancy, median CD4+ lymphocytes count was 100/uL (range 5-620) and in 27 (82%) patients, CD4+ lymphocytes count were less than 200/uL. For 13 patients (40%), malignancy was initial presentation of HIV infection. Excluding patients initially diagnosed as malignancy, median follow-up duration from the first visit to diagnosis of malignancy was 36 months (range 3-96). Non-Hodgkin's lymphoma was the most frequent malignancy (13 patients), followed by Kaposi's sarcoma (7), Hodgkin's disease (3), acute myeloid leukemia (1), and other solid cancer (9) including one case of anal cancer associated with human papillomavirus. Among 13 patients with non-Hodgkin's lymphoma, 4(31%) achieved the complete remission after chemotherapy and/or radiation therapy, and had been followed without evidence of recurrence. CONCLUSION: Malignancy was diagnosed in 3.76% of patients infected with HIV. Non-Hodgkin's lymphoma is the most prevalent malignancy in HIV patients in South Korea.
Antiretroviral Therapy, Highly Active ; Anus Neoplasms ; Continental Population Groups ; Diagnosis ; Drug Therapy ; Follow-Up Studies ; HIV Infections ; HIV* ; Hodgkin Disease ; Humans ; Humans* ; Korea* ; Leukemia, Myeloid, Acute ; Lymphocytes ; Lymphoma ; Lymphoma, Non-Hodgkin ; Male ; Medical Records ; Prevalence ; Recurrence ; Retrospective Studies ; Sarcoma, Kaposi ; Seoul

BACKGROUND: Since highly active antiretroviral therapy has lengthened the life span of individuals infected with human immunodeficiency virus (HIV), the importance of malignancy associated with HIV has been increased. The relative frequencies of malignancies in HIV infected patients may vary in different race and region. The aim of this study is to determine the prevalence and characteristics of malignancies in patients with HIV infection in South Korea. MATERIALS AND METHODS: To identify HIV patients with malignancy, we reviewed the electronic database of pathological reports for all HIV-infected patients seen from January 1986 to December 2005 at the Seoul National University Hospital. We retrospectively reviewed the medical records of them. RESULTS: Among 850 patients infected with HIV, 33 episodes of malignant diseases were diagnosed in 32 patients (3.76%). Thirty were males, and median age was 46 years (range 29-70). At the time of the diagnosis of malignancy, median CD4+ lymphocytes count was 100/uL (range 5-620) and in 27 (82%) patients, CD4+ lymphocytes count were less than 200/uL. For 13 patients (40%), malignancy was initial presentation of HIV infection. Excluding patients initially diagnosed as malignancy, median follow-up duration from the first visit to diagnosis of malignancy was 36 months (range 3-96). Non-Hodgkin's lymphoma was the most frequent malignancy (13 patients), followed by Kaposi's sarcoma (7), Hodgkin's disease (3), acute myeloid leukemia (1), and other solid cancer (9) including one case of anal cancer associated with human papillomavirus. Among 13 patients with non-Hodgkin's lymphoma, 4(31%) achieved the complete remission after chemotherapy and/or radiation therapy, and had been followed without evidence of recurrence. CONCLUSION: Malignancy was diagnosed in 3.76% of patients infected with HIV. Non-Hodgkin's lymphoma is the most prevalent malignancy in HIV patients in South Korea.
Antiretroviral Therapy, Highly Active ; Anus Neoplasms ; Continental Population Groups ; Diagnosis ; Drug Therapy ; Follow-Up Studies ; HIV Infections ; HIV* ; Hodgkin Disease ; Humans ; Humans* ; Korea* ; Leukemia, Myeloid, Acute ; Lymphocytes ; Lymphoma ; Lymphoma, Non-Hodgkin ; Male ; Medical Records ; Prevalence ; Recurrence ; Retrospective Studies ; Sarcoma, Kaposi ; Seoul