PURPOSE: We investigated the effectiveness and safety of DA-3030 for prophylatic use in patients receiving chemotherapy for malignant disease. MATERIALS AND METHODS: Seventy cancer patients were randomized to receive chemotherapy alone (36 patients) or with DA-3030 administered (34 patients) after stratified block randomization according to chemotherapeutic regimen. DA-3030 was subcutaneously administered at the dose of 100 pg/m/day for 10 days from 24 hours after the completion of chemotherapy. RESULTS: Of the 70 enrolled patients, 62 patients were evaluable. The neutropenia (absolute neutrophil count [ANC] <1,000/mm) occurred in 9 of 32 (28.1%) of the DA-3030 group and 21 of 30 (90.0%) of the control group, giving relative risk for control group of 0.154 (95% confidence interval [CI], 0.05 to 0.45; p-0.0001). Severe neutropenia (ANC 500/mm') occurred in 4 of 32 (12.5%) of the DA-3030 group and in 20 of 30 (66.7%) of the control group (relative risk for control group of 0.316 [95% CI, 0,18 to 0.55]; p=0.0001). The mean duration of neutropenic period (+/-standard error) was 1.13+/-0.34 days in the DA-3030 group and 6.73+/-0.69 days in the control group respectively, and was significantly shorter in the DA-3030 group (p<0.0001). And, there was higher nadir ANC in the OA-3030 group than that in the control group (p=0.0001); the mean nadir ANC was 2,547+/- 343/mm and 442+/-120/mm, respectively. The DA-3030 group had significantly higher incidence of myalgia in comparison to the control group (43.8% compared with 3.3%; p=0.001). However, it was tolerable and was easily managed by conservative therapy CONCLUSION: The use of DA-3030 was effective in preventing chemotherapy-induced neutropenia.
Drug Therapy* ; Humans ; Incidence ; Myalgia ; Neutropenia* ; Neutrophils ; Random Allocation

PURPOSE: Soft tissue sarcomas are uncommon primary malignancies. So studies on the effective chemotherapy for soft tissue sarcomas are limited. We started this study to evaluate the effectiveness of VIP (etoposide, ifosfamide, cisplatin) combination chemotherapy for advanced soft tissue sarcomas. MATERIALS AND METHODS: Thirty patients with recurrent or metastatic soft tissue sarcoma were treated with VIP combination chemotherapy between December 1989 and June 1996. Each patient was given etoposide 75 mg/m2, ifosfamide 1000 mg/m2, cisplatin 20 mg/m2 intravenously for five consecutive days every three weeks. Mesna (sodium-2-mercaptoethansulfonate) was given to avoid the urologic toxicity. RESULTS: Twenty-eight of 30 patients were evaluable for response, and among the 28 evaluable patients, there were 9 partial response (32%). Duration of response in 9 responders ranged from 4.1 to 16.2 months (median 8.8 months). Overall survival ranged from 1.7 to 41.5 months (median 11 months) and survival was better for patients with partial response (median survival 14.8 months vs. 9.7 months with stable disease vs. 5.1 months with progressive disease p=0.0006). Nausea and vomiting was noted in more than 90% of cycles, but was markedly severe in only 4%. Leukopenia was noted in 60% of cycles, including 11% of cycles with counts <2,000/mm3. There was no treatment related death, but we had to stop chemotherapy in 2 patients due to leukopenia (1 patient) and neurotoxicity (1 patient). CONCLUSION: Combination of etoposide, ifosfamide, and cisplatin was fairly active for advanced soft tissue sarcoma, with myelosuppresion and peripheral neuropathy being the most serious toxicities.
Cisplatin* ; Drug Therapy* ; Drug Therapy, Combination ; Etoposide* ; Humans ; Ifosfamide* ; Leukopenia ; Mesna ; Nausea ; Peripheral Nervous System Diseases ; Sarcoma* ; Vomiting

OBJECTIVE: To test if the intake of H2 receptor antagonists (H2-RAs) increases the risk of gastric cancer in the elderly. METHODS: The source population for this study was drawn from the responders to a questionnaire survey administered to the Korea Elderly Pharmacoepidemiological Cohort (KEPEC), who were beneficiaries of the Korean Medical Insurance Corporation, were at least 65 years old, and residing in Busan in 1993. The information on H2-RAs exposure was obtained from a drug prescription database compiled between Jan. 1993 and Dec. 1994. The cases consisted of 76 gastric cancer patients, as confirmed from the KMIC claims data, the National Cancer Registry and the Busan Cancer Registry. The follow-up period was from Jan. 1993 to Dec. 1998. Cancer free controls were randomly selected by 1:4 individual matching, which took in to consideration the year of birth and gender. Information on confounders was collected by a mail questionnaire survey. The odds ratios, and their 95% confidence intervals, were calculated using a conditional logistic regression model. RESULTS: After adjusting for a history of gastric ulcer symptoms, medication history, and body mass index, the adjusted OR (aOR) was 4.6 (95% CI=1.72-12.49). The odds ratio of long term use (more than 7 days) was 2.3 (95% CI=1.07-4.82). The odds ratio of short term use was 4.6 (95% CI=1.26-16.50). The odds ratio of parenteral use was 4.4 (95% CI=1.16-17.05) and combination use between the oral and parenteral routes (aOR, 16.8; 95% CI=1.21-233.24) had the high risk of gastric cancer. The aOR of cimetidine was 1.7 (95% CI=1.04-2.95). The aOR of ranitidine was 2.0 (95% CI=1.21-3.40). The aOR of famotidine was 1.7 (95% CI=0.98-2.80). CONCLUSION: The intake of H2-RAs might increase the risk of gastric cancer through achlorhydria in the elderly.
Achlorhydria ; Aged* ; Body Mass Index ; Busan ; Case-Control Studies* ; Cimetidine ; Cohort Studies ; Drug Prescriptions ; Famotidine ; Follow-Up Studies ; Humans ; Insurance ; Korea ; Logistic Models ; Odds Ratio ; Parturition ; Pharmacoepidemiology ; Postal Service ; Surveys and Questionnaires ; Ranitidine ; Stomach Neoplasms* ; Stomach Ulcer

No abstract available.
Carcinoma, Squamous Cell* ; Cisplatin* ; Drug Therapy* ; Head* ; Neck*

PURPOSE: For malignant diseases, predictions about tumor behavior and determination of appropriate therapy are based on the primary tumor sites, but 2-9% of cancer patients are diagnosed without identifiable primary tumor sites. Metastatic tumors of unknown primary origin (MUO) are a heterogeneous group of tumors with variable natural histories. The majority of these patients fall outside of treatable subjects and seldom respond to therapy. To define further the natural history of MUO and identify prognostic factors, we undertook a clinical analysis of 141 consecutive patients with a presumed diagnosis of MUO. MATERIALS AND METHODS: One hundred forty-one patients were diagnosed with unknown primary tumor from Jan. 1, 1992 through Aug. 31, 1995. The primary end point for the study was survival, which was calculated from the first day of patient registration diagnosed histologically. The survival curves were estimated using the Kaplan-Meier method and compared using the log-rank test. To identify important prognostic factors, univariate and multivariate analyses were conducted. RESULTS: Most of the 141 patients had histologic or cytologic evidence of adenocarcinoma and had more than one site metastatically involved. The predominant sites of tumor involvement were lymph node, peritoneum, bone, liver, lung, and pleura. Univariate and multivariate analyses identified numerous important prognostic factors with a significant influence on survival, including performance status (P 0.0001), specific organ sites involved (lung P 0.0076 or liver P 0.0310), and chemotherapy group (P- 0.0480). CONCLUSION: This study validated clinical courses and important prognostic factors that had an impact on survival in MUO.
Adenocarcinoma ; Diagnosis ; Drug Therapy ; Humans ; Liver ; Lung ; Lymph Nodes ; Multivariate Analysis ; Natural History ; Neoplasms, Unknown Primary ; Peritoneum ; Pleura

No abstract available.
Bleomycin* ; Drug Therapy, Combination* ; Etoposide* ; Germ Cells* ; Neoplasms, Germ Cell and Embryonal*

No abstract available.
Drug Therapy* ; Drug Therapy, Combination* ; Fluorouracil* ; Humans ; Stomach Neoplasms*

No abstract available.
Korea* ; Lymphoma*

Although it is well known that cancer patients suffer from malnutrition, there are few published studies on malnutrition in outpatients receiving chemotherapy in Korea. This study aimed to evaluate nutritional risk in oncology outpatients receiving chemotherapy and to show the baseline data to set up nutritional management programs for cancer patients. This is a retrospective observational analysis on 1,962 patients referred for nutritional education before or during chemotherapy at Seoul National University Hospital Cancer Center from January 2006 to May 2007. According to a malnutrition screening tool, the proportion of patients having malnutrition risk was 23.0%. In the case of upper gastrointestinal cancer, more than 50% of patients were assessed as being at the risk of malnutrition. They showed more than 7% weight loss compared to their usual body weight and poor oral intake; energy intake was less than 100% of Basal Energy Expenditure (BEE) and protein intake was less than or equal to 0.77 g/kg/d. However, only 6.3% of breast cancer patients had risk of malnutrition and their oral intake was better; energy intake was 121% of BEE, and protein intake was 0.90 g/kg/d. Outpatients receiving chemotherapy had different nutritional risk depending on their cancer site. Nutritional management program should be conducted differently, depending on the cancer site and upper gastrointestinal cancer patients at high risk of malnutrition should basically have nutritional assessment and intervention.
Bees ; Body Weight ; Breast Neoplasms ; Energy Intake ; Energy Metabolism ; Gastrointestinal Neoplasms ; Humans ; Korea ; Malnutrition ; Mass Screening ; Nutrition Assessment ; Outpatients ; Retrospective Studies ; Weight Loss

Although it is well known that cancer patients suffer from malnutrition, there are few published studies on malnutrition in outpatients receiving chemotherapy in Korea. This study aimed to evaluate nutritional risk in oncology outpatients receiving chemotherapy and to show the baseline data to set up nutritional management programs for cancer patients. This is a retrospective observational analysis on 1,962 patients referred for nutritional education before or during chemotherapy at Seoul National University Hospital Cancer Center from January 2006 to May 2007. According to a malnutrition screening tool, the proportion of patients having malnutrition risk was 23.0%. In the case of upper gastrointestinal cancer, more than 50% of patients were assessed as being at the risk of malnutrition. They showed more than 7% weight loss compared to their usual body weight and poor oral intake; energy intake was less than 100% of Basal Energy Expenditure (BEE) and protein intake was less than or equal to 0.77 g/kg/d. However, only 6.3% of breast cancer patients had risk of malnutrition and their oral intake was better; energy intake was 121% of BEE, and protein intake was 0.90 g/kg/d. Outpatients receiving chemotherapy had different nutritional risk depending on their cancer site. Nutritional management program should be conducted differently, depending on the cancer site and upper gastrointestinal cancer patients at high risk of malnutrition should basically have nutritional assessment and intervention.
Bees ; Body Weight ; Breast Neoplasms ; Energy Intake ; Energy Metabolism ; Gastrointestinal Neoplasms ; Humans ; Korea ; Malnutrition ; Mass Screening ; Nutrition Assessment ; Outpatients ; Retrospective Studies ; Weight Loss