PURPOSE: Post-authorization survey(PAS) is a useful tool for obtainting wider range of data on the safety and efficacy of new drugs following their approval, as they can detect uncommon, unreported adverse events(AEs), which enables more attention to be directed to the practioners. Especially, the limited number of patients in oncology trial cannot usually give the actual incidence of AEs. METHODS: Since Nov. 1998, when docetaxel gained Korean approval in the treatment of breast cancer, a PAS to investigate its safety profiles has been conducted targeting more than 600 patients over 4 calendar years. RESULTS: Case report forms from 626 out of 646 patients were assessable for safety and 444 for efficacy. The patient characteristics are: mean age, 48.1 years; male/female 4/622; Wt/Ht/BSA 57.9 kg/156.1 cm/1.56 m2 ; stage I-II/III/IV 109 (18.2%)/125 (20.8%)/366(61.0%). In 344 patients, 960 AEs were reported in severity of mild/moderate/severe in 6.7, 40.9 and 51.1 % of cases. From AE results, 36.0% needed dose reduction; 34.3% transient interruption of the cycle; and 1.3% permanent discontinuation of docetaxel. Thirty five serious AEs such as febrile neutropenia, alopecia, diarrhea, abdominal pain and headache were reported in 21 patients. Unexpected AEs such as skin ulcer, discoloration of skin, H. Zoster infection, ulticaria, facial flush, chest pain, hemoptysis, pneumonia, stridor, nasal bleeding, photophobia, haematuria, Cushing's syndrome, hyperglycemia and insomnia were reported regardless of any causal relationship. Factors affecting the development of AEs were age, stage, concomitant medication other than chemotherapeutic agents and the number of cycles treated. The efficacy was evaluable in 444 patients with overall response rate of 36.5% (CR/PR 6.3/30.2%). Factors affecting the efficacy were stage, concommitant medication other than chemotherapeutic agents and the number of treatment cycles. CONCLUSION: This post-authorization survey on the safety and efficacy of docetaxel in breast cancer offers oncology practice in the real world without subject selection as is the case in clinical trials, although it was performed to fulfill the registrative requirement of the Korean health authority with limited data. The efficacy and safety profile of docetaxel in breast cancer was no much different from those reported in clinical trials.
Abdominal Pain ; Alopecia ; Breast Neoplasms* ; Breast* ; Chest Pain ; Cushing Syndrome ; Diarrhea ; Epistaxis ; Febrile Neutropenia ; Headache ; Hemoptysis ; Herpes Zoster ; Humans ; Hyperglycemia ; Incidence ; Photophobia ; Pneumonia ; Respiratory Sounds ; Skin ; Skin Ulcer ; Sleep Initiation and Maintenance Disorders

OBJECTIVE: To evaluate the frequency and obstetric consequences of women with uterine anomalies and correlation between obstetric consequence and congenital uterine anomalies. Materials and METHODS: A retrospective study was made on 65 patients with uterine anomalies in order to evaluate the obstetric consequence at department of obstetrics and gynecology, Soonchunhyang University Hospital from January 1994 to June 1997. The diagnosis of uterine anomalies was made with hysterosalpingogram or ultrasonogram, or at the time of cesarean section. The uterine anomalies were classified according to the classification of Buttram and Gibbons and compared the pregnancy outcome for each classification. The obstetric consequences were divided into preterm delivery, premature rupture of membranes, intrauterine growth restriction, and abnormal presentation of fetus. Statistical analysis was carried out using chi-square test, the significance was defined as P< 0.05. RESULTS: 1. The incidence of uterine anomalies accounted for 1.04% (65/6,250 deliveries). 2. The most common uterine anomalies were class III (Uterine didelphys, 47.7%). 3. We noted preterm birth rate (16.9%), premature rupture of membranes rate (20%), intrauterine growth restriction rate (9.2%) in 65 patients. 4. The rate of breech presentation was 41.5% and the mean birth weight was 2,747 gram. 5. When uterine anormalies were present, the incidence of obstetric consequences was significantly increased. CONCLUSION: We concluded that congenital uterine anomalies were closely related to obstetric consequences, such as preterm, breech presentation, intrauterine growth retardation.
Birth Weight ; Breech Presentation ; Cesarean Section ; Classification ; Diagnosis ; Female ; Fetal Growth Retardation ; Fetus ; Gynecology ; Humans ; Hylobates ; Incidence ; Membranes ; Obstetrics ; Pregnancy ; Pregnancy Outcome ; Premature Birth ; Retrospective Studies ; Rupture ; Ultrasonography

PURPOSE: We prospectively conducted a multi-center, open-label, randomized phase II trial to compare the efficacy and safety of docetaxel plus cisplatin (DC) and etoposide plus cisplatin (EC) for treating advanced stage non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: Seventy-eight previously untreated patients with locally advanced, recurrent or metastatic NSCLC were enrolled in this study. The patients received cisplatin 75 mg/m2 on day 1 and either docetaxel 75 mg/m2 on day 1 or etoposide 100 mg/m2 on days 1 to 3 in the DC or EC arm, respectively, every 3 weeks. RESULTS: The objective response rate was 39.4% (15/38) and 18.4% (7/38) (p=0.023) in the DC and EC arms, respectively. The median time to progression (TTP) was 5.9 and 2.7 months (p=0.119), and the overall survival was 12.1 and 8.7 months (p=0.168) in the DC and EC arms, respectively. The prognostic factors for longer survival were an earlier disease stage (stage III, p=0.0095), the responders to DC (p=0.0174) and the adenocarcinoma histology (p=0.0454). The grades 3 and 4 toxicities were similar in both arms, with more febrile neutropenia (7.9% vs. 0%) and fatigue (7.9% vs. 0%) being noted in the DC arm. CONCLUSION: DC offered a superior overall response rate than does EC, along with tolerable toxicity profiles, although the DC drug combination did not show significantly improved survival and TTP.
Adenocarcinoma ; Arm ; Carcinoma, Non-Small-Cell Lung* ; Cisplatin* ; Etoposide* ; Fatigue ; Febrile Neutropenia ; Humans ; Prospective Studies