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

PURPOSE: To analyze the controversies surrounding therapeutic decision-making and the withholding of life- sustaining treatments, values held concerning therapeutic interventions of terminal cancer patients are compared between physicians and family members. MATERIALS AND METHODS: 42 advanced or terminal stage cancer patients were enrolled for the study. The questionnaires were administered to the duty doctor and the family of the patients. Questions included whether to use new agents with a 15% partial efficacy and whether to use opioid analgesics, intravenous nutrition, a feeding tube, antibiotics, and hemodialysis. Additionally, we asked about the administration of CPR, ventilator application, and euthanasia. If the family permitted, the same questionnaires were given to the patients. RESULTS: Of the 42 cases, 5 families refused to answer the questionnaire. Of the available 37 families, only 5 families permitted access to the patients. Of the 5 patients, 2 patients refused the questionnaire. Only 67.6% and 8.1% of families and the patients clearly understood the stage of cancer. The use of a new agent was accepted by 45.2% of the physicians and 45.9% of the families. The rankings of the acceptance of treatment in the physicians and in the families were similar. The concordance rate between the physicians and the families was lowest on ventilator application and CPR. 31% of the physicians and 43.2% of the families agreed on the issue of euthanasia. CONCLUSION: Values held on issues like therapeutic decision-making and the withholding of life-sustaining treatments in terminal cancer patients are discordant between physicians and family members. In order to resolve controversies on the role of physicians in end-of-life decisions, the values of physicians as well as patients and their family members should be considered in the final decision-making process.
Analgesics, Opioid ; Anti-Bacterial Agents ; Cardiopulmonary Resuscitation ; Euthanasia ; Humans ; Medical Futility ; Renal Dialysis ; Ventilators, Mechanical ; Withholding Treatment ; Surveys and Questionnaires