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문용화,김승기,이근석,이문희,박연희,박경화,김건민,임승택,이승아,최재덕,백은혜,한혜선,백승재,임석아 대한암학회 2023 Cancer Research and Treatment Vol.55 No.3
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.
공존이환(Comorbidity)이 있는 암환자에서의 항암약물치료
문용화,정희철,Moon Yong-Wha,Jeung Hei-Cheul 대한위암학회 2004 대한위암학회지 Vol.4 No.2
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.
문용화,김지현,강웅철,박병은,고영국,최동훈,유경종 대한내과학회 2004 대한내과학회지 Vol.66 No.3
관동맥우회술을 포함한 심장수술 후에 생기는 급성 장간막경색은 매우 드물지만 치명적인 합병증으로 발생률은 비교적 낮으나 사망률은 매우 높게 보고 되고 있다. 본 증례에서는 55세 여자 환자가 관동맥우회술을 시행받고 수술 후 1일째에 발생한 복부통증에 대해서 장간막경색증을 의심하지 못하고 수술과 연관된 비특이적 증상으로 판단하였으나 그 후 환자의 증상이 악화되면서 상장간막동맥 혈전 색전증에 의한 광범위한 급성 장괴사로 판명되었다. 관독맥우회술 후 상장간막 동맥에 생긴 혈전색전증에 의해 발생한 급성 장간막경색의 증례는 국내에 보고된 바 없고 본 증례를 통해 교육적인 경험을 하였기에 저자들은 문헌고찰과 함께 보고하는 바이다. 심폐우회술을 요하는 심장수술을 받은 환자 중 특히 급성 장간막허혈의 위험인자를 가지고 있는 환자에 대해서는 급성 장간막허혈이 생길 수 있다는 세심한 관찰이 진단이 늦어지지 않게 하는 방법이며 장간막허혈이 의심되면 즉시 적극적인 진단 및 치료적인 접근을 시도해야 하겠다. 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.(Korean J Med 66:317-320, 2004)
문용화,최상태,조병철,최혜진,김용태 연세대학교의과대학 2007 Yonsei medical journal Vol.48 No.6
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.
공존이환(Comorbidity)이 있는 암환자에서의 항암약물치료
정희철,문용화 대한위암학회 2004 Journal of gastric cancer Vol.4 No.2
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.