Quality assurance may be defined as the complete set of systemic actions that is required to achieve a better treatment result by standardizing treatment and by using various audit programs. In general, application of a quality assurance program in surgery is considered to be more difficult than it is in chemotherapy or radiotherapy. However, recently, the importance of quality assurance in the surgical field has been emphasized in clinical trials comparing different surgical procedures and evaluating the role of postoperative adjuvant therapy. In the case of gastric cancer surgery, excellent quality assurance programs have rarely been applied in most large prospective clinical trials. Although the quality assurance in Dutch trial was conducted very systemically and strictly, the situation is quite different from ours. On the other hand, several quality assurance programs in Japanese trials comparing D2 and D2 plus para-arotic lymph node dissection seem to be applicable to Korean clinical trials. Several factors, including selection of appropriate surgeons based on personal experience and annual number of operations, standardization of surgical procedures by education and consensus, development of a unified database program, application of standardized perioperative management, and standardization of pathologic examination, are required to guarantee a successful multi-institutional prospective clinical trial. In contrast, one needs to realize that protocols that are too strict and sophisticated can make the enrollment of patients and surgeons more difficult and can promote protocol violation during the clinical trials. (J Korean Gastric Cancer Assoc 2005;5:79-88)
Kim, Eun-Mi;Kim, Se-Won;Kim, Sang-Woon;Song, Sun-Kyo
Journal of Yeungnam Medical Science
/
v.23
no.2
/
pp.193-204
/
2006
Purpose: Various postoperative adjuvant chemotherapy regimens have been proposed for the patients with advanced gastric cancer. The majority of clinical trials have shown no significant difference in the survival benefit. The aim of this study was to compare the survival rates of postoperative adjuvant chemotherapies used in stage III gastric cancer patients who received curative gastrectomy. Materials and Methods: Between 1990 and 1999, a survival analysis was performed in 260 patients who received curative gastric resection and postoperative adjuvant chemotherapy. The patients were divided into four groups according to the chemotherapeutic regimens received. The groups were: the F group: furtulon alone, FM group: furtulon and mitomycin, FAM group: 5-FU, adriamycin and mitomycin, FLEP group: 5-FU, leucovorin, etoposide and cisplatin. The survival rates were analyzed using the Kaplan-Meier method and the Cox proportional hazards model. Results: There were no differences among the groups of patients with regard to tumor characteristics except for lymph node metastasis and the ratio of metastasis to lymph nodes. In the FLEP group, the ratio of metastasis to lymph nodes was higher than in the other groups. The five and ten year survival rates of F, FM, FAM and FLEP were 51.9%, 28.9%, 59.5%, 49.8%, 66.1%, 57.4% and 30.0%, 27.5%, respectively. The univariate analysis showed that age, Borrmann type, lymph node metastasis, ratio of metastasis to lymph nodes, postoperative adjuvant chemotherapy and recurrence were significant factors for survival. For the multivariate analysis, recurrence, age, Borrmann type, ratio of lymph node metastasis and lymph node dissection were independent prognostic factors; however, the postoperative adjuvant chemotherapy was not an independent prognostic factor. Conclusion: The FAM regimen was the most beneficial postoperative adjuvant chemotherapy for improved survival rates; the FM regimen was the second and the FLEP regimen was the last. In order to determine the effectiveness of postoperative adjuvant chemotherapy in stage III gastric cancer, well designed prospective studies including a surgery only group will be needed.
Kim, Yang-Ki;Lee, Young-Mok;Kim, Ki-Up;Uh, Soo-Taek;Kim, Yong-Hoon;Park, Choon-Sik
Tuberculosis and Respiratory Diseases
/
v.57
no.1
/
pp.72-77
/
2004
Background : A tracheobronchial obstruction in lung cancer is associated with significant morbidity and mortality due to dyspnea, cough, hemoptysis, and recurrent respiratory infection. It is well known that one of standard treatments is photodynamic therapy (PDT) in tracheobronchial obstruction after radiotherapy, chemotherapy, and/or surgery. We reported here the role of PDT in airway obstruction in patients advanced lung cancer. Method : Pre-treatment protocol consisted of clinical, radiologic, and bronchoscopic examination, pulmonary function test, and assessment of Karnofsky performance status. A 2 mg/kg of porfimer sodium was injected intravenously, and then followed by cylindrical and/or interstitial irradiation with 630 nm of laser after 48 hours. The repeated bronchoscopy for debridement of necrotic tissue and re-illumination was performed after 48 hours. Result : Improved airway obstruction and selective tumor necrosis were achieved by photodynamic therapy in all cases. Dyspnea and performance status were improved in three cases. A purulent sputum, fever and hemoptysis were improved in one of five cases. After PDT, all patients showed temporarily aggravation of dyspnea, two of five showed febrile reaction for a few days and nobody presented photosensitivity reaction, hemoptysis and respiratory failure. Conclusion : Our experiences of PDT are effective in palliation of inoperable advanced lung cancer in terms of tracheobronchial obstruction.
The clinical significance of hepatic resection for gastric metastases is controversial, even though hepatic resection has been widely accepted as a modality for colorectal metastases. Very few patients with gastric hepatic metastases are good candidates for hepatic resection because of multiple bilateral metastases, extrahepatic disease, or advanced cancer progression, such as peritoneal dissemination or extensive lymph node metastases. Therefore, several authors have reported the clinical significance of hepatic resection for gastric metastases in a small number of patients. Considering the present results with previous reports. The number and distribution of tumors in hepatic metastases from gastric cancer was considered based on the present and previous reports. Several authors have reported significantly better survival in patients with metachronous metastasis than in those with synchronous disease. However, metachronous hepatic resection necessitates the dissection of adhesions between the pancreas, liver, and residual stomach to prepare for Pringle's maneuver. Patients with unilobar liver metastasis, and/or metastatic tumors <4 cm in diameter may be good candidates for hepatic resection. Synchronous metastasis is not a contraindication for hepatic resection. Most of the long-term survivors underwent anatomic hepatic resection with a sufficient resection margin. After hepatic resection, the most frequent site of recurrence was the remaining liver, which was associated with a high frequency of mortality within 2 years. A reasonable strategy for improvement in survival would be to prevent recurrence by means of adjuvant chemotherapy and careful follow-up studies.
Ahn Seung Do;Choi Eun Kyung;Kim Jin Cheon;Kim Sang Hee
Radiation Oncology Journal
/
v.13
no.3
/
pp.253-258
/
1995
Purpose : To evaluate the effects of postoperative radiotherapy and chemotherapy on the pattern of failure and survival for locally advanced rectal carcinoma, we analyzed the two groups of patients who received curative resection only and who received postoperative radiochemotherapy retro-spectively. Materials and Methods : From June 1989 to December 1992, ninety nine patients with rectal cancer were treated by curative resection and staged as B2-3 or C. Group I(25) patients received curative resection only and group II(74) patients postoperative adjuvant therapy. Postoperative adiuvant group received radiation therapy (4500cGy/25fx to whole pelvis) with 5-FU (500mg/$m^2$, day 1-3 IV infusion) as radiosensitizer and maintenance chemotherapy with 5-FU(400mg/$m^2$ for 5 days) and leucovorin (20mg/m^2$ for 5 days) for 6 cycles. Results : The patients in group I and group II were comparable in terms of age sex, performance status, but in group II $74{\%}$ of patients showed stage C compared with $56{\%}$ of group I. All patients were followed from 6 to 60 months with a median follow up of 29 months. Three year overall survival rates and disease free survival rates were $68\%,\;64\%$ respectively in group I and $64\%,\;61\%$, respectively in group II. There was no statistical difference between the two treatment groups in overall survival rate and disease free survival rate. Local recurrences occurred in $28{\%}$ of group I, $21{\%}$ of group II (p>.05) and distant metastases occurred in $20{\%}$ of group I, $27{\%}$ of group II(p>.05). The prognostic value of several variables other than treatment modality was assessed. In multivariate analysis for prognostic factors stage and histologic grade showed statistically significant effect on local recurrences and lymphatic or vessel invasion on distant metastasis. Conclusion : This retrospective study showed no statistical difference between two groups on the pattern of failure and survival. But considering that group II had more advanced stage and poor prognostic factors than group I, postoperative adjuvant radiochemotherapy improves the results for locally advanced rectal carcinoma as compared with curative surgery alone.
$\underline{Purpose}$: To evaluate the pathological prognostic factors related to local recurrence after radical surgery and adjuvant radiation therapy in advanced rectal cancer. $\underline{Materials\;and\;Methods}$: Fifty-four patients with advanced rectal cancer who were treated with radical surgery followed by adjuvant radiotherapy and chemotherapy between February 1993 and December 2001 were enrolled in this study. Among these patients, 14 patients experienced local recurrence. Tissue specimens of the patients were obtained to determine pathologic parameters such as histological grade, depth of invasion, venous invasion, lymphatic invasion, neural invasion and immunohistopathological analysis for expression of p53, Ki-67, c-erb, ezrin, c-met, phosphorylated S6 kinase, S100A4, and HIF-1 alpha. The correlation of these parameters with the tumor response to radiotherapy was statistically analyzed using the chi-square test, multivariate analysis, and the hierarchical clustering method. $\underline{Results}$: In univariate analysis, the histological tumor grade, venous invasion, invasion depth of the tumor and the over expression of c-met and HIF-1 alpha were accompanied with radioresistance that was found to be statistically significant. In multivariate analysis, venous invasion, invasion depth of tumor and over expression of c-met were also accompanied with radioresistance that was found to be statistically significant. By analysis with hierarchical clustering, the invasion depth of the tumor, and the over expression of c-met and HIF-1 alpha were factors found to be related to local recurrence. Whereas 71.4% of patients with local recurrence had 2 or more these factors, only 27.5% of patients without local recurrence had 2 or more of these factors. $\underline{Conclusion}$: In advanced rectal cancer patients treated by radical surgery and adjuvant chemo-radiation therapy, the poor prognostic factors found to be related to local recurrence were HIF-1 alpha positive, c-met positive, and an invasion depth more than 5.5 mm. A prospective study is necessary to confirm whether these factors would be useful clinical parameters to measure and predict a radio-resistance group of patients.
Park, In-Kyu;Kim, Dae-Joon;Kim, Kil-Dong;Bae, Mi-Kyung;Chung, Kyung-Young
Journal of Chest Surgery
/
v.38
no.8
s.253
/
pp.564-569
/
2005
Background: Thymic carcinoma is a rare malignant disease with sparse data for treatment and prognosis. We intended to investigate the prognostic factors of thymic carcinoma. Material and Method: Data of 42 patients, who were diagnosed and treated for thymic carcinoma from January of 1986 to August of 2003 were reviewed retrospectively. Influences of characteristics of patients, Masaoka stage, histologic grade, completeness of resection and adjuvant treatment on survival were evaluated. Result: There were 30 male and 12 female patients and their mean age was $52.0\pm15.7$ years old. There were 28 patients with low-grade histology and 13 patients with high-grade histology. Clinical stage according to Masaoka stage were I in 2, II in 2, III in 15 $(35.7\%)$, IVa in 10 $(23.8\%),\;and\;IVb\;in\;13\;(31\%)$ patients. Surgical resection was done in 22 patients, Complete resection was possible in 13 patients and incomplete resection was done in 9 patients. Among 20 patients without resection, 8 patients received chemotherapy, 7 patients received radiotherapy and 5 patients received combined therapy. Median survival time was $31.7\pm6.1$ months and 5 year survival rate was $28.5\%$. High grade histology (hazard ratio=3.009, $95\%\;confidence\;interval=1.178\sim7.685,$ p=0.021) and incompleteness of resection (hazard ratio=3.605, $95\%$ confidence interval= $1.1541\sim1.580$, p=0.023) were the prognostic factors of thymic carcinoma. Conclusion: In thymic carcinoma, low grade histology is a good prognostic factor and complete resection can prolong the survival of patients.
Purpose : Testicular seminomas are radiosensitive and adjuvant radiation therapy after orchiectomy results in long term survival in early stage diseases, Ten year results of radiation therapy after orchiectomy and results of definitive treatment of recurrent seminoma are Presented. Materials and Methods : Between August 1980 and February 1990. 32 Patients with testicular seminomas were treated at the Department of Therapeutic Radiology, Seoul Natoinal University Hospital. Twenty-seven Patients received radiation therapy after orchiectomy and 5 patients for treatment of recurrent tumors. Two of postoperatively treated patients and 2 of recurrent patients were excluded from the study because of incomplete treatment. Of the patients treated postoperatively, 18 were stage I, 5 were stage IIA, one was stage IIB, and one was stage IIC. There were 4 ipsilateral and 2 contralateral cryptorchids. Preoperatively, ${\beta}$-HCG levels were elevated in 5 patients. Median dose to pelvic and paraaortic lymph node area was 2900 cGy (1550-4550 cGy). One patient with stage I, 4 with stage IIA, and 1 with stage IIB received prophylactic mediastinal irradiation. Two patients were treated with chemotherapy before radiation therapy. Median follow-up period was 104(3-144) months. Result: Local control rates were 100% at 5 years after orchiectomy. Five year survival rates were 94.4% in Stage I and 100% in Stage II patients, One patient with stage I disease died 3 months after surgery due to mediastinal metastasis. AII the 3 patients treated for recurrent disease are alive without disease. Conclusion : Postorchiectomy radiation to the pelvis and para-aortic area remains the treatment of choice for Patient with early stage testicular seminoma. Radiation therapy is also an excellent treatment modality for recurrent seminoma.
Kim, Won-Gon;Oh, Sam-Sae;Kim, Ki-Bong;Ahn, Hyuk;Kim, Chong-Whan
Journal of Chest Surgery
/
v.31
no.9
/
pp.877-883
/
1998
Background: Cardiopulmonary bypass(CPB), a standard adjunct for open heart surgery, can also play an important role in treating patients with noncardiac diseases. Material and Method: We report a collective analysis of noncardiac applications of cardiopulmonary bypass experienced at Seoul National University Hospital from 1969 to 1996. Out of a total of 20 patients, 8 were treated for membranous obstruction of inferior vena cava(MOVC), 5 for malignant melanoma, 3 for pulmonary embolism, 1 for double lung transplantation, 1 for intracranial giant aneurysm(GA), 1 for renal cell carcinoma(RC), and 1 for liposarcoma. CPB was used to induce profound hypothermia with circulatory arrest in 6 patients(MOVC 4, GA 1, RC 1). Result: CPB time was 113 mins on average for MOVC, 161 mins for GA, and 156 mins for RC, while the lowest rectal temperature was 26$^{\circ}C$ on average in MOVC, and 19$^{\circ}C$ in GA and RC. Postoperative recovery was good in all MOVC patients. The patient with GA, who underwent reoperation for the removal of hematoma, died 14 days postoperatively. The patient with RC recovered from the operation in a good condition but died from metastatic spread 6 months later. CPB was instituted for pulmonary embolectomy in 3 patients, in whom postoperative courses were uneventful, except in 1 patient who showed transient neurologic symptoms. CPB was used in a patient with double-lung transplantation for hemodynamic and ventilatory support. The patient was weaned successfully from CPB but died from low output and septicemia 19 days postoperatively. CPB without circulatory arrest was used to treat in 4 patients with MOVC. These patients showed good postoperative courses. CPB was used to administer high concentrations of chemotherapeutic agents to the extremities in 6 patients(malignant melanoma 5, recurrent liposarcoma 1). CPB time was 153 mins on average. No complications such as edema and neurologic disability were found. Conclusion: Although CPB has a limited indication in noncardiac diseases, if properly applied, it can be a very useful adjunct in a variety of surgical cases.
Purpose: To study the effect of recombinant human epidermal growth factor (rhEGF) on oral mucositis induced by cisplatin and radiotherapy in a mouse model. Materials and Methods: Twenty-four ICR mice were divided into three groups-the normal control group, the no rhEGF group (treatment with cisplatin and radiation) and the rhEGF group (treatment with cisplatin, radiation and rhEGF). A model of mucositis induced by cisplatin and radiotherapy was established by injecting mice with cisplatin (10 mg/kg) on day 1 and with radiation exposure (5 Gy/day) to the head and neck on days $1{\sim}5$. rhEGF was administered subcutaneously on days -1 to 0 (1 mg/kg/day) and on days 3 to 5 (1 mg/kg/day). Evaluation included body weight, oral intake, and histology. Results: For the comparison of the change of body weight between the rhEGF group and the no rhEGF group, a statistically significant difference was observed in the rhEGF group for the 5 days after day 3 of. the experiment. The rhEGF group and no rhEGF group had reduced food intake until day 5 of the experiment, and then the mice demonstrated increased food intake after day 13 of the of experiment. When the histological examination was conducted on day 7 after treatment with cisplatin and radiation, the rhEGF group showed a focal cellular reaction in the epidermal layer of the mucosa, while the no rhEGF group did not show inflammation of the oral mucosa. Conclusion: These findings suggest that rhEGF has a potential to reduce the oral mucositis burden in mice after treatment with cisplatin and radiation. The optimal dose, number and timing of the administration of rhEGF require further investigation.
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