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1.
Article in Korean | WPRIM (Western Pacific) | ID: wpr-228681

ABSTRACT

PURPOSE: This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy of ondansetron (Zofran(R)) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. MATERIALS AND METHODS: Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tablets including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. RESULTS: Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy charcteristics were similar except mean age was 52.9+/-11.2 in group M, 46.5+/-9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly score for all three symptoms. Ondansetron (Zofran ) 8 mg bid dose and metoclopramide 5 mg tid dose were well tolerated without significant side effects. There were no clinically important changes in vital signs or clinical laboratory parameters with either drug. CONCLUSION: Concerning the fact that patients with younger age have higher emetogenic potential, there are possibilities that age difference between two treatment groups lowered the statistical power of analysis. There were significant difference favoring ondansetron group with respect to the severity of nausea, vomiting and loss of appetite. We concluded that ondansetron is more effective anti-emetic agents in the control of radiotherapy-induced nausea, vomiting, loss of appetite without significant toxicity, compared with commonly used drug, i.e., metoclopramide. However, there were patients suffering emesis despite the administration of ondansetron. The possible strategies to improve the prevention and the treatment of radiotherapy-induced emesis must be further studied.


Subject(s)
Humans , Appetite , Drug Therapy , Informed Consent , Metoclopramide , Nausea , Neoplasm Metastasis , Ondansetron , Prescriptions , Prospective Studies , Radiotherapy , Statistics as Topic , Tablets , Treatment Refusal , Vital Signs , Vomiting
2.
Article in Korean | WPRIM (Western Pacific) | ID: wpr-11900

ABSTRACT

PURPOSE: Transcatheter arterial chemoembolization (TACE) has been actively performed for the treatment of unresectable or inoperable hepatocellular carcinoma. However, for the patients with treatment failure after TACE, few options are available for salvage. The purpose of this study was to investigate the efficacy of local radiotherapy as a salvage moda- lity for treatment failure after TACE. MATERIALS AND METHODS: From January 1993 to December 1997, 27 patients were included in this study. Exclusion criteria included the presence of extrahepatic metastasis, liver cirrhosis of Childs class C, tumors occupying more than two thirds of the entire liver, and performance status on the ECOG scale of more than 3. Mean tumor size was 7.2+/- 2.9 cm. Liver cirrhosis was associated in 10 patients. Portal vein thrombosis was presented in 5 patients. Serum alpha-fetoprotein was positive in 8 patients. According to VICC staging, the number of patients in III and IVA were 17 and 10, respectively. Treatment failure to TACE was evaluated by CT scan and angiography. Radiotherapy was given to the field including tumor with generous margin using 10-MV X-ray. Mean tumor dose was 51.8+-7.9 Gy in daily 1.8 Gy fractions. Tumor response was based on CT scans 4~6 weeks following completion of treatment. RESULTS: An objective response was observed in 16 of 24 patients who were possible to be evaluated, giving a response rate of 66.7%. Survival rates after salvage radiotherapy at 1, 2, 3 years were 55.9%, 35.7%, and 21.4%, respectively. The median survival was 14 months. Six patients among responders are surviving at present. Acute toxicity included G1 elevation of AST/ALT in 4 patients, G2 thrombocytopenia in 2, G2 hyperbilirubinemia in 5, and G2 hypoalbuminemia in 3. During follow-up, 4 patients developed ascites. At 6 months after treatment, gastric ulcers and duodenal ulcer were developed in 2 and 1 patient, respectively. CONCLUSION: Local radiotherapy for treatment failure after TACE in hepatocellular carci- noma appears to be a feasible and effective salvage modality. It gives a 66.7% response rate with a median survival of 14 months. Acute toxicity was self-limiting and manageable. Gastric and duodenal ulcer were significant toxicities after treatment. Further studies are required to find optimal methods of radiotherapy to minimize toxicity.


Subject(s)
Child , Humans , alpha-Fetoproteins , Angiography , Ascites , Carcinoma, Hepatocellular , Duodenal Ulcer , Follow-Up Studies , Hyperbilirubinemia , Hypoalbuminemia , Liver , Liver Cirrhosis , Neoplasm Metastasis , Noma , Radiotherapy , Stomach Ulcer , Survival Rate , Thrombocytopenia , Tomography, X-Ray Computed , Treatment Failure , Venous Thrombosis
3.
Article in Korean | WPRIM (Western Pacific) | ID: wpr-43332

ABSTRACT

PURPOSE: This study was designed to demonstrate the potential therapeutic advantage of 3-dimensional (3-D) treatment planning over the conventional 2-dimensional (2-D) approach in patients with carcinoma of the nasopharynx. MATERIAL AND METHODS: The two techniques were compared both qualitatively and quantitatively for the boost portion of the treatment (19.8 Gy of a total 70.2 Gy treatment schedule) in patient with T4. The comparisons between 2-D and 3-D plans were made using dose statistics, dose-volume histogram, tumor control probabilities, and normal tissue complication probabilities. RESULTS: The 3-D treatment planning improved the dose homogeneity in the planning target volume. In addition, it caused the mean dose of the planning target volume to increase by 15.2% over 2-D planning. The mean dose to normal structures such as the temporal lobe, brain stem, parotid gland, and temporomandibular joint was reduced with the 3-D plan. The probability of tumor control was increased by 6% with 3-D treatment planning compared to the 2-D planning, while the probability of normal tissue complication was reduced. CONCLUSION: This study demonstrated the potential advantage of increasing the tumor control by using 3-D planning, but prospective studies are required to define the true clinical benefit.


Subject(s)
Humans , Brain Stem , Nasopharynx , Parotid Gland , Temporal Lobe , Temporomandibular Joint
4.
Article in Korean | WPRIM (Western Pacific) | ID: wpr-17119

ABSTRACT

PURPOSE: To investigate the role of adjuvant chemoradiotherapy in adenocarcinoma of the rectum, we retrospectively compared the treatment results between postoperative adjuvant radiotherapy alone and combined chemoradiotherapy. MATERIAL AND METHODS: From October 1989 to May 1994, 141 patients with rectal carcinoma were treated by postoperative adjuvant therapy in Yonsei Cancer Center. Sixty eight patients were treated by radiation therapy alone. Seventy three patients were treated by combined chemoradiotherapy. Radiation therapy was delivered with 10 MV linear accelerator, 180cGy fraction/5 days per week. Total radiation doses were 5400cGy in the postoperative radiotherapy alone group. Three to twelve cycles of Fluorouracil (mean dose 393.9mg/m2) with Leucovorin (20mg/m2) and 5040cGy of radiation were delivered in the combined chemoradiotherapy group. Third and 4th cycle of chemotherapy were administrated during the radiation treatment in the combined group. The median follow up was 38 months with a range of 3 to 81 months. RESULTS: The 5 year overall survival rate of radiation alone group and combined group were 60.1% and 66.3%, respectively. The 5 year disease free survival rate of radiation alone group and combined group were 54.2% and 65.5%, respectively. There was no significant difference of overall survival and disease free survival between RT alone group and combined group (P<0.05). But the 5 year Local failure free survival rate of combined group was significantly better than radiotherapy alone group (65.8% vs. 50.3%, P=0.04). CONCLUSION: There was no significant difference in overall survival, disease free survival, and distant metastasis free survival between postoperative adjuvant radiotheray alone group and combinded chemoradiotherapy group. Only the Local failure free survival rate was superior in the combined treatment group. These results confirm the radiosensitizing effect of the chemotherapeutic agent in the combined chemoradiotherapy treatment.


Subject(s)
Humans , Adenocarcinoma , Chemoradiotherapy , Chemoradiotherapy, Adjuvant , Disease-Free Survival , Drug Therapy , Fluorouracil , Follow-Up Studies , Leucovorin , Neoplasm Metastasis , Particle Accelerators , Radiation-Sensitizing Agents , Radiotherapy , Radiotherapy, Adjuvant , Rectal Neoplasms , Rectum , Retrospective Studies , Survival Rate
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