Purpose: A phase II study was conducted to evaluate the safety and efficacy of preoperative, intra-arterial perfusion of epirubicin, etoposide, and oxaliplatin combined with oral chemotherapy S-1 (SEEOX) for the treatment of type 4 gastric cancer. Materials and Methods: A single-center, single-arm phase II trial was conducted on 36 patients with histologically proven type 4 gastric cancer without distant peritoneal or organ metastasis. Patients received 3, 21-day courses of SEEOX preoperative chemotherapy. The primary endpoint was overall survival (OS) and the secondary outcomes assessed were chemotherapeutic response, radical resection rate, pathological regression, toxicities, postoperative morbidity, and mortality. Results: All patients were at an advanced stage of cancer (stage III or IV) and completed the entire course of treatment. Based on changes in tumor volume and peritoneal metastasis, the objective response rate was 55.6% (20/36; 95% confidence interval [CI], 38.5%-72.6%) and the disease control rate was 69.4% (25/36; 95% CI, 53.6%-85.3%). The radical resection rate was 75% (27/36; 95% CI, 60.1%-89.9%) and the proportion of R0 resections was 66.7% (21/36; 95% CI, 50.5%-82.8%). The pathological response rate was 33.3%, of which 13.9% showed complete pathological regression. The median survival was 27.1 months (95% CI, 22.24-31.97 months), and the 2-year OS was 48.5% (95% CI, 30.86%-66.1%). Conclusions: Preoperative SEEOX is a safe and effective treatment for type 4 gastric cancer. Based on these preliminary data, a phase III study will be conducted to confirm the superiority of this regimen over standard treatment.
Background: There is no standard treatment for patients with platinum-resistant or refractory epithelial ovarian cancer. Single agent chemotherapies have evidence of more efficacy and less toxicity than combination therapy. Most are very expensive, with appreciable toxicity and minimal survival. Since it is difficult to make comparison between outcomes, economic analysis of single-agent chemotherapy regimens and best supportive care may help to make decisions about an appropriate management for the affected patients. Objective: To evaluate the cost effectiveness of second-line chemotherapy compared with best supportive care for patients with platinum-resistant or refractory epithelial ovarian cancer. Materials and Methods: A Markov model was used to estimate the effectiveness and total costs associated with treatments. The hypothetical patient population comprised women aged 55 with platinum-resistant or refractory epithelial ovarian cancer. Four types of alternative treatment options were evaluated: 1) gemcitabine followed by BSC; 2) pegylated liposomal doxorubicin (PLD) followed by BSC; 3) gemcitabine followed by topotecan; and 4) PLD followed by topotecan. Baseline comparator of alternative treatments was BSC. Time horizon of the analysis was 2 years. Health care provider perspective and 3% discount rate were used to determine the costs of medical treatment in this study. Quality-adjusted life-years (QALY) were used to measure the treatment effectiveness. Treatment effectiveness data were derived from the literature. Costs were calculated from unit cost treatment of epithelial ovarian cancer patients at various stages of disease in King Chulalongkorn Memorial Hospital (KCMH) in the year 2011. Parameter uncertainty was tested in probabilistic sensitivity analysis by using Monte Carlo simulation. One-way sensitivity analysis was used to explore each variable's impact on the uncertainty of the results. Results: Approximated life expectancy of best supportive care was 0.182 years and its total cost was 26,862 Baht. All four alternative treatments increased life expectancy. Life expectancy of gemcitabine followed by BSC, PLD followed by BSC, gemcitabine followed by topotecan and PLD followed by topotecan was 0.510, 0.513, 0.566, and 0.570 years, respectively. The total cost of gemcitabine followed by BSC, PLD followed by BSC, gemcitabine followed by topotecan and PLD followed by topotecan was 113,000, 124,302, 139,788 and 151,135 Baht, respectively. PLD followed by topotecan had the highest expected quality-adjusted life-years but was the most expensive of all the above strategies. The incremental cost-effectiveness ratios (ICER) of gemcitabine followed by BSC, PLD followed by BSC, gemcitabine followed by topotecan and PLD followed by topotecan was 344,643, 385,322, 385,856, and 420,299 Baht, respectively. Conclusions: All of the second-line chemotherapy strategies showed certain benefits due to an increased life-year gained compared with best supportive care. Moreover, gemcitabine as second-line chemotherapy followed by best supportive care in progressive disease case was likely to be more effective strategy with less cost from health care provider perspective. Gemcitabine was the most cost-effective treatment among all four alternative treatments. ICER is only an economic factor. Treatment decisions should be based on the patient benefit.
Journal of the Korean Association of Oral and Maxillofacial Surgeons
/
제30권2호
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pp.136-142
/
2004
Malignant fibrous histiocytoma(MFH) is the malignant part of mesenchymal cell-originated tumor, which is supposed that the tumor is presented various histologic features consisted of fibrosarcomatic and histiocytic portions. When the tumor is arisen in the head and neck region, the most affected sites are the nasal cavity and paranasal sinuses, and secondly the maxillary alveolar bone is occasionally influenced. Therefore, MFH can readily involve the adjacent alveolar bone. The treatment of MFH in the head and neck is various, that is, the involved sites and the differentiation of tumor must be considered when the tumor is treated. The treatment protocols are subjected to general ones of soft tissue sarcoma, and simple or combination therapy is used in the surgery, chemotherapy and radiation therapy. So, we report a clinical case of chemotherapy involving intraarterial chemotherapy, and surgery of malignant fibrous histiocytoma(MFH) in the maxilla, with review of the literature.
Background: Systemic chemotherapy for patients with metastatic gastric cancer (MGC) is generally palliative, although some patients experience long-term survival after treatment. Thus, we identified clinical characteristics that are associated with long-term survival of patients with MGC after palliative chemotherapy. Materials and Methods: We retrospectively reviewed 514 MGC patients who received systemic chemotherapy at our institution from 2001 to 2008. To identify clinical predictors of survival beyond 2 years, multivariate logistic regression analyses were performed, and 5-year survival rates were estimated among MGC patients following chemotherapy. Results: Among 514 patients, 96 (19%) and 16 (3%) survived beyond 2 and 5 years, respectively, and performance status of 0 or 1 (odds ratio [OR]=3.39; p=0.01), previous gastrectomy (OR=1.86; p=0.01), single metastatic site (OR=1.80; p=0.03), and normal alkaline phosphatase levels (OR=2.81; p<0.01) were identified as independent predictors of long-term survival. Of the 16 5-year survivors, six were alive at the end of the study and showed no evidence of disease despite cessation of chemotherapy. Conclusions: The present data demonstrate distinct clinical characteristics that are associated with long-term survival of MGC patients, and indicated that palliative chemotherapy can be curative in highly selected patients.
Purpose: To examine informational needs of cancer patients receiving chemotherapy. Methods: A cross-sectional survey design was utilized. The sample was 198 cancer patients receiving chemotherapy for a diagnosis of stomach or lung cancer at a university hospital. A modified version of Toronto Informational Needs Questionnaire was applied. Results: Subjects reported highest informational needs in prognosis dimension, followed by the treatment dimension including side effects and alternative therapy. Information about medical tests and follow-up care after the treatment was also in great need. Dimensions of support for patients/family and sexuality were low in need. The degree of informational needs was negatively correlated with patient's age and number of children. Differences were found in informational needs according to the educational level employment status, and gender of the patients, while diagnosis and treatment options did not make differences in informational needs. Conclusion: Health care professionals need to perceive informational needs of cancer patients receiving chemotherapy, and to provide them with information especially in the area of prognosis and treatment. Informational intervention would be effective when it is given with consideration of patient's characteristics.
This study aimed to identify the change patterns of fatigue and quality of life during consecutive chemotherapies and to determine the relationship of these two variables. Method: Stomach cancer patients receiving chemotherapy were recruited from a university hospital in Seoul. Each chemotherapy, subjects were asked to respond to the questionnaires regarding their fatigue and quality of life. The number of subjects who completed 4 cycles and over was 11. Fatigue was measured with Lee's tool(1999). Quality of life was measured with a tool revised by the author based on Padilla et al(1983). Result: Most patients were in 1st stage(5 patients) or 3rd stage(5 patients). Fatigue was revealed at its highest level in the 3rd or 4th chemotherapy and at its lowest level in the 1st or 6th chemotherapy. A quality of life appeared at its highest level in the 5th or 6th chemotherapy and the lowest level in 3rd or 4th chemotherapy. Conclusion: Among 6 cycles of chemotherapy, in 3-4th chemotherapy the fatigue was the highest and the quality of life were the lowest. Many patients decided to stop treatment at the same period. Therefore we can recognize cancer patients receiving chemo- therapy are in the highest risk at the time of the 3-4 th chemotherapy.
This study purports to find out the meanings of chemotherapy among cancer patients. The subjects of this study were selected from those patients who have taken chemotherapy at least twice at a hospital affiliated with a university. The twelve subjects agreed to join the present study and had no problem in communication with others. The data were collected through observations and interviews by the researcher. The phenomenological analysis method proposed by Giorgi was adopted for analyzing the data. The experiences of the subjects to chemotherapy were classified into 24 atributes. These attributes were also categorized into four groups such as hope, pain, fear, and ordea according to their meanings. The subjects expressed hope through the attributes such as "the wish for a new life." "the wish for healing." "the plasure form improvement of cancer." "the wish for being discharged form a hospital." "the interest in dietectic treatment." and "the trust in medical staff." Pain was represented by such attributes as "the physical pain", "the suffering from intravenous injection." "the discomfort of hospital environment." and "the economic burden." As for the attributes represention fear, "fear of being hospitalized." "tehr obscurity of uncertain situations." "the fear of side effects." "the fear of recurrence of cancer," "the lack of knowledge of the disease." Finally, nine attributes werw frouped to ordeal "the will endeavouring to recover cancer" "the adaptation to the present situation." "the giving up of being healthy," "the regret of the past life." "the recognition of significant others." "the physical changes." "the emotional changes." "the social changes." "the recollection of illness experiences." The above findings indicate that chemotherapy means hope, pain, fear, and ordeal to those cancer patinests under treatment. Hence, the nursing interventions for those cancer patients need to be directed to maintaining hope, alleviating pain and fear, and overcoming ordeal. There are some suggestions in achieving these goals : (1) the nurses caring for cancer patients need to understand the meaning of chemotherapy experienced by those patients, (2) a nursing specialty of intravenous injection needs to be developed, (3) interventions for providing emotional support should be devised, (4) nursing care should also be available to those cancer patients being dischaged at home.
Purpose: This analysis was conducted to evaluate the cost-effectiveness of gemcitabine-cisplatin chemotherapy for non small-cell lung cancer patients in an outpatient setting compared with the traditional inpatient setting. Methods: A cost-effective analysis was conducted from a societal perspective. The effects of treatment, which was measured as an adverse event rate, were abstracted from a published literature search and empirical data from one university hospital. The costs included both direct and indirect costs. Direct costs included hospitalizations, outpatient visits, and lab tests. Pharmaceutical costs were excluded in analysis because they were same for both options. Indirect costs included productivity loss of patients as well as care-givers. In order to determine the robustness of the results, sensitivity analysis on treatment protocol was conducted. Results: Literature search showed no difference in adverse effect rates between inpatient treatment protocol and outpatient treatment protocol. Therefore, this analysis is a cost-minimization analysis. Cost-savings in the outpatient setting was 555,936 won for one treatment cycle. Our sensitivity analysis indicated that the outpatient chemotherapy still showed cost-savings, regardless of changes in treatment protocol. Conclusion: The outpatient gemcitabine-cisplatin chemotherapy for non small-cell lung cancer resulted in cost savings compared to inpatient chemotherapy. More importantly, outpatient chemotherapy could improve the utilization of health service resources in terms of available beds.
Objective: To explore the clinical efficacy and toxic and side effects of recombinant human endostatin (rhendostatin/endostar) combined with chemotherapy in the treatment of advanced gastric cancer. Materials and Methods: A total of 70 patients with advanced gastrointestinal adenocarcioma confirmed by histopathology and/or cytological examination were divided into group A (37 patients) and group B (33 patients). Patients in group A were given intravenous drip of 15 mg endostar added into 500 mL normal saline, once every other day until the cessation of chemotherapy or patients' maximal tolerance to chemotherapy. Patients in group B received chemotherapy alone. Two groups selected the same chemotherapy regimens. FOLFIRI scheme: 90-min intravenous drip of $180mg/m^2$ irinotecan, intravenous drip of $200mg/m^2$ calcium folinate (CF) and $400mg/m^2$ 5-fluorouracil (5-Fu) on d1, and continuous intravenous pumping of 2 $400mg/m^2$ 5-Fu for 46 h. FOLFOX4 scheme: intravenous injection of $85mg/m^2$ oxaliplatin (L-OHP), $200mg/m^2$ calcium folinate (CF) and $400mg/m^2$ 5-FU on d1 for 2 h, and then continuous intravenous pumping of 2 $400mg/m^2$ 5-Fu for 46 h. XELOX scheme: oral administration of 1 $500mg/m^2$ xeloda (or tegafur 50~60 mg) in twice during d1~14 and intravenous drip of $135mg/m^2$ L-OHP on d1 for 2 h. The modified FOLFOX scheme: intravenous injection of $135mg/m^2$ L-OHP on d1 for 2 h, $200mg/m^2$ CF and 1.0 g tegafur during d1~5. Whereas, control Group B received chemotherapy regimens which were same as Group A, but no addition of endostar. Before chemotherapy, patients were given intravenous injection of 8 mg ondansetron, intramuscular injection of 10 mg metoclopramide and 20 mg diphenhydramine for prevention of vomiting, protection of liver and stomach as well as symptomatic supportive treatment. One cycle was 21 d, 4~6 cycles in total. The efficacy was evaluated every 2 cycles. Results: 32 patients in Group A could be evaluated, and the response rate (RR) and disease control rate (DCR) were 59.38% and 78.13%, respectively. 31 patients in Groups could be evaluated, and the RR and DCR were 32.26% and 54.84%, respectively. The differences between 2 groups were significant. The toxic effects include myelosuppression, gastrointestinal reaction, fatigue, cardiotoxicity and peripheral neurotoxicity. Conclusions: Preliminary observations show that endostar (once every other day) combined with chemotherapy is effective in the treatment of advanced gastrointestinal cancer, with low toxic effects, good tolerance, deserving further study.
Background: This systemic analysis was conducted to evaluate the efficacy and safety of pemetrexed based chemotherapy in treating patients with metastatic breast cancer as first or second line chemotherapy. Methods: Clinical studies evaluating the efficacy and safety of pemetrexed based regimens on response and safety for patients with breast cancer were identified using a predefined search strategy. Pooled response rate (RR) of treatment were calculated. Results: In first line pemetrexed based regimens, 10 clinical studies which including 513 patients with advanced breast cancer were considered eligible for inclusion. For second line pemetrexed based chemotherapy, 5 clinical studies which including 281 patients with advanced breast cancer were considered eligible. Systemic analysis suggested that, in all patients, pooled RR was 32.6% (167/513) in pemetrexed based first line regimens, and 13.9 % (39/281) in pemetrexed based second line regimens. Major adverse effects were neutropenia, leukopenia, fatigue, and anemia in pemetrexed based first line treatment; and lymphopenia, neutropenia, leukopenia, as well as anemia in second line chemotherapy. One treatment related death occurred with pemetrexed based second line treatment. Conclusion: This systemic analysis suggests that pemetrexed based first line regimens are associated with a reasonable response rate and acceptable toxicity, however with low response rate for treating patients with metastatic breast cancer when is used in the second line.
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