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Better Response Rate (good + response_rate)
Selected AbstractsEpidermal growth factor receptor mutations in needle biopsy/aspiration samples predict response to gefitinib therapy and survival of patients with advanced nonsmall cell lung cancerINTERNATIONAL JOURNAL OF CANCER, Issue 4 2006Jin-Yuan Shih Abstract Recently, mutations in the epidermal growth factor receptor (EGFR) gene in nonsmall cell lung cancer (NSCLC) patients were reported to correlate with gefitinib response. Less than 30% of NSCLC patients are surgically resectable; however, molecular analysis has to rely on nonsurgical diagnostic tissue samples. The objective of this study is to investigate EGFR mutation analysis on needle biopsy/aspiration samples and its correlations with gefitinib response and patients' survival. EGFR mutation was assessed from DNA of 63 paraffin-embedded small needle biopsy/aspiration specimens from 62 patients with NSCLC treated with gefitinib. The peripheral blood lymphocyte DNA of the patients was sequenced to verify the EGFR mutation. EGFR mutations were found in 47% of 62 patients (60% of 20 CT-guided biopsies, 44% of 18 ultrasound-guided biopsies, 31% of 16 endoscopic biopsies and 44% of 9 effusion cell blocks). EGFR mutations were frequently present in females (p = 0.006) and never smokers (p = 0.04). Patients with EGFR mutations had a significantly better response rate compared to that of the nonmutation group (p < 0.001). Multivariate analysis showed that EGFR mutation (p < 0.001) and PS 0,1 (p = 0.02) were independently associated with a better response rate. Cox regression analysis showed that EGFR mutation was the independent prognostic factor for progression-free survival (p = 0.008) and overall survival (p = 0.03). In conclusion, EGFR mutation analysis is feasible in needle biopsy/aspiration paraffin-fixed specimens. EGFR mutation is an independent predictor of gefitinib response and survival in patients of advanced NSCLC treated by gefitinib. © 2005 Wiley-Liss, Inc. [source] A prospective, multicentre clinical trial comparing cisplatin plus gemcitabine with cisplatin plus etoposide in patients with locally advanced and metastatic non-small cell lung cancerRESPIROLOGY, Issue 4 2005Tuncay GOKSEL Objective: Cisplatin-gemcitabine (PG) and cisplatin-etoposide (PE) combinations are active regimens for non-small cell lung cancer (NSCLC). The present study aimed to compare PG with PE in the treatment of patients with stage IIIB and IV NSCLC. Methodology: We conducted a prospective, multicentre trial. A total of 166 patients were enrolled into the study and received either gemcitabine (1000 mg/m2) on days 1, 8 and 15 plus cisplatin (80 mg/m2) on day 2 every 4 weeks, or etoposide (100 mg/m2) on days 1, 2 and 3 plus cisplatin (80 mg/m2) on day 1 every 3 weeks. Results: The overall response rate was superior in the PG group (54.8%vs 39.0%, P = 0.045). There was no significant difference in survival between the two groups, with respective median and 1-year survival of 38 weeks and 33.3% for the PG group, and 34 weeks and 23.2% for the PE group. There was also no statistical difference for time to progression between the two groups. Neutropenia and thrombocytopenia were seen more frequently in the PG group (grade 3 neutropenia, 33.3%vs 15.9%, P = 0.012; grade 3 thrombocytopenia, 27.4%vs 3.7%, P < 0.001 and grade 4 thrombocytopenia, 10.7%vs 1.2%, P = 0.018). Conclusion: PG is an active chemotherapy regimen and has a better response rate than PE in advanced NSCLC, although there was no difference in time to progression and overall survival. A higher incidence of haematological toxicity was seen with PG than with PE. [source] A Phase II study of gemcitabine and cisplatin in advanced biliary tract cancerCANCER, Issue 6 2006Seung Tai Kim M.D. Abstract BACKGROUND The authors performed a Phase II study of combination chemotherapy with gemcitabine and cisplatin in patients with inoperable biliary tract cancer to evaluate efficacy and toxicity of this combination. In addition, the correlation between the CA 19-9 response and clinical outcome was analyzed. METHODS The eligibility criteria for this study were 1) histologically or cytologically confirmed inoperable biliary tract cancer in patients with metastatic or recurrent disease; 2) age between 18 and 70 years; 3) at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria; 4) an Eastern Cooperative Oncology Group (ECOG) performance status , 2; 5) a life expectancy of at least 3 mos; and 6) adequate bone marrow, hepatic, and renal function. The patients received gemcitabine (1250 mg/m2, Days 1 and 8) and cisplatin (60 mg/m2, Day 1) every 3 weeks. Tumor response was assessed by RECIST criteria every 2 cycles of chemotherapy. Treatment was continued until progression of disease was documented. RESULTS Twenty-nine patients were enrolled. The median age of these patients was 52 years (range, 37 to 69 yrs), and the median ECOG performance status was 1. No complete response was observed, and 10 of 29 patients had partial responses. The overall response rate was 34.5% (95% confidence interval [CI], 17.9,54.3) for the intent-to-treat analysis. Stable disease was observed in 4 (13.8%) patients and progressive disease in 13 (44.8%) patients. The median follow-up time was 10.0 months (95% CI, 7.2,12.8). The median time to progression (TTP) was 3.0 months (95% CI, 2.12,3.88), and the median overall survival was 11 months (95% CI, 5.49,16.5). Although these results showed a better response rate (57.1 % vs. 27.3%) and survival (12 vs. 10 mos) in patients with a decline in CA 19-9 of at least 25%, these data were statistically not significant. In addition, there was a significant positive correlation between the increment in CA 19-9 values and tumor progression as determined with RECIST criteria (r = 0.96, P < 0.01). However, there was no definite correlation between the CA 19-9 response and the response according to RECIST criteria (P = 0.087). National Cancer Institute (NCI) common toxicity criteria (CTC) Grade 3 or 4 hematologic toxicities included neutropenia in 4 (14%) patients and anemia in 1 (3%) patient. Two of 4 patients with Grade 3 or 4 neutropenia had febrile episodes (7%) and required hospital admissions. NCI-CTC Grade 3 or 4 nonhematologic toxicity included nausea in 1 (3%) patient. There were no treatment-related deaths. CONCLUSION The combination chemotherapy with gemcitabine and cisplatin in inoperable biliary tract cancer was tolerable for most patients and showed modest response rates. The role of CA 19-9 monitoring as a surrogate biomarker in patients with BTC treated with gemcitabine chemotherapy should be further investigated. Cancer 2006. © 2006 American Cancer Society. [source] Methodological challenges in assessing general population reactions in the immediate aftermath of a terrorist attackINTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, Issue S2 2008G. James Rubin Abstract Assessing mental health needs following a disaster is important, particularly within high-risk groups such as first responders or individuals who found themselves directly caught up in the incident. Particularly following events involving widespread destruction, ingenuity and hard work are required to successfully study these issues. When considering responses among the general population following less devastating events such as a conventional terrorist attack, or following an event involving a chemical, biological, radiological or nuclear agent, other variables may become more relevant for determining the population's overall psychosocial well-being. Trust, perceived risk, sense of safety, willingness to take prophylaxis and unnecessary attendance at medical facilities will all be important in determining the overall psychological, medical, economic and political impact of such attacks. Assessing these variables can help government agencies and non-governmental organizations to adjust their communication and outreach efforts. As there is often a need to provide these data quickly, telephone surveys using short time-windows for data collection or which use quota samples are often required. It is unclear whether slower, more conventional and more expensive survey methods with better response rates would produce results different enough to these quicker and cheaper methods to have a major impact on any resulting policy decisions. This empirical question would benefit from further study. Copyright © 2008 John Wiley & Sons, Ltd. [source] Caterers' experiences and perceptions of implementing the 2006 school meal standardsJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 5 2008C.J. Weir Background:, School meal standards were introduced in 2006 (Department for Education and Skills) and caterers are expected to comply with these standards. No research has been conducted looking at the caterer's experiences and perceptions of implementing these standards. This area has 32 school meal provider organisations for 103 schools. Half the schools are with one provider and the others are, mostly, single-handed in-house operations, often managed by a local community member. The aim of the current study was to explore caterers' understanding of the school meal standards, the barriers to implementation, and proposed solutions, to inform local practice. Methods:, A combined quantitative and qualitative design was used. A questionnaire was used to assess understanding and implementation of the standards and distributed to all the catering provider organisations (n = 32), with a good response rate of 78% (n = 25). For each question about achievement of the ten food-based standards the responses were scored 0,4 where: 0 = ,Do not intend to achieve this standard'; to 4 = ,Fully achieved'. This gave a total standards achievement score for each catering provider organisation, where the minimum score that could be achieved was zero which indicated the minimum level of achievement and the maximum score which could be achieved was forty which indicated all ten standards fully achieved. Four focus group were undertaken involving 40 people who considered themselves to be in a management role within a catering provider organisation. Semi structured interviews were undertaken with 11 people (until saturation), using purposive sampling, to explore barriers and solutions to implementation of the standards in detail. Descriptive and appropriate inferential statistics (Fisher's Exact tests and independent samples t- tests) were performedon the datausingStatistical Package for Social Sciences (SPSS). The process undertaken for the qualitative analysis was thematic analysis, and used analytic hierarchy (Richie & Lewis, 2003). Approval for this study was obtained from Leeds Metropolitan University ethics committee. Results:, The qualitative discussions led to caterers' identifying two main themes. These were: support from various groups, and the roles and responsibilities caterers believed these groups had and should be performing in order to achieve successful implementation of the standards ,Think it's good someone's shaken up school meals but who is doing the actually work , it's us isn't it'.(Semi structured interview respondent medium primary provider) ,I've found it really difficult as I'm on my own at the school, totally on my own without anyone to help'. (Focus group participant primary school group). The groups that caterers identified as those who had roles and responsibilities and who should be providing support were the ,whole school'; catering provider organisations; parents; the local authority; and, the broader environment/whole population. Caterers felt the standards had ,gone too far too soon' and did not allow choice. Caterers felt finances were a barrier, and that training was required across all sectors to achieve success. The standards implementation achievement score were statistically higher for caterers who had received formal training compared with those with only food and hygiene (P = 0.001); and, between caterers who provided to a secondary school as opposed to a primary school only (P = 0.034). There was a statistically significant relationship between providers and qualifications with those providing to secondary schools more likely to have had formal qualifications (P = 0.015). Discussion:, Caterers felt all those involved in schools and school meals needed to undertake their roles and responsibilities, to provide support, and, to implement the ethos of a whole school approach. The caterers in this study identified many barriers and practical obstacles either experienced or perceived to implementing the new school meals standards. Conclusions:, The results will be used to inform the Local Authority and Primary Care Trust to ensure the effective implementation of the school meal standards. There may be opportunity to transfer these results to other school caterers, and to develop support and training to assist implementation. [source] About the cutaneous targets of bexarotene in CTCL patientsEXPERIMENTAL DERMATOLOGY, Issue 8 2010Anne Chantal Knol Please cite this paper as: About the cutaneous targets of bexarotene in CTCL patients. Experimental Dermatology 2010; 19: e299,e301. Abstract:, There are several approved therapies for cutaneous T-cell lymphoma (CTCL). The retinoids are one of the major biologic response modifiers used in CTCL, producing good response rates but few complete responses. Bexarotene has been demonstrated to act on malignant T-cells by inducing their apoptosis, but nothing is known about its role on keratinocytes and Langerhans cells. Immunohistochemical analysis using CD1a, HLA-DR, ICAM-1 (activation markers), CD95 and CD40 (apoptosis markers) was conducted on frozen sections of bexarotene-exposed cutaneous explants and skin biopsy specimens from patients treated with bexarotene. None of the studied markers was significantly modulated both on cutaneous explants and on skin biopsy specimens after treatment with bexarotene, compared to controls. Langerhans cells and keratinocytes do not appear to play a central role in the therapeutic control of CTCL by bexarotene therapy. The main bexarotene's target thus remains T-cells by inducing their apoptosis, a mechanism that is different from the other retinoids used in CTCL. [source] Therapy of metastasized Merkel cell carcinoma with liposomal doxorubicin in combination with radiotherapyJOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, Issue 6 2009Marion Wobser Summary Background: Merkel cell carcinoma is a rare skin cancer of neuroendocrine origin, which is characterized by a high rate of recurrence, metastatic spread and mortality. Because of its rarity, evidence-based therapeutic regimens are difficult to establish. Merkel cell carcinoma is known to be both radio- and chemosensitive. Toxicity is a key factor in assessing any regimen, as the patients are usually elderly and likely to have other significant medical problems. Patients and Methods: We retrospectively evaluated five patients with metastatic Merkel cell carcinoma to see if liposomal doxorubicin (Caelyx® or Myocet®) in combination with radiotherapy exhibited clinical anti-tumoral effects accompanied by acceptable side effects. Results: The outpatient chemotherapy regimen was tolerated without major side effects and produced good response rates. All patients achieved at least tumor stabilization; four of five had a partial remission. Effects of therapy were usually seen in the first cycle of therapy but the responses were of short duration with an average interval of two months until progression. Conclusions: As combined radiochemotherapy with liposomal doxorubicin is well tolerated even in older patients with other illnesses and can be given on an outpatient basis, it is an attractive option for metastatic Merkel cell carcinoma. Based on response rate or overall survival, it offers no advantages compared to polychemotherapy. [source] |