health services and public health

Annals of Oncology 21 (Supplement 8): viii337–viii347, 2010 doi:10.1093/annonc/mdq529 1085PD MAINTENANCE CHEMOTHERAPY IN ADVANCED NONSMALL CELL LUNG...
Author: Horace Wade
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Annals of Oncology 21 (Supplement 8): viii337–viii347, 2010 doi:10.1093/annonc/mdq529

1085PD

MAINTENANCE CHEMOTHERAPY IN ADVANCED NONSMALL CELL LUNG CANCER: COST UTILITY OF PEMETREXED AND GEMCITABINE

T.K. Takahashi, F.H. Souza, T.B.C. Rosa, G. Castro, P.M. Hoff Clinical Oncology, Instituto do Caˆncer do Estado de Sao Paulo, Sao Paulo/ BRAZIL Background: Maintenance chemotherapy (MCT) prolongs both progression-free survival (PFS) and overall survival in selected non-small cell lung cancer (NSCLC) patients (pts). In this setting, pemetrexed and gemcitabine were shown to be effective in comparison to best supportive care (BSC) in randomized controlled trials, at least in terms of PFS. Here the incremental cost-utility ratio (ICUR) of pemetrexed and gemcitabine as MCT were estimated, taking into account that docetaxel + BSC is a standard practice in those pts with progressive disease (PD) after first-line platinumbased chemotherapy. Methods: A retrospective chart review was conducted to obtain demographic, clinicalpathological and associated medical resource costs in pts presenting advanced NSCLC, ECOG-PS 0-2, admitted after first-line platinum-based chemotherapy, with no PD. A Markov model with a 2-year horizon was constructed using TreeAge Pro Suite 2009 software, to estimate ICUR of MCT, based on its efficacy, measured by the hazard ratio derived from published data and observed costs. Costs associated with MCT were based on medical resource use; unit costs were derived from national and local resources; utilities were based on the available literature data. The analysis took a Brazilian government perspective and drug costs were based on 2008 Brazilian maximum wholesales price to government. Costs and utilities were discounted at 5%. Sensitivity analyses were conducted. Results: Relative to standard treatment, the costs of gemcitabine and pemetrexed gained per quality-adjusted life year (QALY) were BRL 75418 and BRL 1841922 respectively (1 EUR = 2.18 BRL). The model showed robustness for variations in deterministic sensitivity analyses and no impact on parameter uncertainties of the model results were detected. Conclusions: Pemetrexed-based MCT has a high cost of drug acquisition and it is a very expensive strategy to the Brazilian Public Healthcare system, without relevant gains in QALY. ICUR of gemcitabine and pemetrexed over standard treatment does not seem to be cost-effective from our perspective, and docetaxel after PD remains the most cost-effective strategy. Disclosure: All authors have declared no conflicts of interest.

1086PD

IMPROVING THE QUALITY OF ABSTRACTS FOR COSTEFFECTIVENESS ANALYSES (CEA) IN ONCOLOGY

W.Y. Cheung1, M.Y. Ho1, K. Chan2, M. Cheung2, S. Peacock1 1 Medical Oncology, British Columbia Cancer Agency, Vancouver/CANADA, 2 Sunnybrook Odette Cancer Center, Toronto/CANADA Background: Increasing costs of new cancer drugs underscore the importance of CEA, which convey key information about the incremental costs versus benefits of novel interventions in oncology. While guidelines for abstract reporting exist for phase I studies and randomized controlled trials, similar recommendations are lacking for CEA. Our objectives were to 1) identify elements considered by experts as essential for CEA abstracts, 2) evaluate the quality of CEA abstracts submitted to international oncology meetings, and 3) propose guidelines to improve future reporting. Methods: Health economic experts were surveyed and asked to rate each of 24 possible CEA elements on a 5-point Likert scale. A composite scoring system for abstract quality (where 0=poor and 100=excellent) was devised based on CEA elements with an average expert rating ‡3.5. CEA abstracts from international oncology meetings between 1997 and 2009 were reviewed and assigned a quality score. Results: Among 99 experts surveyed, 50 (51%) responded. Characteristics of the 50 survey respondents: average age = 53; male = 78%; USA / Europe / Canada = 54% / 28% / 18%; years of experience = 24. A total of 216 abstracts were reviewed. The median quality score was 75 (range 48 to 93), but notable deficiencies were observed in abstract reporting. For instance, the cost perspective of the economic analysis was described in only 61% of abstracts, while the time horizon of the analysis was reported in only 47%. A significant association was seen between the year of presentation and the overall quality of abstract, with those from recent years demonstrating better

quality scores. CEA involving hematological malignancies also possessed higher quality scores compared to those exploring other cancer sites. Conclusion: Quality of CEA abstracts has improved over time at major oncology meetings, but there is room for further improvements. Abstracts may be enhanced using the guidelines derived from our survey of experts (see table).

ITEMS THAT ARE ABSOLUTELY ESSENTIAL Type of CEA Description of intervention Description of comparator ITEMS THAT SHOULD BE REPORTED Target population for intervention Time horizon Perspective Method in which denominator was derived Cost-effectiveness ratio Conclusion about cost-effectiveness of intervention Currency ITEMS THAT MAY BE REPORTED IF SPACE PERMITS Background of cost problem Costs that were included Sensitivity analysis Setting of study Discounting

Disclosure: All authors have declared no conflicts of interest.

1087PD

ORAL PREVALENCE AND CLEARANCE OF HIGH-RISK HUMAN PAPILLOMA VIRUS (HR-HPV) IN HEALTHY PEOPLE IN SAN PATRIGNANO, A REHABILITATION COMMUNITY FOR SUBSTANCE ABUSERS

D.B. Pugliese1, G. Bruzzesi2, C. Montaldo3, M. Landi4, A. Mastinu3, L. Porcu5, V. Torri5, L.D. Locati6, L. Licitra7 1 Odontostomathology Center, Centro Medico San Patrignano, Coriano/ITALY, 2 Odontostomathology Service, Centro Medico San Patrignano, Rimini/ITALY, 3 Oral Cavity Biotechnology Service, University of Cagliari, Cagliari/ITALY, 4 Fondazione Andi Onlus, Milano/ITALY, 5Laboratory of New Drug Development Strategies, Oncology Department, Mario Negri Institute, Milano/ITALY, 6Head and Neck Medical Oncology, IRCCS Istituto Tumori Milano, Milano/ITALY, 7 Medical Oncology, Head and Neck Dept., Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan/ITALY Background: Very few data are available about the prevalence of HR-HPV oral infection in healthy people [4% for HPV16 was reported in a case-control study from a US series (D’Souza, NEJM 2007)]. Some factors seem to contribute to increase the risk of infection (e.g. poor oral care, marijuana and tobacco exposure, alcohol abuse). San Patrignano is a drug-free rehabilitation community designed to cure substance abusers. At entrance into the community a program of oral care is established and since May 2007, a strict smoke-free policy has been adopted. This community-based population is considered at ‘‘high-risk’’ for HPV due to their behavioral habits. Our aim was to measure the prevalence of HR-HPV oral infection in this selected population. Methods: From March 2007 to April 2008 all subjects who agreed to follow the oral care program were evaluated. A brushing of the base of the tongue, bilateral tonsils and glossotonsillar sulcus was performed at baseline, at 6 and at 12 months. All baseline samples were collected before the smoke-free policy was adopted while the other samples were collected after this date. HPV DNA analysis was carried out by seminested PCR while HPV genotype was analyzed by capillary sequencing method. The logistic regression model was used to determine if demographic, behavioural characteristics and immunological status were correlated to the prevalence of HR-HPV and to estimate the relative risk; a p-value less than 0.05 was considered statistically significant. Results: One hundred and ninety-four (148 M/46 F) subjects were analyzed. Twentyfive (13%) were HR-HPV positive (8 HPV31, 5 HPV16, 5 HPV18, 3 HPV26, 2 HPV33, 2 HPV35) at baseline, 1 sample was still positive at 6 months which turned out negative at 12 months. HR-HPV infection was not statistically associated to age, gender, HIV status, AIDS, HCV, number of years resident in the community, use of marijuana/ hashish, number of years of drug consumption, tobacco and alcohol exposure, sex with drug addicts and condom use. Conclusions: In this ‘‘high-risk’’ population the baseline oral prevalence of HR-HPV was 13%. Intensive efforts towards lifestyle behaviour changes were made. After one year 100% clearance of HPV was observed. Supported by Fondazione ANDI (Associazione Nazionale Dentisti Italiani) onlus Disclosure: All authors have declared no conflicts of interest.

ª The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected]

abstracts

health services and public health

abstracts 1088PD

BREAST CANCER IS A MORE AGGRESSIVE DISEASE IN PALESTINIAN ARAB WOMEN THAN IN JEWISH WOMEN IN ISRAEL

J. Zidan1, N. Sikorsky2, E. Friedman2, W. Basher2, M. Steiner2, A. Sharabi2 1 Oncology, Ziv Medical Center, Safed/ISRAEL, 2Ziv medical center, Safed/ ISRAEL Purpose Breast cancer does not affect ethnic groups equally. Breast cancer mortality is higher in Israeli Palestinian Arab than among Israeli Jewish women. This study aims to compare clinical, biological and pathological characteristics of breast cancer in the two populations. Patients and methods Records of 1140 women with breast cancer treated at Northern Israel between 2002 and 2007 were reviewed: 872 Jews and 268 Arabs. Age at diagnosis, tumor stage, pathological differentiation, estrogen receptor (ER), and HER2 overexpression were evaluated. Results: Mean age at diagnosis was 49.9 years for Arabs and 59.4 years for Jews (P26 (P=0.031). HER-2

doi:10.1093/annonc/mdq529 | viii345

abstracts

Annals of Oncology

negative are more likely to be obese (RR 1.26, CI 1.079-1.47); postmenopausal women have a bigger risk to be obese (RR 1.29, CI 1.08-1.56). In the subanalysis of association between triple negative, obesity and menopausal status, there was no difference. We found the combination obesity-insulin resistance frequently in postmenopausal women. Conclusion: Two thirds of Mexican breast cancer patients have a BMI>25, however we could not show the association between obesity and poor prognosis, probably because the sample is small, obesity prevalence is too large and follow-up is short. A strong trend for triple negative patients to be overweight (BMI >26) was seen. More analysis is needed to support this claim. Disclosure: All authors have declared no conflicts of interest.

1119

MOUTH CANCER AWARENESS PROGRAMME IN SINGAPORE

V. Fan1, L.C. Wong2 Oral and Maxillofacial Surgery, National University Hospital, SINGAPORE, 2 Radiation Oncology, National Cancer Institute, SINGAPORE

1

Introduction: As a small nation with easy access to medical care, the cases of advanced oral cancer was considered high. This Mouth Cancer Awareness Week was the first initiative in Singapore to hope to improve early detection of oral cancers. Methodology: An annual Mouth Cancer Awareness Week was initiated in 2007 through collaboration among Faculty of Dentistry (National University of Singapore), Department of Oral and Maxillofacial Surgery (OMS, National University Hospital), Singapore Dental Association and Association of Oral and Maxillofacial Surgeons (Singapore). There were three categories of activities : 1. Public Oral Health Symposium and General Practitioner (GP) Educational Talks in English and Chinese – target audience included Dentists and Oral Health Therapists in General Practice and public. 2. Free Mouth Cancer/Oral Health screening for public by appointments. Clinical oral examination with Velscope screening tool was used for assessment. 3. Public Forum on Mouth Cancer. The emphasis was on multidisciplinary approach in the care of oral cancer patients. The speakers consisted of Oral Maxillofacial Surgeon, Radiation Oncologist, Radiation Therapist, Medical Oncologist, Dental Surgeon, Speech Therapist and Dietitian. There were questions and answers sessions. Results:

No of Participants

19-24 Nov 2007

24-29 Nov 2008

7-14 Nov 2009

GP Talks1 Free Oral Health Screening Public Forum Total

98 97 72 267

213 73 47 333

81 128 48 257

1 General Practitioners (GP) Outcome Most of the participants who attended the programmes were unaware of the fact that there was such a thing as mouth or tongue cancer. This was seen in the questionnaire form that was given to participants in the free oral cancer screening clinic. Analysis of some of responses will be referred to in the presentation.

Conclusion: This Mouth Cancer Awareness Week is a small step forward in increasing public awareness and early detection of mouth cancers. Reference 1Singapore cancer Report 1998-2002 Disclosure: All authors have declared no conflicts of interest.

1120

TIME ELAPSED BETWEEN SYMPTOM ONSET, MEDICAL CONSULTATION, DIAGNOSIS AND TREATMENT IN PATIENT WITH ADVANCED NON-SMALL-CELL LUNG CANCER

E. Richardet Oncologia, Instituto Oncologico de Cordoba, Cordoba/ARGENTINA Purpose: to determine the time elapsed between the first symptom to the initial treatment, the first medical consultation and the diagnosis in advanced non-small-cell lung cancer, in patients at the Instituto Oncologico de Cordoba and to compare results with historical records. Patients and methods: We reviewed data from a 180 patients that assisted at our institution from 2002 to 2009. We recorded the first symptom date as well as the first medical contact, diagnosis and treatment date. Time was expressed in weeks. Results: The average time from the first symptoms to the beginning of treatment was 19.3 weeks. From symptoms to the first doctor contact there were 8.4 weeks, and between diagnosis and treatment were 4.4 weeks. No differences were found between both genders. Those who were tobacco consumers delayed their consultation when

viii346 | abstracts

compared to smokers (8.1 weeks vs 5.1 weeks, P=0.05). In elderly patients, it took them 5.8 weeks from symptoms onset to the first medical provider contact; those under 70 delayed 8.2 weeks (P=0.08). Women received treatment earlier compared with men (3.5 weeks vs 4.8 weeks, P=0.07). In a multivariate analysis, only nicotine habit and ECOG performance status (0 and 1 vs 2) were found strongly related with a longer time to the first contact with a doctor. Only females showed a shorter time from diagnosis to treatment (P=0.07). A trend toward a shorter time between symptoms and medical consultation favored health care professionals (3.6 weeks vs 6.4 weeks, P=0.11). Those patients under public health insurance were diagnosed earlier compared with private health insurances (5.2 weeks vs 9.2 weeks, P=0.01). There were no differences between the patients who actually lived in Cordoba and those whose residence was in the interior, neither was there any difference between professionals and those with lower education. Conclusions: Our findings showed a mean delay of 19.3 weeks from the first symptoms to the beginning of treatment; we found that the average time elapsed between symptoms onset and first medical contact was 6.5 weeks and between then and diagnosis was 8.4 weeks. There are few studies and little literature that we can use to compare this with. Disclosure: All authors have declared no conflicts of interest. 1121

IMPROVING PATIENTS ACCEPTANCE OF TOTALLY IMPLANTED PORTS (TIP); THE EXPERIENCE OF A SINGLE INSTITUTION

A. Marino, P. Fedele, A. Nacci, L. Orlando, M. D’Amico, S. Cinieri U.O.C. Oncologia, Ospedale Brindisi, Brindisi/ITALY Background: Venous access devices are indicated for many persons who require reliable long term venous access. Totally implanted ports (TIP) have become a standard part of patient care, providing long term central venous access for treatment administration and other procedures. Central venous catheters (CVC) have provided many benefits in modern-day medical practice; however they also put patients at risk of catheter-related complications. While there were several systematic reviews of CVC related issues, there was few reports about the patient’s degree of satisfaction and psycological and physical problems CVC related. Methods: From December 2009 to Febrary 2010 we evalueted patient’s knowledge about TIP, degree of satisfaction and patient’s changes in quality of life, frequent complications (infection, thrombosis, occlusion and extravasation), issues of TIP management, through a questionnaire administered to 65 consecutive patients. Moreover we developed an information leaflet to improve patient’s understanding and acceptance of TIP. Results: Among 65 enrolled patients, 64 were evaluable; 33 male and 32 female. Age was: 30-50 in 20%; 50-70 in 66% ; and >70 in 14%. ECOG performance status (PS) was >2 in 4 patients < 2 in 61 pts . TIP holding time was >6 months in 43%,

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