EU5 Countries Research Articles

Epidemiology Projection Trends for Non-Hodgkin Lymphoma (NHL) and Its Subtypes in the United States (US) and Europe (EU)

AbstractAbstract 5074 BackgroundNHL is the 10th most common cancer worldwide, and a major cause of cancer-related deaths despite major advances in therapy (GLOBOCAN 2008). It encompasses a heterogeneous group of hematological malignancies originating in lymphoid tissue, mainly B lymphocytes (B-cell NHL) with an overall 5-year survival of 50–60%. There is lack of published data on the distribution of patients across lines of therapy and by subtype. MethodEpidemiological data was obtained for US and EU using the 'epic oncology' 2012 database (Epiphany Partners Inc.). The database includes line of therapy estimations using an advanced patient flow model combining survival by subset and course of treatment, response rates and outcomes, and treatment data from U. S. and EU cancer registries coupled with primary research with a representative sample of physicians and secondary therapeutic reviews.We analyzed projection estimates up to 2020 across US and EU5 countries by subtype and line of therapy with specific attention to relapsed/refractory patients. Refractory patients are those who do not respond (do not go into remission) following therapy. Relapsed patients are defined as those who have responded to therapy (enter remission) who then re-enter the treatment population due to progression of their cancer, recurrence of diagnostic markers, or symptomatology. ResultProjection estimates from 2010 to 2020 by line of therapy varied by country. Among EU countries the highest number of treated patients was in Italy followed by Germany and UK. By 2020, the percentage of patients that will have relapsed and/or be refractory to all lines of therapy will increase by about 35% in US and 11% in EU with regional variation observed among France (18%), Italy (15. 2%), Spain (3%), and UK (18%). In both the US and EU, about 30% of patients relapse and 20% are refractory after 1st line treatment. In 2nd as well as 3rd line, about 35% relapse or are refractory after treatment in the respective lines. In the US, the percent increase from 2010 to 2020 by line of therapy (1st, 2nd, 3rd) is greatest for MCL patients (55, 58, 59%) followed by FL (40, 49, 41%) and DLBCL (28, 33, and 36%).Epidemiology projection trends for US and EU by line of therapy and sub typeUSEU5 (France, Germany, Italy, Spain, UK)TotalFollicularDLBCLMantle CellOther B-cellTotalFollicularDLBCLMantle CellOther B-cell20101L47,7897,77122,3662,74111,74339,5416,65917,9761,82010,8841L Refractory9,4512,3702,7535262,9569,4749845,2005321,9721L Relapse14,7754,3253,5088805,4649,8472,2942,5944443,7002L16,5402,8947,8941,2223,27411,2751,2076,6716192,0062L Refractory5,7879872,5464581,1063,9454122,1532316772L Relapse5,5041,1542,2484371,1563,7524811,9002227083L9,7541,3085,6027571,2204,5273032,9372475523L Refractory3,3894161,8662743941,57396979901793L Relapse3,9965782,3872944941,8551331,2509522320201L643201089928524424516447438097396198772018120711L Refractory13006332735118144352104871091574658921861L Relapse204436158446214067922109752554287650141212L2279540751045619324565125171338739569622222L Refractory7974138633707231544437945523832617522L Relapse7597163629767021621417153721052527903L135681841763412051645502533632572796113L Refractory47115872541435528174410710851011963L Relapse5531814325147466120481491387110245Source: ‘epic oncology' 2012 Database, Epiphany Partners Inc., Accessed August 2, 2012.Note: T cell data not shown due to word count limit. Estimates include all stages. ConclusionDue to the indolent or aggressive nature of NHL, the proportion of patients who will progress from 1st line to 2nd line therapy varies between 35% in US and 29% in EU based on current treatment options. This, along with the high percentage of relapsed and refractory patients in 2nd or higher lines argues for continued efforts to be made for the development of more efficacious treatments for NHL. The observed three fold difference between US and EU increase could be due to an increased incidence in recent historical years or an association between one or more of the risk factors, such as hepatitis C, which is more common in US or autoimmune disorders such as HIV. Real world data and disease based registries can help in validating emerging trends in therapy through providing up to date global projection estimates across line of therapy. Disclosures:Trask:Sanofi: Employment. Mehta:Sanofi: Employment. Abbe:Sanofi: Employment, Equity Ownership. RuizSoto:Sanofi: Employment.

Treatment pattern by hormone receptors and HER2 status in patients with metastatic breast cancer in the UK, Germany, France, Spain and Italy (EU-5): results from a physician survey

The differences in country-specific treatment patterns across Europe for metastatic breast cancer (mBC) patients have not been extensively studied. This study compared the treatment choices in aggregate, as well as by biomarker status, between various lines of therapy in clinical practice in the EU-5 countries among newly diagnosed mBC patients. The IMS LifeLink™ Oncology Analyzer database, based on surveys of practicing oncologists, was used to identify mBC patients aged ≥21 years. In this database, sample-level data are projected to national-level estimates for each country using a sample projection technique. The prevalence of hormone receptors (71-74%) is quite similar across different countries, while HER2 overexpression varies from 22 (France) to 34% (Italy); chemotherapy combined with HER2-targeted medicine was the mainstay of treatment for HER2(+) patients. The use of HER2-targeted medicine and bevacizumab greatly varied: while they were most frequently used in France, they were least frequently used in the UK. Fewer treatment options existed for triple-negative patients and patients with HER2(+) disease following trastuzumab treatment. Chemotherapy was the treatment choice for triple-negative patients, as these patients do not respond to hormonal therapy and HER2-targeted medicine. This study found that, while a trastuzumab-based regimen is the preferred option for treating HER2(+) mBC patients in the EU-5, variations in this personalized medicine approach exist between different EU-5 countries. However, fewer treatment options exist for triple-negative and HER2(+) patients after trastuzumab treatment, highlighting the unmet need for these patient subgroups.

981P - Epidemiology Projection Trends for Ovarian Cancer (OC) Patients by Platinum Response Status in Europe and U.S.

ABSTRACT Background Ovarian cancer is the eighth most commonly diagnosed cancer among women worldwide with an estimated 225,500 new cases and 140,000 deaths per year. There is a lack of published data on the distribution of patients across lines of therapy based on their platinum response status i.e. platinum resistant/refractory or platinum-sensitive. Table: 981P Year Line of therapy * Number of patients France Germany Italy Spain UK EU 5 US 2010 1L ** 4046 7546 4479 2649 5386 24106 16301 2L Platinum Sensitive 1448 2711 1604 947 1937 8647 4546 2L Platinum Refractory 1196 2238 1324 782 1599 7139 2557 3L 1233 2316 1366 806 1656 7377 4430 ^ 4L 407 767 451 266 549 2440 NA 2020 1L ** 4552 8015 4928 3067 5774 26336 19258 2L Platinum Sensitive 1631 2874 1767 1098 2069 9439 5354 2L Platinum Refractory 1346 2373 1458 906 1708 7791 3011 3L 1389 2451 1506 935 1763 8044 5218 ^ 4L 459 810 498 308 582 2657 NA NA = not available Source: CancerMPact® Kantar Health (www.cancermpact.com) Accessed Mar 2011 for EU, Jan 2012 for US * patient may receive multiple lines of therapy in given year; ** stage II, III, IV combined; ^ for US, includes 3L + 4L; Methods Epidemiological data was obtained for US and EU using CancerMPact® database. This database includes line of therapy estimations using the US National Oncology Data Alliance numbers combined with a survey of a representative sample of physicians in the U.S. and Europe. Using historical data, we analyzed projection estimates up to 2020 across US and EU5 countries by line of therapy and platinum response status. Results Projection estimates from 2010 to 2020 by line of therapy varied by country. Among EU countries, the highest number of treated patients was in Germany, followed by United Kingdom (UK) and Italy. By 2020, the percentages of patients that are platinum sensitive and platinum refractory are expected to increase by about 17% in the US and 9% in the EU. Regional variation was observed across Europe with percentage increase in France being 12%, Germany 6%, Italy 10%, Spain 16% and UK 7%. The table below refers to the number of ovarian cancer patients by line of therapy. Conclusions Despite ongoing therapeutic efforts, only 44%of patients in US and 65% in EU who receive 1L go on to 2L. This argues for continued efforts to be made for the development of more efficacious treatments for ovarian cancer. Real world data and disease based registries can help in validating emerging trends in therapy through providing up to date global projection estimates across line of therapy. Disclosure J. Mehta: Employee of Sanofi R. Olivares: Employee of Sanofi O. Moulard: Employee of Sanofi P. Trask: Employee of Sanofi and owns stock A. Hamed: Employee of Sanofi.

902P - Prevalence of Non-Metastatic Castration-Resistant Prostate Cancer in Europe

ABSTRACT Background Non-metastatic (M0) castration-resistant prostate cancer (CRPC) is a growing public health burden that has not been adequately quantified. The increased incidence of prostate cancer (PC) in Europe in the last two decades is a result of widespread prostate-specific antigen (PSA) screening, and associated with declines in mortality and improved survival as more men are diagnosed with M0 disease. A proportion of men with M0 PC will receive medical or surgical androgen deprivation therapy (ADT). Many ADT-treated men eventually relapse to develop M0 CRPC, characterized by rising PSA without evidence of metastases while on ADT. We report results of a model to estimate the prevalence of M0 CRPC in key populations in Europe. Methods The model uses age-specific incidence and survival data from population-based national cancer registries to estimate 5-, 10-, and 20-year limited duration prevalence of PC and M0 PC in each country, each year from 2008 to 2026. ADT rates for M0 PC by country reported by the literature and IMS Oncology Analyser™ and disease relapse and progression rates from the literature are applied to estimate prevalence of ADT-treated and M0 CRPC subgroups. Results For EU-5 countries (France, Germany, Italy, Spain, and UK), the model projects that 5-year prevalence of PC will increase from approximately 1.0 million in 2012 to 1.3 million in 2026 as a result of wider adoption of PSA testing and aging of the populations. M0 PC, which comprises about 85% of total PC 5-year prevalence, will increase from approximately 0.8 million in 2012 to 1.0 million by 2026. In 2012, prevalence of M0 CRPC (4-7% of total PC, depending on ADT use in the M0 setting) in EU-5 is estimated to reach up to 70,000 with a projected increase to 110,000 patients by 2026. Conclusion This model provides the first understanding of how many men in Europe are living with M0 CRPC. Although M0 CRPC represents a small subset of the PC population, the model predicts an increase in the prevalence of M0 CRPC over the next 14 years. As men with M0 CRPC have an increased risk of developing metastases (particularly to bone) resulting in a shortened lifespan, these findings highlight the need for clinical trials to establish standards of care for these patients, and for new therapeutic options. Disclosure A. Liede: Employed by and own stock in Amgen Inc. The study was funded by Amgen Inc. O. Gunther: Employed by Amgen Ltd and own stock in Amgen. The study was funded by Amgen Inc. B. Bennett: Consultant at Plan A, Inc. S. Wong: Consultants at Plan A, Inc.

Treatment pattern by hormone receptors and HER2 status in patients with metastatic breast cancer in the United Kingdom, Germany, France, Spain, and Italy (EU-5): Results from a physician survey.

570 Background: The differences in country-specific treatment patterns across Europe for Stage IV metastatic breast cancer (mBC) patients have not been extensively studied. This study compared treatment choices, by biomarker status, between various lines of therapy (LOT) in clinical practice in the EU-5 countries among newly diagnosed stage IV mBC patients. Methods: The IMS LifeLink Oncology Analyzer (OA) database, based upon practicing oncologist surveys, was used to identify mBC patients aged ≥21 and surveyed between July 2008 – June 2010. The database encompasses over 100,000 unique patients per year, treated by nearly 3,000 physicians, including nearly 60,000 patients and 800 physicians in the EU5. Results: A total of 152,311 mBC patients were included in the study. In Italy, 30.8% of HER2+/HR+ patients received chemotherapy following mBC diagnosis, as compared to only 8.6% in France. The majority of these patients in France received chemotherapy plus a HER2 targeted therapy (58.2%) as their first treatment. For HER2+/ HR- patients, chemotherapy plus a HER2 targeted therapy was provided to the majority of the patients in France (70.8%), with the UK providing this regimen to the fewest patients with this biomarker status (44.9%). Monotherapy hormonal regimens were given as a first LOT for HER2-/HR+ patients (UK 64.7%, Spain 52.8%). Triple negative patients received chemotherapy (UK 84.1% as compared to France 57.3%) or chemotherapy plus bevacizumab (France 36.6% as compared to UK 0.9%) as a first treatment. Conclusions: Thisstudy confirmed that chemotherapy combined with HER2-targeted therapy was the most frequent initial treatment option for HER2+ patients, while the vast majority of ER/PR+ patients were initially treated by hormonal therapy, suggesting that a personalized medicine approach has been accepted in the EU-5. However, the use of HER2-targeted therapy and bevacizumab greatly varied; while they were most frequently used in France, they were least frequently opted for in the UK. Also, fewer treatment options existed for triple negative patients and patients with HER2+ disease following trastuzumab treatment.

P1-08-21: Demographic and Clinical Characteristics of Metastatic Breast Cancer Patients and Biomarker-Based Prevalence in the UK, Germany, France, Spain and Italy (EU-5).

Abstract Background: Much peer-reviewed literature focuses on metastatic breast cancer (mBC) treatment regimens. However, research around mBC patients’ demographic/clinical characteristics across Europe is limited. This study compared such mBC characteristics as well as biomarker-based prevalence across the EU-5. Methods: IMS LifeLink™ Oncology Analyzer (OA) database, based upon practicing oncologist surveys, was used to identify mBC patients aged ≥18 between 01/2005-06/2010. The study investigated the distribution of mBC population based on age, biomarker, co-morbidities and stage at diagnosis. This study also estimated the proportion of patients, and sites of metastasis, by lines of drug therapies (LOT). Results: A total of 186,640 mBC patients were identified — Germany (30.2%), France (22.4%), UK (21.2%), Italy (17.7%) and Spain (8.4%). The majority of patients were aged 61–70yrs (24%-32%), except in Spain (22.3% aged 71–80yrs). Proportion of mBC patients with ≥1 co-morbid condition were highest in Germany (36.3%), followed by Spain (32.8%), UK (31.5%), Italy (27.6%) and France (20.1%), with diabetes (12.9−23.9%) and cardiac dysfunction (5.2−21.7%) being most prevalent. The distribution of mBC patients by biomarker status was 53.9% HER-/HR+, 17.8% HER+/HR+, 11.1% HER+/HR- and 17.2% triple negative, and was similar amongst the EU5 countries. The top three metastatic sites were bone (54.4%), lung (36.0%) and liver (32.7%), with proportion of bone metastasis increasing from 1st LOT (38.1%) to 4th LOT (69.6%). Almost 50% of the mBC patients were diagnosed at Stage IV, 14% at Stage III, 26% at Stage II and 6% at Stage I. Of all mBC patients, 93% received 1st LOT, 31% received 2nd LOT, 27% received 3rd LOT and 6.8% received 4thLOT. Conclusion: In the EU-5, mBC patients were primarily elderly and HER-/HR+. The burden of bone metastasis was higher in later LOTs. Following the 1st LOT, fewer patients moved to subsequent treatments. Additional research on EU-5 clinical practice patterns is warranted. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P1-08-21.

PHP12 Then and Now: The Evolution of International Reference Pricing Globally

This study assesses the evolution of international reference pricing (IRP) across 34 countries, from 2006 to 2011. Its current influence on innovative drug pricing in the leading five European Union (EU) markets was also considered. An international reference pricing matrix was created and reviewed to see if the basket of countries referred by nations to price their pharmaceuticals had changed. Pharmaceutical prices were also used to review 2011 prices of five randomly selected innovative blockbuster molecules across EU-5 countries; the molecules in question were bevacizumab, adalimumab, etanercept, rosuvastatin and infliximab. The EU-5 markets lead the reference basket used by countries in their price setting process both in 2006 and 2011. Countries that reference these markets are varied and not limited to economically similar markets both within and outside the EU. While there have been additions and deletions, many countries have largely maintained their reference basket of countries. Since 2006, more emerging markets have become IRP prescribers. Unlike Brazil, and Turkey, which followed IRP prior to 2006 and exclusively use developed country prices to price their own products, the newer emerging market followers have also chosen to include neighbouring countries and/or economically similar country prices in their mechanism. A comparison of 2011 prices across the EU-5 markets showed less price variation between countries that followed IRP compared to those that followed free pricing, but prices were not necessarily lower. Countries using IRP still rely on EU-5 drug prices to price their medicines. However, new adopters of the mechanism are including similar and neighbouring countries to arrive at affordable rates and prevent parallel export. With more emerging markets rolling out IRP, it is notable that in the absence of a set formula that identifies the lowest prices, this technique is one of cost harmonization rather than cost containment.

3504 POSTER Understanding the Variation in the Treatment Patterns for Newly Diagnosed Metastatic NSCLC Patient Among EU-5 Countries

3504 POSTER Understanding the Variation in the Treatment Patterns for Newly Diagnosed Metastatic NSCLC Patient Among EU-5 Countries