Insights into cancer surveillance in Central and Eastern Europe, Israel and Turkey The current ca... more Insights into cancer surveillance in Central and Eastern Europe, Israel and Turkey The current cancer landscape within transitional economies in central and Eastern Europe and the Mediterranean area is not particularly optimistic. Current perceptions are often based on extrapolations from other countries and regions; and hence the authors collaborated with the South Eastern Europe Oncology Group (SEEROG) to collect information on cancer registration in Central and Eastern Europe, Israel and Turkey. Healthcare authorities and specialist oncology centres in 21 countries in the region were contacted for information on cancer registries in their countries. Based on this information, the authors believe that the recording and reporting of data on cancer in the region is at an acceptable level. The authors discuss and compare institution-and population-based registries, and present opinions on elements of an 'ideal registry' based on the survey replies and comparisons with other registries. A comparison with the sources used for GLOBOCAN 2008 illustrates the need for consistent data to be communicated, published and utilised throughout the region and the oncology community. The authors conclude by considering the potential value of collaboration between health authorities across the region, as well as between the clinical and epidemiological communities, to ensure that cancer data are consistently collected, verified and made public.
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Increased biological understanding of cancer diseases has resulted in a paradigm shift in the med... more Increased biological understanding of cancer diseases has resulted in a paradigm shift in the medical treatment of cancer. Despite encouraging advances, most cancer types are still incurable and cancer is the second most common cause of death in developed countries.The high price of cancer drugs is a major challenge to equal access and puts heavy strains on public health care payers. After sharp increases in the 2000s, total expenditures on cancer drugs have levelled off due to patent expiration of many expensive and widely used drugs.Cancer drug utilization studies cover a great variety of topics. Four main research areas are patient adherence, physician adherence to guidelines, effectiveness and safety (outcomes research) and access (market uptake).Most cancer drugs are classified under Anatomical Therapeutic Chemical (ATC) group L. The use of defined daily dose (DDD) as a measurement unit is feasible for oral cancer drugs. As most cancer drugs are administered as infusions or injections at hospitals, usage is commonly measured in milligrams.Drug utilization research in the area of cancer is faced with a lack of data. Comparisons are challenging, as prices and population bases vary across regions. The linkage of registries and health care databases that include cancer drug usage will create improved opportunities in the future. (Less)
Key stakeholders from the cancer research continuum met in May 2021 at the European Cancer Resear... more Key stakeholders from the cancer research continuum met in May 2021 at the European Cancer Research Summit in Porto to discuss priorities and specific action points required for the successful implementation of the European Cancer Mission and Europe's Beating Cancer Plan (EBCP). Speakers presented a unified view about the need to establish high‐quality, networked infrastructures to decrease cancer incidence, increase the cure rate, improve patient's survival and quality of life, and deal with research and care inequalities across the European Union (EU). These infrastructures, featuring Comprehensive Cancer Centres (CCCs) as key components, will integrate care, prevention and research across the entire cancer continuum to support the development of personalized/precision cancer medicine in Europe. The three pillars of the recommended European infrastructures – namely translational research, clinical/prevention trials and outcomes research – were pondered at length. Speakers ...
ZD1694 ('Tomudex'), a novel, direct and specific thymidylate synthase (TS) inhibitor, was develop... more ZD1694 ('Tomudex'), a novel, direct and specific thymidylate synthase (TS) inhibitor, was developed in a collaborative research programme between Zeneca Pharmaceuticals and the Institute of Cancer Research (UK) and entered clinical trials in 1991; phase II studies began in 1992, using 3.0 mg m2 every 3 weeks as a short 15 min infusion. Forty-six patients entered a phase II study of ZD1694 in advanced breast cancer. A total of 74% of patients had received prior systemic therapy (either as adjuvant cytotoxic or hormonal therapy or hormone therapy for advanced disease); 39% had received prior adjuvant cytotoxic chemotherapy. All patients had measurable disease and 50% had liver metastases. In all 43 patients were evaluable for response. Of these patients 26% achieved complete (CR) or partial response (PR) (95% Cl 14-42%). A response rate of 44% was seen in liver metastases. Two patients achieved CR of 265 and 301 days' duration respectively, one in locoregional disease, and one in liver metastases. The most common grade 3/4 adverse events were nausea and vomiting (11%), diarrhoea (11%) and leucopenia (20%). Grade 3/4, selflimited and reversible increases in transaminases were seen in 22% of patients. ZD1694 has useful single agent activity in patients with hormone-refractory advanced breast cancer, comparable with that reported for other anti-metabolites, with acceptable tolerability.
Cancer places a heavy burden on healthcare systems. The cost of cancer drugs is increasing, drive... more Cancer places a heavy burden on healthcare systems. The cost of cancer drugs is increasing, driven largely by the introduction of new, ever more innovative cancer treatments. This raises questions about value for money and the future sustainability of cancer care, and presents significant challenges for decision-makers in providing all patients with access to treatments and effective new cancer medicines. The aims of this article are to provide an understanding of how sustainability in cancer care is defined, what signs indicate that the limits of sustainability are being reached, and what potential impact this may have on patients with cancer within Europe. Each country is faced with making difficult decisions about the allocation of healthcare resources to cancer care, to best meet the health needs of their patients. Determining the value of individual cancer drugs can help to inform these decisions, because premium pricing for incremental innovation is no longer sustainable. When...
Goals: Endocrine treatments for breast cancer such as tamoxifen and fulvestrant have broadly simi... more Goals: Endocrine treatments for breast cancer such as tamoxifen and fulvestrant have broadly similar efficacy and tolerability profiles but have different routes of administration. Perceptions that patients do not like injections may contribute to the efforts made by industry to produce oral compounds wherever possible, but there is little systematic data to support this view. Here, we investigated breast cancer patients' preference for different routes of administration. Methods: 208 women, at least 2 years post-diagnosis but with stable disease, who had received ?1 hormonal breast cancer treatment were recruited from UK cancer centres. They were interviewed in their own homes by trained researchers using a semi-structured interview schedule. Patients provided basic socio-demographic information and details of their breast cancer treatments, comorbidities, concurrent medications, ease of travel to cancer centre, relationship with healthcare professionals, and attitudes toward injections. They then considered various scenarios with two unnamed drugs (an oral daily tablet or a monthly intramuscular injection) and were asked for their preferences and reasons for their choices.
Biosimilars are similar, but non-identical, versions of existing biological drugs for which paten... more Biosimilars are similar, but non-identical, versions of existing biological drugs for which patents have expired. Despite the rigorous approval process for biosimilars, concerns have been expressed about the efficacy and safety of these products in clinical practice. Biosimilars of filgrastim, based on the originator product Neupogen®, have been available since 2008 and are now in widespread clinical use in Europe and elsewhere. Three biosimilar G-CSFs have been approved based on a combination of physicochemical and biological protein characterisation, pharmacokinetic and phar-macodynamic assessment in healthy volunteers and efficacy and safety data in patients with cancer. To assess whether biosimilars are effective in the real-world clinical practice setting, a pooled analysis of five post-approval studies of biosimilar G-CSF (Zarzio®) that included 1,302 adult patients who received at least one cycle of chemotherapy with G-CSF support for the prevention of neutropenia was conducted. A total of 36 % of patients had a febrile neutropenia risk of >20 %, while 39.6 % had a risk of 10-20 % based on chemotherapy regimen. The occurrence of severe or febrile neutropenia was within the range of that observed in previous studies of originator G-CSF. In addition, the safety profile of Zarzio® was consistent with that reported for originator G-CSF and the known safety profile of G-CSF. Initial concerns about the use of biosimilars, at least with regard to biosimilar G-CSFs, appear to be unfounded. Adoption of cost-effective biosimilars should help reduce healthcare costs and improve patient access to biological treatments.
The Gastrointestinal Tract Cancer Liaison Office (GITCLO) was developed in an attempt to organise... more The Gastrointestinal Tract Cancer Liaison Office (GITCLO) was developed in an attempt to organise the increasing body of clinical research in gastrointestinal tumours in Europe. This paper represents an analysis, by tumour localisation, of the trials collected for the second edition of the GITCLO booklet. The list of cooperative groups, chairmen and study coordinators is given with their respective telephone and telefax numbers. A total of 84 trials were collected, conducted by 46 co-operative groups in 14 countries. For each organ and stage of disease, a summary of concepts investigated is given with the references of the study co-ordinator. Obviously, too many questions are raised at the same time. In colorectal cancer, for example, a total of 41 trials exploring 22 concepts are currently open for patients' registration. We hope that the present attempt to clarify the situation of clinical research in the field of gastrointestinal cancers in Europe will speed up therapeutic progress in the best interest of the patients.
From 1976 to 1984, 427 postmenopausal women with high-risk breast cancer (pN + or pT greater than... more From 1976 to 1984, 427 postmenopausal women with high-risk breast cancer (pN + or pT greater than 30 mm) were randomized between postoperative radiation therapy (RT), radiation therapy plus tamoxifen (RT-TAM), adjuvant chemotherapy (CT), or chemotherapy plus tamoxifen (CT-TAM). Surgery was a modified radical mastectomy in all cases. The radiation therapy was given with high-voltage techniques and included the chest wall and regional nodes. The dose was 4600 cGy/4 1/2 weeks. Tamoxifen was given at a dose of 40 mg daily for 2 years. The adjuvant chemotherapy consisted of 12 cycles of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) (or chlorambucil, methotrexate, and 5-fluorouracil [LMF] for patients entered before 1978). At a median follow-up time of 6 1/2 years the recurrence-free survival was significantly better for patients allocated to radiation therapy compared to chemotherapy and for patients allocated to tamoxifen compared to no adjuvant endocrine treatment (P less than 0.01). At 10 years the recurrence-free survival for patients in the RT-TAM, RT, CT-TAM, and CT groups was 63%, 57%, 47%, and 31%, respectively. A significant reduction of treatment failures with tamoxifen was only observed among patients with estrogen receptor-positive tumors. The overall survival difference in favor of patients allocated to radiation therapy or tamoxifen was not significant: the respective survival percentage at 10 years in the RT-TAM, RT, CT-TAM, and CT group was 65%, 62%, 52%, and 50%. The results indicate that postoperative radiation therapy continues to play an important role in the primary management of postmenopausal women with high-risk breast cancer and that the addition of tamoxifen may further improve the results among ER-positive patients.
The paper presents long-term results of a randomized trial of adjuvant tamoxifen (40 mg daily for... more The paper presents long-term results of a randomized trial of adjuvant tamoxifen (40 mg daily for 2 or 5 years) versus surgery alone including 1,347 postmenopausal patients with histologically negative axillary nodes and a tumour diameter less than or equal to 30 mm. Data on the estrogen receptor status of the primary tumour were available in 1,136 patients (84%). At a median follow-up of 7 years (range 1.7-13.0 years) there was a significant prolongation of the recurrence-free survival among those allocated to tamoxifen (p less than 0.01), significantly fewer deaths due to breast cancer (p = 0.02) and a trend towards improved overall survival (p = 0.11). The treatment benefit was restricted to patients with ER-positive tumours. There was no significant reduction of breast cancer recurrences in the tamoxifen group among patients whose tumours were classified as ER-negative. The results support and extend previous studies in showing a long-term benefit of tamoxifen in postmenopausal breast cancer patients with node-negative, estrogen receptor positive disease.
6612 Background: A number of new innovative cancer drugs have recently been approved or are in th... more 6612 Background: A number of new innovative cancer drugs have recently been approved or are in the process of being approved. We have analysed the access and uptake of 65 oncology drugs in 25 countries (19 European countries, Australia, Canada, Japan, New Zealand, South Africa and the USA) over a 10 year period based on sales data provided by IMS Health. Methods: We calculated an index of number of patients treated based on sales per inhabitant or per person who died from a specific cancer type. The age composition (vintage) of the drug arsenal used was calculated based on sales for cancer drugs introduced before 1995; between 1995–1999, 2000–2002 and after 2002 respectively. The vintage of the drug arsenal used was also analysed in relation to different economic and health care system characteristics. We performed three types of analysis of the effect of cancer drug vintage on cancer survival and mortality using difference-in-difference research designs. Results: Different patterns...
1088 Background: Trastuzumab is a monoclonal antibody that together with chemotherapy significant... more 1088 Background: Trastuzumab is a monoclonal antibody that together with chemotherapy significantly improves time to progression and overall survival for MBC patients with tumours overexpressing HER2. The aim of this study was to analyse the cost- effectiveness of HER2 testing and trastuzumab in combination with chemotherapy compared with chemotherapy alone from a societal perspective in a Swedish setting. Methods: We used a Markov state transition model to simulate HER2 testing and subsequent treatment in a hypothetical cohort of 65 year old metastatic breast cancer patients based on the study by Marty et al (Marty et al, J Clin Oncol. Jul 1 2005;23(19):4265–4274). Outcomes included life-time costs, quality adjusted life years (QALY), and cost per QALY gained. Five different testing and treatment strategies were evaluated. Results: We estimated the cost per QALY gained to be about 485,000 SEK (approximately 70,000 USD) and the cost per life year (LY) gained to be about 332,000 SEK ...
e18015Background: Cancer drugs are fundamental parts of cancer care. The costs of new cancer drug... more e18015Background: Cancer drugs are fundamental parts of cancer care. The costs of new cancer drugs have increased dramatically over the last 10-20 years. This study investigates the introduction an...
Purpose: To determine the predictive value of vascular endothelial growth factor (VEGF) for relap... more Purpose: To determine the predictive value of vascular endothelial growth factor (VEGF) for relapse-free survival (RFS) and overall survival (OS) in primary node-positive breast cancer (NPBC) after adjuvant endocrine treatment or adjuvant chemotherapy. Materials and Methods: VEGF was quantitatively measured in tumor cytosols from 362 consecutive patients with primary NPBC using an enzyme immunoassay for human VEGF165. Adjuvant treatment was given to all patients, either as endocrine therapy (n 5 250) or chemotherapy (n 5 112). The median follow-up time was 56 months. Results: Univariate analysis showed VEGF to be a significant predictor of RFS (P 5 .0289) and OS (P 5 .0004) in the total patient population and in patients who received adjuvant endocrine treatment (RFS, P 5 .0238; OS, P 5 .0121). In the group of patients who received adjuvant chemotherapy, no significant difference was seen in RFS, but a difference was seen in OS (P 5 .0235). Patients with bone recurrences tended to h...
Insights into cancer surveillance in Central and Eastern Europe, Israel and Turkey The current ca... more Insights into cancer surveillance in Central and Eastern Europe, Israel and Turkey The current cancer landscape within transitional economies in central and Eastern Europe and the Mediterranean area is not particularly optimistic. Current perceptions are often based on extrapolations from other countries and regions; and hence the authors collaborated with the South Eastern Europe Oncology Group (SEEROG) to collect information on cancer registration in Central and Eastern Europe, Israel and Turkey. Healthcare authorities and specialist oncology centres in 21 countries in the region were contacted for information on cancer registries in their countries. Based on this information, the authors believe that the recording and reporting of data on cancer in the region is at an acceptable level. The authors discuss and compare institution-and population-based registries, and present opinions on elements of an 'ideal registry' based on the survey replies and comparisons with other registries. A comparison with the sources used for GLOBOCAN 2008 illustrates the need for consistent data to be communicated, published and utilised throughout the region and the oncology community. The authors conclude by considering the potential value of collaboration between health authorities across the region, as well as between the clinical and epidemiological communities, to ensure that cancer data are consistently collected, verified and made public.
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Increased biological understanding of cancer diseases has resulted in a paradigm shift in the med... more Increased biological understanding of cancer diseases has resulted in a paradigm shift in the medical treatment of cancer. Despite encouraging advances, most cancer types are still incurable and cancer is the second most common cause of death in developed countries.The high price of cancer drugs is a major challenge to equal access and puts heavy strains on public health care payers. After sharp increases in the 2000s, total expenditures on cancer drugs have levelled off due to patent expiration of many expensive and widely used drugs.Cancer drug utilization studies cover a great variety of topics. Four main research areas are patient adherence, physician adherence to guidelines, effectiveness and safety (outcomes research) and access (market uptake).Most cancer drugs are classified under Anatomical Therapeutic Chemical (ATC) group L. The use of defined daily dose (DDD) as a measurement unit is feasible for oral cancer drugs. As most cancer drugs are administered as infusions or injections at hospitals, usage is commonly measured in milligrams.Drug utilization research in the area of cancer is faced with a lack of data. Comparisons are challenging, as prices and population bases vary across regions. The linkage of registries and health care databases that include cancer drug usage will create improved opportunities in the future. (Less)
Key stakeholders from the cancer research continuum met in May 2021 at the European Cancer Resear... more Key stakeholders from the cancer research continuum met in May 2021 at the European Cancer Research Summit in Porto to discuss priorities and specific action points required for the successful implementation of the European Cancer Mission and Europe's Beating Cancer Plan (EBCP). Speakers presented a unified view about the need to establish high‐quality, networked infrastructures to decrease cancer incidence, increase the cure rate, improve patient's survival and quality of life, and deal with research and care inequalities across the European Union (EU). These infrastructures, featuring Comprehensive Cancer Centres (CCCs) as key components, will integrate care, prevention and research across the entire cancer continuum to support the development of personalized/precision cancer medicine in Europe. The three pillars of the recommended European infrastructures – namely translational research, clinical/prevention trials and outcomes research – were pondered at length. Speakers ...
ZD1694 ('Tomudex'), a novel, direct and specific thymidylate synthase (TS) inhibitor, was develop... more ZD1694 ('Tomudex'), a novel, direct and specific thymidylate synthase (TS) inhibitor, was developed in a collaborative research programme between Zeneca Pharmaceuticals and the Institute of Cancer Research (UK) and entered clinical trials in 1991; phase II studies began in 1992, using 3.0 mg m2 every 3 weeks as a short 15 min infusion. Forty-six patients entered a phase II study of ZD1694 in advanced breast cancer. A total of 74% of patients had received prior systemic therapy (either as adjuvant cytotoxic or hormonal therapy or hormone therapy for advanced disease); 39% had received prior adjuvant cytotoxic chemotherapy. All patients had measurable disease and 50% had liver metastases. In all 43 patients were evaluable for response. Of these patients 26% achieved complete (CR) or partial response (PR) (95% Cl 14-42%). A response rate of 44% was seen in liver metastases. Two patients achieved CR of 265 and 301 days' duration respectively, one in locoregional disease, and one in liver metastases. The most common grade 3/4 adverse events were nausea and vomiting (11%), diarrhoea (11%) and leucopenia (20%). Grade 3/4, selflimited and reversible increases in transaminases were seen in 22% of patients. ZD1694 has useful single agent activity in patients with hormone-refractory advanced breast cancer, comparable with that reported for other anti-metabolites, with acceptable tolerability.
Cancer places a heavy burden on healthcare systems. The cost of cancer drugs is increasing, drive... more Cancer places a heavy burden on healthcare systems. The cost of cancer drugs is increasing, driven largely by the introduction of new, ever more innovative cancer treatments. This raises questions about value for money and the future sustainability of cancer care, and presents significant challenges for decision-makers in providing all patients with access to treatments and effective new cancer medicines. The aims of this article are to provide an understanding of how sustainability in cancer care is defined, what signs indicate that the limits of sustainability are being reached, and what potential impact this may have on patients with cancer within Europe. Each country is faced with making difficult decisions about the allocation of healthcare resources to cancer care, to best meet the health needs of their patients. Determining the value of individual cancer drugs can help to inform these decisions, because premium pricing for incremental innovation is no longer sustainable. When...
Goals: Endocrine treatments for breast cancer such as tamoxifen and fulvestrant have broadly simi... more Goals: Endocrine treatments for breast cancer such as tamoxifen and fulvestrant have broadly similar efficacy and tolerability profiles but have different routes of administration. Perceptions that patients do not like injections may contribute to the efforts made by industry to produce oral compounds wherever possible, but there is little systematic data to support this view. Here, we investigated breast cancer patients' preference for different routes of administration. Methods: 208 women, at least 2 years post-diagnosis but with stable disease, who had received ?1 hormonal breast cancer treatment were recruited from UK cancer centres. They were interviewed in their own homes by trained researchers using a semi-structured interview schedule. Patients provided basic socio-demographic information and details of their breast cancer treatments, comorbidities, concurrent medications, ease of travel to cancer centre, relationship with healthcare professionals, and attitudes toward injections. They then considered various scenarios with two unnamed drugs (an oral daily tablet or a monthly intramuscular injection) and were asked for their preferences and reasons for their choices.
Biosimilars are similar, but non-identical, versions of existing biological drugs for which paten... more Biosimilars are similar, but non-identical, versions of existing biological drugs for which patents have expired. Despite the rigorous approval process for biosimilars, concerns have been expressed about the efficacy and safety of these products in clinical practice. Biosimilars of filgrastim, based on the originator product Neupogen®, have been available since 2008 and are now in widespread clinical use in Europe and elsewhere. Three biosimilar G-CSFs have been approved based on a combination of physicochemical and biological protein characterisation, pharmacokinetic and phar-macodynamic assessment in healthy volunteers and efficacy and safety data in patients with cancer. To assess whether biosimilars are effective in the real-world clinical practice setting, a pooled analysis of five post-approval studies of biosimilar G-CSF (Zarzio®) that included 1,302 adult patients who received at least one cycle of chemotherapy with G-CSF support for the prevention of neutropenia was conducted. A total of 36 % of patients had a febrile neutropenia risk of >20 %, while 39.6 % had a risk of 10-20 % based on chemotherapy regimen. The occurrence of severe or febrile neutropenia was within the range of that observed in previous studies of originator G-CSF. In addition, the safety profile of Zarzio® was consistent with that reported for originator G-CSF and the known safety profile of G-CSF. Initial concerns about the use of biosimilars, at least with regard to biosimilar G-CSFs, appear to be unfounded. Adoption of cost-effective biosimilars should help reduce healthcare costs and improve patient access to biological treatments.
The Gastrointestinal Tract Cancer Liaison Office (GITCLO) was developed in an attempt to organise... more The Gastrointestinal Tract Cancer Liaison Office (GITCLO) was developed in an attempt to organise the increasing body of clinical research in gastrointestinal tumours in Europe. This paper represents an analysis, by tumour localisation, of the trials collected for the second edition of the GITCLO booklet. The list of cooperative groups, chairmen and study coordinators is given with their respective telephone and telefax numbers. A total of 84 trials were collected, conducted by 46 co-operative groups in 14 countries. For each organ and stage of disease, a summary of concepts investigated is given with the references of the study co-ordinator. Obviously, too many questions are raised at the same time. In colorectal cancer, for example, a total of 41 trials exploring 22 concepts are currently open for patients' registration. We hope that the present attempt to clarify the situation of clinical research in the field of gastrointestinal cancers in Europe will speed up therapeutic progress in the best interest of the patients.
From 1976 to 1984, 427 postmenopausal women with high-risk breast cancer (pN + or pT greater than... more From 1976 to 1984, 427 postmenopausal women with high-risk breast cancer (pN + or pT greater than 30 mm) were randomized between postoperative radiation therapy (RT), radiation therapy plus tamoxifen (RT-TAM), adjuvant chemotherapy (CT), or chemotherapy plus tamoxifen (CT-TAM). Surgery was a modified radical mastectomy in all cases. The radiation therapy was given with high-voltage techniques and included the chest wall and regional nodes. The dose was 4600 cGy/4 1/2 weeks. Tamoxifen was given at a dose of 40 mg daily for 2 years. The adjuvant chemotherapy consisted of 12 cycles of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) (or chlorambucil, methotrexate, and 5-fluorouracil [LMF] for patients entered before 1978). At a median follow-up time of 6 1/2 years the recurrence-free survival was significantly better for patients allocated to radiation therapy compared to chemotherapy and for patients allocated to tamoxifen compared to no adjuvant endocrine treatment (P less than 0.01). At 10 years the recurrence-free survival for patients in the RT-TAM, RT, CT-TAM, and CT groups was 63%, 57%, 47%, and 31%, respectively. A significant reduction of treatment failures with tamoxifen was only observed among patients with estrogen receptor-positive tumors. The overall survival difference in favor of patients allocated to radiation therapy or tamoxifen was not significant: the respective survival percentage at 10 years in the RT-TAM, RT, CT-TAM, and CT group was 65%, 62%, 52%, and 50%. The results indicate that postoperative radiation therapy continues to play an important role in the primary management of postmenopausal women with high-risk breast cancer and that the addition of tamoxifen may further improve the results among ER-positive patients.
The paper presents long-term results of a randomized trial of adjuvant tamoxifen (40 mg daily for... more The paper presents long-term results of a randomized trial of adjuvant tamoxifen (40 mg daily for 2 or 5 years) versus surgery alone including 1,347 postmenopausal patients with histologically negative axillary nodes and a tumour diameter less than or equal to 30 mm. Data on the estrogen receptor status of the primary tumour were available in 1,136 patients (84%). At a median follow-up of 7 years (range 1.7-13.0 years) there was a significant prolongation of the recurrence-free survival among those allocated to tamoxifen (p less than 0.01), significantly fewer deaths due to breast cancer (p = 0.02) and a trend towards improved overall survival (p = 0.11). The treatment benefit was restricted to patients with ER-positive tumours. There was no significant reduction of breast cancer recurrences in the tamoxifen group among patients whose tumours were classified as ER-negative. The results support and extend previous studies in showing a long-term benefit of tamoxifen in postmenopausal breast cancer patients with node-negative, estrogen receptor positive disease.
6612 Background: A number of new innovative cancer drugs have recently been approved or are in th... more 6612 Background: A number of new innovative cancer drugs have recently been approved or are in the process of being approved. We have analysed the access and uptake of 65 oncology drugs in 25 countries (19 European countries, Australia, Canada, Japan, New Zealand, South Africa and the USA) over a 10 year period based on sales data provided by IMS Health. Methods: We calculated an index of number of patients treated based on sales per inhabitant or per person who died from a specific cancer type. The age composition (vintage) of the drug arsenal used was calculated based on sales for cancer drugs introduced before 1995; between 1995–1999, 2000–2002 and after 2002 respectively. The vintage of the drug arsenal used was also analysed in relation to different economic and health care system characteristics. We performed three types of analysis of the effect of cancer drug vintage on cancer survival and mortality using difference-in-difference research designs. Results: Different patterns...
1088 Background: Trastuzumab is a monoclonal antibody that together with chemotherapy significant... more 1088 Background: Trastuzumab is a monoclonal antibody that together with chemotherapy significantly improves time to progression and overall survival for MBC patients with tumours overexpressing HER2. The aim of this study was to analyse the cost- effectiveness of HER2 testing and trastuzumab in combination with chemotherapy compared with chemotherapy alone from a societal perspective in a Swedish setting. Methods: We used a Markov state transition model to simulate HER2 testing and subsequent treatment in a hypothetical cohort of 65 year old metastatic breast cancer patients based on the study by Marty et al (Marty et al, J Clin Oncol. Jul 1 2005;23(19):4265–4274). Outcomes included life-time costs, quality adjusted life years (QALY), and cost per QALY gained. Five different testing and treatment strategies were evaluated. Results: We estimated the cost per QALY gained to be about 485,000 SEK (approximately 70,000 USD) and the cost per life year (LY) gained to be about 332,000 SEK ...
e18015Background: Cancer drugs are fundamental parts of cancer care. The costs of new cancer drug... more e18015Background: Cancer drugs are fundamental parts of cancer care. The costs of new cancer drugs have increased dramatically over the last 10-20 years. This study investigates the introduction an...
Purpose: To determine the predictive value of vascular endothelial growth factor (VEGF) for relap... more Purpose: To determine the predictive value of vascular endothelial growth factor (VEGF) for relapse-free survival (RFS) and overall survival (OS) in primary node-positive breast cancer (NPBC) after adjuvant endocrine treatment or adjuvant chemotherapy. Materials and Methods: VEGF was quantitatively measured in tumor cytosols from 362 consecutive patients with primary NPBC using an enzyme immunoassay for human VEGF165. Adjuvant treatment was given to all patients, either as endocrine therapy (n 5 250) or chemotherapy (n 5 112). The median follow-up time was 56 months. Results: Univariate analysis showed VEGF to be a significant predictor of RFS (P 5 .0289) and OS (P 5 .0004) in the total patient population and in patients who received adjuvant endocrine treatment (RFS, P 5 .0238; OS, P 5 .0121). In the group of patients who received adjuvant chemotherapy, no significant difference was seen in RFS, but a difference was seen in OS (P 5 .0235). Patients with bone recurrences tended to h...
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Papers by Nils Wilking