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Relevant Endpoints for Advanced Breast Cancer Patients
S18
Abstracts / The Breast 20 (2011) S12–S55
the disease is seldom oligometastatic even in one organ. Evidence is required of efficacy before such sophisticated and expensive therapies are applied. When RT is prescribed for palliation in ABC, it should be delivered according to best available evidence, of which there is much, in terms of numbers of fractions, dose and technique. This will maximise the palliative effect and minimise not just the toxicity but also the potential socioeconomic and psychological stress, impact and inconvenience of a treatment that, while absolutely essential to reduce symptoms, is unlikely to prolong life. Quality of life is unlikely to improve with prolonged therapeutic interventions. And, in delivering a high quality palliative RT service, radiation oncologists must work closely with their other colleagues in the broader palliative multidisciplinary team that includes not only surgical and medical oncologists but also support staff and palliative medicine physicians.
IN17 RELEVANT ENDPOINTS FOR ADVANCED BREAST CANCER PATIENTS Patricia A. Ganz Jonsson Comprehensive Cancer Center and UCLA Schools of Medicine & Public Health, Los Angeles, CA, USA Patients with advanced breast cancer are a heterogeneous group, as they may represent newly diagnosed patients with disseminated disease, or patients who have been disease-free for many years with an isolated recurrence in bone or soft tissue. Whenever a woman learns that she has metastatic breast cancer, she experiences psychological distress and may also suffer from persistent intrusive thoughts about the disease. These psychological impacts are most significant at the time of first metastasis or recurrence, and are generally followed by improved coping and functioning as treatment plans are developed and therapy for the advanced disease is undertaken. Most women with advanced breast cancer suffer from significant deterioration in physical health, with abrupt changes and limitations in physical functioning, associated with pain, fatigue, sleep disruption, and depression. To the extent that these symptoms are controlled by effective cancer treatments, the outlook and functioning for women improves substantially. Improvement in symptoms can result from tumor response, as well as appropriate palliative interventions. Given this set of circumstances, what are the relevant endpoints for advanced breast cancer patients, and how should we incorporate them into clinical trials and other descriptive/intervention research? Highly effective targeted treatments (endocrine therapy, HER2 directed therapies) that do not require chemotherapy in addition, have the advantage of good treatment responses, excellent symptom relief (e.g., pain, fatigue), and the possibility of durable and sustained remissions without frequent need for change in therapies. Unfortunately, when chemotherapy must be given, either with targeted therapy or alone, its adverse side effect profile (e.g., fatigue, neuropathy, mucositis, pain) may counter the symptom relief from tumor response to the treatment. This is one of the major concerns with the current debate regarding the use of progression-free survival (PFS), as statistical gains of a few months in PFS may be at the cost of treatment toxicity. More than in any other setting, patient preferences for the treatment strategy and goals of therapy must be included. Clinical trials that investigate new therapies in advanced breast cancer must include patient reported outcomes, especially symptoms, as a means to evaluation of the benefits of treatments. These important outcomes can then be integrated into patient decision-making in the clinic.
IN18 DIFFERENCES ON SIDE EFFECTS ASSESSMENT AMONG DOCTORS, NURSES AND PATIENTS Lesley Fallowfield Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Brighton, UK
There have been exciting developments and advances made in the treatment of cancer in the past decade. Thanks to improvements in diagnostic and imaging techniques, surgical procedures, and systemic therapies, more patients with breast cancer have a realistic chance of cure. Many of those with metastatic disease also have the possibility of living longer lives. No treatment modalities are entirely risk free however and some side effects maybe less tolerable than others. When healthcare professionals discuss the different therapeutic options available it is important that decision-making is based on accurate information about the harms and benefits associated with various management policies. This includes some appreciation of the burden and effort demanded with different routes of administration. There is some doubt about the veracity of safety and side-effect data and methods with which these are collected and recorded. [1] Concordance of patient reported outcomes and those reported by healthcare professionals is often poor. Several studies have shown that many of the quality of life threatening, rather than life-threatening side-effects of disease and treatment go under-recognised, under-reported and undertreated. [2]. In adjuvant clinical trials of aromatase inhibitors for example, concordance between physicians and patients was more likely for symptoms such as vaginal bleeding (which rarely occurred) than were concordance of for vaginal dryness or loss of libido, which had a high frequency of reporting by patients.[3] In metastatic disease where palliation is the primary goal, the patient is arguably the most reliable source of information about the presence of a symptom and its severity. Faulty judgements may lead to inadequate treatment e.g. a survey of pain in >1300 patients with metastatic disease showed that discrepancies between patient and physician assessments was predictive of inadequate pain management.[4]. The causes for these discrepancies are multi-factorial and include:- poor communication skills, inaccurate recording, and attribution bias in data collection. More attention does need to be paid to these issues however as the level of symptom burden collected via Patient Reported Outcomes (PROs) maybe much higher than that reported in many of our pivotal clinical trials where reliance is placed on physician reported common toxicity criteria. Better systems for capturing PRO data in an efficient and systematic fashion are now available which might lead to more accurate assessment of symptom burden, timely supportive and ameliorative interventions and improved adherence to efficacious treatments. 1. Basch, E., et al., Lancet Oncol, 2006. 7(11): p. 903-9. 2. Fellowes, D., et al., Breast Cancer Res Treat, 2001. 66(1): p. 73-81. 3. Cella, D. and L.J. Fallowfield, Breast Ca Res Treat, 2008. 107(2): p167-80. 4. Cleeland, C.S., et al., N Engl J Med, 1994. 330(9): p. 592-6.
IN19 MANAGING BREAST CANCER IN LOW AND MIDDLE INCOME COUNTRIES Nagi S. El Saghir Breast Center of Excellence, NK Basile Cancer Institute, American University of Beirut, Beirut, Lebanon Definitions of Resource Levels Breast cancer incidence rates are rising, though at different paces, in most low and middle income countries. We will refer to those countries as Lowand Middle- resource Countries (LMC). According to World Bank 2009 report, low income countries have a Gross National Income of $995 or less, per month. And lower middle income countries as those that have a GNI of $996 - $3,945. Their health services are often limited, and alternative medicine is commonly employed. WHO describes “low-resource scenario” as one where the infrastructure and human resources for cancer prevention or control are non-existent or very limited in quantity, quality and accessibility. Some may suffer from political or social instability, or excessive bureaucracy, while others may have large, remote, rural populations limiting access to centralized health care. Communicable diseases and malnutrition are a major cause of morbidity and mortality, and life expectancy is less than 60 years. Cancer is becoming a leading causes of death for people older than 15 years of age. Breast Health Global Initiative (BHGI) developed evidence-based, economically feasible, and culturally
Abstracts / The Breast 20 (2011) S12–S55
the disease is seldom oligometastatic even in one organ. Evidence is required of efficacy before such sophisticated and expensive therapies are applied. When RT is prescribed for palliation in ABC, it should be delivered according to best available evidence, of which there is much, in terms of numbers of fractions, dose and technique. This will maximise the palliative effect and minimise not just the toxicity but also the potential socioeconomic and psychological stress, impact and inconvenience of a treatment that, while absolutely essential to reduce symptoms, is unlikely to prolong life. Quality of life is unlikely to improve with prolonged therapeutic interventions. And, in delivering a high quality palliative RT service, radiation oncologists must work closely with their other colleagues in the broader palliative multidisciplinary team that includes not only surgical and medical oncologists but also support staff and palliative medicine physicians.
IN17 RELEVANT ENDPOINTS FOR ADVANCED BREAST CANCER PATIENTS Patricia A. Ganz Jonsson Comprehensive Cancer Center and UCLA Schools of Medicine & Public Health, Los Angeles, CA, USA Patients with advanced breast cancer are a heterogeneous group, as they may represent newly diagnosed patients with disseminated disease, or patients who have been disease-free for many years with an isolated recurrence in bone or soft tissue. Whenever a woman learns that she has metastatic breast cancer, she experiences psychological distress and may also suffer from persistent intrusive thoughts about the disease. These psychological impacts are most significant at the time of first metastasis or recurrence, and are generally followed by improved coping and functioning as treatment plans are developed and therapy for the advanced disease is undertaken. Most women with advanced breast cancer suffer from significant deterioration in physical health, with abrupt changes and limitations in physical functioning, associated with pain, fatigue, sleep disruption, and depression. To the extent that these symptoms are controlled by effective cancer treatments, the outlook and functioning for women improves substantially. Improvement in symptoms can result from tumor response, as well as appropriate palliative interventions. Given this set of circumstances, what are the relevant endpoints for advanced breast cancer patients, and how should we incorporate them into clinical trials and other descriptive/intervention research? Highly effective targeted treatments (endocrine therapy, HER2 directed therapies) that do not require chemotherapy in addition, have the advantage of good treatment responses, excellent symptom relief (e.g., pain, fatigue), and the possibility of durable and sustained remissions without frequent need for change in therapies. Unfortunately, when chemotherapy must be given, either with targeted therapy or alone, its adverse side effect profile (e.g., fatigue, neuropathy, mucositis, pain) may counter the symptom relief from tumor response to the treatment. This is one of the major concerns with the current debate regarding the use of progression-free survival (PFS), as statistical gains of a few months in PFS may be at the cost of treatment toxicity. More than in any other setting, patient preferences for the treatment strategy and goals of therapy must be included. Clinical trials that investigate new therapies in advanced breast cancer must include patient reported outcomes, especially symptoms, as a means to evaluation of the benefits of treatments. These important outcomes can then be integrated into patient decision-making in the clinic.
IN18 DIFFERENCES ON SIDE EFFECTS ASSESSMENT AMONG DOCTORS, NURSES AND PATIENTS Lesley Fallowfield Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton & Sussex Medical School, University of Sussex, Brighton, UK
There have been exciting developments and advances made in the treatment of cancer in the past decade. Thanks to improvements in diagnostic and imaging techniques, surgical procedures, and systemic therapies, more patients with breast cancer have a realistic chance of cure. Many of those with metastatic disease also have the possibility of living longer lives. No treatment modalities are entirely risk free however and some side effects maybe less tolerable than others. When healthcare professionals discuss the different therapeutic options available it is important that decision-making is based on accurate information about the harms and benefits associated with various management policies. This includes some appreciation of the burden and effort demanded with different routes of administration. There is some doubt about the veracity of safety and side-effect data and methods with which these are collected and recorded. [1] Concordance of patient reported outcomes and those reported by healthcare professionals is often poor. Several studies have shown that many of the quality of life threatening, rather than life-threatening side-effects of disease and treatment go under-recognised, under-reported and undertreated. [2]. In adjuvant clinical trials of aromatase inhibitors for example, concordance between physicians and patients was more likely for symptoms such as vaginal bleeding (which rarely occurred) than were concordance of for vaginal dryness or loss of libido, which had a high frequency of reporting by patients.[3] In metastatic disease where palliation is the primary goal, the patient is arguably the most reliable source of information about the presence of a symptom and its severity. Faulty judgements may lead to inadequate treatment e.g. a survey of pain in >1300 patients with metastatic disease showed that discrepancies between patient and physician assessments was predictive of inadequate pain management.[4]. The causes for these discrepancies are multi-factorial and include:- poor communication skills, inaccurate recording, and attribution bias in data collection. More attention does need to be paid to these issues however as the level of symptom burden collected via Patient Reported Outcomes (PROs) maybe much higher than that reported in many of our pivotal clinical trials where reliance is placed on physician reported common toxicity criteria. Better systems for capturing PRO data in an efficient and systematic fashion are now available which might lead to more accurate assessment of symptom burden, timely supportive and ameliorative interventions and improved adherence to efficacious treatments. 1. Basch, E., et al., Lancet Oncol, 2006. 7(11): p. 903-9. 2. Fellowes, D., et al., Breast Cancer Res Treat, 2001. 66(1): p. 73-81. 3. Cella, D. and L.J. Fallowfield, Breast Ca Res Treat, 2008. 107(2): p167-80. 4. Cleeland, C.S., et al., N Engl J Med, 1994. 330(9): p. 592-6.
IN19 MANAGING BREAST CANCER IN LOW AND MIDDLE INCOME COUNTRIES Nagi S. El Saghir Breast Center of Excellence, NK Basile Cancer Institute, American University of Beirut, Beirut, Lebanon Definitions of Resource Levels Breast cancer incidence rates are rising, though at different paces, in most low and middle income countries. We will refer to those countries as Lowand Middle- resource Countries (LMC). According to World Bank 2009 report, low income countries have a Gross National Income of $995 or less, per month. And lower middle income countries as those that have a GNI of $996 - $3,945. Their health services are often limited, and alternative medicine is commonly employed. WHO describes “low-resource scenario” as one where the infrastructure and human resources for cancer prevention or control are non-existent or very limited in quantity, quality and accessibility. Some may suffer from political or social instability, or excessive bureaucracy, while others may have large, remote, rural populations limiting access to centralized health care. Communicable diseases and malnutrition are a major cause of morbidity and mortality, and life expectancy is less than 60 years. Cancer is becoming a leading causes of death for people older than 15 years of age. Breast Health Global Initiative (BHGI) developed evidence-based, economically feasible, and culturally