Meeting Highlights: International Expert Consensus on the Primary Therapy of Early Breast Cancer 2005

American Cancer Society Guidelines for the Early Detection of Cancer

The burden of cancer is growing, and the disease is becoming a major economic expenditure for all developed countries. In 2008, the worldwide cost of cancer due to premature death and disability (not including direct medical costs) was estimated to be US$895 billion. This is not simply due to an increase in absolute numbers, but also the rate of increase of expenditure on cancer. What are the drivers and solutions to the so-called cancer-cost curve in developed countries? How are we going to afford to deliver high quality and equitable care? Here, expert opinion from health-care professionals, policy makers, and cancer survivors has been gathered to address the barriers and solutions to delivering affordable cancer care. Although many of the drivers and themes are specific to a particular field-eg, the huge development costs for cancer medicines-there is strong concordance running through each contribution. Several drivers of cost, such as over-use, rapid expansion, and shortening life cycles of cancer technologies (such as medicines and imaging modalities), and the lack of suitable clinical research and integrated health economic studies, have converged with more defensive medical practice, a less informed regulatory system, a lack of evidence-based sociopolitical debate, and a declining degree of fairness for all patients with cancer. Urgent solutions range from re-engineering of the macroeconomic basis of cancer costs (eg, value-based approaches to bend the cost curve and allow cost-saving technologies), greater education of policy makers, and an informed and transparent regulatory system. A radical shift in cancer policy is also required. Political toleration of unfairness in access to affordable cancer treatment is unacceptable. The cancer profession and industry should take responsibility and not accept a substandard evidence base and an ethos of very small benefit at whatever cost; rather, we need delivery of fair prices and real value from new technologies.

https://www.thelancet.com/pdfs/journals/lanonc/PIIS1470204511701413.pdf

Delivering affordable cancer care in high-income countries

� Abstract: Breast cancer is the most common cause of cancer-related death among women worldwide, with case fatality rates highest in low-resource countries. Despite significant scientific advances in its management, most of the world faces resource constraints that limit the capacity to improve early detection, diagnosis, and treatment of the disease. The Breast Health Global Initiative (BHGI) strives to develop evidence-based, economically feasible, and culturally appropriate guidelines that can be used in nations with limited health care resources to improve breast cancer outcomes. Using an evidence-based consensus panel process, four BHGI expert panels addressed the areas of early detection and access to care, diagnosis and pathology, treatment and resource allocation, and health care systems and public policy as they relate to breast health care in limited-resource settings. To update and expand on the BHGI Guidelines published in 2003, the 2005 BHGI panels outlined a stepwise, systematic approach to health care improvement using a tiered system of resource allotment into four levels—basic, limited, enhanced, and maximal— based on the contribution of each resource toward improving clinical outcomes. Early breast cancer detection improves outcome in a cost-effective fashion assuming treatment is available, but requires public education to foster active patient participation in diagnosis and treatment. Clinical breast examination combined with diagnostic breast imaging (ultrasound ± diagnostic mammography) can facilitate cost-effective tissue sampling techniques for cytologic or histologic diagnosis. Breast-conserving treatment with partial mastectomy and radiation therapy requires more health care resources and infrastructure than mastectomy, but can be provided in a thoughtfully designed limited-resource setting. The availability and administration of systemic therapies are critical to improving breast cancer survival. Estrogen receptor testing allows patient selection for hormonal treatments (tamoxifen, oophorectomy). Chemotherapy, which requires some allocation of resources and infrastructure, is needed to treat node-positive, locally advanced breast cancers, which represent the most common clinical presentation of disease in low-resource countries. When chemotherapy is not available, patients with locally advanced, hormone receptor-negative cancers can only receive palliative therapy. Future research is needed to better determine how these guidelines can best be implemented in limited-resource settings. �

Breast Cancer in Limited‐Resource Countries: An Overview of the Breast Health Global Initiative 2005 Guidelines

Patients face difficult decisions about chemotherapy near the end of life. Such treatment might prolong survival or reduce symptoms but cause adverse effects, prevent the patient from engaging in meaningful life review and preparing for death, and preclude entry into hospice. Palliative care and oncology clinicians should be logical partners in caring for patients with serious cancers for which symptom control, medically appropriate goal setting, and communication are paramount, but some studies have shown limited cooperation. We illustrate how clinicians involved in palliative care and oncology can more effectively work together with the story of Mr L, a previously healthy 56-year-old man, who wanted to survive his lung cancer at all costs. He lived 14 months with 3 types of chemotherapy, received chemotherapy just 6 days before his death, and resisted entering hospice until his prognosis and options were explicitly communicated. Approaches to communication about prognosis and treatment options and questions that patients may want to ask are discussed.

The Role of Chemotherapy at the End of Life: “When Is Enough, Enough?”

BACKGROUND

Women who have estrogen receptor (ER)-positive disease with postmenopausal onset and who receive tamoxifen as standard adjuvant treatment constitute the largest subgroup of patients with breast cancer. Recent data from the ATAC (‘Arimidex, Tamoxifen Alone or in Combination’) randomized trial indicate that anastrozole significantly reduces breast cancer recurrence rates but does not provide any advantage in terms of survival at 4 years posttreatment. Furthermore, anastrozole and tamoxifen were found to have different toxicity profiles. The goals of the current study were to estimate the disease-free survival (DFS) rates and potential survival benefits associated with anastrozole use and to determine whether the incremental cost-effectiveness (ICE) was low enough to warrant an immediate switch to the use of this agent, as the long-term conclusions of the ATAC trial will not be available for several years.



METHODS

A computer simulation model assessed the outcomes of 64-year-old women with ER-positive breast cancer who subsequently received either anastrozole or tamoxifen for 5 years. Daily recurrence risks, as well as the relative risks associated with various treatment-related events, were calculated using data from the ATAC trial. Study endpoints included breast cancer recurrence–free survival, anticipated survival resulting from an anastrozole-induced decrease in systemic disease recurrence rates, and survival adjusted for quality of life and for hip fracture risk over periods of 4, 12, and 20 years.



RESULTS

After 4 years, the projected DFS benefit associated with anastrozole was 14 days, with an ICE of $167,500 per year. Projected 12 and 20 years into the future, DFS benefits increased to 2.9 months and 5.3 months, respectively. The corresponding benefits in terms of overall survival were 0.9 months and 2.0 months, respectively, with the ICE becoming < $100,000 per life year once the projection horizon exceeded 12 years. The inclusion of quality-of-life weightings for nonfatal outcomes modestly favored anastrozole in the short term; however, if anastrozole use is associated with an increased risk of hip fracture, then the long-term benefit associated with this agent is reduced by approximately 25%.



CONCLUSIONS

Adjuvant anastrozole is projected to result in a substantial improvement in DFS for patients with breast cancer. If this DFS benefit were to ultimately lead to a survival benefit, then the ICE of anastrozole use would be acceptable for patients expected to live longer than 12 years. Decision models are useful for generating realistic projections for stakeholders who are considering competing options that impact survival and quality of life and have associated societal costs. Cancer 2004. © 2004 American Cancer Society.

Benefit and projected cost-effectiveness of anastrozole versus tamoxifen as initial adjuvant therapy for patients with early-stage estrogen receptor-positive breast cancer.

BACKGROUND

The results of a randomized comparison study (N9741) showed that oxaliplatin and infusional fluorouracil (FU) (FOLFOX) was superior to the previous standard of care in the United States, irinotecan and bolus FU (IFL), as first-line therapy for patients with metastatic colon carcinoma. The trade-offs between costs and survival for these two regimens have not been explored.



METHODS

A post-hoc, incremental cost-effectiveness (ICE) projection using simulated cohorts of patients starting FOLFOX or IFL was tracked for major clinical events, toxicities, and survival. Recurrence and survival risks were based on clinical trial data. Resource use was projected using observed dose intensity, duration of therapy, delays in therapy, and toxicities Grade > 2 in N9741. The frequency, costs, and consequences of second-line therapy were examined. The time frame was 5 years, and the perspective was that of Medicare as a third-party payer.



RESULTS

Initial treatment with FOLFOX versus IFL had an average incremental cost of $29,523, a survival benefit of 4.4 months, and an ICE of $80,410 per life year (LY), $111,890 per quality-adjusted LY, and $89,080 per progression-free year. By using the 95% confidence interval for the time to progression observed in N9741, the ICE associated with FOLFOX ranged from $121,220 to $59,250 per LY. In the clinical trial, dose delays and skipped doses were frequent. If progression-free patients were treated without delay for the first year or lifetime, then the ICE for FOLFOX increased to $117,910 and $222,200 per LY, respectively. The ICE increased to $84,780 per LY when the model incorporated a revised IFL schedule with lower early toxicity and similar rates of treatment with second-line regimens.



CONCLUSIONS

FOLFOX provided substantial benefits that incurred substantial additional costs. The ICE for FOLFOX fell into the upper range of commonly accepted oncology interventions in the context of the United States healthcare system. Cancer 2005. © 2005 American Cancer Society.

Cost-effectiveness projections of oxaliplatin and infusional fluorouracil versus irinotecan and bolus fluorouracil in first-line therapy for metastatic colorectal carcinoma.

BACKGROUND
The objective of this study was to determine the potential economic implications resulting from using exemestane (EXE), a new steroidal, irreversible aromatase inactivator, compared with megestrol acetate (MA) in patients with advanced breast carcinoma.

METHODS
The model used the clinical results from the manufacturer-sponsored, international, randomized, controlled, double-blind trial of patients with postmenopausal, tamoxifen-refractory advanced breast carcinoma. Seven hundred sixty-nine women were randomized to EXE 25 mg per day or MA 40 mg four times daily EXE was well tolerated, significantly delayed tumor progression (relative risk [RR], 0.82; 95% confidence interval [95% CI], 0.70–0.97), and prolonged survival (RR, 0.77; 95% CI, 0.59–0.99). Lifetime effectiveness projections were made using the trial efficacy results to the U.S. market using a 1000-day (≈3-year) time frame. Because the median survival of patients who received EXE was not reached, it was projected from the Cox model. There were no differences in the rate of hospitalization. The average wholesale prices for EXE and MA were used.

RESULTS
Patients who received EXE were projected to have a mean survival benefit of 53.5 days (estimated 95% CI, 2–100 days) and to incur at an additional cost of $1559 per patient (estimated 95% CI, $880–2075). The incremental cost effectiveness (CE) ratio using EXE was $10,600 per life year gained (estimated 95% CI, $6200–209,000). If MA had no costs, then the CE ratio increased to $12,200 per life year. Using a 5-year projection, the CE ratio for EXE was $5900 per life year. The projected survival at 1000 days was 53.9% in the EXE cohort compared with 44.8% in the MA cohort.

CONCLUSIONS
EXE, compared with MA, is projected to increase survival at a modest added cost. If treatment with EXE delays or defers initiating more costly therapies, then it may even be cost saving. Cancer 2001;91:484–9. © 2001 American Cancer Society.

Cost-effectiveness analysis of exemestane compared with megestrol in patients with advanced breast carcinoma.

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Benefit and projected cost-effectiveness of anastrozole versus tamoxifen as initial adjuvant therapy for patients with early-stage estrogen receptor-positive breast cancer.

Cost-effectiveness projections of oxaliplatin and infusional fluorouracil versus irinotecan and bolus fluorouracil in first-line therapy for metastatic colorectal carcinoma.

Cost-effectiveness analysis of exemestane compared with megestrol in patients with advanced breast carcinoma.