Abstract
BackgroundBreast-cancer incidence and mortality have been increasing in Japan. Japanese-specific clinical validity and utility data for the 21-gene assay (Oncotype DX® Breast Cancer Assay; Genomic Health, Inc., Redwood City, USA) are now available. The objective of this study was to evaluate the cost-effectiveness of the 21-gene assay for the guidance of adjuvant chemotherapy decisions in estrogen-receptor–positive, lymph-node–negative, early-stage breast cancer patients, from the Japanese societal perspective.MethodsThe recurrence risk group distribution by the 21-gene assay result and the assay’s influence on adjuvant chemotherapy recommendations were obtained from a study of 104 patients. A state-transition cohort (Markov) model tracked time from surgery until distant recurrence and from distant recurrence to death. Adjuvant chemotherapy benefit by 21-gene assay risk group was based on published clinical validation studies. Direct and indirect medical costs were obtained from the referral centers. Utilities associated with progression and chemotherapy-related adverse events were extracted from literature. Sensitivity analyses assessed the key drivers and robustness of the primary outcomes.ResultsThe 21-gene assay identified 48% of patients as low-risk, 36% as intermediate-risk, and 16% as high-risk. Total acute chemotherapy-related costs decreased by ¥154,066 due to less adjuvant chemotherapy usage. In the high-risk group, adjuvant chemotherapy use increased 18%, leading to survival benefits. Chemotherapy use overall decreased by 19%. Monitoring costs increased by ¥3,744 but recurrence costs declined by ¥46,113 per patient. Use of the 21-gene assay increased quality-adjusted–life-years (QALYs) by 0.241 per patient on average; the net cost per QALY gained was ¥636,752 ($6,368).ConclusionsThe 21-gene assay for women with estrogen-receptor–positive, lymph-node–negative, early-stage breast cancer is projected to be cost-effective in Japan.
Highlights
Breast-cancer incidence and mortality have been increasing in Japan
Gallen International Breast Cancer Conference indicate that patients with ER+, LN- early-stage breast cancer (ESBC) have the options of systemic adjuvant treatment with either endocrine therapy and/or chemotherapy [7,8]
Using the decision impact data from Japanese clinical practice, this study aimed to evaluate the cost-effectiveness of the 21-gene assay compared to traditional prognostic indicators for the guidance of adjuvant chemotherapy decisions in ER+, LN- ESBC patients from a societal perspective in Japan
Summary
Breast-cancer incidence and mortality have been increasing in Japan. Japanese-specific clinical validity and utility data for the 21-gene assay (Oncotype DX® Breast Cancer Assay; Genomic Health, Inc., Redwood City, USA) are available. The objective of this study was to evaluate the cost-effectiveness of the 21-gene assay for the guidance of adjuvant chemotherapy decisions in estrogen-receptor–positive, lymph-node–negative, early-stage breast cancer patients, from the Japanese societal perspective. Guidelines issued by the National Comprehensive Cancer Network (NCCN) and the expert panel at the 2011 St. Gallen International Breast Cancer Conference indicate that patients with ER+, LN- early-stage breast cancer (ESBC) have the options of systemic adjuvant treatment with either endocrine therapy and/or chemotherapy [7,8]. Gallen International Breast Cancer Conference indicate that patients with ER+, LN- early-stage breast cancer (ESBC) have the options of systemic adjuvant treatment with either endocrine therapy and/or chemotherapy [7,8] They recommend that clinicians consider selecting candidates for adjuvant chemotherapy to prevent distant recurrence on the basis of clinical and pathologic features, such as patient age, tumor size, degree of lymph node involvement, and tumor differentiation. The potential risk reduction in distant recurrence must be weighed against the risks of adverse events with adjuvant chemotherapy; at least 10% of patients experience serious or life-threatening adverse effects with chemotherapy treatment [9]
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