OBJECTIVE: The 21-gene assay (Oncotype DX Breast Cancer Test (Genomic Health Inc., Redwood City, CA)) is a well validated test that predicts the likelihood of adjuvant chemotherapy benefit and the 10-year risk of distant recurrence in patients with ER+, HER2- early-stage breast cancer. The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Germany. METHODS: A Markov model was developed to make long-term projections of distant recurrence, survival, quality-adjusted life expectancy, and direct costs for patients with ER+, HER2-, node-negative, or up to 3 node-positive early-stage breast cancer. Scenarios using conventional diagnostic procedures or the 21-gene assay to inform treatment recommendations for adjuvant chemotherapy were modeled based on a prospective, multi-center trial in 366 patients. Transition probabilities and risk adjustment were based on published landmark trials. Costs (2011 Euros (€)) were estimated from a sick fund perspective based on resource use in patients receiving chemotherapy. Future costs and clinical benefits were discounted at 3% annually. RESULTS: The 21-gene assay was projected to increase mean life expectancy by 0.06 years and quality-adjusted life expectancy by 0.06 quality-adjusted life years (QALYs) compared with current clinical practice over a 30-year time horizon. Clinical benefits were driven by optimized allocation of adjuvant chemotherapy. Costs from a healthcare payer perspective were lower with the 21-gene assay by ∼€561 vs standard of care. Probabilistic sensitivity analysis indicated that there was an 87% probability that the 21-gene assay would be dominant (cost and life saving) to standard of care. LIMITATIONS: Country-specific data on the risk of distant recurrence and quality-of-life were not available. CONCLUSIONS: Guiding decision-making on adjuvant chemotherapy using the 21-gene assay was projected to improve survival, quality-adjusted life expectancy, and be cost saving vs the current standard of care women with ER+, HER2- early-stage breast cancer.
OBJECTIVE: The 21-gene assay (Oncotype DX Breast Cancer Test (Genomic Health Inc., Redwood City, CA)) is a well validated test that predicts the likelihood of adjuvant chemotherapy benefit and the 10-year risk of distant recurrence in patients with ER+, HER2- early-stage breast cancer. The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Germany. METHODS: A Markov model was developed to make long-term projections of distant recurrence, survival, quality-adjusted life expectancy, and direct costs for patients with ER+, HER2-, node-negative, or up to 3 node-positive early-stage breast cancer. Scenarios using conventional diagnostic procedures or the 21-gene assay to inform treatment recommendations for adjuvant chemotherapy were modeled based on a prospective, multi-center trial in 366 patients. Transition probabilities and risk adjustment were based on published landmark trials. Costs (2011 Euros (€)) were estimated from a sick fund perspective based on resource use in patients receiving chemotherapy. Future costs and clinical benefits were discounted at 3% annually. RESULTS: The 21-gene assay was projected to increase mean life expectancy by 0.06 years and quality-adjusted life expectancy by 0.06 quality-adjusted life years (QALYs) compared with current clinical practice over a 30-year time horizon. Clinical benefits were driven by optimized allocation of adjuvant chemotherapy. Costs from a healthcare payer perspective were lower with the 21-gene assay by ∼€561 vs standard of care. Probabilistic sensitivity analysis indicated that there was an 87% probability that the 21-gene assay would be dominant (cost and life saving) to standard of care. LIMITATIONS: Country-specific data on the risk of distant recurrence and quality-of-life were not available. CONCLUSIONS: Guiding decision-making on adjuvant chemotherapy using the 21-gene assay was projected to improve survival, quality-adjusted life expectancy, and be cost saving vs the current standard of care women with ER+, HER2- early-stage breast cancer.
Authors: Bradley M Turner; Kristin A Skinner; Ping Tang; Mary C Jackson; Nyrie Soukiazian; Michelle Shayne; Alissa Huston; Marilyn Ling; David G Hicks Journal: Mod Pathol Date: 2015-05-01 Impact factor: 7.842
Authors: Young Chandler; Clyde B Schechter; Jinani Jayasekera; Aimee Near; Suzanne C O'Neill; Claudine Isaacs; Charles E Phelps; G Thomas Ray; Tracy A Lieu; Scott Ramsey; Jeanne S Mandelblatt Journal: J Clin Oncol Date: 2018-01-08 Impact factor: 44.544
Authors: L Masucci; S Torres; A Eisen; M Trudeau; I Tyono; H Saunders; K W Chan; W Isaranuwatchai Journal: Curr Oncol Date: 2019-10-01 Impact factor: 3.677
Authors: Joseph Gligorov; Xavier B Pivot; William Jacot; Hervé L Naman; Dominique Spaeth; Jean-Louis Misset; Rémy Largillier; Jean-Loup Sautiere; Anne de Roquancourt; Christophe Pomel; Philippe Rouanet; Roman Rouzier; Frederique M Penault-Llorca Journal: Oncologist Date: 2015-06-25
Authors: Berit Maria Müller; Elke Keil; Annika Lehmann; Klaus-Jürgen Winzer; Christiane Richter-Ehrenstein; Judith Prinzler; Nikola Bangemann; Angela Reles; Sylvia Stadie; Winfried Schoenegg; Jan Eucker; Marcus Schmidt; Frank Lippek; Korinna Jöhrens; Stefan Pahl; Bruno Valentin Sinn; Jan Budczies; Manfred Dietel; Carsten Denkert Journal: PLoS One Date: 2013-06-27 Impact factor: 3.240