A Randomized Phase III Trial of the Value of Early … 2108.pdfPresented on: ASCO20 Virtual, 29.05....
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Presented on: ASCO20 Virtual, 29.05. – 31.05.2020 A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer: ECOG-ACRIN 2108 Seema A. Khan, Fengmin Zhao, Lawrence J. Solin, Brian Leyland-Jones, Lori J. Goldstein, David Cella, Mark Basik, Mehra Golshan, Thomas Julian, Barbara A. Pockaj, Christine A. Lee, Wajeeha Razaq, Joseph A. Sparano, Gildy V. Babiera, Irene A. Dy, Sarika Jain, Paula Silverman, Carla S. Fisher, Amye J. Tevaarwerk, Lynne I. Wagner, George W. Sledge.
Transcript of A Randomized Phase III Trial of the Value of Early … 2108.pdfPresented on: ASCO20 Virtual, 29.05....
Presented on: ASCO20 Virtual, 29.05. – 31.05.2020
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact PrimaryTumor in Patients with Metastatic BreastCancer: ECOG-ACRIN 2108
Seema A. Khan, Fengmin Zhao, Lawrence J. Solin, Brian Leyland-Jones, Lori J. Goldstein, David Cella, Mark Basik, Mehra Golshan, Thomas Julian, Barbara A. Pockaj, Christine A. Lee, Wajeeha Razaq, Joseph A. Sparano, Gildy V. Babiera, Irene A. Dy, Sarika Jain, Paula Silverman, Carla S. Fisher, Amye J. Tevaarwerk, Lynne I. Wagner, George W. Sledge.
Design of E2108Opened in 2011, last patient enrolled in 2015.
Presented on: ASCO20 Virtual, 29.05. – 31.05.2020
Statistical design amended in 2013 due to slow accrual.With 368 enrolled, 258 randomized and totalinformation of 152 deaths, we would have 85% powerto detect a 19% difference in the 3-year OS rates
Results: overall survival
Presented on: ASCO20 Virtual, 29.05. – 31.05.2020
• As of December 10, 2019, 121 patients had died (80% of full information).
• Median follow-up time was 53 months (0-91)
• Median survival was 54 months
• Stratified log rank test and Cox proportional hazard model were usedto compare OS between treatmentgroups.
Locoregional progression.
Presented on: ASCO20 Virtual, 29.05. – 31.05.2020
Definitions
Continued systemic therapy arm: Development of symptoms leading to a decision for local therapy.
Early local therapy arm1) Regional nodal progression2) Chest wall disease or invasive
in-breast recurrence;
The occurrence of distant progressiondid not preclude the reporting of laterlocal-regional recurrence/progression
Conclusions
Presented on: ASCO20 Virtual, 29.05. – 31.05.2020
• Early local therapy does not improve survival in patients with de novo metastaticbreast cancer and an intact primary tumor.
• Although we saw a 2.5-fold higher risk of local disease progression without LRT, the use of LRT for the primary site did not lead to improvement HRQOL.
• Based on available data, LRT for the primary tumor should not be offered to womenwith Stage IV breast cancer with the expectation of a survival benefit.
• When systemic disease is well-controlled with systemic therapy but the primary siteis progressing, LRT may be considered.
• Results from JCOG-1017 are pending.
