Etienne Brain, MD, PhD, on Breast Cancer: Adjuvant Endocrine Therapy With or Without Chemotherapy in Older Patients
2022 ASCO Annual Meeting
Etienne Brain, MD, PhD, of the Institut Curie, discusses phase III findings from the Unicancer ASTER 70s trial, in which patients aged 70 or older with estrogen receptor–positive, HER2-negative breast cancer and a high genomic grade index received adjuvant endocrine therapy with or without chemotherapy. The data did not find a statistically significant overall survival benefit with this treatment after surgery (Abstract 500).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
ASTER 70s study is a landmark study, which has been conducted in older women with luminal breast cancer in adjuvant setting questioning the addition of chemotherapy to endocrine treatment. The rationale behind is that the literature is very limited in terms of data published for the use of adjuvant chemotherapy in this situation in older ones. Multimorbidity competes with cancer on outcome and therapeutic ratio is also more narrow because there are higher risk of side effects in this population.
This trial screened near 2000 patients with the genomic grade index, the GGI, to assess the aggressivity of the disease and to spare the burden of chemotherapy in those patients with low-GGI tumor, while those with a high-GGI tumor were randomized between endocrine treatment alone as a standard arm versus chemotherapy followed by endocrine treatment. Near 2000 patients enrolled, 1,100 randomized between the two arms.
This trial shows, on the primary endpoint, which was overall survival by intent-to-treat analysis, that chemotherapy doesn't add a significant benefit in addition to endocrine treatment. That's the first message of caution from this study. Second one is that we can look at different subgroups and perform also the analysis according to the per protocol concept. This modifies or brings a nuance in the results, but I would say that the final potential benefit on overall survival in this case remains marginal. And in this population of older women, it is a key point and a double cautious message.
The next step for this study will be to try to improve the discriminative capacity of this kind of signature to identify those who could benefit still from chemotherapy, despite these global message and results on overall survival. This will be certainly possible with the use of the mass and the volume of data which has been collected in the randomized groups in this study, because there was a longitudinal collection of geriatric data, quality of life data, and treatment acceptability socioeconomic data, which will be very helpful to modelize differently, the prognosis of these ladies.
That's in the near future, and I think what brings the most in terms of information ASTER 70s, is that on the provisor that you change a bit of rules for inclusion criteria, because in this study we had very flexible inclusion criteria, we made a focus on quality of life and we use a single informed consent for screening and randomization, on the provisor that you facilitate or you simplify the processes, you can run large studies in a vast population, which is very often not considered for clinical trials left behind.
Related Videos
The ASCO Post Staff
Lisa A. Carey, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center, and Shanu Modi, MD, of Memorial Sloan Kettering Cancer Center, discuss the phase III findings from the DESTINY-Breast04 trial, which compared fam-trastuzumab deruxtecan-nxki (T-DXd) vs treatment of physician’s choice (TPC) in patients with HER2-low unresectable and/or metastatic breast cancer. T-DXd is the first HER2-targeted therapy to demonstrate clinically meaningful improvement in progression-free and overall survival compared with TPC in this patient population, regardless of hormone receptor or immunohistochemistry status or prior use of CDK4/6 inhibitors (Abstract LBA3).
The ASCO Post Staff
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, The University of Sydney, discusses phase III findings from the KEYNOTE-716 study. The trial showed that compared with placebo, adjuvant pembrolizumab significantly improved distant metastasis–free survival in patients with resected stage IIB and IIC melanoma. The findings also suggest a continued reduction in the risk of recurrence and a favorable benefit-risk profile (Abstract LBA9500).
The ASCO Post Staff
Apar Kishor Ganti, MD, of the University of Nebraska Medical Center, discusses results from the CALGB 30610 study, which showed a similar clinical benefit for once- and twice-daily radiotherapy administered to patients with limited-stage small cell lung cancer. While both regimens were well tolerated, patients who received radiotherapy once daily had better quality-of-life scores at week 3 and slightly worse scores at week 12. Patients believed the once-daily regimen was more convenient (Abstract 8504).
The ASCO Post Staff
Rami Manochakian, MD, of Mayo Clinic Florida, discusses the phase II findings of the NADIM II trial, which confirmed that, in terms of pathologic complete response as well as the feasibility of surgery, combining nivolumab and chemotherapy was superior to chemotherapy alone as a neoadjuvant treatment for locally advanced, resectable stage IIIA non–small cell lung cancer (Abstract 8501).
The ASCO Post Staff
Courtney D. DiNardo, MD, MSCE, of The University of Texas MD Anderson Cancer Center, and Stéphane de Botton, MD, PhD, of Institut Gustave Roussy, discuss phase III findings from the IDHENTIFY trial, which showed that mutational burden and co-mutational profiles differed between patients with relapsed or refractory acute myeloid leukemia that exhibited IDH2-R140 and IDH2-R172 mutations. Enasidenib improved survival outcomes for patients with IDH2-R172 mutations: median overall survival and 1-year survival rates were approximately double those in the conventional care arm (Abstract 7005).