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.
The ASCO Post Staff
Mairéad G. McNamara, PhD, MBBCh, of The Christie NHS Foundation Trust, discusses phase II findings of the NET-02 trial, which explored an unmet need in the second-line treatment of patients with progressive, poorly differentiated extrapulmonary neuroendocrine carcinoma. In the trial, the combination of liposomal irinotecan, fluorouracil, and folinic acid, but not docetaxel, met the primary endpoint of 6-month progression-free survival rate (Abstract 4005).
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).
Paul G. Richardson, MD, of Dana-Farber Cancer Institute, discusses phase III findings from the DETERMINATION trial, which showed that, for patients with newly diagnosed multiple myeloma, lenalidomide, bortezomib, and dexamethasone (RVd) with or without autologous stem cell transplant (ASCT) and lenalidomide maintenance to disease progression resulted in the longest median progression-free survival reported for each approach, and a highly significant difference in progression-free survival in favor of early transplant. While overall response rates were similar, rates of MRD favored early transplant also, but toxicity was greater and quality of life was transiently but significantly diminished. No overall survival advantage has been observed to date (Abstract LBA4).
The ASCO Post Staff
Martin McCabe, PhD, of the University of Manchester, discusses a phase III assessment of chemotherapy for patients with recurrent and primary refractory Ewing sarcoma. The trial, called rEECur, is the first study to provide comparative toxicity and survival data for the four most commonly used chemotherapy regimens in this disease. The analysis showed that high-dose ifosfamide is more effective in prolonging survival than topotecan plus cyclophosphamide (Abstract LBA2).
The ASCO Post Staff
Manali I. Patel, MD, MPH, of Stanford University School of Medicine, discusses clinical trial findings on the best ways to integrate community-based interventions into cancer care delivery for low-income and minority populations. Such interventions may improve quality of life and patient activation (often defined as patients having the knowledge, skills, and confidence to manage their health), as well as reduce hospitalizations and the total costs of care (Abstract 6500).