ASCO 2021: Adjuvant Durvalumab Treatment for Triple-Negative Breast Cancer
Posted: Thursday, June 17, 2021
The addition of the anti–PD-L1 checkpoint inhibitor durvalumab before chemotherapy improved long-term outcomes in some patients with early triple-negative breast cancer, according to results from the phase II GeparNUEVO study. However, there was just a slight increase in pathologic complete response and no continued treatment after surgery. These findings were presented by Sibylle Loibl, MD, PhD, of the University Hospital and German Cancer Research Center, Heidelberg, and colleagues during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 506).
“It needs to be questioned whether adjuvant therapy with checkpoint inhibitors is needed at all [in this patient population,” stated the investigators.
This randomized clinical trial was conducted in multiple centers in Germany. Women with no history of radiation therapy or chemotherapy and centrally confirmed triple-negative breast cancer with cT1b–cT4a–d tumors were enrolled (n = 174). Patients were randomly assigned to receive either intravenous durvalumab (1.5 g) or a placebo every 4 weeks. Subsequently, all patients received durvalumab/placebo monotherapy for 2 weeks (window phase), followed by durvalumab/placebo plus nab-paclitaxel weekly for 12 weeks, followed by durvalumab/placebo plus epirubicin/cyclophosphamide every 2 weeks for four cycles.
The pathologic complete response seemed to be improved in patients who received durvalumab (61.0%) compared with placebo, but only in the window cohort (41.4%, P = .035). Follow-up at 3 years appeared to indicate that distant disease–free survival and overall survival were increased in the durvalumab versus the placebo group (P = .014 vs. P = .007, respectively). At 3 years, invasive disease–free survival in patients with complete pathologic responses was 92.0% compared with 71.9% in those without complete responses (P = .002). There were no differences in survival measures between the window and no-window cohort.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
