The following is the summary of “Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response” published in the November 2022 issue of Oncology by Loibl, et al.
A potential treatment in early breast cancer is the addition of immune checkpoint inhibitors to neoadjuvant chemotherapy (NACT). However the optimal duration of therapy is not yet determined. Adding durvalumab to NACT, as was previously reported, increased the rate of pathological complete responses (pCRs) by a modest absolute 9% (P=0.287) in the GeparNuevo (NCT02685059) trial. Durvalumab 1.5 g or placebo every 4 weeks was added to nab-paclitaxel 125 mg/m2 weekly for 12 weeks in patients with cT1b-cT4a-d triple-negative breast cancer (TNBC), and then durvalumab/placebo every 4 weeks was added to epirubicin/cyclophosphamide every 2 weeks before surgery.
Following surgery, durvalumab treatment was discontinued. Researchers were primarily concerned with achieving pCR. Overall survival, progression-free survival, and time to progression were secondary goals (OS). Between June 2016 and October 2017, 174 patients were assigned at random. At the end of the median 43.7-month follow-up period, 34 incidents occurred. Three-year iDFS was 85.6% with durvalumab compared with 77.2% with placebo [hazard ratio (HR) 0.48, 95% confidence interval (CI) 0.24-0.97, stratified log-rank P=0.036]; DDFS was 91.7% compared with 78.4% (HR 0.31, 95% CI 0.13-0.74, P=0.005); and OS was 95.2% compared with 83.5% (HR 0. Durvalumab increased the 3-year iDFS of pCR patients from 95.5% to 96.5% (HR 0.22%, 95% CI 0.05-1.06).
Without durvalumab, the pCR patients’ iDFS was 86. 3 iDFS was 76.3% in the non-pCR group, compared to 69.7% in the pCR group (HR 0.67, 95% CI 0.29-1.54). Results from a multivariate analysis corroborated the independence of the durvalumab impact from the pCR effect. There were no fresh warning signs. The addition of durvalumab to NACT in TNBC considerably increased survival, despite only a moderate improvement in pCR and the absence of an adjuvant component of durvalumab. More research is required to determine the best timing and number of cycles of checkpoint inhibitors for treating early-stage TNBC.