medwireNews: Adding perioperative durvalumab to neoadjuvant chemotherapy could be a feasible option for patients with resectable, locally advanced non-small-cell lung cancer (NSCLC) with mediastinal lymph node involvement, suggest phase 2 trial data.
In the SAKK 16/14 study, 67 individuals with stage IIIA (N2) disease received up to three cycles of neoadjuvant cisplatin 100 mg/m2 plus docetaxel 85 mg/m2 every 3 weeks followed by two doses of durvalumab 750 mg every 2 weeks. The PD-L1 inhibitor was continued at the same dose for up to a year after surgery.
Ninety percent of the participants completed all three cycles of neoadjuvant chemotherapy, 93% started neoadjuvant durvalumab, 82% underwent tumor resection, and 75% initiated adjuvant durvalumab, report Sacha Rothschild, from University Hospital Basel in Switzerland, and collaborators.
The objective response rate (ORR) after neoadjuvant chemotherapy was 43%, with complete responses in 3% and partial responses in 40%. After neoadjuvant durvalumab treatment, the ORR rose to 58%, with complete responses in 7% and partial in 52%.
Of the 55 patients who had surgery, 62% achieved a major pathologic response (≤10% viable tumor cells) and 18% had a complete pathologic response (no viable tumor cells).
At the 1-year mark, the event-free survival rate in the total study cohort was 73%, and thus “the primary end point of the trial was reached,” say the investigators in the Journal of Clinical Oncology.
They add that the 1-year overall survival rate was 91%, and the median had not been reached for either survival endpoint after a median follow-up of 28.6 months.
In all, 88% of the study participants experienced an adverse event (AE) of at least grade 3; the rates were 67% during neoadjuvant chemotherapy and 13% and 50% with neoadjuvant and adjuvant durvalumab, respectively.
AEs of special interest with durvalumab were hepatic function abnormalities, hypersensitivity reactions, and pneumonitis, and these occurred in 10%, 5%, and 3% of patients, respectively.
There were two deaths due to AEs during the course of the study – one case of respiratory failure during neoadjuvant chemotherapy and one of bronchopulmonary hemorrhage 10 days after surgery, neither of which were considered related to study treatment.
And the overall 30-day postoperative mortality rate was low, at 2%, “and comparable with previous trials of our group with neoadjuvant chemotherapy alone,” comment Rothschild and colleagues.
The researchers therefore summarize: “Our results show that the addition of perioperative durvalumab to neoadjuvant chemotherapy with cisplatin and docetaxel in patients with resectable stage IIIA(N2) NSCLC is a highly active and safe therapy that needs to be further investigated.”
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J Clin Oncol 2021; doi:10.1200/JCO.21.00276