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Rothschild, Sacha I.; Zippelius, Alfred; Eboulet, Eric I.; Savic Prince, Spasenija; Betticher, Daniel; Bettini, Adrienne; Früh, Martin; Joerger, Markus; Lardinois, Didier; Gelpke, Hans; Mauti, Laetitia A.; Britschgi, Christian; Weder, Walter; Peters, Solange; Mark, Michael; Cathomas, Richard; Ochsenbein, Adrian F.; Janthur, Wolf-Dieter; Waibel, Christine; Mach, Nicolas; Froesch, Patrizia; Buess, Martin; Bohanes, Pierre; Godar, Gilles; [...]

SAKK 16/14: Durvalumab in Addition to Neoadjuvant Chemotherapy in Patients With Stage IIIA(N2) Non–Small-Cell Lung Cancer—A Multicenter Single-Arm Phase II Trial

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  • Media type: E-Article
  • Title: SAKK 16/14: Durvalumab in Addition to Neoadjuvant Chemotherapy in Patients With Stage IIIA(N2) Non–Small-Cell Lung Cancer—A Multicenter Single-Arm Phase II Trial
  • Contributor: Rothschild, Sacha I.; Zippelius, Alfred; Eboulet, Eric I.; Savic Prince, Spasenija; Betticher, Daniel; Bettini, Adrienne; Früh, Martin; Joerger, Markus; Lardinois, Didier; Gelpke, Hans; Mauti, Laetitia A.; Britschgi, Christian; Weder, Walter; Peters, Solange; Mark, Michael; Cathomas, Richard; Ochsenbein, Adrian F.; Janthur, Wolf-Dieter; Waibel, Christine; Mach, Nicolas; Froesch, Patrizia; Buess, Martin; Bohanes, Pierre; Godar, Gilles; [...]
  • imprint: American Society of Clinical Oncology (ASCO), 2021
  • Published in: Journal of Clinical Oncology
  • Language: English
  • DOI: 10.1200/jco.21.00276
  • ISSN: 0732-183X; 1527-7755
  • Origination:
  • Footnote:
  • Description: <jats:sec><jats:title>PURPOSE</jats:title><jats:p> For patients with resectable stage IIIA(N2) non–small-cell lung cancer, neoadjuvant chemotherapy with cisplatin and docetaxel followed by surgery resulted in a 1-year event-free survival (EFS) rate of 48% in the SAKK 16/00 trial and is an accepted standard of care. We investigated the additional benefit of perioperative treatment with durvalumab. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> Neoadjuvant treatment consisted of three cycles of cisplatin 100 mg/m<jats:sup>2</jats:sup> and docetaxel 85 mg/m<jats:sup>2</jats:sup> once every 3 weeks followed by two doses of durvalumab 750 mg once every 2 weeks. Durvalumab was continued for 1 year after surgery. The primary end point was 1-year EFS. The hypothesis for statistical considerations was an improvement of 1-year EFS from 48% to 65%. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Sixty-eight patients were enrolled, 67 were included in the full analysis set. Radiographic response rate was 43% (95% CI, 31 to 56) after neoadjuvant chemotherapy and 58% (95% CI, 45 to 71) after sequential neoadjuvant immunotherapy. Fifty-five patients were resected, of which 34 (62%) achieved a major pathologic response (MPR; ≤ 10% viable tumor cells) and 10 (18%) among them a complete pathologic response. Postoperative nodal downstaging (ypN0-1) was observed in 37 patients (67%). Fifty-one (93%) resected patients had an R0 resection. There was no significant effect of pretreatment PD-L1 expression on MPR or nodal downstaging. The 1-year EFS rate was 73% (two-sided 90% CI, 63 to 82). Median EFS and overall survival were not reached after 28.6 months of median follow-up. Fifty-nine (88%) patients had an adverse event grade ≥ 3 including two fatal adverse events that were judged not to be treatment-related. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> The addition of perioperative durvalumab to neoadjuvant chemotherapy in patients with stage IIIA(N2) non–small-cell lung cancer is safe and exceeds historical data of chemotherapy alone with a high MPR and an encouraging 1-year EFS rate of 73%. </jats:p></jats:sec>
  • Access State: Open Access