{"entity":{"id":"paper-pless-sakk-16-00-induction-chemoradiation-lancet-2015","kind":"paper","name":"Induction chemoradiation in stage IIIA/N2 non-small-cell lung cancer: a phase 3 randomised trial (SAKK 16/00)","aka":[],"tldr":"The Swiss trial group's randomised test of adding radiotherapy before lung cancer surgery: it added side effects and no benefit, so chemotherapy and one local treatment are enough.","summary":"The report of SAKK 16/00, led from Kantonsspital Winterthur with investigators at CHUV Lausanne, University Hospital Zurich and other centres. Patients with resectable stage IIIA/N2 non-small-cell lung cancer received three cycles of cisplatin and docetaxel and were randomised to 44 Gy of radiotherapy before surgery or to surgery directly. Event-free survival did not differ, and 91 per cent of patients completed the three chemotherapy cycles.","asOf":"2026-11-03","links":[{"label":"Lancet 2015","url":"https://doi.org/10.1016/S0140-6736(15)60294-X"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/26275735/"}],"tags":[],"related":[],"cancers":["nsclc"],"sections":["radiation","chemotherapy"],"technologies":[],"targets":[],"drugs":[],"companies":["swiss-cancer-institute"],"institutions":["chuv-lausanne","usz-zurich","swiss-cancer-league"],"pathways":[],"terms":[],"trials":["sakk-16-00"],"people":["roger-stupp","rolf-stahel"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"The Lancet","year":2015,"doi":"10.1016/S0140-6736(15)60294-X","pmid":"26275735","authors":"Pless M, Stupp R, Ris HB, Stahel RA, Weder W, et al.","paperType":"rct","findings":["232 patients were randomised at 23 centres in Switzerland, Germany and Serbia from 2001 to 2012: 117 to chemoradiotherapy and 115 to chemotherapy alone before surgery.","Median event-free survival was 12.8 months (95 per cent CI 9.7 to 22.9) with radiotherapy and 11.6 months (8.4 to 15.2) without, p=0.67.","Median overall survival was 37.1 months (22.6 to 50.0) with radiotherapy and 26.2 months (19.9 to 52.1) without.","Grade 3 dysphagia from radiotherapy occurred in seven patients (7 per cent); three patients in the control group died within 30 days of surgery."],"whatItMeans":"For resectable stage IIIA/N2 disease, induction chemotherapy followed by a single definitive local treatment, surgery or radiotherapy, is adequate; stacking radiotherapy before surgery adds toxicity without improving event-free survival.","caveats":["The trial predates immunotherapy before and after surgery, which has since changed treatment of resectable stage III disease.","Overall survival was a secondary endpoint and its confidence intervals overlap widely."],"changedPractice":true,"participants":232},"route":"/key-papers/paper-pless-sakk-16-00-induction-chemoradiation-lancet-2015/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"radiation","kind":"section","name":"Radiation Therapy","route":"/fronts/radiation/"}],"company":[{"id":"swiss-cancer-institute","kind":"company","name":"Swiss Cancer Institute (formerly SAKK)","route":"/companies/swiss-cancer-institute/"}],"institution":[{"id":"chuv-lausanne","kind":"institution","name":"Lausanne University Hospital (CHUV) / Ludwig Institute Lausanne","route":"/institutions/chuv-lausanne/"},{"id":"swiss-cancer-league","kind":"institution","name":"Swiss Cancer League (Krebsliga Schweiz)","route":"/institutions/swiss-cancer-league/"},{"id":"usz-zurich","kind":"institution","name":"University Hospital Zurich / Comprehensive Cancer Center Zurich","route":"/institutions/usz-zurich/"}],"trial":[{"id":"sakk-16-00","kind":"trial","name":"SAKK 16/00","route":"/trials/sakk-16-00/"}],"person":[{"id":"roger-stupp","kind":"person","name":"Roger Stupp","route":"/people/roger-stupp/"},{"id":"rolf-stahel","kind":"person","name":"Rolf A. Stahel","route":"/people/rolf-stahel/"}]}}