{"id":26910,"date":"2021-03-27T12:00:00","date_gmt":"2021-03-27T12:00:00","guid":{"rendered":"http:\/\/3d4a4f6d5b3531b5d726884cc22438ca"},"modified":"2024-11-03T15:15:00","modified_gmt":"2024-11-03T15:15:00","slug":"safety-analysis-shows-that-durvalumab-treatment-after-sbrt-is-feasible-in-patients-with-early-stage-nsclc","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/safety-analysis-shows-that-durvalumab-treatment-after-sbrt-is-feasible-in-patients-with-early-stage-nsclc\/","title":{"rendered":"Safety Analysis Shows that Durvalumab Treatment After SBRT Is Feasible in Patients with Early Stage NSCLC"},"content":{"rendered":"

A toxicity report from the phase II ASTEROID study demonstrated that durvalumab administered after stereotactic body radiotherapy (SBRT) in patients with early stage non-small cell lung cancer (NSCLC) was well tolerated, according to findings presented at the European Lung Cancer Virtual Congress 2021<\/a> (25-27 March).<\/p>\n

Andreas Hallqvist of the Institute of Clinical Sciences, Sahlgrenska Academy, Department of Oncology, Sahlgrenska University Hospital in G\u00f6teborg, Sweden presented the results of the randomised multicentre open-label phase II ASTEROID study (EudraCT: 2016-005225-37; NCT03446547).<\/p>\n

He explained that, while SBRT is associated with excellent local control, approximately 30% of patients develop distant metastases over time. Due to a lack of data and the fragility of this patient population, adjuvant chemotherapy is rarely administered. Therefore, Dr. Hallqvist and colleagues investigated immunotherapy, which has less toxicity and may provide a potential synergistic effect, as a treatment option. The investigators evaluated whether durvalumab in combination with radiation could improve outcomes in patients with T1-2N0M0 NSCLC.<\/p>\n

Twenty-five patients in arm A were treated with 3 to 4 fractions of SBRT only, whereas 22 patients in arm B received the same SBRT regimen followed by adjuvant treatment of 1500 mg durvalumab every 4 weeks. Most (66%) of the patients were women with a median age of 76 (range, 58 to 89) years. Adenocarcinomas were reported for 66% of the patients; 28% were ECOG performance status (PS) 0, 51% PS 1, and 21% were PS 2. The majority (98%) of the patients were former or current smokers and the mean FEV1 was 1.6 (0.64-4.5) L.<\/p>\n

The primary endpoint was time to progression (TTP), but the present analysis is an initial safety report.<\/p>\n

Durvalumab addition increased the number of adverse events but most were grade 1 or 2<\/h4>\n

Among all 47 patients included in the primary report and in the 24 patients completing treatment, the median number of durvalumab infusions was 6 (range, 1 to 12) and 11 (range, 3 to 12), respectively.<\/p>\n

Adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) v4.0 related to SBRT were reported in 7 (28%) patients in arm A and in 6 (27%) patients in arm B. All of the SBRT-related AEs were grade 1-2 events and consisted of pneumonitis, cough, dyspnoea, skin reactions, fatigue, and pain.<\/p>\n

Of the patients receiving durvalumab in arm B, 12 (55%) reported durvalumab-related AEs that were primarily grade 1 or 2; the most commonly reported events were skin reactions and\/or rash in 45% of patients, pruritus in 27%, and 18% of patients had thyroid disorders. Grade 3 AEs occurred in 6 patients; 2 patients had grade 3 pneumonitis, one patient had dyspnoea, and 3 patients had grade 3 asymptomatic hepatitis. One patient receiving durvalumab had grade 4 asymptomatic increased lipase.<\/p>\n

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The addition of durvalumab to SBRT in early stage NSCLC patients seems feasible and well tolerated.<\/p>\n

\u00a9 Andreas Hallqvist.<\/p>\n<\/div>\n<\/figcaption><\/figure>\n<\/div>\n<\/div>\n

Regarding the primary efficacy endpoint, TTP data were not yet mature.<\/p>\n

Conclusions<\/h4>\n

The investigators remarked that SBRT followed by adjuvant durvalumab appears to be feasible and well tolerated.<\/p>\n

The study is continuing to enrol participants as planned and to assess the primary endpoint of TTP.<\/p>\n

This study was funded by AstraZeneca.<\/p>\n

Reference<\/h4>\n

63MO – Hallqvist A, Koyi H, de Petris L, at al.<\/em> Safety analysis of durvalumab following stereotactic body radiotherapy (SBRT) in early-stage non-small-cell lung cancer (NSCLC) patients – A first report of a randomized phase II trial (ASTEROID). European Lung Cancer Virtual Congress 2021<\/a> (25-27 March).<\/p>\n

Source<\/a><\/p>","protected":false},"excerpt":{"rendered":"

A toxicity report from the phase II ASTEROID study demonstrated that durvalumab administered after stereotactic body radiotherapy (SBRT) in patients with early stage non-small cell lung cancer (NSCLC) was well tolerated, according to findings presented at the European Lung Cancer Virtual Congress 2021 (25-27 March). Andreas Hallqvist of the Institute of Clinical Sciences, Sahlgrenska Academy, Department […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-26910","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26910","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=26910"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26910\/revisions"}],"predecessor-version":[{"id":45364,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26910\/revisions\/45364"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=26910"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=26910"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=26910"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}