Carolin C Hack, Nicolai Maass, Bahriye Aktas, Sherko Kümmel, Christoph Thomssen, Christopher Wolf, Hans-Christian Kolberg, Cosima Brucker, Wolfgang Janni, Peter Dall, Andreas Schneeweiss, Frederik Marme, Matthias Ruebner, Anna-Katharin Theuser, Nadine M Hofmann, Sybille Böhm, Katrin Almstedt, Sara Kellner, Paul Gass, Marc W Sütterlin, Hans-Joachim Lück, Sabine Schmatloch, Matthias Kalder, Christoph Uleer, Ingolf Juhasz-Böss, Volker Hanf, Christian Jackisch, Volkmar Müller, Brigitte Rack, Erik Belleville, Diethelm Wallwiener, Achim Rody, Claudia Rauh, Christian M Bayer, Sabrina Uhrig, Chloë Goossens, Hanna Huebner, Sara Y Brucker, Lothar Häberle, Tanja N Fehm, Alexander Hein, Peter A Fasching
{"title":"在常规临床护理中使用来曲唑对早期乳腺癌患者进行前期治疗后的长期随访及其安全性 - PreFace 研究。","authors":"Carolin C Hack, Nicolai Maass, Bahriye Aktas, Sherko Kümmel, Christoph Thomssen, Christopher Wolf, Hans-Christian Kolberg, Cosima Brucker, Wolfgang Janni, Peter Dall, Andreas Schneeweiss, Frederik Marme, Matthias Ruebner, Anna-Katharin Theuser, Nadine M Hofmann, Sybille Böhm, Katrin Almstedt, Sara Kellner, Paul Gass, Marc W Sütterlin, Hans-Joachim Lück, Sabine Schmatloch, Matthias Kalder, Christoph Uleer, Ingolf Juhasz-Böss, Volker Hanf, Christian Jackisch, Volkmar Müller, Brigitte Rack, Erik Belleville, Diethelm Wallwiener, Achim Rody, Claudia Rauh, Christian M Bayer, Sabrina Uhrig, Chloë Goossens, Hanna Huebner, Sara Y Brucker, Lothar Häberle, Tanja N Fehm, Alexander Hein, Peter A Fasching","doi":"10.1055/a-2238-3153","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Adjuvant treatment of patients with early-stage breast cancer (BC) should include an aromatase inhibitor (AI). Especially patients with a high recurrence risk might benefit from an upfront therapy with an AI for a minimum of five years. Nevertheless, not much is known about the patient selection for this population in clinical practice. Therefore, this study analyzed the prognosis and patient characteristics of postmenopausal patients selected for a five-year upfront letrozole therapy.</p><p><strong>Patients and methods: </strong>From 2009 to 2011, 3529 patients were enrolled into the adjuvant phase IV PreFace clinical trial (NCT01908556). Postmenopausal hormone receptor-positive BC patients, for whom an upfront five-year therapy with letrozole (2.5 mg/day) was indicated, were eligible. Disease-free survival (DFS), overall survival (OS) and safety in relation to patient and tumor characteristics were assessed.</p><p><strong>Results: </strong>3297 patients started letrozole therapy. The majority of patients (n = 1639, 57%) completed the five-year treatment. 34.5% of patients continued with endocrine therapy after the mandated five-year endocrine treatment. Five-year DFS rates were 89% (95% CI: 88-90%) and five-year OS rates were 95% (95% CI: 94-96%). In subgroup analyses, DFS rates were 83%, 84% and 78% for patients with node-positive disease, G3 tumor grading, and pT3 tumors respectively. The main adverse events (any grade) were pain and hot flushes (66.8% and 18.3% of patients).</p><p><strong>Conclusions: </strong>The risk profile of postmenopausal BC patients selected for a five-year upfront letrozole therapy showed a moderate recurrence and death risk. However, in subgroups with unfavorable risk factors, prognosis warrants an improvement, which might be achieved with novel targeted therapies.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 2","pages":"185-195"},"PeriodicalIF":2.4000,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10853028/pdf/","citationCount":"0","resultStr":"{\"title\":\"Long-term Follow-up and Safety of Patients after an Upfront Therapy with Letrozole for Early Breast Cancer in Routine Clinical Care - The PreFace Study.\",\"authors\":\"Carolin C Hack, Nicolai Maass, Bahriye Aktas, Sherko Kümmel, Christoph Thomssen, Christopher Wolf, Hans-Christian Kolberg, Cosima Brucker, Wolfgang Janni, Peter Dall, Andreas Schneeweiss, Frederik Marme, Matthias Ruebner, Anna-Katharin Theuser, Nadine M Hofmann, Sybille Böhm, Katrin Almstedt, Sara Kellner, Paul Gass, Marc W Sütterlin, Hans-Joachim Lück, Sabine Schmatloch, Matthias Kalder, Christoph Uleer, Ingolf Juhasz-Böss, Volker Hanf, Christian Jackisch, Volkmar Müller, Brigitte Rack, Erik Belleville, Diethelm Wallwiener, Achim Rody, Claudia Rauh, Christian M Bayer, Sabrina Uhrig, Chloë Goossens, Hanna Huebner, Sara Y Brucker, Lothar Häberle, Tanja N Fehm, Alexander Hein, Peter A Fasching\",\"doi\":\"10.1055/a-2238-3153\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Adjuvant treatment of patients with early-stage breast cancer (BC) should include an aromatase inhibitor (AI). Especially patients with a high recurrence risk might benefit from an upfront therapy with an AI for a minimum of five years. Nevertheless, not much is known about the patient selection for this population in clinical practice. Therefore, this study analyzed the prognosis and patient characteristics of postmenopausal patients selected for a five-year upfront letrozole therapy.</p><p><strong>Patients and methods: </strong>From 2009 to 2011, 3529 patients were enrolled into the adjuvant phase IV PreFace clinical trial (NCT01908556). Postmenopausal hormone receptor-positive BC patients, for whom an upfront five-year therapy with letrozole (2.5 mg/day) was indicated, were eligible. Disease-free survival (DFS), overall survival (OS) and safety in relation to patient and tumor characteristics were assessed.</p><p><strong>Results: </strong>3297 patients started letrozole therapy. The majority of patients (n = 1639, 57%) completed the five-year treatment. 34.5% of patients continued with endocrine therapy after the mandated five-year endocrine treatment. Five-year DFS rates were 89% (95% CI: 88-90%) and five-year OS rates were 95% (95% CI: 94-96%). In subgroup analyses, DFS rates were 83%, 84% and 78% for patients with node-positive disease, G3 tumor grading, and pT3 tumors respectively. The main adverse events (any grade) were pain and hot flushes (66.8% and 18.3% of patients).</p><p><strong>Conclusions: </strong>The risk profile of postmenopausal BC patients selected for a five-year upfront letrozole therapy showed a moderate recurrence and death risk. 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Long-term Follow-up and Safety of Patients after an Upfront Therapy with Letrozole for Early Breast Cancer in Routine Clinical Care - The PreFace Study.
Introduction: Adjuvant treatment of patients with early-stage breast cancer (BC) should include an aromatase inhibitor (AI). Especially patients with a high recurrence risk might benefit from an upfront therapy with an AI for a minimum of five years. Nevertheless, not much is known about the patient selection for this population in clinical practice. Therefore, this study analyzed the prognosis and patient characteristics of postmenopausal patients selected for a five-year upfront letrozole therapy.
Patients and methods: From 2009 to 2011, 3529 patients were enrolled into the adjuvant phase IV PreFace clinical trial (NCT01908556). Postmenopausal hormone receptor-positive BC patients, for whom an upfront five-year therapy with letrozole (2.5 mg/day) was indicated, were eligible. Disease-free survival (DFS), overall survival (OS) and safety in relation to patient and tumor characteristics were assessed.
Results: 3297 patients started letrozole therapy. The majority of patients (n = 1639, 57%) completed the five-year treatment. 34.5% of patients continued with endocrine therapy after the mandated five-year endocrine treatment. Five-year DFS rates were 89% (95% CI: 88-90%) and five-year OS rates were 95% (95% CI: 94-96%). In subgroup analyses, DFS rates were 83%, 84% and 78% for patients with node-positive disease, G3 tumor grading, and pT3 tumors respectively. The main adverse events (any grade) were pain and hot flushes (66.8% and 18.3% of patients).
Conclusions: The risk profile of postmenopausal BC patients selected for a five-year upfront letrozole therapy showed a moderate recurrence and death risk. However, in subgroups with unfavorable risk factors, prognosis warrants an improvement, which might be achieved with novel targeted therapies.
期刊介绍:
Geburtshilfe und Frauenheilkunde (GebFra) addresses the whole field of obstetrics and gynecology and is concerned with research as much as with clinical practice. In its scientific section, it publishes original articles, reviews and case reports in all fields of the discipline, namely
gynecological oncology, including oncology of the breast
obstetrics and perinatal medicine,
reproductive medicine,
and urogynecology.
GebFra invites the submission of original articles and review articles.
In addition, the journal publishes guidelines, statements and recommendations in cooperation with the DGGG, SGGG, OEGGG and the Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF, Association of Scientific Medical Societies, www.awmf.org). Apart from the scientific section, Geburtshilfe und Frauenheilkunde has a news and views section that also includes discussions, book reviews and professional information.
Letters to the editors are welcome. If a letter discusses an article that has been published in our journal, the corresponding author of the article will be informed and invited to comment on the letter. The comment will be published along with the letter.