Oncology Research and Treatment最新文献

{"title":"[Vorwort des DGHO-Vorstands].","authors":"Hermann Einsele, Andreas Hochhaus, Maike de Wit, Carsten-Oliver Schulz","doi":"10.1159/000533464","DOIUrl":"https://doi.org/10.1159/000533464","url":null,"abstract":"","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41137310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of a Sound Intervention on Physical and Emotional Well-Being in Patients with Cancer: A Prospective Randomized Trial.","authors":"Anna Hohneck,&nbsp;Rosa Meissner,&nbsp;Christina Reyser,&nbsp;Lara Heinemann,&nbsp;Kathrin Christians,&nbsp;Kirsten Merx,&nbsp;Simone Weingärtner,&nbsp;Athanasios Mavratzas,&nbsp;Nadine Schulte,&nbsp;Iris Burkholder,&nbsp;Wolf-Karsten Hofmann,&nbsp;Ralf-Dieter Hofheinz","doi":"10.1159/000528187","DOIUrl":"https://doi.org/10.1159/000528187","url":null,"abstract":"<p><strong>Aim: </strong>Cancer remains a disease with a significant impact on morbidity and mortality but also on quality of life. This prospective randomized pilot study investigated the effects of a sound intervention on physical and emotional well-being in outpatients with cancer.</p><p><strong>Methods: </strong>Two self-applied sound interventions were used for this purpose, either active \"music playing\" with a body monochord or passive sound intervention with headphones to listen to a given music compilation. Interventions were carried out over a period of 4 weeks for at least 15 min in the evening before bedtime. The following self-assessment questionnaires were completed both at baseline and after 4 weeks to evaluate the response: the Pittsburgh Sleep Quality Index (PSQI), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Visual Analogue Scale (VAS) for pain and fatigue, and the Fear of Progression (FoP) questionnaire. Primary endpoint of this exploratory trial was to describe the rate of patients with improvement in at least one dimension without worsening of any other.</p><p><strong>Results: </strong>73 patients (29 male, 44 female) were included in the study and randomized to either active (n = 34, 47%) or passive sound intervention (n = 39, 53%). Median age was 52.0 years (range 21-79). Fourteen patients (19%) stated that they were musically active. The sound intervention was carried out on a median of 26 days (range 5-28). A higher percentage of patients in the passive group reached the primary endpoint: n = 15 (39%) versus n = 9 (27%). Response differences in favour of the passive group were seen with the VAS fatigue and with QLQ-30 questionnaires. Overall, an improvement in QLQ-30 questionnaire was seen in 12 patients (31%) in the passive group versus 3 patients (9%). Moreover, sound intervention significantly improved social functioning and shortness of breath in the passive group according to QLQ-C30. Significant improvements were also noticed in the passive group in terms of affective reactions as a domain of the FoP questionnaire. No effects on pain or sleep quality could be observed.</p><p><strong>Conclusion: </strong>A 4-week self-administered sound intervention was feasible in outpatients suffering from cancer. Using a panel of 5 questionnaires, passive sound interventions appeared to be more likely to positively influence patient-reported outcomes. In particular, a positive impact was documented in social functioning and fatigue.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10015753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9113182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment and Evaluation of Psychosocial Distress in Outpatients with Cancer at a University Hospital in Germany.","authors":"Laura Hohmann,&nbsp;Kirsten Merx,&nbsp;Simone Weingaertner,&nbsp;Annette Schreiber,&nbsp;Svetlana Hetjens,&nbsp;Wolf-Karsten Hofmann,&nbsp;Ralf-Dieter Hofheinz,&nbsp;Deniz Gencer","doi":"10.1159/000531888","DOIUrl":"10.1159/000531888","url":null,"abstract":"<p><strong>Introduction: </strong>Cancer patients (pts) suffer from a significant amount of psychosocial distress related to tumor disease itself or straining treatments. Despite recommendations on how to screen for and to deal with psychosocial distress in cancer pts, data about implementation of psycho-oncological interventions (poi) in outpatient settings of cancer pts are scarce. The aim of this study was to identify outpatients with cancer in need of poi and to evaluate different assessment instruments.</p><p><strong>Methods: </strong>N = 200 outpatients with hemat-/oncological malignancies were interviewed between October 2015 and December 2017 at the University Hospital Mannheim using the Basic Documentation for Psycho-Oncology (PO-Bado) and the Hornheider Screening Instrument (HSI) - both clinician-administered assessment tools - followed by descriptive, univariate, and agreement analysis.</p><p><strong>Results: </strong>N = 61 cancer pts (31%) were identified to be in need for poi considering the results of both questionnaires. The number of identified pts in need of poi was lower when analyzing the results of the PO-Bado (n = 42, 21%) and the HSI (n = 39, 20%) separately. The degree of agreement between the results of PO-Bado and HSI was low (kappa = 0.3655). Several factors like gender, age and diagnosis were identified to have significant impact on the need for poi (p ≤ 0.05).</p><p><strong>Conclusion: </strong>Our study underlines that different screening instruments for psychosocial distress may identify disparate populations of cancer pts. The study data also revealed significant characteristics that might be associated with elevated levels of psychosocial distress and a clear indication for poi. However, further analyses on larger populations of cancer pts are needed to provide information how to transfer positive screening to poi in clinical routine.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10222157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High In-Hospital Mortality in SARS-CoV-2-Infected Patients with Active Cancer Disease during Omicron Phase of the Pandemic: Insights from the CORONA Germany Study.","authors":"Francis Maren Konermann,&nbsp;Nele Gessler,&nbsp;Peter Wohlmuth,&nbsp;Jürgen Behr,&nbsp;Johannes Feldhege,&nbsp;Christian Glöckner,&nbsp;Melanie A Gunawardene,&nbsp;Klaus R Herrlinger,&nbsp;Thomas Hölting,&nbsp;Ulrich-Frank Pape,&nbsp;Niels Reinmuth,&nbsp;Axel Stang,&nbsp;Sara Sheikhzadeh,&nbsp;Dirk Arnold,&nbsp;Claas Wesseler","doi":"10.1159/000529788","DOIUrl":"https://doi.org/10.1159/000529788","url":null,"abstract":"<p><strong>Introduction: </strong>SARS-CoV-2 infected patients with cancer have a worse outcome including a significant higher mortality, compared to non-cancer patients. However, limited data are available regarding in-hospital mortality during the Omicron phase of the pandemic. Therefore, the aim of the study was the comparison of mortality in patients with history of cancer and patients with active cancer disease during the different phases of the COVID-19 pandemic, focusing on the current Omicron variant of concern.</p><p><strong>Methods: </strong>We conducted a multicenter, observational, epidemiological cohort study at 45 hospitals in Germany. Until July 20, 2022, all adult hospitalized SARS-CoV-2 positive patients were included. The primary endpoint was in-hospital mortality regarding cancer status (history of cancer and active cancer disease) and SARS-CoV-2 virus type.</p><p><strong>Results: </strong>From March 11, 2020, to July 20, 2022, a total of 27,490 adult SARS-CoV-2 positive patients were included in the study. 2,578 patients (9.4%) had diagnosis of cancer, of whom 1,065 (41.3%) had history of cancer, whereas 1,513 (58.7%) had active cancer disease. Overall 3,749 out of the total of 27,490 patients (13.6%) died during the hospital stay. Patients with active cancer disease had a significantly higher mortality compared to patients without cancer diagnosis, in both phases of the pandemic (wild-type to Delta: OR 1.940 [1.646-2.285]); Omicron: 2.864 [2.354-3.486]). After adjustment to co-variables, SARS-CoV-2 infected patients with active cancer disease had the highest risk for in-hospital mortality compared to the other groups, in both phases of the pandemic.</p><p><strong>Conclusion: </strong>The CORONA Germany study indicates that hospitalized patients with active cancer disease are at high risk of death during a SARS-CoV-2 infection. Mortality of patients with history of cancer improved to nearly the level of non-cancer patients during Omicron phase.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9530326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality Measurement for Soft Tissue Sarcomas in Germany: First Results of the Certified Sarcoma Centres.","authors":"Johannes Rückher,&nbsp;Ellen Grießhammer,&nbsp;Thomas Langer,&nbsp;Gregor Wenzel,&nbsp;Martin Utzig,&nbsp;Peter Hohenberger,&nbsp;Lars H Lindner,&nbsp;Jens Jakob,&nbsp;Simone Wesselmann","doi":"10.1159/000530425","DOIUrl":"https://doi.org/10.1159/000530425","url":null,"abstract":"<p><strong>Introduction: </strong>Soft tissue sarcomas (STSs) are rare diseases. A high level of standardization and centralization was lacking in Germany until 2018.</p><p><strong>Methods: </strong>By developing an evidence-based guideline and a certification system for sarcoma centres, foundations for structured, guideline-based, and centralized sarcoma care were defined. First results of the certified sarcoma centres are presented.</p><p><strong>Results: </strong>The first 3 years of data collection show good results for case volume, presentation rates in pretherapeutic and postoperative tumour boards, psycho-oncological counselling, and study rates. However, other indicators (e.g., preoperative or postoperative radiotherapy for operated high-risk STS without GIST, counselling rates social services) still have potential for improvement. Based on these results, the set of indicators could be further improved.</p><p><strong>Conclusions: </strong>A sarcoma-specific quality assurance scheme that includes guideline-derived quality indicators was developed. In future, a broader database will allow further insights into sarcoma care in Germany.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9589284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Outcome and Treatment Sequences of Patients with Advanced Pancreatic Cancer Treated with Contemporary Chemotherapy Protocols.","authors":"Julius Roehrle, Stefan Kasper, Jürgen-Walter Treckmann, Peter Markus, Brigitte Schumacher, David Albers, Johanna Wendling, Saskia Ting, Bastian Mende, Marlene Maßmann, Maximilian Markus, Isabel Virchow, Vivian Rosery, Katharina Laue, Gregor Zaun, Karina Kostbade, Michael Pogorzelski, Timm M Reissig, Sven-Thorsten Liffers, Kurt Schmid, Hans-Ulrich Schildhaus, Martin Schuler, Jens T Siveke, Marcel Wiesweg","doi":"10.1159/000529452","DOIUrl":"10.1159/000529452","url":null,"abstract":"Introduction: Systemic therapy is firmly established in patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). Clinical efficacy is still modest and options are limited. Combination therapy protocols such as FOLFIRINOX and gemcitabine/nab-paclitaxel (Gem/NP) define standard-of-care. Patients may receive a sequence of both regimens as first- and second-line palliative treatment. However, there is no guidance regarding a preferred order. Methods: This is a retrospective analysis of clinical characteristics, treatment trajectories, and outcomes of patients with advanced PDAC treated at the West German Cancer Center Essen from 2014 to 2020 to inform treatment decisions with respect to predictive factors, impact of chemotherapy regimen sequence, and maintenance treatment. Results: We identified 170 patients with available follow-up. Of those, 160 (94.1%) patients received palliative CTX for primary metastatic, locally advanced, or recurrent PDAC. Median progression-free survival (PFS) upon first palliative chemotherapy was 4.1 (3.1–5.9) months. First-line FOLFIRINOX was associated with superior PFS (median 6.3 months) and OS (9.7 months, HR 0.7, p = 0.03) as compared to Gem/NP or other regimens (PFS 3.0, OS 6.9 months). However, OS benefit of first-line FOLFIRINOX was lost in patients who received at least two treatment lines (median OS 12.1 vs. 13.1 months, p = 0.43). A landmark analysis of patients with clinical benefit (defined as CR/PR/SD for at least 20 weeks) upon first-line therapy revealed improved OS (HR 0.53, p = 0.02) for patients receiving continued deescalated maintenance therapy. Second-line regimens resulted in similar PFS (overall log-rank p = 0.92, median PFS upon second-line therapy 2.3 [1.8–2.9], per-regimen median between 1.8 and 3.9 months). A previously established systemic inflammation score proved to be strongly prognostic and allowed identification of a patient subgroup with dismal prognosis (OS 2.9 vs. 11.4 months, HR 5.23, p < 0.001), independent of other prognostic factors and with no relevant interaction with the choice of first-line regimen. Conclusion: In this real-world population of PDAC patients treated with contemporary combination chemotherapies, a positive impact of first-line FOLFIRINOX was only observed when no second or further line treatment was administered. Intensity-reduced maintenance therapy may lead to superior survival.","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9288142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Career and Professional Development for Young Oncologists.","authors":"Maximilian J Mair,&nbsp;Claudia Cardone,&nbsp;Elizabeth Anne Connolly,&nbsp;Maria Kfoury,&nbsp;Matteo Lambertini,&nbsp;Kok Haw Jonathan Lim,&nbsp;Elene Mariamidze,&nbsp;Alexios Matikas,&nbsp;Rille Pihlak,&nbsp;Kevin Punie,&nbsp;Christoph Oing,&nbsp;Rodrigo Sánchez-Bayona,&nbsp;Pawel Sobczuk,&nbsp;Hongcheng Zhu,&nbsp;Anna Berghoff,&nbsp;Teresa Amaral","doi":"10.1159/000528541","DOIUrl":"https://doi.org/10.1159/000528541","url":null,"abstract":"<p><p>Young oncologists around the globe face many challenges when it comes to their career and professional development. Aspects such as time management, work-life balance, career progression, and educational opportunities are only some of them. Professional societies have identified these challenges in this professional group and designed programs to tackle them specifically. The importance of this strategy cannot be overstated, as young oncologists, defined by most societies as oncologists under 40 years of age, compose almost 50% of the oncology workforce. On the other hand, recent surveys have shown that many young oncologists are considering alternative career paths due to burnout issues aggravated by the COVID-19 pandemic, on top of all other challenges. The virtual setting that has been forcedly introduced into our professional life has shortened distances between professionals and might have contributed to more accessible access to information and opportunities that some young oncologists could not profit from due to their traveling constraints. On the other hand, this virtual setting has shown us the asymmetries in opportunities for these professionals. Knowledgeable of all this, we summarize in this article some of the career and professional development offers available to all young oncologists, which we consider could help them deal with current and future challenges.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10833603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Management of Aortoesophageal Fistula in a Palliative Patient with Non-Small-Cell Lung Cancer: A Case Report.","authors":"Kathrin Adler,&nbsp;Ruben Evertz,&nbsp;Albrecht Neesse,&nbsp;Lorenz Biggemann,&nbsp;Tobias R Overbeck","doi":"10.1159/000531250","DOIUrl":"https://doi.org/10.1159/000531250","url":null,"abstract":"<p><strong>Introduction: </strong>Aortoesophageal fistulas are a rare but life-threatening complication in patients with thoracic malignancies.</p><p><strong>Case presentation: </strong>We describe a case of a 55-year-old female patient with metastatic non-small-cell lung cancer. Due to esophageal tumor compression, a fully covered self-expanding metal stent (fcSEMS) had been deployed in the esophagus several months before. The patient was subsequently admitted to the emergency department with massive hematemesis. Endoscopy suggested a fistula between the aorta and the esophagus proximal of the fcSEMS, which was confirmed by computed tomography and led to hemodynamical relevant upper gastrointestinal bleeding. A thoracic endovascular aortic repair was performed to stop the hemorrhage. After the successful intervention, the patient needed long-term antibiotic treatment, and the fcSEMS remained in place. Afterward, the patient continued palliative tumor therapy using pembrolizumab for further 5 months. The patient died 8 months after the initial admission to the emergency department.</p><p><strong>Conclusion: </strong>This is to the best of our knowledge the first case of a technically successful interventional therapy of an aortoesophageal fistula which did not only achieve hemostasis but also enabled the patient to continue tumor therapy to regain quality of life.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9962946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Society Bulletins","authors":"","doi":"10.1159/000533651","DOIUrl":"https://doi.org/10.1159/000533651","url":null,"abstract":"","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134889621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neoadjuvant Pyrotinib plus Trastuzumab, Docetaxel, and Carboplatin in Early or Locally Advanced Human Epidermal Receptor 2-Positive Breast Cancer in China: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.","authors":"Yuqin Ding,&nbsp;Wenju Mo,&nbsp;Xiaohong Xie,&nbsp;Ouchen Wang,&nbsp;Xiangming He,&nbsp;Shuai Zhao,&nbsp;Xidong Gu,&nbsp;Chenlu Liang,&nbsp;Chengdong Qin,&nbsp;Kaijing Ding,&nbsp;Hongjian Yang,&nbsp;Xiaowen Ding","doi":"10.1159/000531492","DOIUrl":"https://doi.org/10.1159/000531492","url":null,"abstract":"<p><strong>Introduction: </strong>This multicenter, randomized, double-blind, placebo-controlled phase 2 trial compared the efficacy, and safety of adding pyrotinib to trastuzumab, docetaxel, and carboplatin versus placebo, trastuzumab, docetaxel, and carboplatin in Chinese patients with human epidermal receptor 2 (HER2)-positive early or locally advanced breast cancer (<ext-link ext-link-type=\"uri\" xlink:href=\"http://ClinicalTrials.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">ClinicalTrials.gov</ext-link> identifier: NCT03756064).</p><p><strong>Methods: </strong>Sixty-nine women with HER2-positive early (T1-3, N0-1, M0) or locally advanced breast cancer (T2-3, N2 or N3, M0; T4, any N, M0) were recruited from October 1, 2019, to June 1, 2021. Before surgery, patients received 6 cycles of orally pyrotinib (400 mg once per day), trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance doses), docetaxel (75 mg/m2), and carboplatin (AUC = 6 mg/mL·min) or orally placebo, trastuzumab, and docetaxel, and carboplatin every 3 weeks. The primary end point was independent review committee-assessed total pathologic complete response rate. The 2-sided Cochran-Mantel-Haenszel test, stratified by age, hormone receptor status, tumor stage, nodal status, cTNM stage, and Ki-67 level was used to compare rates between treatment groups.</p><p><strong>Results: </strong>In total, 69 female patients were randomized (pyrotinib, 36; and placebo, 33; median age, 53 [31-69] years). In the intention-to-treat population, total pathologic complete response rates were 65.5% (19/29) in the pyrotinib group and 33.3% (10/30) in the placebo group (difference, 32.2%, p = 0.013). Diarrhea was been reported in 86.1% of patients (31/36) in the pyrotinib group as the most common adverse events (AEs) and 15.2% of patients (5/33) in the placebo group. But no grade 4 or 5 AEs were reported.</p><p><strong>Conclusion: </strong>Treatment with pyrotinib, trastuzumab, docetaxel, and carboplatin resulted in a statistically significant improvement in the total pathologic complete response rate versus placebo, trastuzumab, docetaxel, and carboplatin for the neoadjuvant treatment of HER2-positive early or locally advanced breast cancer in Chinese patients. Safety data were in line with the known pyrotinib safety profile and generally comparable between treatment groups.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10318178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}