After successful dosimetric beam commissioning, quality assurance measurements performed during a 24-month period show very stable beam characteristics, which are therefore suitable for performing safe and accurate patient treatments.
No gold standard treatment exists for metastatic breast cancer (MBC). Clinical decision making is based on knowledge of prognostic and predictive factors that are extrapolated from clinical trials and, sometimes, are not reliably transferable to a real-world scenario. Moreover, misalignment between endpoints used in drug development and measures of outcome in clinical practice has been noted.The roles of overall survival (OS) and progression-free survival (PFS) as primary endpoints in the context of clinical trials are the subjects of lively debate. Information about these parameters in routine clinical practice is potentially useful to design new studies and/or to interpret the results of clinical research. This study analyzed the impact of patient and tumor characteristics on the major measures of outcome across different lines of treatment in a cohort of 472 patients treated for MBC. OS, PFS, and postprogression survival (PPS) were analyzed. The study showed how biological and clinical characteristics may have different prognostic value across different lines of therapy for MBC. After first-line treatment, the median PPS of luminal A, luminal B, and human epidermal growth factor receptor 2 (HER2)-positive groups was longer than 12 months. The choice of OS as a primary endpoint for clinical trials could not be appropriate with these subtypes. In contrast, OS could be an appropriate endpoint when PPS is expected to be low (e.g., triple-negative subtype after the first line; other subtypes after the third line). The potential implications of these findings are clinical and methodological. The Oncologist 2014;19:608-615 Implications for Practice: Although randomized clinical trials are recognized as the highest level of scientific evidence to demonstrate the efficacy of a treatment, sometimes they do not reflect the clinical circumstances faced in a real-world scenario. The present study provides data about outcomes of consecutive metastatic breast cancer patients treated at an academic hospital. The findings support the importance of considering breast cancer in distinct subgroups with the aim of obtaining more precise information about prognosis and expected benefit from treatment. The study also provides insights for future clinical trial design.
Background: Triple negative breast cancers of high proliferation or grade are a subgroup characterized by very poor prognosis, rapid progression to metastatic stage and rapid onset of resistance to chemotherapy after initial response. As a whole, triple negative breast cancer (TNBC) represents a specific area of medical need, in which new therapeutic approaches deserve appropriate test. Retrospective data showed that a subset of patients have an ongoing immune response within the tumor microenvironment, and that PD-L1 expression is an adaptive method of tumor resistance to tumor infiltrating lymphocytes, which in turn are needed for response to chemotherapy. Overall, the data suggests a role for immune regulation of response to chemotherapy, and support the concept that blockade of immune check-points may favor the achievement of durable response by immune mechanisms themselves, and in combination with classical chemotherapy. Methods: In this multicenter open label study (NCT002620280), a total of 280 patients with TNBC were randomized to neoadjuvant carboplatin AUC 2 and abraxane 125 mg/m2 iv on days 1 and 8, with or without atezolizumab 1200 mg iv on day 1. Both regimens were given every 3 weeks for 8 cycles and were followed by surgery and by 4 cycles of an anthracycline regimen as per investigator choice. The primary aim of the study is to compare event-free survival 5 years after randomization of the last patient. Important secondary aim is the rate of pCR (defined as absence of invasive in breast and lymph nodes). The comparison among treatments will be carried out by a two-sided Cochran-Mantel-Haenszel test, controlling for disease stage (early high-risk vs locally advanced) and PD-L1 expression (positive vs negative). The primary population for all efficacy endpoints will be the ITT (intent-to-treat) population, the safety population is defined as all randomized patients who received at least one dose of either regimen. pCR and safety data will be presented at the meeting. Patients will continue to be followed up to allow for assessing comparative long-term event-free and overall survival analyses. Supported in part by unrestricted grants from Hoffman-La Roche, Ltd, Switzerland and Celgene International Sarl, Switzerland Citation Format: Luca Gianni, Chiun-Sheng Huang, Daniel Egle, Begona Bermejo, Claudio Zamagni, Marc Thill, Antonio Anton, Stefania Zambelli, Giampaolo Bianchini, Stefania Russo, Eva Ciruelos, Richrad Greil, Vladimir Semiglazov, Marco Colleoni, Catherine Kelly, Gabriella Mariani, Lucia Del Mastro, Ilaria Maffeis, Pinuccia Valagussa, Giuseppe Viale. Pathologic complete response (pCR) to neoadjuvant treatment with or without atezolizumab in triple negative, early high-risk and locally advanced breast cancer. NeoTRIPaPDL1 Michelangelo randomized study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr GS3-04.
These findings indicate that a complete diagnostic work-up to detect metastases is unnecessary in the majority of patients with newly diagnosed breast cancer, whereas it may be indicated for specific patient categories such as those with stage III disease.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.