Ana Magdalena Glas

Klinička bolnica "Sveti Duh"

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Dora Gudelj

University Hospital Centre Zagreb

Marina Popović

University Hospital Centre Zagreb

Maša Alfirević

Klinička bolnica "Sveti Duh"

Adelina Hrkać

Klinička bolnica "Sveti Duh"

Stjepko Pleština

University of Zagreb

Pero Bokarica

Klinička bolnica "Sveti Duh"

Igor Tomašković

University of Osijek

Natalija Dedić Plavetić

University Hospital Centre Zagreb

Maja Sirotković-Skerlev

University Hospital Centre Zagreb

Tajana Silovski

University of Zagreb

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University Hospital Centre Zagreb

University of Zagreb

Klinička bolnica "Sveti Duh"

Ministry of Health

Psychiatric Hospital Sveti Ivan

Sisters of Charity Hospital

Oncology Institute of Vojvodina

European Centre for Minority Issues

Center for Health, Exercise and Sport Sciences

Institut za Zdravstvenu Zastitu Majke i Deteta

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Abstract PO3-05-04: Characteristics and clinical outcome of patients with HR positive HER2 low metastatic breast cancer treated with CDK 4/6 inhibitors

Cancer Research (2024)

Katarina Čular Kristina Kanceljak Ana Magdalena Glas Dora Gudelj Marija Križić

Abstract Introduction Breast cancer (BC) is a disease characterized by significant intra- and intertumoral heterogeneity. Hence, it is not surprising that new subtypes with distinct biological features are being discovered, even among previously well-defined BC groups. Recently, HER2-low BC emerged as a new entity with specific clinical behavior, response to treatment and prognosis. HER2-low is a subset of HER2-negative BC, with HER2 immunohistochemical (IHC) score of 1+ or 2+, without HER2 gene amplification measured by in situ hybridization (ISH). As new therapeutic options become available for HER2-low patients, the best treatment sequence is yet to be determined. Furthermore, it is important to distinguish whether there is a difference in the response to standard treatment lines, such as CDK 4/6 inhibitors in metastatic HR positive BC patients, depending on HER2-low status. Methods A retrospective study of 369 metastatic BC (mBC) cases who started CDK 4/6 inhibitor therapy from January 2018 through December 2022 at University Hospital Centre Zagreb was conducted, with prior Ethics Committee approval. All patients with HR positive HER2 negative mBC, determined by standard IHC and ISH, were included in the research. Patient demographics and clinical presentation, tumor characteristics and treatment information were collected. Progression-free survival (PFS) analysis was done with the final data cut-off date being June 1st, 2023. Type 1 right censoring was performed. The data was analyzed using the Kaplan-Meier method and Cox proportional-hazards regression for clinically relevant covariates (age, line of treatment, de novo metastatic disease, endocrine resistance, liver metastases, and detected PIK3CA mutation). Results Median follow-up was 23 months. Of the 283 patients included, 146 (51.59%) had HER2-low disease. A change in HER2 expression between primary tumor and metastasis was found in 16.96% (N=48) patients. Of them,10.25% (N=29) who were initially HER2-low, were found to be HER2-0 in metastatic disease. Meanwhile, 6.71% (N=19) of patients had a change in HER2 expression from 0 to low upon becoming metastatic. In the HER2-low group, 47.06% (N=45) patients had a PIK3CA mutation as opposed to 33.33% (N=30) in the HER2-0 group. Odds ratio for a PIK3CA mutation in HER2-low patients was 1.86 (95% confidence interval (CI): 1.01-3.43, p-value 0.046). Median PFS in the HER2-low group was 18 months (95% confidence interval (CI): 14-24) versus 23 (95% CI: 18-30) in the HER2-0 group. Using multivariable analysis an adjusted hazard ratio of 1.15 (95% CI:0.84-1.57; p-value 0.389) was calculated. Covariates associated with a statistically significant increased risk of disease progression were a higher line of therapy (HR 1.39, 95% CI 1.36-1.71, p-value 0.002) and the presence of liver metastases (HR 2.17, 95% CI 1.42-3.32, p-value 0.0004). A covariate associated with a statistically significant longer PFS was de novo metastatic disease (HR 0.63, 95% CI 0.41-0.97, p-value 0.034). Conclusion There was a trend toward worse PFS in HER2-low mBC that did not reach statistical significance. HER2-low patients were more likely to harbor PIK3CA mutations than HER2-0 patient group. Longer follow-up and a larger cohort are needed in order to make definitive conclusions. Citation Format: Katarina Čular, Kristina Kanceljak, Ana Magdalena Glas, Dora Gudelj, Marija Križić, Marina Popović, Natalija Dedić Plavetić, Maja Sirotković-Skerlev, Stjepko Pleština, Tajana Silovski. Characteristics and clinical outcome of patients with HR positive HER2 low metastatic breast cancer treated with CDK 4/6 inhibitors [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-05-04.

10.1158/1538-7445.sabcs23-po3-05-04

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Letter to the Editor regarding the Article “Postoperative Mortality Rate after Radical Cystectomy: A Systematic Review of Epidemiologic Series”

Urologia Internationalis (2023)

Pero Bokarica Maša Alfirević Adelina Hrkać Ana Magdalena Glas Igor Tomašković

Dear Editor,We have read an article recently published by Korkes and associates with great interest [1]. This interesting systematic review makes us question different aspects of radical and reconstructive surgery of muscle-invasive bladder cancer. The emphasis of the article is on the mortality rate after cystectomy. As expected, it resulted in mortality rates that are significantly lower in countries with major developed economies than in developing countries. Mortality rates are also lower in high-volume centers than those in low-volume centers.Interestingly, Canada simultaneously had the lowest rate of in-hospital mortality and the highest rate of 90-day mortality (90M). Korkes et al. did not offer a possible explanation for these results. The answer could be the importance of the availability of a center experienced in managing complications. Another topic from this article that deserves attention is the proportion of patients treated with cystectomy among patients who have an absolute indication for this type of surgery. If we know that radical surgical treatment is "the gold standard" for patients with pT2–pT4 M0 disease, the percentage of 18.9% of the patients treated with radical surgery is extremely low [2]. An alternative to operative treatment is trimodal treatment, which according to the guidelines is reserved for small, solitary tumors or patients with contraindications for surgery [3]. We are well aware that both of these groups of patients make up a minor part of the total number of candidates for radical treatment. The third question from this article is the choice of urinary diversion. It was shown that only 10.4% of patients receive continent diversion, which is similar to the results of Hautmann and associates from 2015, where the percentage in institutions worldwide is 15%, it reaches 30–45% in leading oncology centers, and only in pioneering institutions amounts to about 75% [4].Given that our Department of Urology performs about 100 cystectomies per year, of which 40–50% are with orthotopic derivation, the above questions are extremely interesting to us. We believe there is a unique answer to all three open questions. The centralization of patients in high-volume centers brings with it (1) a lower mortality rate, as stated in this article; (2) an adequate form of treatment considering the significantly higher percentage of patients treated with radical cystectomy; (3) the most appropriate form of urinary diversion.All the authors declare no conflict of interests.This work has not received any funding.Pero Bokarica, Masa Alfirevic, Adelina Hrkac, Ana Magdalena Glas, and Igor Tomaskovic participated in the writing of the manuscript. Pero Bokarica, Masa Alfirevic, and Adelina Hrkac did the concept and design of the manuscript.

10.1159/000530576

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