Challenges and Limitations of Endocrine Toxicity Evaluation in Non-Small Cell Lung Cancer Patients Treated with Immunotherapy-Retrospective Study from a Tertiary-Level Hospital in Romania.

(1) Background: The endocrine system has become a prominent target to autoimmune damage during treatment with immune checkpoint inhibitors (ICIs) in cancer patients. Real-world data regarding endocrine immune-related adverse events (irAEs) are needed to explore their impact in cancer patients. An analysis was conducted to evaluate endocrine irAEs caused by ICIs, besides the challenges and limitations of daily medical practice in oncology in Romania. (2) Methods: This was a retrospective cohort study of lung cancer patients treated with ICIs at Coltea Clinical Hospital, Bucharest, Romania, from 1 November 2017 to 30 November 2022. Endocrine irAEs were identified through endocrinological assessment and were distinguished as any occurring endocrinopathy during treatment with ICIs and related to immunotherapy. Descriptive analyses were performed. (3) Results: Of 310 cancer patients treated with ICIs, we identified 151 with lung cancer. From this cohort, 109 NSCLC patients qualified for baseline endocrine estimation and 13 patients (11.9%) developed endocrine irAEs, such as hypophysitis (4.5%), thyroid disorder (5.5%) and primary adrenal insufficiency (1.8%), with one or more endocrine glands being affected. There might be a correlation between endocrine irAEs and duration of ICI treatment. (4) Conclusions: Early diagnosis and adequate management of endocrine irAEs may be challenging in lung cancer patients. A high incidence of endocrine irAEs is expected with the growing use of ICIs, and because not all endocrine events are immune-related, cooperation between oncologists and endocrinologists is crucial in the management of these patients. More data are needed to confirm the correlation between endocrine irAEs and the efficacy of ICIs.

Surgical Features after Neoadjuvant Treatment for Breast Cancer.

Introduction: Patients with breast cancer may receive neoadjuvant cancer treatment in order to benefit from radical surgery or to turn an indication for extensive surgery into a conservatory or oncoplastic operation. AIM: To establish the main implications of therapeutic management of the cases of breast cancer treated initially with chemotherapy followed by surgery. MATERIAL AND METHOD: 35 breast cancer patients operated in 2020 after NACT (neoadjuvant chemotherapy) in Surgery Clinic of Coltea Hospital are analyzed, and the response after treatment is pathologicaly evaluated using the Residual Cancer Burden method Results: The results of the analysis of the group of patients showed that most patients presented downstaging of the disease after neoadjuvant treatment with a proportion of 17,14% with complete pathologic response. DISCUSSIONS: We performed clinical and imagistic evaluation of patients before and after NACT and pathologic evaluation of the surgical specimen using residual tumor burden method, taking into account the age of the patients, clinical and pathological staging and the status of hormone receptors and Her 2. Conclusions: Neoadjuvant chemotherapy is currently part of the therapeutic arsenal of breast cancer being followed in most cases by downstaging of tumors and increasing the number of cases that can be operated. 17.1% of cases achieved pathologic complete response, 2 of them being Her 2 positive carcinomas. The use of conservative and oncoplastic surgical techniques is possible after downstaging tumors by NACT.

Effectiveness and safety profile of ipilimumab therapy in previously treated patients with unresectable or metastatic melanoma - the Romanian Patient Access Program.

PURPOSE: The Romanian Patient Access Program (Ro-PAP, CA 184-427), part of the European Expanded Access Program (EAP), was developed to evaluate the effectiveness and safety profile ipilimumab in previously treated patients with advanced melanoma (unresectable or metastatic melanoma). The objective of our retrospective observational study of patients included in this program was to provide data recorded in real-life settings. METHODS: We analysed 89 patients enrolled in Ro-PAP, CA 184-427 (54 men and 35 women) aged between 29 and 89 years. The patients received ipilimumab 3mg/kg, administered with short 30-min i.v. infusion every 3 weeks, having a total of 4 doses. Patients were assessed for tumor response, overall survival (OS) and progression-free survival (PFS), and were monitored for adverse events (AE). RESULTS: At 12 weeks after the completion of therapy, the complete and partial response rates were 6.74% each, stable disease 15.73%, with the best overall response rate 13.48% and disease control rate 29.21%. Median OS was 189.00 days (95% CI 69.50-308.49) and median PFS 124.00 days (95% CI 85.05-162.94). The level of patient functionality at the beginning of ipilimumab treatment showed to be an important predictor of outcome, as patients with ECOG performance status (PS) (0) before therapy with ipilimumab had a higher OS compared with those with impaired functionality. CONCLUSIONS: The use of ipilimumab in daily clinical practice demonstrated to be effective and safe, consistent with data coming from randomized clinical trials or other observational studies.