Mariana Cristina Costache-Outas

(1) Background: Globally, lung cancer is the leading cause of cancer death, but immunotherapy has impressively improved the outcomes, generating longer progression-free survival and overall survival. Endocrine immune-related adverse events (irAEs) are mostly irreversible and need life-long hormonal substitution therapy. The evaluation of the quality of life of lung cancer patients experiencing endocrine toxicities during immune checkpoint inhibitor (ICI) treatment is relevant for both patients and healthcare providers. (2) Methods: This was a prospective cohort study of lung cancer patients treated with immune checkpoint inhibitors in a tertiary-level hospital in Romania from 1 December 2021 to 30 September 2024. Quality of life was assessed using versions of the EORTC QLQ-C30 and EORTC QLQ-LC-13 validated and translated into the Romanian language. We investigated several clinical variables to evaluate their impact on QoL. (3) Results: Fifty-nine lung cancer patients were evaluated for their QoL before ICI initiation and at the end of the study. Endocrine-irAEs occurred in 17 lung cancer patients (28.8%). Quality of life as assessed using the EORTC questionnaires was statistically significantly improved, even in patients experiencing endocrine-irAEs. (4) Conclusions: Our prospective cohort study succeeded in delivering the proof of concept of an increased QoL in lung cancer patients who had developed endocrine-irAEs under immunotherapy. Despite toxicities, especially rather frequent endocrine-irAEs, ICIs enabled durable disease control and symptom relief, improving the QoL of the overall trial population. As more lung cancer patients undergo immunotherapy in metastatic or early stages, we draw attention to this particular patient population with autoimmune endocrinopathies, as they will live longer and require life-long hormonal therapy.

(1) Background: Exploring real-world data (RWD) regarding immune-related adverse events (irAEs) is crucial to better understand the efficacy and safety of immunotherapy in cancer patient populations excluded from clinical trials. An analysis was conducted to evaluate the presumptive predictive causality between endocrine irAEs and the efficacy of immune check-point inhibitors (ICIs) in metastatic non-small-cell lung cancer (mNSCLC) patients treated in daily practice in Romania. (2) Methods: This was a retrospective cohort study of mNSCLC patients treated with ICIs in a tertiary level hospital in Romania for a period of almost seven years, from November 2017 till July 2024. Endocrine irAEs were well defined as any occurring autoimmune endocrinopathy during ICIs and related to immunotherapy. The hospital endocrinologist (M.C.C.O) diagnosed, treated, and followed these endocrine irAEs in a multidisciplinary approach. We investigated multiple medical variables to assess their impact on ICI effectiveness. Descriptive and statistical analyses were performed. (3) Results: Of 487 cancer patients treated with ICIs, we identified 215 mNSCLC patients who were evaluated for endocrine irAEs and co-medications during ICI therapy. Forty-seven (21.8%) patients experienced endocrine irAEs, thyroiditis being the most frequent and prevalent autoimmune endocrinopathy in 60% of cases. Endocrine irAEs were statistically significant, correlated with ICI efficacy (p = 0.002) for survival analysis. Steroids and proton-pump inhibitors used as co-medication during ICIs had a negative impact on response to therapy. (4) Conclusions: Endocrine irAEs might be considered predictive biomarkers for successful immunotherapy in mNSCLC patients. Co-medication during ICIs had a major influence on the effectiveness of these cutting-edge therapies. RWD plays an important role for oncology daily practice whenever clinical trial evidence is not available to guide decision.

(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.