Medical Oncology Department Research Articles

Evaluation of Demographic and Clinical Characteristics of Turkish Patients With Primary Cutaneous Melanoma: A 5-Year Experience of a Tertiary Referral Center.

Data about the demographic and clinical characteristics of melanoma patients in Turkey is limited. Data about the demographic and clinical characteristics of melanoma patients in Turkey is limited. We aimed to review the features of patients with primary cutaneous melanoma (PCM) diagnosed and treated in a tertiary referral center. The medical records of melanoma patients followed up by the Departments of Dermatology and Medical Oncology were retrospectively reviewed. Within a 5-year period, 180 patients had been diagnosed with melanoma. Of all, 158 (87.8%) had PCM, 9 (5%) had mucosal melanoma, 9 (5%) had unknown primary melanoma, and 4 (2.2%) had ocular melanoma. Of 146 patients with PCM, 32.9% had stage I, 28.8% had stage II, 17.8% had stage III, and 20.5% had stage IV disease. The most common subtype was superficial spreading melanoma (38.8%). A statistically significant correlation was found between the patients Breslow thickness and lymph node involvement, histopathological subtype, and tumor ulceration (P < 0.001). Among all PCM patients, those in stage IV had the lowest 5-year survival rate when compared to the other disease stages (P < 0.001). Relatively younger age at melanoma diagnosis, frequent presence of thick (> 4 mm) tumor, and frequent acral lentiginous subtype are the most remarkable features that suggest the low awareness and knowledge of melanoma in our population.

Efficacy and Safety of Low-Dose Nivolumab in Treatment of Advanced Solid Tumors: A Retrospective Audit from Resource-Constrained Settings

Background Immunotherapy has improved outcomes in many advanced solid tumors. In resource-constrained settings, less than 2% of patients can afford standard dose immunotherapy. A recent phase II study showed the efficacy of low-dose immunotherapy in this setting. We used low-dose immunotherapy on a compassionate basis in patients who had progressed on available standard treatment options and standard dose immunotherapy was not feasible. Patients and Methods We retrospectively collected data from the medical oncology department for consecutive patients who had initially received standard lines of therapy followed by low-dose immunotherapy (nivolumab 40 mg) on a compassionate basis. The demographic details, histology, prior treatment, clinical and radiological response, date of disease progression, date of death, and toxicity data were collected. Results A total of 54 consecutive patients, who received low-dose immunotherapy with nivolumab from January 1, 2018 to February 14, 2020, were included in this analysis; 4 patients were not radiologically evaluable. The median age was 50.4 years (range 35–74 years), male:female ratio was 6:1. The most common comorbidities were hypertension and diabetes seen in 12 (22.2%) and 6 (11.1%) patients, respectively. The majority of the patients (70.4%) were of head and neck cancer. The median follow-up was 4.5 months (range 0.5–11.7). Clinical benefit was observed in 18 (33.3%) patients. Partial response and stable disease were achieved in 9 (16.7%) and 5 (9.3%) patients, respectively. Median survival was not reached for these patients. Six months progression-free survival and overall survival were 100 versus 8.7% (hazard ratio [HR] 0.05, 95% confidence interval [CI]: 0.01–0.36; p = 0.003) and 100 versus 29.7% (HR 0.03, 95% CI: 0.00–0.95; p = 0.047), respectively, for responders and nonresponders. The side effects were manageable. Conclusion In resource-constrained settings, low-dose immunotherapy with nivolumab seems to be an effective treatment option. Further studies are warranted to evaluate this approach.

Evaluation of Hepatitis Serology Screening Frequency and Viral Reactivation in Patients Followed with Biological Therapy or Cytotoxic Chemotherapy

Objective: Our study aimed to evaluate the results of hepatitis B and C serology screening before biological therapy and chemotherapeutic treatments in internal medicine clinics (rheumatology, medical oncology, and gastroenterology) by comparing between departments and investigating the virus reactivation status. Material and Method: The study included 1147 patients aged 18 and over who were admitted to the medical oncology, rheumatology, and gastroenterology departments between 2019 and 2021 and received cytotoxic chemotherapy and biological treatment. HBsAg, Anti-HBs, Anti-HBc, and Anti-HCV data were used to screen for hepatitis. The departments were compared and evaluated based on the frequency of screening and reactivation. Results: Before undergoing chemotherapy or biological therapy, 77% of patients in oncology, 40% in rheumatology, and 43% in gastroenterology were fully screened for hepatitis. The rates of incomplete screening were 16%, 48%, and 52%, respectively, while 3%, 10%, and 4% were never screened. In total, reactivation was observed in twelve patients (1.0%), while no reactivation was observed in 1135 patients (99.0%). A statistically significant correlation was found between the departments and the presence of reactivation (p

Questionnaire survey and analysis of drug clinical research implementation capabilities of breast cancer treatment departments in Chinese hospitals

BackgroundClinical research competence determines the quality of clinical research and the reliability of research findings. We aimed to explore the clinical research implementation capabilities of breast cancer treatment departments in China. MethodsThis was a department-based cross-sectional study conducted in the form of electronic questionnaires on the Wenjuanxing platform from 7th August to 31st August 2023 among hospitals from the first batch of breast cancer standardized diagnosis and treatment quality control pilot centers in China. ResultsA total of 127 questionnaires from 122 hospitals were ultimately included in the analysis. Medical personnel involved in the clinical research of 118 (92.9 %) departments received good clinical practice (GCP) training. The steps of the approval process from research initiation to completion lasted 2–4 weeks or longer. The majority of departments initiated or participated in 2 or fewer clinical research projects over the past year. Among the differences between different departments, the Department of Medical Oncology had a better qualification profile and process and greater number of initiated and participated clinical studies than did the Department of Surgical Oncology. For needs and problems, most of the departments were strongly willing to undertake clinical research and receive professional training; the most common problem in the process of conducting studies was patient recruitment. ConclusionsMost departments generally exhibited complete capabilities for implementing clinical research. Improvements in implementation efficiency, quality of research and patient recruitment are still needed. Professional training and communication, as well as the recommendation of clinical research, are required in future development.

CDK4/6 Inhibitor-Associated Mean Corpuscular Volume Change: A Potential Parameter for Predicting Survival in Metastatic Breast Cancer?

To evaluate the impact of CDK4/6 inhibitors on erythrocyte mean corpuscular volume (MCV) change and its possible correlation with progression-free survival (PFS) and overall survival (OS). Observational study. Place and Duration of the Study: Department of Medical Oncology, Kahramanmaras Necip Fazil City Hospital, Kahramanmaras, Turkiye, between January 2020 and 2023. The data of 74 patients with HR (+) HER2 (-) metastatic breast cancer were analysed retrospectively. MCV and other complete blood count metrics were noted before and after the treatment. The first post-treatment evaluation was performed at three months. The median ΔMCV values at the third month after treatment-baseline were calculated. The patients were all females, with a median age of 55 years (between 35 and 80). Prior to the therapy, the baseline median MCV level was 90.4 (min-max: 77.3-113.2). After three months, the median MCV level was 95 (min-max: 84.3-115.3). Moreover, 7.15 was the median ΔMCV level. Regarding PFS (16.53 vs. 15.26 months) (p = 0.13) and OS (21.46 vs. 17.83 months) (p = 0.08), there was no statistically significant difference seen between the group with ΔMCV ≥7.15 and the group with ΔMCV <7.15. CDK4/6 inhibitors led to an increase in MCV but there was no significant difference between PFS or OS and the increase in MCV. To figure out whether the rise in MCV represents a prognostic or predictive marker, further research is required. Breast cancer, CDK4/6 inhibitors, Mean corpuscular volume, Prognosis.

B2 Prognostic Index in Determining Prognosis in Metastatic Breast Cancer.

To determine the relationship between the B2 prognostic index (B2PI) scoring method and prognosis in metastatic breast cancer, and to create a formula based on parameters that can be easily accessed in daily practice. Descriptive study. Place and Duration of the Study: Department of Medical Oncology, Dokuz Eylul University, Izmir, Turkiye, between May 2010 and June 2021. The clinicopathological characteristics of the patients were compared between the groups. All female breast cancer patients over the age of 18 years with de novo metastatic and non-metastatic breast cancers who developed metastasis during follow-up, were included in the study. Those with a second solid cancer or haematological malignancy and with a life expectancy of less than 3 months were excluded from the study. Chi-square and Fisher's exact tests were used to compare categorical data between the groups. Overall survival evaluations were made using the Kaplan-Meier analysis method and Log-Rank test. Risk factors for mortality were evaluated in Cox regression analysis. In all statistical tests, p <0.05 was considered statistically significant. There were 176 patients in this study, out of which 111 (63.1%) were de novo metastatic. When the effect of B2PI risk groups on overall survival in intrinsic subtypes was analysed, significant differences were found in the overall survival of B2PI risk groups in all subtypes except HER2+ ER- (HER2 overexpression subtype). According to the B2PI scoring system, the median overall survival was higher for both low-risk and moderate-risk patients compared to those in the high-risk category. For metastatic breast cancer patients, the B2PI can be used to determine prognosis and develop treatment strategies, as it is a clinical decision-making tool based on parameters that are easily accessible in daily practice. Metastatic breast cancer, B2 prognostic index, Prognosis, Survival.

Significance of Runt-related transcription factor 1 and Notch1 expression in non-small-cell lung cancer: involvement in epithelial-mesenchymal transition and epidermal growth factor receptor-tyrosine kinase inhibitor therapy resistance

Objective One of the main obstacles to treating patients with non-small-cell lung cancers (NSCLC) is the emergence of drug resistance to epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) therapy. Aim To investigate the prognostic relevance of Runt-related transcription factor 1 (RUNX1) and Notch1 in NSCLC and to evaluate their potential involvement in induction of epithelial-mesenchymal transition and resistance to EGFR-TKI therapy. Materials and methods Immunohistochemical study of RUNX1, Notch1, E-cadherin, and hypoxia-inducible factor 1α (HIF-1α) was conducted upon 83 cases diagnosed as NSCLC. The research was conducted in the departments of pathology, chest, and medical oncology of the Faculty of Medicine, Benha University. Results A significant relation was found between RUNX1 and sex (P=0.001), smoking history (P=0.002), and tumor grade (P=0.002). High RUNX1 expression was associated with poor OS and DFS (P=0.003 and 0.005), respectively. Cases with positive Notch1 expression were significantly associated with tumor grade (P=0.005) and tumor stage (P=0.024). A significant association was detected between Notch1 expression and poor OS and DFS (P=0.025 and 0.011), respectively. A statistically significant correlation was found between RUNX1 and Notch1 expressions (P=0.040). Moreover, high RUNX1 and positive Notch1 expressions were significantly associated with negative E-cadherin and positive HIF-1α expressions. Resistance against EGFR–TKI therapy was significantly associated with high RUNX1, positive Notch1, negative E-cadherin, and positive HIF-1α expressions, in EGFR-mutated cases. Conclusions RUNX1 and Notch1 may be involved in therapy resistance through the induction of epithelial–mesenchymal transition and may serve as prognostic markers in patients with NSCLC.

Impact of opioid analgesics on survival in cancer patients receiving immune checkpoint inhibitors

PurposeThis study aimed to assess the effects of concurrent opioid analgesic (OA) use with immune checkpoint inhibitors (ICIs) on progression-free survival (PFS) and overall survival (OS).MethodsIn this observational retrospective study, we included advanced cancer patients who received ICIs at Hacettepe University Hospital’s Department of Medical Oncology between June 2018 and January 2023.ResultsOur study included 375 recurrent or metastatic cancer patients treated with ICIs in the first, second line, or beyond. There were no significant differences between the OA-treated and OA-untreated groups regarding median age, age group, gender, primary tumor location, ICI type, or the presence of baseline liver and lung metastases. However, the OA-treated group exhibited a significantly higher proportion of patients who had received three or more prior treatments before initiating ICIs (p = 0.015). OA-Untreatment was significantly correlated with prolonged mPFS (6.83 vs. 4.30 months, HR 0.59, 95% CI 0.44–0.79, p < 0.001) and mOS (17.05 vs. 7.68 months, HR 0.60, 95% CI 0.45–0.80, p < 0.001).ConclusionsOur study demonstrates an association between the concurrent use of OAs and reduced OS and PFS in patients treated with ICIs. While OA treatment serves as a surrogate marker for higher disease burden, it may also suggest a potential biological relationship between opioids and immunotherapy efficacy.

Retrospective evaluation of the contribution of radiotherapy to survival in breast cancer treatment with propensity score based on stage and subgroup

BackgroundBreast cancer has been a disease in which treatment strategy has changed over time under the influence of different hypotheses and evidence for more than a century. We analyzed the contribution of radiotherapy to disease-free survival and overall survival by classifying according to stage, 1–3 lymph node involvement, and molecular subgroups.MethodsFollowing the approval of the Institutional Review Board, records of patients with breast cancer who were admitted to University School of Medicine Departments of Radiation Oncology and Medical Oncology between July 1999 and December 2020 were reviewed. Using data propensity score matching was performed between the groups that did and did not receive radiotherapy using an optimal matching algorithm (optimum, 1:1). Disease-free survival and overall survival after propensity score matching were calculated using the Kaplan-Meier method. Univariate and multivariate Cox regression analysis was used to estimate hazard ratios.ResultsIn the radiotherapy and non-radiotherapy groups, disease-free survival was 257.42 ± 5.46 (246.72- 268.13), 208,96 ± 8,15 (192,97–224,94) months respectively, (p = < 0.001), overall survival was 272,46 ± 8,68 (255,43–289,49), 219,05 ± 7,32 (204,70–233,41) months respectively (p = .002). We compared the 19 N1 patient groups who received radiotherapy with the 19 patients who did not receive radiotherapy and calculated the disease-free survival times was 202,21 ± 10,50 (181,62–222,79) and 148,82 ± 24,91 (99,99–197,65) months respectively (p = .011) and overall survival times was 200,85 ± 12,79 (175,77–225,92) and 166,90 ± 20,39 (126,93–206,82) months respectively (p = .055). We examined disease-free survival and overall survival times in both groups according to Luminal A, Luminal B, TNBC, and HER2-enriched subgroups. In the Luminal B subgroup, the disease-free survival duration in the groups receiving radiotherapy and not receiving radiotherapy was 264.83 ± 4.95 (255.13-274.54) and 187.09 ± 11.06 (165.41-208.78) months (p < .001), and overall survival times were 252.29 ± 10.54 (231.62-272.97) and 197.74 ± 9.72 (178.69–216.80) months (p = .001) respectively.ConclusionsThanks to studies proving that RT increases long-term survival rates in breast cancer as a result of reducing locoregional recurrence and systemic metastasis rates, it has been understood that the spectrum hypothesis is the hypothesis that most accurately describes breast cancer to date. We found that patients with Luminal B invasive breast cancer benefited significantly more from RT compared to other subgroups.

Improving quality of care by standardising patient data collection in electronic medical records in an oncology department in Spain

BackgroundEvaluation of quality of care in oncology is key in ensuring patients receive adequate treatment. American Society of Clinical Oncology’s (ASCO) Quality Oncology Practice Initiative (QOPI) Certification Program (QCP) is...

Randomized double-blind placebo-controlled trial evaluating pregabalin for chronic cough in patients with lung cancer.

LBA12082 Background: Chronic cough is a distressing symptom that detracts from the quality of life (QoL) of patients with cancer. Developing effective therapies for cough is an unmet need, with no approved medicines available. Neuromodulators like pregabalin may act centrally as cough suppressants. Methods: Randomized double-blind placebo-controlled study in the Department of Medical Oncology at Tata Memorial Hospital (Mumbai, India) in patients with locally advanced/metastatic non-small-cell lung cancer (NSCLC) with at least 2 weeks history of moderate or severe cough. Patients had ECOG PS 0-2, and creatinine clearance &gt; 60 mL/min. Randomization was 1:1 to pregabalin 300 mg orally daily or matching placebo, both administered for 9 weeks. Primary endpoint was the difference in cough severity as measured by Visual Analog Scale (VAS) after 9 weeks treatment with pregabalin versus placebo. Secondary endpoints included cough severity on day 7 and week 9 measured by VAS, and Manchester Cough in Lung Cancer Scale (MCLCS); side-effects, and QoL assessed by EORTC QLQ C30 and LC13. Means of the change from baseline scores were calculated for patients in each arm, and compared between two arms by independent samples Mann Whitney U test. P &lt; 0.05 was considered significant. Results: Between Jul 2022 and Dec 2023, we enrolled 166 patients: 83 to each arm. Median age was 56 years (IQR, 47-62.5); 112 (67.5%) were male, and 149 (89.8%) had metastatic NSCLC. Baseline cough severity was grade 2 in 127 (76.5%) and grade 3 in 37 (22.6%); median cough duration was 163 days. The therapy (pregabalin/placebo) was well tolerated in both arms, with no difference in grade &gt; 3 toxicities between the two arms; P=0.908. Systemic cancer-directed therapy was started in 95.2% and 91.4% of patients in the pregabalin and placebo arms, respectively; P=0.328. By week 9, subjective improvement in cough was reported by 45 (57%) patients in pregabalin arm, and 40 (52.6%) patients in placebo arm; P=0.846. The mean VAS score (in mm) decreased from 71.58 at baseline, to 45.32 at day 7, and 19.73 by week 9 in the pregabalin arm; corresponding values in the placebo arm were 71.74, 46.23, and 21.18, respectively; P=0.530. Cough assessment by mean MCLCS scores showed a similar decrease throughout the course of the study, with no statistically significant differences between the two arms (Pregabalin-Baseline: 27.63, Day 7: 23.49, Week 9: 17.39; Placebo-Baseline: 27.28, Day 7: 23, Week 9: 17.34); P=0.455. There was no significant difference in QoL between the two arms. Mean LCCO (cough symptom question on QLQ LC13) score decreased from 75.9 (baseline) to 54.2 (day 7) to 36.4 (week 9) in pregabalin arm, vs 66.3, 54, and 31.4, respectively, in placebo arm; P=0.150. Conclusions: Pregabalin does not lead to a significant decrease in cough in patients with lung cancer. Systemic cancer-directed therapy is the most effective antitussive therapy for cancer-induced cough. Clinical trial information: CTRI/2020/11/029275 .

Role of celecoxib in reducing cognitive impairment in patients receiving definitive chemoradiation for head and neck carcinoma: A phase II randomized placebo controlled trial (CELCI-HN study).

TPS12150 Background: Head and neck squamous cell carcinoma (HNSCC) is common in the Indian subcontinent and majority (65%) patients present in an advanced stage. Chemotherapy related cognitive impairment (CRCI) is a poorly defined and underestimated phenomenon in the HNSCC population. Through this study, we are attempting to establish evidence of activity of agents targeting neuro-inflammation in reducing or halting cognitive decline associated with definitive chemoradiotherapy for head and neck malignancies without adding to treatment-associated toxicity. This study can potentially aid in developing a cost effective approach with a readily available and cheap agent like celecoxib in improving the quality of life in this cohort of patients. Methods: This is a single center, double blinded placebo controlled phase 2 randomized trial. We intend to randomize 92 non metastatic HNSCC patients registered at a large tertiary cancer center of North India {Department of Medical Oncology (Head and Neck Cancer Clinic, All India Institute of Medical Sciences-National Cancer Institute, India)} planned for definitive chemoradiation (CTRT) with or without induction chemotherapy. Patients in the experimental arm will receive celecoxib 100 mg or matched placebo tablet orally twice a day starting with day 1 of initiation of definitive chemoradiotherapy/induction chemotherapy for a duration of 6 months or until unacceptable toxicity. Our primary objective is to determine the activity of celecoxib versus placebo in reducing cognitive decline in patients undergoing definitive CTRT with or without induction chemotherapy in HNSCC through patient reported outcome tools (FACT cog questionnaire). Secondary objectives include assessment of adverse event profile (measured using CTCAE v5.0), objective assessment of neurocognitive decline using neuropsychological battery of tests, to identify predictors of cognitive decline on the basis of site of malignancy, radiation dose to the base of skull and brainstem, age, comorbidities and educational status. Tertiary objective include evaluation of inflammatory biomarkers e.g serum COX-2, serum Interleukin and tumor necrosis factors-alpha levels at the end of therapy and on follow up. Clinical trial information: CTRI/2022/09/045579.

Metastatic breast cancer in elderly women: A retrospective cohort study in Morocco.

e13073 Background: Breast cancer (BC) stands as the predominant malignancy among women worldwide, presenting a significant global public health problem. In Morocco, it is the leading cause of cancer-related mortality in females. However, there exists a limited understanding of outcomes and treatment patterns for elderly patients with metastatic breast cancer (MBC) in our context. Methods: We conducted a retrospective cohort study at the Department of Medical Oncology, Hassan II University Hospital of Fez, focusing on 92 female patients aged 65 years or older diagnosed with MBC, between January 2012 and December 2016. The primary objectives were to estimate overall survival (OS) and progression-free survival (PFS), describe treatment patterns, and characterize the clinicopathological, and prognostic aspects of MBC in elderly women in Morocco. Results: The cohort’s median age was 70.88 (range, 65-88years) with 45.6% of patients aged of 65 to 69 years, 34.8% between 70 to 74 years old, and 19.6% over 75. Most patients (77.2%) had an Eastern Cooperative Oncology Group (ECOG) score of 0 to 1, and only 33.7% had comorbidities. De novo stage IV constituted 59.8% of all cases. Metastatic recurrences represent 40.2% with 16.2% having recurrence within 12 months, and 83.8% having a recurrence interval exceeding 12 months. The median time to recurrence was 45.5 months. Invasive ductal carcinoma (IDC) was the predominant histological type (81.1%), with SBR grade II (51%) and grade III (21.7%). Metastases were observed in pleuropulmonary (78.3%), bone (56.5%), lymph nodes (33.7%) and liver (30.4%). With 71.7% having metastases in fewer than three sites, while 28.3% had metastases in three or more sites. Molecular profiling showed Luminal A (38%) and Luminal B (26.1%) subtypes as the most prevalent, followed by triple-negative (17.4%) and HER2+ (15.2%). Treatment modalities included chemotherapy (50%), hormone therapy (15.2%) or a combination of the two (17.4%), and anti-HER2 targeted (14.1%). Median OS was 37 months (95% CI: 16.86 - 57.13 months), and median PFS was 33.16 ± 4.1 months. Anti-HER2 therapy showed a significant association with survival (p = 0,05). Conclusions: This study highlights the characteristics, survival, and treatment modalities of elderly patients with MBC in Morocco. Despite the predominance of luminal BC an intriguing observation was the frequent use of chemotherapy as first line modality.

Questionnaire survey and analysis of drug clinical research implementation capabilities of breast cancer treatment departments in Chinese hospitals.

e23257 Background: Clinical research competence determines the quality of clinical research and the reliability of research findings and is vital in the development of new antitumor drugs and the diagnosis and treatment of breast cancer. Our study aimed to explore the clinical research implementation capabilities of breast cancer treatment departments in China and to analyze the differences among regions, departments and different hospital classifications. Methods: This was a department-based cross-sectional study conducted in the form of electronic questionnaires in China from 7th August to 31st August 2023; this study was initiated by the breast cancer expert committee of the National Cancer Center (NCC). The questionnaire was designed on the Wenjuanxing platform. Our study was conducted among the first batch of breast cancer standardized diagnosis and treatment quality control pilot centers, which includes 200 hospitals selected by the NCC on the basis of the level of breast cancer diagnosis and treatment, surgery volume and other factors. The centers cover 30 provinces, and all of them are tertiary-level general hospitals or cancer hospitals. Results: A total of 127 questionnaires from 122 hospitals were ultimately included in the analysis. Medical personnel involved in the clinical research of 118 (92.9%) departments received good clinical practice (GCP) training. A total of 89.3% (109/122) underwent centralized institutional review board (IRB) review. The steps of the approval process from research initiation to completion lasted 2-4 weeks or longer. The majority of departments initiated or participated in 2 or fewer clinical research projects over the past year. Among the differences between different departments, the Department of Medical Oncology had a better qualification profile and process and greater number of initiated and participated clinical studies than did the Department of Surgical Oncology. There were more patients enrolled in registered clinical trials in specialized cancer hospitals than in general hospitals (50 and below, 50-200, and more than 200 patients from specialized cancer hospitals vs. general hospitals: 39.1%, 52.2%, and 8.7% vs. 76.9%, 16.4%, and 6.7%, respectively; p = 0.001). For needs and problems, most of the departments were strongly willing to undertake clinical research and receive professional training; the most common problem in the process of conducting studies was patient recruitment. Conclusions: Most departments generally exhibited complete capabilities for implementing clinical research. Improvements in implementation efficiency, quality and quantity of research and patient recruitment are still needed. Professional training and communication, as well as the recommendation and implementation of clinical research, are required in future development.

Pan-cancer G2C-Pro: A two-stage Gaussian clustering to prognostically stratify patients with advanced tumors treated with immune checkpoint inhibitors.

e13605 Background: Immune checkpoint inhibitors (ICIs) have revamped the clinical outcomes of patients (pts) affected by advanced solid tumors. The aim of our study is to develop a two-stage Gaussian Clustering algorithm (G2C) integrated with a logistic regression model (Pro) to prognostically stratifypts with advanced solid tumors treated with ICIs (pan-cancer G2C-Pro) based on baseline features. Methods: Data extraction involved, retrospectively, pts with advanced solid tumors (lung, melanoma, renal cancer, head and neck, urothelial carcinoma) treated with ICIs at Department of Medical Oncology, Ancona. Baseline body mass composition (BC) was assessed through computed tomography (CT) scan at L3 level, abstracting subcutaneous and visceral fat and muscle mass indicators. Moreover, baseline clinicopathologic features, nutritional status through The Controlling Nutritional Status (CONUT) score, and comorbidities were collected. An unsupervised clustering analysis was used to identify two groups of pts with different BC phenotype risk groups. Then, another unsupervised clustering analysis was used to identify two groups of pts within the dataset that hold prognostic significance according to BC risk groups, clinicopathologic features, CONUT score, and comorbidities. G2C was constructed by sequentially integrating two Gaussian Mixture models, each employing K-means++ initialization. Next, Pro was used to predict clusters’ label. The metrics used to evaluate the average performance of Pro on test sets were ACCuracy (ACC) and Area Under the Curve (AUC). The model was developed in Python on-cloud using the Google Colab service. Results: A total of 87 pts with complete data available were included in the final analysis. The two generated clusters for BC phenotype were BC_Low_Risk (n = 39) and BC_High_Risk (n = 48). Then, considering BC risk groups, clinicopathologic features, nutritional status, and comorbidities, two generated clusters were cluster 1 (n = 55) and cluster 2 (n = 32). Looking at clinical outcomes, median progression free survival was 16.1 months for cluster 1 versus 7.1 months for cluster 2 (HR: 0.57, 95% CI: 0.33-0.98, p = 0.04), and median overall survival was 41.8 months for cluster 1 versus 10.5 months for cluster 2 (HR: 0.47, 95% CI: 0.27-0.83, p = 0.008). The average ACC and AUC across all splits achieved by Pro model for patient classification into clusters were 0.94 and 0.89, respectively. From the feature ranking, it emerged that the one with higher importance was CONUT score, followed by BC phenotype risk groups and neutrophil-to-lymphocyte ratio. Conclusions: By using an easy-to-obtain and reproducible baseline BC, clinicopathologic, nutritional features, and comorbidities, we demonstrated that pan-cancer G2C-Pro is a promising and accurate prognostic model for stratifying pts with advanced tumors treated with ICIs.

Therapeutic Efficacy, Safety and Predictive Indicators of Eribulin Plus Anti-Angiogenic Medicine for Metastatic Breast Cancer.

To evaluate the efficacy and safety of eribulin plus anti-angiogenic medicine in metastatic breast cancer (MBC), and explore the potential biomarkers. Observational study. Place and Duration of the Study: Department of Medical Oncology, Xi'an International Medical Centre Hospital, Xi'an, China, from May 2022 to 2023. A total of 40 MBC patients treated with eribulin were enrolled. Patients were divided into two groups based on whether they received eribulin monotherapy or combined therapy. Median progression-free survival (mPFS), the time from the start of erbium treatment to the time of disease progression, was calculated using the Kaplan-Meier method. The eribulin plus anti-angiogenic medicine treatment group had a significantly prolonged mPFS compared to the group without anti-angiogenic medicine treatment (7.0 months vs. 2.0 months, p <0.001). The multivariate analysis identified that the combination of anti-angiogenic therapy (HR = 0.043, p = 0.004) and the occurrence of grade 3-4 neutropenia after the treatment were two predictive factors for longer PFS (HR = 0.322, p = 0.009). In contrast, prior resistance to taxane was predictive of shorter PFS (HR = 4.583, p = 0.019). Other clinic-pathological factors were not significantly associated with PFS. Fisher's exact test showed no significant increase in treatment-related adverse events (all grades) after combination with anti-angiogenic medicine. The eribulin plus anti-angiogenic combination may act as a potential therapy for late-line MBC patients with clinically beneficial therapeutic effects. Metastatic breast cancer, Eribulin, Anti-angiogenic therapy, Predictive indicators of efficacy.

Single institution analysis of glioblastoma multiforme (GBM) outcomes based on year of diagnosis: A 17 year review.

e14023 Background: GBM is the most common brain tumour in adults. The latest WHO classification excludes IDH mutated tumours, acknowledging their favourable prognosis. MGMT methylation is a prognostic biomarker and predicts level of benefit from Temozolomide. The standard of care management includes maximal surgical resection followed by radiotherapy with concurrent and adjuvant Temozolomide. This has remained largely unchanged for nearly 20 years. We analysed 17 years of newly diagnosed GBM cases attending Medical Oncology at our institution to assess outcome advancements. Methods: Demographic information, clinicopathological characteristics, surgery, radiotherapy and systemic anti-cancer treatment data were collected from the charts of patients diagnosed with GBM and seen by the Medical Oncology department at Cork University Hospital between 2005-2021. The study population was divided into 2 time periods: 2005-2016 and 2017-2021. Overall survival was recorded. Baseline characteristics was compared across time periods using the Chi-Square test. Univariate and multivariate analysis was performed to assess impact of different variables on overall survival. Results: The analysis comprised 306 patients, with 142 and 164 diagnosed between 2005-2016 and 2017-2021 respectively. Median age was 62 years (range 17-86) and patients were predominantly male (65%). Patients in the earlier time period were more likely to have ECOG performance status 0-1 (80% vs 65% p = 0.011) and were more likely to commence treatment on Stupp protocol (99% vs 80% p = &lt;0.001). IDH and MGMT testing were less prevalent in the earlier time period. Median overall survival (mOS) for the entire cohort was 11.6 months. Univariate analysis revealed correlations between overall survival and time period of diagnosis, age &gt;65, MGMT status, ECOG performance status, steroid use, surgery, re-resection, and completion of adjuvant chemoradiation protocols. The mOS was 12.3 months in the earlier time period and 10.4 months in the later time period (HR = 1.35 p = 0.012). Time period of diagnosis remained an independent prognostic factor for poor outcome on multivariate analysis. Notably, mOS during the COVID-19 pandemic (2020-2021) was 10.6 months, showing no difference from other time periods. Conclusions: Despite advances in our knowledge regarding the molecular biology of GBM, prognosis remains poor. Our institution’s 17 year survival data indicates no improvement over time emphasising the urgent need for new treatment strategies. Notably, the more recent time period had an increased number of frailer patients who were too unwell to commence any adjuvant treatment, possibly indicating a lower referral threshold which may have negatively impacted mOS in that cohort. Additionally, the absence of IDH status assessment in the earlier era means some IDH mutant patients were likely included, thereby inflating the mOS for that cohort.

Adherence to adjuvant hormone therapy in hormone-sensitive breast cancer: Insights from the Medical Oncology Department at Hassan II University Hospital, Morocco.

e12505 Background: Adjuvant endocrine therapy (AET) improves long-term survival for hormone-sensitive breast cancer; However, suboptimal adherence is prevalent, with many women failing to follow prescribed dosage and frequency. Long-term adherence patterns to AET are poorly understood. Additionally, there is a lack of data regarding the adherence to AET among Moroccan women and the factors that may influence it. Objectives: The primary objective of the study was to assess the adherence rate to AET in patients with HR-positive early breast cancer being treated at Hassan II University Hospital of Fez, Morocco. Secondary objectives included determining factors associated with poor adherence and assessing the adverse events associated with AET and their prevalence. Methods: We conducted a cross-sectional study involving 335 breast cancer patients undergoing AET. Eligible patients, who had received at least one dispensing of AET, participated in the study through a direct questionnaire survey after providing signed consent. The questionnaire comprised sections covering patient demographics, clinical data (stage, type of AET, duration of therapy), side effects or symptoms related to AET, other factors that may impact adherence. Adherence to AET was assessed at three points of measurement: 1 year, 3 years, and ≥ 5 years after the initiation of therapy. The study was carried out with respect to the Moroccan regulation in effect. Results: The study included 335 cases with an average age of 54 years. Participants were predominantly illiterate (62%) and post-menopausal (50.7%). Most were classified as stage II UICC (53.5%). Mastectomy was performed in the majority (74%). Neo(adjuvant) CMT was given to 79.4%, and adjuvant radiotherapy to 86.9%. Tamoxifen was administered to 55.4%, and aromatase inhibitors to 44.6%. Medical castration was associated with 12.5%, and 35 patients switched AET over time. Only 12.8% exceeded 5 years of AET during recruitment. Adherence assessment revealed an overall adherence rate of 53.4%. Notably, 67.2% claimed never to forget their medication, and about 20% temporarily stopped it, primarily due to lack of information. Most participants used a reminder strategy, notably alarms (43.3%). Treatment tolerance varied, with hot flushes and arthralgia being predominant side effects. Statistical analyses found a significant link between treatment lasting over 5 years and non-adherence (p = 0.003). However, the use of an alarm as a reminder strategy strengthened adherence (p = 0.021). No statistically significant differences were noted in other variables. Conclusions: Despite the benefits, ensuring adjuvant hormone therapy adherence is challenging. Our analysis, estimating a 53.4% global adherence, found that only treatment duration and recall strategy significantly correlated with adherence.

Are the clinical trials in lung cancer an advantage for patients in developing countries?

e20523 Background: Clinical trials are critical to developing new drugs. This study examined the characteristics of patients diagnosed with metastatic non-small cell lung cancer (mNSCLC) and who wanted to participate in clinical trials. This study aims to compare the outcomes of patients who enrolled in clinical trials or not. Methods: The data of the patients who applied to Ankara Yildirim Beyazit University Medical Oncology Department to participate in the first-line treatment-related clinical trials in mNSCLC were retrospectively reviewed. Survival outcomes of patients included in clinical trials (CT) and patients who signed informed consent for clinical trials but could not enroll (standard treatment-ST) were compared. Results: Data from 155 patients who applied to participate in clinical trials were analyzed. Patients who died during the screening process and who lacked systemic treatment information were excluded (n = 14). While 55.3% (n = 78) of the patients participated in the clinical trials, 44.7% (n = 63) could not. Not meeting the inclusion criteria (pathological and clinical) was the most common reason for screen-fail. At a median follow-up of 29 months, median overall survival was 17.1 months (95%CI, 15.1 to 19.1) in the CT group and 9.6 months (95%CI, 7.1 to 12.1) in the ST group (p = 0.015). Median progression-free survival was 11.6 (95% CI, 5.9 - 17.4) and 5.4 (95% CI, 3.7 - 7.2) months, respectively (p = 0.014). Conclusions: Being able to take part in clinical trials is not unfavorable, and it may even improve survival for patients with metastatic non-small cell lung cancer (mNSCLC), particularly in areas of the world where access to novel and effective treatments is limited.

Genomic and biomarker analysis of immunotherapy combined with chemotherapy treated for patients with metastatic BTC cancer: A real world study.

e16373 Background: Biliary tract cancer (BTC) is a heterogeneous group of diseases with dismal prognosis. The TOPAZ-1 phase III trial and KENOTE 966 reported a survival benefit with the immune checkpoint inhibitor (ICI) plus chemotherapy (GemCis,GC) in patients with advanced BTC. Consequently, immunotherapy plus chemotherapy has become a new standard care for advanced BTC. Understanding the association between genomic alterations and immunotherapy outcomes of BTC could further improve the clinical benefits. Therefore, we conducted this real-world study in China. Methods: This study included 47 patients with metastatic BTC treated with PD-1/PD-L1(ICI) antibodies in combination with chemotherapy from January 2019 to January 2023 in Medical Oncology department of Chinese PLA General Hospital. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall response rate (ORR), disease control rate (DCR). The exploration endpoint was genomic and biomarker analysis. Genomic tumor DNA was isolated from 30 patients and used for targeted next-generation sequencing genes to identify the genomic profiles. Results: 47 patients received immune checkpoint inhibitor (ICI) plus with chemotherapy in first line were enrolled in this study. The median PFS were 5.4m (95%CI,4.4-6.3), ORR and DCR was 21.3% and 83.0%, respectively. Patients were grouped into two group:AS+PD1(n=34) group and GC+ICI(n=13) group. In the AS(Albumin paclitaxel+S1)+PD1 group, mPFS was 5.0m (95%CI 3.8-6.1), ORR were 20.6% and DCR were 79.4% as we reported previously. In the GC+ ICI, mPFS was 7.9m (95%CI 4.7-11.1), ORR was 23.1% and DCR was 92.3%. There was no difference in terms of PFS, ORR and DCR between two groups. With regard to biomarker analysis, PD-L1 expression positive were 16 patients, which of mPFS were 4.2m and ORR were 18.8%, otherwise 12 patients were PDL1 expression negative, of whom mPFS were 9.1m and 33.3% as unexpected. Average TMB were 4.5mt/MB for MSS type patients. There is no difference of PFS between TMB high(&gt;4.5mt/MB) or low(&lt;4.5mt/MB). As for genomic analysis, the most common gene alterations were TP53(N=13, 43%))KRAS(N=8, 26.7%), NTRK1\2\3(N=8, 26.7%), IDH1/2(N=6, 20%), PIK3CA(N=6, 20%), BRCA2(N=5, 16.7%). MDM2(N=5,16.7%), BRAF(N=4,13.3%). The mutations are mainly concentrated in the DDR (20) pathway followed by the RTK-RAS (16), TP53 (13), CPF (9), FA (9), HRR (9), and PI3K (8) pathways. Compared between long term survival(PFS&gt;5.4m)and short term survival(PFS&lt;5.4m), MDM2 was only predictor for short survival(p&lt;0.05). Conclusions: Compared to AS+pd-1, patients received GP+ ICI numerically had better outcomes. It seems PD-L1 and TMB were not good predictors to select patients who can more benefit from immunotherapy plus chemotherapy. MDM2 mutation suggest patients tend to less active to immunotherapy-based modality.