Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World.

INTRODUCTION: The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients. METHODS: Herein, we report updated survival data, post-progression management, cost/effectiveness and budget impact (BI) of osimertinib compared with a RW population receiving gefitinib or erlotinib. RESULTS: Overall, 189 Caucasian patients receiving first-line osimertinib were included. After a follow-up of 20.7 months, 74(39.2%) patients discontinued osimertinib, median time-to-treatment discontinuation (mTTD) was 27.9 months, overall survival 36.8 months. At progression, tissue biopsy was performed in 29 (56.9%), liquid biopsy in 15 (29.4%) and both in 7 (13.7%) cases. The most frequent resistant mechanism was MET amplification (N = 14, 29.8%). At data cutoff, 13 (6.9%) patients were continuing osimertinib beyond progression; 52 (67.5%) received second-line treatment; no further treatments were administered in 25 (32.5%) cases. Thirty-three (63.4%) patients received chemotherapy, 12(23.1%) TKIs combination. Cost-effectiveness analysis showed a total cost per patient based on RW mTTD of 98,957.34€, 21,726.28€ and 19,637.83€ for osimertinib, erlotinib and gefitinib, respectively. The incremental cost-effectiveness ratio (ICER)/month for osimertinib was 359,806.0€/life-year-gained (LYG) and 197,789.77€/LYG compared to erlotinib and gefitinib. For osimertinib, the BI-gap between RW-TTD and theoretical-TTD was 16,501.0€ per patient. CONCLUSIONS: This updated analysis confirms the effectiveness of osimertinib in RW. Although the ICER of osimertinib seems not cost-effective, additional costs for the management of disease progression to old generation TKIs were not considered in this study. The BI-gap suggests RW mTTD as a more reliable measure for expense estimation.

Oral Problems in Oncology Patients Undergoing Chemotherapy for Solid Tumors: A Prospective Observational Study.

PURPOSE: Oral problems in a group of oncological patients undergoing chemotherapy (CT) for solid tumors have been examined. Incidence and severity of patients' self-reported oral problems have been evaluated along their interaction with age, gender, tumor diagnosis and stage, presence of mestastasis, CT agent type, and number of CT cycle. We also analyzed the presence of paraesthesia and anaesthesia and their predisposing factors associated with clinical and treatment-related variables. METHODS: Patients were asked to fill in a questionnaire to evaluate the onset and the intensity of oral and perioral pain, oral mucositis, salivary gland hypofunction, dysgeusia, dysphagia, dysphonia, and sensitivity neuropathy (paraesthesia or dysaesthesia) since the last CT infusion. We also investigated which types of medications have possibly been used and who recommended it, as well as patients' degree of awareness about the possibility of oral problems arising during CT. RESULTS: We recruited 194 patients and obtained 491 questionnaires. We found that a metastatic disease was a risk factor for OM (OR 2.02, p = 0.026) and salivary gland hypofunction (OR 1.66, p = 0.042) and that platinum agents, compared to mitotic inhibitors, increased the risk of developing salivary gland hypofunction (OR 2.16, p = 0.013), dysphagia (OR 3.26, p = 0.001), and anaesthesia (OR 5.16, p = 0.041). Young age was a slight protective factor for most symptoms. The 80% of enrolled patients were informed by the oncologist about possible oral problems arising during CT. CONCLUSIONS: Our study highlighted the importance of collecting observational data from the patients' perspective on oral problems arising during the routine oncology practice, across a range of solid tumors and CT regimens. The relevance of these findings focused on the key role of the multidisciplinary team in advising the patients on the possible occurrence of oral problems, also by recommending their management.