Bashar Abuqayas

Introduction: Enfortumab vedotin‐ejfv (EV), an antibody–drug conjugate approved for advanced urothelial carcinoma (aUC), has limited real‐world safety data and no validated predictive biomarkers. Retrospective studies suggest higher objective response rates (ORR) among patients developing EV‐related dermatologic toxicities, but survival implications remain unclear. This analysis assessed the safety of EV monotherapy and the impact of dermatologic and neurologic toxicities on efficacy outcomes in a multi‐institutional cohort. Materials and Methods: UNITE is a multicenter, retrospective study across 16 US sites of patients with aUC treated with targeted agents, including EV. Primary endpoints were the incidence of EV treatment‐related adverse events (TRAEs, any grade) and TRAE‐related treatment modifications. Secondary endpoints included a comparison of ORR, progression‐free survival (PFS), and overall survival (OS) between patients with and without dermatologic toxicities and neuropathy. To reduce immortal time bias, Cox regression models incorporated TRAEs as time‐dependent covariates to adjust for EV treatment duration as well as Eastern Cooperative Oncology Group performance status (ECOG PS), hemoglobin, and liver metastases. Results: Between 2018 and 2023, 485 patients with aUC received > 1 dose of EV monotherapy. Most (67%) received > 2 prior therapy lines. Any grade TRAEs occurred in 77%, most frequently neuropathy (36%) and dermatologic toxicities (27%); 57% required treatment modification and 21% discontinued EV, primarily due to neuropathy (9%) and fatigue (3%). Patients with dermatologic toxicities and neuropathy had higher ORR (56% vs. 42%; p = 0.007 and 64% vs. 35%; p < 0.0001, respectively). Neuropathy was independently associated with improved OS (HR 0.66; 95% CI 0.50–0.87; p = 0.002); dermatologic TRAEs were not associated with PFS or OS benefit. Conclusions: EV safety outside clinical trials was consistent with prior reports, with no new signals. Treatment modifications were most often due to neuropathy, dermatologic toxicities, and fatigue. Both dermatologic toxicities and neuropathy correlated with higher ORR, but only neuropathy was independently associated with improved OS.

Myelodysplasia syndrome is a heterogeneous group of hematological disorders that are characterized by abnormal morphology and cytopenias of bone marrow elements. Azacitidine is a hypomethylating agent that is commonly used in treatment of myelodysplasia syndrome. We present an extremely rare case of cryptogenic organizing pneumonia following therapy with azacitidine and a review of the relevant literature. This is the fifth case of azacitidine-induced interstitial lung disease and the sixth one due to hypomethylating drugs; of interest, this is the first reported case that has occurred after the second cycle. Our case report highlights an important, potentially treatable and rare side effect of azacitidine and hypomethylating agents in general that might be overlooked by oncologists. Furthermore, our review of the literature showed heterogeneity in the clinical outcome which might, in part, be due to delay in initiating corticosteroids treatment. A 67-year-old white man presented with worsening shortness of breath and mild productive cough that started 1 week prior to his presentation. An initial chest X-ray showed infiltration of both lung fields. Radiographic findings of computed axial tomography, results of bronchoscopy and a lung biopsy were consistent with cryptogenic organizing pneumonia. The patient showed variable clinical response to steroids and he remained dependent on home oxygen. We concluded that there is a recognizable potentially life-threatening toxicity due to organizing pneumonia secondary to azacitidine in the setting of myelodysplasia syndrome treatment. This toxicity is not limited to the first cycle as in previous cases; furthermore, pleural effusion can be associated with this toxicity. Health care professionals should be aware of this recognizable side effect. Early recognition and timely management are critical to prevent permanent lung fibrosis.

Health related quality of life (HRQOL) is an important outcome in cancer care and needs assessment by a valid questionnaire. HRQOL questionnaires need to be validated after translations to other languages and cultural settings. The purpose of this study is to evaluate the psychometric properties of the Arabic version of the European Organization for Research and Treatment of Cancer Quality of Life 15 items Questionnaire for Palliative Care (EORTC QLQ-C15-PAL). This is a cross-sectional study of a convenient sample of inpatients with cancer. One hundred seventy-five patients completed the EORTC QLQ-C15-PAL questionnaire. Cronbach’s alpha coefficient met the 0.7 alpha criterion. Confirmatory factor analysis met the goodness of fit criteria; goodness-of-fit index (GFI), comparative fit index (CFI), normed fit index (NFI) and non-normed fit index (NNFI) >0.90 and root mean square error of approximation (RMSEA) P value <0.05) were found in all scales except for nausea. Age groups were compared and showed significant differences for physical function, fatigue, and global score of HRQOL. The Arabic version of the EORTC QLQ-C15-PAL is valid and reliable.