Avelumab first-line (1L) maintenance is recommended as the standard of care for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression following 1L platinum-based chemotherapy (PBC). We report results from READY, a real-world study of avelumab 1L maintenance in an Italian compassionate use program (CUP). In this prospective, noninterventional CUP, avelumab was provided on physician’s request to patients with la/mUC without disease progression following four to six cycles of 1L PBC, after approval by the local ethics committees, per Italian compassionate use regulations. Between January 2021 and March 2022, 414 patients received avelumab 1L maintenance and were assessable for survival/safety analyses; 79.2% were male and median age was 71 years. At data cut-off (30 July 2023), median follow-up was 20.30 months [95% confidence interval (CI) 19.78-20.93 months]. From the start of avelumab treatment, median overall survival (OS) was 26.22 months [95% CI 19.97 months-not estimable (NE); 12-month OS rate, 65.6%] and median progression-free survival was 7.63 months (95% CI 6.02-9.31 months). In patients who had received 1L carboplatin plus gemcitabine (n = 221) or cisplatin plus gemcitabine (n = 184), median OS (95% CI) was 25.10 months (19.97 months-NE) and not reached (16.05 months-NE), respectively. Clinical benefit was observed across other subgroups, including those based on age and best response to PBC. Any-grade treatment-related adverse events occurred in 112 patients (27.1%). In READY, avelumab 1L maintenance showed clinical benefit in patients in Italy with la/mUC without progression following PBC, including across clinical subgroups, further supporting its use as the standard of care in this setting.

Prostate cancer (PC) is the second most common cancer and the fifth leading cause of cancer mortality in men, worldwide. Genomic analysis identified alterations in DNA damage repair (DDR) pathways, in up to 30% of metastatic castration-resistant prostate cancer (mCRPC). Homologous recombination repair (HRR) mutations in BRCA1/2 emerged as a relevant biomarker in PC, linked to aggressive behavior, unfavorable outcomes and notable responses to poly-ADP ribose polymerase inhibitors (PARPi). While PARPi efficacy in BRCA-mutated mCRPC is well established, their role in earlier disease stages is currently under investigation. This non-systematic narrative review aims to summarize current evidence on PARPi in PC, outlining approved indications, ongoing clinical trials, and emerging therapeutic strategies across different disease settings.

Background Biosimilar drugs have a similar, but usually not inferior although not hidentical effects of old registred drugs. Safety is hidentical to old registred drug. Aims Aim of this study is to verify if in MDS patient with refractory anemia biosimilar erythropoietin alpha is not inferior to erythropoietin alpha in terms of safety, efficacy and costs. Methods This study is a dicentric, nonrandomized, retrospective study. Between july 2008 and june 2012, 92 patients affected by refractory anemia were studied. Median follow-up was 22 months (R3-34). Patients received in group A erythropoietin alpha 40000 IU sc/weekly. In group B patient received biosimilar erythropoietin alpha 40000 IU sc/weekly. In both groups patients received liposomal iron (Sideral^®) 14 mg, 2 tablets orally/day calcium levofolinate 7.5 mg/day orally + Vitamin B12: 400 mg/day orally. In group A median age was 70 years (R63-75), M/F: 18/28; in group B median age was 64 years (R60-70), M/F: 25/21. IPSS was low in 30 patients and int-1 in 13 patients in group A, and low in 32 patients and int-1 in 11 patients, in group B. Patients with 5q- were excluded from this study. Median level of haemoglobin was 8.5 g/dl in group A (R8-11) and 9.2 g/dl (R8.5-11.5) in group B. Results Group A patients increased Hb level of 1 g/dl after a median time of 5 weeks (R4-9) and after a median time of 4 weeks (R3-8) in group B. No relevant side effects were observed in both groups. Erythropoietin alpha was reduced in group A because Hb achieved a level > 12g/dl after a median of 12 weeks (R 4-18). Biosimilar erythropoietin alpha was reduced in group B because Hb achieved a level > 12g/dl after a median of 10.5 weeks (R 3-16). In group A maintenance dose was administered with a median of every two weeks (2-4), In group B maintenance dose was administered with a median of every three weeks (2-5). Median cost for every month of erythropoietic therapy was 1536 euros/month (R1240-1850) in group A and 1354 euros/month (R954-1550) in group B. Five patients need transfusion support in group A and seven patients need transfusion support in group B Summary/conclusion Biosimilar erythropoietin alpha plus liposomal iron (Sideral^®) and B12 and folates support seems to be safe, feasible, probably equally cost-effective and substantially not inferior to classical erythropoietin alpha support in patients affected by refractory anemia. This study needs confifrmation on a larger cohort of patients.