ABSTRACT Background This ambispective study was designed to assess the efficacy and safety of avelumab maintenance in a real‐world population of patients with metastatic urothelial cancer (UC). Methods Patients with metastatic UC and measurable disease that had not progressed following first‐line platinum‐based chemotherapy were treated with maintenance avelumab (800 mg administered every 2 weeks). The primary endpoint was overall survival (OS). Results A total of 110 patients were enrolled. The majority of patients were male (81%), with a median age of 65 years (range, 36–84). The median OS was not reached, with a 1‐year OS rate of 78.7%. The median PFS was 9.5 months (95% CI, 7.8–11.2 months). The ORR to first‐line chemotherapy was 48.2%, and an additional 34.6% of patients responded to avelumab therapy (16 complete and 22 partial responses). Grade 3 adverse events during avelumab therapy were experienced by 11.8% of patients. Conclusions These findings demonstrate similar efficacy and safety of avelumab in a real‐world setting when compared to data from pivotal study. Trial Registration: KCRB registry number: RAVE‐Bladder
Hepatocellular carcinoma is the most common primary malignant neoplasm of the liver, accounting for more than 90% of cases. Before the introduction of targeted therapy, there were virtually no options for the treatment of unresectable HCC. Currently, sorafenib and lenvatinib are registered as first-line therapy for unresectable HCC. The introduction of the combination of atezolizumab and bevacizumab has significantly improved the results of HCC treatment. In the IMbrave 150 study, the median OS was 19.2 months in the atezolizumab and bevacizumab group and 13.4 months in the sorafenib group. The median progression-free survival was 6.9 and 4.3, respectively. The presented clinical observation describes a case of treatment of a patient with unresectable HCC, a large tumor burden and portal vein thrombosis. In the first line of therapy, we considered the combination of atezolizumab and bevacizumab. A rapid response to the therapy was obtained, a complete response was registered after 42 months of therapy with a combination of atezolizumab and bevacizumab. A minimum number of adverse events and satisfactory tolerability were noted. Currently, the patient continues therapy with this combination. Currently, an increasing number of patients receive therapy with atezolizumab and bevacizumab for a long time. Experience is accumulating in real clinical practice of monitoring patients who have been receiving a combination of immunooncologic and targeted drugs for a long time.
Background and Aims: In the global phase III HIMALAYA study in unresectable HCC, STRIDE significantly improved overall survival (OS) versus sorafenib; durvalumab was noninferior to sorafenib. Immune checkpoint inhibitor studies have shown an association between the occurrence of immune-mediated adverse events (imAEs) and improved OS. We assessed potential associations between the occurrence of imAEs and OS, and temporal patterns of imAEs, in HIMALAYA. Approach and Results: OS in participants who did and did not experience imAEs and the frequency and timing of imAEs were assessed for STRIDE and durvalumab in the safety analysis set of HIMALAYA. imAEs occurred in 139/388 (35.8%) and 64/388 (16.5%) participants with STRIDE and durvalumab, respectively; most were low grade. OS HRs (95% CI) in participants who experienced imAEs versus those who did not were 0.73 (0.56–0.95) for STRIDE and 1.14 (0.82–1.57) for durvalumab. The 36-month OS rate (95% CI) for STRIDE was 36.2% (28.1–46.7) and 27.7% (22.4–34.2) in participants who did and did not experience imAEs, respectively. The most common imAE category with STRIDE was endocrine events (16.5%). Most imAEs occurred ≤3 months after treatment initiation. Conclusions: Participants who experienced imAEs with STRIDE had a numerical improvement in OS versus those who did not, which was not observed for durvalumab. Long-term OS with STRIDE was observed regardless of imAEs. Most imAEs were low grade, manageable, and occurred in the first 3 months after treatment initiation. Results continue to support the benefits of STRIDE in a diverse population that reflects unresectable HCC globally.
Epithelial thymic tumors constitute a heterogeneous group of thymic neoplasms with diverse clinical behavior and underlying molecular genetic features. Thymic carcinomas are associated with a worse prognosis. They are much less common than thymomas, but are much more often invasive. Given the rarity and aggressive nature of thymic carcinomas, their optimal treatment remains an unsolved issue. The purpose of this review is to analyze research on the genetic profile of thymic tumors and its clinical significance.
Aim. To evaluate the early and long-term outcomes of multivisceral surgery for ductal adenocarcinoma of the pancreatic head. Materials and methods . Group 1 (main group) included 63 patients who underwent multivisceral surgery for ductal adenocarcinoma of the pancreatic head. Group 2 (control group) consisted of 442 patients with ductal adenocarcinoma of the pancreatic head who underwent standard pancreatoduodenectomy. Patients with stage IV tumors were excluded. Results. Immediate outcomes were comparable between the groups, except for a higher incidence of intra-abdominal abscesses in Group 1 (12.7% vs. 2.1%; p < 0.001). Postoperative mortality differed insignificantly (6.3% vs. 4.3%; p = 0.465). The median overall survival in Group 1 was 22 months compared to 33 months in Group 2, and the 5-year overall survival rates were 9.1% and 20.4%, respectively (p = 0.001). The frequency of adjuvant chemotherapy administration (p = 0.285) and the median number of chemotherapy cycles (p = 0.446) differed insignificantly between the groups. The 5-year overall survival among patients who received adjuvant chemotherapy was 13.3% in Group 1 and 19.4% in Group 2. The median overall survival in these groups was 30 and 35 months, respectively (p = 0.108). In Group 2, the median overall survival without neoadjuvant chemotherapy was 35 months, compared to 31 months with neoadjuvant chemotherapy (p = 0.411). Conclusion. Multivisceral resections involving pancreatoduodenectomy for ductal adenocarcinoma of the pancreatic head are associated with comparable immediate outcomes to standard pancreatoduodenectomy without adjacent organ resection. These outcomes are comparable only when the procedures are performed in specialized centers and when adequate adjuvant chemotherapy is administered; without it, survival rates following multivisceral surgery were significantly lower. Indications for multivisceral procedures require a personalized approach that takes into account all prognostic factors.
