Bone biomarkers for overall survival in men with castration-resistant prostate cancer

According to a recent study, in newly diagnosed metastatic prostate cancer, high levels of bone turnover biomarkers are linked with a shorter lifespan, which are strongly prognostic for overall survival (OS). This study was published in the journal, European Urology.

This phase 3 study evaluated bone biomarkers in hormone-sensitive prostate cancer (HSPC) of 1279 men, out of which 949 had evaluable baseline bone biomarkers. The patients were randomly divided into training (n=316) and validation (n=633) sets. Cox proportional hazard models and recursive partitioning were employed. Bone resorption and bone formation markers were assessed from patient sera.

At the end of the study, it was found that after adjusting for clinical risk factors in the validation set, increased bone biomarkers were statistically significantly associated with an increased risk of death. As for the training set, three risk groups were identified with differential OS outcomes, after recursive partitioning algorithms were applied. The validation set confirmed these results.

Thus, it can be concluded that bone biomarkers may strongly and independently be prognostic for OS in men with HSPC initiating androgen deprivation therapy. These bone biomarker levels alone or in combination with clinical covariates, may help identify unique subsets of men with differential OS outcomes. In conclusion, high levels of bone turnover biomarkers are associated with a shorter lifespan in men with HSPC.

Overall survival and progression-free survival of subgroups with avelumab first-line maintenance for advanced urothelial carcinoma

A recent study suggests that avelumab maintenance treatment was found to help advanced urothelial carcinoma (UC) patients who did not show disease progression after having at least four cycles of prior chemotherapy and were on maintenance treatment at least 4 weeks after the chemotherapy, to live longer. This study was published in the journal, European Urology.

The JAVELIN Bladder 100 was a phase 3 trial in which 700 patients with advanced UC were included who did not show disease progression after 4-6 cycles of chemotherapy. They were randomized to receive either avelumab + Best Supportive Care (BSC) or BSC alone. Subgroups were defined according to quartile duration (Q), estimated chemotherapy cycles, and the interval between maintenance and chemotherapy. The duration of median follow-up in both arms was >19 mo. The primary endpoint of the study was overall survival (OS); additionally, progression-free survival (PFS) and safety were also assessed.

After the study was over, it was observed that the hazard ratio for OS with avelumab + BSC versus BSC alone were by chemotherapy duration- <Q1: 0.65, Q1-Q2: 0.79, Q2-Q3: 0.74, and >Q3: 0.63. By number of cycles-4 cycles: 0.69, 5 cycles: 0.98, and 6 cycles: 0.66 while by interval -4-<6 wk: 0.75, 6-<8 wk: 0.67, and 8-10 wk: 0.69. Similarly, PFS and safety showed similar results across subgroups.

It can be concluded that OS and PFS in subgroups may be generally consistent in the overall population and with similar safety findings. Thus, avelumab maintenance treatment helped patients with advanced UC to live longer.

High-dose vitamin D supplementation well-tolerated and effective in managing overactive bladder dry in children

According to a recent study, high-dose vitamin D supplementation (VDS) plus standard urotherapy (SU) is safe and efficacious in managing overactive bladder dry in children. This study’s findings were published in The Journal of Urology.

This 3-arm, randomized clinical trial included 303 pediatric patients. Out of these, 100 children were randomized to receive 8 weeks of high-dose VDS, which consisted of vitamin D3 drops encapsulated as soft capsules, 2400 IU/d, plus SU (VDS + SU group). The other groups were administered 5-10 mg/d of solifenacin plus SU (SOL + SU group; n=102), or SU alone (SU group; n=101). The primary outcome of the study was reduction in voiding frequency. Secondary outcomes included nocturia, quality of life score, improvement in urgency, participant satisfaction, and pediatric lower urinary tract symptom score. Also, the treatment-related adverse events were recorded for each group.

It was observed that the VDS + SU group showed greater improvements in voids/d than the SOL + SU group and the SU group post intervention. The greatest improvement in quality of life and pediatric lower urinary tract symptom scores was also seen in the VDS + SU group. Both the SOL + SU and SU groups showed similar patient satisfaction. The VDS + SU group did not exhibit an increased risk of treatment-emergent adverse events as found in the other groups.

Based on the above results, it can be concluded that high-dose of VDS plus SU, when given to children for managing overactive bladder dry, may be effective and well-tolerated and hence, may be used as a novel therapeutic option.

Lenvatinib plus pembrolizumab shows improved efficacy and overall survival in patients with advanced renal cell carcinoma

A recent study suggests that lenvatinib plus pembrolizumab shows improved efficacy and overall survival (OS) in specific subgroups of patients with advanced renal cell carcinoma(RCC). This study was published in the journal, European Urology Oncology.

The CLEAR trial was a phase 3, open-label, multicenter, randomized study that included 1069 patients who were randomized in a 1:1:1 ratio. The participants received either 20mg orally once a day of lenvatinib plus 200mg pembrolizumab intravenously once every 3 weeks, lenvatinib plus everolimus, or 50 mg sunitinib taken orally once daily for a period of 4 weeks and subsequently no treatment for 2 weeks. The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk subgroup analyzed progression-free survival, duration of response and objective response rate (ORR).

It was found that the patients administered with lenvatinib plus pembrolizumab with a confirmed complete response or >75% target-lesion reduction by 6 months showed an OS of ≥91.7% at 24 months. Compared to sunitinib, lenvatinib plus pembrolizumab showed longer median progression-free survival and a higher ORR. Based on the above results, it can be concluded that lenvatinib plus pembrolizumab may provide improved efficacy and better survival than sunitinib in patients with advanced RCC.