Our preliminary data demonstrate the potential usefulness of PET/CT for the assessment of patients with testicular tumour. It provides valuable information for the clinical management, particularly for clinical surveillance, post-therapy assessment and when relapse is suspected.
613 Background: NIVO showed an increased on OS in pre-treated mRCC. The introduction of metastasis SBRT could improve the clinical outcomes. NIVES Study evaluated the efficacy and safety of SBRT in combination with NIVO in II and III line of mRCC pts. Methods: This is a phase II, single arm, multicentre study in mRCC pts with PD after ≤2 prior anti-angiogenic therapies with measurable metastatic sites, and at least one suitable for SBRT. The pts received hypofractionated radiation in 1 lesion at dose of 10 Gy/3 fractions after 7 days from the first infusion of NIVO. NIVO is given as flat dose of 240 mg on day 1 every 14 days for 6 months, then 480 mg q4-weekly in responding pts until PD or unacceptable toxicity. The primary end point is ORR. Secondary endpoints are PFS, OS, ORR of irradiated and non-irradiated metastasis and safety profile. Results: 69 pts were enrolled from July 2017 to March 2019 in 12 Italian centers. Pt characteristics were: 79.7% clear cell histology, 82.6% males, 79.7%% IMDC intermediate/poor, median age 67 yrs (43-85), 18.8% third line, 21.7% non-nephrectomy. The most frequent sites of SBRT were lung (37.7%), lymphonodes (15.9%), bone (11.6%). At the time of this analysis, median number of NIVO doses received was 12 (1-32). The ORR was 19% (1 CR) and DCR 63.5% (no statistically difference between site of SBRT and ORR); the largest benefit in pts with clear cell histology (p=0.01). Median PFS was 4 months (95%CI, 2.8-7.1), median OS 22.1 months (95%CI, 18.1-NR). With a median follow-up of 15 months (0-25.6), 6-month and 9-month survival rates were 80.3% and 56.1% respectively. 7 pts (10.1%) discontinued treatment due to AEs; grade(G) 3-4 toxicities related to NIVO were experienced in 17 pts (24.6%). The most frequent G3-4 toxicities included diarrhea (5.8%), amylase/lipase increased (4.3%) and hypothyroidism (4.3%); no G3-4 toxicities related to SBRT. Conclusions: The NIVES Study represents the first prospective trial of NIVO and SBRT combination in pre-treated mRCC pts. At present the Study showed a high DCR and no-increase of toxicity. It is ongoing the analysis of correlation between efficacy and PD-L1 expression. Clinical trial information: NCT03469713.
In the coronavirus disease (COVID-19) pandemic, cancer patients could be a high-risk group due to their immunosuppressed status; therefore, data on cancer patients must be available in order to consider the most adequate strategy of care. We carried out a cohort study on the risk of hospitalization for COVID-19, oncological history, and outcomes on COVID-19 infected cancer patients admitted to the Hospital of Reggio Emilia. Between 1 February and 3 April 2020, a total of 1226 COVID-19 infected patients were hospitalized. The number of cancer patients hospitalized with COVID-19 infection was 138 (11.3%). The median age was slightly higher in patients with cancers than in those without (76.5 vs. 73.0). The risk of intensive care unit (ICU) admission (10.1% vs. 6.7%; RR 1.23, 95% Confidence Interval (CI) 0.63–2.41) and risk of death (34.1% vs. 26.0%; RR 1.07, 95% CI 0.61–1.71) were similar in cancer and non-cancer patients. In the cancer patients group, 89/138 (64.5%) patients had a time interval >5 years between the diagnosis of the tumor and hospitalization. Male gender, age > 74 years, metastatic disease, bladder cancer, and cardiovascular disease were associated with mortality risk in cancer patients. In the Reggio Emilia Study, the incidence of hospitalization for COVID-19 in people with previous diagnosis of cancer is similar to that in the general population (standardized incidence ratio 98; 95% CI 73–131), and it does not appear to have a more severe course or a higher mortality rate than patients without cancer. The phase II of the COVID-19 epidemic in cancer patients needs a strategy to reduce the likelihood of infection and identify the vulnerable population, both in patients with active antineoplastic treatment and in survivors with frequently different coexisting medical conditions.
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