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This is a retrospective analysis on the safety and activity of compassionate Ipilimumab and Nivolumab (IPI-NIVO) administered to patients with metastatic Renal Cell Carcinoma (mRCC) with intermediate or poor International Metastatic RCC Database Consortium (IMDC) score as a first-line regimen. IPI was infused at 1 mg/kg in combination with Nivolumab 3 mg/kg every three weeks for four doses, followed by maintenance Nivolumab (240 or 480 mg flat dose every two or four weeks, respectively) until disease progression or unacceptable toxicity. A total of 324 patients started IPI-NIVO at 86 Italian centers. Median age was 62 years, 68.2% IMDC intermediate risk. Primary tumor had been removed in 65.1% of patients. Two hundred and twenty patients (67.9%) completed the four IPI-NIVO doses. Investigator-assessed overall response rate was 37.6% (2.8% complete). Twelve-month survival rate was 66.8%, median progression-free survival was 8.3 months. Grade 3 or 4 treatment-related adverse events occurred in 67 patients (26.9%). IMDC intermediate risk, nephrectomy, BMI ≥ 25 kg/m2, and steroid use for toxicities correlated with improved survival, while age < 70 years did not. IPI-NIVO combination is a feasible and effective regimen for the first-line treatment of intermediate-poor IMDC risk mRCC patients in routine clinical practice.

Purpose: Post-operative pain and swelling are frequently observed after sinus lift procedures. The aim of the present study was the clinical evaluation of swelling and pain of two different sinus flap lift techniques using a visual analogue scale (VAS), verbal rating scale (VRS), and infrared thermal imaging (i.e., thermography). Materials Methods : A randomized controlled trial was conducted with 15 patients (30 sinuses in total) randomly allocated into two groups. For the sinuses of Group I a trapezoidal flap was used, while for Group II a modified triangular flap without anterior release was utilized. Postoperative pain was scored by means of a 100-mm VAS ranging from 0 (no pain) to 100 (worst pain imaginable), and was recorded at 2, 4, 6 and 14 days after surgery. Swelling was recorded by a verbal rating scale (VRS) and was classified into four categories: a score of 1 referred the absence of swelling, patients with intra-oral swelling in the surgical zone scored 2, any extra-oral swelling in the surgical zone scored 3, and intense swelling exhibited by extra-oral swelling extending beyond the surgical zone scored 4. The facial temperature was recorded before and after sinus augmentation, and at 2, 4, 6, and 14 days post-surgery to check the course of healing. Results : In Group I pain intensity was recorded at 2 days after surgery with a mean score of 38.67 ± 6.4 mm. Swelling was greater at 2 and 4 days, and was absent at day 6. The facial temperature difference before and after the procedure was 4.737 &deg;C ± 0.37. In Group II the pain score were lower than in Group I ( p < 0.05). The score for swelling was 2 on the first and second days, and was reduced on day 4. After the second day the difference in temperature was significantly reduced as compared to the day of surgery (0.77 &deg;C); at 2 and 4 days no difference was registered. Conclusions : The results of this clinical study show the significant effectiveness of the modified triangular flap in the sinus lift procedure for reducing pain and swelling.