S. Buti

Adjuvant low-dose interleukin-2 (IL-2) plus interferon-α (IFN-α) in operable renal cell carcinoma (RCC): a phase III, randomized, multicentre trial of the Italian Oncology Group for Clinical Research (GOIRC).

There is currently no standard therapy to reduce the recurrence rate after surgery for renal cell carcinoma (RCC). The aim of this study was to assess efficacy and safety of adjuvant treatment with low doses of interleukin-2 (IL-2)+interferon-&agr; (IFN-&agr;) in operable RCC. The patients were randomized 1:1 to receive a 4-week cycle of low-dose IL-2+IFN-&agr; or observation after primary surgery for RCC. Treatment cycles were repeated every 4 months for the first 2 years and every 6 months for the subsequent 3 years. The primary endpoint was recurrence-free survival (RFS); safety; and overall survival (OS) were secondary endpoints. ClinicalTrials.gov registration number was NCT00502034. 303/310 randomized patients (156 in the immunotherapy arm and 154 in the observation group) were evaluable at the intention-to-treat analyses. The 2 arms were well balanced. At a median follow-up of 52 months (range, 12–151 mo), RFS, and OS were similar, with an estimated hazard ratio (HR) of 0.84 [95% confidence interval (CI), 0.54–1.31; P=0.44] and of 1.07 (95% CI, 0.64–1.79; P=0.79), respectively in the 2 groups. Unplanned, subgroup analysis showed a positive effect of the treatment for patients with age 60 years and younger, pN0, tumor grades 1-2, and pT3a stage. Among patients with the combined presence of ≥2 of these factors, immunotherapy had a positive effect on RFS (HR=0.44; 95% CI, 0.24–0.82; P⩽0.01), whereas patients with <2 factors in the treatment arm exhibited a significant poorer OS (HR=2.27; 95% CI, 1.03–5.03 P=0.037). Toxicity of immunotherapy was mild and limited to World Health Organization grade 1-2 in most cases. Adjuvant immunotherapy with IL-2+IFN-&agr; showed no RFS or OS improvement in RCC patients who underwent radical surgery. The results of subset analysis here presented are only hypothesis generating.

Immunotherapy beyond progression in advanced renal cell carcinoma: a case report and review of the literature

Immunotherapy is associated with different response patterns compared with chemotherapy and targeted therapy, including delayed response and stabilization after progression (pseudoprogression). According to new immuno-based response criteria, immunotherapy can be continued after radiological progression when a clinical benefit is observed. We report a case of an advanced renal cell carcinoma patient treated with nivolumab,xa0who developed clinical benefit and delayed radiological response after initial progression. We performed a review of the literature on immunotherapy beyond progression in advanced solid tumors. 12 clinical trials were identified and showed that selected patients have subsequent response and survival benefit receiving immunotherapy beyond progression. Future studies are needed to optimize timing and duration of immunotherapy and to define patient selection criteria for treatment beyond progression.

827PRENAL METASTASES TO PANCREAS: DO NOT OPERATE ALL AND ALWAYS?

ABSTRACT Methods: Data from 19 Italian centers involved in the treatment of metastatic RCC were retrospectively collected. Kaplan-Meier and log-rank test methods were used to evaluate the overall survival (OS). Clinical variables considered were sex, age, concomitant metastasis to other sites, surgical resection of PM-RCC and time to PM-RCC occurrence. A subsequent univariate and backward multivariate Cox regression model was fitted to the data to correct for the effect of covariates. Results: 103 patients were enrolled in the analysis; 66 of them were males. Median age was 67 yrs (range 43–85 yrs). PM-RCC were synchronous in only 3 patients (3%). In 56 patients (54%), the pancreas was the only metastatic site, whereas in the other 47 patients lung (57%), lymph nodes (28%) and liver (21%) were the most common concomitant metastatic sites. Median time for PM-RCC occurrence was 9.6 yrs (range 0–24 yrs) after nephrectomy. Surgical resection of PM-RCC was performed in 40 patients (39%) and consisted of total (21%), distal (71%) or central pancreatectomy (8%). Median OS was not reached in patients who underwent surgical resection of PM-RCC and 11.1 yrs in the unresected patients (p Conclusions: The presence of PM-RCC is associated with long survival, which is surprisingly not associated with surgical resection, time of PM-RCC occurrence and the presence of concomitant metastases to other sites, although these data should be confirmed in a larger population. Disclosure: All authors have declared no conflicts of interest.