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Background The impact of free triiodothyronine (FT3)/free thyroxine (FT4) ratio on survival in hospitalized geriatric patients was recently described. Up today, there are no data regarding the prognostic role of FT3/FT4 ratio in patients with advanced cancer. We evaluated the impact of FT3/FT4 ratio on survival in patients with refractory colorectal cancer (CRC) treated with regorafenib. Methods Patients with metastatic CRC treated with regorafenib with available clinical data and baseline measurement of FT3, FT4, and thyroid-stimulating hormone (TSH) were considered eligible. Exploratory analyses included subjects treated at Istituto Oncologico Veneto. A confirmatory analysis was planned based on FT3/FT4 ratio tertile results, and a validation cohort was built on data retrieved from University of Cagliari. Results In an exploratory cohort, the median overall survival in patients with low, intermediate, and high FT3/FT4 ratios, according to tertiles' value, was 4.8, 5.0, and 7.6 months, respectively (P = .003). The differences were significant in the multivariate model (hazard ratio, 0.43; 95% confidence interval, 0.28-0.68; P = .0003). Confirmatory results were obtained in a validation cohort, both in univariate (P = .0002) and in multivariate (hazard ratio, 0.56; 95% confidence interval, 0.36-0.88; P = .0118) models. Conclusions High baseline FT3/FT4 ratio is strongly associated to better outcome in patients with progressive metastatic CRC treated with regorafenib. Further investigations are ongoing to draw definitive conclusions regarding a potential predictive effect.

TPS3627Background: Based on available data, a reasonable upfront treatment for elderly mCRC pts is a fluoropyrimidine-based monotherapy plus bevacizumab, irrespectively of RAS status. Up today, dat...

733 Background: Few data are available on outcome of clinical practice unselected patients (pts) with mCRC. Methods: We retrospectively collected data of pts with mCRC followed at our Institution from January 2010 to December 2013 evaluating the clinical characteristics, treatments and survival outcomes. Results: A total of 584 pts were evaluated, 461 were followed at our Center while 123 were seen for a second opinion. Median age was 66 ys (25-94), 59% were male, 63% had an ECOG PS = 0 while 11% ≥2. 33% had right colon primary, 68% synchronous metastatic (mts) disease and 70% a single mts site. 81% underwent surgery on primary and 41% on metastases. 51% were RAS mutated (mut) and 5% BRAF mut. 57 pts didn't receive any systemic treatment, 33 due to frail clinical conditions and 24 due to radical surgical approach (R0). Among 404 treated pts, 239 received all 3 available cytotoxic agents (oxaliplatin, irinotecan, 5FU), 324 bevacizumab and 98 anti-EGFR; 153 (38%) were enrolled in clinical trials. Median overall survival (OS) was 27.6 months (mo) for the entire mCRC population, 3.7 mo for untreated frail pts, 28.7 mo for treated pts while it is still not reached for untreated R0 pts. OS was significantly longer for pts receiving first line combination therapy (29 vs 17 mo, p < 0.01) while a poor prognosis was confirmed for BRAF mut pts (p < 0.001). In a multivariate analysis age < 70, PS 0 and R0 surgery on mts disease showed a positive prognostic impact on OS while a right site of primary was a negative predictor of outcome. At logistic regression older age, low PS and peritoneal disease negatively affected the possibility to receive all 3 active drugs. Conclusions: Despite being an unselected population our outcomes are comparable with results of clinical trials in the corresponding period. We feel that such positive evidence derives from a personalization of treatment and a multidisciplinary approach to mts disease.

673 Background: Induction chemotherapy (CT) is a promising option in LARC. FOLFOXIRI + BV is an effective treatment in metastatic colorectal cancer. Methods: Patients (pts) with LARC at < 12 cm from the anal verge, N+ or cT4 or high risk cT3 (MRI criteria) underwent 6 cycles of FOLFOXIRI + BV followed by CRT (50.4 Gy + 5FU 225 mg/m2/day or capecitabine 800 mg/m2/bid 5 days/week + BV 5 mg/kg on days 1, 15, 28). Surgery was planned 8 weeks after CRT. Primary endpoint is 2-year disease-free survival (DFS). Results: From April 2012 to April 2015 48 pts were enrolled. At now, 46 pts completed induction CT, 43 completed CRT and 39 underwent surgery (5 pts ongoing). Pts characteristics were: median age, 53 years (range 30-74); cT2/cT3/cT4, 4%/60%/36%; cN0/N+, 4%/96%. Main grade (G) 3/4 toxicities during induction were neutropenia (42%), febrile neutropenia (4.2%), diarrhea (12.5. Two pts did not complete induction: one died due to bowel perforation and sepsis and one discontinued CT after acute kidney injury. Response rate (RR) after induction was 77%. Forty-five pts started CRT (1 pts underwent surgery after induction because of SAE). After the first 13 patients, protocol was amended and schedule of capecitabine modified due to an excessive rate of G3 toxicities during CRT: hand-foot syndrome (23%), proctalgia (23%), proctitis (23%) and diarrhea (15%). After amendment all pts completed CRT with acceptable toxicity: G3 proctitis 6.7% and proctalgia 3.3%. One pts died due to early progressive disease (PD) after CRT. RR after CRT was 88%. Surgery was low anterior resection 87%, abdomino-perineal resection 8%, other 5%. Radical resection was achieved in 95% of pts. Early post-surgical complication rate was 31%. Pathologic complete response was reached in 33% and pathological downstaging in 44% of pts. At a median follow up of 17 months, 8 pts had PD and estimated 2y-DFS is 72%. Conclusions: Induction CT with FOLFOXIRI + BV is feasible and highly active. A protocol amendment was needed due to toxicities during CRT. The rate of early post-surgical complications is not negligible. A longer follow up is needed for DFS. Clinical trial information: 2011-003340-45.