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5004 Background: Docetaxel (DOCE) is a standard of care in metastatic castration-resistant prostate cancer (mCRPC). Several retrospective cohort studies suggest a decrease in PC incidence and mortality with metformin (MET). MET has also demonstrated anti-tumor activity in PC preclinical models, with increase apoptosis when added to DOCE. The addition of MET could enhance DOCE efficacy in mCRPC patients (pts). Methods: TAXOMET is a phase II prospective multicentric randomized controlled trial. Non-diabetic mCRPC pts were assigned 1:1 to receive DOCE 75mg/m2 every 21 days + prednisone (P) 5 mg twice a day and either MET 850mg twice a day (arm A) or placebo (arm B), up to 10 cycles. The primary end point was PSA response rate (≥50% decrease). Main secondary endpoints included objective response rate (ORR, according to RECIST v1.1), clinical and biological progression-free survival (PFS), overall survival (OS), toxicity and quality of life (QoL). Comparisons between arm A and B were performed using Chi² test for qualitative data and Log-rank test for survival data. Results: From January 2013 to December 2015, 99 pts were randomized (50 pts in arm A and 49 pts in arm B) in 10 french centers, and 95 pts were evaluable. No difference was observed between arm A and arm B in PSA-response rate (72% in both arms), ORR (28% in both arms), clinical or biological mPFS (7.3 months vs 5.8 months p = 0.848) and mOS (24.2 months (95CI: 17.2 – 33.7) vs 19.7 months (95CI: 14.8 – 36.8), p = 0.53), respectively. There was no difference between arms in adverse events, except a trend for diarrhea to be more common with MET (70% in arm A vs 50% in arm B, p = 0.072), but few grade 3-4 events. There was no difference in QoL according to QLQ-C30 score between the two arms during the treatment period. Conclusions: This is the first prospective randomized controlled trial to evaluate the combination of MET with DOCE+P in mCRPC. The addition of MET has no meaningful clinical benefit in this setting. Clinical trial information: NCT01796028.

149 Background: There is no therapeutic consensus after failure of two drug lines for metastatic gastric adenocarcinoma. The theoretical benefit of a third-line chemotherapy has to be weighed with the potential toxicity it could generate. It is essential to have prognostic and predictive factors to better select the candidate patients for a 3rd line chemotherapy. Methods: The medical records of patients (pts) treated in our institute from 2008 to 2018 who received at least two chemotherapy lines have been retrospectively analyzed. The main objective was to look for prognostic factors after failure of two chemotherapy lines. The secondary objectives were to look for predictive factors of progression-free survival, global survival, and RECIST response in 3rd line. Results: Out of a total of 153 pts identified, 68 received at least 2 chemotherapy lines and were eligible for analysis (44%). A third line was initiated for 41 pts (27%). Overall survival from the date of failure of a 2nd line treatment was 4.4 months (95% CI: 3.2-6.2). The median of progression-free survival in 3rd line was 1.68 months (CI 95%: 1.5-3.5 months), 5% of the patients responded to the treatment. In multivariate analysis, a period of less than 12 months between the administration of the 1st line of chemotherapy and the failure of a 2nd line was associated with a Hazard Ratio (HR) for death of 2.7 (p < 0.001; 95% CI 1.44 – 5.1). Pts who did not receive a 3rd line and female patients had a HR for death of 3.7 (p < 0.001; CI 95%: 1,9–7.3), and 2.8 (p < 0.001; 95% CI: 1,3–5.8) respectively. For patients who started a 3rd line: a PS ≥ 2 increased the risk of progression by 4.05 (p < 0.001; 95% CI: 1.1–15.7). Conclusions: Nearly one-third of pts were able to receive a third line chemotherapy. However, the benefit of this chemotherapy is low given the RECIST response rate, and the short overall and progression-free survival medians. Our results suggest that the administration of a third-line chemotherapy should only be considered for pts with 12 months or older ongoing metastatic lesions and whose general health condition is unaltered.

497 Background: Recent reports demonstrate prognostic and predictive impacts of the location of the primary tumor in metastatic colorectal cancer (mCRC). Our retrospective analysis aimed to determine the influence of primary site on metastatic distribution and disease evolution. Methods: From our database all patients (pts) with mCRC (except transverse carcinoma) treated from 1/12/2007 to 1/12/2016 in our institution were collected. Univariate and multivariate analyses were performed to identify predictors of overall survival (OS). Results: A total of 284 pts with available data were analyzed: 83 with Right-sided Colon Cancer (RCC) (29%), 123 with Left-sided Colon Cancer (LCC) (43%) and 78pts with Rectal Cancer (RC) (28%). Hepatic, lung, lymph nodes and peritoneal metastases were respectively found in 63%, 36%, 23% and 20% of the population. The incidence or number of liver metastases were not influenced by sidedness (p = 0.06), LCC presented more bilobar involvement compared to RCC and RC (p = 0.017). Peritoneal carcinomatosis was significantly correlated to colon cancer (p = 0.002), whereas lung metastases were more common in RC (p < 0.001). Patients with RCC more often presented distal lymph node involvement (p = 0.008). RAS mutation status was known for 241pts (80%), of those 110 (37%) were RAS mutated with no significant differences between RCC, LCC and RC (p = 0.4), BRAF mutation (p = 0.007) was more common in RCC. On a multivariable analysis, primary tumor resection (PTR) and complete response after first line therapy were associated with a better OS but only a trend was observed for LCC and RC. Lung, lymph and peritoneal metastasis were associated with worse OS (Table). Conclusions: These results suggests that mCRC had different clinical presentation at diagnosis, the association with molecular features may explain the independent prognostic factor for OS of the sidedness. [Table: see text]

4120 Background: Treating metastatic pancreatic cancer (MPC) remains a challenging issue. Significant improvement was achieved recently by combining 4 drugs with Folfirinox regimen at the cost of i...

9511 Background: The purpose of this study is to analyse predictive factors of early death in older patients with cancer during 100 days after a geriatric comprehensive assessment (CGA) in order to...

4624 Background: Docetaxel monotherapy is active in hormone refractory metastatic prostate cancer. Pre-clinical models indicate a synergistic cytotoxicity between capecitabine and docetaxel. Recently, this association has proven survival benefits in advanced breast cancer. This multicenter phase II study reports on preliminary efficacy and safety data of docetaxel-capecitabine combination in hormone-refractory prostate cancer with metastases (HRPC). Methods: Eligible pts had histologically and biologically confirmed HRPC. Other requirements included a Karnofsky index of more than 50% and no prior chemotherapy except estramustine. Treatment consisted of 4 cycles of docetaxel 35mg/m2 on day 1, day 8, day 15 and capecitabine 1250mg/m2/day in 2 divided doses from day 5 to day 18 of each 28 days cycle. A minimum of 2 treatment cycles were required for response assessment. Biological efficacy was defined as a decline of >50% from baseline PSA levels. Clinical response was evaluated using RECIST criteria. Result...