e566 Background: Cabazitaxel is an approved second-line treatment in metastatic castration-resistant prostate cancer therapy with a significant survival benefit compared to mitoxantrone. There are few data about cabazitaxel's toxicity in patients not selected. Objective: Evaluate the efficacy and toxicity among younger (< 70 years) and older (> 70 years) population. Methods: We selected 62 patients with metastatic castration resistant prostate cancer treated in AC Camargo Cancer Center from January 2011 to July 2015. 58 patients fulfilled the study criteria: diagnosis of adenocarcinoma prostate cancer, at least one session of cabazitaxel, with more than 18 years old. Results: We had in our sample 33 patients less than 70 years and 25 over 70 years. The initial dose of cabazitaxel was 25 mg/m2 in 75.8% of patients < 70 years and 52% in > 70 years patients. The use of granulocytics growing factor was observed in 64% of the older patients and more than 80% of this indication was in primary profilaxis. There were five deaths associated to the treatment, 4 lung infection and 1 kidney failure. The worst grade of adverse event up to 30 days after last administration was grade 2, including hematological and non-hematological events, both with no statistical significance between the groups. However, there was a greater number of febrile neutropenia in elderly people (28% versus 6%) with a statistical significance between < 70 e > 70 years (p 0.031). OS was 13,7 months (IC 9.16 – 18.2) and PFS was 4,6 months (IC 3.43 – 5.73). OS among the two groups was lower in < 70 years reaching 9,3 months (IC 2.06-16.5) versus 22.2 months (IC 4.86-39.50 ), p= 0.073. As well, PFS in < 70 years was 3.8 months (IC 3.26-4.36) versus 4.6 months (IC 2.4-14.1), p = 0.02. Conclusions: Treatment with cabazitaxel is tolerable, with manageable adverse events in a real-world patient population. In our cohort, elderly population (> 70 years) had more febrile neutropenia, suggesting dose reduction in this population, indication of granulocytic growing factor as primary profilaxis, close monitoring, and adequate patient counseling.
525 Background: TKI have improved the prognosis of patients with mRCC, but rarely lead to durable response. Predictive clinical biomarkers have been studied in the last few years, but most are still controversial. Objective: Identify the role of the clinical and laboratorial biomarkers of prognosis and outcome in mRCC. Methods: A retrospective study with mRCC treated with VEGFR-TKi in first line at A C Camargo Cancer Center (Jan-07 to Apr-16). Studied biomarkers: induced hypertension (HTN), acquiried hypothyroidism, proteinuria, and neutrophil to lymphocyte ratio (NLR). Data were analized in relation to progression free survival (PFS), overall survival (OS), and objetive response rate (ORR) stratified by each marker. Results: We included 94 patients (76.6% sunitinib, 21.3% pazopanib, 2.1% sorafenib). Overall, ORR to VEGFR-TKI was 41.1%; clinical benefit rate was 82.1% (43% Stable disease). Median PFS was 11.4 months (mo)(CI 95% 8.7-14.1) and median OS was 32.1 mo(CI 95% 23.4-40.8). HTN was numerically associated with longer PFS (20.1 vs. 8.2 mo) and OS (37.2 vs. 28.2 mo), but not statistically significant. Only high level TSH (>10) was associated with significant longer PFS and OS, p=0.001 and p<0.001, respectively. There was no association between proteinuria and better outcome. Finally, NLR≥3 pre-treatment was independent prognostic factor, and NLR≥3 post treatment (12aweek) predicted poor OS (9.6 vs 33.9 mo). A “NLR conversion” (before ≥3, turn to <3) was associated with longer OS (28.2 vs. 11.6 mo, p=0.0012). Conclusions: TSH elevation is a good biomarker of better outcome in patients in treatment with TKI. NLR is an important inflamatory marker associated with shorter survival and NLR conversion can be an early biomarker of better outcome to mRCC patients in first line.
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