Recently, phase I studies with novel antibody drug conjugates targeting HER2 suggested benefit in HER2-low patients -defined as immunohistochemistry(IHC) +1 or +2 FISH/ISH non-amplified, with advanced breast cancer(BC). Data on the prognostic value of HER2-low in early stage disease is scarce. The purpose of this study was to evaluate the impact of HER2-low status on response to neoadjuvant chemotherapy(NACT) and survival outcomes in early stage HER2negative BC. MethodsRecords from all BC patients treated with NACT from January 2007 to December 2018 in a single cancer center were retrospectively reviewed. Primary objective was to compare differences between pathologic complete response(pCR) and relapse free survival(RFS) in luminal HER2-low/HER2-0 and triple negative(TNBC) HER2-low/HER2-0. Results855 non-HER2-positive patients were identified. Median follow-up was 59 months. 542 had luminal BC (63.4%) and 313 TNBC (36.6%). 285 (33.3%) were HER2-low. Among luminal tumors, 145 had HER2 IHC+1 (26.8%) and 91 IHC+2/ISH non-amplified (16.8%). In TNBC, only 36 had HER2 IHC+1 (11.5%) and 13 IHC+2/ISH non-amplified (4.2%). Among luminal/HER2-low and luminal/HER2-0 population, there was a high proportion of clinical T3/4 (61.5% vs 69.2%, p=0.053), node positive (74.2% vs 66.3%, p=0.27) and stage III tumors (63.1% vs 65%, p=0.51). The same was true TNBC/HER-low as compared to TNBC/HER2-0, despite a non-statistically significant higher cT4 among TNBC/HER-low (32.7% vs. 19.3%, p=0.17). pCR was 13% in luminal/HER2-low versus 9.5% in luminal/HER2-0 (p=0.27), and 51% in TNBC/HER2-low versus 47% in TNBC/HER2-0 (p=0.64). 5y RFS was 72.1% in luminal/HER2-low and 71.7% in luminal/HER2-0 (p=0.47), and 75.6% in TNBC/HER2-low versus 70.8% in TNBC/HER2-0 (p=0.23). HER2-low status was not associated with RFS in multivariate analysis (HR 0.83, 95%CI 0.6-1.11, p=0.21). ConclusionOur data does not support HER2-low as a biologically distinct BC subtype, with no predictive effect on pCR after NACT nor prognostic value on survival outcomes.

Modified FOLFIRINOX presents the same activity against MPA as standard FOLFIRINOX. We found no significant differences in toxicity, possibly due to patient selection and a higher dose reduction rate in the standard FOLFIRINOX arm. NLR stood as an important prognostic marker and further research is needed to comprehend its biological meaning in pancreatic cancer.

Background: Metastatic pancreatic adenocarcinoma (MPA) represents a highly lethal condition.Despite the improvements seen with FOLFIRINOX, there is no randomized data to guide treatment selection beyond this regimen. We aimed to evaluate the outcomes of patients with MPA progressing on FOLFIRINOX who were treated with Gemcitabine-based chemotherapy afterwards. Methods: We included patients aged 18 years or older, treated for MPA with FOLFIRINOX in the firstline setting and who experienced disease progression, with Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and treated with at least one cycle of Gemcitabine-based chemotherapy in second or further lines of treatment. We used descriptive statistics to characterize the study population and Cox proportional-hazards models to describe factors associated with survival. As an exploratory analysis, we compared the outcomes of patients treated with single-agent Gemcitabine with those of patients undergoing Gemcitabine-based polychemotherapy. Results: The study population consisted of 42 patients. Median age was 59 years and 78.6% of patients presented ECOG 0-1. Thirty-three patients (78.6%) were treated with Gemcitabine-based chemotherapy in the second-line setting and 27 patients (64.3%) were treated with single-agent Gemcitabine. Objective response rate and disease control rate were 2.4% and 33.4%, respectively. Median progression-free survival (PFS) and median overall survival (OS) were 2.9 and 5.5 months, respectively. Six-month PFS and OS rates were 19.2% and 46.2%, respectively. We observed no significant difference in OS according to the type of Gemcitabine-based chemotherapy, despite numerically improved disease control rate and PFS for those treated with Gemcitabine-based polychemotherapy. In multivariate analysis, ECOG 2 (vs. ECOG 0-1) was the only factor significantly associated with inferior PFS and OS.Conclusions: a subgroup of patients with MPA derives benefit from treatment with Gemcitabine-based regimens after FOLFIRINOX. There is a suggestion that Gemcitabine-based combinations, in particular Gemcitabine plus Nab-Paclitaxel, provide superior outcomes compared to single-agent Gemcitabine.Additionally, treatment in this setting should be offered carefully to patients with ECOG 2, as they present shorter survival and increased risk of toxicity.

Background: Tyrosine kinase inhibitors (TKI) and immunotherapy improved survival in metastatic renal cell carcinoma (mRCC). Disparities in treatment access are present in healthcare systems globally. The aim of this study was to analyze survival outcomes of mRCC patients treated with first-line TKIs in the public (PHS) and private (PrS) health system in a Brazilian Cancer Center. Materials and Methods: Records from all mRCC patients treated with first-line TKIs from 2007-2018 were reviewed retrospectively. Categorial variables were compared by Fisher's exact test. Survival was estimated by Kaplan-Maier method and survival curves were compared using the log-rank test. Prognostic factors were adjusted by Cox regression model. Results: Of the 171 eligible patients, 37 (21.6%) were PHS patients and 134 (78.4%) were PrS patients. There were no difference in age, gender, or sites of metastasis. PHS patients had worse performance status (ECOG ≥2, 35.1% vs. 13.5%, p=0.007), poorer risk score (IMDC poor risk, 32.4% vs. 16.4%, p=0.09), and less nephrectomies (73% vs. 92.5%, p=0.003) than PrS patients. Median lines of therapy was one for PHS versus two for PrS patients (p=0.03). Median overall survival (OS) was 16.5 versus 26.5 months (p=0.002) and progression-free survival (PFS), 8.4 versus 11 months (p=0.01) for PHS and PrS patients, respectively. After adjusting for known prognostic factors on multivariate analysis, PHS patients still had a higher risk of death (HR: 1.61, 95% CI: 1.01-2.56, p=0.047). Conclusion:Patients with mRCC treated via the PHS had worse overall survival, possibly due to poorer prognosis at presentation and less drug access.

Background: Pancreatic cancer plays an important role in cancer-related mortality.Few studies have been performed in Brazil to characterize patients affected by this disease. We aimed to describe the clinico-pathological characteristics and the survival of patients with pancreatic cancer seen at AC Camargo Cancer Center (ACCCC). Methods:We included patients ≥ 18-year old, with a histologically confirmed diagnosis of exocrine pancreatic cancer, that attended at least one visit at ACCCC from 2008 to 2016. Results:The study included 739 patients. Median age at diagnosis was 64 years. Most patients were male. About 5% presented a family history of pancreatic cancer. A total of 40% had diabetes and 51.4% presented with ECOG performance status 1. Tumors most often arose in the pancreatic head and roughly half of the patients had metastatic disease at presentation. Median overall survival of patients with potentially resectable disease submitted to surgery at ACCCC was 35.4 months.Median overall survival times of patients with the unresectable and metastatic disease were 14.1 and 9.3 months, respectively. Conclusions:The features of our population match those of studies done in developed countries. We believe multicentric data from patients with pancreatic cancer in Brazil could enable more effective preventive and therapeutic approaches to the disease. K E Y W O R D S cancer, epidemiology, features, outcomes, pancreas 1 | INTRODUCTION Pancreatic cancer represents an important cause of cancer-related morbidity and mortality. In 2015, pancreatic cancer was ranked 13thin cancer incidence worldwide. 1 In the same year, it was the 7th most common cause of cancer-related death, with 412 000 estimated deaths. Moreover, studies performed in developed countries have shown an upward trend in both incidence and mortality rates, and it J Surg Oncol. 2019;119:71-78.wileyonlinelibrary.com/journal/jso

588 Background: Data on 1st line treatment with tyrosine kinase inhibitors (TKI) in elderly patients(pts) with metastatic renal cell carcinoma (mRCC) is controversial, and there is rationale for inferior outcomes due to multiple comorbidities and polypharmacy. We aimed to compare the efficacy and safety between the elderly (E) and non-elderly (NE) in 1st line therapy, and to explore factors influencing survival and toxicity. Methods: We retrospectively reviewed all medical records of mRCC pts treated with 1st line TKI at our institution (2007 – 2018). Categorial variables were compared by Fisher’s exact test and continuous, Mann–Whitney. Survival was estimated by Kaplan-Maier method, prognostic factors adjusted by Cox regression model. Results: From 171 eligible pts, 64 (37.4%) had ≥ 65years old, with median age of 70.5 for E and 56 for NE. In both groups most were male, had clear cell histology, good/intermediate IMDC risk, prior nephrectomy and > 1 metastatic (mets) site. Sites of mets were evenly distributed. E pts had more diabetes (35.9 vs16.8%, p.009) , hypertension (67.2 vs 46.7%, p.01), cardiovascular disease (15.6 vs 6.5%, p.06), moderate/severe renal dysfunction (62.5 vs 28.8%, p < 0001), high Charlson Comorbidities Index (CCI≥3, 48.4% vs 20.8%, p < .0001), polypharmacy (34.4 vs15.9%, p.008), worst ECOG (≥2, 28.2 vs 12.3%, p.01), and a trend to worst nutrition (weight loss 35.9 vs 22.5%, p.07). Sunitinib was used for 60.9 vs 79.4%, Pazopanib 35.9 vs 18.7%, Sorafenib 3.1 vs 1.9%, comparing E and NE pts. Median overall survival (OS) and progression free survival (PFS) was 23.7 vs 25.6m (p.8) and 9.3 vs 10.9m (p.7), respectively. After adjusting for prognostic factors, age continues not to influence OS (HR 1.17, IC95 0.77-1.78, p.45). Grade (G) 3/4 toxicity was seen in 59.4 vs 53.3%, dose reduction in 54.7 vs 53.3% and suspension due to toxicity 25 vs 13.3% for E and NE, respectively. In the E, none of the comorbidities, CCI or polypharmacy impaired OS or toxicity, but pts using sunitinibe had greater G3/4 toxicity than with pazopanib (71.8 vs 39.1%, p.02). Conclusions: Elderly had similar outcomes to NE pts, despite greater comorbidities and polypharmacy, hence efficacious therapies shouldn’t avoided. Pazopanib seems to be safer in this subgroup.

644 Background: The introduction of tyrosine kinase inhibitors (TKI) and recently immunotherapy has brought major survival benefits for metastatic renal cancer (mRCC) patients (pts). In Brazil, there is no approved 2nd line treatment for mRCC in the Public Health System (PHS). Our center is unique, because it provides care for both PHS and Private System (PrS) population, enabling us to make the comparison of overall survival (OS) of these pts. Methods: We retrospectively reviewed medical records of all mRCC pts treated with 1st line TKI at our service from 2007 to 2018. Categorial variables were compared by Fisher’s exact test and continuous by Mann–Whitney. Survival was estimated by Kaplan-Maier method, prognostic factors adjusted by Cox regression model. Results: 171 pts were eligible, 37 (21.6%) PHS and 134 (78.4%) PrS pts. Between the two groups, there was no differences in age, gender, number and sites of metastasis (mets). PHS pts had worst ECOG (≥2, in 35.1 vs 13.5%, p .007), a trend towards more poor IMDC risk (IMDC favorable 16.2 vs 26.6%, intermediate 51.4 vs 57%, poor 32.4 vs 16.4%, p.09), had less nephrectomies (73 vs 92.5%, p.008) and more non clear cell histology (32.4 vs 12.7%, p.01). Median lines of therapy were 1 for PHS vs 2 for PrS pts (p.03). Sunitinib was the 1st line agent for 91.9 vs 67.2%, and pazopanib 8.1 vs 29.9%, of the PHS and PrS pts, respectively. Median time from diagnosis of mets to treatment start was 2.29 vs 1.79 m (p.59). Median OS was 16.5 vs 26.5 m (p.0002) and progression free survival, 8.4 vs 11 m (p.01), for the PHS vs PrS. On multivariate analysis, after adjusting for factors that were present before the beginning of treatment and were statistically significant for OS in the univariate model, PHS pts still had higher risk of death (HR 1.85, IC 95 1.2-2.9, p.01), probably due to having received fewer lines of therapy (≥2 lines of therapy vs 1, HR 0.51, IC95 0.4-0.7, p .001). Conclusions: Brazilian PHS pts had significant worse OS compared to PrS pts, in part due to less access to drugs. Access to cancer drugs is a challenge worldwide, and in Brazil effort has to be done to change this reality.

Background: Vitamin D deficiency is associated with various types of cancer, including breast cancer (BC), therefore interest has been increasing in recent years to address the role of vitamin D supplementation in cancer. Thus, we aimed to clarify whether successful vitamin D supplementation could predict improved survival in BC survivors after completion of adjuvant treatment.Methods: BC survivors who completed primary treatment for early stage BC were enrolled in the study. Patients' clinical features were recorded as follow: age, menopausal status, tumor features, including luminal types, pathological subtypes, and stage. Initial vitamin D levels of the patients and the median value of vitamin D after supplementation for patients who have insufficient vitamin D were noted. The patients were evaluated under four groups according to the vitamin D value at baseline and during follow-up. Log-rank statistics were used to compare survival distributions among groups.Results: In total, 635 patients were analyzed in this retrospective study. 123 patients (19.4%) had sufficient vitamin D levels at baseline (group 1). 512 patients (80.6%) had insufficient vitamin D levels; 225 patients (35.4%) reached sufficient vitamin D values after supplementation (group 3), 287 patients (45.2%) had remained in insufficient levels at follow up (group 2). While stage and vitamin D groups were independently prognostic for disease free survival (DFS), pre-perimenopausal status, triple-negative disease and vitamin D groups (for group 2) were independent prognostic for overall survival (OS).Conclusions: Vitamin D suplementation provide better DFS and OS for patients who have initially insufficient vitamin D. Even vitamin D supplementation, insufficient levels of vitamin D at follow up is still poor prognostic.Legal entity responsible for the study: Elif Isbilen.