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Patients with pathogenic germline and somatic variants in DNA damage repair (DDR) genes may derive greater benefit with platinum-based chemotherapy in metastatic pancreatic ductal adenocarcinoma (PDAC). This study investigates the role of DDR genes as a predictive biomarker for response to first-line platinum chemotherapy with FOLFIRINOX in metastatic PDAC patients. Demographic, clinical, and pathologic variables were collected for patients with metastatic PDAC who received FOLFIRINOX as frontline treatment and who had germline and somatic genetic testing. Kaplan-Meier analysis of overall survival (OS) and progression free survival (PFS) were correlated to the presence of DDR pathogenic variants. Forty patients with metastatic PDAC met inclusion criteria. Germline genetic testing revealed germline pathogenic variants in DDR genes in 5 patients (12%), and somatic pathogenic variants in DDR genes in 4 patients (10%). Median PFS was significantly longer in patients with any (germline or somatic) pathogenic variant in DDR genes than in those without alterations 18.5 vs. 6.9 months (log-rank P=0.003). When restricted to the presence or absence of germline pathogenic variants in DDR genes, the median PFS was 18.5 vs. 7.4 months (log-rank P=0.005). The median OS for the entire cohort was 11.5 months was not statistically different between the two groups, however there were no deaths in the subgroup with germline pathogenic variants in DDR genes treated with frontline FOLFIRINOX. A subset of patients with metastatic PDAC and germline or somatic pathogenic variants in DDR genes have a statistically superior PFS when treated with the platinum containing regimen FOLFIRINOX. The role of DDR gene alterations as a predictive biomarker for FOLFIRINOX benefit should be further evaluated in prospective trials.

Objective Treatment options for HER-2-positive metastatic breast cancer (mBC) patients have expanded markedly since trastuzumab approval in 1998. Several other regimens are now available, including pertuzumab plus trastuzumab plus docetaxel, T-DM1, capecitabine plus lapatinib, and trastuzumab plus lapatinib. This study assesses the cost-effectiveness of four treatment sequences for HER-2-positive mBC according to the Taiwanese National Health Insurance Administration (TNHIA). Methods Costs (U.S. Dollars) and effectiveness (quality-adjusted life years) of four treatment sequences for HER-2-positive mBC patients were examined using a Markov model over a lifetime horizon. Transition probabilities, disease progression, and probability of adverse events and survival were derived from clinical trial data. Costs and health utilities were estimated from TNHIA, Taipei Medical University Hospital, and the literature. Deterministic, probabilistic sensitivity analyses and a scenario analysis examined parameter uncertainty and accounted for drug wastage in dosage and cost calculations. Results Sequence 3 (1st line: trastuzumab plus docetaxel; 2nd line: T-DM1; 3rd line: trastuzumab plus lapatinib) was the most cost-effective sequence followed by sequence 1 (1st line: pertuzumab plus trastuzumab plus docetaxel; 2nd line: T-DM1; 3rd line: capecitabine plus lapatinib), and sequence 4 (1st line: trastuzumab plus docetaxel; 2nd line: trastuzumab plus lapatinib; 3rd line: trastuzumab plus capecitabine), respectively. The model was sensitive to costs and transition probabilities, but not particularly sensitive to the wastage assumption. Conclusions From the perspective of the TNHIA, trastuzumab plus docetaxel as 1st line followed by T-DM1 and trastuzumab plus lapatinib as 2nd and 3rd line represents the most cost-effective strategy among the four sequences considered for treating HER-2-positive mBC patients., Highlights • In health systems in which resources are scarce, treatment selection should be carefully considered to preserve efficiency. • We conducted a CEA of four treatment sequences for HER-2-positive mBC in Taiwan, accounting for intravenous drug wastage. • Results of such analyses can be useful to policymakers as they decide on coverage of expensive new anticancer treatments.

Despite the benefits of first and second generation anaplastic lymphoma kinase (ALK) inhibitors in the management of ALK-rearranged advanced non-small-cell lung cancer (NSCLC), the development of acquired resistance poses an ongoing dilemma. Brigatinib has demonstrated a wider spectrum of preclinical activity against crizotinib-resistant ALK mutant advanced NSCLC. The current review narrates a brief history of tyrosine kinases, the development and clinical background of brigatinib (including its pharmacology and molecular structure) and its use in ALK-positive NSCLC.

The present data article aims to describe the input parameters for a Markov model assessing the cost-effectiveness of four treatment sequences for patients with HER-2 positive metastatic breast cancer. The model input parameters include costs for physician visits, drugs, adverse event management, computed tomography (CT) scan, laboratory tests, echocardiogram, utilities, disutilities as well as the shape and scale parameters of a log-logistic distribution used for the transition probabilities. Keywords: Markov model, Metastatic breast cancer, Cost-effectiveness analysis, Treatment sequence

Background In Brazil, cancer is the second most common cause of death. Most patients in resource-limited countries are diagnosed in advanced stages. Current guidelines advocate for EGFR mutation testing in all patients with metastatic adenocarcinoma. Tyrosine kinase inhibitors are recommended in patients with advanced or metastatic disease harboring sensitizing mutations. In Brazil, there are limited data regarding the frequency of EGFR testing and the changes in patterns of testing overtime. Materials and Methods This was an observational, retrospective study. We obtained deidentified data from a commercial database, which included 11,684 patients with non-small cell lung cancer treated between 2011 and 2016 in both public and private settings. We analyzed the frequency of EGFR mutation testing over time. We also directly studied 3,664 tumor samples, which were analyzed between 2011 and 2013. These samples were tested for EGFR mutations through an access program to tyrosine kinase inhibitors in Brazil. Results Overall, 38% of patients were tested for EGFR mutations; 76% of them were seen in the private sector, and 24% were seen in the public center. The frequency of testing for EGFR mutations increased significantly over time: 13% (287/2,228 patients) in 2011, 34% (738/2,142) in 2012, 39% (822/2,092) in 2013, 44% (866/1,972) in 2014, 53% (1,165/2,184) in 2015, and 42% (1,359/3,226) in 2016. EGFR mutations were detected in 25.5% of analyzed samples (857/3,364). Deletions in Exon 19 were the most frequent mutations, detected in 54% of patients (463/857). Conclusion Our findings suggest that the frequency of EGFR mutation in this cohort was lower than that found in Asia but higher than in North American and Western European populations. The most commonly found mutations were in Exon 19 and Exon 21. Our study shows that fewer than half of patients are being tested and that the disparity is greater in the public sector. Implications for Practice These data not only indicate the shortage of testing but also show that the rates of positivity in those tested seem to be higher than in other cohorts for which data have been published. This study further supports the idea that awareness and access to testing should be improved in order to improve survival rates in lung cancer in Brazil.

The phase III MPACT trial for metastatic pancreatic cancer (PC) showed improved overall survival (OS), progression free survival (PFS) and response rates (RRs) for first-line nab-paclitaxel (Abraxane) and gemcitabine (the AG combination) compared to gemcitabine monotherapy. The safety and efficacy of the AG combination has not been systematically studied as second-line therapy or beyond for metastatic PC. We conducted an IRB-approved retrospective analysis of all patients diagnosed between September 2010 and August 2014 with advanced refractory PC that received combination treatment with AG at our institution. Demographic and survival data were extracted from the registry. Patients received nab-paclitaxel 125 mg/m2 and gemcitabine 1,000 mg/m2 and on days 1, 8 and 15 of a 28-day cycle with subsequent dose modifications based on tolerance. Data on 59 patients was available; the median age was 61; 55% were male; 56% received AG as second line therapy and 44% received it as third-line or beyond. Five (10%) patients had a confirmed partial response (PR), 23 (47%) had stable disease (SD) and 21 (43%) had disease progression as their best response. Among the 31 (52%) patients who received prior gemcitabine, 18 (58%) had clinical benefit; 3 had a PR and 15 had SD. The median OS was 3.9 months and the median progression-free survival was 3 months. Toxicity was similar to what was reported in the MPACT trial. This retrospective analysis suggests that AG is active in PC patients previously treated with either fluoropyrimidine-based therapy or gemcitabine-based therapy with manageable toxicities.

Introduction Haitians diagnosed with breast cancer in Haiti experience a significantly worse outcome than immigrants in Miami that appears to be related to 1) more advanced stage, 2) younger age, 3) more ER-negative tumors, and 4) lack of timely effective treatments including restricted access to trastuzumab and radiation. The objective of the study was to evaluate the epigenetic differences by DNA methylation between women of African descent who have breast cancer and are native to Haiti, the USA or who have emigrated from Haiti to the USA. Methods The study was IRB approved and conducted between 2017-2019 at University of Miami (n=50), Ministry of Health Haiti and Innovating Health International (n=35) and Moffit Cancer Center (n=14). DNA were extracted from saliva (DNAGenotek PrepIT-LP), FFPE breast tumor and normal adjacent breast epithelia (QIAmp DNA FFEP kit) when available. Reduced representation bisulfite sequencing was performed by BGI Inc (Cambridge MA) with EZ DNA metylation gold kit (Zymo) and followed by directional BS-sequence library preparation on HISeq x Ten, PE150. Data was processed in methylKit package and analyzed in a two-step filtering process to 1) include 200bp tiled regions to maximize CpG coverage, > 10 read coverage, 3 shared CpGs per group or all samples if the number of samples was less than 3 in the group, q Citation Format: Vincent DeGennaro, Kaliyah Brown, Danielle A Cerbon, Daniel Karl, Sofia Palacio, Jennifer Garcia, Camille Ragin, Tuya Pal, Susan Vadaparampil, Carmen Gomez, Judith Hurley, Sophia HL George. Short-term effects of immigration on the development of breast cancer in women of African descent [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr B086.

Esophageal cancer and gastric cancer are aggressive diseases for which treatment approaches are facing a new era. Some molecular pathways, such as VEGF, EGFR, fibroblast growth factor receptor, PIK3CA, and PARP-1, have been studied, and novel targeted drugs are presumed to be developed in the near future. From The Cancer Genome Atlas report, 80% of Epstein-Barr virus tumors and 42% of tumors with microsatellite instability have PIK3CA mutations, suggesting that this pathway could be reevaluated as a possible target for new systemic treatment of gastric cancer. Notably, higher PARP-1 expression can be found in gastric cancer, which might be related to more advanced disease and worse prognosis. In addition, PD-L1 expression, high microsatellite instability, and mismatch repair deficiency can be found in gastric cancer, thus suggesting that immunotherapy may also play a role in those patients. We discuss trends related to the potential of novel therapies for patients with esophageal and gastric cancers in the near future.

Pancreatic cancer is projected to become the second leading cause of cancer death in the United States by 2030. Deleterious germline mutations can contribute to pancreatic cancer susceptibility. Herein we report a case of a patient with metastatic pancreatic adenocarcinoma to the lung and liver who was found to have a deleterious germline mutation in RAD51C who had a remarkable response to chemotherapy with FOLFIRINOX, a platinum-containing regimen.

The phase III MPACT trial for metastatic pancreatic cancer (PC) showed improved overall survival (OS), progression free survival (PFS) and response rates (RRs) for first-line nab-paclitaxel (Abraxane) and gemcitabine (the AG combination) compared to gemcitabine monotherapy. The safety and efficacy of the AG combination has not been systematically studied as second-line therapy or beyond for metastatic PC. We conducted an IRB-approved retrospective analysis of all patients diagnosed between September 2010 and August 2014 with advanced refractory PC that received combination treatment with AG at our institution. Demographic and survival data were extracted from the registry. Patients received nab-paclitaxel 125 mg/m2 and gemcitabine 1,000 mg/m2 and on days 1, 8 and 15 of a 28-day cycle with subsequent dose modifications based on tolerance. Data on 59 patients was available; the median age was 61; 55% were male; 56% received AG as second line therapy and 44% received it as third-line or beyond. Five (10%) patients had a confirmed partial response (PR), 23 (47%) had stable disease (SD) and 21 (43%) had disease progression as their best response. Among the 31 (52%) patients who received prior gemcitabine, 18 (58%) had clinical benefit; 3 had a PR and 15 had SD. The median OS was 3.9 months and the median progression-free survival was 3 months. Toxicity was similar to what was reported in the MPACT trial. This retrospective analysis suggests that AG is active in PC patients previously treated with either fluoropyrimidine-based therapy or gemcitabine-based therapy with manageable toxicities.

266 Background: Germline genetic testing and somatic genomic profiling using commercial multigene panels are now routine in mPDAC. A subset of these patients have deleterious alterations in genes involved with DDR. Herein we investigate the role of daDDR as a predictive biomarker for response to first-line platinum-based chemotherapy. Methods: Utilizing the IRB-approved pancreas cancer and genetics clinic databases at the University of Miami, we identified all patients with mPDAC who had germline and/or somatic mutation testing. We performed a retrospective chart review to extract demographic and clinical characteristics including treatments received, response and survival. Results: Between 2012 and 2018, 116 patients with mPDAC underwent germline (using Invitae, Ambry Counsyl or Myriad) and/or somatic testing (using FoundationOne CDx). Among these, 40 received first-line therapy with FOLFIRINOX (95%) or gemcitabine/cisplatin (5%). The median age was 59 years and 15 (38%) were female. The majority (70%) were Hispanic and 63% had de-novo mPDAC (treatment-naïve). Germline testing revealed daDDR in 5 patients and somatic NGS found an additional 4 patients with daDDR (total of 9 (23%), including 5 with BRCA2, one each with BRCA1, RAD51C, ATM and MUTYH). The median progression-free survival (PFS) was significantly longer in patients with daDDR than without (17.3 vs 7.8 months, log-rank p = 0.01). The median overall survival (OS) was not statistically different between the two groups. Three patients with daDDR had complete or near-complete radiological and tumor marker responses to FOLFIRINOX and were treated with olaparib (a PARP inhibitor) as maintenance and remain progression-free after 7, 12.4 and 13.6 months respectively. Conclusions: daDDR appears to define a subset of patients with mPDAC who may be more sensitive to platinum agents. There are currently no biomarkers for selection of first-line therapy in patients with mPDAC and we demonstrate that this composite biomarker which is easily done via commercially available assays may be able to inform treatment selection.

More than 2 years after the identification and rapid global spread of a novel pandemic A/H1N1 influenza virus in April 2009 [1], there is still debate about the morbidity and mortality burden of this pandemic relative to that of past influenza seasons [2–5]. Quantifying the health burden of influenza is notoriously difficult because diagnostic tests are not conducted routinely, influenza rarely appears on medical records, and death can occur after secondary bacterial infection or exacerbation of comorbidities several weeks after the primary viral infection has subsided [6]. Despite a remarkable increase in laboratory testing during the pandemic, laboratory-confirmed influenza hospitalizations and deaths crudely underestimate pandemic burden [2, 7, 8]. Because of limitations in the identification of influenza as a direct cause of death, influenza-related mortality is traditionally estimated by applying statistical time series methods to broad death outcomes [9]. Age- and cause-specific excess mortality estimates generated by this approach are essential to capture the full burden of the A/H1N1 pandemic and compare its impact with that of previous seasons. Preliminary estimates suggest that this pandemic was relatively mild, especially in Europe [2–5, 10–12]. Available mortality estimates lack precision, however, because they rely on laboratory-confirmed deaths [2, 5, 13] or on nonspecific mortality indicators [4, 10, 12] or concentrate on geographically limited areas [11, 12] that may not be representative of larger populations because of geographic heterogeneity in pandemic transmission dynamics [13]. To compare the mortality burden of the pandemic with interpandemic influenza seasons, it is important to consider the different texture of mortality resulting from the shift of pandemic-related deaths toward younger age groups [14–16]. This can be captured by applying the years of life lost (YLL) approach [3, 17–20]. Here, we use detailed cause- and age-specific vital statistics and viral surveillance data from Mexico to compare the mortality and YLL burdens of the A/H1N1 pandemic with those during seasonal epidemics during 2000–2008. Furthermore, we compare pandemic excess mortality estimates with those from laboratory-confirmed influenza death reports and discuss the implications of our findings for pandemic surveillance and control.

e18002 Background: Lung cancer is the leading cause of cancer death worldwide. In Brazil, cancer is the second most common cause of death and there were an estimated 27,330 new cases of lung cancer in 2014. Targeted therapies have changed disease prognosis and current clinical guidelines advocate for EGFR/ALK molecular testing for all patients with advanced-stage lung adenocarcinoma. Access to this testing is often limited in the developing world. In the case of Brazil, there is limited data regarding the frequency of testing and the changes in patterns of testing overtime. Methods: De-identified data was obtained from a commercial database that surveys approximately 2,000 cancer physicians in Brazil regarding practice patterns. On average 300 physicians responded to the survey, which is conducted every 6 months, and provided information on about 18,000 patients. Subsequently, we identified patients with lung cancer and calculated the frequency of testing for EGFR mutations and ALK rearrangement from 2011 to 2016. Results: 11,684 patients with lung adenocarcinoma were analyzed from 2011 to 2016. The frequency of testing for EGFR mutations increased significantly: 12.8% (287/2,228) in 2011, 34.4% (738/2,142) in 2012, 39.2% in 2013 (822/2,092), 43.9% in 2014 (866/1,972), 53.3% (1165/2,184) in 2015, and 58% (626/1,066) for the first semester of 2016. Testing for ALK rearrangement also increased noticeably over the same period: 0% in 2011 (0/2,228) and 2012 (0/2,142), 0.9% (19/2,092) in 2013, 2.99% (59/1,972) in 2014, 5.5% (121/2,184) in 2015, and 4.8% (52/1,066) for the first semester of 2016. Conclusions: To our knowledge this is the largest data analysis regarding changing practice patterns of molecular testing for lung adenocarcinoma over time in Brazil and Latin America. The frequency of testing for EGFR mutations and ALK rearrangement has increased over the last 5 years but is still below the current guidelines recommending that all patients with advanced disease be tested. Further understanding of the barriers to testing, will hopefully lead to national strategies for universal implementation of molecular testing.

355 Background: Pancreatic adenocarcinoma (PDAC) is now the third leading cause of cancer death. Surgical resection followed by adjuvant chemotherapy has been the standard of care. Due to the significant risk of morbidity following pancreatic surgery, initiation of adjuvant chemotherapy is often delayed. Prior prospective adjuvant trials have suggested that adjuvant therapy can be initiated as late as 12 weeks without detriment, but data regarding the effectiveness of beginning adjuvant therapy beyond that time remains unknown. Methods: We retrospectivelyreviewed data from the National Cancer Data Base (2004-2014) and included adult patients (pts) with PDAC with pathologic stage I-IIB who underwent surgical resection with curative intent. The primary outcome was overall survival (OS) based on time to adjuvant chemotherapy post-surgery as defined by postoperative weeks. Data were analyzed using Cox proportional hazard model and Kaplan-Meier survival curves. Results: 5279 pts. had surgery alone and 4,537 pts. received adjuvant chemotherapy. The median age was 64 years. 52% were male, 88% were white, 46% were treated at comprehensive community cancer centers. The primary surgical approach was whipple procedure in 61% of pts. 63% pts. received single agent chemotherapy and the mean time from surgery to chemotherapy was 61 days. Adjuvant chemotherapy was associated with improved OS irrespective of disease stage compared to those undergoing surgery alone (median OS for surgery alone 14 months vs adjuvant chemotherapy 21 months, p < 0.001). Cox proportional hazard model controlling for stage, surgical technique, lymph node dissection and margin status revealed improved OS in pts. receiving adjuvant chemotherapy. No significant differences in OS were seen for pts. starting adjuvant chemotherapy at 3, 6, 9, 12, 16, 20 or 24 weeks after surgical resection. Conclusions: Current guidelines recommend initiation of adjuvant chemotherapy prior to 12 weeks after pancreatic resection. Initiating adjuvant chemotherapy even up to six months post-operatively improves OS compared to those undergoing surgery alone. Our data supports the use of adjuvant chemotherapy if indicated regardless of time of surgery.

There is no standard chemotherapy regimen that is universally accepted for the treatment of advanced gastric cancer. Trastuzumab added to chemotherapy improves survival in patients with metastatic human epidermal growth factor receptor-2 (Her2/neu)-overexpressing gastric cancer. Data are lacking for the combination of trastuzumab with other chemotherapy regimens, apart from the cisplatin/fluorouracil backbone used in the pivotal TOGA trial.In this retrospective analysis, we included patients with gastric cancer with HER2 overexpression who received trastuzumab in addition to their first-line chemotherapy, with or without trastuzumab maintenance therapy. The end-points were response and tolerance to treatment.We identified seven patients who met the search criteria; six had metastatic disease and one had locally advanced unresectable disease. Four patients received epirubicin/oxaliplatin/capecitabine/trastuzumab, and the others had non-anthracycline-based chemotherapy with trastuzumab. All patients had radiological responses to treatment - one had a complete response and six had partial responses. Among the four patients who received anthracycline-based chemotherapy with trastuzumab, there was a transient decline in cardiac ejection fraction in three, but all resolved without sequelae. All patients received a period of chemotherapy induction followed by trastuzumab monotherapy for maintenance. The median progression-free survival was 14.6 months and median overall survival was 16.4 months.Trastuzumab is an important agent for the treatment of HER2-overexpressing gastric cancer. We recorded an acceptable safety and efficacy profile in this small cohort treated with anthracycline-based chemotherapy with trastuzumab followed by trastuzumab maintenance.

e15744Background: The mean age at diagnosis of PAC is 71. However, many apply age rather than performance status and organ function to decide therapy. Additionally, the elderly are underrepresented...

225 Background: Surgical resection is the only potentially curative modality for PDAC. However, even after a successful surgical resection outcomes are poor due to both local and distant disease recurrence. Patients with early recurrence likely derive no benefit from surgery and could be considered for a non-surgical approach as initial therapy. Since the incidence of recurrent/metastatic disease at first post-operative staging scan is not well documented, our aim was to determine this incidence. Methods: This IRB-approved analysis identified all pts diagnosed with resectable PDAC that underwent surgery with intent to cure at the University of Miami/Sylvester Comprehensive Cancer Center between 2010 and 2012. Patients with imaging before and within 6 months after surgery were included. All post-operative CT scans performed within 3 months after surgery were reviewed for the presence of recurrent and/or metastatic disease. Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method. Results: Data from105 pts were analyzed. Mean age was 61, 63% were male, 91% had adenocarcinoma, 84% had disease in the head of the pancreas. 11 out of 85 (13%) pts had recurrent/metastatic disease detected on first post-operative CT scan; 64% stage IIB and 73% had positive lymph nodes. 54 out of 105 (51%) had disease progression. 60% had local recurrence, 40% had distant metastasis. The mean time from preoperative CT scan to surgery was 35 days. Patients with early and late recurrence had similar OS from diagnosis (median 27.7 and 27.1 months, respectively) but worse than those with no disease recurrence (median not reached, OS rate 78% at 36 months). Conclusions: The relatively high incidence (13%) of early recurrence in this retrospective cohort suggests that further studies aimed at improving patient selection for surgery are warranted and provides a strong rationale for the use of neoadjuvant therapy to select patients with early disease progression who would not have benefitted from surgery.

Mortality due to cervical cancer (CC) has decreased in developed countries given extensive screening and effective coverage. In developing countries mortality rates due to CC remain high. Since the mid-nineties there has been a decrease in mortality due to CC in Mexico, which can be attributed to the increase in coverage of the Papanicolaou (PAP) (beta -.195, IC95% -.274, -.117) and the decrease in the birth rate (beta -.407, IC95% -.632, -.182). The use of the PAP in conjunction with an HPV test within the early CC detection program would have a synergistic effect; HPV testing should be combined with the Pap test. Primary prevention of CC is possible with the HPV vaccine. This vaccine will be an additional tool for reducing CC-related morbidity and mortality, but will not replace screening and treatment. To adopt a prevention policy that includes an HPV vaccine we will need to: determine the burden of HPV-related disease; have sufficient epidemiological evidence and data about technical aspects of the vaccine; take into account the psyschosocial and ethical aspects of the vaccine and guarantee good organization of vaccine implementation.

Cáncer cervicouterino Enfermedades Mujeres Perspectiva de género

413 Background: The combination of nab-P and Gem improves survival compared to Gem alone in first-line therapy of metastatic pancreatic cancer. Efficacy data with this doublet in previously treated pts are scant. Our group presented preliminary results on 10 pts treated with this two-drug combination in the second and third line setting and herein present updated data on 59 pts. Methods: This IRB approved analysis identified all pts diagnosed with advanced refractory pancreatic cancer, treated with second-line Gem and nab-P at University of Miami and Sylvester Comprehensive Cancer Center between September 2010 and June 2014. Response by RECIST, CA19-9, and symptomatic improvement were assessed. Progression-free survival (PFS) and overall survival (OS) were calculated from the start of Gem + nab-P and were analyzed using the Kaplan-Meier method. Clinical benefit was defined as the percentage of patients with a partial response (PR) or stable disease (SD). Results: Data from59 pts were analyzed. The median age was 60; 55% were male; 54% received Gem + nab-P as second line therapy and 46% received it as third-line or beyond. Five (10%) pts had confirmed PR, 23 (47%) SD and 21 (43%) progressed. Among the 31 (52%) pts who received prior Gem, 18 (58%) had clinical benefit, 3 PR and 15 SD. The median OS was 3.9 months. The median PFS was 3 months. Toxicity appears similar to what has been reported on the MPACT trial with the combination. Conclusions: The clinical benefit seen withGem and nab-P in this group of pretreated pancreatic cancer pts suggests that it can be considered as an option. Additionally, prior Gem treatment appears not to decrease Gem and nab-P benefit in this population. Since nab-P monotherapy has modest activity in pre-treated pancreatic cancer pts, our data suggests a positive interaction between Gem and nab-P that may overcome resistance to Gem. [Table: see text]

373 Background: There is no standard chemotherapy regimen for PC patients who have progressed on G and fluoropyrimidine-based therapy. Single agent nab-P had limited activity on a second-line phase II trial in PC. Synergistic preclinical studies with G and taxanes have been reported. Nab-P targets stromal cells and leads to improved delivery of chemotherapy to PC cells. The combination of G + nab-P might be an effective approach in pretreated PC. Methods: A retrospective analysis of advanced refractory PC patients treated from Sep 2010 to Aug 2011 with the combination of G + nab-P was performed at the Sylvester Comprehensive Cancer Center. Patients received G 1000mg/m2 and nab-P 100mg/m2 on D1, 8 and 15 of a 28 day cycle. Treatment response was assessed by review of imaging studies using the RECIST criteria, CA19-9 response and symptomatic improvement. The progression-free survival (PFS) and overall survival (OS) were calculated from time of commencement of G + nab-P until documented progression or death respectively. Results: 10 patients were treated with G + nab-P; 60%, 30% and 10% of patients had received 3, 2 and 1 prior chemotherapy regimen. 90% and 80% received prior G or fluoropyrimidine-based regimen respectively. Therapy was discontinued in one patient following only one dose of G + nab-P (Cycle 1, day 1) due to grade 2 thrombocytopenia. The remaining 9 patients received a median of 4 cycles. Two (22.2%) patients had confirmed PR, 3(33.3%) patients had confirmed stable disease while 4 (44.4%) patients progressed on therapy. The median PFS was 13.7 weeks. The median PFS was 20 weeks in patients with PR or SD and 9.9 weeks in patients with PD. Recurrent malignant ascitis resolved in a patient with peritoneal carcinomatosis. Treatment was well tolerated; grade 3-4 hematologic toxicity included anemia, thrombocytopenia and neutropenia in 2, 1 and 2 patients respectively. 70% of patients required G-CSF support. Non hematologic Grade 3-4 toxicities included fatigue, peripheral neuropathy; nausea and vomiting in 3, 2 and 1 patient respectively. Conclusions: G + nab-P resulted in clinical benefit in half of this group of advanced PC patients who had previously progressed on G and fluoropyrimidine-based regimens.