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Abstract Abstract 2682 Background: The PI3K-Akt pathway is critical to tumor growth in lymphoid malignancies and mTOR inhibitors have shown promising activity in lymphoid malignancies. However, alternate signaling pathways allow cells to escape the effect of mTOR inhibition. Pre-clinical studies have shown that the combination of LBH589, an HDAC inhibitor, with the mTOR inhibitor RAD001 results in potent synergy. We then explored this combination in a phase I/II clinical trial. Patients and Methods: Patients with relapsed multiple myeloma (MM), non-Hodgkin lymphoma (NHL) or Hodgkin Lymphoma (HL) were enrolled into a phase I trial of escalating doses of LBH589 and RAD001. The doses are shown in the table. The study utilized a 3+ 3 design with MTD defined as the maximum dose resulting in less than 2 dose limiting toxicities (DLT) during the first cycle among 6 patients treated at that dose. DLT was defined as a grade 4 neutropenia or thrombocytopenia lasting >= 7 days, febrile neutropenia or any other grade >=3 non-hematologic toxicity considered possibly related to the drugs. Once MTD was determined, patients were enrolled into two separate phase 2 studies, one for relapsed MM and another for relapsed NHL or HL. Results: Twenty-six patients were enrolled to the phase 1 study; 23 were eligible for MTD analysis. There were 16 patients with NHL, 4 with HL and 3 with MM. Median age was 61 (range, 24–73) and 17 were male. The median number of prior therapies was 4 (range 2–11), including a prior stem cell transplant in 11 (48%). No DLT was observed at any of the doses tested in the trial (See below). Hematological toxicities were the most common AEs observed, with a grade 3 or 4 hematologic AE in 15 patients and grade 3 or 4 non-hematologic AEs in 6 patients across all cycles administered. Grade 3 and 4 hematologic AEs included 10 patients with neutropenia and 8 patients with thrombocytopenia. Grade 3 and 4 non-hematologic AEs included hyperglycemia, hypertriglyceridemia, hypophosphatemia, diarrhea, pneumonia and mucositis in one patient each. Overall, 10 responses (43%) were seen (Table). Conclusions: The combination of LBH589 and RAD0001 is tolerated at the doses tested, with hematological toxicities being the most common adverse events. The recommended phase II dose is LBH 40 mg MWF every other week along with 5 mg RAD001 every day in 4-week cycles. Clinical efficacy was seen in all diseases tested with partial responses seen in NHL and HL as well as a minor response in a patient with refractory myeloma, who had previously failed single agent RAD001. Phase 2 trials are ongoing in both disease groups. Disclosures: Kumar: Merck: Consultancy, Honoraria; Celgene: Consultancy, Research Funding; Millennium Pharmaceuticals, Inc.: Research Funding; Genzyme: Research Funding; Novartis: Research Funding. Off Label Use: Use of the investigational agent MLN9708 for the treatment of previously untreated multiple myeloma. Lacy:Celgene: Research Funding. Reeder:Celgene: Research Funding; Millennium Pharmaceuticals Inc.: Research Funding; Novartis: Research Funding.

Abstract Background: Patients diagnosed with cancer experience a significant influx of health care information while continuing to demonstrate understanding deficit regarding their disease and health. This knowledge deficit can negatively impact a patient’s acute and long term health care experience. By identifying patient information deficits and needs, health care providers may be better able to provide targeted education to patients and families. Aims: The aim of this study is to evaluate the impact of a patient centered cancer symposium on knowledge level, reported symptom burden, and desired information from a broad population of cancer patients. Methods: Surveys were distributed to the attendees of the third annual Mayo Clinic “Living with Cancer” patient symposium in January 2014. While 700 individuals registered for the event, only individuals with a past or present cancer diagnosis were asked to participate. Surveys included demographic data in addition to a questionnaire evaluating disease comprehension, symptom burden, desired information and desired role in the health care decision making process. Results: 75 patients completed the pre-intervention and post-intervention survey. There were slightly more female participants (60.2%). Disease types included 40% hematologic malignancies, 27% breast cancer, 20% prostate cancer and 13% other. The majority of patients were greater than 3 years from cancer diagnosis (62%). Baseline Patient Understanding: Most respondents reported understanding their disease quite a bit (54%) or very much (30%). Respondents reported the majority of their knowledge regarding their disease came from their oncologist (56%), oncology nurse (24%), previous symposiums (22%), or the internet (15%). Most respondents reported “quite a bit” or greater comprehension of screening tests (75%), monitoring disease response to treatment (70%), monitoring disease recurrence (70%), treatment options (67%) and treatment side effects (73%). There was no consensus among participants regarding understanding or limiting risk factors, symptoms associated with disease relapse, fatigue and pain management, navigating the health care system, financial considerations, or confidence in their primary care physician’s involvement in their cancer or post-cancer care. A large proportion of attendees reported “quite a bit” or greater desire for increased information/understanding regarding their disease (83%), risk factors (83%), nutrition (80%), screening tests (69%), and management of fatigue (69%) and stress (68%). Knowledge Improvement Durable at 3 months: There was improvement in 18 of 20 areas of self-reported knowledge. This was noted in increased percentage of respondents reporting “quite a bit” or greater comprehension, especially in areas of disease risk factors(55%pre vs 63%post), disease side effects(55%pre vs 63%post), and health care navigation(53%pre vs 69%post). The reported desire for “quite a bit” or more increased understanding on various topics did decrease post symposium regarding their disease(87.9% pre vs 68.9%post), disease risk factors(86.3%pre vs 64.0%post), screening tests(74.7%pre vs 63.3%post), and nutrition(78.4%pre vs 64.9%post)(all p<0.05). There was no significant decrease in the desire for increased understanding managing stress and fatigue. Summary: Demonstrated in this study, individuals choosing to attend a patient-centered cancer symposium, seek to improve an already solid knowledge base. Study participants indicate a significant desire for increased information on all topics, even those with sufficient level of knowledge reported. This indicates that some cancer patients’ thirst for knowledge is difficult to quench, and may benefit from recurrent education opportunities. The improvement in almost all topics assessed indicates a patient centered symposium is an effective method to provide information to patients regarding the spectrum of cancer health management. Disclosures No relevant conflicts of interest to declare.

Abstract Background: A cancer diagnosis results in a multitude of health care decisions that require adequate patient understanding to navigate the health care system. Understanding the type and degree of information needs of cancer patients is imperative to instructing effective and pertinent patient education. This study sought to evaluate the impact of a patient centered cancer symposium on knowledge level, knowledge needs and symptom burden in a cancer patient population. Methods: Surveys were distributed to attendees of the Mayo Clinic "Living with and Surviving Cancer" patient symposium in January 2016. A follow up survey was sent to participants 3 months after the symposium. Surveys included demographic data, questionnaire evaluating disease comprehension and information assessment, symptom burden, desired information and quality of life assessment. Responses were compared between patients with hematologic and solid tumor malignancies by chi-square test. Pre and post comparisons were done in patients completing both surveys by McNemar test. Results: Demographics: 150 patients completed the pre-intervention survey. Average age of participants 67.5 years. Some patients reported more than 1 malignancy. Disease types represented included hematologic malignancies (N=60), specifically multiple myeloma (N=23), lymphoma (N=26), leukemia (N=8) and MPNs (N=3) as well as solid tumor malignancies (N=90). Most patients were diagnosed with cancer at least 1 year prior to the intervention (N=137). Patients with hematologic malignancies were more likely to be on active treatment at the time of the convention (N=35, 58%) compared to solid tumor malignancies (N=37,41%). Baseline Knowledge: Most patients reported an adequate level of knowledge defined as the proportion of participants reporting "quite a bit" or "very much understanding" on the topic of disease understanding (76%). Lowest levels of knowledge were legal issues (18%), pain management (31%), disease relapse symptoms(46%), fatigue management (48%), end of life decision making (50%) and financial management (50%). Patients with hematologic malignancies were more likely to report understanding of fatigue management (N=36, 60%) but less like to report understanding disease risk factors (N=20, 33%), or increased nutritional interest following diagnosis (N=32, 53%) compared to solid tumor malignancy (N=33,37%) (N=55,61%)(N=70,78%), respectively (all p <0.05). The EORTC-INFO25 at baseline revealed hematologic patients had received less information on sexual side effects of treatments (N=7, 14%) compared to solid tumor patients (N=30, 35%; p=0.004), and reported a lower score of treatment information (50 vs 59; p=0.04). Pre and Post Analysis: Of the 150 initial participants, 81 completed the pre and post-convention surveys (54%). Post-symposium, significant improvement defined as the proportion of participants reporting "quite a bit" or "very much" understanding was noted of disease (pre 75% vs post 89%), stress management (pre 56% vs post 69%), maintain relationships (pre 60% vs post 75%) and pain management (pre 33% vs post 51%)(p-value<0.05). The desire for increased information decreased post-symposium regarding all 9 topics, with significant decreases noted in disease, treatment options and side effects, legal issues and stress management. The EORTC INFO25 analysis revealed a decrease in the reported desire for more information (mean; pre 70 vs post 53, p-value <0.05) Discussion: Cancer patients have a variety of information needs. A patient centered educational conference was able to produce significant improvement in understanding in 4 of 17 topics (24%), including general disease, stress and pain management, and relationship maintenance that was durable at 3 months. At least some improvement in understanding was noted in 10 of 17(59%) additional topics. Knowledge deficit improved in all 9 topics assessed, significantly in five. Cancer patient knowledge needs are varied, and likely evolve over time as a patient progress through stages of disease and treatment. Education should re-evaluate and redistribute information to cancer patients over the course of treatment and survivorship. Disclosures Mikhael: Abbvie: Research Funding; Celgene: Research Funding; Sanofi: Research Funding; Onyx: Research Funding. Dueck:Bayer: Honoraria. Mesa:Novartis: Consultancy; Ariad: Consultancy; Promedior: Research Funding; Galena: Consultancy; Incyte: Research Funding; Celgene: Research Funding; CTI Biopharma: Research Funding; Gilead: Research Funding.

Abstract Background: A diagnosis of cancer leads to significant information requirements to facilitate health care decision making, understand management options, and health care system navigation. Many patients demonstrate a knowledge deficit that can lead to decreased quality of life and poor health care compliance. This study sought to evaluate the impact of a patient centered cancer symposium on knowledge level, symptom burden, and desired information in a broad population of cancer patients. Methods: Surveys were distributed to attendees of the Mayo Clinic "Living with and Surviving Cancer" patient symposium in January 2015. A follow up survey was sent to participants 3 months after the symposium. Surveys included demographic data, questionnaire evaluating disease comprehension, symptom burden, desired information and quality of life. Results: Demographics: 113 patients completed the pre-intervention survey. Average age of participants was 64.7 years. Disease types represented included hematologic malignancies (N=50), specifically multiple myeloma (N=24), lymphoma (N=17), leukemia (N=6), MPN/MDS (n=3), as well as solid tumor malignancies (N=77). Highest knowledge topics were disease (80%), screening tests (74%), and monitoring tools (72%). Lowest knowledge topics were financial management (13%), legal issues (13%), and pain management (35%). Pre and Post Analysis: Of the 113 initial participants, 79 patients completed the pre- and post-symposium surveys. In the post-symposium setting significant improvement was noted in understanding of disease (pre 80% vs post 92%), treatment options (pre 60% vs post 76%), nutrition (pre 68% vs post 84%) and legal issues (pre 15% vs post 32%). Non-significant knowledge improvement was noted in areas of risk factors and symptoms, screening/monitoring tools, disease side effects, managing stress/fatigue, end of life decision making and health care navigation. Most patients desired increased understanding regarding disease, screening tests, nutrition, and stress and fatigue management. The level of patient reported desire for information of these topics decreased in the post-symposium setting, statistically significant decrease noted in 4 of 5 topics assessed. In hematology patients who completed pre and post surveys (N=36), a higher level of baseline knowledge was reported regarding disease understanding (89%), tools monitoring response (83%) and recurrence (75%), symptoms (83%), relapse symptoms (64%) and treatment options (72%). In this group the decrease in desire for information was less prominent in the post-symposium setting. Discussion: This data demonstrates improved patient reported understanding on a variety of topics with durable response at 3 months. A majority of patients reported adequate baseline knowledge of many topics prior to the symposium but also a desire of increased cancer specific information. Knowledge deficit in cancer care includes disease specific topics, social stressors and health care navigation. The percentage of participants reporting a high desire for more information remained high but did decrease, suggesting decreased knowledge deficit in the post-symposium setting. Patient education should strive to be accessible, all-inclusive and reactive to patient needs. Table 1.Reported "quite a bit" or "very much" understanding and desired information regarding cancer carePrePostP-valueN=79(%)N=79(%)I understand…How to manage financial considerations of my disease/treatment39(51)41(53)0.85How to manage my pain24(34)23(32)0.81Risk factors that can lead to my disease37 (49)42 (56)0.56How to navigate the health care system43(55)47(60)0.56How to manage fatigue38(50)43(56)0.54Process of making end of life decisions33(47)41(53)0.52Screening tests60 (76)63 (81)0.5Symptoms associated with relapse35(45)42(54)0.27Disease symptoms54(70)60(76)0.2Tools monitoring recurrence49(62)56 (72)0.19Tools monitoring response56(71)63(81)0.15How to manage stress46(60)56(71)0.12Legal issues of my disease11(15)24(32)<0.05Treatment options47(60)60(76)<0.05What to eat49(68)66(84)<0.05My disease62(80)71(92)<0.05I desire increased understanding…Of my disease59(77)53(70)0.4Of managing stress50(65)35(51)<0.05Regarding nutrition64(84)54(70)<0.05Of the screening tests62(79)43(57)<0.05How to manage fatigue54(72)42(54)<0.05 Disclosures Tibes: TetraLogic Pharmaceuticals: Research Funding. Mesa:Novartis. Research- incyte, Gilead, cti, Genentech, promedior, NS Pharma: Consultancy.

Abstract Introduction Non-Hodgkin lymphoma responds to single agents such as cyclophosphamide, combination therapy such as CVP and immunotherapy with monoclonal antibodies such as rituximab. There is no consensus on the optimal treatment for relapsed low grade or mantle cell lymphoma. Based on the success and tolerability of combining alkylating agents with proteasome inhibitors in multiple myeloma, a phase II clinical trial of rituximab, cyclophosphamide, bortezomib, and dexamethasone (R-CyBor-D) was designed to explore the efficacy and safety of this combination in relapsed low grade and mantle cell lymphoma (MCL). Methods This trial enrolled relapsed patients at Mayo Clinic from October 2008 to March 2014. Eligibility required age≥18; biopsy proven follicular grades 1 or 2 lymphoma (FL), MCL, small lymphocytic lymphoma/chronic lymphocytic leukemia, marginal zone B-cell lymphoma, or Waldenström’s macroglobulinemia (WM); life expectancy >3 months; ECOG PS 0, 1 or 2; measurable disease; Hb ≥8g/dl, ANC ≥1200/uL, platelet ≥75,000/uL, creatinine ≤1.5xULN, total bilirubin ≤1.5xULN, alkaline phosphatase ≤3xULN, AST ≤3xULN; and willingness to sign informed consent. Women of child bearing potential had pregnancy testing and all patients followed recommendations for contraception. Treatment included rituximab 375 mg/m2 IV on day 1 and oral cyclophosphamide 300 mg/m2, IV bortezomib 1.3 mg/m2, and oral dexamethasone 40 mg on days 1, 8, 15, and 22 in a 28-day cycle. Treatment was continued two cycles beyond best response or a maximum of 12 cycles. Allopurinol 300 mg on days 0-14 for the first cycle was strongly recommended. Results 21 patients were enrolled prior to study closure due to slow accrual. Bortezomib was initially given on days 1, 4, 8, and 11 in the first 16 patients, but was subsequently modified to days 1, 8, 15, and 22 due to significant peripheral neuropathy (PN). Median age was 69 years (range 51-80) and 13 (62%) were male. 62% had stage IV disease and 17 (81%) had 2 or more prior treatments with 3 (14%) having prior autologous stem cell transplantation. Histologies included FL-I (n=6), FL-II (n=2), MCL (n=8), and WM (n=5). Patients completed a median of 4 cycles of treatment (range 1-12), discontinuing due to 9 (43%) completion per protocol, 4 (19%) progression, 5 (24%) adverse events, 1 (5%) patient refusal, and 2 (10%) other reasons. Median follow-up is 32.8 months (0.9-54.8). CR or PR as best response was observed in 13 (62%, 95% CI 38-82%; 4 CR [19%], 9 PR [43%]) patients. By histology, CR or PR was observed in 7 (88%) FL patients (4 CR, 3 PR); 2 (25%) MCL patients (both PR), and 4 (80%) WM patients (all PR). CR or PR was observed in 10/16 (62%; 4 CR, 6 PR) before and 3/5 (60%; all PR) after the change in bortezomib schedule. Among 13 patients with CR or PR, median duration of response was 25.9 months (95% CI 8.0-not reached). Median PFS and OS were 11.6 months (95% CI 3.8-not reached) and 54.8 months (95% CI 24.6-54.8), respectively. At least one Gr≥3 adverse event at least possible related was observed in 14 (67%) patients, the most common being leucopenia (7, 33%), neutropenia (7, 33%), thrombocytopenia (6, 29%), anemia (5, 24%), PN (5, 24%), and fatigue (3, 14%). Peripheral sensory neuropathy at least possibly related was Gr1, Gr2, and Gr3 in 5 (24%) patients each, with a lower rate observed for patients after the change in bortezomib schedule (before 13/16 [81%] Gr≥1, after 2/5 [40%] Gr≥1). Among 14 patients who completed a baseline and at least one post-baseline FACT/GOG-NTX additional concerns questionnaire, 10 (71%) reported clinically meaningful (≥3-point) worsening in patient-reported neurotoxicity (8/11 [73%] before and 2/3 [67%] after the change in bortezomib schedule). Conclusions Our results suggest R-CyBor-D is a safe and effective combination in patients with relapsed low grade and mantle cell lymphomas. High response rates were seen in FL and WM. The majority of significant AE’s were hematologic. However, sensory neuropathy was common with twice weekly dosing of bortezomib and lessened with weekly dosing. Determination of optimal treatment regimens in this population remains an unmet need. Additional clinical trials including larger patient numbers are necessary to confirm these observations. This trial was sponsored by Millennium Disclosures Off Label Use: bortezomib was used in combination therapy to treat relapsed low grade lymphomas and Waldenstrom's macroglobulinemia. Bergsagel:Novartis: Research Funding; Constellation Pharmaceutical: Research Funding; OncoEthix: Research Funding; MundiPharma: Research Funding. Tiedemann:Janssen: Honoraria. Reeder:Millennium, Celgene, Novartis: Research Funding.

Abstract BACKGROUND: nal-IRI is a liposomal formulation of irinotecan (topoisomerase-1 inhibitor). Preclinical data show that nal-IRI accumulates in BMs and prolongs survival in animal models of BM. Findings from a phase 1 expansion study (NCT01770353), evaluating patients with mBC and active BM, are reported. METHODS: This phase 1 expansion study enrolled patients with mBC who received multiple prior lines of cytotoxic therapy in the metastatic setting, including one cohort with mBC and active BM, defined as radiographic evidence of new or progressive central nervous system (CNS) metastases after radiation therapy with ≥1 lesion of ≥1 cm in the longest dimension on gadolinium-enhanced magnetic resonance imaging. Patients received nal-IRI 50 mg/m2 (free-base equivalent; FBE) every two weeks (q2w) as an intravenous infusion over 90 minutes, escalating to 70 mg/m2 FBE q2w, if tolerated. RECIST v1.1 and modified RECIST criteria were used to assses non-CNS and CNS disease, respectively. RESULTS: In total, 30 patients were enrolled (10 with active BM). Median age was 53 years (range 29–70 years) and median number of prior cytotoxic anti-cancer regimens was 3 (range 0–6); 29 patients received ≥1 dose of nal-IRI 50 mg/m2 FBE. Overall, nal-IRI monotherapy appeared to be well tolerated, and achieved ≥30% objective response rates for both CNS and non-CNS disease. Among the 10 patients with active BM, 6 achieved CNS disease control (3 partial responses [PRs] and 3 stable disease [SD]), including one patient with durable CNS SD and non-CNS PR for 2 years. Among 7 patients with serial evaluation of CNS metastases posttreatment, 6 patients achieved a reduction in target CNS lesions compared with baseline. CONCLUSION: Treatment with nal-IRI resulted in CNS disease control among 6 of 10 heavily pretreated patients with mBC and active BM. Further exploration of nal-IRI in patients with mBC and active BM is warranted.

A robust personalized ctDNA test, TARDIS, achieves high accuracy for residual disease after completion of neoadjuvant therapy.

Abstract Background nal-IRI is a liposomal formulation of irinotecan (topoisomerase-1 inhibitor), using intraliposomal stabilisation technology to enable high drug load and in-vivo stability. The expansion of Phase I NCT01770353 evaluated nal-IRI in patients (pts) with mBC. Methods This Phase I expansion study enrolled mBC pts (Cohort 1: ER+ and/or PR+ HER2 BC (C-1); Cohort 2: Triple Negative BC (TNBC, C-2); Cohort 3: BC with active Brain Metastasis (C-3)). Key inclusion criteria: ECOG ≤1; adequate organ function; received &gt;1 to ≤5 prior lines of cytotoxic therapy in metastatic setting, except TNBC pts who could have progressed within 12 months of adjuvant therapy. Pts received nal-IRI 50 mg/m2 (Free-base equivalent, FBE) q2w iv infusion, escalating to 70 mg/m2 FBE q2w, if tolerated. Results 30 pts (10 per cohort) were enrolled: 29 received &gt;1 dose nal-IRI 50 mg/m2 FBE (median age 53 yrs, range 29-70 yrs). Median number of cytotoxic therapies prior to study entry was 3. The most frequent treatment emergent adverse events (TEAEs) were gastrointestinal disorders (all cohorts, 100%), primarily diarrhea (C-1, 100% / C-2, 100% / C-3, 70%), nausea (C-1, 80% / C-2, 56% / C-3, 30%), and vomiting (C-1, 60% / C-2, 33% / C-3, 30%). The incidence of neutropenia was low (C-1, 10% / C-2, 0% / C-3, 10%), all grade 1 / 2. Most common grade 3 TEAEs were diarrhea (28%), nausea (17%), fatigue (14%), hypokalemia (10%) and asthenia (10%), with none reported as grade 4. No grade 5 TEAEs were reported. Partial response (per RECIST) was observed in 10 pts for an objective response rate (ORR) of 35% (C-1, 40% / C-2, 33%) / C-3, 30%). Stable disease was observed in 5 pts (17%). Duration of Response (median, months) was C-1, 7.5 (6.4-13.0) / C-2, 5.6 (3.7-7.4) / C-3, 4.1 (0.0-22.2, extracranial: RECIST) / C-3, 1.8 (0.0-1.9, intracranial: mRECIST). Table 1.Study Demographics, Adverse Events, and Best Overall ResponseDemographicsCohort 1ER+ and/or PR+ Breast Cancern=10Cohort 2Triple Negative Breast Cancern=10Cohort 3Breast Cancer with Active Brain Metastasisn=10Total PopulationN=30Gender, Female, n (%)10 (100%)10 (100%)10 (100%)30 (100%)Age, Years Median (range)56 (49-68)52.5 (37-70)45.5 (29-63)53 (29-70)Race, n (%)WhiteBlack/AfricanOther8 (80%)02 (20%)8 (80%)1 (10%)1 (10%)7 (70%)1 (10%)2 (20%)23(77%)2 (7%)5(16%)Months Since Metastatic diagnosis, Months Median (Range)63.7 (16-87)20.7 (0-34)32.4 (8-55)24.0 (0-87)Number of Prior Cytotoxic Anti-cancer Regimens Median (Range)3.0 (1-6)3.0 (0-5)32.4 (1-6)3.0 (0-6)Safety PopulationCohort 1ER+ and/or PR+ Breast Cancern=10Cohort 2Triple Negative Breast Cancern=9Cohort 3Breast Cancer with Active Brain Metastasisn=10Total PopulationN=29ExposureTreatment Duration, Weeks Median (range)6.1 (0-78)12.3 (0-49)13.9 (1-105)12.3 (0-105)Adverse EventsAny TEAE10 (100%)9 (100%)10 (100%)29 (100%)Grade 38 (80%)6 (67%)10 (100%)20 (69%)Grade 41 (10%)06 (60%)3 (10%)TEAE Related to nal-IRI10 (100%)8 (89%)10 (100%)28 (97%)Grade &gt; 36 (60%)3 (33%)3 (30%)12 (41%)TEAE Related to nal-IRILeading to Dose Adjustment*7 (70%)3 (33%)4 (40%)14 (48%)SAEs6 (60%)4 (44%)7 (70%)17 (59%)SAE Related to nal-IRI4 (40%)1 (11%)1 (10%)6 (21%)Duration of Objective ResponseRECIST 1.1RECIST 1.1RECIST 1.1mRECISTMonths Median (Range)7.5 (6.4-13.0)5.6 (3.7-7.4)4.1 (0.0-22.2)1.84 (0.0-1.9)Best Overall ResponseRECISTRECISTRECISTmRECISTComplete Response (CR)0000Partial Response (PR)4 (40%)3 (33%)3 (30%)3 (30%)Stable Disease (SD)03 (33%)2 (20%)3 (30%)Progressive Disease (PD)5 (50%)2 (22%)3 (30%)2 (20%)Not Evaluable (NE)1 (10%)1 (11%)2 (20%)2 (20%)Objective Response RateCR+PR(95% CI)4 (40%)12.2 -73.83 (33%)7.5-70.73 (30%)6.7-65.33 (30%)(6.7-65.3)*n=1 patient in Cohort 1 discontinued treatment due to TEAE related to treatment with nal-IRI CI, Confidence Interval; nal-IRI, Irinotecan Liposome Injection; SAE, Serious Adverse Event; TEAE, Treatment Emergent Adverse EventSystemic tumor response was evaluated according to RECIST version 1.1CNS tumor response was evaluated according to mRECIST (Anders C. et al., Breast Cancer Res Treat, 2014: 146(3):557-66) Conclusion nal-IRI monotherapy 50g/m2 FBE Q2W appears well tolerated, and achieved &gt;30% ORR for systemic and CNS disease among heavily pre-treated mBC pts regardless of receptor status. Citation Format: Jasgit Sachdev, Pamela Munster, Donald Northfelt, Hyo S. Han, Cynthia MA, Fiona Maxwell, Tiffany Wang, Bruce Belanger, Bin Zhang, Yan Moore, Carey Anders. Phase I expansion study of irinotecan liposome injection (nal-IRI) in patients with metastatic breast cancer (mBC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT048.

Abstract Background A better understanding of social determinants of health and psychosocial and economic sequelae of cancer for an ethnoculturally diverse population is needed. A Patient-Reported Outcomes Quality of Life (PROQOL) instrument has been developed to capture less commonly discussed patient concerns. We sought to adapt this instrument and pilot it in underserved, ethnic minority cancer patients at Maricopa Integrated Health System (MIHS) in Phoenix, AZ. Methods Two focus groups (FG) were conducted to understand patient perspectives of an adapted Spanish version of PROQOL. A revised version based on FG data was then piloted among patients on active cancer treatment. Patients also completed a Linear Analog Scale Assessment (from 1-10) for quality of life (QOL) and its domains. Results All participants in both FG (11/12 female) were Hispanic, with a median age of 53 years. Participants agreed that the domains covered in the PROQOL represented the most important psychosocial needs in their cancer continuum. No difficulty in understanding the individual domains or questions for delving deeper into each domain was noted. Median age of 34 pilot study participants (74% female, 79% Hispanic) was 48 years. 28/34 completed the Spanish version. The most common concerns were ‘Money’ (32%) and ‘Cancer Diagnosis, Treatment and Survivorship’ (32%). Median overall QOL was 8 (range 3-10). Conclusions PROQOL is feasible for systematic capture of patient concerns in underserved, ethnic minority cancer patients. A better understanding of these concerns can help design interventions to improve psychosocial outcomes for the vulnerable groups and decrease disparities in care delivery.