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Peritoneal metastases (PM) from ovarian, gastric, appendiceal, or colorectal origin can be treated via cytoreductive surgery with or without the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) for selected patients. Unfortunately, not all patients are candidates for aggressive surgical debulking. For these patients, pressurized intraperitoneal aerosolized chemotherapy (PIPAC) has emerged as an alternative method for intraperitoneal (IP) chemotherapy administration. This report presents the design and implementation of the first phase 1 trial to evaluate the safety and efficacy of PIPAC in the United States. This is an ongoing prospective phase 1 clinical trial of PIPAC for patients who have histologically confirmed ovarian, uterine, gastric, appendiceal, or colorectal cancer with PM and have progressed to at least one evidence-based chemotherapeutic regimen. The trial has two clinical arms. The patients in arm 1 have gynecologic and gastric malignancies treated with IP cisplatin and doxorubicin, and the arm 2 patients have colorectal and appendiceal malignancies treated with intravenous fluorouracil and leucovorin followed by IP oxaliplatin. All the patients are monitored for dose-limiting toxicities and adverse events. Practical and technical considerations for the phase 1 PIPAC trial are presented. These considerations include patient selection, operating room setup, and technical details for successful aerosolized chemotherapy delivery. The phase 1 study results will be reported separately at completion of the trial. The PIPAC treatment is a feasible, minimally invasive approach that permits IP delivery of chemotherapy. Once completed, the ongoing phase 1 trial will help to provide safety and initial efficacy data.

As the US transitions from volume- to value-based cancer care, many cancer centers and community groups have joined to share resources to deliver measurable, high-quality cancer care and clinical research with the associated high patient satisfaction, provider satisfaction, and practice health at optimal costs that are the hallmarks of value-based care. Multidisciplinary oncology care pathways are essential components of value-based care and their payment metrics. Oncology pathways are evidence-based, standardized but personalizable care plans to guide cancer care. Pathways have been developed and studied for the major medical, surgical, radiation, and supportive oncology disciplines to support decision-making, streamline care, and optimize outcomes. Implementing multidisciplinary oncology pathways can facilitate comprehensive care plans for each cancer patient throughout their cancer journey and across large multisite delivery systems. Outcomes from the delivered pathway-based care can then be evaluated against individual and population benchmarks. The complexity of adoption, implementation, and assessment of multidisciplinary oncology pathways, however, presents many challenges. We review the development and components of value-based cancer care and detail City of Hope’s (COH) academic and community-team-based approaches for implementing multidisciplinary pathways. We also describe supportive components with available results towards enterprise-wide value-based care delivery.

Nipple-areola sparing mastectomy (NSM) may be offered to some women with breast cancer as an alternative to skin sparing (SSM) or total mastectomy (TM) with excellent cosmetic results and acceptable recurrence risk. The aim of this study is to determine the local/regional recurrence rate of NSM in comparison to SSM and TM at our institution and to determine the factors that may be associated with risk of recurrence. Women who underwent NSM (n=148), SSM (n=660) or TM (n=443) at City of Hope National Medical Center between May 2007 and December 2014 for Stage 0-III breast cancer were identified retrospectively. Exclusions were: women with inflammatory breast cancer and those who had mastectomy for recurrent breast cancer. Overall survival (OS) and disease free survival (DFS) were analyzed using Cox regression controlling for age, race/ethnicity, stage, histology, grade, hormone receptor and Her2 receptor status. There were total of 165 NSMs, 704 SSMs and 466 TMs performed for cancer, accounting for the patients with bilateral cancers. The median follow up time was 38, 58 and 55 months for NSM, SSM and TM, respectively. Median (range) age at diagnosis was 49 (23-74) for NSM, 51 (23-90) for SSM and 59 (26-92) for TM. In the NSM group, 76% of patients had invasive ductal cancer (IDC) and 15% had ductal carcinoma in-situ (DCIS); this was comparable to 73% and 13% in the SSM group and 78% and 9% in the TM group, respectively. The majority of patients who underwent NSM had Stage II disease (45%), which was similar to SSM (43%) and TM (44%). Only 3% of NSM patients had Stage III disease compared to 17% of SSM patients and 29% of TM patients. Most of the patients in all 3 surgical groups received adjuvant chemotherapy (NSM 59%; SSM 52%; TM 51%). Of patients who underwent NSM, 20% received neoadjuvant chemotherapy, compared with 29% of SSM patients and 35% of TM patients. The local/regional recurrence rate per breast was 12/165 (7.3%) for NSM, 23/704 (3.3%) for SSM and 11/466 (2.4%) for TM (n=11). Median time to recurrence was 20, 26 and 16 months for NSM, SSM and TM, respectively. Of the NSMs performed only 1 recurrence occurred at the nipple-areolar complex (0.6%), 9 recurrences were at the chest wall (5.5%) and 2 were at the axilla (1.2%). Eight recurrences after NSM had DCIS in addition to IDC at the time of initial diagnosis while 2 had pure DCIS, 1 had pure IDC and 1 had invasive lobular cancer. There were 8 recurrences with estrogen receptor (ER) and progesterone receptor (PR) positivity at the time of initial diagnosis, that converted to ER+, PR-. One third of recurrences after NSM had multifocal disease. There was no significant difference found in adjusted overall survival (p=0.49) and adjusted disease free survival (p=0.10) among NSM, SSM and TM patients. Even though there is higher rate of local/regional recurrence with NSM, there is no difference in overall and disease-free survival at our institution. Presence of DCIS may be an important factor for recurrence. From these data we conclude that NSM is an oncologically acceptable alternative to SSM and TM, with excellent cosmetic results. Citation Format: Bostanci Z, Wang X, Ottesen R, Nikowitz J, Jones VC, Springer L, Lai L, Taylor L, Vito CA, Paz IB, Niland J, Kruper L, Yim JH. Oncological safety of nipple-areola sparing mastectomy in comparison with skin sparing and total mastectomy: Results from a NCI-designated comprehensive cancer center [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-22-12.

805 Background: The alarming rise in the incidence of gastric (GC) and colorectal (CRC) adenocarcinomas in young adults (YA) over the past three decades is not well understood. How YA populations differ from older patients with the same gastrointestinal malignancies warrants further investigation. Methods: We retrospectively analyzed the California Cancer Registry and the Office of Statewide Health Planning and Development data for all GC and CRC cases from 2000 to 2012. Pearson’s Chi-square analysis was used to analyze differences in demographic, clinical and histopathologic features and log-rank test to compare survival between young (≤ 40 years old) and older adults (40-90 years old) with GC or CRC. Results: Of the GC (n = 19,368) and CRC (n = 117,415) patients included in the study, YA accounted for 4.5% (n = 883) of GC and 3.2% (n = 3723) of CRC. Hispanic ethnicity was more common in YA for both cancers compared to older patients (50.9% vs 26.8% GC, 29.6% vs. 15.7% CRC, p < 0.0001). YA were more likely to have poorly differentiated (74.6% vs. 59.8% GC, 22.5% vs 17.5% CRC, p < 0.0001), higher grade (77.0% vs 61.6% GC, 23.9% vs 18.6 CRC, p < 0.0001), and signet ring features (44.6% vs 21.0% GC, 3.2% vs 1.1% CRC, p < 0.0001) compared to older patients. Synchronous peritoneal metastases were more common in YA compared to older patients (32.1% vs. 14.1% GC, 8.8% vs 5.4% CRC, p < 0.0001). YA with GC or CRC had a greater 5-year survival compared with older patients with the same stage of malignancy. Subgroup analysis of Stage I GC demonstrated lower survival in YA compared with adults aged 41-49 and 50-64 years (65.1% vs. 70.7% and 69.1%, 95% CI 49.7-76.9%, 62.5-77.3%, 65.2-72.7% respectively). Conclusions: GC and CRC in young adults have distinctly worse clinical and histopathologic features compared to older patients with the same malignancy. Ethnic disparity exists in the YA patients. This study contributes to improving the understanding of younger versus older GI cancer patients.

Patients with high-risk locally advanced/inflammatory and oligometastatic (≤3 sites) breast cancer frequently relapse or experience early progression. High-dose chemotherapy combined with peripheral stem cell rescue may prolong progression-free survival/relapse-free survival (PFS/RFS) and overall survival (OS). In this study, patients initiated high-dose chemotherapy with STAMP-V (carboplatin, thiotepa, and cyclophosphamide), ACT (doxorubicin, paclitaxel, and cyclophosphamide), or tandem melphalan and STAMP-V. Eighty-six patients were diagnosed with locally advanced/inflammatory (17 inflammatory) breast cancer, and 12 were diagnosed with oligometastatic breast cancer. Median follow-up was 84 months (range, 6-136 months) for patients with locally advanced cancer and 40 months (range, 24-62 months) for those with metastatic cancer. In the patients with locally advanced cancer, 5-year RFS and OS were 53% (95% CI, 41%-63%) and 71% (95% CI, 60%-80%), respectively, hormone receptors were positive in 74%, and HER2 overexpression was seen in 23%. In multivariate analysis, hormone receptor–positive disease and lower stage were associated with better 5-year RFS (60% for ER [estrogen receptor]/PR [progesterone receptor]-positive versus 30% for ER/PR-negative; P < .01) and OS (83% for ER/PR-positive versus 38% for ER/PR-negative; P

222 Background: Management of small well-differentiated pancreatic neuroendocrine tumors (PNETs) is controversial, and the malignant potential remains uncertain. Treatment options include observation (OB), enucleation (ENUC), and formal resection (Distal pancreatectomy – DP, Whipple/Total pancreatectomy – PD). Our objective was to analyze the association between treatment types of small PNETs and overall survival (OS). Methods: The California Cancer Registry linked with the Office of Statewide Health Planning and Development inpatient database was queried from 2000-2012 for patients with < 3 cm, nonfunctional, stage I–II PNETs. Exclusion: poorly-differentiated PNETs or metastases within 6 months. Non-parametric statistics (Kruskal-Wallis) or Fisher’s exact test were used to determine if any patient characteristics were associated with type of treatment (surgery or observation). Ten-year OS was estimated by the Kaplan-Meier method. A multivariate model was performed using Cox proportional hazards. Results: Of 1,862 patients with PNETs, 204 were small, well-differentiated. Treatments include: OB n = 41, EN n = 20, DP n = 106, or PD n = 67. Few patients developed distant recurrences past 6 months (OB, n = 0; EN, n = 0; DP, n = 2; PD, n = 1). On bivariate analysis, comorbidities (2 or more, p = 0.024), insurance type (p = 0.018), and mean number of lymph nodes retrieved (EN = 1.8 +/- 4.1; DP = 6.3 +/- 7.63; PD = 11.0 +/-8.5) were associated with treatment. Patient gender, race, socio-economic status, hospital type, tumor size, grade (well vs. moderate), and lymph node status at diagnosis were not associated with treatment type. On multivariate analysis, treatment type was not associated with worse OS (p = 0.098). Ten-year OS was similar between treatment groups (OB = 92%, EN = 100%, DP = 95%, PD = 95%, p= 0.1828). Conclusions: In this unique study accounting for time of metastasis in patients who present with early stage, well-differentiated PNETs, observation, enucleation, and resection are equally associated with long-term survival. In the appropriately selected patient group, enucleation or observation may be alternatives to more aggressive surgery.

Esophageal sarcoma (ES) is a rare malignancy. The literature is limited to small case series and reports. This study used a population data set to study the characteristics, treatments, surgical outcomes, and prognostic factors for survival among ES patients. The study identified 178 ES cases (0.3 %) and 63,548 esophageal carcinoma (EC) cases (99.7 %) including adenocarcinoma and squamous cell carcinoma using the Surveillance, Epidemiology, and End Results (SEER) Registry (1973–2011). Characteristics and therapeutics were compared between ES and EC. Survival data were analyzed using Kaplan–Meier estimation. Uni- and multivariate Cox proportional hazard models determined predictors of 5-year overall survival (OS). Compared with the EC patients, the ES patients were more likely to be women, to have localized tumors, and to undergo surgery but less likely to receive radiation (p

Clear cell sarcoma of the tendons and aponeuroses (CCSTA) are rare aggressive soft tissue tumors with tendency for lymph nodes dissemination. Lymph node involvement is a correlate for prognosis. We present three patients with CCSTA in whom simultaneous sentinel lymph biopsy (SLNB) and resection was performed. Sentinel lymph node mapping may have a role in clear cell sarcoma from a prognostic standpoint. Further investigations are needed for validation.

e20651 Background: African and Latina-American breast cancers patients (BCA) experience the greatest morbidity and mortality, suggesting a critical need for improved surveillance and quality care. The Institute of Medicine (IOM) and the Commission on Cancer (CoC) recommend that survivors receive personalized Treatment Summaries and Survivorship Care Plans (TSSCP) in order to facilitate best practice in clinical surveillance and follow-up care. This TSSCP template development study joined advocacy, scientific and medical communities to comprise a diverse advisory council (AC, N=38) to inform the development of the TSSCP-AA (African American) and TSSCP-S (Latino) templates targeting BCA. This abstract reports on the development, and presents the TSSCP-AA and TSSCP-S. Methods: The overall study was guided by the Shared Care and Psychooncology Models, and Contextual Model of Health Related Quality of Life. The AC provided input into the culturally relevant modifications of the American Society of Cancer Oncology (ASCO) TSSCP template to create the TSSCP-AA and TSSCP-S. Health care professionals enlisted from cancer centers and community hospitals (n=51) evaluated the TSSCP-AA and TSSCP-S templates on the following domains: content, clarity, utility, and cultural and socioecological responsiveness. Results: AC input revealed that the clinical (i.e., comorbidities) and cultural contexts (i.e., language, spirituality) must inform TS and SCP, respectively. Preliminary evaluation analyses documented that health professionals rated our TSSCP-AA and TSSCP-S templates as excellent to outstanding on content, clarity, utility, cultural responsiveness, and socioecological responsiveness (p

Leukemic infiltration of muscle is an unusual cause of compartment syndrome. High index of suspicion with early fasciotomy may be the only way to save the leg and prevent life-threatening complications. Biopsy of the muscle should be done when the etiology of the compartment syndrome is not clear. The probable mechanisms and treatment approaches are discussed. © Wiley-Liss, Inc.

Background: Pathologic complete response (pCR) and minimal residual cancer burden (RCB scores of 0 [pCR]-1[near CR]) after NCT may predict for improved survival (Symmans et al. J Clin Oncol 25:4414-22, 2007). Hence, improved NCT regimens in conjunction with molecular markers that predict for both response and/or resistance are needed. Materials and Methods: 115 pts with stages II-III BC were to be prospectively randomized to receive 6 cycles of docetaxel 75 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2 with filgrastim support (TAC, arm A) versus a novel regimen of A 60 mg/m2 and C 600 mg/m2 given every 2 weeks x 4, followed by 3 weekly doses of carboplatin (AUC 2) and nab-paclitaxel 100 mg/m2 repeated as 28 day cycles x 3 (arm B). Pts with HER2 + BC received NCT similar to arm B, but with the addition of 12 weekly doses of trastuzumab given together with carboplatin and nab-paclitaxel (arm C). Core biopsies were performed prior to NCT and were preserved fresh frozen. 70-gene (MammaPrint™) profiling and 80-gene profiling (van de Vijver et al. NEJM 347:1999-2009, 2002) to categorize all tumors for basal-, HER2-, and luminal subtypes were carried out. We set out to assess the predictive value of Mammaprint scores (poor vs. good), as well as basal, vs. luminal, vs. HER2 molecular subtype profiling, for response to treatment on arms A vs. B vs. C. Responses were dichotomized as complete or near complete response (Symmans RCB scores of 0-1) vs. suboptimal response (RCB score > 1). Results: Sufficient amount of BC tissue and good quality RNA for gene array assessment were procured in 64% of the first 90 patients who have undergone pre-treatment core biopsies, and then proceeded to NCT, followed by definitive surgery. Here we report on the first 50 pts with complete set of data analyzed. The median age was 50 years (range:31-69). Pts were treated for stage II (49%) and III locally advanced (41%), and inflammatory BC (10%). By gene profiling, 28% of the tumors were HER2-type (vs. 38% by IHC 3+, or FISH, representing all pts treated on arm C), 26% basal-type, 42% luminal-type, and 4% borderline luminal-type. Poor-prognosis signature by the 70-gene (MammaPrint) assay was observed in 74% of pts: 92% of HER2-type, 100% of basal-type, and 52% of luminal-type tumors were characterized as poor-risk by the 70-gene assay. Following NCT, Symmans RCB scores of 0-1 were observed in 71% of pts with HER2-type, in 38% with basal-type, and 28% of pts with luminal-type molecular subtype characteristics. Conclusion: BC with HER2- and basal-molecular subtypes are more likely to respond to NCT and is frequently associated with poor-risk characteristics as determined by the 70-gene assay. The complete analysis of correlations among response to specific sets of NCT, molecular subtype, and 70-gene assay results in the entire pt population will be presented. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 2026.

567 Background: Pathologic complete response (pCR) and minimal residual cancer burden (RCB) after NCT may predict improved survival (Symmans et al. J Clin Oncol 25:4414–22, 2007). Hence, improved N...

Lymphoepithelioma-like carcinoma (LEC), an undifferentiated carcinoma with pronounced lymphocytic infiltration, often is seen in the nasopharynx as well as in other areas. But such primary pulmonary lung neoplasms in children are rare, and we present the first reported case of primary pulmonary LEC in a child.

To the Editor. —In their recently published article, Moertel et al1concluded that carcinoembryonic antigen (CEA) monitoring has questionable value in the postoperative management of colorectal cancer patients, and that routine determination of postoperative CEA levels is associated with significant expense, without benefit to the patient. While it is important to question the utility of costly testing, we do not feel that the conclusions reached in the article are supported by the data presented. There was no standardized regimen of CEA testing or follow-up of results; the number of CEA levels measured per patient ranged from one to 39; it is unclear whether levels were measured prior to or only after clinical suspicion of metastatic disease; there was no standardized method of interpreting the CEA results or acting on those results, and no standardized protocol was established for evaluating elevated CEA results. In addition, it is probably inappropriate to

1035 Background: Pathologic complete response (pCR) following neoadjuvant chemotherapy (NCT) is predictive of outcome in patients with locally advanced breast cancer (LABC). A non-anthracycline containing NCT regimen (Sikov et al. JCO 10/09) may reduce the risk of associated secondary hematologic malignancies and cardiac toxicity while yielding comparable pCR rates. Methods: A retrospective review of all LABC and inflammatory breast cancer (IBC) cases treated from 4/09 to 12/11 with a NCT regimen of carboplatin (AUC of 6, administered on day 1) and paclitaxel 80 mg/m2 (given weekly on a 21-28 day cycle) was conducted at the City of Hope Cancer Center (COHCC). Pts with HER2+ (HER+) tumors received trastuzumab during the NCT treatment. All pCRs (pCR of primary only – "pCR1°"; pCR of primary and lymph nodes – "pCR-All") were determined by a COHCC pathologist based on final surgical specimens. Results: 38 pts were identified, with 39 breast primaries; 18% had IBC, 62% of LABCs/IBCs were hormone receptor positive (HR+), 46% of tumors were HER2+, and 26% were triple negative. Median age was 51 [27-63]. All pts completed the planned number of cycles. Four pts required carboplatin dose reductions, 4 pts required dose reductions in paclitaxel, 3 pts had paclitaxel changed to nab-paclitaxel, and 17 pts required G-CSF to complete their planned treatment. One pt receiving trastuzumab experienced asymptomatic LVEF decline below normal limits. Conclusions: A non-anthracycline-containing NCT regimen of carboplatin/paclitaxel was well tolerated and resulted in high pCRs when given to triple negative (HER2-/HR-) pts, and HER2+ pts, especially with HER2+HR- subtypes. The findings warrant further studies of this regimen in a prospective randomized setting. [Table: see text]