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Objectives Peritoneal metastasis (PM) from appendiceal cancer or colorectal cancer (CRC) has significant morbidity and limited survival. Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a minimally invasive approach to treat PM. We aim to conduct a dose-escalation trial of mitomycin C (MMC)-PIPAC combined with systemic chemotherapy (FOLFIRI) in patients with PM from appendiceal cancer or CRC. Methods This is a multicenter Phase I study of MMC-PIPAC (NCT04329494). Inclusion criteria include treatment with at least 4 months of first- or second-line systemic chemotherapy with ineligibility for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). Exclusion criteria are: progression on chemotherapy; extraperitoneal metastases; systemic chemotherapy intolerance; bowel obstruction; or poor performance status (ECOG>2). Escalating MMC-PIPAC doses (7–25 mg/m2) will be administered in combination with standard dose systemic FOLFIRI. Safety evaluation will be performed on 15 patients (dose escalation) and six expansion patients: 21 evaluable patients total. Results The primary endpoints are recommended MMC dose and safety of MMC-PIPAC with FOLFIRI. Secondary endpoints are assessment of response (by peritoneal regression grade score; Response Evaluation Criteria in Solid Tumors [RECIST 1.1], and peritoneal carcinomatosis index), progression free survival, overall survival, technical failure rate, surgical complications, conversion to curative-intent CRS-HIPEC, patient-reported outcomes, and functional status. Longitudinal blood and tissue specimens will be collected for translational correlatives including pharmacokinetics, circulating biomarkers, immune profiling, and single-cell transcriptomics. Conclusions This Phase I trial will establish the recommended dose of MMC-PIPAC in combination with FOLFIRI. Additionally, we expect to detect an early efficacy signal for further development of this therapeutic combination.

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.

5570 Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin confers a survival benefit in epithelial ovarian cancer (EOC). Unfortunately, cisplatin is associated with significant renal toxicities. Sodium thiosulfate (ST) has been suggested as a nephroprotectant for patients undergoing HIPEC with cisplatin. Methods: A feasibility trial ( ClinicalTrials.gov: NCT01970722) evaluated safety outcomes of HIPEC with cisplatin 75 mg/m2 during optimal cytoreductive surgery (CRS) in patients with EOC and endometrial cancer (n = 40), with or without ST. Twenty-one patients received no sodium-thiosulfate (nST group), and nineteen patients received sodium thiosulfate (ST group). Toxicities were reported according to CTCAE v. 5. Progression-free survival was followed. Normal tissue biopsies were collected intra-operatively immediately following HIPEC and cisplatin exposure in a subset of patients (n = 21), and profiled with transcriptomic sequencing to identify RNAseq signatures correlating with toxicities. Hierarchical cluster analyses identified distinct transcriptomic signatures in post-HIPEC normal samples of patients with renal AEs (rAEs) compared to no renal AEs (nrAEs). KEGG pathway analysis identified up- or downregulated gene sets using GSEA. Results: Forty patients had HIPEC at time of optimal CRS. Renal toxicities were higher in the nST group (no sodium thiosulfate) compared to the ST group. nST patients had 17% any grade, and 9% Grade 3 AEs for acute and chronic kidney injuries. In contrast, ST patients suffered 0% renal AEs. rAE patients demonstrated upregulation of immune signaling pathways (Toll-like receptor, Natural killer cell, Nod-like receptor); and downregulation of metabolic pathways. Top upregulated genes in rAE patients included immune (e.g. neutrophil) related genes, while downregulated genes included metabolism genes. Kaplan-Meier curves demonstrated improved PFS in primary ovarian cancer patients undergoing HIPEC who were treated with ST vs no ST (p = 0.04, NR vs 13.4 mo). Conclusions: HIPEC with cisplatin results in significant renal toxicities. The mechanisms of cisplatin-induced nephrotoxicity in HIPEC are immune-related and reflect reduced metabolism. Sodium thiosulfate abrogated renal toxicities and did not decrease PFS. Clinical trial information: NCT01970722.

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.

125 Background: Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is being evaluated as a novel minimally invasive palliative treatment of peritoneal metastases (PM). Prior studies have established the feasibility and safety of repeated PIPAC treatments in gastrointestinal and gynecologic cancers. The goal of the present phase 1 trial was to establish the safety and feasibility of PIPAC oxaliplatin in a highly chemotherapy refractory colorectal and appendiceal cancer patient population. Methods: Patients with biopsy-proven peritoneal metastases from colorectal or appendiceal cancer underwent up to three PIPAC treatments using oxaliplatin (92 mg/m2) with a six-week interval at two academic centers. Patients with bowel obstruction, extra-peritoneal metastases, or poor performance status (ECOG>2) were excluded. PIPAC was nebulized over 5 min with a 30 min aerosol dwell time. Apart from the first PIPAC cycle, the patients also received a sensitizing dose of 5FU/LV (400mg/m2) within 24 hours of the procedure. Primary end point was safety as assessed by dose limiting toxicities within 6 weeks of the first PIPAC. Secondary endpoints included safety with the addition of 5FU/LV, efficacy, surgical morbidity, technical failure rate, progression-free and overall survival, pharmacokinetics (PK), and quality of life assessment. Results: A total of 8 patients were included: 5 colorectal; and 3 appendiceal. Median number of prior chemotherapy cycles was 2 (Interquartile range – IQR; 1.5-3.5). All patients were refractory to systemic oxaliplatin-based chemotherapy. Median time from diagnosis to PIPAC was 16 months (IQR; 5.6, 17.5) and Peritoneal Carcinomatosis Index was 29 (IQR; 20.5, 31.5). Five (62.5%) patients completed 3 PIPAC cycles while in 3 (37.5%) patients PIPAC was discontinued due to disease progression within the peritoneal cavity. No surgical complication or dose limiting toxicity was observed. Only one patient developed grade 3 treatment-related toxicity after first PIPAC (anemia), and another patient after second PIPAC (abdominal pain and anemia). At the completion of PIPAC treatment 5 patients had stable disease and 3 had disease progression. Pharmacokinetic, histologic response and preliminary survival data will be presented at the meeting. Conclusions: PIPAC with oxaliplatin is safe and feasible in a highly chemotherapy refractory cohort of appendiceal and colorectal carcinomatosis patients with or without sensitizing 5-FU/ LV. Clinical trial information: NCT04329494.

354 Background: Gastric cancer (GC) is the fourth most common cause of cancer death worldwide. Studies have shown an association of higher macrophage density in the tumor microenvironment with worse outcomes in GC. The presence of M2 specific gene signatures in the peripheral blood of cancer patients are associated with poor prognosis. However, it is unknown whether these immunosuppressive M2 markers are prognostic when found in the primary GC tumors. Methods: Based on previously published differential gene expression profiles that distinguish M1 versus M2 macrophages in the peripheral blood, we used the UCSC Xena webtool to analyze the TCGA Stomach Cancer cohort for tumor-associated immune signatures for their prognostic value. We excluded null entries, normal tissue, and entries with incomplete data. We investigated both M1- and M2-macrophage signatures (M1 signature: CCR7, IL2RA, CXCL11, CCL19, CXCL10, PLA1A, PTX3 and M2 signature: MRC1, MS4A4A, CD36, CCL13, CCL18, CCL23, SLC38A6, FGL2, FN1, MAF); as well as a T cell cytolytic signature defined by genes with cytolytic functions ( GZMA, GZMB, GZMH, GZMM, PRF1). We analyzed the impact of transcriptional gene expression with relation to stage, histological subtype, overall survival (OS), and disease free interval (DFI). The UCSC Xena webtool uses log-rank test to compare Kaplan-Meier curves. Results: A total of 341 entries were analyzed with age ranging from 30-90 and 39.4% female. Increased CD168 expression was associated with increased stage of GC (p = 0.017). Higher expression of the M2-macrophage signature was associated with diffuse type adenocarcinoma and mucinous type intestinal adenocarcinoma, compared to tubular and papillary type intestinal adenocarcinoma (p < 0.001). In addition, higher M2-macrophage signature expression was associated with late stage (Stage II or above) compared to early stage (stage I) (p = 0.022). A low M2-macrophage signature was associated with improved 5-year OS (p = 0.029), and a significantly improved 5-year DFI (p = 0.042). CD8A, cytolytic T cell signature, and M1 macrophage signature were not associated with stage of disease or survival. Conclusions: A transcriptional signature derived from peripheral blood immunosuppressive M2 macrophage phenotype is found in GC primary tumors and associated with higher pathologic staging and with worse outcomes. These M2 defining molecular biomarkers of GC has the potential to serve as targets of novel immune-therapeutic strategies.

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.

2553 Background: nab-Paclitaxel is albumin-bound paclitaxel that achieves higher intratumoral concentrations and undergoes receptor-mediated transcytosis across cell membranes. Previous clinical tr...

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]