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7555 Background: While CAR-T therapy is not myelo-ablative, patients with aggressive lymphoma treated with CD19 chimeric antigen receptor T cell therapy (CAR-T) are lymphodepleted and have prolonged B cell aplasia. The impact of CAR-T on immunologic protection from vaccine-preventable diseases (and thus the need to revaccinate) is not known. We report the vaccine titers of patients treated with axicabtagene ciloleucel (axi-cel) at Mayo Clinic. Methods: Retrospective chart review of adult lymphoma patients who received axi-cel from 9/2018 to 9/2020 for anti-viral and anti-bacterial titers prior to CAR-T infusion and at month 3 (MO3) post CAR-T. Results: Prior to CAR-T therapy, positive titer rate was highest for tetanus and lowest for Strep pneumoniae (Strep PNA) (Table). Similar trends were seen whether patients had stem cell transplant (ASCT) within 2 years of CAR-T (i.e. within immunization timeframe post ASCT) or not (Table). Compared to patients who had ASCT, those who did not had higher rate of positive titer for Strep PNA and lower rate for hepatitis B, Mumps, and VZV. The same trend for sero-positive rate were observed at MO3 post CAR-T. Patients with IgG

e20057 Background: T-cell lymphomas (TCL) are a heterogeneous group of rare, but aggressive non-Hodgkin lymphomas. CD4+ and CD8+ T-cell function plays a vital role in the immunologic response to P.jirovecii infection. Our study aims to define the prevalence of Pneumocystis jirovecii pneumonia (PJP) in HIV-uninfected TCL patients. Methods: All patients at Mayo Clinic, Rochester MN diagnosed with TCL and a positive Pneumocystis PCR assay from either bronchoalveolar lavage (BAL) fluid or other respiratory specimens were identified from March 2005 until November 2019. Patients with TCL and a diagnosis of PJP made outside of our medical center were identified through Advanced Cohort Explorer, a query building tool. Results: A total of 922 patients with TCL were identified, and only 14 cases (1.5%) had confirmed PJP. In confirmed PJP cases, the median age of TCL diagnosis was 62 years (IQR 51-70 years), 79% were male, and the median number of chemotherapy lines was 1.5 (IQR of 1-3). Half of the cases (6/12) received CHOP as first-line of therapy, followed by CHOEP (25%, 3/12). The median time to PJP diagnosis relative to chemotherapy was 18 days (IQR 14-27 days). Peripheral TCL, not otherwise specified was the most common TCL, followed by angioimmunoblastic TCL, and CD30+ T-cell lymphoproliferative disorders (64%, 29% and 7%, respectively). The primary specimen type sampled for PJP diagnosis was BAL fluid (n = 9, 64%), followed by sputum (n = 3, 22%), induced sputum (n = 1, 7%), and transbronchial lung biopsy (n = 1, 7%). Three patients had a prior autologous stem cell transplant (ASCT), and all three cases had relapsed TCL one year after ASCT. 77% of cases received oral prednisone equivalents (median dose of 25 mg, IQR 20-40 mg) 30 days prior to PJP diagnosis. Two patients developed PJP despite anti- Pneumocystis prophylaxis with aerosolized pentamidine. At the time of PJP diagnosis, most patients had lymphopenia (88%, 8/9), and CD4+ T-cells measurement was obtained only in one patient (CD4+ of 100 cells/mL). 71% of the cases were treated with trimethoprim/sulfamethoxazole (TMP/SMX). After the initial PJP episode, 36% of the cases were transitioned to TMP/SMX for secondary prophylaxis. All cause 30-day and 90-day mortality was 7% and 29%, respectively. Mortality attributed to PJP was 7% (n = 1). Conclusions: In our TCL cohort, the occurrence of PJP was low. Primary prophylaxis should be individualized in this population.

Purpose To describe the frequency of chemotherapy use for hormone receptor (HR)–positive, lymph node (LN)–negative breast cancer from 1997 to 2004 at eight National Comprehensive Cancer Network institutions, to explore whether chemotherapy use varied over time and between institutions, and to identify factors associated with the decision to forego chemotherapy. Patients and Methods Among women younger than age 70 years with HR-positive, LN-negative breast cancer measuring more than 1 cm, we analyzed the frequency of chemotherapy use on a yearly basis. A multivariable logistic regression model assessed the relationship between receipt of chemotherapy and year of diagnosis, institution, tumor features, and patient characteristics. Interaction terms were added to the model, and stratified analyses were conducted to further explore the determinants of chemotherapy use. Results Fifty-five percent of 3,190 women received chemotherapy. Chemotherapy use was less common for patients with 1.1- to 2-cm tumors than for patients tumors greater 2 cm (47% v 87%, respectively; P < .01) and for women age 60 to 69 years versus women younger than age 50 years (24% v 76%, respectively; P < .01). On multivariable analysis, predictors independently associated with receiving chemotherapy included larger tumor size, higher grade, human epidermal growth factor receptor 2 overexpression, younger age, and institution (P < .01 for all). Institutions exhibited dramatically different rates of chemotherapy use (from 46% to 65%) and patterns of change in chemotherapy use over time (from a 79% relative increase to a 22% relative decrease). Conclusion Although institutions seemed to agree that not all women with HR-positive, LN-negative breast cancer need chemotherapy, there did not seem to be consensus regarding which women should get chemotherapy. Only prospective randomized controlled trials will conclusively establish which subtypes of HR-positive, LN-negative breast cancer benefit from chemotherapy.

e20610Background: Crizotinib is indicated for treatment of patients with ALK-positive (ALK+) advanced or metastatic non-small cell lung cancer (NSCLC), yet patients eventually progress or develop d...

518 Background: Pts with stage II/III rectal cancers are treated with neoadjuvant chemoradiation and surgical resection followed by adjuvant CT per practice guidelines. It is unclear whether adjuvant CT provides survival benefit, and the purpose of this study was to measure outcome in pts who did and did not receive adjuvant CT. Methods: We used a prospectively collected database for pts treated at The Ohio State University, and analyzed overall survival (OS), time to recurrence (TTR), pt characteristics, tumor features, and treatments. Survival curves were estimated using Kaplan-Meier method and compared by the log-rank test. Age was compared using the Wilcoxon test, and other categorical variables were compared using Chi-square test or Fisher’s exact test. Results: Between August 2005 to July 2011, 110 pts were identified and 71 pts had received adjuvant CT. There was no significant difference in sex, race, pathologic tumor (T) stage, and pathologic complete response between the two pt groups. Pts receiving adjuvant CT were significantly younger (median age 54.3 vs. 62 years, p=0.01) and had more advanced pathologic nodal (N) stage (43 vs. 19%, p=0.02). Median OS was 72.6 months with CT vs. 36.4 months without CT (p=0.0003). Median TTR has not yet been reached. Conclusions: In this retrospective analysis, adjuvant CT was associated with a longer OS despite more advanced pathologic nodal staging. Prospective randomized studies are warranted to determine whether adjuvant CT provides a survival benefit for pts across the spectrum of stage II and III rectal cancer. [Table: see text]

599 Background: According to gene expression profiling, HER2+ BC is heterogeneous and appears to diverge by HR status. Methods: We evaluated 3394 pts who presented to NCCN centers with stage I-III HER2+ BC between 2000-07. Pts were classified as HR+ (ER+ and/or PR+) and HR- (ER- and PR-). Chi-square, univariate logistic regression, log-rank test, and Cox hazard proportional regression were used for analysis. Results: Median follow-up was 51 months. 59% of patients had HR+ and 41% HR- disease respectively. Pts with HR- BC were more likely to be postmenopausal and to present with higher stage and high grade disease (p

9530 Background: Although 12 cycles of Adj FOLFOX are recommended for stage III and high risk stage II colon cancer, toxicity may preclude completion of treatment. We used the NCCN Colorectal Cancer Outcomes Database to identify how frequently Adj FOLFOX is discontinued prematurely for toxicity in a non-clinical trial population. Methods: Newly diagnosed stage II-III colon cancer pts treated with Adj FOLFOX at 7 NCI-designated comprehensive cancer centers between 9/05–12/07 were identified. We assessed completion of the prescribed adjuvant chemotherapy (AC) course, including Adj FOLFOX and 5FU-based adjuvant treatment alone subsequent to discontinuation of oxaliplatin (oxal). Dose limiting toxicity (DLT) of Adj FOLFOX was defined as premature discontinuation of Adj FOLFOX due to toxicity. We evaluated potential predictors of Adj FOLFOX DLT, including older age and history of diabetes in a multivariable logistic model controlling for stage and center. We measured the duration of Adj FOLFOX use in weeks, from first to last dose. Results: 293 pts began Adj FOLFOX. Pts who experienced DLT (40%) had a shorter duration of Adj FOLFOX and were less likely to complete AC, even after oxal was discontinued. The only significant predictor of experiencing a DLT was a history of diabetes. Conclusions: Our analysis of patients treated outside of a clinical trial demonstrated a notably high rate of discontinuation of Adj FOLFOX due to DLT, particularly in pts with diabetes. The results underscore the need for systematic assessment of toxicity especially among diabetics. [Table: see text] [Table: see text]

6517 Background: Obesity (measured using body mass index [BMI]) is regarded as a prognostic factor for worse breast cancer survival. We hypothesized that obesity may influence adherence to NCCN guidelines recommending chemotherapy for patients with operable breast cancer at NCCN centers. Methods: We identified women < 70 years diagnosed with stage I, II, or III breast cancer from 1997 to 2006 at 8 NCCN centers for whom guidelines recommended chemotherapy. Body mass index was assessed in categories (2 [normal], 25 to 2 [overweight], 30 to 39kg/m2 [obese], ≥40 kg/m2 [morbidly obese]) and in 5 kg/m2 increments. Multivariable logistic regression analysis adjusting for center, age at diagnosis, ethnicity, comorbidity score, and guideline was used to examine the association between BMI at diagnosis and non-receipt of chemotherapy. Results: 9,389 women were eligible for the study: 38% normal weight; 30% overweight; 23% obese; 5% morbidly obese; and 4% unknown. In multivariable analysis with BMI as a categorical variable, there was no association between weight status and non-receipt of chemotherapy (p = 0.35). When BMI was assessed in 5kg/m2 increments, weight status was a statistically significant predictor of non-receipt of chemotherapy (p = 0.02), but the odd ratios exceeded 1.0 only for BMIs ≥42.6kg/m2. Other patient-related factors associated with non-receipt of chemotherapy included older age at diagnosis (p < 0.01), presence of comorbidities (p < 0.01) and center (p < 0.01). Conclusions: Overall, the quality of breast cancer care as measured by adherence to NCCN guidelines recommending chemotherapy was not affected by patient overweight or obese status. Chemotherapy use was lower among patients with extreme morbid obesity, which may represent appropriate clinical decision-making. Evaluating factors that may contribute to worse prognosis among obese patients is essential for individualizing care and improving breast cancer outcome. No significant financial relationships to disclose.

6506 Background: To assess the quality of breast cancer care in the National Comprehensive Cancer Network (NCCN), we compared practice against the ASCO/NCCN quality measures (QM). Methods: Using the NCCN Outcomes Database, we studied the care of women with newly diagnosed stage I-III breast cancer treated at 8 NCCN centers in 2003–6 to determine the proportion whose care was consistent with the 3 QMs (tamoxifen or anastrozole within 1 year of diagnosis for HR+ >1 cm tumors [HT]; post- lumpectomy radiation within 1 year of diagnosis for women 1 cm tumors for women [Table: see text] No significant financial relationships to disclose.

4046 Background: The decision to take AC in stage II colon cancer requires weighing uncertain benefits with the potential for acute and, increasingly, long-term toxicity. Methods: The NCCN Colon/Re...

4015 Background: The American College of Pathology has suggested that 12 or more LN be examined from colorectal cancer surgical specimen. Both ASCO and NCCN have considered adopting the 12 LN threshold as a quality metric. The purpose of this study was to determine whether the 12 LN benchmark is achieved at NCCN specialty centers. Methods: Patients with newly diagnosed stage I-III colon or rectal cancer, who had primary surgery at NCCN centers in 2005–6 were selected (n=345). Similarly, data from 14,019 stage I-III colorectal patients diagnosed in 2002 in a SEER region were obtained to determine the extent to which this goal was met in a population-based sample. Patient characteristics of age, gender, location, stage and number of positive nodes were compared for NCCN and SEER data in regards to number of nodes evaluated. Univariate logistic regression models were developed to identify factors associated with the 12 LN target at the NCCN. Factors evaluated were number of positive nodes, age, gender, comorbidity score, ECOG performance status, insurance, location, stage, surgery technique, and NCCN center. Results: As detailed in the Table , 89% of the 2005–6 NCCN sample and 45% of the SEER sample had at least 12 LN evaluated. For patients treated at NCCN centers, stage I compared to stage III (OR=0.20; 95% CI=0.08 to 0.48, p [Table: see text] No significant financial relationships to disclose.

1059 Background: We conducted a phase II multi-institutional trial of gefitinib and docetaxel as first-line treatment in patients with metastatic breast cancer. The primary objectives were to determine the clinical benefit rate (defined as the proportion of patients who experienced confirmed complete response or partial response or who had stable disease for at least 24 weeks) and the toxicity profile of the combination treatment. Methods: All patients had histologically confirmed breast cancer with metastatic disease. They may have received adjuvant chemotherapy, but no prior docetaxel or prior chemotherapy for metastatic disease. Patients received gefitinib 250 mg once daily and docetaxel 75 mg/m2 every 3 weeks, until tumor progression, toxicity or other reasons for discontinuation. Results: Between April 2003 and September 2004, 33 patients were enrolled at 11 participating institutions. Patients received a median of 5 cycles of treatment. The clinical benefit rate was 51.5% (95% CI: 33.5% - 69.2%). There was 1 confirmed complete response and 12 confirmed partial responses, and the overall objective response rate was 39.4% (95% CI: 22.9% - 57.9%). Four patients had stable disease for = 24 weeks. The median duration of clinical benefit was 10.9 months (95% CI: 6.0 - 17.6 months). The most common reason for study discontinuation was disease progression (16 patients), followed by toxicity (10 patients). Toxicities were mainly attributable to docetaxel, including = grade 3 neutropenia in 43% of patients. Conclusion: The combination of gefitinib and docetaxel is an active regimen in patients with previously untreated metastatic breast cancer. Further work is needed to determine which subset of patients with breast cancer will benefit from gefitinib. No significant financial relationships to disclose.

6111 Background: It has been proposed that ethnic neutropenia in African-American (AA) breast cancer patients leads to lower chemotherapy dose intensity (DI) compared to white (W) patients and hence to increased mortality from the disease [Hershman 2003]. Thomas et al. [2005] confirmed that AA patients in NSABP breast treatment trials had lower WBC and ANC than W counterparts and found that the total amount of chemotherapy received was no different in AA and W patients. The aim of the present study was to extend previous work to determine whether postop doxorubicin (A) and cyclophosphamide (C) DIs (as opposed to total doses) were lower in AA pts enrolled in NSABP breast cancer adjuvant treatment trials. Methods: Pooled data from AA and white (W) pts enrolled in NSABP trials B-15, B-16, B-18 (postop pts only), B-22, B-23, and B-25 (N=10,678 total: 1,040 AA pts and 9,638 W pts) were analyzed. Outcome measures were 1) total A received as a % of the total dose projected on the basis of BSA divided by total days of chemotherapy and 2) corresponding % of C divided by total days of chemotherapy. These quantities were compared in AA and W pts using ANOVA with adjustment for protocol, BMI, G-CSF use, C regimen (600mg/m2 ×4, 1200mg/m2 ×2, 1200mg/m2 ×2, 2400mg/m2 ×2, 2400mg/m2 ×4), and significant pairwise interactions among these variables. Results: After adjustment for the above-listed factors, AA was not a significant predictor of dose intensity for either A or C (p = 0.24 for both comparisons). Conclusions: This retrospective exploratory analysis suggests that despite lower baseline WBC and ANC, AA pts enrolled in these NSABP trials did not receive substantially lower A and C DI than did W pts. Recommending identical dose regimens for AA and W patients in AC-based breast treatment trials is thus most likely clinically reasonable. No significant financial relationships to disclose.

6002 Background: Ethnic disparities in mortality from breast cancer are multifactorial. Ethnic neutropenia may, in part, lead to decreased chemotherapy dose in African American (AA) pts [Hershman, ...

654 Background: The addition of adjuvant (ADJ) paclitaxel to N+ BC has been evaluated in 2 large randomized studies. NSABP B28 was first presented in NOV-2000. No survival benefit was reported. In ...