tbuckley/cabot-search huggingface dataset:
Low-dose chemotherapy with methotrexate and vinblastine for desmoid tumors: A single institution experience.
Authors: Juliana Souza, Henrique Monnerat Lourenco, Gelcio L. Q. Mendes
Journal: Journal of Clinical Oncology (2017)

e22524 Background: Desmoid tumor (DT) is a rare and locally invasive proliferative disease. Although, the absence of metastatic potential, it has the propensity for locally invasive growth and recur. Chemotherapy may be considered in inoperable and/or recurrent disease. Methods: Patients with histological diagnosis of DT and treated with weekly low-dose chemotherapy with vinblastine and methotrexate between January 1998 and December 2015 were identified and their medical records were analyzed. Results: Of 23 patients analyzed, most of them were women (female-to-male ratio 2.8:1). The median age at presentation was 29 years (range, 18-59 years). Tumors location was: thoracoabdominal wall (n: 11, 47.8%), extremities (n: 7, 30.4%), abdominal cavity (n: 1; 4 %), and head and neck (n: 4, 17.3%). Tumor sizes were documented in 18 cases and ranged from 3 to 20 cm in largest linear dimension (median, 10 cm). Eight (34.7%) female had pregnancy history and 2 (8%) had familial adenomatous polyposis history. Eleven (47,8%) underwent surgery as first-line treatment. Five (21.7%) patients received first-line treatment with vinblastine and methotrexate, four (17.3%) patients as second-line, and 14 (60.8%) patients as third and fourth-line. Fourteen ( 60.8%) patients had stable disease, four (17.3%) had partial response, and five (21.7%) patients had progressive disease during chemotherapy treatment. After a median follow-up of 58 months, 12 patients had progression disease and 2 patients died. The median PFS was 29 months, without any progression after 32 months. Conclusions: Weekly low-dose chemotherapy with vinblastine and methotrexate appears to have significant activity. Chemotherapy could be an acceptable alternative to radical surgery in selected patients with desmoid tumors.
Outcome of multiple myeloma patients with renal failure: A retrospective study.
Authors: Ramavath Devendra Naik, Lalit Kumar, Abhenil Mittal, Vineet Govinda Gupta, Mukesh Patekar, Prabhat Singh Malik, Santosh Kumar, Vishwajeet Singh
Journal: Journal of Clinical Oncology (2018)

e20026 Background: Renal insufficiency (RI) is seen in 20-30% of patients of multiple myeloma(MM) at presentation and is associated with inferior outcome. There is limited real-world data on the oncological and renal outcomes of such patients. Methods: Case records of MM patients diagnosed between 2012 and 2016, were analyzed. Patients with baseline serum creatinine ³ 2 mg/dl or eGFR < 40ml/min by MDRD equation were defined to have renal insufficiency. Among 300 patients registered in the ‘Myeloma clinic' 90 (30%) had RI at diagnosis. Nine patients died within 4 weeks of diagnosis. The remaining 81 patients comprised the study cohort. IMWG criteria was used to assess the myeloma response while MDRD formula was used to document the renal response. Patients who achieved an eGFR≥40ml/min were considered to have achieved renal recovery(RR). We compared the outcome between the two groups of patients with and without renal recovery. Results: Patients median age was 55.6 years (range, 35 to 86 years ), 43% were males. 78 (96.2%) patients with RI had ISS III. 46 patients (56%) achieved RR. Baseline characteristics are given in table 1. Study subjects received either bortezomib-based therapy (61%) or other drug combinations (39%). The proportion of patients who achieved RR were similar in patients treated with above two groups. 74% of patients achieved myeloma response; CR-20%,VGPR-18% and PR-36%. Patients with renal recovery achieved a better myeloma response (ORR, 89% VS 54 %, P = 0.004). At a median follow up of 37.5 months, median EFS of the cohort was 10.7 months. Patients whose renal functions recovered had longer EFS than patients without renal recovery. (15.5 vs 8.2 months, p = 0.0039) Conclusions: In MM patients with renal insufficiency at diagnosis, RR is associated with better myeloma response and improved EFS. RR is similar with bortezomib-based therapy or other drug combinations. Table 1: Baseline Characteristics Parameter MDRD ( < 40) n = 35 MDRD (≥40) n = 46 P VALUE Age 55.8 ± 10.7 55.67 ± 11.2 0.9 Gender 1.33 0.55 0.04 Male : Female Hypercalcemia ( > 11.5 mg/dl) (N = 29) 13 16 0.8 Serum Creatinine (mg/dl) 5.6 ± 3.8 3.4 ± 1.9 0.0012 Serum Albumin (g/dl) 3.43 ± 0.8 3.38 ± 0.92 0.7 Myeloma Type • Light Chain • Others N = 29 15 14 N = 43 16 (52%) 27 (66%) 0.22
Clinical characteristics and treatment outcomes of patients with pulmonary salivary gland-like tumors.
Authors: Jonathan Mizrahi, Pamela Parker Samson, Siddhartha Hk Devarakonda, Ashiq Masood, Ramaswamy Govindan, Feng Gao, Danielle Carpenter, Cliff Grant Robinson, Varun Puri, Daniel Morgensztern, Saiama Naheed Waqar
Journal: Journal of Clinical Oncology (2016)

8534 Background: Pulmonary salivary gland-like tumors (PSGLTs) are thought to arise from bronchial glands in the central airways. Due to their rare occurrence, there is limited data on demographics and outcomes in this patient population. We queried the National Cancer Database (NCDB) to identify patients with pulmonary salivary gland-like tumors and evaluated their clinical characteristics and treatment outcomes. Methods: Patients with PSGLTs diagnosed between 2004 and 2013 were identified among all patients with lung cancer registered in the NCDB. Demographic variables were summarized using descriptive statistics and Kaplan-Meier method was used to determine overall survival according to histology and in stage IV. Demographics and outcomes of patients with stage IV disease were compared to the Surveillance, Epidemiology and End Results (SEER) for metastatic non-small cell lung cancer (NSCLC) and salivary gland tumors (SGTs) diagnosed in the same period. Results: Among the 1,365,500 patients with lung cancer from NCDB in the study period, there were 1,028 patients (0.07%) with PSGLTs, including 396 (38.5%) with adenoid cystic carcinoma (ACC) and 632 (61.4%) with mucoepidermoid carcinoma (MEC). The median age of patients was 60 years (range 22-90) for ACC and 56 years (18-88 years) for MEC. The percentage of males was 53.3% with ACC and 50.8% of MEC. Stage distribution for ACC and MEC respectively were: I – 53.3% and 48.1%, II – 9.1% and 14.3%, III – 11.6% and 14.3%, IV 15.9% and 15.9%, unknown - 8.1% and 7.1%. The median survival and 5-year overall survival (OS) for all patients combined were 56.6 months (m) and 44.6% for patients with ACC and 57 m and 45% for MEC. The median and 5-year OS for patients with stage IV PSGLTs were 10.8 m and 13% respectively. In the SEER database, the percentage of patients with metastatic disease, and their median OS and 5-year OS were 48%, 5 m and 3% respectively for NSCLC and 5%, 16 m and 20% respectively for SGTs. Conclusions: Primary PSGLTs are rare tumors with an earlier stage at diagnosis and better outcomes compared to NSCLC. Median and 5-year OS in metastatic stage, however, were shorter compared to SGTs suggesting a different biology despite similar histology.
Relationship between sipuleucel-T (sip-T) cytolytic T lymphocyte (CTL) activity and overall survival (OS) in patients (pts) with metastatic castration resistant prostate cancer (mCRPC).
Authors: Charles G. Drake, Emmanuel S. Antonarakis, Daniel Peter Petrylak, David I. Quinn, Adam S. Kibel, Nancy N. Chang, Erica Dearstyne, Dwayne Campogan, Heather Haynes, Tuyen Vu, Nadeem Anwar Sheikh, Eric Jay Small
Journal: Journal of Clinical Oncology (2018)

5027 Background: Sip-T, an autologous cellular immunotherapy approved in the US for pts with asymptomatic/minimally symptomatic mCRPC, is produced by culturing peripheral blood mononuclear cells with the immunogen PA2024 (prostatic acid phosphatase [PAP] conjugated to granulocyte macrophage colony-stimulating factor). A biomarker that can identify mCRPC pts who are likely to respond well to sip-T may inform therapeutic decisions. PA2024 and PAP cellular and humoral immune responses induced by sip-T correlate with prolonged OS (Sheikh, CCI 2013;62:137). Robust CTL activity post sip-T treatment has been reported (Drake, ASCO 2017). We investigated the relationship between sip-T lytic activity (using CD107a expression, a cell surface surrogate marker) and OS in mCRPC pts. Methods: PA2024- and PAP-specific CD8+ T (CTL) cells expressing CD107a were identified via flow cytometry at baseline (BL, prior to sip-T infusion), and at 6 and 26 weeks (wks) post-sip-T in pts who were treated in 2 clinical trials (STRIDE: NCT01981122, n = 12 and STAMP: NCT01487863, n = 10), and 3 healthy volunteers (control). Results: CTL activity was significantly (p < 0.0001) increased in response to PA2024 and PAP at wks 6 and 26 post-sip-T vs BL. A strong correlation between PAP and PA2024-specific CTL activity was seen at wk 26 (Pearson’s R = 0.8973, p < 0.0001), but not at BL or wk 6. At wk 26, there were positive correlations between both PAP-specific CTL activity (R = 0.5187, p = 0.0134) and PA2024-specific CTL activity (R = 0.6735, p = 0.0006) and OS. Median OS for pts with PAP- or PA2024-specific CD107a expression above or below the median CTL activity at 26 wks was 37.1 and 25.2 months, respectively. Conclusions: These analyses demonstrate that sip-T induces a robust PAP-specific CTL activity, indicative of tumor lytic activity, which is positively correlated with prolonged OS in mCRPC pts. This finding is a significant addition to the elucidation of the mechanism of sip-T induced immune responses and OS benefit. Clinical trial information: STRIDE: NCT01981122, STAMP: NCT01487863.
Impact of surveillance-detected metastatic recurrence on treatment outcomes of high-risk melanoma.
Authors: Michael Ong, Melanie Lemay, Xinni Song, Horia Marginean, Carolyn Nessim, Andrea Ibrahim
Journal: Journal of Clinical Oncology (2018)

e21612 Background: While patients (pts) with high-risk resected melanoma often undergo surveillance imaging, it is unknown whether detection of recurrence in an asymptomatic (ASx) state improves outcomes in the era of immune checkpoint inhibitors (ICIs: aPD1, aCTLA4) or targeted treatment (tx) (BRAFi, MEKi). Methods: Pts with resected malignant melanoma, AJCC (7th ed) stage IIB-IIIC diagnosed Jan 2006-Jan 2016, who underwent imaging surveillance at The Ottawa Hospital Cancer Centre were identified. Pt, tumor, and tx characteristics were retrospectively collected, including ASx vs symptomatic (Sx) status at recurrence. Univariate (t-test, χ2), multivariate, and Kaplan-Meier analyses were conducted. Results: 355 pts were identified (IIB 24%, IIC 19%, IIIA 27%, IIIB 16%, IIIC 14%); 28% received adjuvant tx. 162 (46%) pts developed metastases: 78 ASx and 78 Sx pts < 5yrs, and 6 pts > 5yrs. ASx vs Sx groups did not differ by AJCC stage, primary site, age, BRAF status, or adjuvant tx (p = NS). ASx recurrence was detected by CT (55.7%), PET-CT (27.8%), US or CXR (11.4%), and MRI (5.1%). ASx vs Sx pts had similar time to recurrence (Table 1), except Sx IIC pts who had longer imaging intervals (6.5 vs 2.9 mo, p = 0.015), longer time from last clear scan (15.5 vs. 5.2 mo p = 0.005), and lower ICI tx rates (13 vs 45%, p = 0.049). ASx pts received more systemic tx (66 vs 49%, p = 0.04), more ICI tx (48 vs 27%, p = 0.004), and similar BRAF-MEK tx (8 vs 12%, p = 0.342). ASx pts had better survival outcomes (Table 1), particularly with anti-PD1 tx where both 2- and 3-year landmark survival were superior (56 vs 43%; 56 vs 43%, p = 0.001). Conclusions: Our real-world data supports intensified surveillance imaging of high-risk resected melanoma, since asymptomatic detection of metastases was associated with higher rates of systemic treatment and improved survival outcomes. Median Time to Event/Censor (mo) ASx n = 79 Sx n = 83 Log-rank p-value Diagnosis to recurrence 14.2 15.9 0.154 Surveillance to recurrence 10.8 12.0 0.727 Last clear scan to recurrence 4.1 4.3 0.248 Recurrence to death 17.7 5.1 < 0.001 Recurrence to death (ICI-treated pts) 25.1 8.5 0.025 Surveillance to death 37.2 21.5 0.035
Icotinib as first-line or maintenance therapy in patients with advanced lung adenocarcinoma with positive EGFR mutation and the influence of cytokines shift on survival.
Authors: Shengjie Sun, Shun Chang Jiao, Jian Fang, Qiong Sun, Jindi Han, Wei Liu, Chunmei Bai, Fenlai Tan, Lieming Ding
Journal: Journal of Clinical Oncology (2017)

e20658 Background: To compare the efficacy of first-line icotinib or chemotherapy plus icotinib maintenance in EGFR-mutated NSCLC patients, and analyze the correlation between changes in cytokine levels and survival. Methods: Treatment-naive patients with EGFR-mutated NSCLC were enrolled and randomly assigned to recieve icotinib or 2- or 4-cycle chemotherapy (pemetrexed + platinum [PP] or docetaxel + platinum [DP]) with icotinib maintenance. The primary endpoints were progression-free survival (PFS). Plasma samples were collected at baseline and after 6-week treatment. Cytokines, including interleukin-2 (IL-2), interleukin-6 (IL-6), transforming growth factor (TGF), programmed death (PD) 1, PD-ligand (PD-L) 1, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4), and hypoxia-inducible factor-1 (HIF-1), were tested by ELISA. Results: 66 eligible patients were enrolled (November, 2011 to June, 2016), in which 56 patients were treated, including 20 patients receiving icotinib [PFS: 8.17 months (5.5-13.97)], 11 patients receiving 2-cycle chemotherapy (DP) followed by icotinib maintenance [PFS: 12.07 (6.2-12.83)], 10 patients receiving 2-cycle chemotherapy (PP) followed by icotinib maintenance [PFS: 15.37 (4.03-NR)], 4 patients receiving 4-cycle chemotherapy (DP) followed by icotinib maintenance [PFS: 15.37 (7.13-NR)], 9 patients receiving 4-cycle chemotherapy (PP) followed by icotinib maintenance [PFS: 13.82 (1.5-22.93)]. Samples were collected from 20 patients. The shift of level was seen in all cytokines and multivariate analysis showed that the change of IL-6, HIF, PD-L1, and PD1 were associated with significantly longer survival in patients with EGFR-mutated NSCLC. Conclusions: First-line chemotherapy plus icotinib maintenance seems to offer better efficacy in advanced NSCLC patients with EGFR mutation. The shift of level of IL-6, HIF-1, PD 1, and PD-L1 in peripheral blood correlates with a better prognosis, however, further study with larger size is warranted to detect the potential role of immune response in regulating survival of patients with EGFR-mutant NSCLC. Clinical trial information: NCT01665417.
Development of 3-item questionnaire for preoperative evaluation of older cancer patients.
Authors: Armin Shahrokni, Amy Tin, William N. Aiken, Andrew J. Vickers, Beatriz Korc-Grodzicki
Journal: Journal of Clinical Oncology (2017)

e21543 Background: Our study aims at developing a very short screening questionnaire for the preoperative evaluation of older cancer patients in the surgical clinics. Methods: Our study was based on 47-item electronic Rapid Fitness Assessment (eRFA) data presented last year (Shahrokni, et al. (J Clin Oncol 34, 2016 (suppl; abstr 10011). Frail patients were defined as having any of these criteria: Cognitive impairment (Mini-Cog &lt; 3), basic or instrumental activities of daily living dependency, Karnofsky Performance Score ≤80, occurrence of fall in the past year, high level of distress (distress thermometer score ≥7), or Timed Up and Go test ≥ 10 seconds. The dataset was split 2/3 for training set and 1/3 for validation set. The sets were matched based on age and gender. Decision Curve Analysis (DCA) was preformed to assess the clinical utility of different models. Results: Based on a dataset of 1076 older cancer patients who completed the eRFA for preoperative evaluation in the geriatrics clinic, five models of 3 or 4-items showed to have the highest accuracy ( &gt; 78%). For example, one 3-item questionnaire (difficulty with bladder and bowel control, fall in the past year, limitation of walking outside home) was able to identify 100% of non-frail patients and 73% of frail patients. If we use this model in the surgical clinic with a presumed 36% incidence of frailty among 1000 potential patients, the model can correctly indentify 266 out of 363 frail patients and all 637 fit patients who may and may not benefit from referral to geriatrics clinic, respectively. Using the validation set, the sensitivity and specificity of the model remained high and we confirmed the utility of the 3-item questionnaire on decision analysis. Conclusions: We identified a 3-item questionnaire to be used as a screening tool to identify frail and fit older cancer patients. Implementation of the tool is needed to evaluate whether it is useful in distinguishing older cancer patient in surgical clinic for geriatric referral. If effective, further studies should look into correlation between this questionnaire and surgical outcomes.
Longitudinal patient-reported symptom severity and symptom interference with activity-related and mood-related functioning and survival in patients with advanced cancer on early-phase clinical trials of immunotherapeutic or targeted agents.
Authors: Goldy George, Tito R. Mendoza, Eucharia Chiege Iwuanyanwu, Qiuling Shi, Sarina Anne Piha-Paul, Loretta A. Williams, Daniel D. Karp, Aung Naing, Filip Janku, Raza H Bokhari, Xin Shelley Wang, David S. Hong, Charles S. Cleeland
Journal: Journal of Clinical Oncology (2018)

10119 Background: We examined longitudinal changes in symptom severity and symptom interference with activity-related (WAW: work, general activity, walking) and mood-related (REM: relations with others, enjoyment of life, mood) functioning and their association with overall survival in patients with advanced cancer in early-phase clinical trials of immunotherapeutic and targeted agents. We also examined effects of therapeutic class. Methods: Patients completed the MD Anderson Symptom Inventory (MDASI) at baseline (within 1 day before start of an early-phase clinical trial), and twice-weekly assessments thereafter for 60 days. Linear mixed models and Cox proportional hazards modeling with time-dependent covariates were used. Results: 579 MDASI questionnaires were completed by 40 patients (mean age 57y, 50% male) on trials of targeted agents (50%) or immune mono/combination therapy (50%). At least 1 severe symptom (≥7 on 0-10 scale) was reported by 55% of patients and the most frequent severe symptoms were pain (28% of patients), fatigue (25%), disturbed sleep (25%), distress (18%), dry mouth (18%), drowsiness (15%), and lack of appetite (15%). Skin rash (P < 0.00) and symptom interference with WAW (P < 0.001) and REM (P = 0.024) worsened from baseline to Day 60. From baseline to last completed MDASI, worsening by ≥2 points (0-10 scale) was seen in 28% of patients for WAW and 15% of patients for REM; improvement by ≥ 2 points was seen in 8% of patients for WAW and 5% of patients for REM. Targeted therapy was associated with worse fatigue (P = 0.039), drowsiness (P < 0.001), disturbed sleep (P = 0.014) and lack of appetite (P < 0.001); immune therapy was associated with worse REM (P = 0.042). Worsening of composite symptoms, WAW, or REM was associated with lower overall survival (P < 0.001 for each). Conclusions: Symptom burden trajectories varied by class of therapeutic agent. Longitudinal symptomatic assessments during early-phase clinical trials can provide a fuller view of patients’ symptomatic experience and facilitate needed supportive care.
Outpatient evaluation following emergency department presentation concerning for underlying malignancy.
Authors: Onita Bhattasali, Sara Chen, Renzhong Ran, Sanket Borgaonkar, Margaret Griffin Crawford, Martha P. Mims, Cedric Dark
Journal: Journal of Clinical Oncology (2016)

e18004 Background: Cancer diagnoses frequently emerge from the emergency setting yet limited literature is published describing this phenomenon. We identified patients who presented with symptoms suspicious for cancer to a large county emergency department (ED) with over 100,000 annual visits. Patient compliance with our internal referral clinic (IRC) and malignancy work-up outcomes are reported. Methods: A retrospective chart review was conducted between March 2013 and May 2015. ED presentations suspected of harboring underlying malignancy with subsequent referral to the IRC were included in our analysis. Univariate analysis was performed using t-test for patient outcomes. Institutional review board approval was obtained. Results: Three hundred and thirty-four patients were referred to the IRC and included in our final analysis. The mean (range) age at presentation was 52 (15-87). The majority of patients were uninsured (71.0%) and did not have a primary care physician (PCP) (73.1%). Seventeen (5.1%) patients were referred for an incidental finding, 8 (47.1%) of which were diagnosed with cancer. Over 80% of patients exhibited compliance with the referral system and presented to the IRC for further evaluation. The most common cancers diagnosed in patients without a PCP in order of frequency were breast, colorectal, and lung whereas in patients with a PCP were lung, breast, and pancreas. Patients without a PCP were more frequently diagnosed with cancer (59.2 vs. 51.7%, p = 0.2184), as were uninsured patients (58.8 vs. 52.6%, p = 0.2999). Conclusions: A high level of compliance was observed with the IRC with over 4 out of 5 patients presenting for further work-up. Patients without a PCP were more likely to be diagnosed with cancer, and the most common cancers diagnosed in these patients were those with nationally established screening protocols. Patients with more advanced or emergent presentations requiring inpatient admission were not captured in this study, and inclusion of these patients may have influenced findings. Further analysis will provide insight into which factors are associated with initial presentation to the ED with features suspicious for underlying malignancy.
TCT-838 The Changing Landscape of Aortic Valve Replacement in the United States: Insights from a National Database
Authors: Tanush Gupta, Dhaval Kolte, Sahil Khera, Kashish Goel, Pedro Villablanca, Poonam Velagapudi, Divyanshu Mohananey, Ankur Kalra, J. Dawn Abbott, Sammy Elmariah, Gregg Fonarow, Chet Rihal, Giora Weisz, Deepak Bhatt
Journal: Journal of the American College of Cardiology (2018)