tbuckley/cabot-search huggingface dataset:
Patient-reported distress screening outcomes in breast cancer.
Authors: Bridget Smart, Laura Vallow, Laeticia Hollant, Megan Single, Katherine Gaines, Jacob Habboush, Heather Biers, Atiya Day, Katherine S. Tzou, Robert Clell Miller
Journal: Journal of Clinical Oncology (2015)

79 Background: A significant percentage of cancer patients experience psychosocial distress with the highest prevalence observed in breast cancer patients. The importance of psychosocial distress screening and assessment in women with breast cancer has clearly been established. Patients in our clinic are screened for distress. The results were reviewed in an attempt to better understand the psychosocial distress of breast cancer patients undergoing radiotherapy. Methods: Patients treated curatively for breast cancer prospectively completed the 30 question patient reported distress (PRD) survey that also included a linear analog measure of overall distress. The recorded clinical results of the PRD survey were retrospectively assessed in patients receiving breast radiotherapy from June 1, 2013 to February 2, 2015. Results: Completed PRD questionnaires were available on 179 female patients. 21 (12%) were treated for ductal carcinoma in situ and 91 (51%), 35 (20%), and 32 (18%) were treated for invasive carcinoma Stages I, II, and III. 85 (47%) received chemotherapy. Overall distress ranged from 0 to 10, with a median value of 5. Mean distress scores per category ranged from a low of 1.25 to a high of 2.52. Top concerns in descending order of importance were: “How will I feel during treatment” (2.52), “Fatigue” (2.46), “Sleep difficulties” (2.32), “How will I feel about appearance related to treatment” (2.23), &amp; “Pain that affects daily functioning” (2.19). Least distressing symptoms “Spirituality” (1.25), “Housing during treatment” (1.26), “Control of anger” (1.28), “End of life concerns” (1.32), &amp; “Transportation” (1.34). Conclusions: Distress over tumor related issues ranked low among women’s concerns in comparison to distress related to the side effects of therapy concerning treatment related discomfort, fatigue, and changes in appearance, and anxiety. Pain was a significant concern, although in this group of patients receiving definitive, adjuvant or neoadjuvant therapy, this was likely related to treatment associated discomfort rather than from disease progression. These findings highlight the importance of careful patient education and communication of the expected symptoms and effects of therapy.
Sequencing of treatments in metastatic CRPC for patients who have completed all therapeutic interventions.
Authors: Allie E. Steinberger, Elisa M. Ledet, Allison H. Feibus, Vikram J. Premkumar, Aryeneesh Dotiwala, Michael D. Stolten, Brian E. Lewis, A. Oliver Sartor
Journal: Journal of Clinical Oncology (2016)

339 Background: The current treatment paradigm for metastatic, castrate-resistant prostate cancer (mCRPC) has rapidly changed and six therapies [abiraterone (Abi), enzalutamide (Enza), docetaxel (Doc), cabazitaxel (Cab), radium-223 (Ra-223), and sipuleucel-T (Sip-T)] have now been proven to prolong overall survival. Though sequential therapy is the norm, few studies have reported on the variety and prevalence of these agents over the course of patient's lifetime. Herein, we sought to describe the temporal frequencies of mCRPC therapies in patients who completed all of their therapies. Methods: Retrospective chart reviews were conducted on 119 patients who died from mCRPC at Tulane Cancer Center from 2008-2015 (thus completing all possible therapies). Many patients were not treated with multiple life-prolonging therapies given the timing of their death. Post-mCRPC therapies were longitudinally sequenced and a frequency table was generated for first, second, third, etc. line of therapies. Results: Median duration from initial androgen deprivation therapy to mCRPC was 29 months (range: 0-252) and 34.4% of the cohort presented with distant metastatic disease (M1) at diagnosis. The most common front line mCRPC therapies were nilutamide, Doc, Abi, and ketoconazole (Keto) in that order. Keto, Doc, dexamethasone, and Abi were the most common second line therapies. Abi, Doc, DES, and Cab were the most prevalent third line therapies. Doc, Abi, Cab, and Ra-223 were most common fourth line therapies. The median overall survival for our cohort was 69 months (range: 5-270 months) from initial diagnosis. Conclusions: This retrospective analysis provides a temporal snapshot of the timing and frequency of treatments for men dying from mCRPC from 2008-2015. More recent patients are likely to have greater access to contemporary therapies.
Association of increased lymphocyte infiltration with outcome in patients with head and neck cancer treated with the IRX-2 regimen.
Authors: P. Naylor
Journal: Journal of Clinical Oncology (2011)

5588 Background: We have recently completed a single arm open label trial of neoadjuvant IRX-2 in patients with surgically resectable head and neck cancer. The objective of this analysis was to document the immunologic effects of IRX-2 in the resected tumor tissue. Methods: Twenty-five subjects with squamous cell cancer of the head and neck (H&NSCC) received neoadjuvant IRX-2 immunotherapy regimen prior to surgery in a Phase 2 trial. IRX-2 is a primary cell-derived biologic with multiple cytokine components administered subcutaneously for 10 days following an infusion of low dose cyclophosphamide (CY) (Day 1) and oral daily indomethacin (INDO) and zinc in multivitamins. Pre-treatment tumor biopsies were compared with the primary tumor surgical specimen for lymphocyte infiltration, necrosis, fibrosis, and tumor reduction using hematoxylin and eosin stain (H&E) and immunohistochemistry (IHC) for a variety of lymphocyte markers. Results: When the tumor was evaluated at surgery compared to pretreatment biopsy, an increase in lymphocyte infiltration (LI) as assessed on H&E stained sections was noted by all three pathologists reading the specimen. An increase in fibrosis, necrosis and a decrease in tumor was also noted. The infiltration was more prominent when assessed using immunohistochemistry and the increase was in both the CD3 (T cells) and CD20 (B cells). When location was assessed in the surgical tumor specimen, the increase in CD3+CD4+T cells and CD20+ B cells was mainly peritumoral and the increase in CD3+CD8+ T cells and CD68 macrophages were mainly intratumoral. Overall LI in the tumor at surgery was associated with x-ray assessed decreases in tumor size, clinical sign and symptom improvement and increase survival. Conclusions: We conclude that IRX-2 has the potential to increase the intra and peri-tumor infiltration of immune effector cells by generating an immune response, presumably to endogenous tumor antigens. Based on the data presented here, this appears to correlate with immune mediated tumor response in as many as 80% of subjects.
How can palliative care specialists best integrate into multidisciplinary oncology care for patients with metastatic breast cancer?
Authors: Tara Laura Kaufmann, Melissa F Miller, Joanne S. Buzaglo, Arif Kamal
Journal: Journal of Clinical Oncology (2016)

182 Background: Current evidence for palliative care/oncology integration derives from cancers with either very short prognoses or relatively limited treatment options (e.g. pancreas). Little is know about the role of palliative care in metastatic breast cancer, where prognosis may be measured in years and the treatment option portfolio is continuously expanding. Methods: The Cancer Support Community Metastatic Breast Cancer Experience Registry is a voluntary, patient-reported, online registry of patient experiences with cancer. We evaluated data reported by patients from March 2013 to March 2014. The registry includes demographic information and data regarding physical, emotional, social, and financial distress measured using Likert scales. We calculated descriptive statistics and Pearson’s chi-squared. Results: We evaluated 599 patients. The sample median age was 56; 93% were White; 61% had a bachelor’s degree or higher Median time from diagnosis of metastatic cancer was 3 years. Regarding physical distress, over 50% reported “moderate” or higher issues with sleep, nutrition and eating, and fatigue. Depression and anxiety prevalence increased by 15% and 20%, respectively, from pre-treatment to post-treatment. Among social distress, 25% felt alone, 62% worried about burdening their family, and over 50% limited contact with others. 30% or higher desired more assistance with: diagnostic and treatment information, making decisions, managing symptoms and emotions, and managing disruptions to family and work life. Respondents were more likely to have been asked about distress if they received part or all of their care at an academic or comprehensive cancer center (p &lt; 0.001) or treatment through a clinical trial (p = 0.012). Conclusions: We identified a high prevalence of unmet needs across several supportive care domains. These areas of distress should be a targeted focus of palliative care and oncology integration to improve the care of patients with metastatic breast cancer.
The effects of treatment on sexual function of patients with operable breast cancer.
Authors: N. Besic, H. Burger
Journal: Journal of Clinical Oncology (2011)

e19588 Background: In women with operable breast carcinoma the prevalence and severity of problems with sexual functions is not well defined. The aim of this prospective study was to find out the factors associated with changes in sexual life of breast cancer patients. Methods: A total of 128 women aged 31 to 83 years (mean age 58 years) with breast cancer were anonymously surveyed one day before surgical treatment and 9-12 months after treatment through questionnaires WHO DAS II, WHOQoL-8 and EORTC QLQ – BR23. The results of patients’ interviews were statistically analysed using nonparametric McNemar Test or Wilcoxon Signed Rank test. Results: Breast conserving therapy and mastectomy was performed in 52% and 48%, respectively. Adjuvant treatment comprised chemotherapy, hormonal therapy and irradiation of breast region in 39%, 55% and 42% of cases. Problems in sexual life before surgery and 9-12 months thereafter were reported in 16% and 37% of cases, respectively. Younger patients had more sexual problems than older ones after the treatment (<40 years of age 55%, 40-50 years 43%, >50 years 23%). The patients had the same interest in sex before and after the treatment. Furthermore, the frequency of sexual activity (with or without intercourse) did not change and the extent of sex enjoyable for them did not differ before and after the treatment. But a patient felt more often dissatisfaction with her body, a difficulty to look at herself naked, being less attractive and less feminine after the treatment than beforehand. The patients after mastectomy felt more often less feminine than those after breast conserving procedure. Conclusions: Many breast cancer patients feel changes in sexual life due to factors related to treatment. The patients who were younger and who had mastectomy had more problems in sexual life than older patients with breast conserving therapy.
High Complete Response Rates with Dose Dense/Dose Intense Chemotherapy Plus Radioimmunotherapy in High Risk Diffuse Large B Cell and Mantle Cell Lymphoma
Authors: Anne W Beaven, David A. Rizzieri, Zachary Powell, Zhiguo Li, Peggy Alton, Julie Warzecho, Louis F. Diehl, Joseph O. Moore, Carlos Manuel de Castro, Jon P. Gockerman
Journal: Blood (2011)
Subgroup analyses of METEOR, a randomized phase 3 trial of cabozantinib versus everolimus in patients (pts) with advanced renal cell carcinoma (RCC).
Authors: Bernard J. Escudier, Robert J. Motzer, Thomas Powles, Nizar M. Tannir, Ian D. Davis, Frede Donskov, Viktor Grünwald, Daniel Yick Chin Heng, Thomas Hutson, Bohuslav Melichar, Dimitry Nosov, Brian I. Rini, Pamela Salman, Cora N. Sternberg, Cezary Szczylik, Pascal Wolter, Alan M Arroyo, Milan Mangeshkar, Neeraj Agarwal, Toni K. Choueiri
Journal: Journal of Clinical Oncology (2016)

499 Background: Cabozantinib (C) inhibits tyrosine kinases including VEGFRs, MET, and AXL. The METEOR phase 3 trial (NCT01865747) met its primary endpoint of significant improvement in PFS with C versus everolimus (E) in pts with advanced clear cell RCC and prior exposure to VEGFR TKIs (7.4 mo median PFS [C] vs 3.8 mo [E], HR = 0.58, 95% CI, 0.45 to 0.75; p &lt; 0.001). The improvement in PFS was accompanied by a significant improvement in ORR and a trend for improved OS at an interim analysis. Safety profiles of C and E in this trial were similar to prior experience with each drug in this pt population. This analysis further evaluates PFS and ORR across pt subgroups. Methods: Pts had advanced RCC with clear cell component, measurable disease per RECIST 1.1, KPS ≥ 70%, and were stratified by MSKCC prognostic criteria and number of prior VEGFR TKIs. Pts must have progressed during treatment or within 6 months of the last dose of their most recent VEGFR TKI. 658 pts were randomized 1:1 to receive C (60 mg QD) or E (10 mg QD). The primary endpoint was PFS among the first 375 pts randomized. ORR was a secondary endpoint. Results: In the PFS group, 187 pts were randomized to C and 188 to E. 73% pts had 1 and 27% pts ≥ 2 prior VEGFR TKIs; 43% pts had favorable, 41% intermediate, and 15% poor risk by MSKCC criteria. Across multiple subgroups defined by baseline characteristics, PFS HRs favored C over E. PFS HRs were similar for subgroups defined by prior number of TKIs (HR = 0.56 [1 prior] and 0.67 [ ≥ 2 prior]), and showed higher activity of C over E in pts with fewer MSKCC risk factors (HR = 0.54 [0 factors], 0.56 [1 factor], 0.84 [ ≥ 2 factors]) or with metastases in various organs (HR = 0.47 [lung mets], 0.53 [liver mets], 0.50 [bone mets]). Detailed analysis of the clinical activity of C and E (PFS and ORR) across pt subgroups will be presented, including treatment duration with first VEGFR TKI ( &lt; or ≥ 6mo), receipt of prior anti-PD1/PDL1 agents, time to progression after most recent TKI ( &lt; or ≥ 3mo), and frequency/location of metastases. Conclusions: The METEOR trial met its primary endpoint of improved PFS, and subgroup analyses of the endpoints PFS and ORR generally favored C over E in patients with advanced RCC. Clinical trial information: NCT01865747.
Exploration of patient anxiety 1 year after surgery for breast cancer.
Authors: S. A. McLaughlin, S. P. Bagaria, J. H. Nguyen, M. Arnold, N. N. Diehl, T. Gibson, J. Crook, A. S. Parker
Journal: Journal of Clinical Oncology (2011)

e19590 Background: Women treated surgically for breast cancer (BrCa) can experience anxiety that affects their quality of life (QoL), sexual function, mood and even tumor-specific immune response. What remains unclear however is whether or not this anxiety correlates with known predictors of BrCa patient outcome. To address this, we completed a pilot study to explore associations of anxiety and clinicopathologic features in women one year after BrCa surgery. Methods: We prospectively identified 72 women with Tis-T3 BrCa who had surgery between 12/2008 and 12/2009. All patients completed the FACT-B questionnaire at one year. We determined anxiety based on response to the question “I worry my condition will worsen” and categorized anxiety as ‘none’ or ‘some’(a little bit to very much). We abstracted information on demographic and clinical covariates from our BrCa Registry and made comparisons using Kruskal-Wallis test or Kendall’s tau correlation. Results: At one year, 24 (33%) women reported no anxiety and 48 (67%) reported some anxiety. With issues of sample size in mind, women who reported anxiety were more likely to have DCIS compared to women who reported no anxiety (55% vs. 4%; p=0.04). Further, we noted little evidence that anxiety was associated with tumor size (p=0.23), positive nodes (p=0.97), lymphovascular invasion (p=0.23), type of surgery (BCT or mastectomy) (p=0.86), receipt of chemotherapy (p=0.55), or marital status (p=0.59). Interestingly, many women reporting anxiety had favorable pathologic features as 47% had tumors <2cm, 61% had negative nodes, and 71% had ER+/Her2 negative tumors. Conversely, of women reporting no anxiety, 30% had grade 3 tumors, 23% had >4 positive nodes, and 8% had tumors >5cm. Conclusions: In our pilot study, 67% of women having surgery for BrCa report some disease-specific anxiety at one year; however, anxiety does not correlate with clinicopathologic factors associated with prognosis. Given the documented adverse affects of anxiety, further investigation is warranted. Ideally, improving our understanding of BrCa-specific anxiety would allow for targeted interventions to allay fears in women with a favorable prognosis and provide coping strategies for women with more aggressive disease.
Randomized, phase II trial comparing continuous versus intermittent capecitabine monotherapy for metastatic breast cancer (MBC)
Authors: M. Martín, L. Calvo, N. Martínez, M. Ramos, M. Muñoz, P. Zamora, B. Hernando, A. Casado, J. A. García-Saenz, J. Puente
Journal: Journal of Clinical Oncology (2009)

1086 Background: The approved capecitabine (X) regimen in MBC is 1,250 mg/m 2 bid, d1–14 q21d (X int ). However, dose modifications are often required primarily for hand-foot syndrome and diarrhea. Therefore we designed an alternative regimen aimed to reduce the severity of these side effects while maintaining the total cumulative dose and efficacy of X. Methods: The primary objective was to show non-inferiority of X 800 mg/m 2 bid, d1–21 q21d (X cont ) to X int in terms of 1-year PFS rate. Secondary endpoints included response rate (RECIST), PFS, duration of response, OS, and safety (NCI CTCAE v2.0). Assuming median PFS of 5 months and 2-sided α=0.05, 176 evaluable patients (pts) will be needed to give 80% power. Pts are ineligible if they have received &gt;2 chemotherapy regimens for MBC or prior X, or if they have HER2-positive MBC or symptomatic CNS metastases. Treatment is continued until progression, unacceptable toxicity, or refusal. Dose interruption/reduction is implemented if pts experience grade 2–4 clinically relevant adverse events. Results: The current interim analysis includes the first 60 pts, with median age 55 years (range 33–79) in the X cont arm and 67 years (range 34–88) in the X int arm. 26% and 14%, respectively, were hormone receptor negative. Prior chemotherapy included a taxane in 48% vs 52% and an anthracycline in 65% vs 76%, respectively. X was given as first-line chemotherapy in 48% and 38% of pts, respectively. Median duration of treatment was 7 cycles for X cont vs 6 cycles for X int . Dose reduction was required in 10% of cycles in each arm. Toxicity led to treatment discontinuation in 1 vs 8 pts, respectively. Activity and safety results at interim analysis are summarized below (Table). Conclusions: X cont and X int seem similarly active in MBC in this interim analysis. X cont appeared slightly better tolerated. The study will continue recruiting additional pts. [Table: see text] No significant financial relationships to disclose.
An exploratory analysis of transfusion risk when initiating darbepoetin alfa (DA) therapy at baseline hemoglobin (Hb) &lt; 9 g/dl vs 9 to &lt; 10 g/dl versus ≥ 10 g/dl in patients (pts) with chemotherapy-induced anemia (CIA).
Authors: J. R. Canon, J. F. Vansteenkiste, M. Hedenus, P. Gascon, C. Bokemeyer, H. Ludwig, J. B. Vermorken, J. C. Legg, K. R. Bridges, B. Pujol
Journal: Journal of Clinical Oncology (2010)

9077 Background: DA is an erythropoiesis-stimulating agent (ESA) approved in the US and EU to treat CIA based on controlled studies showing a reduction in transfusion needs and an increase in Hb levels. Due to recent ESA safety concerns, a Hb level of 10 g/dL for ESA initiation was recently instituted for CIA pts. Here we show an exploratory analysis of phase III trial data stratified by the baseline Hb (< 9 g/dL vs 9 to < 10 g/dL vs ≥ 10 g/dL) at DA initiation in CIA pts. Methods: Pts with CIA (Hb < 11 g/dL), nonmyeloid malignancies, and ECOG performance status ≤ 2 were randomized to DA 500 mcg Q3W or DA 2.25 mcg/kg QW for 15 weeks. Pts with Hb ≤ 8 g/dL or anemia symptoms could receive transfusions. A prior trial report showed DA 500 mcg Q3W was non-inferior to 2.25 mcg/kg QW for reducing transfusions from week 5 to end-of-the-treatment period (EOTP) (the primary endpoint). The current exploratory analysis examined transfusion, Hb, and safety outcomes by baseline Hb at DA initiation. Results: Of 705 randomized pts, baseline Hb was < 9 g/dL in 126 pts (18%), 9 to < 10 g/dL in 225 pts (32%), and ≥ 10 g/dL in 354 pts (50%). With each lower Hb stratum of DA initiation, transfusion rates progressively increased while the percentage of pts with a 1 g/dL Hb rise in 14 days (with no transfusions) progressively decreased (Table). Incidence of deaths was highest in the < 9 g/dL Hb group while incidence of venous thromboembolic events (VTEs) was highest in the ≥ 10 g/dL Hb group. Conclusions: Transfusion rates with DA use progressively increased with lower Hb levels at DA initiation. Starting DA close to 10 g/dL Hb may reduce transfusion risk when following recommendations to initiate ESAs at a Hb level ≤ 10 g/dL. Baseline Hb at DA initiation < 9 g/dL (N = 126) 9 to < 10 g/dL (N = 225) ≥ 10 g/dL (N = 354) K-M % transfusions, week 1 to EOTP (95% CL) 62 (54,71) 35 (29,42) 19 (15,24) K-M % transfusions, week 5 to EOTP (95% CL) [N] 55 (46, 65) [119] 30 (24, 37) [212] 17 (13, 21) [341] 1 g/dL Hb rise in 14 days, n (%) 59 (47) 143 (64) 252 (71) Serious adverse events, n (%) 64 (51) 94 (42) 115 (32) VTEs, n (%) 7 (5.6) 10 (4.4) 24 (6.8) Deaths on study, n (%) 24 (19) 32 (14) 34 (10) Abbreviation: K-M, Kaplan-Meier. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen, Amgen Europe GmBH Amgen Amgen Amgen, Hospira, Ortho Biotech, Sandoz Amgen Amgen