tbuckley/cabot-search huggingface dataset:
Initial reliability and validity of the childhood trauma interview: a new multidimensional measure of childhood interpersonal trauma
Authors: L A Fink, D Bernstein, L Handelsman, J Foote, M Lovejoy
Journal: American Journal of Psychiatry (1995)

The Childhood Trauma Interview, a new instrument for brief and comprehensive retrospective assessment of childhood interpersonal trauma, is presented with initial evidence of its reliability and validity.Drug- or alcohol-dependent patients (N = 220) were given the Childhood Trauma Interview and a questionnaire measure of child abuse, the Childhood Trauma Questionnaire. Convergent and discriminant validity for the Childhood Trauma Interview were tested by comparing correlations between analogous and nonanalogous trauma scales to those of the Childhood Trauma Questionnaire.Interrater reliability for the majority of trauma dimensions measured by the Childhood Trauma Interview was very high (63% had intraclass correlations above 0.90). Principal-components analysis yielded six rotated factors that accounted for 74% of the variance among scores: separations and losses, physical neglect, emotional abuse or assault, physical abuse or assault, witnessing violence, and sexual abuse or assault. Since these six factors exactly represented the areas that the interview was designed to assess, the construct validity of the Childhood Trauma Interview was supported. Without exception, convergent correlations were significantly higher than discriminant correlations, and convergence was improved when multidimensional variables from the Childhood Trauma Interview and their interactions were regressed onto Childhood Trauma Questionnaire scores.These initial findings suggest that the Childhood Trauma Interview is a reliable and valid method for brief assessment of multiple dimensions of six types of childhood interpersonal trauma.
A phase II study of chemoradiation followed by adjuvant temozolomide and poly-ICLC in patients with newly diagnosed glioblastoma: 12- and 18-month survival data (NABTT 0501)
Authors: M. R. Rosenfeld, M. Chamberlain, S. A. Grossman, D. M. Peereboom, G. J. Lesser, T. T. Batchelor, S. Desideri, A. M. Salazar, X. Ye
Journal: Journal of Clinical Oncology (2009)

2002 Background: Polyinosinic-polycytidylic (poly-ICLC), is a double-stranded RNA that stimulates a variety of host defense mechanisms including T-cell and natural killer cell activation, cytokine release and specific anti-proliferative and anti-viral effects. The objective of this study was to determine the safety and efficacy of poly-ICLC when added to adjuvant treatment for newly diagnosed glioblastoma. Methods: Newly diagnosed patients &gt; 18 years with histologically proven glioblastoma received standard external beam radiation with concurrent low-dose temozolomide (TMZ) (75 mg/m 2 ) followed by adjuvant cycles of TMZ for 5 days (150–200 mg/m2) (week 1) then intramuscular injections of poly-ICLC (20 mcg/kg) 3 times a week (weeks 2–8; total 21 injections) with week 9 off and no limit to the number of adjuvant cycles (TMZ + poly-ICLC). Imaging evaluations were performed before every cycle. Results: There were 97 patients enrolled (60 men); median age 56 yrs (range 21–85); median KPS 90 (range 60–100). Fourteen patients did not start adjuvant treatment (5 patient request and 4 investigator withdrawal; 2 progressive disease; 1 death; 1 toxicity; 1 other). The most frequent CTC grade 3–4 toxicities occurring in &gt; 5% of subjects at least possibly related to poly-ICLC were leukopenia (20%), thrombocytopenia (14%), anemia (13%), neutropenia (10%), and SGPT (9%) or alkaline phosphatase (7%) elevation. Two deaths during adjuvant treatment were considered unlikely related to poly-ICLC. To date 71 of 97 patients have survived at least 12 months from diagnosis. The estimated median survival for the entire cohort was 17.2 months (95% CI: 15.5–19.3 months). Overall survival for the cohort at 12 months was 73.2% (95% CI: 63%-82%) and at 18 months 47.4% (95% CI: 37–58%). For only those subjects 18–70 years, overall survival at 18 months was 51.8% (95% CI: 41–63%). This is contrasted with EORTC 26981/22981 that reported an 18 month overall survival of 39.4% (95% CI: 33.8–45.1). Conclusions: The addition of poly-ICLC to a modified adjuvant treatment regimen for newly diagnosed GB is well-tolerated. Survival data at 12 and 18 months suggest increased efficacy compared to chemoradiation with adjuvant TMZ only. [Table: see text]
Safety and clinical activity of the histone deacetylase inhibitor givinostat in combination with meclorethamine in relapsed/refractory Hodgkin lymphoma (HL).
Authors: C. Carlo-Stella, A. Guidetti, S. Viviani, V. Bonfante, A. Marchiano, B. Gatti, C. D'Urzo, M. A. Di Nicola, P. Corradini, A. M. Gianni
Journal: Journal of Clinical Oncology (2010)

3068 Background: Encouraging safety and clinical activity of givinostat (ITF2357, Italfarmaco, Italy, EU) in combination with the alkylating agent meclorethamine observed in a compassionate use trial, established the rationale for a recently concluded phase II study aimed to determine efficacy and safety of givinostat/meclorethamine in relapsed/refractory HL. Methods: Reported are 35 relapsed/refractory HL patients (12 in compassionate use and 23 in phase II) with a median age of 31 years (range, 15-78). Before study entry, patients received a median of 4 (range, 2-7) lines of treatment with autografting performed in 71% and an additional allografting in 17% of cases. Givinostat (50 mg QID, per os, days 1-3) and meclorethamine (6 mg/sqm, intravenously, day 4) were dosed in 2- to 3-week cycles. Tumor response was assessed according to the revised response criteria for malignant lymphoma. NCI CTCAE v3.0 was used for toxicity assessment. Results: Patients received a median of 4 (range, 1–12) givinostat/meclorethamine cycles. Nonhematological toxicities included grade 1-2 nausea (33%) and fatigue (55%). No prolongation of QT/QTc interval was detected over 174 cycles. Grade 3-4 anemia, neutropenia and thrombocytopenia were observed in 22%, 44%, and 44% of patients, respectively. Best response to therapy included 5 (15%) complete remissions (CR) and 8 (23%) partial remissions (PR), with an overall response rate (ORR) of 38%. Eleven patients (31%) achieved stable disease (7/11 cases for ≥4 months) whereas 11 patients (31%) progressed. As of December 2009, the median time to progression for responding patients is 13 months. The median survival for all patients is 28 months and the projected 2-year survival 52% (95% CI: 32%-77%). Serum TARC levels after the first cycle of therapy were decreased by 70%±6% (mean±SEM, P ≤0.05) in responding patients, whereas they were significantly increased in patients with disease progression. Conclusions: Givinostat/meclorethamine is safe and effective in relapsed/refractory HL. An early decrease in serum TARC represent an easy-to-detect biomarker predicting response to therapy. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Italfarmaco
Analysis of the costs of bevacizumab plus cisplatin and gemcitabine versus cetuximab plus vinorelbine and cisplatin in patients with advanced non-small cell lung cancer (NSCLC) in France: Results from a cost modelling study
Authors: C. Chouaid, A. Vergnenègre, V. Florentin, S. Walzer
Journal: Journal of Clinical Oncology (2009)

e17560 Background: New treatment options for advanced NSCLC can offer improved survival over standard chemotherapy (CT). Bevacizumab (BEV), a humanized monoclonal antibody (MAb) directed against VEGF when combined with CT increases overall survival (median 13.6 months in the AVAiL study) and progression-free survival (PFS) in patients with advanced NSCLC compared with CT alone. Cetuximab (CTX), an IgG1 MAb which targets the epidermal growth factor receptor, achieved a median survival of 11.3 months when combined with CT in the FLEX study; marketing authorization is anticipated during 2009. The aim of this study was to compare the costs of treating patients with BEV plus cisplatin and gemcitabine (BCG) versus CTX plus vinorelbine and cisplatin (CVC) in France. Methods: A Markov model was used to compare drug and administration costs associated with treating advanced NSCLC with either BCG or CVC. The model assumes patients move from non-progressive to progressed disease to death, according to transition probabilities derived from an indirect comparison of the efficacy of BCG and CVC in terms of PFS using data from the respective pivotal trials and appropriate indirect comparison methodology. Cost data were derived from local sources. Drug costs assumed CT was given for up to 6 cycles, that CTX was administered at an initial dose of 400 mg/m 2 followed by 250 mg/m 2 weekly until progression and that BEV was administered at 7.5 mg/kg every 3 weeks until progression. The model estimated average drug and administration costs per patient treated with either BCG or CVC. Results: The mean cost for BCG and CVC was €23849 and €35678 respectively, resulting in a saving of €11829 per patient for BCG. The acquisition of BEV was less costly than the acquisition of CTX (€15374 vs €23530) and, BCG acquisition and administration costs were lower than CTX's respectively, €19756 versus €24750 and €4093 versus €10928. Conclusions: Targeted therapy using BEV is less costly than CTX in France, and therefore, from a budget perspective offers the best value for money approach to improving outcomes in patients with advanced NSCLC. [Table: see text]
The efficacy of amifostine to reverse moderate to severe acute chemoradiation-induced esophagitis in patients with lung cancer
Authors: J. Lattanzi, V. Ruiz, L. Moran, L. Coia
Journal: Journal of Clinical Oncology (2004)

8096 Background: The chemoradioprotectant Amifostine has been used prophylactically in multiple studies to reduce treatment-related esophagitis in patients with locally advanced lung carcinoma. However, severe esophagitis is encountered in only approximately 20% of patients receiving chemoradiation. Therefore, the current study is designed to assess Amifostine's ability to retard and/or reverse early acute esophagitis, potentially sparing asymptomatic patients the costs and toxicity of the agent. Methods: Eligible patients with locally advanced non-small cell lung cancer after informed consent were enrolled in an IRB approved Phase I/II study. Patients with IIIA/IIIB disease receiving definitive chemoradiation were included. Paclitaxel (45mg/m2) and Carboplatin (AUC 2) were delivered weekly with 3D conformal thoracic radiation. Patients that developed grade I/II esophagitis were offered Amifostine (500 mg I.V.) prior to further radiation delivery. Results: Twelve patients have been enrolled between 09/02 and 12/03.All patients were experiencing grade 2 or worse esophagitis prior to drug administration. Patients presented between week 2 and week 5 of a planned six-week course of thoracic radiation. A mean of two doses was delivered. Reassessment revealed near complete resolution of toxicity following intervention in all but one patient. Two patients had also received an increase in narcotic medication with Amifostine. The duration of response ranged from several days through the completion of thoracic radiation. Drug related toxicities as expected included hypotension and nausea/vomiting. Conclusions: The administration of amifostine resulted in rapid unexpected improvement in moderate to severe esophagitis in patient's receiving chemoradiation for lung carcinoma. Although the duration of response varied, all but one patient showed improvement in esophagitis symptoms. Early intervention in only the patients that develop early esophagitis appears to be an effective strategy in symptom management. The mechanism of this response and confirmation in additional patients warrants further study. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration MedImmune MedImmune
Pegfilgrastim Compared to Granulocyte Colony Stimulating Factor (G-CSF) with Hyper-CVAD Chemotherapy Regimen for Aggressive Lymphoid Malignancy.
Authors: Steven W. Lane, Julie Crawford, Melita Kenealy, Gavin Cull, John F. Seymour, Miles Prince, Paula Marlton, Devinder Gill, Peter N. Mollee
Journal: Blood (2005)
Single cell metrics of the efficacy of CAR T cells
Authors: Gabrielle Romain, Harjeet Singh, Ivan Liadi, Jay R Adolacion, Badrinath Roysam, Laurence Cooper, Navin Varadarajan
Journal: Journal for ImmunoTherapy of Cancer (2015)

Meeting abstracts T cells genetically modified to enforce expression of a chimeric antigen receptor (CAR) have shown considerable promise in clinical trials even in tumors refractory to all other treatment methods. In particular, the use of CAR T cells rendered specific for CD19 demonstrated
Phase II trial of gemcitabine and carboplatin, plus trastuzumab in HER2+ patients as first line therapy in metastatic breast cancer
Authors: D. A. Yardley, N. W. Peacock, D. Shipley, D. Waterhouse, R. Landgdon, L. Simons, S. Thomas, J. D. Hainsworth, D. R. Spigel, H. A. Burris
Journal: Journal of Clinical Oncology (2006)

10590 Background: Gemcitabine (G) and carboplatin (C) demonstrate significant preclinical synergy together as well as in combination with trastuzumab (H) in metastatic breast cancer (MBC) pts. This multicenter phase II trial evaluates the efficacy and safety of G + C with trastuzumab in HER2 + pts as 1 st line therapy in MBC. Methods: Eligibility requirements: females &gt; 18 with no prior regimens for MBC, ECOG 0–2, RECIST bidimensional disease, and adequate organ function. FISH HER2 + pts received H with GC. Treatment: G 1,000 mg/m 2 D1&amp; 8 with C AUC 5 D1 in the first 20 pts. Following a toxicity assessment revealing significant myelosuppression, C was administered in subsequent pts at AUC 4. 14 HER2+ pts received H 8 mg/kg loading dose followed by 6 mg/kg q21 days. Pts were evaluated for response after 9 weeks; treatment continued until progression or toxicity except in HER2+ pts who received up to 6 cycles GCH followed by single agent H. Results: Between 11/03 &amp; 11/05, 45 pts have been treated: median age 55 for GC, 65 for GCH, ECOG 0/1 22/23. 19 pts were chemonaive. 26 pts received prior adjuvant chemotherapy: 20 pts adjuvant anthracyclines (A) &amp; taxanes (T), 3 only prior A and 3 prior T. 73% had 2 or more metastatic sites of disease. 31 pts received GC &amp; 14 pts received GCH. 18 of 41 evaluable pts (44%) had objective responses (PR 16, CR 2) with 17 pts (42%) exhibiting SD &amp; 6 pts PD (15%). 91% of AT pretreated pts demonstrated SD or better. 9 remain on study. 6 went off study due to heme related toxicities and 9 due to MD discretion [4 max benefit, 3 XRT]. Median # of cycles was 5. Combined G3/4 hematologic toxicity was notable for 66% neutropenia (only 1 FN), 55% thrombocytopenia, and 32% anemia, predominately occurring at the carboplatin AUC 5 dose level. Transfusions of PRBCs and plts were administered in 14 and 8 pts respectively. Nonhematologic toxicity was minimal and remarkable for G3/4 fatigue in 20%. Conclusions: In FISH HER2+ pts, the addition of trastuzumab to GC yielded a 50% RR, with no evident cardiotoxicity. The combination of gemcitabine with carboplatin AUC 4 is active, albeit with moderate hematologic toxicity, warranting further exploration of alternate GC ± H schedules in breast cancer. [Table: see text]
m-BACOD treatment for intermediate- and high-grade malignant lymphomas: a Southwest Oncology Group phase II trial.
Authors: B W Dana, S Dahlberg, T P Miller, R J Hartsock, S Balcerzak, C A Coltman, J O Carden, K Hartley, R I Fisher
Journal: Journal of Clinical Oncology (1990)

One hundred six eligible patients with advanced intermediate- or high-grade malignant lymphoma were treated with methotrexate with leucovorin rescue, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone (m-BACOD) in a Southwest Oncology Group phase II trial. Patients were stratified by estimated bone marrow reserve, and impaired marrow reserve patients received reduced doses of cyclophosphamide and doxorubicin. The complete remission rate for normal marrow reserve patients was 65%, while the complete remission rate for impaired marrow reserve patients was 29%. With a median follow-up period of 41 months, 64% of complete responders in the normal marrow group are disease-free 3 years after their response. Three-year survival is 61% in the normal marrow reserve group and is 29% in the impaired marrow reserve group. Eighty-seven percent of treatment courses were given in accordance with protocol dosing and schedule. For doxorubicin, relative dose intensities were 0.75 and 0.61 (normal and impaired marrow reserve arms, respectively), for cyclophosphamide, 0.76 and 0.61, and for methotrexate, 0.55 and 0.45. Serum lactic dehydrogenase (LDH) level was the only pretreatment characteristic found to have a significant effect on overall survival. Severe or greater toxicity occurred in 97% and 89% of the normal and impaired marrow reserve groups, respectively, with granulocytopenia the principal toxicity. Treatment-related fatalities occurred in 8% of patients. m-BACOD is an effective but toxic treatment program for intermediate- and high-grade malignant lymphomas.
Improved survival in patients with locally advanced esophageal cancer utilizing a multidisciplinary approach
Authors: Z. Skaff, K. Hannigan, S. Hughes, U. Atabek, M. Shum, S. Kankipati, M. Elkhoury, A. Hageboutros
Journal: Journal of Clinical Oncology (2006)

14130 Background: Locally advanced esophageal cancer studies have reported a three year overall survival rate of 32% with a median survival of 16 months. These patients were treated with combined chemotherapy and radiation with surgery, when applicable. We conducted this study to determine whether using an individualized, multidisciplinary approach affected survival outcomes in patients treated for locally advanced esophageal cancer. Methods: All patients treated for locally advanced esophageal cancer were retrospectively identified from our database at The Cancer Institute of New Jersey at Cooper University Hospital. All patients were presented and discussed in a multidisciplinary gastrointestinal tumor board conference. After a consensus was obtained, a treatment plan was established for each patient based on his or her respective clinical characteristics: stage, performance status, medical suitability for surgery and resectabilty. Results: A total of 23 patients (median age: 66 years [range, 55–88 years]) were identified, the histopathologic diagnosis was adenocarcinoma in 13 and squamous cell carcinoma in 10 cases. TNM staging was as follows: 18 (78.3%) stage II or III and 5 (21.7%) stage IV. Initial management included esophagectomy for 9 (39.1%), 6 of which received preoperative chemotherapy (5-FU) and three received postoperative adjuvant chemotherapy, 14 (60.9%) received only combined chemotherapy (average four cycles of 5FU 1000 mg per square meter of body surface + Cisplatin 75 mg per square meter of body surface) and radiation at doses 50–64 Gy. Overall median survival was not reached since only five patients (21.7%) have died. The 1- year and 2-year survival rates were 87% and 74% respectively. Median follow-up for patients who received combination chemotherapy and radiation vs. surgery with preoperative therapy was 29 and 41 months, respectively. Conclusion: This retrospective analysis shows promising outcomes compared to published data supporting the role of an individualized, multidisciplinary approach in the management of each patient with esophageal cancer. No significant financial relationships to disclose.
High expression of nucleoside transporter hENT1 predicts a worse event-free survival in relapsed/refractory Hodgkin lymphoma patients treated with gemcitabine, vinorelbine, and liposomal doxorubicin—A CALGB 59804 correlative study
Authors: R. Lai, E. D. Hsi, J. Mackey, S. Jung, J. L. Johnson, J. R. Cook, D. Jones, J. W. Said, B. D. Cheson, N. L. Bartlett
Journal: Journal of Clinical Oncology (2006)

7581 Background: CALGB 59804 was a phase I/II trial of gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) for pts with relapsed Hodgkin lymphoma (HL). Overall response rate (RR) was 70% (manuscript in review). Plasma membrane nucleoside transporters such as hENT1 are important in transporting nucleoside analogs into cells to exert their pharmacologic effects. We hypothesized high hENT1 expression would predict better RR and outcome in pts treated with GVD. Methods: 58 of 91 pts enrolled in CALGB 59804 had sufficient tissue for study; 31 relapse biopsies and 27 initial diagnosis biopsies. Expression of hENT1 was evaluated by immunohistochemistry in formalin fixed tissue and scored independently by two hematopathologists (RL and EH) blinded to the clinical outcomes. Positivity for hENT1 was defined as &gt;25% of Reed-Sternberg (RS) cells expressing hENT1. Expression was correlated with clinical factors, including IPS at relapse, as well as the overall (OS) and event-free survival (EFS). Results: Expression of hENT1 in RS cells was heterogeneous among cases. 28/58 cases (48%) were hENT1-positive. hENT1-expression was not associated with age, gender, stage, IPS (≤2 or &gt;2), or maximum toxicity grade (≤2 or &gt;2). Compared to hENT1-negative pts, hENT1-positive pts were less likely to have complete or partial response (19/30, 63% versus 22/28, 76%, P=0.20, chi square). hENT1 expression was not significantly associated with OS (P=0.18). Univariate log-rank analysis showed hENT1 positivity and IPS &gt;2 correlated significantly with a lower EFS (P=0.05, and P=0.03, respectively). Multivariate Cox regression analysis confirmed that IPS &gt;2 and hENT1 positivity were independent predictors of EFS (Hazard ratio 2.16, 95%CI 1.08–4.35, P=0.03; and Hazard ratio 2.10, 95% CI 1.06–4.19, P=0.03, respectively). P-values are two-sided. Conclusions: Contrary to our hypothesis, there is an inverse relationship between EFS and hENT1 expression in relapsed HL pts treated with GVD. High expression of hENT1 did not identify gemcitabine-sensitive disease, but may identify a biologically aggressive and/or treatment refractory subtype of HL. No significant financial relationships to disclose.
A novel hematopoietic multilineage clone, Myl-D-7, is stromal cell- dependent and supported by an alternative mechanism(s) independent of stem cell factor/c-kit interaction
Authors: K Itoh, J Friel, N Kluge, T Kina, A Kondo-Takaori, S Kawamata, T Uchiyama, W Ostertag
Journal: Blood (1996)