tbuckley/cabot-search huggingface dataset:
Treatment of colorectal liver metastases using talaporfin sodium and intratumoral placement of LEDs
Authors: M. J. Winship, S.-S. Wang, J. C. Chen, L. Keltner, J. S. Christophersen
Journal: Journal of Clinical Oncology (2005)

3663 Background: Recurrent or refractory liver metastases from colorectal cancer (CRC) leave few options after failure of multiple standard therapies. Patients require creative applications of combination therapies to reduce tumor burden. Aggressive but minimally morbid treatments may prolong and improve period of disease control. Method: 17 lesions in 10 patients were treated in a Phase II study using a percutaneous ablative interstitial light activation system (Litx) that combines a photosensitizing drug with light of a specific wavelength delivered to the center of the tumor that results in tumor destruction. Eligibility for enrollment included 1 or more unresectable ≤ 7cm hepatic lesions metastatic from CRC. Up to 4 Litx devices were placed in up to 4 lesions per patient to photoactivate talaporfin sodium administered intravenously at a dose of 1 mg/kg. Percutaneous insertion of each device was guided by computed tomography (CT) or ultrasound. After a 15 to 60 minute interval, Litx devices were activated for a 2 hour 46 minute period (500 joules total dose per device). A standard but variable chemotherapeutic regimen, to which the patient was naïve, was administered 3 or 30 days following Litx. Follow-up CT imaging of the lesions occurred at days 30 and 60. Results: The lesion control rate was 87% [9 stable disease (56%) + 5 partial response (31%)]. Conclusions: In larger lesions (> 4 cm) treated with a single device, a smaller area of cell kill was observed. Multiple devices placed in larger tumors expanded the area of cell kill with no increase in adverse events. Preliminary results suggest that Litx could be used in combination with chemotherapy for control of local and systemic disease. Accrual to the Phase 2 trial is ongoing. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Light Sciences Light Sciences
Phase III trial of sunitinib (SU) in combination with capecitabine (C) versus C in previously treated advanced breast cancer (ABC).
Authors: J. Crown, V. Dieras, E. Staroslawska, D. A. Yardley, N. Davidson, T. D. Bachelot, V. R. Tassell, X. Huang, K. A. Kern, G. Romieu
Journal: Journal of Clinical Oncology (2010)

LBA1011 Background: Recent trials support combining an antiangiogenic agent with chemotherapy (CT) in pretreated patients (pts) with metastatic BC (MBC). SU, an oral multitargeted tyrosine kinase inhibitor demonstrated single-agent activity (11% ORR) in heavily pretreated pts with MBC. Antitumor activity with SU+C was reported in pts with advanced solid tumors. This multicenter, randomized, phase III trial (SUN 1099) compared the efficacy and safety of SU + C vs. C in pts with ABC. Methods: Eligibility criteria were: age ≥18 yrs, ECOG PS ≤1, measurable HER2-positive (FISH+, CISH+ or IHC3+) or -negative ABC, no brain metastases, prior treatment (tx) with an anthracycline and taxane in the (neo)adjuvant or metastatic setting, and ≤2 prior CT regimens for advanced disease. Prior C tx was not permitted. Pts were randomized (1:1) to combination tx with C 2,000 mg/m 2 /d po days 1–14 every q3w + SU 37.5 mg/d po daily, or to C 2,500 mg/m 2 /d days 1–14 q3w. Pts with progressive disease per RECIST on the C arm were offered single-agent SU (37.5 mg/d). Endpoints included PFS (primary), ORR, OS, QoL, and safety. Stratified and unstratified log-rank tests compared PFS between arms. Results: At the data cutoff (December 15, 2009), the ITT population comprised 442 pts: 221 in each arm with baseline characteristics well balanced between arms. The trial did not meet its primary endpoint of prolonging PFS based on the independent radiologic assessment nor secondary endpoint of longer OS (final analysis March 10, 2010). Median PFS was 5.5 mos (95% CI 4.5–6.0) in the SU+C arm vs. 5.9 mos (95% CI 5.4–7.6) in the C arm (HR 1.224). Median OS was 16.4 mos (95% CI 13.6–18.4) for the SU+C arm and 16.5 mos (95% CI 14.2–18.6) for the C arm (HR 0.995). ORR was 18.6% for the SU+C arm and 16.3% for the C arm. The most common all causality grade 3/4 AEs (≥10%) were neutropenia (32%), hand–foot syndrome (HFS; 16%), thrombocytopenia (17%), asthenia (12%), fatigue (10%) in the SU+C arm and HFS (24%) and diarrhea (10%) in the C arm. Intended drug delivery for each arm was &gt;80%. Discontinuations due to an AE were more frequent in the SU+C arm vs. the C arm. Discontinuations by drug in the SU+C arm: SU 39%, C 42%, SU and C 33%; in the C arm: 18%. Conclusions: Data from this randomized phase III trial do not support use of SU+C for therapy of patients with ABC. [Table: see text]
Real-Time 3D echocardiographic quantification of left atrial volume: Multicenter study for validation with magnetic resonance imaging
Authors: Victor Mor-Avi, Chattanong Yodwut, Carly Jenkins, Harold Kuhl, Hans-Joachim Nesser, Thomas H. Marwick, Andreas Franke, Johannes Niel, Regina Steringer-Mascherbauer, Lisa Sugeng, Roberto M. Lang
Journal: Circulation (2011)
Quality of life in advanced non-small cell lung cancer patients receiving first-line gefitinib monotherapy
Authors: Y. Shao, Z. Lin, F. Hu, C. Yu, J. Shih, W. Hu, Y. Chang, A. Cheng, P. Yang, C. Yang
Journal: Journal of Clinical Oncology (2009)

9614 Background: Gefitinib is a potential first-line treatment option for patients with advanced non-small cell lung cancer (NSCLC), especially for patients with activating mutations in the EGFR gene. However, little is known about patient-reported health-related quality of life (HRQOL) in this patient population. The aims of this study were to explore the prognostic values of baseline HRQOL for time-to-treatment failure (TTF), as well as the predictors of repeatedly measured posttreatment HRQOL, in advanced NSCLC patients receiving first-line gefitinib. Methods: A total of 106 chemonaive patients with advanced NSCLC were enrolled in a phase II trial. Gefitinib was given at a dose of 250 mg/d. HRQOL was assessed monthly with the EuroQoL instrument (EQ-5D) and the Lung Cancer Symptom Scale (LCSS) questionnaire. Baseline HRQOL and clinical/molecular predictors of TTF were jointly examined by multiple Cox's proportional hazards model. The associations between the clinical/molecular factors and repeatedly measured posttreatment HRQOL were analyzed by fitting marginal linear regression model using the generalized estimating equations (GEE) method. Results: In this prospective study, HRQOL data were obtained from 94 patients. Baseline EQ-5D index (estimated hazard ratio = 0.286, 95% C.I.: 0.135–0.603, p = 0.001) and the presence of L858R EGFR mutation in adenocarcinoma (estimated hazard ratio = 0.520, 95% C.I.: 0.307–0.880, p = 0.015) were retained as independent prognostic factors in the final multiple Cox's proportional hazards model for TTF. According to preliminary GEE analysis of repeatedly measured posttreatment HRQOL, the patients with wild-type EGFR consistently had worse HRQOL in EQ-5D index (p &lt; 0.0001), EQ-5D VAS score (p = 0.0002), and LCSS global score (p &lt; 0.0001), respectively. Conclusions: In advanced NSCLC patients receiving first-line gefitinib, better baseline EQ-5D index and L858R EGFR mutation in adenocarcinoma predict longer TTF. In addition, patients with wild-type EGFR had worse posttreatment HRQOL. No significant financial relationships to disclose.
Multimodal treatment of nodal localizations from Merkel cell carcinoma with no identifiable primary site and distant metastases.
Authors: N. Fazio, F. Spada, M. Squadroni, D. Radice, G. Di Meglio, S. Terzi, F. Luca, R. Lazzari, G. Pelosi, F. G. De Braud
Journal: Journal of Clinical Oncology (2010)

e19020 Background: Merkel cell carcinoma (MCC) is an aggressive cutaneous neuroendocrine carcinoma. In sporadic cases nodes represent the only site of disease, anecdotally due to a spontaneous regression of the primary cutaneous tumor. Besides differential diagnosis primary/metastatic nodal localization is debated. No standard treatment exists in this setting. We report our multimodal management. Methods: Among patients with MCC examined at European Institute of Oncology of Milan between October 1995 and March 2009, we selected those with nodal involvement without evidence of primary tumor. Then we considered: histological diagnosis at IEO, no visceral sites of disease, staging with CT ± fluorodeoxyglucose (FDG) positron emission tomography (PET) ± somatostatin receptor scintigraphy (SRS), multidisciplinary discussion. We evaluated staging, multimodality, time to progression (TTP), median overall survival (mOS). Results: Among a total of 83 patients 28 had the above mentioned characteristics. All patients were staged with CT. A FDG-PET was positive for staging in 14/17 patients, and SRS in 12/17. Concordance FDG-PET/SRS was positive in 8 and negative in 1 cases. In 2 cases PET positive/SRS negative occurred. Thirteen patients underwent excisional biopsy, without lymphadenectomy. Six received chemoradiation, 3 chemotherapy, 1 chemo-biotherapy, 1 radiotherapy, 2 no treatment. Fifteen patients underwent lymphadenectomy, 7 with adjuvant chemoradiation, 4 chemotherapy, 1 radiation, 1 with neoadjuvant chemotherapy, 1 no further treatment, and 1 too early. With 22 months median follow-up median TTP was 17 months (95%CI: 7-NE). Median OS was 29 months (95%CI: 15-NE). TTP and mOS for patients underwent lymphadenectomy were not reached vs. 9 months (95%CI: 4-NE; p = 0.35) and 29 months (95%CI: 11.7, NE; p = 0.34) for patients without lymphadenectomy, respectively. Conclusions: In patients with nodal localizations of MCC without evidence of primary tumor and distant metastases lymphadenectomy improved TTP and mOS. FDG-PET for staging seems to be more accurate than SRS. The role of a multimodal therapeutic strategy should be studied in prospective trials. No significant financial relationships to disclose.
Isolation of large numbers of human mesenchymal stem cells from discarded filters after bone marrow harvests: Implications for therapy
Authors: A. S. Mageed, D. Pietryga, S. Gagin, R. West
Journal: Journal of Clinical Oncology (2006)

12501 Background: Bone Marrow (BM) is an excellent source of Mesenchymal Stem Cells (MSCs) which can be expanded and used clinically. There is a growing evidence that MSCs can promote engraftment and reduce Graft versus Host Disease (GVHD). Bone marrow harvests are passed through 850μ, 500μ and 200μ filters to trap bony spicules and clots before infusion into patients. We hypothesize that the filters would also trap a significant number of MSCs which can be useful clinically after isolation and possible expansion. Methods: Bone marrow collection kits were obtained after informed consent of the donor (n = 11). Specimens were obtained in the course of scheduled bone marrow harvests. Cells were isolated and cultured from each portion of the device. Results: An average of 1×10 9 total mononuclear cells was obtained from the discarded marrow collection devices. Cells isolated in this experiment conform to published data regarding MSCs. The immunophenotype was CD44 + , CD73 + , CD90 + , CD105 + , CD14 − , CD34 − , CD45 − , HLA-DR − , negative for leukocyte lineage specific antigens and positive for Prolyl-4-Hydroxylase. The cells were morphologically consistent with published data, being bilaterally symmetrical and forming conspicuous fibroblastoid colonies which readily grew to confluence and followed differentiation pathways to both adipose osteoid tissue. Fresh cells from the kits may also contain a precursor for MSCs that is CD90 − and CD73 − . Sorting for this precursor population yielded colony forming units consistent with MSCs. Conclusion: This represents a novel strategy for obtaining “healthy” material for potential therapy and study. No significant financial relationships to disclose.
A randomised phase II study of two regimens of high dose palliative chemoradiation therapy in the management of locally advanced non-small cell lung cancer (TROG 03.07)
Authors: Michael Michael, Bryan Burmeister, Elizabeth Burmeister, Sharon Cox, Keith Horwood, Andrew Wirth, Guiseppe Sasso, Bahram Forouzesh, Margot Lehman, David Ball
Journal: Journal of Thoracic Oncology (2009)
Economic assessment of capecitabine/cisplatin versus 5-FU/cisplatin regimens in adjuvant treatment of advanced gastric cancer in Spain
Authors: M. Safont, J. Darba, G. Restovic, J. Sastre, J. Bellmunt Molins, M. A. Gomez, M. Salgado, C. Vila, A. Ramírez de Arellano
Journal: Journal of Clinical Oncology (2008)

15549 Background: A randomized phase III trial of Capecitabine/Cisplatin (XP) versus continuous infusion of 5-FU/Cisplatin (FP) as first-line therapy in patients with advanced gastric cancer (AGC) met its primary endpoint of non-inferior progression-free survival (PFS). There was a trend toward superior efficacy with XP in terms of both PFS (median 5.6 months for XP versus 5.0 for FP) and response rates. An economic assessment was conducted in Spain to compare the costs of the two therapies taking into account unit costs and medical resource consumption for year 2007. Methods: Direct medical costs during the study period were estimated from the perspective of the Spanish National healthcare system. The costs of the two alternative therapies were estimated based on the trial results on actual dose and the number of administrations, and unit costs in different hospitals in Spain. The adverse event (AE) profiles were used to estimate the costs of treating AEs. An expert panel estimated typical treatment patterns and costs of treating major AEs. Indirect costs for time and travel for study drug administration were also estimated. Results: Annual pharmacologic cost in the XP arm were estimated to be €1,333 greater than in the XP arm, but drug administration costs and AE costs were lower in the XP arm (€2,575 and €27, respectively). Overall, direct an indirect medical cost were estimated at €2,688 in the XP arm and at €4,014 in the FP arm. According to budget impact results, 1.58 patients are likely to be treated with XP for each patient treated with FP. Conclusions: In Spain, oral capecitabine benefits AGC patients by reducing the number and time spent in infusion visits, and would produce significant direct medical cost savings. Given the trend to superior efficacy, the projected direct and indirect cost savings, and the convenience of oral treatment, XP treatment would be considered less costly than FP treatment for AGC from both a healthcare system and a societal perspective. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Roche Pharma
Peripheral Arterial Occlusive Disease (PAOD) In Patients (Pts) Receiving Dasatinib: Experience Across Multiple Clinical Trials
Authors: Philipp D. le Coutre, Timothy P. Hughes, Francois-Xavier Mahon, Dong-Wook Kim, Juan Luis Steegmann, Neil P. Shah, Nicola Wallis, Jorge E. Cortes
Journal: Blood (2013)
The impact of obesity on adherence to the National Comprehensive Cancer Network (NCCN) guidelines recommending chemotherapy for patients with operable breast cancer
Authors: A. M. Brewster, C. Etzel, R. Zhou, Y. Wong, S. B. Edge, D. W. Blayney, J. Wilson, C. Hudis, J. C. Weeks, R. L. Theriault
Journal: Journal of Clinical Oncology (2009)

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 &lt; 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 (&lt;25 kg/m 2 [normal], 25 to &lt;30 kg/m 2 [overweight], 30 to 39kg/m 2 [obese], ≥40 kg/m 2 [morbidly obese]) and in 5 kg/m 2 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/m 2 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/m 2 . Other patient-related factors associated with non-receipt of chemotherapy included older age at diagnosis (p &lt; 0.01), presence of comorbidities (p &lt; 0.01) and center (p &lt; 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.
Same day administration of pegfilgrastim with dose dense doxorubicin in early breast cancer patients
Authors: K. T. Vance, J. Carpenter
Journal: Journal of Clinical Oncology (2006)

671 Background: Pegfilgrastim is indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy. In licensing studies, patients received a single dose of pegfilgrastim on day 2 of each chemotherapy cycle, which added an extra visit for day 2 administration. We administered pegfilgrastim to a series of early breast cancer patients on the same day of chemotherapy. We reviewed charts retrospectively to assess both efficacy and safety. Methods: Data on blood counts, toxicity and chemotherapy dosing was collected from July 1, 2003 to May 6, 2005 for all patients with early breast cancer who received sequential or combination doxorubicin, cyclophosphamide and paclitaxel on a 14 day schedule. Herceptin was given with paclitaxel and/or cyclophosphamide in 2 patients. Results: 64 patients with a median age of 50 years (range 22–67 years) were treated. 14 patients had stage I disease, 39 stage II and 11 stage III disease. Forty-one patients were treated postoperatively and 23 preoperatively. 211 cycles of doxorubicin were administered. After administration of doxorubicin, pegfilgrastim 6 mg s.c. was given on the same day. The lowest absolute neutrophil count on day 14 after doxorubicin was 1693/mm 3 with no episodes of febrile neutropenia. The highest absolute neutrophil count was 23,671/mm 3 . The only dose reductions were five doxorubicin doses for grade 1–2 mucositis. Grade 1–2 nausea and vomiting was the most common toxicity seen after doxorubicin. Grade 1 bone pain was the most common side effect seen after pegfilgrastim occurring in 13/64 patients. There was no grade 3 or 4 toxicity of any kind. Conclusion: Pegfilgrastim administered on the same day as doxorubicin on a 14 day schedule was both safe and effective. Side effects were mild and included bone pain most likely attributable to pegfilgrastim. Neither granulocytopenia nor febrile neutropenia were seen and no treatments were delayed or postponed. Pegfilgrastim given on the same day as chemotherapy was effective in maintaining adequate granulocyte counts to allow treatment 14 days later and to avoid infection from granulocytopenia. Toxicity from pegfilgrastim was mild and tolerable. [Table: see text]
Survival for melanoma patients with pre-existing chronic lymphocytic leukemia.
Authors: Eric D. Whitman, Rami Bustami
Journal: Journal of Clinical Oncology (2012)

e19057 Background: Recent successes in melanoma drug development have rekindled interest in immunotherapy for melanoma (MM). Patients (pts) with chronic lymphocytic leukemia (CLL), a malignant expansion of B-lymphocytes, have an impaired immune system and not uncommonly develop secondary MM. We hypothesized that MM pts with pre-existing CLL are more likely to die than MM pts without a second malignancy. Methods: Pts were identified in the updated Surveillance Epidemiology and End Results (SEER) (1973-2008) database with MM only (MEL) or with primary CLL and secondary MM (MELpCLL). Time between diagnosis and death or last follow up and other demographic SEER data were recorded. The Chi-Square Test was used to make unadjusted comparisons between group death rates. A Cox proportional hazards regression model, adjusted for patient characteristics, predicted the risk of death by group. Results: 8,294 SEER pts were included (8,115 in MEL, 179 in MELpCLL). With a median follow-up time of 7 years, 2,454 pts (30%) died. There was a significant difference in mortality rates between the groups: MEL 29% / MELpCLL 71%; p&lt;0.001 by Chi-Square. In the multivariate Cox model (Table), MELpCLL pts were significantly more likely to die than MEL pts (HR = 1.22, 95% CI = 1.02-1.46, p = 0.034). Higher risk of death was also significantly associated with older age and male gender (p&lt;0.001) but not MM location (data not shown). MM data like thickness and ulceration were only available in more recent SEER records, precluding survival analysis. Conclusions: MELpCLL pts had a 22% increased risk of death compared to MEL pts in multivariate analysis, consistent with the hypothesis. [Table: see text]
Psychiatric disorders in a community sample of adolescents [published erratum appears in Am J Psychiatry 1987 Aug;144(8):1114]
Authors: J H Kashani, N C Beck, E W Hoeper, C Fallahi, C M Corcoran, J A McAllister, T K Rosenberg, J C Reid
Journal: American Journal of Psychiatry (1987)

The prevalence of psychiatric disorders diagnosed according to DSM-III in adolescents in the general population is not known. The authors address this issue in a community sample of 150 adolescents 14-16 years of age. Structured interviews as well as other instruments were used to collect data. Twenty-eight (18.7%) of the 150 adolescents were identified as having a psychiatric disorder. These 28 adolescents viewed their parents as less caring, had lower self-esteem, and resolved their conflicts through verbal aggression and physical violence more often than did the adolescents who did not have a psychiatric disorder. The authors make recommendations regarding the use of structured interviews in future research.