tbuckley/cabot-search huggingface dataset:
Comparison of hypnotherapy versus gabapentin in the treatment of hot flashes: A pilot study.
Authors: S. MacLaughlan, S. Salzillo, P. Bowe, S. Scuncio, B. Malit, C. Raker, J. S. Gass, C. O. Granai, D. S. Dizon
Journal: Journal of Clinical Oncology (2011)

168 Background: The purpose of this study is to compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in women with an increased risk or personal history of breast cancer. Methods: In a prospective trial, eligible women were randomized to receive gabapentin (control arm) or hypnotherapy (experimental arm). Eligibility was defined by a personal history of breast cancer or an increased risk of developing breast cancer in women who reported at least one daily hot flash. The duration of participation was eight weeks, and women were asked to keep a daily journal of the number and severity of their hot flashes. The primary endpoints were number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was quality of life, measured using the Hot Flash Related Daily Interference Score (HFRDIS). Results: Twenty-seven women were enrolled (n=14 gabapentin, n=13 hypnotherapy) and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrollment was 4.5 in the gabapentin arm, and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After eight weeks, the median number of daily hot flashes was reduced by 33.3% among women in the gabapentin arm, and 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm, and 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and 55.2% in the hypnotherapy group. Conclusions: Hypnotherapy and gabapentin both demonstrate efficacy in improving hot flashes in women with an increased risk or personal history of breast cancer. Complementary and alternative medicine (CAM) therapies are preferable to many women over hormone therapy due to the perceived risk of breast cancer, but objective data have been lacking comparing its use to conventional therapies. This pilot study provides evidence supporting the use of hypnotherapy for the treatment of hot flashes and emphasizes the need to perform further studies aimed at defining evidence-based recommendations for CAM.
Impact of eribulin on overall survival in patients with metastatic breast cancer with visceral disease.
Authors: L. T. Vahdat, J. Cortes, C. Twelves, J. Wanders, S. Seegobin, C. Dutcus, J. O'Shaughnessy
Journal: Journal of Clinical Oncology (2011)

239 Background: Visceral disease is associated with poor survival outcome in women with metastatic breast cancer (mBC). Eribulin mesylate is a nontaxane microtubule dynamics inhibitor indicated for 3rd-line monotherapy in patients (pts) with mBC previously treated with at least two chemotherapeutic regimens in the metastatic setting, including an anthracycline and a taxane. Methods: Evidence from the global, randomized, multicenter, phase III clinical trial of eribulin in mBC (EMBRACE) demonstrated improved overall survival (OS) for eribulin-treated pts when compared to treatment of physician’s choice (TPC). In this unplanned subgroup analysis, we compare the clinical benefit of eribulin to TPC in mBC pts with visceral disease using the Independent Review database. Patients were categorized as having visceral disease if they had target or non-target lesion involvement in the adrenal gland, liver, lung, pleural, pericardial/peritoneal cavity, spleen, or thyroid. Patients with brain metastases were excluded from the trial. Results: EMBRACE enrolled 762 pts with mBC, with single organ disease present in 120 pts (15.7%). The remaining pts had multi-organ disease. A total of 81.9% (624) of pts were classified as having visceral disease–81.3% (413) randomized to receive eribulin and 83.1% (211) to receive TPC. Metastatic tumor site was similar in eribulin and TPC arms, with liver (58.3%; 62.6%), lung (38.8%; 37.4%) and pleural (17.1%; 16.5%) involvement. Patients with visceral disease treated with eribulin demonstrated a significant benefit in OS compared to TPC (HR 0.77, p=0.02). Median OS in mBC pts with visceral disease was 12.45 months (mos) for eribulin-treated pts, with ORR=11.0% and CBR*=21.7% compared to OS=10.12 mos, ORR=5.0%, CBR*=16.6% for TPC-treated patients (*CBR defined as CR+PR+SD&gt;6mos). No significant treatment difference was observed in the non-visceral disease patients however due to the small number of patients with non-visceral disease, no robust statistical conclusions can be made. Conclusions: Treatment with eribulin resulted in significant improvement in overall survival for mBC pts with visceral disease compared to other commonly used chemotherapeutic agents.
Real-World Data from Long Term Follow-up in Chronic Myeloid Leukemia (CML) Patients (PTS) Treated with Imatinib. Predictive Factors for Achievement of Deep Molecular Responses and for Failure
Authors: María Jose Mela Osorio, Isabel Amanda Giere, Isolda Fernandez, Miguel A Pavlovsky, Guillermina Remaggi, Federico Sackmann, Dante Intile, Carolina Pavlovsky
Journal: Blood (2015)
The BCL-2-Specific BH3-Mimetic ABT-199 (GDC-0199) Is Active and Well-Tolerated in Patients with Relapsed Non-Hodgkin Lymphoma: Interim Results of a Phase I Study
Authors: Matthew S. Davids, Andrew W. Roberts, Mary Ann Anderson, John M. Pagel, Brad S. Kahl, John F. Gerecitano, David E. Darden, Cathy E. Nolan, Lori A. Gressick, Jianning Yang, Brenda J. Chyla, Todd A. Busman, Alison M. Graham, Elisa Cerri, Sari H. Enschede, Rod A. Humerickhouse, John F. Seymour
Journal: Blood (2012)
Impact of Minimal Residual Disease after Allografting Detected By JAK2V617F, MPL or Calreticulin in Myelofibrosis Patients
Authors: Nicolaus Kroeger, Anita Badbaran, Tatjana Zabelina, Maximilian Christopeit, Christine Wolschke, Francis Ayuk, Axel R. Zander, Haefaa Alchalby, Ulrike Bacher, Ioanna N Triviai, Boris Fehse
Journal: Blood (2015)
Phase II trial of bevacizumab (A), lenalidomide (R), docetaxel (D), and prednisone (P) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).
Authors: X. Huang, Y. M. Ning, J. L. Gulley, P. G. Kluetz, D. Adelberg, M. Mulquin, R. A. Madan, C. Bassim, W. D. Figg, W. L. Dahut
Journal: Journal of Clinical Oncology (2011)

138 Background: Angiogenesis appears to play critical role in the progression of mCRPC. Previously we have shown anti-tumor activity in mCRPC with the combination of D, thalidomide (T), A and P (Ning JCO 2010). We hypothesized that combining R, an analogue of T, with A, D and P would have a more favorable toxicity profile and similar anti-tumor activity. Methods: All pts had chemotherapy-naïve progressive mCRPC. 6 pts were treated with R at 15 and 20 mg prior to doses at 25 mg. Treatment is 75 mg/m 2 D, 15 mg/kg A every 21 days as one cycle (C), plus 25 mg R for 14 days with daily 10 mg P and enoxaparin. After grade 3 neutropenia was seen in &gt; 80% of pts in all cohorts, the protocol was amended to include prophylactic pegfilgrastim. PSA is tested each C with imaging after C2 and then every 3C. Dental exams with mandible CT's are at baseline, after C5, and then every 6C or earlier if needed. Results: 28 of a planned 51 pts have been enrolled. Pt characteristics include: median age 65.5 [51-78], Gleason score 8 [67.9% 8-10, 32.1% 6-7], on-study PSA 94.3 ng/mL [9.2-3520], and pre-study PSA doubling time 1.43 months [0.52-4.07]. Median C number was 8 [1-21]. 2/28 pts were off study due to clinical or radiographic progression. 26 pts remain on study. 22/24 (91.7%) and 20/24 (83.3%) pts who have completed ≥ 4C had PSA- decline of ≥ 50% and ≥ 75%, respectively. 14 pts with measurable disease were evaluable with 2 CRs (1 unconfirmed), 9 PRs (2 unconfirmed), and 3 SDs (a 78.6% overall RR). Grade ≥ 3 toxicities include neutropenia (16/28), anemia (6/28), thrombocytopenia (3/28), hypertension (1/28), and infection (2/28). 1/28 pts had febrile neutropenia. 8/28 pts (28.6%) developed grade 2 osteonecrosis of the jaw (ONJ), defined as bone death on dental exam, higher than 18.3% as reported by Ning. 5/8 had concomitant and 2/8 pts had history of bisphosphonate use. Conclusions: Combined therapy with anti-angiogenic agents R and A, plus D and P is associated with high response rates, 91.7% in PSA and 78.6% in measurable disease in mCRPC pts, with manageable toxicities. Further study is underway to characterize the activity and to explore the high incidence of ONJ, including the possibility of ascertainment bias. No significant financial relationships to disclose.
Incidence of Allergic Reactions to Pegaspargase (PEG) Administered Intramuscularly Versus Intravenously (IM vs. IV) in Children and Young Adults with High Risk B-Lymphoblastic Leukemia (HR B-ALL): Results of Children's Oncology Group (COG) Studies AALL0232/AALL1131
Authors: Wanda Salzer, Michael J. Burke, Eric C. Larsen, Si Chen, Lia Gore, Joanne M. Hilden, Mignon L. Loh, Elizabeth Raetz, Naomi J. Winick, William L. Carroll, Meenakshi Devidas, Stephen P Hunger
Journal: Blood (2015)
Prognostic impact of post-prostatectomy PSA slope determined with a novel, nucleic acid detection immunoassay (NADiA ProsVue) for total PSA.
Authors: J. W. Moul, O. J. Semmes, R. Vessella, J. E. McDermed, H. Lilja
Journal: Journal of Clinical Oncology (2011)

47 Background: ProsVue is an investigational PSA immunoassay whose reporter antibody is labeled with a synthetic DNA sequence. RT-PCR detects the DNA signal indicating the PSA concentration. Pilot studies showed ProsVue slope (least-squares linear slope of 3 post-RP PSA values) to correctly classify prostate cancer (PC) patients (pts) with no evidence of disease (NED) and clinical progression (CP) using a 2 pg/mL/month (mo) decision threshold. In a retrospective, multicenter clinical trial, we evaluated potential prognostic value of ProsVue slope at this decision threshold. Methods: 392 PC pts having RPs 11/1991 to 8/2001 were studied. Eligibility required first post-RP PSA &lt;100 pg/mL, full pathologic and radiographic data and 3 frozen serum samples drawn 6 weeks to 19.4 mo post-RP. Adjuvant radiotherapy (RT) and/or hormone therapy (HT) was not allowed. CP was documented by positive imaging, biopsy results or PC-related death. Efficacy of ProsVue slope as a prognostic test for NED/CP at a 2 pg/mL/month decision threshold was determined and also examined with regards to Gleason score (GS), pre-RP PSA and final pathology stage. Results: Median (range) of pre-RP PSA was 6.3 (0-60.6) ng/mL and post-RP GS was 7.0 (4-10). 73 pts received neoadjuvant HT. Pathologic stage was pT0-2 (228), pT3 (147), pT4 (17); 116 pts had positive margins and 8 had positive lymph nodes. The 3 PSA values were drawn after a median of 4.9, 8.6 and 12.8 mo and showed median values of 10.7, 23.0 and 50.7 pg/mL, respectively. Calculated sensitivity, specificity, PPV and NPV for a 2 pg/mL/mo ProsVue slope were 75.0%, 96.6%, 81.4% and 95.2%, respectively. Median follow-up (f/u) was 10.5 years. There were 40 deaths (14 from PC). Conclusions: ProsVue provides information previously unknown in post-RP pts. ProsVue slope ≤2pg/mL/mo in the first year is highly associated with NED over long-term f/u. Potential clinical utility may include predicting pts not requiring long-term oncologic f/u and predicting a need for post-RP adjuvant RT. ProsVue slope may become a new paradigm for identifying those patients at reduced risk for recurrence of prostate cancer post-RP. Further studies are planned to address these questions. [Table: see text]
Abstract 2136: Increased risk of Infective Endocarditis in adults with Tetralogy of Fallot and Bicuspid Aortic Valve disease
Authors: Aman Saw, Jamil Aboulhosn, Paul J Kim, Risa Hoffman, John S Child
Journal: Circulation (2007)

Background: The new infective endocarditis (IE) guidelines of the British Society for Antimicrobial Chemotherapy (BSAC) 2006 and AHA 2007 state that the only high risk cardiac factors requiring dental prophylaxis are previous IE, prosthetic cardiac valves/surgically created shunts or conduits, unrepaired cyanotic congenital heart disease patients (CHD), or repaired CHD with residual defects. We performed a retrospective analysis of the Ahmanson/UCLA Adult Congenital Heart Disease registry to assess prevalence, anatomy, interventions, and outcomes of IE to determine those at highest risk.

Results: Of 2,842 adults in the registry, 135 pts (70 male & 65 female, median age 28 yrs at time of diagnosis) had 157 episodes of IE (157/2842, 6%). Tetralogy of Fallot (TOF) accounted for 23%, bicuspid aortic valve (BAV) 17%, ventricular septal defect 14%, “single ventricle” physiology 14%, TGA physiology 8%, & double outlet right ventricle 6%. Native valves affected were aortic 46%, mitral 12%, tricuspid 10%, and pulmonic 4%; prosthetic valves/conduits or palliative shunts 17%. Organisms were documented in 54 episodes; Streptococcus Viridans (37%) & Staphylococcus Aureus (7%) predominated. Of 242 TOF pts: there were 37 IE episodes, 31 had sufficient data (44% of identifiable locations were aortic valve, 22% prosthetic conduits, 6% tricuspid valve, 6% mitral valve); median age at diagnosis = 24 yrs, 1:3 male-to-female ratio; 76% had previous cardiac surgery remote from the episode; there was 1 acute (within 6 weeks) death and 3 pts required acute surgery. Of 271 BAV pts: there were 26 episodes of IE (81% on native aortic valves, 15% on aortic valve prostheses), 27% had prior valvuloplasty; median age at IE diagnosis =32 yrs, 9:4 male-to-female ratio; there were no acute deaths; 4 cases required acute surgery.

Conclusions: Certain substrates of CHD are known to increase the risk for IE. TOF represents the largest proportion of IE cases in our center, followed next by BAV. Repaired TOF often has residual aortic regurgitation - a substrate for aortic valve IE. In contrast to new AHA and BSAC guidelines, we demonstrate that BAV and operated TOF constitute a high-risk for IE.
Patient-reported toxicities and comorbidities after treatment for cancers of the upper gastrointestinal tract.
Authors: James M. Metz, Margaret K. Hampshire, Carolyn Vachani, Gloria A. Di Lullo, Christine E. Hill-Kayser
Journal: Journal of Clinical Oncology (2012)

148 Background: Patients may be at risk for significant late effects after multimodality therapy for gastric and esophageal (GE) cancers, the impact of which may be difficult to evaluate using conventional methods. This Internet-based study evaluates patient perceptions of toxicity after treatment for GE cancer. Methods: Patient-reported data was gathered via a convenience sample frame from GE cancer survivors voluntarily utilizing a publically available, free, Internet-based tool for creation of survivorship care plans. Available at www.livestrongcareplan.com and through the OncoLink website, the tool allows survivors to enter data regarding diagnosis, demographics, and treatments, and provides customized guidelines for future care. During use of the tool, GE cancer survivors are queried regarding late effects associated with specific treatments. All data have been maintained with IRB approval. Results: Sixty-six GE cancer survivors answered queries regarding late effects; 62% were female and 93% Caucasian. Median diagnosis age was 55 yrs (19–74 yrs), median current age 59 yrs (19–77 yrs), and average time since diagnosis 3.8 yrs. Most reported having had multimodality therapy—88% surgery, 80% chemotherapy, and 48% radiation. When queried regarding persistent health problems after cancer treatment, 35% reported cardiovascular disease (21% hypertension, 13% hyperlipidemia, 3% angina), 28% sexual dysfunction, 36% tinnitus, 24% peripheral neuropathy, 42% cognitive changes, 100% difficulty swallowing, 60% dry mouth or taste changes, 40% dental changes, and 14% chronic lung disease. Conclusions: Survivors using this tool anonymously and voluntarily report significant health problems after treatment for GE cancers. The data reported here may be of significant impact in future study of quality of life, as well as patient counseling and survivor care.
A phase II dose expansion of TH-302 in combination with doxorubicin in soft-tissue sarcoma.
Authors: L. D. Cranmer, K. N. Ganjoo, D. Adkins, D. R. Reed, S. H. Okuno, J. E. Butrynski, D. A. Rushing, G. A. Lorente, S. Kroll, S. P. Chawla
Journal: Journal of Clinical Oncology (2011)

10024 Background: TH-302 is a 2-nitroimidazole prodrug of the DNA alkylator, bromo-isophosphoramide mustard. TH-302 is designed for activation in severe hypoxia, releasing Br-IPM. The MTD of TH-302 in combination with doxorubicin (Dox) was established at 300 mg/m2. A Phase II expansion at the MTD investigated the activity and safety of TH-302 in combination with Dox in soft tissue sarcoma (STS). Methods: Eligible patients (pts) had ECOG ≤1, advanced or metastatic STS (AJCC grade 3 or 4), no prior chemotherapies (neoadjuvant permitted), evaluable by RECIST and acceptable hematologic, liver, renal and cardiac function. TH-302 (300 mg/m2) was administered IV over 30-60 minutes on Days 1 and 8, full dose Dox (75 mg/m2) as IV bolus 2 hours after TH-302 on Day 1 of a 21-day cycle and G-CSF was administered on Day 8. Results: 60 pts with STS (18 leiomyosarcoma, 16 MFH, 12 liposarcoma, 4 unclassified/undifferentiated, 3 angiosarcoma, 2 synovial, 2 high grade fibrosarcoma, 3 other) were treated between August 2009 and December 2010. Median age: 59 (range 23-78); 25 M/35 F. 14 pts are ongoing, 37 completed 6 cycles (27 received extra cycles TH-302 alone), 18 discontinued prior to Cycle 6 (PD-9, AE-4, clinical deterioration-2, pt decision-2, investigator decision-1). TH-302 related skin toxicities were reported in 35% of pts (two Grd 3: pruritus, pruritus/urticaria); mucosal toxicities were reported in 54% of pts (no Grd 3/4). Non-hematologic AEs: fatigue (61%), nausea (58%), alopecia (44%), stomatitis (40%). Gr3/4 hematologic toxicity: neutropenia (23%), thrombocytopenia (23%) and anemia (19%). Best response assessments in 58 pts: 17 (29%) PRs (15 confirmed, 2 unconfirmed), 34 (59%) SDs and 7 (12%) PDs. 6 mo progression-free rate is 56%. The median progression-free survival was 6.7 mo (95% CI: 5.6 to 8.1 mo). Median overall survival has not been reached (95% CI: 10.4 mo to not reached). Conclusions: TH-302 dosed at 300 mg/m2 in combination with full dose Dox in STS is well tolerated with a predictable safety profile including acceptable hematologic, skin and mucosal toxicity. The response rate and progression-free survival exceed that expected with doxorubicin alone and a randomized controlled study is planned.
Practice pattern for patients receiving bevacizumab in metastatic breast cancer.
Authors: R. Veiga, G. Duran, M. J. Lamas, J. F. Cueva, B. Bernardez, T. Curiel, R. Lopez
Journal: Journal of Clinical Oncology (2011)

e11533 Background: Bevacizumab in metastatic breast cancer (MBC) has been controversial. After considering new data from AVADO and RIBBON trials, FDA has recommended removing MBC indication from Avastin label and EMA only keeps the combination with paclitaxel. Methods: This is a utilization study of bevacizumab in 41 MBC patients (pts) in a Spanish teaching hospital from July 2008 to January 2011. Toxic effects were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC), version 3.0. Disease status was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Clinical evaluation included clinical response, time to progression (TTP), and toxicity. Median survival times were estimated from Kaplan–Meier curves. Results: Median age was 59 years (34-75) and 87.8% of patients had ECOG PS 0 or 1. Our pattern of use only matches with the current European indication in 12 cases (29.3% paclitaxel-bevacizumab); other combinations were: docetaxel (46.3%), taxane-carboplatin (17.1%) or capecitabine (7.3%); it was used as a first line in 19 cases (46.3%), second line in 5 and following lines in 17 cases. Sites of metastases were: 35 visceral and 6 skeletal. Safety outcomes were similar among treatments. Most common toxicities G1-2 were bleeding (13 pts), anemia (21.8%), mucositis (21.9%), diarrhea (9.7%). 9 pts presented hypertension: 1 of them was grade 4 and resulted in discontinuation. 2pts suffered deep vein thromboembolisms. Other non-specific toxicities were: neutropenia (31.2%, G3-4=7.3%), neuropathy (19.5%), alopecia (24.4%), nausea and vomiting (9.8%). Overall response rate is 46.4% (4.9% CR and 41.5% PR). Only 17.1% had progressive disease. Median TTP is 7.8 months (6.5-9.2; 95%CI). TTP of paclitaxel-bevacizumab 1st line is 11 vs 7.7 months for the rest of combinations (p=0.501). There were not differences according to the hormonal status (8.4 ER+ vs 7.2 ER-). Conclusions: Bevacizumab toxicity was not excessive as in our population is considered safe. Safety profile was similar among different combinations of bevacizumab. Activity is in the high ranges previously reported.
Long-term outcome of randomized trial between cryoablation and external beam therapy for locally advanced prostate cancer (T2C-T3B).
Authors: A. A. Al-zahrani, A. Autran Gomez, A. Williams, G. Bauman, J. Izawa, J. Chin
Journal: Journal of Clinical Oncology (2011)

78 Background: Our primary objective is to assess and compare the survival outcomes between cryoablation (CRYO) and external beam radiation therapy (EBRT) in locally advanced prostate cancer. Methods: This is a single institution, retrospective study. Our institution ethics board had approved this study. Patients were initially recruited for the trial between 1999 and 2002. The inclusion criteria for the trial were patients with cT2c–cT3b prostate cancer, PSA &lt; 25ng/ml, with negative metastatic evaluation on CT and bone scan. Patients with evidence of metastasis, prior pelvic radiotherapy or hormone therapy, prostate volume &gt; 75 ml or American Society of Anesthesiology Risk class &gt; 3 were excluded. The biochemical failure was based on the Phoenix criteria (PSA nadir + 2ng/dl). Patients were subjected for regular trans-rectal ultrasound and biopsy until 24 months of follow-up (at 3, 6, 12, 18, 24 months for CRYO and at 18, 24 months for EBRT) and then as clinically indicated. Biochemical disease-free survival (bDFS), disease-specific survival (DSS) and overall survival (OS) were analyzed with Kaplan-Meier curve. Results: Sixty-two patients completed the trial with a median follow-up of 105.2 (± 35.8) months. Preoperative demographic and clinicopathological characteristics of both groups were comparable. All patients received neoadjuvant hormonal therapy for 3 months prior and continued for 3 months after the procedures. The prostate volume before the therapy was smaller in the CRYO group (31.3 ml vs 40.9 ml; p≤0.01). There was greater reduction in the prostate volume in the CRYO group after the intervention (–54% vs 34%; p≤0.01).Three patients in the cryotherapy arm and 2 patients in the radiotherapy arm were crossed over to the other modality at the time of biochemical or biopsy proven progression. The DSS and the OS were comparable between both groups. The 8-year bDFS rate was significant lower in the CRYO group (17.4% vs 59.1%; p=0.01). Conclusions: This randomized trial showed that CRYO was suboptimal in attaining bDFS at 8 years in patients with locally advanced prostate cancer (cT3). Other recent randomized trial showed favorable outcome with CRYO for localized prostate cancer. No significant financial relationships to disclose.
Consciousness for perception and for action: A perspective from unconscious binding
Authors: Zhicheng Lin
Journal: Behavioral and Brain Sciences (2016)

Abstract I argue that the scope and strength of unconscious perception have been overestimated in extant theories. I describe an unconscious binding perspective, and how in conjunction with rigorous methodology it can guide the delineation of unconscious processing. Under this perspective, the function of consciousness is to increase the saliency of conscious contents by facilitating the deployment of focal attention.