tbuckley/cabot-search huggingface dataset:
A prospective assessment of the quality of multidisciplinary tumor boards in Mexico and its relationship with decision making.
Authors: Raul Rogelio Trejo rosales, Enrique Soto Perez De Celis, Edgar Baltazar-Avalos, Yanin Chavarri Guerra
Journal: Journal of Clinical Oncology (2016)

188 Background: Multidisciplinary Tumor Boards (MDTB) allow the review of cases and have been associated with improved decision making and outcomes. There is limited information regarding the performance of MDTBs in developing countries. The aim of this study was to assess the quality of MDTBs and its relationship with decision making at an academic hospital in Mexico City. Methods: We used a validated tool (MTB-MODe) to prospectively assess the quality of MDTBs at our institution. MTB-MODe assigns a score of 1-5 to various aspects of case presentations at a MDTB, including the quality of the information presented and the performance of team members, which are then averaged to obtain a mean score. The scores of MTDBs which reached a decision were compared against those who failed to do so using Mann-Whitney U-test. Results: 100 cases presented at MDTBs between April and June 2015 were analyzed. Median patient age was 57 years (19 - 87). The most common diagnoses were hepatic (23%), breast (20%) and prostate cancer (15%). 50% of cases (n = 50) were localized. Mean MTB-MODe score was 3.27 (range 1.75-4.75), and a decision was reached in 83% of cases (n = 83). Cases in which a multidisciplinary decision was reached had a better MTB-MODe score than those without a decision (n = 17) (3.4 vs 2.8, p = 0.01). The ability of the MDTB to reach a decision was associated with the quality of case presentation (4.1 vs 3.2, p = 0.01), the presentation of comorbidities (3.5 vs 2.6, p = 0.006), better leadership of the coordinator (3.5 vs 2.5, p = 0.002) and better participation of team members (4.2 vs 2.9, p &lt; 0.001). The patient’s point of view was discussed in only 8% of cases (n = 8), while psychosocial issues were only considered in 10% of cases (n = 10). Conclusions: We found that the quality of case presentations at MDTBs, and the performance of its members, are associated with the ability to reach multidisciplinary decisions. In contrast with reports from developed nations, we found that the patient’s point of view and psychosocial issues were not only largely ignored, but also irrelevant for decision making. The continuous evaluation and improvement of MDTBs is necessary for successful decision making in order to improve patient outcomes.
Influence of clinical and psychological variables on coping strategies and quality of life of cancer patients: NEOCOPING study.
Authors: David Rodriguez Rubi, Caterina Calderon, Carmen Beato, Teresa Garcia, Avinash Ramchandani, Beatriz Castelo, Carmen Soriano, Pilar de la Morena, Mar Munoz Sanchez, Ana Fernandez Sanchez, Montserrat Mangas, Eva Martinez de Castro, Rafael Carrion Galindo, Olga Donnay, Jose David Cumplido Buron, Raquel Hernández San Gil, Alberto Carmona Bayonas, Paula Jiménez-Fonseca, Francisco Ayala, Carlos Jara-Sanchez
Journal: Journal of Clinical Oncology (2016)

205 Background: NEOCOPING study analyzes the influence of clinicopathological, personal and social variables on coping strategies and quality of life (QoL) in patients with resected tumors at the time of starting adjuvant chemotherapy. Methods: NEOCOPING is a prospective, multicenter, observational study that involves 19 centers and 34 researchers. Applied main questionnaires were: Mini-Mental Adjustment to Cancer (MAC), EORTC QLQ-C30, Brief Symptom Inventory (BSI-18), Shared Decision Making Questionnaire (SDM-Q) patient and doctor, and Multidimensional Scale of Perceived Social Support (MSPSS). Results: Table summarizes the characteristics of the first 71 patients enrolled. The most used coping strategies were fighting spirit (X=75.8, SD=25.9) and avoidance (X=64.6, SD=25); most patients were found to have good QoL (X=76.5, SD=16.6). Most did not have psychiatric symptoms, and were pleased with family and social support perceived. Patients were very satisfied with the information received (X=83, SD=19.9), and shared opinions with the doctor (X=90, SD=22.9). QoL was significantly negatively correlated with depression (r=-.688, r=.0001), anxiety (r=.-655, p=.0001), somatization (r=-.638, p=.0001) and hopelessness (r =-.287, p =.033). Depression and somatization predicted 54.8% of the QoL of this sample (F=23,636, p=.0001). Conclusions: Even though patients have a good QoL, adaptative coping strategies and no noticeable psychopathological symptoms at baseline, these symptoms may influence the well-being perception and modulate personal adaptations to the diagnosis and treatment of cancer at a curable stage. [Table: see text]
The role of magnetic resonance imaging in targeting prostate cancer in patients with elevated prostate-specific antigen levels.
Authors: K. Kamoi, K. Okihara, N. Takaha, T. Nakamura, F. Hongo, Y. Naito, A. Kawauchi, T. Miki
Journal: Journal of Clinical Oncology (2011)

e15062 Background: The aim of this study was to evaluate the efficacy of MRI for targeting cancer in patients with elevated prostate-specific antigen (PSA) levels. Methods: 136 consecutive men who had elevated PSA levels >4ng/ml and dynamic contrast enhanced (DCE)-MRI before biopsy were included. We used a Philips Achiva 3.0T system for DCE-MRI acquisition. MRI signal criteria were a deep and homogeneous low T2-WI intensity, an asymmetric, early, and intense enhancement on DCE T1-WI. MRI-targeted biopsies were performed including 1 to 3 cores from MRI-based suspicious area as well as 8 cores from normal octant area. For patients who underwent radical prostatectomy, tracings from MRI images and histopathology maps from whole mount section were matched. Results: The overall cancer-detection rate at biopsy was 56% (76/136). The overall sensitivity for predicting positive biopsies by DCE-MRI was 87% (66/76), the specificity 58% (35/60) and the accuracy 74% (101/136). Specific MRI-targeted biopsies and standard cores were taken, with a significant proportion (21/66, 32%) having cancer detected purely because of the MRI-targeted cores. Among 21 patients with biopsy-proven solitary lesion by DCE-MRI, 7 patients underwent radical prostatectomy. Histopathology revealed solitary and significant focus of prostate cancer (Gleason sum greater than 6 and/or tumor volume >0.5 cc) in 5 patients who were considered to be candidates for focal therapy, multiple significant tumor in 1 patient and single insignificant tumor in 1 patient. In 45 patients without suspicious lesion on DCE-MRI, 10 patients had positive biopsy result from systematic octant biopsy cores (22% detection rate). Among these 10 patients, 6 patients had Gleason 3+3, minute focus (<1 mm), and single-core positive cancer who were considered to be candidates for watchful waiting. Conclusions: Targeted prostatic biopsy based on DCE-MRI findings revealed a remarkable potential to select candidates for focal therapy of prostate cancer.
Early toxicity in a randomized trial of high dose-rate (HDR) brachytherapy as monotherapy for low- and intermediate-risk prostate cancer.
Authors: Gerard Morton, Hans T. Chung, Merrylee McGuffin, Liying Zhang, Ananth Ravi, Laura D'Alimonte, Andrew Loblaw
Journal: Journal of Clinical Oncology (2016)

44 Background: Evidence supports the use of high dose-rate brachytherapy (HDR) as monotherapy for selected patients with low- and intermediate-risk prostate cancer when given in schedules of 4 or more fractions. There is limited data on the safety and efficacy of HDR given in fewer fractions. Our purpose is to report on acute toxicity (within 3 months) and early changes in health-related quality of life in a randomized trial comparing a single fraction and a 2-fraction protocol. Methods: A single center, randomized phase II clinical trial of HDR either as a single fraction of 19 Gy (1F), or as two fractions of 13.5 Gy (2F) given 1 week apart was undertaken between June 2013 and April 2015. Eligible patients had NCCN low- or intermediate-risk disease, a prostate volume &lt; 60 cc, International Prostate Symptom Score (IPSS) of 18 or lower, no previous prostate surgery and no use of androgen deprivation therapy. Treatment was delivered using an out-patient ultrasound-based technique. Follow-up assessment was with CTCAE v4, IPSS and Expanded Prostate Composite Index (EPIC). Results: A total of 168 patients were randomized: 86 to 1F and 82 to 2F arms. Median age was 65 years, median prostate volume was 35 cc, and 91% had intermediate risk. Median follow-up was 12 months. Only 3 patients (1.8%) experienced acute grade 2 GI toxicity. The percentage of acute grade 2 GU toxicities is as follows: retention (48%), frequency (20%), urgency (4%). One patient experienced grade 3 hematuria. Ten patients (6%) had urinary retention but only 4 (2.5%) required use of a catheter for longer than 2 days. There was no difference in rate of grade 2 toxicity between treatment arms; the only factor associated with grade 2 urinary retention on univariate and multivariate analysis was prostate volume (p=0.0033). Mean EPIC urinary (p=0.0016) and sexual domain scores (p&lt;0.0001) were lower at 6 months with no difference between treatment arms. Bowel and hormonal domain scores were unchanged. Conclusions: HDR 19 Gy x 1 or 13.5 Gy x 2 is very well tolerated acutely with no acute bowel toxicity. Mild to moderate acute urinary symptoms are common. No difference is found in acute toxicity or early health-related quality of life between treatments. Clinical trial information: NCT01890096.
Targeted therapy for incurable solid cancers: A meta-analysis.
Authors: H. J. Conter, R. Sengupta, D. Conter, I. Colman, Q. S. Chu
Journal: Journal of Clinical Oncology (2010)

e19617 Background: Despite the growing number of trials incorporating targeted chemotherapy in the treatment of metastatic solid tumors, their overall impact on treatment is unknown. Methods: An electronic bibliographic search of MEDLINE, EMBase, and the Cochrane Central Register of Controlled Trials, was performed to identify recently published English-language RCTs on the treatment of end-stage solid cancers with monoclonal antibodies or small molecules compared to conventional chemotherapy. Two reviewers independently assessed all papers for eligibility. Abstracted data included tumor type, phase of trial, methods for the intervention's incorporation into treatment regimen, progression free survival, and overall survival. Results: Of the 5,846 papers identified on the original search, 65 were included in the final analysis. Targeted chemotherapy has led to an increase in median progression free survival of 0.81 months (95% CI, 0.29-1.29, i∧2=79%), and median survival of 0.87 months (95% CI, 0.29- 1.29, i∧2=53%). However, using standardized mean differences and grouping trials by positive or equivocal effect virtually eliminates heterogeneity, with effect sizes of 0.3 (95% CI, 0.25-0.34, i∧2=33%) and 0.21 (95% CI, 0.16-0.26, i∧2=0%) for progression-free survival and median survival, respectively. Conclusions: Targeted chemotherapy has a significant positive effect on survival in specific cancers. However, determining the prognostic mutations that are required to render equivocal treatments effective will probably lead to similar gains only for smaller numbers of patients. It is unclear whether such a significant investment is worthwhile. No significant financial relationships to disclose.
A quality improvement approach to oncologist referrals for hospice care.
Authors: Charles F. Von Gunten
Journal: Journal of Clinical Oncology (2016)

45 Background: Cancer patients frequently experience short lengths of service in home hospice care. Methods: The Oncology Clinical Guidance Council, composed of medical, surgical, gynecological and radiation oncologists sets standards of care for the OhioHealth system serving central Ohio. The Council was polled for consensus on how long a cancer patient should be enrolled in hospice care. Then, median length of stay of patients referred by 18 medical oncologists from their offices to OhioHealth hospice for calendar year 2014 were obtained. A letter from the Chairs of the Oncology Clinical Guidancee Council was sent to each medical oncologist noting the council's opinion about optimal length of stay, the length of stay reported by the National Hospice and Palliative Care Organization (NHPCO), and the median length of stay of all patients referred by OhioHealth oncologists. A chart graphing the median length of stay by oncologist, indicating the name of the oncologist to which the letter was directed, was mailed to each oncologist. One year later, for calendar year 2015, the measurement of median length of stay by oncologist was repeated. Results: 64% of the Oncology Clinical Guidance Council members polled think the median length-of-service for hospice care for cancer patients should be 90 days (3 months) and 20% think it should be 45 days (6 weeks). The NHPCO national median is 43 days. At baseline, the median length of stay for 176 cancer patients referred in calendar 2014 was 19.7 days. The median length of stay for 133 patients referred in the first 10 months of 2015 was 39.6 days. Conclusions: A simple quality improvement approach to improving hospice length of service by oncologists yielded a doubling to reach the national median in one year.
Phase I/II study evaluating the maximum tolerated dose, pharmacokinetics, safety, and efficacy of approved hyperthermia and lyso-thermosensitive liposomal doxorubicin in patients with breast cancer recurrence at the chest wall.
Authors: N. Borys, F. Muggia, W. Simonich, S. A. Lewis
Journal: Journal of Clinical Oncology (2010)

TPS117 Background: Breast cancer recurrence at the chest wall (RCW) typically causes pain, lymphedema, and/or loss of freedom of movement. Lyso-thermosensitive liposomal doxorubicin (LTLD) is a temperature-sensitive liposome that selectively accumulates in tumors due to their leaky vasculature. Doxorubicin is active against breast cancer. Local hyperthermia is lethal to cancer cells; in addition, it selectively increases liposomal permeability in tumor microvasculature, stimulates LTLD to release doxorubicin at the tumor site, and upregulates influx of doxorubicin into tumor cells. LTLD is not associated with congestive heart failure or palmar-plantar erythrodysesthesia. An earlier physician-sponsored phase I trial of LTLD and hyperthermia found that, for subjects treated at ≥ 30 mg/m2, 2 of 10 (20%) had a complete local response. (Jones E. An update of thermally sensitive liposomes for patients with breast cancer chestwall recurrence. Society for Thermal Medicine Annual Meeting, Tucson, AZ, 3-7 April 2009.). Methods: A phase I/II study is now enrolling RCW patients to assess dosing, safety, pharmacokinetics, and efficacy of LTLD/hyperthermia therapy. Eligible patients have RCW tumors < 3 cm deep and have failed standard therapy including surgery, radiation, hormones, and chemotherapy. Subjects are to receive 6 LTLD/hyperthermia treatments at 21-day intervals unless unacceptable toxicity or progressive disease is seen. Hyperthermia may be supplied from either microwave or ultrasound devices. Up to 9 subjects will be enrolled in phase I. LTLD dosing will start at 40 mg/m2 and escalate to 50 mg/m2. LTLD is infused intravenously over 30 minutes; then, within 60 minutes, hyperthermia is administered to the target field. This schedule is designed to optimize the accumulation of LTLD into tumors. The thermal dose goal is 40°C-42°C in > 90% of measured points for 60 minutes duration. In phase II, 100 evaluable patients will be enrolled; with the primary endpoint being the durable (lasting ≥ 3 month) complete local response rate. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Celsion Corporation Celsion Corporation Celsion Corporation
A phase I dose-escalation study of the novel gamma secretase inhibitor PF-03084014 in patients (pts) with advanced solid tumors.
Authors: W. A. Messersmith, P. LoRusso, J. M. Cleary, A. Dasari, X. Zhang, M. N. Shaik, R. D. Courtney, S. Randolph, G. Shapiro
Journal: Journal of Clinical Oncology (2011)

3100 Background: Aberrant Notch signaling is implicated in tumor genesis. Gamma secretase plays a key role in Notch-dependent signaling. The reversible, noncompetitive, selective gamma secretase inhibitor, PF-03084014, has demonstrated broad antitumor efficacy at well-tolerated doses in Notch-dependent preclinical models. This first-in-patient phase I dose-escalation study evaluated safety, tolerability, and the PK profile of PF-03084014 in pts with advanced solid tumors. Methods: Cohorts of 3~6 pts received escalating doses of PF-03084014 orally BID. In cycle (C) 1, pts were dosed continuously for 21 days followed by 7 days off; in C ≥2, dosing was on continuous 21-day cycles. Blood samples for PK analysis were collected up to Day (D) 21 C1, on D1 and 15 of subsequent cycles, and at the end of treatment. Results: 16 pts have been enrolled (9 males/7 females; 20 mg, 3; 40 mg, 3; 80 mg, 4; 100 mg, 6). Median age was 60.5 (23-76) yrs and ECOG PS 0/1: 2/14. Most common treatment-related AEs were low grade and included nausea (25%), diarrhea (19%), and decreased appetite (19%). The only grade ≥3 treatment-related AE was hypophosphatemia (80 mg, 1; 100 mg, 1). Since the data cut-off, 2 pts have experienced DLTs: 1 developed anaphylactic shock following 100 mg BID PF-03084014 and then IV morphine; the pt was stabilized and subsequently withdrew from the study. The second pt developed grade 3 diarrhea following 150 mg BID despite being maximally treated with anti-diarrheals. There was 1 CR (20 mg BID; papillary thyroid cancer; C17), 1 uPR (80 mg BID; sporadic desmoid tumor; C10), and 6 pts with stable disease (20 mg, 1; 40 mg, 1; 80 mg, 1; 100 mg, 3) for at least 2 cycles. PF-03084014 was rapidly absorbed with a median Tmax of 1 hr. Steady state was achieved by D8. PF-03084014 showed dose proportional exposure with a large volume of distribution and a mean terminal half-life on D21 of 22-38 hrs. Conclusions: PF-03084014 was well tolerated in pts with advanced solid tumors, with early evidence of clinical activity and favorable PK characteristics. Accrual is ongoing. Once the MTD of PF-03084014 is established, pts with relapsed/refractory acute T-cell lymphoblastic leukemia/lymphoblastic lymphoma will be evaluated.
Implementing value-based cancer care: A multidisciplinary approach to defining breast cancer outcomes.
Authors: Oluwadamilola M. Fayanju, Tinisha L. Mayo, Tracy E. Spinks, Seohyun Lee, Carlos Hernando Barcenas, Benjamin D. Smith, Sharon Hermes Giordano, Rosa F. Hwang, Richard A. Ehlers, Jesse C. Selber, Ronald Stewart Walters, Debu Tripathy, Kelly Hunt, Thomas A. Buchholz, Thomas W. Feeley, Henry Mark Kuerer
Journal: Journal of Clinical Oncology (2016)

16 Background: Value in healthcare (patient-centered outcomes achieved per dollar spent) unifies performance improvement goals with health outcomes of importance to patients. We describe the process through which value-based measures for breast cancer patients and dynamic capture of these metrics via our new electronic health record (EHR) were developed at our institution. Methods: A review of the breast cancer literature was conducted on treatment options as well as expected outcomes and potential treatment complications. Patient perspective was obtained via focus groups. Multidisciplinary teams met to inform a 3-phase process of (1) concept development, (2) measure specification, and (3) implementation via EHR integration, planned for spring 2016. Results: Outcomes were divided into 3 previously defined tiers (NEJM 2010; 363:2477-2481) that reflect the entire cycle of care (Table).Within these tiers, 22 patient-centered outcomes were defined with inclusion/exclusion criteria, specifications for reporting, and sources for data including the EHR and validated patient-reported outcome questionnaires (e.g., FACT-B+4) administered via our patient portal. Conclusions: A value-based approach to cancer care with transparently reported patient outcomes not only creates opportunity for performance improvement but also enables benchmarking within and across providers, healthcare systems, and even countries. Our value-based framework for breast cancer is the first of its kind in the United States, with a similar model being pursued internationally as well. [Table: see text]
TLI-ATG for nonmyeloablative stem cell transplant: A single-center experience.
Authors: D. A. Wong, A. S. Steinberg, C. Bresee, A. M. Lopez, S. Lim, M. Lill
Journal: Journal of Clinical Oncology (2011)

6578 Background: Myeloablative hematopoietic cell transplant (HCT) for leukemia/lymphoma is highly toxic and often not well tolerated. Total lymphoid irradiation and antithymocyte globulin (TLI-ATG) is a nonmyeloablative (NMA) stem cell therapy developed at Stanford that protects against GVHD by increasing T-reg proportion. We have incorporated TLI-ATG as our preferred NMA regimen in pts with increased age, poor performance status, or other unfavorable markers. We describe our experience thus far with our first pts treated with TLI-ATG. Methods: Six pts with mantle cell lymphoma, AML or ALL underwent TLI-ATG and allogeneic HCT from 4/2009 to 7/2010. Protocol is in NEJM 2005;353:1321-31. Median age was 63y and median no. of prior chemotherapy cycles was 7.5; 1 pt had prior auto HCT. All pts were in CR prior to TLI-ATG and received HLA matched grafts. GVHD prophylaxis was tacrolimus/cyclosporine with MMF. Chimerism studies were performed and GVHD development, RFS, and OS were assessed. Results: All pts tolerated TLI-ATG well and all but 2 achieved donor lymphocyte chimerism >90% by day +32 (range 92-97.5%). RFS and OS at 100d was 100%. Using Kaplan-Meier analysis, the 1y overall survival rate is 62.5%. Pt 1 relapsed day +613 and responded to salvage therapy. Pt 2 failed to engraft even after 2nd HCT with flu/TBI and DLI. Pts 3 and 5 experienced aGVHD of the skin (grade 1; improved w/steroids) and GI tract, respectively. Pt 4 developed oropharyngeal cGVHD. Pts 2 and 5 developed CMV colitis/esophagitis. Pts 3 and 4 are doing well off immunosuppressants at ~1y post HCT. Pt 6 started to lose his graft ~day +165 but has responded to DLI with increasing donor chimerism. Conclusions: In this heavily pretreated pt population, TLI-ATG was well tolerated. The lack of myeloablative toxicity makes it a reasonable option for pts who may not otherwise be candidates for transplant. Patients, transplantation, and outcomes. Characteristic Patients - 6 Age Median 63 Range 39-68 Diagnosis Mantle cell lymphoma 2 AML 2 ALL 2 First remission vs. relapsed disease 2, 4 Cycles of chemotherapy prior to TLI-ATG Median 7.5 Range 2-10 Donor MRD 5 MUD 1 Donor T-cell chimerism – median % Day 27-32 (evaluable pts, n=6) 93.9 Day 52-60 (n=4) 84.6 Day 88-98 (n=3) 99.6 RFS at 100d 100% OS at 100d 100%