tbuckley/cabot-search huggingface dataset:
Benefits of immediate versus delayed palliative care to informal family caregivers of persons with advanced cancer: Outcomes from the ENABLE III randomized clinical trial.
Authors: J Nicholas Dionne-Odom, Andres Azuero, Kathleen Lyons, Zhongze Li, Tor Tosteson, Zhigang Li, Jay Hull, Jennifer Frost, Mark Hegel, Konstantin H. Dragnev, Imatullah Akyar, Marie Bakitas
Journal: Journal of Clinical Oncology (2014)

LBA9513 Background: Family caregivers of individuals with advanced cancer experience significant burden and diminished QOL; few interventions have been found to reduce these outcomes. Methods: Randomized clinical trial conducted from 10/11/2010 to 9/5/2013 of immediate versus delayed (initiated 12 weeks after randomization) entry patients (n=207) and caregivers (n=122) into ENABLE (Educate, Nurture, Advise, Before Life Ends), a phone-based concurrent oncology palliative care intervention. QOL (Caregiver Quality of Life-Cancer, lower scores=better QOL), depression (Center for Epidemiological Study-Depression) and burden (Montgomery Borgatta Caregiver Burden Scale; subjective burden [SB], objective burden [OB]; demand burden [DB]) measures were collected at baseline, 6, 12, 18, and 24 weeks, and every 12 weeks until patient death or study completion. Results: Estimated treatment effects (immediate minus delayed) for caregivers from randomization to 12 weeks were (mean [SE]): -3.1 [2.3] for QOL (P=.17), -4.1 [1.3] for depression (P=.003), -1.0 [0.4] for SB (P=.02), 0.3 [0.6] for OB (P=.60), and -0.5 [0.6] for DB (P=.39). Estimated treatment effects (immediate minus delayed) from intervention initiation to 12 weeks were (mean [SE]): -6.4 [3.4] for QOL (P=.06), -7.4 [2] for depression (P&lt;.001), -1.0 [0.6] for SB (P=.08), -0.6 [0.7] for OB (P=.44), and -0.5 [0.8] for DB (P=.50). Estimated treatment effects (immediate minus delayed) measured backwards from the time of patient’s death were (mean [SE]): of -4.9 [2.6] for QOL (P=.07), -3.8 [1.5] for depression (P=.02), -1.1 [0.4] for SB (P=.01), -0.6 [0.6] for OB (P=.26), and -0.7 [0.6] for DB (P=.22). Conclusions: Caregivers in the immediate group had lower depression, SB, and trends towards better QOL in comparisons up to 12 weeks, following initiation of the intervention in both groups, and in the terminal decline analysis. These results suggest that concurrent oncology palliative care should be initiated as early as possible to maximize benefit to caregivers. Clinical trial information: NCT01245621.
Urinary n-telopeptide (NTX) predicts palliative pain response in metastatic breast cancer patients receiving second-line zoledronic acid
Authors: G. Dranitsaris, M. Clemons, W. Ooi, D. Cole
Journal: Journal of Clinical Oncology (2006)

679 Background: A substantial number of breast cancer patients will have bony progression or develop skeletal related events (SRE) despite treatment with a bisphosphonate (BP) such as clodronate or pamidronate. What could be of use to the practicing oncologist is a marker for predicting which patients will derive palliative benefit with the second-line use of a more potent BP such as zoledronic acid. In this study, we assessed the clinical utility of using early changes in urinary NTX as a predictor of palliative response to second-line zoledronic acid. Methods: 30 patients with either a documented SRE or bony progression while on either clodronate or pamidronate were switched to infusions of zoledronic acid (4 mg) every 4 weeks for 12 weeks. Urinary NTX and worst pain score using the Brief Pain Inventory were evaluated weekly for the first 4 weeks &amp; again at week 8. No change in systemic anti-cancer treatment was allowed in the month before or after commencing study treatment. A palliative response was defined as a reduction of at least two units in the worst pain score. Logistic regression analysis was used to determine if a decrease in urinary NTX at week 1 relative to baseline was a significant predictor of palliative response to zoledronic acid when measured at week 8. Results: At week 1, 23 of 30 (76.7%) had a drop in their urinary NTX excretion relative to baseline. At week 8, these 23 patients experienced a 2.4 unit decline in their worst pain score, compared to only a 0.28 unit reduction in the 7 patients whose week 1 urinary NTX increased relative to baseline (P=0.11). A week 1 drop in urinary NTX was identified as an important predictor for palliative response to zoledronic acid when measured at week 8 (OR=9.4; 95%CI: 2.28 to 79.8, P=0.014). Conclusions: Our findings imply that a decline in urinary NTX at week 1 is a useful marker for identifying which patients will derive palliative benefits from second-line zoledronic acid. Additional data on a larger sample of patients is needed to validate the clinical utility of using early changes in urinary NTX as a rapid predictor of patient benefit. [Table: see text]
Factors affecting the prognosis of primary liver carcinoma.
Authors: F M Sutton, N C Russell, V F Guinee, E Alpert
Journal: Journal of Clinical Oncology (1988)

Analysis of the clinical records of 163 patients with primary liver carcinoma was performed to identify factors affecting prognosis. The overall 3-year survival rate was 10%, and the median survival was 7.8 months. Survival was similar for patients with single or multiple tumor nodules. There was no significant association between nodule size of 3 cm or larger and survival. Patients who underwent resection had a longer survival. For patients without cirrhosis, location of the tumor in the left lobe regardless of whether it is resected appears to be a prognostic factor associated with prolonged survival. Female sex and the absence of cirrhosis were also associated with longer survival.
An exploratory analysis of cardiac biomarkers in women receiving trastuzumab
Authors: S. Goel, R. J. Simes, J. M. Beith
Journal: Journal of Clinical Oncology (2008)

20557 Background: Trastuzumab induced cardiotoxicity may warrant discontinuation of therapy in up to 19% of women with early stage breast cancer, and is measured through assessment of left ventricular ejection fraction (LVEF). Previous studies have shown that elevated serum troponin I levels (Trop I - a cardiomyocyte structural protein) predict anthracycline-induced cardiac dysfunction prior to a decrease in LVEF. N-terminal pro-B type natriuretic peptide (NT pro-BNP) is a marker of increased left ventricular wall tension that may detect trastuzumab-induced heart dysfunction. Methods: We performed a cross sectional study in women receiving trastuzumab for breast cancer. Patients were required to have a normal LVEF and no clinical signs of heart failure. Serum Trop I and NT pro-BNP were assayed immediately prior to trastuzumab infusion (t0; n=36) and 24 hours later (t24; n=31). Results: Patient characteristics were: mean age 52 (range 25–86); 30 (83%) anthracycline pre-treated; 23 (64%) early stage and 13 (36%) advanced disease; median duration of trastuzumab therapy 30 weeks (range 3–182). Trop I was not elevated (>0.20ng/mL) in any patient at 0 or 24 hours. 15/36 (42%) patients had at least one NT pro-BNP level above the upper limit of normal (ULN, defined as >95th centile amongst healthy volunteers) and both levels were above the ULN in 8/31 (26%) patients. There was no significant difference between NT pro-BNP levels taken at t0 and t24 (Table 1). Conclusion: NT pro-BNP levels are elevated in a significant proportion of patients with normal LVEF receiving trastuzumab. Trastuzumab does not induce an acute rise in NT pro-BNP levels at 24 hours. Troponin I levels are not raised in this group, perhaps reflecting the mechanism of cardiotoxicity. These data are exploratory and have informed the design and power calculations of a larger study examining the predictive utility of serial serum NT pro-BNP levels for trastuzumab-induced cardiotoxicity in the adjuvant setting. NT pro-BNP levels (pg/mL) Pre-infusion, t0 Post-infusion, t24 N 36 31 Mean 163.5 168.1 SEM 56.6 49.3 Median 86.4 74.6 Spearman’s correlation 0.844 Wilcoxon signed ranks p value 0.969 ULN : <75 yrs : 110 pg/mL; >75 yrs : 589 pg/mL No significant financial relationships to disclose.
Establishing a research network in Scotland more than doubles trial recruitment
Authors: J. Cassidy, S. Bonner-Shand, M. Nicoloson, D. Cameron, R. McLaren, A. Gordon
Journal: Journal of Clinical Oncology (2007)

6630 Background: Scotland has a population of 5.4 million people with 26, 000 new cases of cancer per annum. In 2002 the Scottish Executive established a research network covering all of the country with the objective of doubling recruitment to cancer trials within 3 years. Methods: A grant of £1million (circa $2 million) was provided to establish a network covering all of Scotland. The network was centred on 3 of the main cancer centres. Support staff consisting mainly of data managers and research nurses were employed in each region. Clinical trials were selected by interested clinicians from the existing NCRI portfolio in the UK. These trials were then opened in centres and regional units with the intention of recruiting patients locally. Each trial was approved by appropriate local university and NHS ethics, research and development boards. Recruitment numbers were collated by trials co-ordinators and compared with baseline figures derived from 2001–2 Results: 31 members of staff were recruited and trained. These were a mix of data managers and research nurses. In 2001, 927 patients were entered in trials which is 3.5% of all cases. In 2005 this had risen to 3557 (13.7% of all cases). These ranged across all the major common solid and haematological malignancies. In portfolio includes therapy studies in phase 1–3 including large scale RCTs, screening and prevention studies. The breakdown of patients treated within the cancer centres versus those in regional units indicated that the biggest impact on recruitment was in the latter. The network has introduced streamlined procedures for multiple ethics and R+D submissions which has facilitated recruitment in cancer units. Web based tools have been piloted to allow patient screening to be performed remote from the cancer centres. A breakdown of recruitment by trial and tumour type will be presented. Conclusions: Investment in infrastructure support in a targeted manner can very significantly improve trial recruitment. No significant financial relationships to disclose.
Prognosis of medullary breast cancer: Analyses of 13 International Breast Cancer Study Group (IBCSG) trials.
Authors: J. B. Huober, S. Gelber, B. Thürlimann, M. M. Regan, K. N. Price, A. Goldhirsch, A. S. Coates, G. Viale, C. Oehlschlegel
Journal: Journal of Clinical Oncology (2010)

630 Background: Medullary breast cancer is a rare histology that often has biological features associated with a more aggressive phenotype. Methods: Among 12,409 patients enrolled in 13 IBCSG trials, 127 were recorded as having medullary invasive tumors (MT) and 8,096 as having ductal invasive tumors (DT). Histology was determined by central pathology review in 11 of the 13 trials. For patients known to have grade 3 (G3) and estrogen receptor-negative (ER-) tumors, 47 were reported as MT and 1407 as DT. MT and DT were compared with regard to stage, age at diagnosis, grade, hormone receptor status, vessel invasion, local treatment and randomly assigned treatment. Pattern of relapse, disease-free (DFS) and overall survival (OS) were determined for both histological groups. DFS and OS hazard ratios (HR) were stratified by trial. Results: The incidences of reported MT and DT were 1.0% and 65.2%. Unfavorable prognostic factors such as positive nodes, larger tumor size, and negative hormone receptors were more frequently observed with MT, while vessel invasion was present less often. For the full cohort, 14-year DFS percents for MT (n = 127) and DT (n = 8,096) were 57% and 45% (HR = 0.68, p = 0.0013), and OS percents were 66% and 57% (HR = 0.75, p = 0.029). For patients with G3 and ER-tumors, 14-year DFS percents for MT (n = 47) and DT (n = 1407) were 64% and 46% (HR = 0.53, p = 0.006), and OS percents were 74% and 54% (HR = 0.55, p = 0.015). For the G3/ER- cohort, DFS events (at 13.5 years median follow-up) were breast cancer-related, 30% MT vs. 48% DT; second (non-breast) primary, 6% vs. 3%; death without prior breast cancer event, 6% vs. 3%. Conclusions: MT have a favorable prognosis compared to DT despite worse associated biological features. Especially for patients with G3/ER- tumors, medullary histology should be considered when deciding on appropriate adjuvant treatment. No significant financial relationships to disclose.
Idiopathic Hypoparathyroidism with Thin Bones
Authors: H K IBBERTSON, R FRASER
Journal: JAMA (1963)

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Concurrent chemoradiation in stage II laryngeal carcinomas.
Authors: R. Rajendranath, A. Surendranath, A. Vasanthan
Journal: Journal of Clinical Oncology (2010)

5567 Background: Early glottic carcinoma has a good prognosis compared to other head and neck carcinomas, but we must aim for voice preservation in the treatment. Regarding T1N0, larynx preservation rates are favorable even with radiotherapy alone. However for T2N0, the treatment strategies differ in each institution, and larynx preservation rates range from 72% to 85%, and are not high enough. The aim of the study was to determine the efficacy and toxicity profile of concurrent chemoradiotherapy compared to radiotherapy alone in patients with T2N0 squamous cell carcinoma of the larynx. Methods: 17 patients were treated with radiotherapy + concurrent chemotherapy and 30 patients with radiotherapy alone. Chemotherapy consisted of CDDP-5FU combination, every 3 weeks, for 3 cycles, or weekly CDDP to a total of 6 cycles. Radiotherapy was given with 6 MV x-rays delivering 200 cGy per day, 5 days a week, to a total dose of 60-66 Gy.Treatment schedule was pended for grade 3/4 toxicities. Statistical tests used are Log Rank Test and Actuarial/Life table method to calculate the survival difference. Results: The duration of symptoms prior to diagnosis ranged from 1 month to 12 months with median duration of 2 months. The median duration of symptoms were 1.8 months for supraglottic cancer and 3.9 months for glottis cancers.All the 17 patients in the RT+CT group achieved CR but only 24/30 (80%) in RT alone group achieved. The 2-year NED rates were 100% in the chemoradiation group and 70% (21/30 patients) in the RT alone group. This difference was statistically significant with a p value of 0.01. Out of the recurrences 2 were distant metastases ( lung ), 2 nodal and 6 were local recurrences. 3 patients had lost to follow up in the RT alone arm. Follow up ranged from 6-42 months. Toxicities in RT+CT group included grade 3/4 neutropenia in 5 patients (29.4%), grade 3 febrile neutropenia in 2 (11.8%), grade 3 emesis in 2 (11.8%), and grade 2/3 mucocitis in 13 (76.5%). Toxicity profile in RT alone group included grade 2/3 mucositis in 10 patients (33.3%). Conclusions: Concurrent chemoradiotherapy for T2N0 squamous cell carcinoma of the larynx was safe with acceptable toxicity profile and effective in improving local control with voice preservation. No significant financial relationships to disclose.
Capecitabine (cape)-associated hand-foot skin reaction (HFS) as a clinical predictor of improved survival in patients (pts) with colorectal cancer.
Authors: Ralf Hofheinz, Volker Heinemann, Ludwig Fischer von Weikersthal, Ruediger Paul Laubender, Deniz Gencer, Iris Burkholder, Andreas Hochhaus, Sebastian Stintzing
Journal: Journal of Clinical Oncology (2012)

3541 Background: HFS is frequently observed during treatment with cape. Post hoc analyses of the X-ACT trial suggested that HFS may be associated with improved prognosis in cape recipients in stage III colon cancer. In the present analysis we evaluated the potential association of HFS and survival in pts with metastatic colorectal cancer and locally advanced rectal cancer. Methods: Pts receiving cape within AIO KRK-0104 and Mannheim rectal cancer trials were analyzed. HFS was graded according to NCI-CTC. Time to first occurrence of HFS was described per cycle and HFS developing during cycles 1 and 2 was defined as “early HFS”. Baseline characteristics in the groups of pts with or without HFS were compared using standard tests. Toxicities observed in both groups were compared with Fisher’s exact test. Progression-free (PFS) or disease-free (DFS) and overall survival (OS) data from both trials were pooled and the HFS group was compared to the non-HFS using Kaplan-Meier analysis. Results: A total of 374 pts are included, of whom 29.3% developed HFS. Of these, 70.9% had “early HFS”. Baseline characteristics were comparable between the HFS and the non-HFS groups concerning age, gender, ECOG status and UICC stage. On multivariate analysis none of these factors had influence on the occurrence of HFS. The percentage of all-grade hematological toxicities did not differ between both groups. Contrarily, patients in the HFS group had a significantly higher rate of all grade (but not grade 3-4) diarrhea, stomatitis/mucositis and fatigue (p&lt;0.01 resp.). Moreover, pts in the HFS group had improved PFS/DFS (29.0 vs. 11.4 months; p=0.015, HR 0.69) and OS (75.8 vs. 41.0 months; p=0.001, HR=0.56). Within the HFS group the PFS/DFS and OS were comparable between pts in the “early” and the “late HFS” groups. Conclusions: This analysis provides further evidence for the association of HFS and survival in patients with colorectal cancer. Baseline characteristics and the time of occurrence of HFS had no impact on survival. Patients developing HFS had a higher probability of developing any-grade gastrointestinal toxicity and fatigue while no correlation with hematological toxicity was noticed.
Rh-Thrombopoietin-derived autologous cryopreserved platelet support for peripheral blood progenitor cell transplantation
Authors: M. Bentley, K. Taylor, S. Wright, C. Kelly, D. Taylor, R. Rodwell, B Leach, R Minchinton, D. Fontana, K. Jardim-Surman, S. Lanzalone
Journal: Blood (2000)
Final results of phase I and pharmacokinetic study of SJG-136 administered on a daily x 5 schedule
Authors: T. M. Kadia, S. Faderl, Z. Estrov, M. Konopleva, S. George, W. Lee, I. Puzanov, A. Chen, H. Kantarjian, F. Ravandi
Journal: Journal of Clinical Oncology (2009)

e13506 Background: SJG-136 is a pyrrolobenzodiazepine dimer that forms covalent DNA crosslinks in a sequence-specific manner in the minor groove. In vitro testing demonstrated a broad pattern of antitumor activity in sub-nmol concentrations. A phase I study in patients (pts) with solid tumors revealed clinical activity, defined MTD as 30 mg/m 2 /d administered on daily x 3 schedule, and confirmed manageable toxicity. Here we report the results of a CTEP-sponsored phase I trial of SJG-136 administered on a daily x 5 schedule in pts with relapsed or refractory (R/R) leukemias. Methods: Previously treated pts with R/R acute leukemias (AML, ALL, high risk MDS, CML blast phase) or R/R CLL with adequate organ function and ECOG performance status of ≤ 2 were eligible for the study. The starting dose level was 6 mcg/m 2 given intravenously daily x 5 days on a 21 day cycle. Pts were sequentially enrolled in cohorts of 3 and the dose was escalated in a classic 3+3 schema at the dose levels: 6, 12, 24, and 36 mcg/m 2 . Repeat courses and intrapatient dose escalation were allowed. Results: Sixteen pts (11M, 5 F) were enrolled on the study. The median age of the patients was 53 (21–84). Thirteen (81%) pts had R/R AML, and 3 (19%) had R/R ALL of which 5 (31%) had diploid and 6 (38%) had adverse cytogenetics. Median number of prior therapies was 3 (2–6). Pts enrolled at each dose level (mcg/m 2 ) were: 6 (3 pts), 12 (5 pts), 24 (4 pts), 36 (4 pts). The median number of cycles delivered was 1 (0–5). The dose of 36 mcg/m 2 was found to be above the MTD, with the DLT being grade 3 soft tissue edema. Other manifestations of vascular leak including grade I, II hypoalbuminemia, edema, and pleural effusions were seen in a number of patients starting at dose level 24 mcg/m 2 and above. Other non-dose limiting toxicities included nausea, dyspnea, fatigue, bloating, and insomnia. One pt had a PR, 8 pts had stable disease, and 6 had progression. Pharmacokinetic characteristics in this population will be reported. Conclusions: SJG-136 is safe and active in patients with advanced leukemias. Edema and other vascular leak syndromes are characteristic toxicities of the agent at higher dose levels. 24 mcg/m 2 is the recommended phase II dose for the daily x 5 schedule. No significant financial relationships to disclose.