tbuckley/cabot-search huggingface dataset:
A randomized phase II trial of 1 month versus 1 year of adjuvant high-dose interferon alfa-2b in high-risk acral melanoma patients.
Authors: L. Si, L. L. Mao, Z. H. Chi, C. L. Cui, X. N. Sheng, S. M. Li, B. X. Tang, J. Guo
Journal: Journal of Clinical Oncology (2011)

8544 Background: Acral melanoma (AM) is the predominant subtype of cutaneous melanoma in the Chinese population. Clinical trials on adjuvant therapy have not previously been reported in this subgroup. Therefore, we conducted this exploratory study in order to observe potential optimal dose intensity and duration of high-dose interferon (HD-IFN) in Chinese postoperative high-risk AM patients. Methods: Patients with resected high-risk (stages IIb-IIIc) AM were randomly assigned to a regimen of 4-week (arm A: 15×106 U/m2 d1-5/w×4w) or 1-year adjuvant HD-IFN (arm B: 15×106 U/m2 d1-5/w×4w, 9×106 U tiw×48w), respectively. The endpoints were relapse-free survival (RFS), overall survival (OS) and toxicities. Results: 158 postoperative patients with AM of stage IIb-IIIc were enrolled in this study, of whom 147 patients were eligible for survival analysis. With a median follow-up of 36.1 months, median RFS for arm A (4 weeks) and arm B (1 year) were 17.9 months and 22.5 months, respectively (P=0.72). There was a trend towards longer RFS with arm B (1 year) although not statistically significant. Stratified analysis demonstrated that RFS of very-high-risk patients (IIIb-IIIc) was statistically shorter in arm A compared with arm B (7.6 months and 12.0 months, respectively; P=0.02). The median RFS of patients with more nodal metastases (n ≥3) was shorter in arm A compared with arm B (3.3 months and 11.9 months, respectively; P=0.004). In addition, there were no statistical differences between groups stratified by age, gender and primary ulceration. Safety analysis showed the most common adverse effects to be Grade 1/2 flu-like symptoms, fatigue, hepatotoxicity, hematologic toxicity and anorexia in both arms; patients in arm B had higher incidence of Grade 3/4 hepatotoxicity (P=0.03), but these were reversible. Conclusions: The preliminary results of this study demonstrated no statistically significance were detected in RFS between the 4 weeks and 1 year regimen for all the high-risk population, while a 1-year regimen showed a significant clinical benefit in patients with stage IIIb-IIIc AM or nodal metastases ≥3. Further survival data are needed for long-term follow-up.
Safety and efficacy of sorafenib in elderly patients (pts) ≥65 years: A subset analysis from the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) Expanded Access Program in North America
Authors: R. M. Bukowski, W. M. Stadler, R. A. Figlin, J. J. Knox, N. Gabrail, D. F. McDermott, L. Cupit, W. H. Miller, J. D. Hainsworth, C. W. Ryan
Journal: Journal of Clinical Oncology (2008)

5045 Background: Sorafenib, an orally active multikinase inhibitor, has been approved by the US Food and Drug Administration for the treatment of advanced RCC. Prior to the drug’s approval for RCC, the North American ARCCS expanded access program was initiated to make sorafenib available to patients (pts) who were not eligible for or did not have access to sorafenib clinical trials in the United States and Canada. Because sorafenib is likely to be used in elderly pts with advanced RCC, we evaluated its safety and efficacy profile in a subset of pts ≥65 years (yrs) who enrolled in the ARCCS program. Methods: Eligible pts were ≥15 yrs of age with advanced RCC, Eastern Cooperative Oncology Group performance status of 0–2 (with waivers granted for pts with status 3–4), and adequate prior therapy of brain metastases. Major exclusion criteria included treatment with other investigational drugs in the 4 weeks prior to enrollment; life expectancy <2 months; active coronary artery disease, ischemia or hypertension; and renal impairment requiring dialysis. Pts received oral sorafenib 400 mg bid as a single agent until disease progression or intolerance. Results: Of 2,504 pts assessed for safety, 1,135 (45%) pts were ≥65 yrs. Grade 2 and Grade ≥3 adverse events (AEs) observed in ≥5% of pts ≥65 yrs and <65 yrs are listed in the table. Grade ≥3 cardiac-related AEs were reported in 8% of pts ≥65 yrs and in 7% of pts <65 yrs. Of the 762 pts >65 yrs of age who were evaluable for response, partial response was reported in 3% and stable disease in 81%. Conclusions: In the ARCCS program, sorafenib 400 mg bid was associated with similar rates of clinically manageable side effects in elderly pts with advanced RCC as compared to younger pts. Response rates to sorafenib in elderly pts were comparable to previously reported results for total ARCCS pts and phase III data for sorafenib 400 mg bid in advanced RCC.Grade 2 and ≥ 3 AEs observed in ≥ 5% of pts ≥ 65 yrs (n = 1,135) and < 65 yrs (n = 1,361) Adverse Events Grade 2 (%) Grade 2 (%) Grade ≥3 (%) Grade ≥3 (%) ≥65 yrs <65 yrs ≥65 yrs <65 yrs Hand-foot skin reaction 7 10 9 10 Rash/desquamation 10 8 6 4 Fatigue 8 7 8 4 Hypertension 8 8 5 5 Diarrhea 6 6 3 3 Nausea 3 5 2 3 Anorexia 6 4 2 2 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bayer HealthCare Bayer/Onyx, Pfizer, Wyeth, Genentech, Novartis, Antigenics, Bayer/Onyx, Pfizer, Genentech, Wyeth, Novartis Bayer/Onyx, Pfizer, Genentech, Wyeth
Increased Peripheral T Cell Responses to EBV-Infected Cells with Frequent Detection of EBV-DNA In Plasma and Viral mRNA In Peripheral B-Cells In Immunocompetent EBV-Positive Diffuse Large B-Cell Lymphoma Patients
Authors: Satoko Morishima, Kazuhito Yamamoto, Hiroshi Kimura, Seiko Iwata, Tomohiro Kinoshita, Hirokazu Nagai, Isamu Sugiura, Keitaro Tsushita, Yoshitoyo Kagami, Koichi Miyamura, Kiyotaka Kuzushima, Shigeo Nakamura, Yasuo Morishima
Journal: Blood (2010)
Toxicity in combined modality treatment of HNSCC: Cisplatin versus cetuximab.
Authors: A. Chew, J. Hay, J. J. Laskin, J. Wu, C. Ho
Journal: Journal of Clinical Oncology (2011)

5526 Background: The standard of care for locally advanced HNSCC remains concurrent cisplatin (CIS) and radiotherapy (RT). In British Columbia patients ineligible for CIS (eg. renal or cardiac dysfunction, hearing loss), receive cetuximab (CET) and RT. We conducted a population based retrospective review at the British Columbia Cancer Agency (BCCA) to compare deliverability, toxicity and outcomes. Methods: Charts of locally advanced HNSCC pts treated with RT (standard, hypofractionated or concomitant boost) and CIS (100mg/m2day 1, 22, 43) or CET (400mg/m2 on Day -7 and 250mg/m2 weekly) between Aug 2007 and Jan 2010 were reviewed. Data was collected on diagnosis, treatment intended and received, adverse effects and outcomes. Statistical analyses were undertaken using t-tests and chi-square. Results: 190 patients (118 CIS, 72 CET) were analyzed on an intention to treat basis. Baseline characteristics were similar except in age (56.5 CIS vs 63.1 CET, p=0.005) and RT fractionation. CIS patients required more dose reductions and delays (33.9 vs 8.3%, p<0.0001; 15.3 vs 1.4%, p=0.002). Percentage of weight lost was higher in the CIS group (9.01 vs 6.87%, p=0.006), and more had greater than 10% weight loss (44.1 vs 23.6%, p=0.004). There was a trend to more unexpected admissions and g-tube insertions in CIS patients (22.8 vs 16.6%, p=0.337; 53.4 vs 41.7%, p=0.473). There was no significant difference in CIS vs CET primary and nodal complete response rate at assessment 3 to 6 months post treatment (84.7 vs 75%, p=0.266) or in distant metastases (11.9 vs 11.1%, p=0.875) at early follow-up (14.15 vs 10.25 months). There was a difference in primary and nodal recurrences (CIS 7.6 vs CET 20.8%, p=0.008). Conclusions: At the BCCA, treatment of locally advanced HNSCC with RT and CET results in less dose reductions, delays and weight loss than CIS. A trend towards a higher complete response rate with CIS was paralleled by a significantly lower local recurrence rate compared to CET. Follow-up and further analysis is ongoing.
High linear energy transfer (LET) radiation therapy in recurrent, metastatic, or unresectable rectal adenocarcinoma.
Authors: P. Paximadis, D. Elliott, A. F. Shields, P. A. Philip, D. W. Weaver, A. A. Konski
Journal: Journal of Clinical Oncology (2011)

612 Background: The purpose of this study was to retrospectively analyze the outcomes of patients with recurrent, metastatic, or unresectable rectal adenocarcinoma treated with mixed beam photon and high LET radiotherapy. Methods: Between 1995 and 2005, the high LET database was queried to identify patients with rectal adenocarcinoma. Local control and overall survival (OS) were calculated using the Kaplan-Meier method. Acute and chronic toxicities were graded using the common terminology criteria for adverse events (CTCAE) v4.0 grading system. Biological equivalent dose (BED) was calculated for tumor and normal tissue of both the photon dose and neutron dose for 10 patients. Results: 11 patients with recurrent, metastatic, or unresectable rectal adenocarcinoma were identified as being treated with mixed photon-neutron radiation. The median age of patients in the study was 58 (range: 38-79). There were 8 male patients and 3 female patients. Median follow-up was 6 months (range: 4-76 months). Patients received a median photon dose of 40Gy (range: 26-50.4Gy) and a median neutron dose of 8nGy (range: 6-10nGy). Seven patients received radiation given concurrently with 5-FU. The median OS was 16 months (range: 4-76 months), with 1 and 2-year OS of 56% and 22%, respectively. Local control was achieved in 9 of 11 (82%) patients. Local progression occurring in two patients occurred at 5 months after completion of RT. The median tumor BED in patients achieving local control was 72.5 Gy (range: 57.1-83.5 Gy). There was a nonsignificant difference in median normal tissue BED of patients with grade 3-4 late toxicity of 104.8 Gy (range: 81.1-115.1 Gy), compared with 95.3Gy (range: 89.0-104.6 Gy) for those patients with grade 1-2 late toxicity. Conclusions: Our experience demonstrates that treatment of unresectable rectal tumors with mixed photon-neutron achieved excellent local control. With the added capabilities of intensity modulated neutron radiation therapy (IMNRT), the incidence of treatment-related morbidity may be improved while taking advantage of the superior tumor control that high-LET radiation can impart. No significant financial relationships to disclose.
Incident myocardial infarction associated with major types of arthritis in the general population: a systematic review and meta-analysis
Authors: Orit Schieir, Cedomir Tosevski, Richard H Glazier, Sheilah Hogg-Johnson, Elizabeth M Badley
Journal: Annals of the Rheumatic Diseases (2017)

To synthesise, quantify and compare risks for incident myocardial infarction (MI) across five major types of arthritis in population-based studies.A systematic search was performed in MEDLINE, EMBASE and CINAHL databases with additional manual/hand searches for population-based cohort or case-control studies published in English of French between January 1980 and January 2015 with a measure of effect and variance for associations between incident MI and five major types of arthritis: rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), gout or osteoarthritis (OA), adjusted for at least age and sex. All search screening, data abstraction quality appraisals were performed independently by two reviewers. Where appropriate, random-effects meta-analysis was used to pool results from studies with a minimum of 10 events.We identified a total of 4, 285 articles; 27 met review criteria and 25 criteria for meta-analyses. In studies adjusting for age and sex, MI risk was significantly increased in RA (pooled relative risk (RR): 1.69, 95% CI 1.50 to 1.90), gout (pooled RR: 1.47, 95% CI 1.24 to 1.73), PsA (pooled RR: 1.41, 95% CI 1.17 to 1.69), OA (pooled RR: 1.31, 95% CI 1.01 to 1.71) and tended towards increased risk in AS (pooled RR: 1.24, 95% CI 0.93 to 1.65). Traditional risk factors were more prevalent in all types of arthritis. MI risk was attenuated for each type of arthritis in studies adjusting for traditional risk factors and remained significantly increased in RA, PsA and gout.MI risk was consistently increased in multiple types of arthritis in population-based studies, and was partially explained by a higher prevalence of traditional risk factors in all types of arthritis. Findings support more integrated cardiovascular (CV) prevention strategies for arthritis populations that target both reducing inflammation and enhancing management of traditional CV risk factors.
Process outcome measures of patients with head/neck, thoracic, and gynecologic malignancies in the MDC clinic.
Authors: AnnaLyn S. Ogata, Francisco A. Conde, Paul Morris, Peter Halford, Darlena Chadwick, Perry Tsuruoka
Journal: Journal of Clinical Oncology (2014)

61 Background: Queen’s Medical Center (QMC) was selected as one of 14 sites nationwide to participate in the expansion of the National Cancer Institute’s Community Cancer Centers program in 2010. In 2011, QMC implemented Multidisciplinary Clinics (MDC) to make the treatment of patients with head and neck (H&amp;N), thyroid, thoracic, and GYN malignancies more efficient and seamless. The purpose of this study was to examine the following process outcomes: timeliness of care, adherence to MDC treatment plans and national guidelines, and utilization of ancillary services in H&amp;N, thyroid, thoracic, and GYN MDC. Methods: Retrospective, chart review of patients with H&amp;N, thyroid, thoracic, and GYN malignancies who were seen at the MDC from Jan 2012 to Dec 2012 was conducted. Variables collected were patient demographics, initial date of referral to the MDC, date of first cancer treatment, clinical variables (e.g. cancer diagnosis, co-morbidities, social habits [smoking, drinking, drug use]), and hospital process variables (e.g. reasons for delay in treatment, adherence to national guidelines, and use of ancillary services [e.g. navigation, dietary, survivorship, social work, chaplain, genetic counseling]). Results: 222 charts were reviewed (H&amp;N = 69, Thyroid = 54, Thoracic = 48, Gyn = 51). Ethnic minorities represented over 50% of the sample. For all cancers combined, average time to referral to first treatment was 32 days. Post-hoc analysis showed that patients seen in GYN MDC (mean = 17.5 + 12.3 days) had significantly fewer days from referral to first cancer treatment compared to patients seen in the H&amp;N MDC (mean = 41.3 + 25.6 days), F = 4.3, p = 0.003. For all sites combined, there was 99.5% adherence to the MDC recommended treatment plans, and 100% adherence to NCCN guidelines in the treatment received. Most patients with GYN malignancy (96.1%) were referred to one or more ancillary services followed by H&amp;N (88.4%), thoracic (85.4%), and thyroid (46.3%). Conclusions: Study provided baseline process outcomes for MDC of disease sites which are often less studied in literature. MDC nurse coordinator played a critical role in ensuring efficient and quality patient care. Results can serve as basis for further quality improvement.
Real-time extraction of breast cancer treatment process and outcome measures from an EPIC electronic health record (EHR).
Authors: Julie Lawrence Kuznetsov, Kathryn Bailey, Pacharintra K. Bombach, Stacey Carmichael, Xuemei Chen, Maja Lichstein Herberg, Terri Owen, Jorge Wilson, Douglas W. Blayney
Journal: Journal of Clinical Oncology (2013)

1 Background: In 2011, Stanford Cancer Institute (SCI) clinical leadership began process improvements to enhance patient satisfaction and quality of care. To measure impacts, unnecessary care variation, and outcomes, we recently developed an informatics infrastructure utilizing data from our EHR (epic modules: BEACON, Cadence, OpTime). We report successful initial efforts including real-time cohort identification (comparing with “gold standard” registry data), and improvements in time to treatment. Methods: A cohort of 1,692 patients was defined by 3 criteria: newly evaluated at SCI, AND received treatment [surgery, chemotherapy (chemo), or radiation (XRT)] at SCI, AND had a breast cancer related ICD-9 code. We analyzed data by fiscal year (FY), starting September, 2010 to FY13 year-to-date. “Time to treatment (Rx)” was measured as the interval between first EHR time stamp for SCI patient contact and Rx date. We used discrete data from the BEACON staging module to create sub-cohorts by stage, and used BEACON protocols to identify chemo regimens. Our cohorts were compared with SCI tumor registry data, and presented in a dynamic Qlikview dashboard. Results: 98% of the EHR-defined cohort matched a similarly defined tumor registry cohort. We detected the effect of process improvements (including scheduling a visit on first contact, coordinating among surgical specialties, outside records available pre-visit, etc.), which resulted in an accelerated time to Rx (Table). Discrete BEACON stage is available for 7% of these 1692 patients. The methodology is scalable and has been successfully replicated in GI and thoracic cohorts. Conclusions: Our work demonstrates utility of EHR data to track process improvements. Uniform use of the BEACON staging module will facilitate variation analysis across cancer types and stages, and allow us to explore variation within modalities (chemo, surgery, XRT). We will analyze associated costs and intermediate clinical outcomes (e.g., unplanned emergency visits and hospitalizations) to inform care pathway choice. [Table: see text]
Risk factors for the development of chemotherapy-related hospitalization (CRH) in patients treated with palliative intent: Results of a 9-year nested case control study.
Authors: Ankit J Kansagra, Gabriel Brooks, Jenny Hong Gao, Layli Jamali, Meenakshi Kundi, Neeraj Saini, Rosemary Stankiewicz, Sowmya R Rao, Erica Ann Linden, Joseph O. Jacobson
Journal: Journal of Clinical Oncology (2013)

3 Background: Palliative chemotherapy is aimed at improving quality of life and increasing life expectancy, without curative intent. Toxicity during palliative treatment defeats the goal of care and increases healthcare cost. We describe the predictors of CRHs among cancer patients treated for palliative intent at a community cancer center. Methods: We conducted a nested case-control study of adult cancer patients who received chemotherapy from Jan 03 to Dec 11. Utilizing a pharmacy database we identified patients who had received chemotherapy for palliative intent. For quality measures cancer center prospectively collects data on all the patients who developed CRH, which was used to identify cases. Hospitalizations were classified as CRH, disease-related or unrelated by a multidisciplinary panel. We frequency matched 2 controls to per case on lines of their chemotherapy treatment (3 groups). We obtained odds ratios (OR) and 95% confidence intervals (CI) from a multivariable logistic regression model on this set of 199 cases and 398 controls to identify predictors of CRH. A two-sided p-value of 0.05 was used for all measures of statistical significance. Results: During the selected period 6,850 patients received chemotherapy, 2,559 (37.3%) for palliative intent. 230 (9%) of 2,559 developed CRH. 76.5 % of CRH happened during the first 3 cycles of chemotherapy, and the mean length of stay was 5 days. Significant predictors on multivariable regression were ECOG score (p = .03), Charlson score (p= .0018), cancer site (p &lt;.006,) abnormal creatinine (p &lt;.0001) and low albumin (p &lt; .007). Conclusions: The results of this mature study demonstrate that patients treated with palliative chemotherapy have a substantial risk of severe hospital-requiring toxicity resulting in morbidity and cost. The finding that risk of severe toxicity is increased among patients with poor PS, multiple comorbidities and renal insufficiency suggests that some events may be avoidable. Furthermore, identified risk factors will enable the development and testing of a predictive model which could be used to identify patients at high risk of CRH prior treatment initiation.
A novel preoperative protocol for locally advanced rectal cancer: Hyperfractionated short-course radiotherapy combined with chemotherapy.
Authors: Hiroshi Doi, Naohito Beppu, Yasuhiro Takada, Yasue Niwa, Masayuki Fujiwara, Fumihiko Kimura, Hidenori Yanagi, Naoki Yamanaka, Norihiko Kamikonya, Shozo Hirota
Journal: Journal of Clinical Oncology (2013)

577 Background: Neoadjuvant chemoradiotherapy (NACRT) has become a widely accepted strategy for rectal cancer (RC). The purpose of this study is to examine the safety and efficacy of a novel protocol of neoadjuvant hyperfractionated short-course radiotherapy (NAHSRT) combined with chemotherapy for locally advanced RC. Methods: 82 patients (pts) with RC were treated with NACRT followed by radical surgery between March 2008 and May 2012. 50 pts with RC of cT3N1M0 were analyzed in the present study. NAHSRT was performed with a dose of 2.5 Gy twice daily, with an interval of at least 6 hours between fractions, up to a total dose of 25 Gy (25 Gy in 10 fractions for 5 days) with chemotherapy. Radical surgery was performed within 3 week following the end of the NAHSRT. Results: 50 pts included 37 men and 13 women. The median age was 65.0 (range: 39-85) years. The median follow-up term was 12.0 (2-36) months. S-1, oxaliplatin with capecitabine, and fluorouracil, leucovorin plus irinotecan (FOLFIRI) was administered with NAHSRT in 48 pts, 1 pt, and 1 pt, respectively. 48 pts (96%) had no apparent adverse events before surgery. 49 pts (98%) completed NACRT except for 1 pt stopped chemotherapy (S-1) because of grade 3 gastrointestinal toxicity (CTCAE v.3). In addition, no pts showed grade 4 toxicities. Postoperative complications were found in 30 pts (60.0%). 33 pts (66.0%) received adjuvant chemotherapy. S-1, capecitabine, oxaliplatin with capecitabine, uracil/tegafur (UFT) and oral leucovorin, and oxaliplatin combined with S-1 (SOX) was delivered after surgery in 20 pts, 4 pts, 4 pts, 4 pts, and 1 pt, respectively. No pts. developed local failure, although distant failures were found in 3 pts. The median disease free survival and overall survival was 11.6 (2-36) months and 12.0 (2-36) months, respectively. In addition, disease-specific survival rate was 100.0%. Conclusions: We presented a novel protocol of NAHSRT for locally advanced RC and the short-term outcome. NAHSRT was well tolerated and produced excellent short-term outcomes in pts with locally advanced RC.