tbuckley/cabot-search huggingface dataset:
Oral vitamin B12 to improve aromatase inhibitors (AI)-associated musculoskeletal symptoms (AIMSS).
Authors: Aleli Campbell, Zeina A. Nahleh, Rosalinda Heydarian, Cecilia Ochoa, Alok Dwivedi
Journal: Journal of Clinical Oncology (2017)

e21679 Background: Breast cancer patients undergoing Aromatase Inhibitor (AI) therapy often experience many side effects, which include musculoskeletal and joint pain. Vitamin B12 has often been used as a naturopathic supplement to relieve joint pain that is caused by arthritis. The purpose of this study was to evaluate the effect of Vitamin B12 supplements on musculoskeletal pain and arthralgias induced by aromatase inhibitors (AI) therapy. Methods: After approval by Institutional Review Board (IRB), we enrolled consecutive patients treated at the Texas Tech Breast Care Center who had a diagnosis of invasive breast cancer, Stages I-III, and were taking an AI and experiencing significant musculoskeletal symptoms assessed by the Brief Pain Inventory-Short Form (BPI-SF) questionnaire. Participants received 2500 mcg of sublingual vitamin B12 daily for 90 days. Assessments included improvement in BPI-SF pain scores at 3 months, the impact on quality of life determined by the Functional Assessment of Cancer Therapy–Endocrine Symptoms, FACT-ES and correlative serum markers. Results: A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study. Analysis of the data collected indicate a 34% average pain improvement (P-value = 0.0001) as reported by patients at baseline and at the end of treatment in the BPI-SF questionnaire. Additionally, a 23 % worst pain improvement (P-value = 0.0003) was obtained for worst pain scores evaluated similarly, at baseline and at the end of treatment. Analysis of the results for the FACT-ES scoring showed improvement on all scales. No significant adverse events were observed. Additionally, decrease in pain score was correlated with increased serum B12 levels. A paired t-test was used to assess the mean difference between baseline and endpoint. Conclusions: This study suggests that vitamin B12 reduces pain and improves quality of life for patients taking AIs who experienced AI-related musculoskeletal symptoms. If confirmed in large randomized prospective trials, Vitamin B12 would be a safe and cost effective option for the treatment of AI -related musculoskeletal symptoms.
Long-term survival in patients with NSCLC treated with single fraction vs multi-fraction palliative radiotherapy in the case of lung tumor, brain metastases, and bone metastases.
Authors: Sylwia Szablewska, Magdalena Adamczak-Sobczak, Zofia Roszkowska, Krzysztof Roszkowski
Journal: Journal of Clinical Oncology (2017)

e20082 Background: Patients with advanced non-small cell lung cancer (NSCLC) are candidates for different types of treatment, including chemotherapy and radiotherapy or supportive care. Despite the fatal prognosis in advanced disease, many experienced radiation oncologists will apply radiation at low doses with the intention of palliative care. Choosing an effective radiation dose that does not cause significant complications remains under discussion. Methods: We used an extensive database of medical patients diagnosed with NSCLC, treated with palliative radiotherapy at the Oncology Centre in Bydgoszcz, Poland, from June 1998 to December 2013. A group of 3202 patients was divided into subgroups: A) 1762 patients irradiated on the lung tumor (without distant metastases): Total dose: A1) 6 Gy/1 fr.(n = 19); A2) 8 Gy/1 fr.(n = 276); A3) 20 Gy/5 fr.(n = 1349); A4) 30 Gy/10 fr.(n = 118). B) 548 patients irradiated on the central nervous system (CNS) metastases: B1) 20 Gy/5 fr.(n = 476); B2) 30 Gy/10 fr.(n = 72). C) 892 patients irradiated on the bone metastases: C1) 8 Gy/1 fr.(n = 452); C2) 10 Gy/1 fr.(n = 30); C3) 20 Gy/5 fr.(n = 341); C4) 30 Gy/10 fr.(n = 69). Date of death was obtained from medical records. Patients who were alive or whose date of death could not be determined were censored at the date of their last encounter. Survival was calculated from the start of treatment to the date of death or censorship. Results: Overall Survival (in months) for each group was: A1) = 6; A2) = 5; A3) = 7; A4) = 7. B1) = 4; B2) = 4. C1) = 5; C2) = 4; C3) = 4; C4) = 5. There was no significant difference in survival between patients treated with single fraction pRT or multi-fractionation schedules in all groups of patients. Conclusions: The patients who were prescribed single fraction palliative radiotherapy did not have poorer prognoses or experience shorter survival than patients who were prescribed multi-fraction pRT in the case of lung tumor, brain metastases and bone metastases.
Prognostic effects of clinical and tumor (t) factors in bevacizumab (BEV)-treated patients (pts) with ovarian cancer (OC).
Authors: Nicoletta Colombo, Cesar Mendiola, Frédéric Selle, Jacob Korach, Regula Deurloo, Nicolas Martin, Stephen Robb, Amit M. Oza
Journal: Journal of Clinical Oncology (2016)

5556 Background: We explored potential prognostic effects of biomarkers (BMs) and clinical risk factors in OC pts receiving 1st-line BEV in the single-arm ROSiA study [Oza, ECC 2015]. Methods: Pts with newly diagnosed OC received 12‒24 weeks of chemotherapy (CT) + BEV (15 or 7.5 mg/kg q3w) until progression or for up to 24 mo. PFS was a secondary endpoint. CD31 and tVEGF-A were analyzed by IHC in baseline (BL) samples from pts in the optional BM substudy. PFS was analyzed in subgroups with high (≥ median) vs low (< median) levels of each BM. Cox regression models explored PFS in relation to clinical factors in the ITT population (ITTP) and also tumor BM in the biomarker-evaluable population (BEP). Prognostic factors identified in univariate analyses (p<0.15) were included in multiple Cox regression analyses with backward selection of covariates for inclusion in the final model (p<0.05). The final model used only retained variables to give final HR estimates for these covariates. Results: BL characteristics and PFS were generally similar in the ITTP (N=1021) and BEP (N=346; 34%). In univariate analyses, median PFS was shorter in pts with high vs low tVEGF-A (21.2 [95% CI 19.8–25.2] vs 30.4 [26.0–40.9] mo, respectively) but did not differ according to CD31. Multivariate analyses in the ITTP showed worse PFS associated with ECOG PS ≥1, prior neoadjuvant CT, BL ascites, BL CA125 ≥2 × upper normal limit (UNL), high-risk (MRC ICON7 definition) and low-grade serous OC. Multivariate analyses in the BEP are below. Conclusions: In OC pts treated with CT + BEV, prior neoadjuvant CT, high-risk status, BL ascites and BL CA125 (but not CD31 or tVEGF-A) were prognostic for PFS on multivariate analysis. Clinical trial information: NCT01239732.Parameter No. of PFS events/pts (%) HR (95% CI) p-value Prior neoadjuvant CT* Yes 64/78 (82) 3.45 <0.0001 No 129/266 (48) (2.50–4.75) High risk* Yes 115/153 (75) 2.31 <0.0001 No 78/191 (41) (1.71–3.11) BL ascites* Yes 45/63 (71) 1.34 0.1056 No 148/281 (53) (0.94–1.91) BL CA125* <2 × UNL 90/190 (47) 0.51 <0.0001 ≥2 × UNL 103/154 (67) (0.37–0.70) tVEGF-A H-score† < median 88/172 (51) 0.82 0.1720 ≥ median 105/172 (61) (0.61–1.09) *Included in final model at p<0.05 in step backward selecting variables. †Estimate including final model covariates.
In ANCA-associated vasculitis in remission, tailored vs fixed-schedule rituximab did not differ for relapse at 28 months
Authors: E. William St. Clair
Journal: Annals of Internal Medicine (2018)

Source Citation Charles P, Terrier B, Perrodeau E, et al; French Vasculitis Study Group. Comparison of individually tailored versus fixed-schedule rituximab regimen to maintain ANCA-associated vasculitis remission: results of a multicentre, randomised controlled, phase III trial (MAINRITSAN2). Ann Rheum Dis. 2018;77:1143-9. 29695500
Differences in survival between Caucasians and Asians.
Authors: John K. Chan, Amandeep Mann, Kathleen M. Darcy, Daniel Stuart Kapp
Journal: Journal of Clinical Oncology (2018)

5570 Background: To compare the difference in the presentation and survival of Asian subgroups and whites with epithelial ovarian cancer. Methods: Data were extracted from the National Cancer Database between 2004-2013. Chi-squared tests, Kaplan-Meier methods, and Cox-proportional hazard models were used for statistical analyses. Results: Of the 81,355 women, 78,531 (96.5%) were White and 2,824 (3.5%) were Asians. Of Asians, 495 (23.5%) were Chinese, 487 (23.1%) Indian/Pakistani, 476 (22.6%) Filipino, 207 (11%) Vietnamese, 224 (10.6%) Japanese, and 219 (10.4%) Korean. Compared to Whites, Asians were younger (54 vs. 61 years: p < 0.001) had more early stage disease (47.8% vs. 35.0%; p < 0.001), non-serous histology (56.7% vs. 44.5%; p < 0.001), and better survival (63.9% vs. 50.6%; p < 0.001). Of the Asians, Korean and Vietnamese were younger at 53 years compared to Chinese, Indian/Pakistani, Filipino, and Japanese (54, 54, 55, and 59 years) Vietnamese presented with 38.2% of stage I disease compared to 37.8%, 28.8%, 36.6%, 33.8%, and 34.8% in Chinese, Indian/Pakistani, Filipino, Korean, and Japanese. The 5 years disease specific survivals for Vietnamese, Chinese, Indian/Pakistani, Korean, Filipino, and Japanese were 74%, 67.6%, 67.5%, 60.3%, 59.3%, and 53.4%, respectively (p < 0.001). On multivariate analysis, Chinese (HR: 0.78, 95%CI: 0.65-0.95, p = 0.01), Vietnamese (HR: 0.64, 95%CI: 0.47-0.87, p = 0.005), Indian/Pakistani (HR: 0.70, 95%CI: 0.57-0.85, p < 0.001) race predicted for better survival compared to whites. In addition. younger age at diagnosis (HR: 1.03, 95%CI: 1.027-1.029, p < 0.001), advanced stage of disease (HR: 1.98, 95%CI: 1.95-2.01), and endometrioid cell type (HR:0.72, 95%CI: 0.69-0.75, 0 < 0.001) predicted for survival. Conclusions: Our data suggest that asians presented at a younger age, had more early stage disease with better survival compared to whites. More specifically, the subgroups of Chinese, Vietnamese and Indian/Pakistani have better survival compared to whites.
The impact of an educational program on patient practices on safe use, storage, and disposal of opioids in a comprehensive cancer center.
Authors: Maxine Grace De la Cruz, Akhila Sunkepally Reddy, Vishidha Reddy Balankari, Susan Frisbee-Hume, Margeaux Epner, Diane D Liu, Jimin Wu, Janet L. Williams, Eduardo Bruera
Journal: Journal of Clinical Oncology (2016)

e21659 Background: Improper use, storage, and disposal of prescribed opioids can lead to diversion or accidental poisoning. Our previous study showed a large proportion of cancer patients have unsafe opioid practices. Our objective was to determine if there was an improvement in the patterns of use, storage, and disposal of opioids among cancer outpatients following the implementation of a patient educational program. Methods: Our supportive care center (SCC) provides every patient with an educational material (EM) on safe opioid use, storage, and disposal every time they receive an opioid prescription. We prospectively assessed 300 adult cancer outpatients receiving opioids in our SCC who received EM and compared to 300 patients who had not received EM. The previously used questionnaires pertaining to opioid use, storage and disposal was administered and demographic information was collected. Sharing or losing their opioids was defined as unsafe use. Results: Patients who received EM were more aware of proper opioid disposal methods (76% vs. 28%, p = < 0.0001), less likely to share their opioids with someone else (3% vs. 8%, p = 0.0311), less likely to practice unsafe use of opioids (18% vs. 25%, p = 0.0344), and more likely to be aware the danger of their opioids when taken by others (p = 0.009). Patients who received the EM were less likely to have unused medication at home (38% vs. 47%, p = 0.0497), and more likely to keep their medications in a safe place (hidden 75% vs. 70%; locked 14% vs. 10%, p = 0.0025). Conclusions: The use of an EM on opioid safety in patients with advanced cancer was associated with improved patient reported safe opioid use, storage and disposal.
A randomized control trial of outpatient occupational and physical therapy for older adults with cancer: The CARE program.
Authors: Mackenzi Pergolotti, Allison Mary Deal, Grant Richard Williams, Ashley Leak Bryant, Lauren McCarthy, Erin Coffman, Ethan M. Basch, Bryce B. Reeve, Hyman B. Muss
Journal: Journal of Clinical Oncology (2017)

10038 Background: Limitations in functional status and reduced health status are common among older adults with cancer, yet occupational and physical therapy (OT/PT) remain underutilized (Pergolotti, et.al. JGO,2015). For this population, we evaluated an outpatient CAncer REhabilitation (CARE) program and compared it to usual care (UC). Methods: We recruited adults 65 years and older who had a diagnosis of cancer or recurrence within 5 years and had at least one functional limitation as measured by a geriatric assessment (GA). Participants were then randomized to OT/PT (CARE) or UC. CARE delivered individualized outpatient intervention; OT addressed functional activities, and PT strength/endurance needs. UC participants received a brochure on supportive care services. Primary outcome was functional status (Nottingham Extended Activities of Daily Living Scale [NEADL] (range 0-22)) and secondary outcomes were global Mental and Physical Health, and ability to participate in Social Roles (SR) and activities (Patient-Reported Outcomes Measurement Information System [PROMIS] (range 0-100)), for all measures, higher scores indicate better health. We used t-tests to compare groups. Results: 51 adults were randomized: median age 73 years, 55% male, 92% White, 33% with Leukemia/lymphoma, 26% Breast, 22% Colorectal, 67% in active treatment, and 37% with Stage 3 or 4. After 3 months, both groups experienced a significant decline in functional status ( p = .046; p = .005), but change in functional status (-1.5 UC, -1.1 CARE, p = .637) , physical health status (0.0 UC, 2.4 CARE, p = .121) and participation in SR (.11 in UC, 3.71 CARE, p = .088) between UC and CARE were not significant. However, change in mental health (-1.0 in UC, 3.0 CARE, p= .032) significantly different between groups. Conclusions: CARE was associated with a significant improvement in participant’s mental health status compared to a decline in UC. Results suggest CARE may influence ability to participate in social roles and activities and physical health, but further study is needed with larger sample sizes. We demonstrated that for older adults with cancer, OT/PT are promising interventions to improve mental health. Clinical trial information: NCT02306252.
Acceptance of illness of advanced cancer patients in palliative care center in Kuwait.
Authors: Khalid Al Saleh, Najla Soliman, Maha Abdullah, Fatima Abdelshokoor, Huda Sheab
Journal: Journal of Clinical Oncology (2016)

e21501 Background: Cancer is a life threatening disease and has an enormous effect on patient’s physical, mental and social aspects. Acceptance of illness can reduce the negative emotions associated with the disease and its complications thus could help to improve patient’s quality of life. The palliative care center of Kuwait (PCC–K) was established a few years ago as the first stand-alone PC center in the region. So the aim of the study was to study is to explore the relationship between patient psychological acceptance of his illness and QOL thus his physical, functional and psychological problems. Methods: A cross sectional survey was conducted on 50 patients with advanced cancer receiving palliative managements. Patients were counseled after 7 days of admission to complete the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-pal and The Edmonton Symptom Assessment System (ESAS) Acceptance of Illness questionnaire through patient’s interview. Results: Mean age was 57.8 ± 8.5 years. 52% (n = 26) of the patients was males and 48% (n = 24) was females. The most common cancer diagnosis was lung cancer (16%, n = 8) followed by colonic cancer and breast cancer, each is 12% (n = 6). By using the Acceptance of Illness questionnaire, 14% of the patients were not accepting their illness while 42% was moderate acceptance and finally 44% was good acceptance of illness. Conclusions: Assessment acceptance of illness in palliative care is likely to disclose important information about patients’ psychology which can help the physician to elucidate the plan of management of the patients. Keywords: Cancer, Acceptance, Palliative Care
Survival benefit of neoadjuvant versus adjuvant radiotherapy in lymph node positive esophageal cancer patients undergoing curative resection.
Authors: Nishitha Thumallapally, Mohamed Hendawi, Ahmed Meshref, Mohammed Mousa, Mei Lan, Ahmed I. Salem
Journal: Journal of Clinical Oncology (2016)

e15516 Background: The impact of radiation therapy on the survival of patients with locally advanced esophageal cancer (EC) is not clear. This study investigates the difference in survival benefit comparing neoadjuvant versus adjuvant radiotherapy in lymph nodes positive patients who received curative resection for esophageal cancer, using data from the Surveillance, Epidemiology, and End Results (SEER) Registry. Methods: Retrospectively collected data on patients undergoing esophagectomy for EC from SEER database using all 18 SEER registries was evaluated. All patients with lymph node positive pathology who received either adjuvant or neoadjuvant radiotherapy and esophageal cancer resection with curative intent between 2004 and 2007 were included. 5-year relative survival outcome among groups categorized by sex, race, age, histology, and tumor size were analyzed. Results: 910 patients were evaluated, 629 patients (69%) in the neoadjuvant group and 281 patients (31%) in the adjuvant group. Over all 5 year relative survival rate of the neoadjuvant group was 32.6%(95% CI:28.6-36.8%) compared with the adjuvant group which was 27.3%(95% CI:28.6-36.8). Patients who underwent curative resection for squamous cell carcinoma of EC in the neoadjuvant group had an improved 5-year relative survival rate of 44.3%(95% CI:33.2-54.9) when compared to those in the adjuvant group 26.9%(95% CI:15.3-39.9) (P = 0.03). The results revealed a significant increase in the 5-year relative survival rates for stage T3 disease in the neoadjuvant group 28.5%(95% CI:23.7-33.5) compared to the adjuvant group 20.2%(95% CI:14.1-27.2) (P = 0.01). There was no statistically significant difference according to radiation sequence with surgery in the other histological or T stage groups, or according to race, sex or age. Conclusions: Neoadjuvant radiotherapy has a better 5 year relative survival in patients with squamous cell neoplasms and/or T3 stage disease compared to adjuvant radiotherapy.
The angiotensin II type 2 receptors protect renal tubule mitochondria in early stages of diabetes mellitus
Authors: Tamara Micakovic, Stamatia Papagiannarou, Euan Clark, Yalcin Kuzay, Katarina Abramovic, Jörg Peters, Carsten Sticht, Nadine Volk, Thomas Fleming, Peter Nawroth, Hans-Peter Hammes, Natalia Alenina, Hermann-Josef Gröne, Sigrid Christa Hoffmann
Journal: Kidney International (2018)
A phase II study of oxaliplatin/5FU/bevacizumab and concurrent pelvic radiation in patients with simultaneous primary and metastatic rectal cancer: The Chrome-B trial.
Authors: Michael Michael, Julie Chu, Mathias Bressel, Joseph McKendrick, Prasad Cooray, Sarat Chander, Michael Jefford, Marijana Vanevski, Rachel Wong, Malcolm Steel, Trevor Leong, Alexander Graham Heriot, Sam Ngan
Journal: Journal of Clinical Oncology (2016)

3613 Background: Current chemotherapy regimens used during chemoradiation (CRT) are adequate for radiosensitization but suboptimal for systemic control. The aim of this study was to assess tolerability, and local/systemic benefits of a new regimen delivering intensive chemotherapy plus bevacizumab (Bev) and radical radiotherapy in an interdigitating manner. Methods: Phase II study for patients (pts) with untreated simultaneous symptomatic primary & metastatic rectal cancer. Pts received, in 12 weeks, 3 courses of FOLFOX-Bev and pelvic radiation 50.4Gy with concurrent Oxaliplatin/5-FU/Bev. A) FOLFOX chemotherapy: Oxaliplatin (Ox) 100mg/m2, Leucovorin 200mg/m2, 5FU 400mg/m2 bolus, all day 1, and 5FU CI 2.4g/m2/46 hours given in weeks 1, 6, and 11. B) Bev 5mg/kg in weeks 1, 3, 5, 9, 11. C) Pelvic CRT: 25.2Gy in 3 weeks, 1.8Gy/fr, with concurrent Ox 85mg/m2 day 1 and 5FU CI 200mg/m2/day given in weeks 3-5, and 8-10. All pts staged with CT, MRI and FDG-PET before and post treatment. The primary endpoint was tolerability. Results: 30 pts treated. The mean age: 57 years. Rectal primary MRI stages: T2 3%, T3 73% and T4 24%. All pts had metastasis: liver 80%, lung 10%. 42% of pts had ≥ 3 sites of metastatic disease. 24 pts (80%) completed the 12 week treatment regimen and the planned radiation dose. Overall 80% of pts received the planned number of Ox courses. 77% and 80% of pts received ≥ 75% of protocol Ox and Bev dose. Treatment related grade (Gr) 3 toxicities were: neutropenia 40%, diarrhea 7%, radiation perineal skin reaction 13%, 1 patient each with hypertension and enterocolits. Gr 4 neutropenia in 23%. Febrile neutropenia in 3 (10%) pts, no septic deaths. The overall CT/MRI response rates for rectal primary and metastatic disease were 62% and 48% respectively. The PET metabolic response rate for rectal primary (CR+PR) was 100% (CR 39%) and for metastatic disease 90% (CR 21%). Conclusions: It is feasible to deliver intensive chemotherapy plus bevacizumab and radical radiotherapy in an interdigitating manner treating both primary and metastatic rectal cancer simultaneously. High response rates are encouraging. This treatment design warrants further investigations. Clinical trial information: ACTRN12611000033943.
The prognostic significance of ATRX in pulmonary carcinoid tumors.
Authors: Hao Xie, Simone Terra, Jennifer Boland, Aaron Scott Mansfield, Julian R. Molina, Anja Roden
Journal: Journal of Clinical Oncology (2018)

e20543 Background: Loss of ATRX, a transcriptional regulator, has been associated with reduced survival in patients with pancreatic neuroendocrine tumors. We aimed to evaluate the prognostic role of ATRX in patients with pulmonary carcinoid tumors in addition to the histological classification. Methods: Resected pulmonary carcinoid tumors and clinical information from 1995 to 2017 were retrospectively identified and recorded. ATRX expression by immunohistochemistry was recorded as percentage of tumor nuclei staining by two pathologists independently. Logistic regression and receiver operating characteristic curve (ROC) were used to establish the cutoff for ATRX expression. Kaplan-Meier method and Cox proportional hazards model were used for survival analysis. Results: 120 patients (38% male) with median age of 59.7 years (range, 14.8-87) were included. The median follow-up was 4.2 years. 52 (43%) patients had atypical carcinoid; 68 (57%) patients had typical carcinoid. 74 (62%) tumors had < 2 mitoses per 10 high-power field. 15 (12%) tumors had necrosis. Loss of ATRX nuclear expression was defined as less than 7.5%, a cutoff identified from ROC curves with area under the curve (AUC) of 0.61. Loss of ATRX nuclear expression was independently associated with atypical pulmonary carcinoid tumor with odds ratio 8.6 (95% CI: 3.0-29, p = 0.0002), after adjusting for lymphovascular invasion and perineural invasion. Although histological classification (atypical vs. typical histology) remains to be the best prognostic predictor for the survival of patients with pulmonary carcinoid tumors, loss of ATRX nuclear expression was also independently associated with shorter disease specific overall survival with hazard ratio 8.6 (95% CI 1.6-46, p = 0.01), after adjusting for tumor necrosis, lymphovascular invasion, and the presence of metastatic disease at diagnosis. Conclusions: Loss of ATRX nuclear expression has significant diagnostic and predictive roles in patients with pulmonary carcinoid tumors in addition to the current histological classification. Further studies on the function of ATRX in the pathogenesis of pulmonary carcinoid tumors and larger outcome studies are needed.