tbuckley/cabot-search huggingface dataset:
The safety of chemotherapy for colorectal cancer patients with hepatitis C virus infection.
Authors: Kenji Tomizawa, Koichi Suyama, Yuji Miura, Akihiko Shimomura, Yutaka Hanaoka, Shigeo Toda, Jin Moriyama, Shuichiro Matoba, Toshimi Takano, Hiroya Kuroyanagi
Journal: Journal of Clinical Oncology (2014)

629 Background: Hepatitis C virus (HCV) infection is one of the most common blood-borne infection in the world, and with an estimated to be infected more than 880,000 people in Japan. Little is known about the changes of HCV status during chemotherapy and the influence of HCV infection on toxicity of chemotherapy. Methods: We reviewed all patients diagnosed with colorectal cancer in our institution between 2001 and 2012 who had been screened for HCV infection by testing for anti-HCV antibody and identified 77 HCV-infected patients. We retrospectively analyzed the change in HCV load and the toxicities of chemotherapy in these patients. Results: Twenty-four of the 77 HCV-infected patients with colorectal cancer had received chemotherapy.The median age was 66 years (range: 42-80 years). Four patients had liver cirrhosis at the initiation of chemotherapy. The remaining 20 patients were diagnosed with chronic hepatitis, and their liver function tests and complete blood cell counts at baseline were normal. First-line chemotherapy included 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) (n = 6), S-1 and irinotecan (IRIS) (n = 1), tegafur-uracil (n = 14), capecitabine (n = 1), capecitabine and oxaliplatin (XELOX) (n = 2).Serum HCV-RNA levels both before and after chemotherapy were evaluated in 10 patients, and the median serum HCV-RNA level before and after chemotherapy was 4.0 and 3.05 logIU/ml, respectively. Transaminase levels were elevated during chemotherapy in 2 patients. There were no patients suffered from grade 3-4 neutropenia or febrile neutropenia. Conclusions: This study indicates that chemotherapy can be safely performed in HCV-infected patients with colorectal cancer without change in HCV load.
Readmission after robotic Ivor Lewis esophagectomy: Earlier discharge, increased readmissions?
Authors: Ahmed I. Salem, Ravi Shridhar, Sarah E. Hoffe, Khaldoun Almhanna, Kenneth Meredith
Journal: Journal of Clinical Oncology (2016)

149 Background: Readmissions after esophagectomy are costly and incidence can be as high as 25%. The robotic assisted approach has potential benefits of earlier discharge compared to conventional techniques, however it is unclear what impact an earlier discharge will have on readmission rates. We sought to examine the impact of early discharge on readmission rates with robotic approaches. Methods: A retrospective review of all patients undergoing robotic assisted Ivor Lewis esophagectomy (RAIL) from 2009-2015 was conducted. Clinicopathologic factors and surgical outcomes were recorded and compared. We then compared outcomes to a historical cohort from the Surveillance, Epidemiology, and End Results-Medicare data (2002 to 2009). Length of stay, 30-day and 90-day readmissions, and mortality were determined. All statistical tests were two-sided and a p-value &lt; 0.05 was considered statistically significant. Results: We identified 147 patients who underwent RAIL. There were 78.9% (116) male with an average age 66 ±10 years. Adenocarcinoma was the predominant histology in 86% (126) patients, 9.52% (14) patients had squamous cell histology, and 4.76% (7) patients had other histology. Neoadjuvant therapy was administered to 77.6% (114) patients. In the SEER database 1,744 patients with esophageal cancer underwent esophagectomy: 80% of patients (1,390) were male, with a mean age of 73 years; 71.8% of tumors (1,251) were adenocarcinomas, and 38% of patients (667) received neoadjuvant therapy. Median length of stay was 13 days, 30-day mortality was 8.8% (158 patients), and 90 day mortality was 17.9% (302) compared to median LOH of 9 days, 30-day mortality of 0.6% (1) and 90-day mortality of 1.4% (2)% in the robotic cohort, p &lt; 0.0001, p = 0.007, and p &lt; 0.0001. Readmission rates at 30 and 90 days were 18.6% (212) and 31.3% (356) in the SEER patients, and 3.4% (5) and 5.4% (8) in the robotic cohort p = 0.001 and p &lt; 0.001. Conclusions: RAIL is a safe surgical technique that provides an alternative to conventional approaches to esophageal resection. Patients undergoing RAIL had lower mortality rates and LOH. Despite the lower LOH, RAIL was associated with lower 30 and 90-day readmissions.
Predictors of early referral of advanced cancer patients to an outpatient palliative care specialty clinic in a tertiary cancer hospital.
Authors: Shalini Dalal, Rony Dev, Kimberson Tanco, Janet L. Williams, Eduardo Bruera
Journal: Journal of Clinical Oncology (2015)

136 Background: Integration of palliative care (PC) with oncologic care has been advocated. In recent years our group has observed increased referral of cancer patient in earlier stages of illness. Our study objective was to compare clinical characteristics of advanced cancer (aCA) patients referred by their oncologists within 2 months of aCA diagnosis (early referral, ER) versus those referred more than 2 months later (late referral, LR). Methods: We collected data on baseline characteristics, symptoms, and the timing of PC referral on consecutive cancer patients seen in first consultation at the outpatient PC specialty clinic in fiscal year 2013. Results: Of the 1225 cancer patients referred for PC consultation, 968 (79%) patients had aCA, of which 38% (n = 372) were seen as ER, and 62% (n = 596) as LR. As compared to the LR group, patients in the ER group had significantly higher severity of pain, SOB, anxiety and drowsiness. In the ER group, a significantly higher proportion of patients had aCA status at initial presentation to their oncologist as compared to the LR group (83% versus 60%; p &lt; 0.0001). Of all the referring primary services, Thoracic Medicine was the only service where a majority of aCA patients were in the ER group (161 versus 122 patients; p &lt; 0.05). In regression analysis, the odds of patients being referred early was higher if they belonged to the Thoracic Medicine service, had aCA at initial presentation to their oncologist, and had higher severity of fatigue and drowsiness. Overall, the median survival of aCA patients, calculated from date of PC consultation, was 5.9 months, and did not differ between ER and LR groups (6.1 and 5.8 months; log-rank 0.832). Conclusions: Our study demonstrates that oncologist’s decision to refer patients early to PC clinic depends on the type of primary service, having advanced stage disease at initial presentation, presence of symptoms of fatigue and drowsiness, and prognostication of decreased survival. The median survival time of 6 months from PC consultation is encouraging and suggests earlier PC referral of cancer patients as compared to earlier reports.
Micro-RNA-21 (miR21) expression in colorectal cancer (CRC) as a predictor for fluoropyrimidine-based adjuvant chemotherapy.
Authors: Albert Y. Lin, Natalia B. Kouzminova, Jonathan Pollack, Gerard Nuovo
Journal: Journal of Clinical Oncology (2013)

408 Background: Fluoropyrimidine-based adjuvant chemotherapy is a standard treatment option for patients with high risk II or stage III CRC. It is, however, unclear if a subset of patients will benefit from chemotherapy more than others. MiR21, a small non-coding RNA, has been associated with promotion of tumor cell growth and metastasis. To assess the effect of miR21 on chemotherapy, we analyzed the association of miR21 expression with clinical outcomes and known prognostic factors. Methods: MicroRNA detection was performed by in situ hybridization on a CRC tissue microarray containing specimens from 130 cases (stage I, 21 patients; II: 44; III: 33; IV: 32). MiR21 expression was graded as negative (no staining in all tissue cores), low (0-10% staining), moderate (20-40%) and strong (50-100%), and was analyzed with stage, grade, expression of VEGF, Ki67, LEF1, OPN and MSH2 by immunohistochemistry. Cox proportional hazards regression analysis was performed to assess the association of miR21 expression with 10-year recurrence-free survival in the subgroup of 77 stage II or III patients. Results: In all, miR21 expression had moderate positive correlation with genes associated with tissue proliferation and invasion, including Ki67 (Spearman's r=0.42, p&lt;0.001), VEGF (r=0.32, p&lt;0.001) and OPN (r=0.32, p&lt;0.001), and weak correlation with LEF1 (r=0.22, p=0.012) and MSH 2 (r=0.18, p=0.039). In the subgroup of 36 patients treated with adjuvant therapy, low or negative miR21 expression (≤10%, n=15) was associated with increased recurrence (HR =3.5; p=0.05). In the multivariate Cox regression model including stage, grade and LEF1 expression, the association of low or negative miR21 with cancer recurrence remained significant along with grade and LEF1. Ki67 was excluded from the multivariate model because of significant association with miR21 (r=0.44, p=0.007) in the analyzed group. Conclusions: Our results suggest that low miRNA21 expression is associated with increased risk for recurrence in CRC patients received adjuvant chemotherapy. Further investigation of miR21 in randomized studies is warranted to establish its role as a predictor for CRC in the setting of adjuvant therapy.
Hemi salvage HIFU in patients with radio recurrent prostate cancer: Early experience and results.
Authors: Gilles Pasticier, Eduard Baco, Olivier Rouviere, Sebastien Crouzet, Jean-Yves Chapelon, Albert Gelet
Journal: Journal of Clinical Oncology (2013)

99 Background: One third of patients treated with External beam radiation therapy (EBRT) for localized prostate cancer (PCa) experience local recurrence. Salvage treatment options include prostatectomy, cryoablation, and High Intensity Focused Ultrasound (HIFU). Whole gland treatment in these patients offers acceptable cancer control, but carries a risk of severe urinary incontinence in at least 20% of cases and reduction of Quality of Life (QoL). In patients with unilateral local relapse, focal HIFU is feasible. The aim of this prospective study was to evaluate the effect of Hemi HIFU in patients with unilateral recurrence after radiotherapy. Methods: Between 2009 and 2012, 48 patients were prospectively included in 2 centers. Inclusion criteria were positive MRI and biopsy in one lobe diagnosing unilateral cancer after EBRT (46 patients) and after brachytherapy (2 patients). Mean age was 68.8 ± 6 years, mean pre HIFU PSA was 5.2 ± 5.2 ng/mL and the repartition of Gleason score was ≤7: 28, ≥8: 18 and not determined: 2. Median follow-up was 16.3 months [range 3-43]. Treatments were performed with Ablatherm® HIFU device. Results: The mean PSA nadir value was 0.69 ± 0.83 (median: 0.4). Disease progression occured in 16 patients (35,5%). Local recurrence was found in 4 patients in the controlateral lobe, and in 4 patients in both lobes. Six patients developped metastases and 2 had rising PSA without local recurence or proven metastasis. Fifteen of these 16 patients received salvage treatments (3 re-HIFU, 11 androgen-deprivation, and 1 re-HIFU plus androgen-deprivation). Thirthy-six patients (75%) were pad-free. Seven patients (14.6 %) required 1 pad a day. Severe incontinence occured in 5 patients (10.4%). One of them received artificial urinary sphincter. Paired results indicated no significant change in QoL and IPSS scores: EORTC-QLC-30: (from 35.7 ± 8.7 to 36.8 ± 8.6, p=0.22) and IPSS: (from 7 ± 5.6 to 8.5 ± 5.1, p=0.13) Conclusions: Hemi-salvage HIFU is efficient in patients with unilateral radio-recurrent PCa with a preserved QoL offering comparable cancer control to whole gland treatment.
Rectal cancer: The relevance of the interval between chemoradiation (CT) and surgery.
Authors: E. Uña, P. Alonso, C. Perea
Journal: Journal of Clinical Oncology (2011)

e14029 Background: The aim was to determine the effect of a longer interval between neoadjuvant (N) CRT and surgery on perioperative morbidity and complete response rate. Methods: We reviewed rectal cancer patients records to perform a retrospective study. Inclusion criteria were clinical stage II and III rectal cancer patients undergoing N CRT followed by proctectomy between 2008 and 2010. The N regimen consisted of long course external beam RT and concomitant capecitabine 850 mg/m2 daily from Monday to Friday. Doses of RT were 45 Gy to the whole pelvis plus 5.4-9 Gy to the tumour mass. Patients with inflammatory bowel disease, hereditary cancer, extracolonic neoplasia, urgent surgery, or metastatic disease were excluded. Patients were divided into two groups according to the interval between CRT and surgery (<6 and ≥6 weeks). Perioperative complications were compared and also pathological complete response (pCR). Results: Ninety patients were included. Groups were similar with respect to demographics, tumor, and treatment characteristics. Group 1: <6 weeks with 42 patients and Group 2: ≥6 weeks with 48 patients. Perioperative complications were not affected by the interval between CRT and surgery. Patients undergoing surgery ≥6 weeks after CRT experienced a significant improvement in pCP rate (33% vs. 18%, p = 0.04). 19 patients have experienced local recurrence without significant difference between two arms (10 [23.8%] and 9 [18.7%] respectively). Conclusions: An interval between CRT and surgery ≥6 weeks is safe and associated with a higher rate of pCR. We need futher prospective studies to define better the role of longer interval between CRT and surgery.
Phase I trial of oral ABT-751 in pediatric patients: Preliminary evidence of activity in neuroblastoma (NBL)
Authors: E. Fox, P. C. Adamson, A. Hagey, B. C. Widemann, J. M. Maris, S. L. Cohn, Y. Cai, D. M. Medina, K. A. Meek, F. M. Balis
Journal: Journal of Clinical Oncology (2005)

8527 Background: ABT-751 is an orally bioavailable sulfonamide that binds to the colchicine site on β-tubulin and inhibits microtubule polymerization. In adults, the maximum tolerated dose (MTD) is 250 mg daily x 7 days (d) or 200 mg daily x 21d. Dose limiting toxicities (DLTs) were ileus and peripheral neuropathy. Methods: Forty children ages 4 to 18 (median 13 yrs) with refractory solid tumors were enrolled, including 16 with NBL. For each cycle, patients received ABT-751 orally once daily for 7 consecutive days followed by a 14-day break or for 21 consecutive days followed by a 7-day break. Dose levels were 100 (n=4), 130 (n=6), 165 (n=6), 200 (n=7), and 250 (n=2) mg/m2/d on the 7d schedule and 75 (n=3), 100 (n=4), 130 (n=5), and 165 (n=3) mg/m2/d on the 21d schedule. PK sampling was performed on Day 1 of Cycle 1, and plasma concentrations were assayed using HPLC with tandem mass spectrometric detection method. Results: The MTD is 200 mg/m2/d (adult equivalent 375 mg) on the 7d schedule. DLTs included Grade (Gr) 2 motor neuropathy (n=1) at 130, Gr 3 constipation (n=1) at 165, and asymptomatic decrease left ventricular shortening fraction (n=2), neuropathic pain (n=1), fatigue (n=2), and neutropenia (n=1) at 250 mg/m2/d. On the 21d schedule, DLTs included Gr 4 neuropathy (n=1), vomiting and dehydration (n=1), Gr 3 fatigue (n=3), pain (n=1), and Gr 3 transaminase elevation (n=1) at 165 mg/m2/d. Accrual on the 21d schedule continues at 130 mg/m2/d (adult equivalent 260 mg). ABT-751 is rapidly absorbed (Tmax= 2.5 ± 1.2 h) and eliminated (t1/2 = 6.0 ± 2.5 h) (mean ± SD, N = 33). AUC and Cmax increase in proportion to the dose. Patients with NBL experienced prolonged disease stabilization. The median duration for evaluable patients with NBL (n=13) was 5 cycles (range 1–40); 7 patients continue on treatment and 3 are too early to evaluate. Three have had resolution of 123I-meta-iodobenzylguanidine (MIBG) positive lesions. Conclusions: ABT-751 is well tolerated in children at doses exceeding the adult MTD on the 7d and 21d schedules. Absorption after oral administration is rapid and exposure is dose proportional. Disease stabilization and improvement in MIBG scans suggests ABT-751 activity in neuroblastoma. A Phase 2 trial is in development. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Abbott Laboratories
Weekly paclitaxel versus standard 3-week schedule in patients with metastatic breast cancer.
Authors: I. I. Abdel Halim, M. El Ashri, W. El Sadda
Journal: Journal of Clinical Oncology (2011)

627 Background: Paclitaxel is one of the active drugs in metastatic breast cancer. Weekly paclitaxel seems less toxic and more efficient compared with paclitaxel every 3 weeks (possibly because of the proapoptotic and antiangiogenic activity), the dose intensity is quiet higher with tolerable toxicity. The purpose of study is to compare the efficacy of weekly paclitaxel to every 3 weeks schedule in terms response, toxicity profile, PFS and OS. Methods: Between September 2006 and September 2008, 140 patients with measurable metastatic breast cancer after adjuvant anthracycline treatment, WHO PS 0-1, adequate renal, liver and bone marrow function. Patients received no prior chemotherapy for meatstasis. Patients were randomized for 6-8 cycles to either weekly paclitaxel 80 mg/m2 D1, D8, D15(one hour IV infusion) and paraplatin AUC 5 D1 (IV infusion over half an hour) every 4 weeks (group A) or paclitaxel 175 mg/m2 and paraplatin AUC 5 every 3 weeks (group B). Prophylactic growth factor support was allowed if indicated in arm B. Response was assessed every 2 cycles, patients showed an objective response (CR, PR or SD) had continued to 8 cycles. Results: All patients were evaluable for response, toxicity and survival. The median age was 50 years range (42-64 years) in both groups, median WHO PS 0. Previous adjuvant therapy with anthracycline was 100%, hormonal therapy was 40% in gp A and 50% in gp B. Main metastatic sites: lung 40%, skin %, LN 21% in both gps, bones 50% and 60% respectively, 40% of pts had one metastatic site in both gps, 50% and 9% of pts had >2 metastatic sites. The total number of cycles delivered was 543 and 527 in both groups respectively, with a median of 7 cycles/pt, with no dose reduction. The overall response were 71.6% (CR 28.5 %, PR 42.9) and 35.5 % (CR 9.8%, PR 25.7 %) in gps A and B respectively (p= 0.01). No Grade 4 toxicity. In gps A and B respectively , G2 anemia were 14% and 21%, G3 neutropenia observed in 9.8% and 21% of pts and G2 neuropathy occurred in 14% and 42% of pts. Median time to progression and median survival were 18.5 and 10.5 months and 28 and 20 months, respectively. Conclusions: Weekly paclitaxel is more effective than the every 3 weeks administration for MBC with higher RR, TTP and OS and less toxic.
Securing discharge follow-up appointments in a women’s cancer program.
Authors: Carole Dalby, Susana M. Campos, Lisa Doverspike, Melissa Spinks, Joseph O. Jacobson
Journal: Journal of Clinical Oncology (2012)

81 Background: Ensuring patients have a follow-up appointment scheduled prior to discharge is one of several key interventions shown to reduce hospital readmission rates (Hansen L.O., Young R.S., Hinami K., et al. [2011, October]. Interventions to reduce 30-day rehospitalization: a systematic review. Annals of Internal Medicine, 155[8], 520-528). Lack of follow-up diminishes continuity between the inpatient and outpatient setting, can lead to patient dissatisfaction, as well as delays in proposed therapy. Methods: A three-month review of discharge data highlighted 49% of Women’s Cancer Gynecologic patients at an academic medical center were discharged from the hospital without securing a follow-up appointment. A multidisciplinary team involved in the scheduling process was assembled and determined failure to schedule appointments was attributed to a lack of communication between the inpatient and outpatient services, a complicated scheduling process, as well as ambiguity regarding when patient’s should return. Several rapid PDSA cycles were implemented over a three month period of time. The intervention created a standardized electronic template, including the establishment of standard time frames for follow-up appointments post discharge (7 to 10 days). The template details all required scheduling elements such as services requested, required laboratory studies, and patient preferences. Within the electronic template is the ability to directly email essential staff through a centralized email address embedded within the form. Staff engaged through reviewing of data, identification of the importance of securing a follow-up appointment, and weekly huddles. Results: Post intervention, the rate of compliance of scheduled discharge follow-up appointments rose from 49% to 87%. Staff reported high satisfaction with the new process, highlighting its simplicity and efficiency. Conclusions: Securing a follow-up appointment prior to discharge is feasible as evidence by increased compliance from baseline 49% to 87%. Future endeavors will implement this process across other disease programs in hopes of obtaining similar results.
Salvage brachytherapy for locally recurrent prostate cancer following definitive radiation therapy.
Authors: Marisa Kollmeier, Niyati Harneja, Mary Lin, Sean Matthew McBride, Michael J. Zelefsky
Journal: Journal of Clinical Oncology (2016)

118 Background: To report the toxicity and outcomes of patients undergoing salvage brachytherapy for locally recurrent prostate cancer. Methods: Between 4/03 and 4/15, 98 patients with biopsy-proven locally recurrent prostate cancer underwent low dose rate (LDR-125Gy) (n=37) or high dose rate (HDR-32Gy in 4 fractions) (n=61) brachytherapy. The median PSA at relapse was 2.57ng/mL (range 0.43-13.5) with median time to relapse was 6 years (range 0.96-14.4y). Gleason score at relapse was upgraded from initial Gleason score in 67 patients (70%) with 38 patients graded ≥8 at relapse. 44 patients also received hormone therapy (median duration of 17.3 months) pre and post-salvage brachytherapy. Patients were followed q3-6months with PSA and symptom assessment. Acute and late (&gt;90days) genitourinary (GU) and gastrointestinal (GI) toxicity was recorded using CTCAE v 4.0 and International Prostate Symptom Score (IPSS). Nadir+ 2 definition was used for PSA failure. Kaplan-Meier method was used for survival analyses. Results: Median followup is 31 months (range 1-101 mos). Median peak IPSS score was 19 with a median time to peak IPSS of 4 mos. Overall, mean change in IPSS from baseline was +2.4. Acute grade ≥3 GU and GI toxicity occurred in 6% and 0%, respectively. Late grade ≥3 GU and GI toxicity occurred in 6% and 4%, respectively. Six patients (6%) developed late urethral strictures requiring intervention, 3 of whom developed subsequent urinary incontinence. Urinary incontinence requiring pads occurred in 16% (16/98). 1 patient developed gross hematuria requiring irrigation. Rectal bleeding was the most common late GI toxicity (14%); however only 2 patients required intervention. PSA relapse occurred in 26/98 (27%) patients and 14/98 (14%) developed distant metastasis during the followup period. The 3 year PSA RFS, DMFS and OS was 70.1%, 92%, and 90.5%, respectively. Conclusions: Salvage brachytherapy is curative for a significant proportion of patients with locally recurrent prostate cancer following radiation therapy. Urinary symptoms peak at 4 months post-brachytherapy. The rate of moderate to severe GU or GI toxicity is 5-15%. Further efforts to reduce toxicity including focal approaches are ongoing.
Symptom Burden Among PV and ET Patients Receiving A Novel Histone Deacetylase Inhibitor: Findings From a Open-Label Phase II Study
Authors: Christen Lykkegaard Andersen, Mary Frances McMullin, Robyn M. Emanuel, Amylou C. Dueck, David Bareford, Claire N Harrison, Hans Hansselbalch, Steven Knapper, Holly Lynn Geyer, Ruben A. Mesa
Journal: Blood (2012)