tbuckley/cabot-search huggingface dataset:
Adjuvant chemotherapy in the management of cholangiocarcinoma: A 10-year cohort analysis.
Authors: Tahir M. Shaikh, Timothy R. Asmis, Derek J. Jonker
Journal: Journal of Clinical Oncology (2013)

330 Background: The evidence regarding treatment outcomes from chemotherapy for cholangiocarcinomas (CCAs) is limited because of the high mortality rate and a low overall incidence. Most studies are small and include a heterogeneous group of tumors (biliary, pancreatic, hepatocellular, and ampullary cancers) that each have a unique natural history and response to chemotherapy. The aim of this study is to assess the effect of chemotherapy on survival of patients with surgically resected (R0-negative margins/R1-positive margins) and unresectable (R2-gross residual tumor/metastatic) CCAs. Methods: In a retrospective single-center study, data on all CCA patients (n=209) from 1998 to 2008 were evaluated. Survival time was assessed as a primary outcome measure. Patient demographics, pathological diagnosis, performance status, chemo-radiation therapy, surgical resection, relapse rates and laboratory outcomes were assessed. Results: 209 cases of CCA (female n=116, mean age 65, adenocarcinoma n=166 (79.4%), stage 0/1 n=17 (8.1%), stage 2/3 n=99 (47.3%), stage 4 n=93 (44.4 %)) were identified. 162 (77.5%) patients received treatment (surgical resection n=118 (R0 n=53, R1 n=21) chemotherapy n=85, radiation therapy n=33). Median overall survival (months) was 9.8 (no treatment =2.1, treatment =12.4 (R0 and R1 surgical resection =21.9 and 10.9 p&lt;.001). Median survival (months) in patients with surgical resection with and without adjuvant chemotherapy was 22.2 vs 21.9 p=0.75 for R0 resection and 18.1 vs 10.9 p=0.10 for R1 resection. In patients with unresectable tumor, median survival with and without chemotherapy was 10.7 and 2.1 months (p&lt;.05) respectively. Conclusions: CCAs are associated with poor survival if untreated. Complete surgical resection was associated with significantly improved survival outcomes. Adjuvant chemotherapy in the setting of R0 resection did not improve survival compared to surgical monotherapy. In the setting of unresectable or metastatic CCA, survival was significantly prolonged in patients who received palliative chemotherapy. Although not conclusive, these data suggests the use of adjuvant chemotherapy in the setting resection with positive margins (R1) may also prolong survival.
Quality and value-focused albumin-bound paclitaxel decision support for pancreatic, lung, and breast cancer in southeastern United States.
Authors: Anmol Baranwal, William J. Hrushesky, Dinah Faith Q. Huff, William S. Shimp, Avinash Mamgain, Marc L. Fishman, Laura Rose Bobolts, Anna E. Schorer, Jurgen Kogler, Sharon Davis, Melissa Armitage, Charles L. Bennett
Journal: Journal of Clinical Oncology (2014)

246 Background: Albumin-bound paclitaxel is FDA approved as single agent for breast cancer, in combination with carboplatin for non-small cell lung cancer (NSCLC), and with gemcitabine for pancreatic cancer. Oncology Analytics (OA) is a cancer care decision support group comprised of board-certified oncologists, interacting with more than 2,800 cancer doctors in the Southeastern U.S. We have been making oncologists aware of comparative efficacy data, and the relative values of albumin-bound paclitaxel vs other taxanes. We hypothesized our work has impacted albumin-bound paclitaxel use in these diagnoses with improved cost effective care and value enhancement. Methods: We analyzed all albumin-bound paclitaxel requests for FDA approved indications from April 2013 to June 2014. Requests withdrawn by the treating oncologist after OA consultation were compared with albumin-bound paclitaxel persistence over these five consecutive quarters. Financial outcomes of voluntary oncologist withdrawal of albumin-bound paclitaxel-based therapy in favor of another taxane were calculated as per standard Medicare reimbursement rates. Results: Over the entire 15 month span, we received a total of 265 evaluable albumin-bound paclitaxel requests, on a total of 181 patients. Ninety-two percent (155/168) of requests for albumin-bound paclitaxel with gemcitabine in pancreatic cancer were automatically approved by Oncology Analytics’ web based software. One third each of the requests for breast cancer (12/37, 32.43%) and NSCLC (21/60, 35%) were withdrawn by the requesting MD after OA consultation. Changing albumin-bound paclitaxel to another taxane reduced pharmaceutical costs by approximately $1,124,115 for these 15 months, or $74,941.00 monthly. Conclusions: When paclitaxel or docetaxel are safe and effective alternatives to albumin-bound paclitaxel, OA consultation enhances cancer care quality and value.
Navcap (vinorelbine and capecitabine) versus navcap followed by weekly docetaxel as first-line treatment in metastatic breast cancer patients: A randomized multicenter phase II trial
Authors: M. Ghosn, F. S. Farhat, J. G. Kattan, C. Hanna, F. Younes, N. Haddad, P. Aftimos, F. Nasr, W. Moukadem, G. Chahine
Journal: Journal of Clinical Oncology (2008)

1119 Background: Capecitabine (C), vinorelbine (V) and docetaxel (D) are effective in the 1st-line treatment of metastatic breast cancer (MBC). Based on the efficacy and the tolerability of Navcap (M. Ghosn et al. Anticancer Research 2006) and Navcap followed by docetaxel in MBC (M. Ghosn et al. Cancer Chemother Pharmacol 2007), we initiated a 2 arm phase II randomized study. Primary Objective: To compare the objective response rate (ORR) of 8 cycles of Navcap vs. 4 cycles of Navcap followed by 12 weekly docetaxel in the 1st-line setting of MBC. Methods: Patients (pts) with measurable disease, no prior chemotherapy in MBC and Her-2/neu negative are eligible. All pts will receive Navcap (V 25 mg/m2 on d1 and d8 as IV push and C 825 mg/m2 bid D1–14 q3w) for a total of 4 cycles. Pts progressing under treatment with Navcap are withdrawn and receive Docetaxel as 2nd-line treatment. Pts responding or stable after completing 4 cycles of Navcap are randomized to 2 arms: Arm A (4 Navcap) or Arm B (12 weekly docetaxel 25 mg/m²/week). Results: From July 2004 to September 2007, a total of 63 pts over 96 planned were enrolled. Median age is 52 years (30 -78). The frequent metastatic sites are lymph nodes (43%), liver (38%), lung (37%) and bone (33%). The number of metastatic sites: 1 (35%), 2 (35%), 3 (24%), more than 3 (6%). 52 pts completed the 1st 4 cycles of Navcap with an ORR of 65% (CR 17%) and a stable disease of 21%. 8 pts (15%) were excluded from randomization due to PD. 44 pts were randomized into Arm A: 25 pts and Arm B: 19 pts. At the time of the analysis, 19 and 12 pts had completed the treatment in Arms A and B respectively. The majority of adverse events were mild. Pts treated with Navcap 5 pts (8%) developed Gr 3 neutropenia, 4 pts (6%) developed Gr 3–4 anemia & 1 pt developed Gr3 hand-foot syndrome. Pts treated with docetaxel, 2 pts (11%) had Gr 4 elevation in liver enzymes and 1 pt had Gr 4 creatinine elevation. Conclusions: The preliminary results show that Navcap confirms its high response rate in the 1st-line MBC. Long-term follow-up is needed to show if maintenance docetaxel will have an added value vs. maintenance Navcap, after 4 cycles of Navcap induction treatment. Recruitment is expected to end by March 2008 and mature results will be presented during the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Pierre Fabre, sanofi-aventis Pierre Fabre, sanofi-aventis
Nebraska Lymphoma Study Group (NLSG) results of treatment for non-Hodgkin’s lymphoma (NHL) in patients (pts) aged 80 years or greater
Authors: T. L. Koeneke, P. Wong, R. G. Bociek, F. Loberiza, J. M. Vose, P. J. Bierman, J. O. Armitage
Journal: Journal of Clinical Oncology (2008)

8534 Background: Little data has been published describing treatment results in pts with NHL ≥ 80 years of age. Methods: A retrospective study of pts with NHL treated by the NLSG between December 1982 and January 2005. Results: Two hundred forty-nine pts were evaluated/treated. Median age was 83 years (yrs) (range 80–96 yrs). Karnofsky performance status was ≥ 80 in 20% of pts. Ninety percent of pts had aggressive histology. Forty-nine percent of pts had advanced stage disease at diagnosis; 47% had masses ≥ 5 cm; 27% had B symptoms; 34% had elevated LDH values; 63% had extranodal disease. Fifty six percent of pts received ≥ 4 cycles of chemotherapy. Ninety percent of pts received CAPBOP or CNOP/CHOP± rituximab. Twenty four percent of pts received combined modality therapy. Thirty percent were not evaluable for response because of early withdrawal of therapy or lack of follow-up. The response rate for evaluable pts was 86%. With a median follow-up of 54 months (2–161 months) the five year probabilities of progression-free and overall survival are 22% and 28% respectively. Including 206 evaluable pts completing planned therapy the five year probabilities of progression-free and overall survival are 25% and 29% respectively. For pts completing all planned therapy a high age adjusted International Prognostic Index (IPI) score was independently associated with a higher risk of treatment failure (relative risk [RR]=1.84, 95% confidence interval [CI]=1.20–2.80, P=0.005) whereas treatment which included radiation (RR=0.35, 95% CI=0.21–0.56, P<0.001) and reception of ≥ 4 cycles of chemotherapy (RR=0.25, 95% CI=0.13–0.48, P<0.001) were associated with decreased risks of treatment failure. The same factors were independently associated with the risk of death (RR=1.77, 95% CI=1.16–2.71, P=0.009 for high age adjusted IPI, RR=0.36, 95% CI=0.22–0.59, P<0.001 for treatment that included radiation, and RR=0.29, 95% CI=0.15–0.56, P<0.001 for reception of ≥ 4 cycles of chemotherapy. The five year probability of progression was 42%. Conclusions: Anthracycline-based therapy in pts ≥ 80 years is feasible and results in long-term disease-free survival in a good proportion of pts. This intensity of therapy precludes completion of treatment in a sizeable number of pts. No significant financial relationships to disclose.
Utilization of hepatocellular carcinoma surveillance in the United States.
Authors: Samar Harris, Adam C. Yopp, Jasmin A Tiro, Muhammad Shaalan Beg, Celette Sugg Skinner, William M Lee, Amit G Singal
Journal: Journal of Clinical Oncology (2012)

174 Background: Surveillance for hepatocellular carcinoma is recommended in high-risk patients, but several studies have suggested it is being underutilized.The aim of this study is to quantify utilization rates for HCC surveillance among patients with cirrhosis and summarize patterns of association between utilization rates and patient and clinic characteristics. Methods: A systematic literature review using the Medline database and national meeting abstracts identified all cohort studies that described HCC surveillance rates among at-risk patients in the United States. Two investigators independently extracted data on patient populations, study methods, and results. A pooled surveillance rate with 95% confidence intervals was calculated. Pre-specified subgroup analysis was performed to find correlates of surveillance utilization. Results: We identified 9 studies that met all inclusion criteria. There were a variety of definitions for surveillance among the studies, with only 4 assessing surveillance every 6-12 months as recommended by the AASLD guidelines. The pooled surveillance rate was 18.4% (95% CI 17.8% - 19.0%). Surveillance rates were significantly higher among patients followed in gastroenterology clinics compared to those followed in primary care clinics (51.7% vs. 16.9%, p&lt; 0.001). Elderly, non-Caucasians, and people of low socioeconomic status had lower surveillance rates than their counterparts. Current studies fail to identify specific reasons for the underutilization of HCC surveillance. Conclusions: Utilization rates for HCC surveillance are low, although they are significantly higher among patients followed in subspecialty clinics. Appropriate intervention targets to increase surveillance rates and reduce socio-demographic disparities have not been identified to date, and this should be a primary goal for future studies.
Association of increased survival with surgery and radiation therapy in metastatic gastric cancer: A SEER database analysis.
Authors: Ravi Shridhar, Khaldoun Almhanna, Sarah Hoffe, William J. Fulp, Jill Weber, Michael Chuong, Kenneth Meredith
Journal: Journal of Clinical Oncology (2013)

109 Background: Metastatic gastric cancer has poor survival. The purpose of this study was to compare outcomes of metastatic gastric cancer patients stratified by surgery and radiation therapy. Methods: The SEER database was accessed to identify AJCC M1 stage IV (6 th ed) gastric cancer patients between 2004 thru 2008. Patients were divided into 4 groups; group 1: no surgery or radiation; group 2: radiation alone; group 3: surgery alone; group 4: surgery and radiation. Survival analysis was determined by Kaplan-Meier and log-rank analysis. Multivariate analysis (MVA) was analyzed by Cox proportional hazard ratio model. Results: We identified 5072 patients. Surgery and/or radiation were associated with a survival benefit. Median and 2 year survival for groups 1, 2, 3, and 4 was 7 months and 8.2%, 8 months and 8.9%, 10 months and 18.2%, and 16 months and 31.7%, respectively (p&lt;0.00001). MVA for all patients revealed that surgery and radiation were associated with decreased mortality while T-stage, N-stage, age, signet ring histology, and peritoneal metastases were associated with increased mortality. In patients treated with surgery, MVA showed that radiation was associated with decreased mortality while T-stage, N-stage, age, removing &lt;15 lymph nodes, signet ring histology, and peritoneal metastases was associated increased mortality. Age was the only prognostic factor in nonsurgical patients. Conclusions: Surgery and radiation are associated with increased survival in a subset of patients with metastatic gastric cancer. Prospective trials will be needed to address the role and sequence of surgery and radiation in metastatic gastric cancer.
Phase I study of lorvotuzumab mertansine (LM, IMGN901) in combination with lenalidomide (Len) and dexamethasone (Dex) in patients with CD56-positive relapsed or relapsed/refractory multiple myeloma (MM).
Authors: J. G. Berdeja, S. Ailawadhi, S. D. Weitman, S. Zildjian, J. J. O'Leary, J. O'Keeffe, R. Guild, K. Whiteman, A. A. A. Chanan-Khan
Journal: Journal of Clinical Oncology (2011)

8013 Background: LM is a conjugate of a maytansinoid cytotoxic agent with a CD56-binding antibody. It is designed to bind to and kill CD56-expressing cancer cells. About 70% of MM cases express CD56. LM has been shown to be active and well tolerated as a single agent for MM in a separate phase I study. Based on the single agent activity and on data from preclinical models of MM showing enhanced activity when LM is combined with Len/Dex, a phase I study assessing the combination was initiated. Methods: The study objectives are to determine the MTD, DLT and activity of LM in combination with fixed doses of Len and Dex. Patients with CD56+ relapsed or relapsed/refractory MM who have received at least 1 prior therapy (may have included Len) are eligible during dose escalation. The total trial is expected to include ~52 patients. Response is assessed per IMWG criteria. LM is given IV once weekly for 3 weeks, Len (25 mg) is given orally on Days 1-21, and Dex (40mg) is given orally once weekly for 4 weeks, all in a 4-week cycle. PK at the MTD is planned, and pharmacodynamic studies are being conducted. Results: Twelve patients have been enrolled (3 patients at 75, 4 at 90, and 5 at 112 mg/m2 of LM). Patient accrual to the 112 mg/m2 cohort continues. No DLTs have been reported. One SAE (fatigue considered related to Dex) and 7 combination-treatment-related grade 3 toxicities have been reported in 4 patients. No grade 4 toxicities have been observed. To date, 2 VGPRs (1 active Cycle 9; 1 off after 6 cycles to receive transplant and 4 PRs (3 active Cycles 2, 3 and 4; 1 off after 4 cycles per patient decision) have been observed; 5 of the 6 responding patients had previously received thalidomide or Len. Among the 12 patients enrolled, the median number of prior therapies is 3, with 42% having received prior Len. Both patients with VGPRs and 1 patient with a PR had prior transplant. Efficacy and safety data for all patients will be reported. Conclusions: LM in combination with Len and Dex has shown objective evidence of clinical activity with an acceptable safety profile. The dose-escalation portion of the study is open to enrollment for further exploration of the MTD.
Sensitivity and specificity of BP180 NC16A enzyme-linked immunosorbent assay for the diagnosis of pemphigoid gestationis
Authors: Fatimah Al Saif, Fabienne Jouen, Vivien Hebert, Helene Chiavelli, Basma Darwish, Sophie Duvert-Lehembre, Pascal Joly, Thierry Passeron, Laurent Misery, Jean-Jacques Grob, Catherine Michel, Eric Esteve, Gerard Geillet, Philippe Berbis, Jean Friedel, Herve Maillard, Jean-Francois Stalder, Nicolas Dupin, Pierre Vabres, Olivier Dereure, Philippe Humbert, Brigitte Lagrange, Luc Thomas, Philippe Saiag, Laurent Machet, Francois Skowron, Philippe Bernard, Noemie Litrowski, Laurence Verneuil, Valerie Pallure, Philippe Modiano, Alain Taieb, Olivier Carpentier, Pascal Schomoor, Michel D’Incan
Journal: Journal of the American Academy of Dermatology (2017)
Determining the highest risk of the high intermediate–risk patients with endometrial adenocarcinoma.
Authors: A. Y. Bahng, L. L. Lin
Journal: Journal of Clinical Oncology (2011)

e15569 Background: The role of adjuvant therapy remains controversial in the management of intermediate risk endometrial adenocarcinoma. Several studies have identified risk factors that were associated with increased risk of disease recurrence. GOG 99 identified a high intermediate risk (HIR) group based on clinical and pathologic factors that may benefit from adjuvant radiotherapy. The purpose of this retrospective study was to examine prognostic factors in the HIR patient group. Methods: We retrospectively reviewed the charts of 103 consecutively treated patients with HIR endometrial adenocarcinoma treated between 1990 and 2009 with total hysterectomy and bilateral salpingo-oophorectomy. Seventy four percent of the population received adjuvant radiation. Median follow-up for all patients was 4 years. Median dose of EBRT and brachytherapy was 50.4 Gy and 21 Gy respectively. Patients were restaged using the AJCC 7th edition. Kaplan-meier, log-rank test, and cox proportional hazards modeling were used. Results: The 5 year overall survival in our study population was 81%. The 5 year rate of local recurrence free survival and distant metastasis free survival were 96% and 82% respectively. On univariate analysis, grade (G) 3 histology (p = 0.0111, p = 0.0125), increasing myometrial invasion (p < 0.0001, p = 0.0061), and the presence of all three GOG risk factors (LVSI, 2/3 myometrial invasion, and G 2-3; p = 0.0026, p = 0.0019) were significantly associated with increased risk for distant metastases and decreased disease free survival (DFS) respectively. On multivariate analysis, increasing myometrial invasion and G 3 pathology maintained their significant association with decreased DFS (p = 0.025 and p = 0.015 respectively). The presence of all three risk factors was associated with a decrease in DFS (p = 0.0019). Five-year DFS was 57% vs 87%, for patients with three or more risk factors vs patients with less than 3 risk factors, respectively. Conclusions: Rates of local failure are low with adjuvant radiotherapy. Patients with multiple pathologic risk factors may benefit from chemotherapy. Further prospective studies should be performed to validate our observations.
Response Adapted Induction Treatment Improves Outcomes for Myeloma Patients; Results of the Phase III Myeloma XI Study
Authors: Graham H Jackson, Faith E Davies, Charlotte Pawlyn, David A Cairns, Alina Striha, Corinne Collett, Anna Waterhouse, John R Jones, Bhuvan Kishore, Mamta Garg, Cathy D Williams, Kamaraj Karunanithi, Jindriska Lindsay, Matthew W Jenner, Gordon Cook, Martin F Kaiser, Mark T Drayson, Roger G Owen, Nigel H Russell, Walter M Gregory, Gareth J Morgan
Journal: Blood (2016)
Shorter duration therapy that includes vincristine (V), dactinomycin (A), and lower doses of cyclophosphamide (C) with or without radiation therapy for patients with newly diagnosed low-risk embryonal rhabdomyosarcoma (ERMS): A report from the Children’s Oncology Group (COG).
Authors: D. Walterhouse, A. S. Pappo, J. L. Meza, J. C. Breneman, A. A. Hayes-Jordan, D. Parham, T. P. Cripe, W. H. Meyer, D. S. Hawkins
Journal: Journal of Clinical Oncology (2011)

9516 Background: Intergroup Rhabdomyosarcoma Study (IRS) trials showed excellent survival with VA or VAC for patients with Stage 1 or 2, Group I or II ERMS or with Stage 1, Group III orbit ERMS. In COG ARST0331, we hypothesized that VA in combination with lower doses of C (total cumulative dose = 4.8 g/m2) would produce the benefit of IRS-IV VAC with less toxicity and that length of therapy could be reduced without compromising failure free survival (FFS) of patients with low-risk ERMS. Methods: This single arm, noninferiority, phase III study enrolled newly diagnosed patients with Stage 1 or 2, Group I or II ERMS or patients with Stage 1, Group III orbit ERMS onto Subset 1. Therapy was 4 cycles of VAC followed by 4 cycles of VA over 22 weeks (total cumulative doses: V=27 mg/m2, A=12 mg/m2, C=4.8 g/m2). The radiation therapy dose was 36 Gy for Group IIA patients, 41.4 Gy for Group IIB/C patients, and 45 Gy for Group III orbit patients. The primary endpoint was FFS, and results were compared with a fixed expected outcome. Results: Accrual to Subset 1 was closed after a planned interim analysis of 259 patients. With a median follow-up of 1.8 yrs, we observed 23 failures vs. 35 expected failures and are 99% confident that the FFS is no worse than 83%. Estimated 2-yr FFS was 88% (95% CI: 82%, 92%) (n=259), and overall survival (OS) was 97% (95% CI: 92%, 99%). Estimated 2-yr FFS was 91% (95% CI: 81%, 95%) for patients with paratestis ERMS (n=114) and 89% (95% CI: 79%, 95%) for orbit ERMS (n=79). Conclusions: Shorter duration therapy that includes lower doses of C did not compromise FFS for low-risk RMS. Study Duration (weeks) Chemotherapy cumulative dose FFS (5-yr) OS (5-yr) V (mg/m2) A (mg/m2) C (g/m2) IRS-III 45 72 13.5 – 83% 93% IRS-IV 45 48 22.5 26.4 93% 98%