tbuckley/cabot-search huggingface dataset:
High-risk radically resected gastric cancer patients do not benefit of an adjuvant cisplatin containing regimen
Authors: S. Cascinu, R. Labianca, C. Barone, A. Santoro, V. Catalano, O. Bertetto, S. Barni, L. Frontini, E. Aitini, I. Floriani
Journal: Journal of Clinical Oncology (2005)

4023 Background: Adjuvant therapy of high risk gastric cancer is a debated question. Meta-analyses of randomized trials suggest a possible but small benefit for adjuvant chemotherapy but no study using cisplatin containing regimen was included in such meta-analyses. Recently, we reported a high level of activity in metastatic and locally advanced disease by using a weekly intensive chemotherapy with cisplatin, epidoxorubicin, 5fluorouracil and lederfolin (wPELF). Aim of this study is to assess the efficacy of this combination in adjuvant setting. Methods: Patients (pts) were randomized to PELF: 8 w of 1-day per w administration of CDDP 40 mg/sqm, epi-ADR 35 mg/sqm, LV 250 mg/sqm, 5FU 500 mgsqmq, GSH 1500 mg/sqm; on the other days lenograstim was administered at a dose of 6 μ/kg or 5FU/LV: 6 cycles of 5FU 370 mg/sqm days 1–5, LV 20 mg/sqm days 1–5; every 28 days. Results: Characteristics of the 397 pts enrolled from 1/98 to 1/03: median age 59 y (range 23–76); male 63%; PS (WHO) 0: 86%; 1: 10%, NV: 4%; histology: intestinal adenocarcinoma: 77%, diffuse undiff:11%, other: 10%, NV: 2%; grading: G1: 2%, G2: 23%, G3: 53%, NS: 22%; positive nodes (N+): N0: 5%, 1–6: 46%, 7–15: 29%, >15: 15%, NS: 5%. 74% had >15 resected nodes. WHO grade III/IV toxicities included: neutropenia (PELF 11%, 5FU/LV 8%), alopecia (PELF 30%, 5FU/LV 1%); diarrhoea (PELF 7%, 5FU/LV 11%); mucositis (PELF 5%, 5FU/LV 8%). No treatment-related death was observed. Only 9% of pts on PELF completed the treatment as scheduled vs 44% on 5FU/LV, while 26% on PELF and 20% on FU/LV interrupted treatment mainly due to toxicity. At a median follow-up of 3.5 y, when compared with 5FU/LV, the risk of death associated with PELF was not statistically different (Hazard Ratio (HR) 0.89, 95%CI 0.65–1.23) such as the risk for progression/death (HR 0.94, 95%CI 0.71–1.24). Pts with >6 N+ had a worse survival compared to pts with ≤ 6 N+ (HR 4.09, 95%CI 2.86–5.84), whereas the number of resected nodes had no prognostic effect. Conclusions: Our results suggest that pts with high risk radically resected gastric cancer do not benefit from an adjuvant cisplatin containing regimen. No significant financial relationships to disclose.
Patterns of radiotherapy practice in the management of gastric cancer: Preliminary findings from the Quality Research in Radiation Oncology (QRRO) GI Committee process surveys.
Authors: K. A. Goodman, N. Khalid, L. A. Kachnic, B. D. Minsky, C. Crozier, J. B. Owen, J. F. Wilson, C. R. Thomas
Journal: Journal of Clinical Oncology (2011)

77 Background: The specific aim of the ACR QRRO survey was to determine the national patterns of radiotherapy (RT) practice in patients (pts) treated for stage IB–IV (non-metastatic) gastric cancer (GC). Methods: A National Process Survey was conducted from randomly selected U.S. RT facilities to assess demographics, staging, geographic region, practice setting, and treatment through retrospective on-site record review of eligible GC cases treated from 2005-2007. Three clinical performance measures (CPMs): 1) use of CT-based treatment planning; 2) use of dose volume histograms (DVHs) to evaluate RT dose to the kidneys and liver; 3) completion of RT within the prescribed time frame were assessed. Three emerging quality indicators: 1) use of intensity modulated RT (IMRT); 2) use of image-guided tools (IGRT), other than CT, for RT target delineation; 3) use of preop RT were also assessed. Results: CPMs were computed on data collected through Aug, 2010 for 250 eligible pts at 45 institutions. Median age was 62 years; 66% male; 60% Caucasian. 13% were AJCC 2002 stage I, 29% II, 32% IIIA, 10% IIIB and 12% IV. Most pts (43%) were treated at academic centers with 32% at large non-academic centers and 25% medium-small facilities. Almost all (99.5%) pts underwent CT-based planning and 75% had DVHs to evaluate normal tissue doses to the kidneys and liver. 70% completed RT within the prescribed time frame. IMRT and IGRT were used in 22% and 17% of pts, respectively. IGRT techniques included: PET (n = 20), MRI (n = 1), respiratory gating and/or 4D-CT (n = 22) and on-board imaging (n = 10). 19% of pts received preop RT. Conclusions: Preliminary findings from QRRO's analysis of radiation practice patterns for non-metastatic gastric cancer indicate widespread adoption of CT-based planning with the use of DVHs to evaluate normal tissue doses. Moreover, most pts completed adjuvant RT in the prescribed time frame. Emerging RT techniques such as IMRT and IGRT were not routinely incorporated into clinical practice during the evaluated time period. These data will serve as a benchmark for future QRRO gastric cancer surveys. No significant financial relationships to disclose.
Analysis of prognostic factors in locally advanced and metastatic pancreatic cancer treated with gemcitabine or gemcitabine and S-1 chemotherapy using individual patient data from three randomized studies.
Authors: Yousuke Nakai, Takuji Okusaka, Takaaki Ikari, Hiroyuki Isayama, Junji Furuse, Hiroshi Ishii, Shogo Imai, Shota Okamura, Chikuma Hamada
Journal: Journal of Clinical Oncology (2014)

223 Background: Both gemcitabine (GEM) and S-1, an oral fluoropyrimidine, are shown efficacy for advanced and resected pancreatic cancer (PC). However PC has one of the poorest outcomes in various cancers. In this pooled analysis, the prognostic factors in locally advanced and metastatic PC were evaluated using individual patient data from three randomized studies (Phase III: GEST, randomized phase II: JACCRO PC-01 and GEMSAP). Methods: Patients (pts) were treated with GEM alone or GEM and S-1 (GS) chemotherapy for advanced PC. Evaluated prognostic factors were standard laboratory data, tumor marker (CA19-9, CEA), clinical and pathological indices and treatment related outcomes e.g. efficacy and safety. To identify the optimal cutoff value to divide continuous data into binomial data, maximized log likelihood value for the model were evaluated and the validity of the model was evaluated by the martingale residuals. The Cox proportional hazards model was performed for overall survival. Results: 770 pts were included in this analysis (389 pts were treated by GEM and 381 pts were GS) and 738 events for survival were observed (95.8%). In continuous data, baseline WBC, AST, CA19-9 and CRP were detected as independent prognostic factors and the cutoff values were identified. The results of multivariate analysis and cutoff value were shown in the table. Conclusions: In our analysis, treatment, extent of disease, target lesion, WBC, AST, CA19-9 and CRP were detected as independent prognostic factors and cutoff values were estimated in continuous data. The further examination is necessary, but these data may help future studies. [Table: see text]
Evaluation of patients with clinically detected recurrence of rectal carcinoma: Current practice patterns of colorectal surgeons
Authors: F. E. Johnson, A. Sangoi, U. Patel, K. S. Virgo
Journal: Journal of Clinical Oncology (2008)

20669 Background: The optimal evaluation of patients with clinically suspected recurrence of rectal carcinoma is not known. Many testing modalities are available and their costs are significant. We documented the intensity of the extent-of-disease workup recommended by colorectal surgeons when their patients with rectal carcinoma develop clinical evidence of recurrence. Methods: A custom-designed questionnaire was mailed to all 1,795 members of the American Society of Colon and Rectal Surgeons (ASCRS). Subjects were asked which laboratory tests and imaging studies they would order for one of their generally healthy patients with a rising serum CEA level following potentially curative low anterior resection of a T3N0M0 adenocarcinoma of the rectum (and no adjuvant therapy). The second scenario described a generally healthy patient with multiple potentially resectable pulmonary nodules following potentially curative low anterior resection of a T3N0M0 adenocarcinoma of the rectum (and no adjuvant therapy). We measured the variability of practice patterns among surgeons and estimated the effects of physician age, US Census Region, health maintenance organization (HMO) penetration rate, and type of recurrence on the intensity of the evaluation. Results: Of the 566 questionnaires completed (33%), 347 (61%) were evaluable. Nonevaluability was usually due to lack of rectal cancer patient follow-up in surgeons’ practices. The tests most frequently recommended for the scenario involving elevated CEA level were: CT (92%), repeat CEA level (87%), and colonoscopy (87%). The tests most frequently recommended for the scenario involving pulmonary nodules were: CT of chest (90%), CT of abdomen/pelvis (74%), CEA level (55%), CBC (55%), and colonoscopy (55%). The effects on workup intensity of physician age, US Census Region, HMO penetration rate, and type of recurrence were small. Conclusions: This is the first empirical data on this subject for a large sample of an international society of highly credentialed experts. The lack of consensus for most tests in current practice is likely due to multiple factors, including the lack of evidence supporting any particular strategy. No significant financial relationships to disclose.
eOutcomes-H&N: Development of an electronic point-of-care outcomes collection system for head and neck cancer.
Authors: Elizabeth Lockhart, Eric Gutierrez, Padraig Richard Warde, Davin Dubeau, Sophie Huang, Harry Johnson, Saul Melamed, Lisa Sarsfield, Roehl Sioson, Ken Sutcliffe, Brian O'Sullivan
Journal: Journal of Clinical Oncology (2013)

247 Background: Outcomes data increases the ability to understand the impact of cancer treatment and helps ensure that we direct appropriate investments to achieve improvements in quality of care. Cancer Care Ontario (CCO) has developed an outcomes data collection system for patients with head and neck cancer treated with radiotherapy. Methods: Clinicians involved in the care of these patients agreed on 5 key clinical outcomes to collect as a part of this initiative: local failure, regional failure, distant metastasis, second primaries, and treatment toxicity. Based on the Princess Margaret Hospital Head and Neck Cancer Anthology of Outcomes process, CCO has developed a similar system to collect outcomes data at the point-of-care on a provincial scale. The population-based provincial system aims to provide practice efficiencies and allow for evolution of the system in response to user feedback and expansion to other clinical areas. Results: The system includes a secure web application and iPad mobile application to facilitate the collection and management of outcomes data for head and neck cancer patients treated with radiotherapy in Ontario. Cancer centres upload patient clinic schedule details (including patient identifiers and appointment dates) prior to clinics. A list of patient summaries, including corresponding diagnosis, radiotherapy information and previously recorded outcomes is then generated. In clinic, physicians use these lists to capture outcomes noted at the point-of-care. Data captured are then transferred in real time to a secure central database. Following initial testing, the application was piloted to assess usability, system reliability, and overall satisfaction. Initial results show high physician satisfaction and no documented issues with system availability. Feedback has identified potential improvements and will inform future modifications. Conclusions: The identification of potential variation in recurrence, toxicity and survival data will inform the areas in which quality improvement initiatives or additional investments may be needed. The intent is to leverage project learnings for future outcomes initiatives in other diseases and treatment modalities.
Comparison of survival outcomes for African American and Caucasian men with advanced penile cancer in Florida.
Authors: Chad Ritch, Nicola Pavan, Samarpit Rai, Nachiketh Soodana-Prakash, Raymond R Balise, Dipen Parekh, Mark L. Gonzalgo
Journal: Journal of Clinical Oncology (2016)

490 Background: Studies suggest that there may be disparity in clinical outcomes for African−American men (AAM) compared to Caucasian men (CM) with penile squamous cell carcinoma (SCC). We sought to determine whether there was a survival difference for African American versus Caucasian men, particularly in locally advanced and metastatic cases of penile SCC where disease mortality is highest. Methods: Using the Florida Cancer Data System, we identified men diagnosed with penile SCC, from 2004 to 2014. We excluded men who were diagnosed on autopsy or at the time of death and with &lt; 6 months of follow up. Demographic variables including: age, follow−up, stage, race and treatment type were compared between AAM and CM. Treatment type was categorized as surgery alone or surgery plus additional therapy (chemotherapy and/or radiation). For locally advanced and metastatic disease, we compared treatment type and overall survival (OS) between AAM and CM. A multivariable model was developed to determine significant predictors of OS. Results: Of the 653 men with penile SCC, 198 [38 (19%) AAM and 160 (81%) CM] had locally advanced and/or metastatic disease. Median follow up for the entire cohort was 12.5 mos. For all stages, AAM demonstrated a significantly decreased median OS compared to CM (26 vs. 37 mos, p=0.03). For locally advanced and metastatic disease, there was a persistent, but non−significant, trend toward disparity in median OS between AAM and CM (17 vs. 23 mos, p=0.06). Fewer AAM compared to CM received surgery plus additional therapy for locally advanced and/or metastatic disease [8 (21%) vs. 42 (26%)], but this difference was not statistically significant. After adjusting for age, stage, and treatment type, AAM had increased likelihood of death from penile SCC (HR 1.63, p=0.015). Conclusions: Mortality rates from penile SCC remain high in contemporary series. For AAM in Florida, advanced stage at presentation, along with treatment disparity, may partially explain decreased survival rates. Further studies are needed to determine the additional socioeconomic, as well as potential biologic, factors that may predict the relatively poor outcome observed in AA men with penile SCC.
Cause of death in patients with hepatocellular carcinoma (HCC) according to Barcelona Clinic Liver Cancer System (BCLC): Tumor versus nontumor-related mortality.
Authors: A. K. Dip Borunda, S. Campos Gomez, F. D. Huitzil Melendez
Journal: Journal of Clinical Oncology (2011)

e14594 Background: Most cases of HCC are associated to liver cirrhosis. Tumor extension and liver failure may be competing causes of death in these patients. Identification of the cause of death in these patients may help define best therapeutic strategies. Methods: All patients with a diagnosis of HCC evaluated at our institution between 2004 and 2009. HCC was defined by histologic or non-invasive criteria (focal lesion > 1 cm with arterial enhancement and venous washout in dynamic CT or MRI in a cirrhotic liver). We selected deceased patients and assigned an immediate cause of death evaluating clinical, biochemical and radiographic variables recorded within the last three months of life: death due to tumor progression, death due to complications of cirrhosis (liver failure, variceal bleeding, hepatorenal syndrome), death due to treatment complications, death due to infectious complications. Given that patients with severe tumor extension may develop associated complications recorded as immediate cause of death, we decided to avoid misclassification by defining tumor related death as any patient deceased with severe tumor extension at time of death, irrespective of the immediate cause of death. Results: 194 patients were evaluated for a diagnosis of HCC at our institution between 2004 and 2009. There were 101 deaths: 18/63 patients in BCLC A, 14/32 patients in BCLC B, 36/65 patients in BCLC C and 24/34 patients in BCLC D. A cause of death could be assigned to 83 patients. The immediate cause of death was tumor progression in 40 patients; cirrhosis complications in 23 patients; treatment related complications in 6 and infectious complications in 14. Tumor related deaths were as follows: BCLC A 7 deaths; BCLC B 6 deaths, BCLC C 26 deaths and BCLC D 18 deaths. Non-tumor related deaths were as follows: BCLC A 8 patients, BCLC B 5 patients, BCLC C 7 patients, BCLC D 6 patients. Non-classifiable or unknown vital status was observed in 5%, 12% 13% and 5% of patients with BCLC A, B, C and D respectively. Conclusions: In early and intermediate HCC categories, non-tumor related mortality is as frequent as tumor related. Only in advanced stages, tumor related mortality is predominant.
Analysis of Spanish Experience During Imiglucerase Shortage
Authors: Pilar Giraldo, Pilar Irún, Pilar Alfonso, Jaime Dalmau, MAngeles Fernández-Galán, Antonio Figueredo, Angela Ibañez, Jesús M Hernández-Rivas, Elisa Luño, Francisca Marín-Jimenez, Guillermo Martin-Nuñez, Jorge Montserrat, Javier De la Serna, Lucia Villalon, Miguel Pocovi
Journal: Blood (2010)
Reduced GVHD in C3-Deficient Mice Is Associated with a Decrease in Donor Th1/Th17 Polarization and Recipient Th1- Driven Dendritic Cell Activation
Authors: Qing Ma, Dan Li, Roza Nurieva, Hernan G. Vasquez, Richard E Champlin, Michael H. Kroll, Vahid Afshar-Kharghan
Journal: Blood (2011)
Multi-Omic profiling (MoP) for patients (pts) with pancreatic cancer (PDA): Initial results of the Know Your Tumor (KYT) initiative.
Authors: Michael J. Pishvaian, Jonathan Robert Brody, Lynn Matrisian, Andrew Eugene Hendifar, Anitra Engebretson, William Arthur Hoos, Sameh Mikhail, Vincent M. Chung, Vincent J. Picozzi, Corinne Ramos, Craig Heartwell, Kimberly Mason, Katelyn Varieur, Lola Rahib, Emanuel Petricoin, Subha Madhavan
Journal: Journal of Clinical Oncology (2016)

282 Background: Emerging insights into the molecular biology of tumors and recent developments in MoP have led to the identification of targets that can be used for selecting treatment (tx) regimens. Multiple testing platforms are available, though most studies to date have used only next generation DNA sequencing (NGS). Methods: The Pancreatic Cancer Action Network (PanCAN) and Perthera have initiated an IRB-approved registry trial wherein we facilitate commercial MoP on tumor tissue from PDA patients. MoP includes NGS, immunohistochemistry (IHC), and phosphoproteomics (PHO). The results are reviewed by a team of PDA specialists in the context of the pt’s tx history. Tx options are prioritized based on the actionable molecular abnormalities. Pts are being followed longitudinally to assess physician acceptance of the tx options and track survival outcomes. Results: From 06/2014 to 09/2015, Perthera reports were delivered for 117 pts. 44% of the analyses were for second-line tx and 43% for ≥ third-line. Tumor based NGS and IHC were available for 75% and 90% of pts, respectively, and research use only PHO data was available for 20 pts. Actionable findings, defined based on a high response rate in pts with an identified molecular abnormality (in any cancer type), or based on a mechanism/pathway-defined implication of response to tx were identified in 43% of pts, primarily based on NGS. Incorporation of IHC refined and expanded chemotherapy tx options in all pts. PHO revealed pathway activation (e.g. mTOR, JAK-STAT, MET, RET, or EGFR) in 16/20 samples. Interestingly, only 45% of KRAS mutant samples had PHO-defined activation of the MEK-ERK pathway. Conclusions: MoP resulted in actionable findings in 43% of PDA pts using NGS and IHC. Incorporation of PHO data could have a significant impact on MoP-based therapy options. Analysis of the MoP in the context of patient history by a PDA specialist provided a service to treating oncologists in the community that was frequently incorporated into their treatment decisions. Survival outcomes will be presented. As additional testing platforms and results become available, the breadth and confidence of actionable markers is expected to increase.
Randomized controlled trial of omental bursectomy for resectable cT2-3 gastric cancer.
Authors: Y. Kurokawa, Y. Fujiwara, S. Takiguchi, J. Fujita, H. Imamura, T. Tsujinaka, M. Mori, Y. Doki
Journal: Journal of Clinical Oncology (2011)

72 Background: Omental bursectomy, a traditional surgical procedure to dissect the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has often been performed against resectable gastric cancer. We have conducted a multi- institutional randomized controlled trial to elucidate the safety and usefulness of this procedure. Methods: Patients with cT2 or cT3 gastric adenocarcinoma were intraoperatively randomized to radical gastrectomy plus D2 lymphadenectomy either with or without bursectomy. The primary endpoint was overall survival (OS). The planned sample size was 464, with an alpha error of 0.05 and statistical power of 80% to detect a 10% margin of non-inferiority for the non-bursectomy group. The first interim analysis was conducted on Sep 2008, and we decided the preliminary data release according to Korn's proposal (J Clin Oncol. 2005). Results: Between Jul 2002 and Jan 2007, a total of 210 patients were randomized to either the bursectomy group or the non-bursectomy group. Background characteristics were well balanced. Intraoperative blood loss was greater in the bursectomy group than in the non-bursectomy group (median, 475 mL vs. 350 mL, p=0.047), while other surgical factors did not vary significantly. The overall morbidity rate was 14%, the same between two groups. The hospital mortality rate was 0.95%; one patient per group. In the first interim analysis, the 3-year OS were 86% in bursectomy group and 79% in non-bursectomy group, and the hazard ratio was 1.55 (95% CI: 0.84-2.84). The non-bursectomy group had more patients with peritoneal recurrences than the bursectomy group (14% vs. 8%). Conclusions: Experienced surgeons could safely perform a D2 gastrectomy with an additional bursectomy. First interim analysis suggested the survival advantage of omental bursectomy for cT2-3 gastric cancer patients. Final analysis will be conducted in 2012. No significant financial relationships to disclose.