bluuebunny/crossref_metadata_2025_split huggingface dataset:
Guideline-based treatment utilization, treatment time, and cost of chemotherapy for metastatic colon cancer patients treated in U.S. community oncology practices from 2005 to 2009.
Authors: Phung Yen , Wang Zhaohui , Aksamit Inga , Green Sarah G. , Todoroff Karen , Bergstrom Kimberly A. 
Published: March 2020

e14118 Background: Adherence (Ad) to national treatment guidelines (TG) is important in improving the quality, outcomes, and cost of cancer treatment (TX) in the U.S. We examined regimens (Reg) utilized, TG-Ad, time on metastatic TX, and cost of chemotherapy prescribed by U.S. community oncology practices to treat patients (Pts) with metastatic colon cancer (MCC) in 2005 and 2009. Methods: Adult colon cancer Pts beginning first line metastatic treatment (LOT-1) in each full calendar year for 2005 and 2009 were reviewed from a large U.S. medical oncology clinical database derived from web-based drug dispensing technology. Reg utilized and 2-yr time on metastatic TX were analyzed and compared to TG recommendations. Reg costs based on Medicare reimbursement were compared. Results: The average number of LOT and number of unique drugs Pts were exposed to were similar between 2005 and 2009. About 70% of Pts received only one LOT. In LOT-1 and 2, TG regs were prescribed more often than Non-TG regs for both groups. TG-Ad was significantly higher in 2009 than in 2005 for LOT-1 (p < 0.0001). Pts receiving TG-Ad Reg for LOT-1 had a significantly longer total metastatic treatment time in both 2005 and 2009. In both 2005 and 2009, FOLFOX+Bev was the most frequent LOT-1 Reg given (37% of Pts), while FOLFIRI+Bev was the most frequent LOT-2 Reg given. 69% of Pts received Bev with LOT-1 in both 2005 and 2009; of those, 28-30% continued to receive Bev with LOT-2. Costs for the top 5 LOT-1 Regs were $17,031 to $34,400 and $5,512 to $39,835 for 2005 and 2009, respectively. Conclusions: U.S. community oncology practices significantly improved guideline Ad in the TX of MCC from 2005 to 2009. In LOT-1, TG Regs were prescribed more than non-TG Regs for both groups. TG Ad for LOT-1 significantly improved time on metastatic TX in both groups. FOLFOX+Bev and FOLFIRI+Bev were most frequently prescribed for LOT-1 and LOT-2, respectively. Costs for the five most utilized Regs vary considerably. [Table: see text]
Treatment of diatal rectal cancer with preoperative intensity-modulated radiation therapy (IMRT) combined with chemotherapy: Updated 5-year results of 42 patients.
Authors: DeNittis Albert S. , Marks John , Troicki Filip , Zeger Erik L. , Nassif George , Marks Gerald J. 
Published: March 2020

e14157 Background: Preoperative chemoradiotherapy is currently the standard of care for patients with distal rectal cancer. With Intensity Modulated Radiation Therapy (IMRT), more conformal doses of radiation can be delivered to tumor while sparing normal tissue. It is our intent to present updated data showing 5 year follow up on patients treated concurrently with chemotherapy and IMRT reporting on local control, overall survival, and toxicity. Methods: From April 2007 to February of 2012 a sequential retrospective study of 42 patients at Lankenau Medical Center were treated for distal rectal cancer using IMRT. Patients staged from T2N0M0 to T3N1M0 and all received 5580 cGy to the pelvis using a 9 field plan to tumor, involved and uninvolved lymph nodes. All but one patient received 5FU based chemotherapy and four patients also received oxaliplatin. All patients then went on to surgery 8 – 12 weeks following neoadjuvant therapy. Twenty six patients underwent transabdominal transanal mesorectal (TATA) resection, 9 patients underwent a transanal endoscopic microsurgery (TEM), and 1 patient had an open low anterior resection. 3 patients have yet to go to surgery. FOLFOX was given to 25 of 42 patients adjuvently. Patients were analyzed for local control (LC), median survival (MS), overall survival (OS), and toxicity. Results: The median follow-up was 35 months. Complete pathological response was achieved in 12 (30.7%) patients, partial response was achieved in 25 (64%) patients, and 2 had stable disease at the time of surgery. There were no patients with local failure and only six (14%) patients progressed with distant metastatic disease. OS at 5 years was 92.8% with a MS of 37 months. Toxicity was acceptable with eight patients with grade 1, 5 patients with grade 2, and 3 grade 3 diarrhea. There were 3 (7%) patients with grade 1 neutropenia. Three patients experienced disease related death. Conclusions: With 5 years of follow-up data, our experience has shown that neoadjuvant chemoradiotherapy using IMRT to treat advanced stage rectal cancer is well tolerated and effective. Still further follow-up and additional studies will be required to confirm our findings.
A randomized, placebo-controlled, double blind, multicenter phase II adjuvant trial of the efficacy, immunogenicity, and safety of GI-4000 plus gem versus gem alone in patients with resected pancreas cancer with activating RAS mutations/survival and immunology analysis of the R1 subgroup.
Authors: Muscarella Peter , Wilfong Lalan S. , Ross Sharona B. , Richards Donald A. , Raynov Julian , Fisher William E. , Flynn Patrick J. , Whiting Samuel H. , Rosemurgy Alexander , Harrell Frank E , Mercaldo Nathaniel D. , Kosten Scott , Quiring John , Speyer Sue , Richman Joni , Ferraro John , Coeshott Claire , Cohn Allen , Rodell Timothy C. , Apelian David 
Published: March 2020

e14501 Background: Patients with resected pancreas cancer treated with standard of care Gem have a median overall survival of 22 months (vs 20 months w/ observation). Activating mutations in ras occur in > 90% of pancreas cancer cases. GI-4000 is whole, heat-killed recombinant S. cerevisiae yeast that expresses mutated Ras proteins. This trial is designed to evaluate the efficacy, immunogenicity, and safety of GI-4000 plus Gem in patients with Ras mutant + resected pancreas cancer. Methods: The study enrolled 176 Ras mutant + pancreas cancer subjects post resection randomized 1:1 to GI-4000 plus Gem or placebo plus Gem (stratified by resection status; R0 or R1). Three weekly injections of GI-4000 or placebo were followed by 6 cycles of Gem 1000 mg/m2 iv (day 1, 8, 15 every 28 days). Monthly GI-4000 or placebo were administered on the Gem off-weeks and continued monthly until intolerance, disease recurrence, or death. The primary endpoint is RFS. Data for the 39 R1 subjects (GI-4000 n=19, Placebo n=20) have been unblinded and analyzed. Results: The GI-4000 group had an 11.4 week advantage in median overall survival (524 Days vs 444 Days), 16% advantage in 1 year survival (72% vs 56%), and a 4.6 week advantage in median RFS (287 Days vs 255 days). The GI-4000 group showed a significantly higher rate of mutation specific T cell response to Ras by ELISpot assay; 7/15 (47%) vs 1/12 (8%), p=0.032,with a more pronounced survival benefit in GI-4000 treated immune responders; 21.7 week advantage in median survival (596 Days vs 444 Days) compared to placebo. No significant novel toxicities have been observed to date. Conclusions: GI-4000 in combination with adjuvant Gem showed a clinically meaningful point estimate for the treatment effect on survival in R1 subjects with Ras mutant + pancreas cancer. GI-4000 was immunogenic and well tolerated. Ras specific immune response was associated with a more pronounced benefit in median survival. These data warrant further study in a definitively powered clinical trial for GI-4000 in the adjuvant setting in R1 subjects.
Relationship between tissue factor expression by human pancreatic cancer cells and activation of coagulation and thrombosis in a mouse model.
Authors: Geddings Julia E. , Wang Jian-guo , Cardenas Jessica C , Chantrathammachart Pichika , Williams Julie C , Back Ronald R , Church Frank C , Pawlinski Rafal , Key Nigel , Yeh Jen Jen , Mackman Nigel 
Published: March 2020

e14505 Background: The increased risk of thrombosis in patients with cancer has been well established. However, the triggers in these patients have yet to be fully defined. Under pathological conditions, the potent procoagulant protein Tissue Factor (TF) is found in the circulation and may trigger thrombosis. Methods: We evaluated the level of TF expression in 4 different human pancreatic cancer cell lines. We also measured TF microparticle (MP) release from these tumors in vivo by flow cytometry and TF activity assay. We then used these lines in a mouse model of pancreatic cancer to evaluate the sources of TF that activate coagulation and contribute to thrombosis using a saphenous vein model. Results: We found that mice bearing orthotopic pancreatic tumors which express higher levels of TF (HPAC and HPAF) show increased activation of coagulation (measured by thrombin-antithrombin complex) as compared to mice bearing TF negative tumors (MIA-PaCa-2 and PANC-1). This activation of coagulation could be reduced by treatment with a human TF antibody. Further, mice bearing tumors derived from TF high cell line HPAC demonstrated an activation of coagulation despite a lack of circulating TF-positive MPs. Mice bearing TF expressing pancreatic tumors also demonstrated increased thrombosis by a saphenous vein model. Treatment of tumor-free mice with TF MPs did not result in an activation of coagulation or increased thrombosis unless mice were given 40-100 fold higher levels of TF bearing MPs than are found in the circulation of tumor bearing mice. Conclusions: The data suggest that TF on the tumor itself is involved in the activation of coagulation whereas circulating TF-positive MPs is likely to contribute to thrombosis. Elevated levels of TF-positive MPs may be used as a biomarker to identify cancer patients at risk for thrombosis.
Phase II study of weekly intravenous and intraperitoneal paclitaxel combined with oral S-1 for advanced gastric cancer with macroscopic peritoneal metastasis.
Authors: Yamaguchi Hironori , Ishigami Hironori , Emoto Shigenobu , Yamashita Hiroharu , Kitayama Joji 
Published: March 2020

e14530 Background: This phase II study was performed to evaluate the efficacy and the tolerability of weekly intravenous and intraperitoneal paclitaxel (PTX) combined with oral S-1 in gastric cancer patients with macroscopic peritoneal metastasis. We previously reported a phase I and II study with the same regimen in gastric cancer patients with peritoneal metastasis, including patients with positive peritoneal washing cytology but negative macroscopic peritoneal metastasis. This trial was scrutinized and approved by a committee appointed by the Ministry of Health, Labour, and Welfare in Japan and performed under the special interim system for Advanced Medical Technology so as to generate an evidence for future approval of the treatment by the Ministry. Methods: Gastric cancer patients with primary tumors with macroscopic peritoneal metastasis confirmed by staging laparoscopy were enrolled. PTX was administered intravenously at 50 mg/m2, and intraperitoneally through a subcutaneous implanted access port at 20 mg/m2 on days 1 and 8. S-1 was administered orally twice daily at 80 mg/m2/day for 14 consecutive days followed by 7 days rest, repeated every 3 weeks. The primary endpoint was the one-year overall survival rate. Secondary endpoints were the response rate, efficacy against malignant ascites and safety. Results: In total, 35 patients were enrolled. All patients had several to numerous metastases to the distant peritoneum. The median number of administration course was 11 (range 2-29). The one-year overall survival rate was 77.1%. Massive malignant ascites decreased in 6 of 9 (66.7%) patients. Peritoneal washing cytology turned negative in 28 of 29 (96.7%) patients. The incidences of grade 3/4 hematological and non-hematological toxicities were 34% and 9%, respectively, all of which were reversible. Grade 3/4 toxicity was observed for neutropenia (34%), leukopenia (23%), anemia (9%). There were no treatment-related deaths. Conclusions: The combination chemotherapy regimen of weekly intravenous and intraperitoneal PTX combined with oral S-1 was well tolerated and active in gastric cancer patients with macroscopic peritoneal metastasis.
Intensity-modulated radiation therapy (IMRT) for anal cancer: Results from a multi-institutional retrospective cohort study.
Authors: Call Jason Andrew , Prendergast Brendan M , Jensen Lindsay G , Ord Celine B , Goodman Karyn A. , Jacob Rojymon , Mell Loren K. , Thomas Charles R. , Jabbour Salma , Miller Robert C. 
Published: March 2020

e14555 Background: This study was done to assess the toxicity and efficacy of IMRT for anal cancer in a multi-institutional setting. Methods: Records of 152 total patients (pts) were reviewed retrospectively. Data on disease control and toxicity were collected as well as pt and treatment characteristics. Acute (<6 months) and late (>6 months) severe toxicity (grade >3) were recorded at each institution. Four were excluded for either presence of metastatic disease (2) or stage TX (2). There was data for late toxicity on 120 pts. Results: T stage was T1 in 28, T2 in 79, T3 in 29 and T4 in 12 pts. N stage was N0 in 77, N1 in 40, N2 in 19 and N3 in 12 pts. The median age was 56 yrs and median follow-up was 26.8 months. Cumulative IMRT dose was 51.25 Gy (median) (range: 4.32-61.2 Gy) in a median of 28 fractions (2-34). Chemotherapy was given in all but 2 pts and the most common regimen was 5- fluorouracil plus mitomycin-C. The median total elapsed treatment time was 40 days. Local control at 3 yrs was 87% and was significantly worse for patients with T3-4 disease (79% vs 90% at 3 years; p=0.04). There was no correlation between dose and local control. Regional control, distant control and overall survival were 97%, 91%, and 87% at 3 yrs, respectively. Nodal status was associated with regional and distal control as well as overall survival (p<0.01 for each). The most common acute severe toxicity was hematologic (41%). Severe acute GI, skin or other toxicity was 11%, 20% and 1% respectively. There were two grade 5 toxicities (hematologic and GI). Severe late toxicity was limited to skin (1%) and GI (3%). Conclusions: IMRT resulted in excellent local control in this multi-institutional cohort of pts. Although T stage did predict for worse local control, most pts with T3-4 disease were controlled with IMRT. Nodal status predicts for regional and distal control as well as overall survival. Severe toxicity was acceptable with this technique.
Defining eligibility of FOLFIRINOX for first-line metastatic pancreatic adenocarcinoma (MPC) in the province of British Columbia: A population-based retrospective study.
Authors: Gill Sharlene , Ho Maria Yi , Kennecke Hagen F. , Renouf Daniel John , Cheung Winson Y. , Lim Howard John 
Published: March 2020

e14588 Background: FOLFIRINOX is a first line treatment option for patients with MPC and is associated with improved survival yet significantly more treatment-related toxicities than standard gemcitabine.. Our aim was to determine the proportion of patients with MPC who would be eligible for FOLFIRINOX therapy based upon the pivotal ACCORD study eligibility criteria. Methods: Patients with confirmed metastatic pancreatic cancer at the time of referral to the BC Cancer Agency between 2004-2007 were identified from the GI Outcomes Unit Database. Proportion of patients that met the ACCORD study eligibility criteria was determined by chart review. Criteria for FOLFIRINOX exclusion were assessed using descriptive statistics. Results: 100 consecutive patients with complete chart records and metastatic pancreatic cancer were identified. 52(52%) were male and the median age was 68. The most common sites of metastases were liver (63%) and peritoneum (22%). Only 26 patients fulfilled the ACCORD study eligibility criteria. The most common reasons for FOLIFIRINOX exclusion per ACCORD were poor ECOG score of 2 or greater (64%), age of 76y or greater (22%), elevated bilirubin (22%) and inadequate renal function (6%). Conclusions: Despite the proven survival benefit of FOLFIRINOX, only one-quarter of real-world patients with MPC would potentially be considered eligible for such combination chemotherapy.
Predictors for survival in hepatocellular carcinoma.
Authors: Misek Glen I. , Jayanti Venkata K 
Published: March 2020

e14640 Background: The global incidence of HCC is over 700,000 patients making it the sixth leading cancer and the prognosis is poor with a 5 year survival of 11%. It is important to understand if there are differences in survival based on the presence of Hepatitis B or C or alcohol cirrhosis, ethnicity and/or treatments employed in various stages of the disease. Methods: A robust global retrospective study of HCC patients was conducted with nearly 4,000 patient records from US, Germany, France, Spain, Italy, China and South Korea in 2011. Of these nearly 800 included deceased patients. These records were analyzed to study if any known factors such as ethnicity, presence of Hepatitis B, Hepatitis C or alcohol cirrhosis and/or treatments used at diagnosis could serve as predictors for survival. Kaplan-Meier curves were plotted to understand the differences in survival based on ethnicity, Child-Pugh status and treatments employed at various stages. Results: One year survival is lower in China/ Korea compared to US and EU, however, five year survival rates are comparable across regions. Associated hepatitis or cirrhosis does not convey any differences in one year survival whether patients received sorafenib as first line treatment or not. Statistically significant higher one year survival rates are observed for HCC patients in Europe and USA receiving transarterial chemoembolization (TACE) compared with patients receiving sorafenib first line. However, in China and Korea there is no such difference. Across all three regions: USA, EU and Asia there is no difference in survival in stage IV patients receiving sorafenib or no sorafenib. No significant differences in one year survival are seen in USA, EU and Asia for patients with Hepatitis C or B or cirrhosis compared to those with no history of liver disease. The Child-Pugh C patients had lower survival compared to Child-Pugh A or B patients. Conclusions: Early diagnosis of HCC, early intervention and treatment appear to show survival benefits as opposed to drug treatment with sorafenib initiated in the later stages of the disease. Efforts should increase for screening, early detection and treatment initiation at early stage to improve outcomes in HCC patients.
Epidermal growth factor receptor (EGFR) status and prognosis in gallbladder cancer.
Authors: Martins Sandro José , Pais-Costa Sérgio Renato , Artigiani-Neto Ricardo , Farah José Francisco de Mattos , Franco Maria Isete Fares , Goldemberg Alberto 
Published: March 2020

e14657 Background: Studies from USA, Asia and Australia showed EGFR over-expression in gallbladder cancer (GC), and recent case reports suggest a role for EGFR targeted therapies in this disease. Methods: We studied the prognostic role of EGFR expression and its association with clinicopathologic features in forty-two GC patients surgically treated at our center, from 1995 to 2006. None received targeted cancer therapeutics. Tissue microarray blocks containing neoplastic tissue and tumor-adjacent non-neoplastic biliary epithelia were obtained and assessed for immunohistochemical (IH) expression of EGFR, cyclo-oxygenase-2 (COX2), E-cadherin and p53 protein. Nonparametric correlations were assessed by Spearman’s rho; survival analysis was performed using the Kaplan-Meier method and Cox regression; and p-values were computed for two-tailed tests. Results: EGFR IH scores 0, +1, +2, and +3 were observed in 48.7%, 23.1%, 17.9%, and 10.3%, respectively. They were correlated with p53 staining (rho=0.48; p=0.002); T-stage (rho=0.38; p=0.016); serum CA-19.9 (rho=0.48; p=0.016); and serum CEA (rho=0.56; p=0.004). Median overall survival (OS) was 8.0 months (95% C.I.: 5.6 to 10.3); 1-year and 2-year survival rates were 43.7% and 23.5%, respectively. OS were 18.0 months, 14.0 months, and 4.0 months for tumors with 0, 1+ and 2+ to 3+ EGFR staining, respectively. Univariate analysis suggested a worse prognostic significance for low serum albumin (p=0.001); elevated CEA (p=0.007) and CA-19.9 (p=0.007) levels; positive surgical margins (p=0.001); gallbladder fundus tumors (p=0.007); histologic grade 3 (p=0.003); positive nodes (p=0.001); lymphovascular invasion (p=0.001); tumoral necrosis (p=0.004); perineural invasion (p=0.002); and EGFR expression (p=0.004). In the multivariate analysis, low serum albumin (p=0.006), tumoral necrosis (p<0.001) and EGFR expression (p<0.001) predicted poor OS. Conclusions: We found tumor immunoreactivity for EGFR in nearly half of the cases and it was independently associated with poor survival in GC patients.
Factors associated with local-regional failure after definitive chemoradiation for locally advanced esophageal cancer.
Authors: Amini Arya , Welsh James , Allen Pamela , Xiao Lianchun , Suzuki Akihiro , Blum Mariela A. , Hofstetter Wayne Lewis , Liao Zhongxing X. , Lee Jeffrey H , Bhutani Manoop S. , Komaki Ritsuko 
Published: March 2020

e14669 Background: Esophageal cancer is often treated with a trimodality approach (chemotherapy and radiation followed by surgery). However a significant proportion of such patients achieve a clinical complete response (cCR) following chemoradiation alone. We retrospectively analyzed patients who reached cCR after definitive chemoradiation for locally advanced esophageal cancer to identify clinical predictors of local disease recurrence. Methods: We identified 141 patients who obtained initial cCR after definitive chemoradiation for esophageal cancer from January 2002 through January 2009. The initial response to treatment was assessed by endoscopic evaluation and biopsy results, with cCR defined as having no evidence of disease present. Patterns of failure were categorized as in-field (within the planned treatment volume [PTV]), outside the radiation treatment field, or both. Results: At a median follow-up of 22 months (range 6-87 months), 77 patients (55%) had experienced disease recurrence. Most first failures (32, or 23%) were outside the radiation field, followed by 30 (21%) within the field and 15 (11%) were both. In multivariate analysis, in-field failure after cCR was associated with a post-treatment standardized uptake value (SUV) on positron emission tomography of >3.5 (odds ratio [OR] 4.93, p=0.022), squamous histology (OR 0.07, p=0.010), and borderline for T3/T4 disease (OR 10.25, p=0.055). All failures, in-field and out-of-field, correlated with T3/T4 disease (OR 11.61, p=0.015), N1 disease (OR 5.07, p=0.010), pretreatment SUV >10 (OR 4.00, p=0.048), and post-treatment SUV >3.5 (OR 3.59, p=0.052). Conclusions: Clinical characteristics can be used to predict failure patterns after definitive chemoradiation. Such risk-assessment strategies can help individualize therapy.