bluuebunny/crossref_metadata_2025_split huggingface dataset:
Implementing quality indicators using health insurance claims data linked to the hospital-based cancer registry.
Authors: Nakamura Fumiaki , Masuda Masato , Teramoto Norihiro , Mizumoto Kazuhiro , Mekata Eiji , Higashide Shunichi , Ohtani Mikinobu , Higashi Takahiro 
Published: February 2017

94 Background: To establish systematic monitoring of cancer care quality, we measured the quality of cancer care in several facilities through chart reviews by tumor registrars. However, this method required both extensive effort of and skills in registrars. To explore less-labor–intensive methods of measuring care quality, we assessed quality measurement using health insurance claims data linked to the Hospital Based Cancer Registry (HBCR). Methods: We previously developed 206 quality indicators (QIs) to assess cancer care processes in collaboration with clinical experts. Ten of these (stomach cancer, 1; colorectal cancer, 1; lung cancer, 2; breast cancer, 3; liver cancer, 1; and supportive care, 2) could be used for analyzing HBCR health insurance claims data. Patients treated at 7 designated cancer hospitals in Japan in 2010 were included. Their characteristics and tumor stages were obtained from HBCR, and processes of care administered to the patients in 2010–2011 were obtained from health insurance claims data. We calculated a score for each QI based on the proportion of patients receiving care among those eligible for QI. Results: Data of 4,785 patients were analyzed (stomach cancer, 1,181; patients with colorectal cancer, 1,077; lung cancer, 1,091; breast cancer, 1,184; and liver cancer, 252). Quality scores of essential laboratory tests were high; 91% patients underwent the HER2 test for invasive breast cancer and 95% underwent the liver function test using indocyanine green clearance before liver cancer surgery. However, indicator scores for adjuvant chemotherapy were relatively lower at only 59% for stomach cancer patients, 57% for colorectal cancer patients, and 56% for lung cancer patients receiving adjuvant chemotherapy. The supportive care scores had even more scope for improvement as only 43% patients received antiemetics for highly emetic chemotherapy and 66% patients received laxatives along with narcotics. Conclusions: These QIs can be implemented for health insurance claims data linked to HBCR and used to identify the potential target area for improvement. In future, such electronic systems will enable rapid cycles of quality measurement and feedback.
Impact of FDA guideline changes on treatment patterns and cost among cancer patients with anemia who do not respond to erythropoietin stimulating agents (ESAs).
Authors: Girvan Allicia C. , Lau Yiu-Keung , Pohl Gerhardt , Landsman-Blumberg Pamela , Shi Nianwen , Varker Helen , Bowman Lee 
Published: February 2017

97 Background: Due to emerging evidence in 2007, the FDA issued warnings in the labeling of ESAs regarding use among cancer patients. Subsequently, ASCO/ASH clinical practice guidelines were also updated to recommend discontinuation of ESAs in patients who fail to respond within 6-8 weeks. Methods: Patients with breast, head and neck, cervical, non-small cell lung cancer, or multiple myeloma initiating ESAs during 1/1/2003 - 7/1/2011 were identified from EMRs in the ACORN Data Warehouse (ACORN, Memphis TN). The study included those with at least 6-8 weeks of ESA use with documented hemoglobin (Hb) values. Following the ASCO/ASH guidelines, patients were defined as non-responders if Hb increased < 1g/dL between baseline (≤ 28 days before ESA initiation) and response determination date (Hb assessment closest to day 56). Non-responders were further classified as continuers or discontinuers based on the presence of ESA treatment following determination of non-response. ESA use, adverse events, and costs were assessed using Chi-square test for comparisons. Results: A total of 1,198 patients were classified as non-responders (591 in pre-2007 and 607 in post-2007). ESA continuation rate was lower for post-2007 compared to pre-2007 (75% vs. 90%, p < 0.0001). Conclusions: The percentage of patients continuing ESA treatment in the absence of Hb response has decreased since 2007, yet still remains high despite guideline recommendations. It is not clear from these data whether the increased risks and cost burden in these patients were offset by other positive outcomes. [Table: see text]
Optimal criteria of treatment change for advanced gastric cancer patients with nonmeasurable peritoneal metastasis alone.
Authors: Hasegawa Hiroko , Fujitani Kazumasa , Nakazuru Shoichi , Hirao Motohiro , Mita Eiji , Sekimoto Mitsugu , Tsujinaka Toshimasa 
Published: February 2017

103 Background: Palliative chemotherapy is the mainstay for the treatment of advanced gastric cancer (AGC) patients with peritoneal metastasis. In general, chemotherapy regimen is changed when patients show disease progression on CT scan. However, nearly 40% of these patients have no measurable lesions. It remains uncertain how clinicians can decide the timing of treatment change for AGC patients with non-measurable peritoneal metastasis alone. Methods: There were 217 patients with primary unresectable or recurrent gastric cancer at our institution between April, 2005 and March, 2012. Among them, 50 patients, who had histologically proven non-measurable peritoneal metastasis alone, were retrospectively identified and investigated in this study. They underwent measurements of tumor markers (TM) every month and abdominal CT scan every 2 months. For these 50 patients, chemotherapy regimen was changed based on the following different 2 criteria; 1. elevated TM and/or aggravated clinical symptoms alone (n=21), 2. radiologically confirmed disease progression (n=29). We assessed whether these two different criteria have any impact on overall survival (OS) by univariate and multivariate analyses. Results: Median survival time of all 50 patients was 604 days. Multivariate analysis identified pre-treatment performance status of 0-1 (hazard ratio (HR) 0.211, 95% confidence interval (CI) 0.045–0.998, P=0.049), initial hemoglobin level of 10 mg/dl or more (HR 0.114, 95% CI 0.014–0.936, P=0.043) and the TM / symptom based treatment change (HR 0.124, 95% CI 0.043–0.360, P=0.001) as significant prognostic factors for favorable OS. Conclusions: Early decision making of treatment change based on elevated TM and/or aggravated clinical symptoms alone might contribute to longer OS in AGC patients with non-measurable peritoneal metastasis alone.
Activity of AT13387, a novel, non-ansamycin inhibitor of heat shock protein 90, against gastrointestinal stromal tumors (GIST).
Authors: Mahadevan Daruka , Shapiro Geoffrey , Kurtin Sandra E. , Cleary James M. , Lyons John F. , Rodriguez-Lopez Ana , Yule Murray , Ahanonu Valarie , Choy Gavin S. , Noursalehi Mojtaba , Azab Mohammad 
Published: February 2017

105 Background: AT13387 is a second-generation potent, novel non-ansamycin HSP90 inhibitor (Kd 0.71nM). The majority of GIST tumors are characterized by activating mutations of c-KIT, an HSP90 client protein. Secondary resistance mutations within c-KIT limit clinical responses to TKIs. The dependence of c-KIT and its mutated forms on HSP90 suggests that HSP90 inhibition may be a valuable treatment option for imatinib-sensitive and resistant clones. In vitro, AT13387 inhibited the proliferation of imatinib-sensitive (GIST882, GIST-T1) and imatinib-resistant (GIST430, GIST48) cell lines. In vivo, AT13387 demonstrated anti-tumor activity in the imatinib-sensitive (GIST-PSW) and imatinib-resistant (GIST430) xenograft models. Induction of HSP70, depletion of phospho-c-KIT and inhibition of c-KIT signaling were observed in both models. Combination treatment of imatinib and AT13387 in the GIST430 model was well tolerated and significantly enhanced tumor growth inhibition over either monotherapies. Methods: In a completed phase I study, AT13387 was administered IV over 1 hour twice weekly or weekly of a 28-day cycle in a standard 3+3 dose-escalation design. The primary endpoint was to determine the MTD; secondary endpoints included PK, PD, safety and tolerability. Results: The PK exposures were dose-dependent and linear. AT13387 was well tolerated on both schedules. DLTs included primarily G2 AEs of GI toxicities, fatigue and infusion site reactions. The once weekly RP2D was determined to be 260 mg/m2. HSP70 induction was 2–7 fold at higher doses. A total of 7 GIST subjects were enrolled. An objective and durable PR was observed in one subject and 2 SDs at 8, 7 and 11 months, respectively. The PR subject demonstrated molecular resistance to kinase inhibitor treatment in the c-KIT gene prior to initiation of AT13387 therapy in two resected lesions by harboring the same activating c-KIT deletion in exon 11 and two separate TKI resistance mutations in exon 17. Conclusions: Overall, these results suggest AT13387 is a promising agent in GIST, including TKI-resistant c-Kit positive GIST. AT13387 is currently being evaluated in combination with imatinib in an ongoing phase I/II study. Clinical trial information: NCT01294202.
New endoscopic treatment for superficial carcinoma of borderline lesions between the cervical esophagus and hypopharynx.
Authors: Kawakubo Hirofumi , Omori Tai , Nakamura Rieko , Takahashi Tsunehiro , Wada Norihito , Koyanagi Kazuo , Takeuchi Hiroya , Saikawa Yoshiro , Kitagawa Yuko 
Published: February 2017

107 Background: Early diagnosis and early treatment are the best ways to improve cancer patient prognoses. We developed ELPS (endoscopic laryngo-pharyngeal surgery) as an endoscopic treatment for superficial pharyngeal carcinoma. ELPS is transoral endoscopic surgery for laryngeal cancer. After lifting the larynx using the laryngoscope, the endoscopist inserts endoscope and the operator inserts forceps and electric device transorally, and resects superficial phayngeal carcinoma. However, ELPS has not been applied for cervical esophagus carcinoma because of the narrow working space. We developed a hybrid endoscopic surgery (ESD+ELPS) for borderline lesions between the cervical esophagus and hypopharynx. The purpose of this study was to examine the usefulness and effectiveness of endoscopic treatment for superficial carcinoma of the hypopharynx and cervical esophagus. Methods: Hybrid endoscopic surgery (ESD and ELPS) was performed on 8 lesions, which involved both the hypopharynx and cervical esophagus. Results: Six of eight patients had esophageal cancer treatments in their past histories, two for ESD, two for esophagectomy and two for chemoradiation. All lesions were completely resected. The complications of this procedure were laryngeal edema for three patients, which required overnight intubation, and stenosis of cervical esophagus for two patients, which required endoscopic dilation more than 10 times. There were no long term complications in all patients. Conclusions: The results indicated the usefulness and effectiveness of hybrid endoscopic treatment (ELPS+ESD) for superficial carcinoma of borderline lesion between the cervical esophagus and hypopharynx.
Association of increased survival with surgery and radiation therapy in metastatic gastric cancer: A SEER database analysis.
Authors: Shridhar Ravi , Almhanna Khaldoun , Hoffe Sarah , Fulp William J. , Weber Jill , Chuong Michael , Meredith Kenneth 
Published: February 2017

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 (6th 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<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 <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.
Combination external beam radiotherapy and brachytherapy for radical treatment of esophageal carcinoma in patients not suitable for surgery or chemoradiation.
Authors: Aggarwal Ajay , Harrison Mark , Sinharay Ricky , Cooper Derek , Glynne-Jones Robert , Hoskin Peter 
Published: February 2017

115 Background: Standard curative therapy for esophageal cancer is surgery or chemoradiotherapy. Many patients are not suitable for this approach due to significant co-morbidity.This study evaluates a combination of external beam radiotherapy and High-Dose-Rate (HDR) brachytherapy as a sole modality of treatment for patients in whom tumour characteristics would indicate radical treatment was appropriate. All patients had previously been discussed in a multi-disciplinary setting in which standard radical therapies had been discounted. Methods: 59 patients were treated between October 2000 and October 2011. 40 (58%) were male. Median age was 77 (53 – 88). 39 (66%) adenocarcinoma, 19 (31%) SCC and 1 undifferentiated tumour. 49 (83%) were lower third esophagus. Tumour stage: 1 12(20%), 2 25(43%), 3 19(32%) and 4 2(3%). 30 (50%) had Adult Comorbidity Score – 27 (ACE) of 2 or 3. External beam radiotherapy was conformally planned. Doses of either 27 Gy/6F or 30 Gy/10F were delivered. HDR brachytherapy was delivered utilising an Ir 192 source dosed at 1cm. Doses of either 10 or 15 Gy were delivered. Results: The Median OS, of all treated patients estimated by the Kaplan Meier methods was 373 days (12.3 months). (Fig 1) The 1-, 2- and 3-year survival rates for treated patients were 51%, 19% and 7% respectively. Patients with stage I disease had a median survival of 16 months compared with 10 months for patients with stage III disease. Review of pre treatment dysphagia score demonstrated that patients with no dysphagia prior to treatment (score =0) had a median survival of 17 months compared to 12.5 months and 10 months for patients with scores of 2 and 3 respectively. Conclusions: This demonstrates the value of a purely radiation based approach in a population unsuited to other radical approaches. The median survival exceeds by several months that seen in patients treated palliatively. Treatment is deliverable without significant co-morbidities and offers a survival advantage comparable to radical chemoradiotherapy.
Robotic-assisted Ivor Lewis esophagectomy with or without neoadjuvant chemoradiation therapy for esophageal cancer.
Authors: Smith Franz Omar , Hoffe Sarah , Almhanna Khaldoun , Shridhar Ravi , Karl Richard C. , Meredith Kenneth 
Published: February 2017

117 Background: Neoadjuvant chemoradiation therapy (NT) has become standard of care for patients with locally advanced esophageal cancer. In selected patients, robotic-assisted Ivor Lewis esophagectomy (RAIL) is a safe and feasible operative strategy in the management of esophageal cancer. This study was designed to determine potential differences in peri-operative morbidity and short term outcomes in patients with esophageal cancer treated with RAIL with or without NT. Methods: A retrospective review of consecutive patients with esophageal cancer who underwent RAIL esophagectomy between October 2010 and June 2012 with and without NT was performed. Clinical and pathological variables were analyzed with two-sided student t-test assuming equal variance. Data were considered significant at a p-value <0.05. Results: Eighty-nine patients underwent RAIL during the study period. Seventy-seven patients (87%) received NT and twenty-two patients did not (13%). The median age was 66 years (range 44 – 84) and the median BMI was 28 kg/m2(range 16.7 – 40.1). All patients had a R0 resection. There were no differences in the mean estimated blood loss (149 vs.153 mL; p = 0.52) and mean operative times (434 vs. 427 minutes; p = 1.0). There were no differences in the incidence of pneumonia or atrial fibrillation, lengths of stay in the ICU, or length of hospitalization. In total, there were two anastomotic leaks and one leak from the gastric conduit. The anastomotic leaks occurred in the group that did not receive NT and the gastric conduit leak occurred in the group that received NT. There were no mortalities in either group. There was no difference in the mean number of lymph nodes harvested in the NT group (22 ± 11 vs. 20 ± 8, p = 0.41). Conclusions: RAIL can be safely performed following neoadjuvant chemoradiation therapy.In this series there were similar perioperative, morbidity and short-term mortality outcomes in patients who received NT compared with RAIL alone. Longer follow-up is required in order to determine long term oncologic outcome.
Relationship of drain amylase and anastomotic leak after esophagectomy.
Authors: Hill Joshua S. , Hanna Erin Marie , Hurley Susie C. , Reames Mark , Salo Jonathan C. 
Published: February 2017

118 Background: Esophagectomy is considered the only curative approach in patients with esophageal cancers without locally advanced or metastasis. Anastomotic leak can lead to significant morbidity and mortality. CT esophagram (CTE) is a sensitive method of evaluating for leak; however this test carries with it financial cost and radiation exposure. This study evaluates the utility of drain amylase in the prediction of anastomotic leak. Methods: Fifty-nine patients underwent esophagectomy between 3/10 and 8/12; serial drain amylases and CTE were obtained in 50. Leak was defined by extravasation of contrast or the presence of empyema on CTE. Elevated drain amylase was defined as any level > 400 IU/L. Chi-square and descriptive statistics were performed and the sensitivity of drain amylase >400 IU/L in predicting leak was calculated. Results: A minimally invasive esophagectomy was performed in 47, and an open Ivor-Lewis in 2 and a minimally invasive Ivor-Lewis in 1. Stapled intra-thoracic anastomoses were performed in 47, 3 had a cervical anastomoses. Average age was 61 years and 84% were males. Leak occurred in 6 patients (12.5%). One patient with a late leak was excluded from analysis as they did not have concurrent drain amylase values. This patient had low amylase levels and a normal CTE, though later presented with leak. The overall peri-operative mortality rate was 4.2% (2/48). Mortality in the non-leak and leak cohorts were 0% & 33%. Drain amylase was an accurate marker of anastomotic leak. Of 6 patients with an elevated drain amylase, 5 had an anastomotic leak (sensitivity 83.3%). 40/41 patients with low drain amylase had no leak. Using a cut-off value of 400 IU/L, the negative predictive value of drain amylase in predicting leak after esophagectomy was 97.6% (95%CI; 85.6, 99.9). Conclusions: Drain amylase is a simple and inexpensive test that has excellent sensitivity and negative prediction for the detection of anastomotic leak after esophagectomy. To our knowledge, this is the first study to demonstrate this finding. Routine evaluation of drain amylase may safely replace CTE in the management of patients after esophagectomy, thus reducing radiation exposure and overall cost.
Survival and toxicity with intensity modulated radiation therapy (IMRT) and chemotherapy for esophageal carcinoma, with or without surgery.
Authors: Kowalchik Kristin , Johnson Elizabeth , Kim George P. , Smith C. Daniel , Kim Siyong , Paryani Nitesh N. , Ko Stephen 
Published: February 2017

125 Background: Treatment for locally advanced esophageal carcinoma is radiation and chemotherapy, with or without surgery. Radiation has traditionally been delivered with 3D conformal radiation therapy (3D CRT). This study evaluates late toxicity in patients treated with IMRT as well as early outcomes and acute toxicity. Methods: This is a retrospective review of 32 patients with esophageal carcinoma treated with IMRT at Mayo Clinic Florida from 2008 -2012. Pathology includes squamous cell and adenocarcinomas. Tumor sites include middle and lower thoracic and GE junction. Clinical stages are TX-T3, N0-3, M0-1. All patients received at least one cycle of concurrent chemotherapy. IMRT dose was 50.4 Gy in 28 fractions prescribed to a target volume including the tumor and regional lymphatics. IMRT plans utilized coplaner beams in a 7-9 beam arrangement or volumetric modulated arc therapy. Results: Median follow-up is 8.9 months (range 2.4-23.0) for all patients and 13.1 months (range 2.8-23.0 months) in surviving patients. Median patient age is 69 (range 46-87). Trimodality treatment was completed in 20 patients (62.5%). Surgery was either an open or minimally invasive esophagogastrectomy. The incidence of grade 3 or greater late toxicity at 1 year was 48% in surgery patients and 26% in non-surgery patients. The most common grade 3 or higher toxicity was esophageal strictures in 25%. The incidence of any grade 3 or greater acute toxicity was 65% in the surgery patients and 75% in the non-surgery patients. Overall survival (OS) for all patients at 18 months is 57% (CI 37-86%) and progression-free survival (PFS) is 60% (36-99%). OS and PFS for trimodality therapy at 12 months is 83% (66-100%) and 81% (63-100%) respectively and for bimodality therapy is 34% (12-93%) and 70% (33-100%) respectively. Conclusions: Increased late toxicity occurs in surgery patients, and increased acute toxicity in non-surgery patients. Lower survival in non-surgery patients may be due to early progression, morbidities which preclude surgery or improved survival with surgery. Overall, IMRT is a feasible treatment modality, which may be equally efficacious to 3D CRT for the treatment of esophageal carcinoma.