bluuebunny/crossref_metadata_2025 huggingface dataset:
Using a statewide collaborative approach to improve tobacco cessation referral rates for cancer patients.
Authors: Severson Jane Alcyne , Baca Hilary , Blayney Douglas W. , Brown Karen , Galiyas Grayce , Minasian Mara , Notier Anna , Schmidt Joan , Warren Graham Walter
Published: February 2017

74

Background: Tobacco use by cancer patients decreases the effectiveness of cancer treatment, increases treatment toxicity, increases the risk of developing a second primary cancer, and increases mortality. Stopping tobacco use may reduce many of these adverse effects in cancer patients. Methods: The Michigan Oncology Quality Consortium (MOQC) collaborated with the Michigan Cancer Consortium (MCC) to implement the Tobacco Cessation Demonstration Project. This entailed designing a standard workflow and other lean tools to assist oncology practices in referring all cancer patients who use tobacco to the free Michigan Tobacco QuitLine or other cessation services. 19 practices participated in three learning sessions during which the following were provided: education by subject matter experts, use of data management and lean tools, and the sharing of barriers and successes. Results: Examination of baseline MOQC Quality Oncology Practice Initiative (QOPI) data demonstrated that < 47% of patients who use tobacco were advised to quit or referred for tobacco cessation (n = 574 charts/44 sites), which was equivalent to the national QOPI mean in Fall 2012. Root cause analysis of this lack of action in tobacco cessation identified limited knowledge to the risks of continued smoking and the lack of available resources as barriers to adopting necessary change. Implementation of the MOQC/MCC Tobacco Cessation Demonstration Project increased total statewide referrals to the QuitLine by 30.9% over the first 2 months with an increasing proportion of patients (41%) being cancer patients referred by MOQC participating sites. Conclusions: Supplying scientific evidence, collaboration, and the use of lean tools improved the referral rate to a tobacco cessation program for oncology patients. [Table: see text]
Determinants of survivorship care plan implementation in U.S. cancer programs.
Authors: Birken Sarah , Mayer Deborah , Weiner Bryan , Deal Allison Mary
Published: February 2017

78

Background: The Institute of Medicine recommended and many professional societies require survivorship care plan (SCP) use to facilitate cancer survivors’ transition from treatment to follow-up care. Rates of SCP adoption (plans to use SCPs) and implementation (current use) in US cancer programs remain unclear. Our objectives were to (1) assess rates of SCP adoption and implementation and (2) determine what distinguishes cancer programs that have implemented SCPs from those that have not moved beyond adoption. Methods: We surveyed employees knowledgeable about SCP adoption and implementation in a nationally representative sample of 100 US cancer programs. Data were analyzed using descriptive and bivariate statistics. Results: The response rate was 80%. Ninety-six percent of programs adopted SCPs, but only 45% implemented SCPs. Among programs that implemented, SCP use remains inconsistent: Use is restricted primarily to breast (81.58%) and colorectal (55.26%) cancer survivors; in 58.33% of these programs, less than a quarter of providers has ever used SCPs; and SCPs are seldom delivered to survivors or their primary care providers. Employees in many programs indicated that SCPs were adopted because of the belief that SCPs would improve care quality and the release of professional society guidelines; however, neither of these factors influenced SCP implementation. Few quality markers (e.g., NCI-designated program type; Commission on Cancer membership) influenced SCP implementation. Determinants of SCP implementation included teaching hospital program type (p = .04) and NCCCP membership (p = .009). Freestanding facility type had a negative relationship with SCP implementation (p = .02). Conclusions: Given inconclusive evidence of SCPs’ effectiveness in improving care coordination and patient outcomes, many scholars have recently advocated for research to promote SCPs’ effectiveness. These efforts may be in vain if SCPs are not more routinely implemented. Efforts should be targeted at enabling programs to implement quality improvement tools. Future research should determine what promotes SCP implementation among teaching hospitals and NCCCP members, and what inhibits freestanding facilities from implementing SCPs.
Bidirectional consultative process as a novel methodology to develop a pan-Canadian cancer quality initiative.
Authors: Mitera Gunita , Agent-Katwala Mary , Porter Geoffrey A. , Bryant Heather E. , Sullivan Terrence
Published: February 2017

80

Background: To foster pan-Canadian quality improvement strategies in cancer diagnosis and treatment, a new publically funded opportunity was launched though a Request for Proposals (RFP). Methods to develop RFPs in the public health care sector are variable. To generate enthusiasm and ensure appropriateness and relevance of the RFP, a novel methodology was developed to refine and validate the focus of the RFP. Methods: An extensive multi-pronged bi-directional consultative process helped identify and engage with clinical experts, senior administrators, and other relevant stakeholders. In-person discussions with relevant stakeholders, an electronic stakeholder engagement survey, and two interactive electronic information sessions (Webinars) were included. The intent of the eBlast was to seek survey responses and also to build awareness of the upcoming opportunity. An eBlast engaged stakeholders and stakeholder networks for the electronic component of the bi-directional process. Secondary distribution encouraged wide-spread dissemination. The survey and recorded Webinar were publically posted online. Results: Approximately 30 in-person consultations occurred and the electronic survey and Webinar details were sent to approximate 1,000 individuals and external networks. 80 responses were received along with 76 Webinar attendees. Feedback was received from a representative cross-section of the Canadian quality community as measured by geographical distribution and discipline. There was general pan-Canadian agreement that the quality topic chosen was relevant and appropriate. Through this methodology refinements were made to finalize the organization and content of the RFP. Conclusions: When developing a national call for a publicly-funded quality improvement opportunity, it is imperative to ensure the topic considered is relevant, appropriate, and there is interest from stakeholders to apply. A bi-directional consultative process is a novel and economical method to ensure wide reaching engagement from relevant pan-Canadian stakeholders. This methodology can also be leveraged to refine and validate the final quality topic considered.
Breast cancer treatment delays in a majority minority community: Is there a difference?
Authors: Lathrop Kate Ida , Parsons Helen M. , Karnad Anand B.
Published: February 2017

83

Background: Recent studies based from large nationwide cancer databases have consistently shown that Hispanic women with breast cancer have delays in treatment compared to non-Hispanic whites. However, time to treatment has not been studied in a community where Hispanics are the majority population. We hypothesized that Hispanic women in greater San Antonio will have no significant treatment delays compared to Non-Hispanic whites in the same community. Methods: We conducted a retrospective, observational study in 362 female breast cancer patients treated at a NCI designated cancer center with a largely Hispanic population. Using Kaplan-Meier analyses and multivariate Cox proportional hazards models, we examined the relationship between race/ethnicity and treatment delays including: 1) time from mammogram to biopsy and 2) time from biopsy to treatment, adjusting for patient demographics and cancer characteristics. Results: In our study, the majority of patients were Hispanic (50.0%, n=181). Hispanic patients were more likely to be obese, have estrogen receptor positive and higher grade tumors than non-Hispanic Whites (p ≤ 0.05 for all). After adjusting for a comprehensive set of socio-demographic and cancer characteristics, we continued to find no significant differences between race/ethnicity and time from mammogram to biopsy or time from biopsy to treatment (Table). Conclusions: Hispanic and non-Hispanic White women with breast cancer treated at our NCI designated cancer center have similar times to treatment. These findings suggest that minority status, as opposed to racial status, is an important risk factor for delays in breast cancer care. Future research should be focused on barriers imposed on minority groups within their community regardless of race. [Table: see text]
Development of a new oncology quality metric: The rate of evidence-based adherence.
Authors: Adelson Kerin , Holcombe Randall F.
Published: February 2017

84

Background: The degree to which electronic health records enhance the quality of patient care depends on how the system is used to monitor and improve practice. In planning the transition to Epic’s electronic chemotherapy ordering platform, we saw an opportunity to increase evidence-based practice. Methods: Our Chemotherapy Council vetted more than 600 electronic protocols based entirely on published clinical trials and NCCN guidelines; modifications made to these protocols represent a divergence from clinical evidence. We examined the number of times the chemotherapy section of a protocol was modified before the first cycle to avoid counting dose modifications made for toxicities. To get the rate for the cancer center we calculated the # of discrete times all protocols were used (denominator) and the number of times all protocols were modified (numerator). We subtracted the ratio from 1 to reflect the proportion of protocols that were not modified. This ratio serves as a new quality metric – the Rate of Evidence-Based Adherence (REBA). REBA institution= 1 - Total # of modifications prior to first cycle for each protocol. The total # of uses of all protocols. Additionally, REBA can be used to examine disease group rates (REBA group), individual provider rates (REBA provider) and rates for individual protocols (REBA protocol). Institutions that have implemented evidence-based clinical pathways have strived for 80% (.80) adherence. We set this as our REBA benchmark. Results: The REBA institution was .86, higher than our pre-defined goal (p<0.001). There was wide variation in the REBA group (range 0.50-0.95). The REBA protocol identified two protocols (rates of .33 and .42 respectively) that were dose reduced the majority of the time. In the example of our Breast Group, the REBA provider, ranged from (.78 to .97) reflecting differing practice among 4 physicians. Conclusions: The REBA can identify faculty and disease groups who underutilize clinical evidence, facilitating feedback for quality improvement. The REBA protocol is a useful tool to identify specific chemotherapy templates that may need modification. The REBA is a powerful electronic tool, which can be utilized to monitor and enhance the rate of evidence-based practice in oncology.
Cancer care transparency: Trying to move the dial in California.
Authors: Teleki Stephanie
Published: February 2017

85

Background: In 2012, approximately 140,000 patients (more than 16 new cases each hour) were diagnosed with cancer in California. Yet there is little useful information about the quality of cancer care to help patients, providers and payers make decisions about care. Methods: In 2012, the California HealthCare Foundation, an Oakland-based independent nonprofit philanthropy, launched an initiative focused on improving cancer care quality measurement and public reporting in the State. Since then, the Foundation has funded a number of projects aimed at filling information gaps: development of an interactive map and reports with data about the variation of care for breast and prostate cancer in California using State discharge and registry data (May 2013); development of a Consumer Assessment of Healthcare Providers and Systems (CAHPS) patient experience of cancer care survey instrument (with NCI and AHRQ, in progress); exploratory analytic work to determine the feasibility of measuring and reporting the number of cancer procedures performed by hospitals using State discharge data, for procedures where there is an established volume-outcome link (with Stanford University, in progress); exploratory analytic work to determine the feasibility of measuring cancer care quality at the medical group level in California (with Integrated Healthcare Association; in progress); a report on cancer care spending in California (with Dana Farber, in progress). Results: Significant challenges exist at the state level to provide information for improved decision-making about cancer care. Among them: access to data, especially cancer registry data that importantly includes detailed diagnostic information; lack of clinical outcome and patient experience measures; time needed to engage partners; and costs of carrying out quality measurement projects. Conclusions: This presentation would review efforts underway in California, providing a view of the challenges and opportunities at the state level for cancer quality measurement and public reporting. This presentation could be conceived as part of an interactive break-out session with 1-2 other panelists with real-world experience.
Limitations of QOPI end-of-life (EOL) data use for purposes of accountability: Comparison of sample versus full cohort analysis.
Authors: Dalby Carole Kathleen , Catalano Paul J. , Donohue Caitlin C. , Bryar Julie M. , Norden Andrew David , Kostka Judith , Jacobson Joseph O.
Published: February 2017

87

Background: Quality Oncology Practice Initiative (QOPI) retrospectively collects process measures at the practice level. Sample size is determined by number of full-time equivalent physicians. Although intended as an improvement program, there is growing pressure to use QOPI for accountability. Methods: We investigated QOPI sampling strategy for EOL measures in a large three-site community oncology practice for all patients meeting QOPI sampling criteria. Analysis period was July 1 to December 31, 2012. We included all patients submitted for the QOPI EOL module and compared the QOPI sample to the full but non-QOPI cohort using Fisher’s exact test. To assess relative precision, we calculated rates and 95% confidence intervals (CI) for the sampled vs. full cohorts (inclusive of QOPI cohort). Results: 246 deaths were analyzed, with 34 (13.8%) from the QOPI sample. No statistically significant differences were found between sampled and full non-QOPI cohorts. However, sampling was associated with wide CIs compared to precision using the full cohort (Table); e.g. #38 yields a CI width of 24.2% QOPI vs. 4.9% full. Similarly, #47 shows CI width of 27.7% vs. 9.0%. Low statistical significance yet wide CIs indicate comparison data are representative but with variability in precision. Conclusions: Although no statistically significant differences were identified, comparing QOPI sampling strategy to full cohort yielded presence of marked differences in precision. We suggest caution in use of current QOPI EOL sampling strategy if used for purposes other than improvement. [Table: see text]
A national survey: The patient’s perspective of gaps in the cancer treatment experience.
Authors: Lis Christopher G. , Patel Kamal , Rodeghier Mark , Rogers Mark , Gupta Digant
Published: February 2017

90

Background: There are expected to be an excess of 1.6 million new cancer cases in the US in 2013. Recent emphasis has shifted to patient-centered care. However, data is lacking on what oncology patients value in their care. We therefore conducted a national survey to evaluate patient experience with service quality. Methods: An online survey was conducted in a national random sample of 1000 cancer patients in Aug-Sept 2012. Importance of 15 service quality items was measured on a 5-point Likert scale ranging from “not at all important” to “extremely important”. Patient experience with those 15 service quality items was captured as a yes/no response. Patient satisfaction was measured on a 5-point Likert scale ranging from “completely dissatisfied” to “completely satisfied”. Results: The top 3 areas of gaps between importance and experience were ‘having a specific individual to coordinate care’ (32%, p < 0.01), ‘after-treatment care and support’ (15%, p<.01) and ‘the presence of an integrated care team’ (15%, p<0.01). Among respondents who rated these areas as very/extremely important, only 43%, 65% and 75% experienced it, respectively. Conclusions: These national findings illustrate a significant void between patients’ desires and care delivered. This survey demonstrates the emphasis patients put on the need for more coordinated cancer care, after-treatment care and an integrated approach. [Table: see text]
Factors related to end-of-life (EOL) chemotherapy in solid tumor (ST) patients.
Authors: Rodriguez Maria Alma , DeJesus Yvette A , Cheng Lee , Buzdar Aman , Burke Thomas W.
Published: February 2017

92

Background: Quality performance measures for cancer care, including use of chemotherapy in the last two-weeks of life, will be required for reporting. In this study, we evaluated the use of chemotherapy in ST patients (pts) within 14 days of EOL relative to several factors that may influence this practice. Methods: Adult pts (≥18 years) treated for ST at our institution, deceased December 01, 2010 through May 31, 2012, were retrospectively studied. Data on demographics, chemotherapy (excluded: hormones) within 14 days EOL, comorbidities, and cancer diagnoses were from administrative databases. Logistic regression analysis was performed for association of EOL chemotherapy with age, gender, ethnicity, comorbidities, cancer types, and metastatic status. Results: 5,607 pts met study criteria: median age 64 years; 48% female; 76% metastatic disease. EOL chemotherapy frequency was 3.9% overall, 4.6% in metastatic disease versus 1.7% in non-metastatic disease (p<0.01). Of 23 patients who received chemotherapy and had non-metastatic disease, the major tumor sites were: brain/other nerve system (34.8%) and lung/bronchus (21.7%).The top 10 frequencies in chemotherapy use by tumour sites were: melanoma (6.7%), female breast (5.5%), lung and bronchus (4.9%), pancreas (4.2%), brain/other never system (3.9%), head and neck (3.8%), female genital system, excluding ovary (3.4%), ovary (3.2%), liver/intrahepatic bile duct (3.0%), colon and rectum (2.6%). By regression analysis, the factor statistically significantly associated with receiving chemotherapy was metastatic disease (odds ratio [OR], 3.29; 95% CI,1.96-5.54), while factors associated with significantly less treatment were age ≥ 65 (OR, 0.66; 95% CI, 0.49-0.90); and any comorbid conditions (≥1 versus 0) (OR, 0.58; 95% CI, 0.38-0.89). Conclusions: A small portion of ST patients who died received EOL chemotherapy (3.9%). However, metastatic disease and diagnosis category influenced treatment. Melanoma and breast cancer patients had higher frequency of EOL treatment. Older age and comorbidities were associated with less treatment. Variation in EOL treatment of ST patients is thus influenced by several clinical factors, but did not seem influenced by gender or ethnicity factors.
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

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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

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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.
Incidence of brain metastases in HER2+ gastric or esogastric junction adenocarcinoma.
Authors: Blay Christophe , Chiforeanu Danchristian , Boucher Eveline , Cabillic Florian , Desgrippes Romain , Leconte Bérengère , Manfredi Sylvain , Meunier Bernard , Edeline Julien
Published: February 2017

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Background: HER2 overexpression is associated with a high risk for brain metastases in breast cancer. We aimed to study if the same correlation exists in gastric or oesogastric junction (OGJ) adenocarcinoma, where brain metastases are uncommon. Methods: We retrospectively reviewed data of patients treated at our institution for metastatic gastric or OGJ adenocarcinoma. We compared incidences with a Fisher’s exact test. Survival was analyzed by the Kaplan-Meier method. Results: Between 2007 and 2011, 74 patients were treated at our institution, 63 patients were analyzed for HER2 status. Median age was 62 (range: 22-81). There were 52 men (82.5%) and 11 women (17.5%). 36 patients (57.1%) had gastric cancer, 27 (42.9%) OGJ adenocarcinoma. After a median follow-up of 9.4 months, 52 patients progressed and 38 patients died. Median progression-free survival was 5.3 months and median overall survival was 15.9 months. 38 patients (60.3%) had hepatic metastases, 32 (50.8%) lymph node metastases, 20 (31.7%) peritoneal carcinomatosis, 12 (19.0%) lung metastases and 3 (4.8%) brain metastases. HER2 was overexpressed in 11 (17.5%) patients (confirmed by IHC in 58 patients, by FISH in 5 patients). Two HER2+ patients did not received trastuzumab. Three HER2+ patients (27.3%) had brain metastases, as compared with 0 (0%) HER2- patients (p=0.004). Control of brain metastases was obtained in all 3 patients with multimodal treatment (surgery for 1 patient, radiotherapy for 3 patients and trastuzumab-containing chemotherapy in 3 patients). Progression-Free Survival (PFS) was significantly higher in HER2+ patients treated with trastuzumab than in HER2- patients: median 9.4 months vs 5.0 months (p=0.049). There was no apparent difference in PFS or overall survival between patients with or without brain metastases, but the numbers are too small to conclude. Conclusions: In this retrospective single-center series, we showed an increased incidence of brain metastases in patients with HER2+ gastric or OGJ adenocarcinoma. Patients with brain metastases benefited from multimodal treatment. Prognosis of HER2+ patients treated with trastuzumab seems better than HER2- patients. These results need confirmation in a multicenter study.
Chemotherapy (CT) treatment patterns and neutropenia management in gastric cancer patients (pts) receiving myelosuppressive chemotherapy in Europe.
Authors: Kalinka-Warzocha Ewa , Gallego Plazas Javier , Mineur Laurent , Salek Tomas , Hendlisz Alain , Bendall Kate , Vogl Florian D. , Passalacqua Rodolfo
Published: February 2017

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Background: Granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP) is recommended for pts undergoing CT who are at overall high risk for febrile neutropenia (FN). No single CT regimen is recognized as standard in gastric cancer and few regimens are represented in G-CSF guidelines. We therefore evaluated neutropenia management in pts receiving CT for gastric cancer. Methods: This was a multicentre prospective observational study that enrolled pts sequentially from 11/2009 to 06/2011. Adult gastric cancer pts (any stage) with ≥3 cycles of myelosuppressive CT scheduled and an investigator-assessed overall FN risk ≥20% were eligible. The primary outcome was the proportion of pts who received PP G-CSF (G-CSF in days 1-7 of cycle 1). Secondary outcomes included FN incidence, chemotherapy administration, and G-CSF use. Posthoc analyses investigated the subgroup who received DCF, including modifications from standard DCF (Van Cutsem. JCO. 2006), and the G-CSF support given up to the first FN (G-CSF prophylaxis given per label in each cycle up to that in which FN occurred). Results: Of 209 pts enrolled, 199 were eligible and their data analyzed. The mean (±SD) age was 62 (±12) years, 76% were male, 17% were ECOG 2 and none ECOG 3-4; 47% were treatment naïve. Planned CT was palliative in 74% of pts; overall, 27 different backbone regimens were planned (10 triplet, 12 doublet, 5 single drug regimens). The most common regimen used was DCF (54 pts, 27%), predominantly given as modified DCF (41 pts). Despite being assessed as high risk for FN, G-CSF PP was administered to only 35% of pts overall (n=70; 54 pegfilgrastim, 16 daily G-CSF) and to 69% of pts who received DCF. FN occurred in 14 pts (10%), 9 of whom received DCF. A large majority of FN pts (12/14, 86%) had not received prophylactic G-CSF per label up to the first FN occurrence; furthermore, 86% of FN pts did not receive G-CSF prophylaxis in the cycle following the FN event. Conclusions: The variety of CT used, frequent modifications to standard CT, and presence of pt risk factors makes FN risk estimation difficult in gastric cancer. Improved risk assessment and appropriate targeting of G-CSF PP to high risk pts is needed.