tbuckley/cabot-search huggingface dataset:
Building a patient-centered model: Palliative medicine and cancer care.
Authors: Kavitha Ramchandran, Derek Galligan, Erika L Tribett, Melissa Valentine, Meryl Selig, Douglas W. Blayney, Steven M Asch
Journal: Journal of Clinical Oncology (2014)

75 Background: Palliative medicine (PM) improves outcomes for cancer patients. Still, there is limited evidence around components of an efficient, patient-centered model for integrating PM into oncologic care. While PM is committed to aligning with a patient's goals of care, very few programs incorporate their input into design or evaluation. The aim of this project is to combine best practice in PM with perspectives of patients, families and providers to develop an empathic PM service. We hypothesize that collaboration with stakeholders and user experience experts will result in a feasible, impactful and translatable model of care that aligns with patient and family goals. Methods: We are conducting semi-structured interviews with 30 patients, family members and 30 oncologists. Patient interviews assess needs and coping mechanisms. Provider interviews assess perceptions and experiences around PM. We will conduct observations to understand how patients and providers interact and how current protocols are operationalized. Data will be coded and analyzed for major themes. An expert panel of patients, family members, health care providers and design experts will assimilate the data and make recommendations for the prototype care model design. The model will be piloted and evaluated in fall 2014. Outcome metrics include patient satisfaction, symptom management, utilization, mortality, and others identified during development. Data from the pilot will inform intervention improvements in preparation for a large-scale, 12- month pilot in an outpatient PM clinic. Results: Preliminary work includes the development of a novel patient and family interview protocol that integrates cutting-edge research on PM with best practices for conducting empathic interviews. We will present initial results from these interviews at the symposium, as well as our iterative design process. Conclusions: This project integrates data on patient and family experience with known best practices to develop a patient-centered model for palliative cancer care. The development process and potential outcomes hold significant promise for the design of patient and provider-centered care models, especially those related to chronic and serious illnesses.
Aggressive surgery for advanced colorectal liver metastases in the era of multidisciplinary approaches.
Authors: Yoshihiro Mise, Yosuke Inoue, Takeaki Ishizawa, Yu Takahashi, Akio Saiura
Journal: Journal of Clinical Oncology (2016)

299 Background: The number of colorectal liver metastases (CLM) is accepted as a strong predictor of survival after surgery. However, recent advances in multidisciplinary approaches have dramatically changed surgical outcomes of CLM. Clinical implications of aggressive surgery for advanced CLM need to be reviewed in relation to the trend in treatment strategies. Methods: We reviewed 581 patients who underwent curative hepatectomy for CLM from 1999 to 2012. One hundred and eighty-nine patients underwent surgery for advanced CLM (n ≥ 4) and were classified according to year of surgery (first: 1999–2003 [n = 30]; second: 2004–2008 [n = 82]; and third: 2009–2012 [n= 77]). The frequency of perioperative chemotherapy for CLM, preoperative gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid-enhanced magnetic resonance imaging (EOB-MRI), and contrast-enhanced intraoperative ultrasonography (CE-IOUS), and long-term outcomes were compared among the three periods. Results: The frequency of perioperative chemotherapy, EOB-MRI, and CE-IOUS increased with time (P &lt;.001). The 3-/5-year overall survival in the third period (58.7/51.8%) was similar to that in the second period (59.8/43.9%, P =.828) and that of 72 patients who had 1–3 CLM in the first period (70.8/51.0%, P =.991). Advanced CLM was an independent factor in the first (P =.001, hazard ratio: 2.91) and second (P=.040, hazard ratio: 1.56) periods. However, multivariate analysis revealed that advanced CLM was not a predictive factor of overall survival in the third period. Conclusions: The prognostic impact of advanced CLM diminished owing to evolution in multidisciplinary treatment. Aggressive surgery for advanced CLM offers favorable prognosis similar to that of patients with few CLM in the early period.
Randomized phase III trial comparing the sequential administration of docetaxel followed by epirubicin plus cyclophosphamide versus FE<sub>75</sub>C as adjuvant chemotherapy in axillary lymph node-positive breast cancer
Authors: D. Mavroudis, N. Malamos, P. Papakotoulas, A. Adamou, C. Christophyllakis, N. Ziras, K. Syrigos, S. Kakolyris, C. Kouroussis, V. Georgoulias
Journal: Journal of Clinical Oncology (2008)

521 Background: The role of adding docetaxel to an anthracycline-based regimen in the adjuvant setting of node-positive early breast cancer was investigated in this multicenter study. Methods: Women with axillary node-positive operable breast cancer who had lumpectomy or mastectomy with axillary lymph node dissection, performance status 0–2 (WHO) and good organ function were randomized to receive either docetaxel 100 mg/m2 every 21 days for 4 cycles followed by epirubicin 75 mg/m2 plus cyclophosphamide 700 mg/m2 on day 1 every 21 days for 4 cycles (T-EC) or FEC (5-fluorouracil 700 mg/m2 plus epirubicin 75 mg/m2 plus cyclophosphamide 700 mg/m2) every 21 days for 6 cycles without primary growth factor support. This was a prospective, randomized, stratified study with 5-year relapse-free survival (RFS) rate as the primary endpoint. Planned sample size was 376 women/arm with power 0.8 and alpha error 0.05. Results: A total of 756 women were randomized to T-EC (n=378) and FEC (n=378). 30% and 27% of women were premenopausal while 37% and 32% had 1–3 positive axillary nodes on T-EC and FEC groups. Treatment was completed as per protocol for 98.1% and 98.4% of patients on the T-EC and FEC arms, respectively. Median follow-up was 62.5 (range 3.4–132.7) months for T-EC and 52.7 (range 2.8–136.2) for FEC patients. The 5-year RFS rate was 74.8% vs 68.9% (log-rank test; p=0.029) for T-EC and FEC patients, respectively. There were 94 (24.9%) vs 115 (30.4%) relapses (p=0.08) and 69 (18%) vs 64 (17%) deaths (p=0.6) in T-EC vs FEC patients, respectively. Severe toxicity included grade 3–4 neutropenia 72% vs 42% (p=0.0001), febrile neutropenia 8% vs 3% (p=0.003), diarrhea 3.7% vs 0% (p=0.0001) for T-EC and FEC patients, respectively. Secondary G-CSF support was used in 342 (90.5%) T-EC and 281 (74.3%) FEC patients (p=0.0001). Conclusions: T-EC is more effective and more toxic than FEC as adjuvant chemotherapy for women with axillary node-positive early breast cancer. No significant financial relationships to disclose.
Disparities in the management of melanoma in elderly patients: An analysis of patients from the National Cancer Database.
Authors: S. Tsai, S. Soong, C. M. Balch, J. R. Lange
Journal: Journal of Clinical Oncology (2011)

8522 Background: Disparities in the surgical management of melanoma in elderly patients has been reported, but the magnitude and distribution of these disparities is ill-defined. Methods: Using the National Cancer Data Base, demographic, socioeconomic, hospital, and surgical data in patients with stage I-III melanoma were analyzed. Proportions were compared using Pearson Chi squared tests and Z tests. Multivariate logistic modeling was used to assess the impact of age on surgical management. Results: From 2003-2007, there were 86,942 cases of Stage I, II, and III melanoma (65.0%, 20.8%, 14.2%, respectively). Thirty one percent of patients were less than 50 years of age, 32% were 50-64 years of age, and 37% were over the age of 65. Patients were categorized by age (group I: 20-49, group 2: 50-64, group 3: 65-74, group 4: 75-84, group 5: 85+). Most patients were male (55.7%) and Caucasian (96.8%). Educational and socioeconomic factors across all age groups were not statistically different. The primary insurer for patients younger than 65 was a managed care plan (62.6%) as compared to Medicare with supplement for patients older than 65 (62.7%). Patients older than 65 were less likely to receive care at an academic research program than younger patients (45.2% vs 52.6%, p <0.005). When compared to group 1, older age groups were less likely to receive a wide local excision (group 3: OR 0.89 [0.85-0.93], group 4: OR 0.79 [0.75-0.82], group 5: OR 0.57 [0.53-0.62], all p <0.005). Among patients with clinically node negative disease and Breslow thickness > 1 mm, older patients were less likely to receive a sentinel lymph node biopsy than group 1 (group 4: OR 0.75 [0.71-0.79], group 5: OR 0.39 [0.35-0.43], p <0.005). Similarly among stage III patients, regional lymphadenectomy was less likely to be performed in older patients than patients in group 1 (group 3: OR 0.75 [0.67-0.83], group 4: OR 0.53 [0.48-0.60], group 5: 0.33 [0.27-0.41], all p <0.005). Conclusions: Elderly melanoma patients are less likely to receive care at academic research program and are less likely to receive adequate surgical management of their disease. Further research should examine the role of health systems factors on variations of care.
Percutaous trans-eshophageal gastrotubing (PTEG) improves QOL in patients involved with advanced gastro-intestinal carcinoma
Authors: M. Nakamura, M. Katano, T. Ueki, M. Sada, H. Oda, T. Morisaki
Journal: Journal of Clinical Oncology (2005)

8273 Background: A number of patients involved with gastro-intestinal carcinoma are suffered by ileus symptom such as nausea and vomiting in the terminal stage. QOL of these patients must be improved if ileus symptom has gone away. Methods: We underwent PTEG to seven patients involved with gastro-intestinal carcinoma (four of gastric carcinomas, one of jejunal carcinoma, two of colon carcinomas). We used PTEG Set (Sumitomo Bakelite CO., LTD., Tokyo) and the procedures were performed according to the company’s protocol. We analyzed period of PTEG, total discharge from PTEG, daily discharge of PTEG, total amount of drinking, daily amount of drinking, and grade of ileus symptom (grade 0; no complaint, grade 1; nausea only, grade 2;mild vomiting, grade 3;moderate vomiting, grade 4;severe vomiting) Results: Shown as table, PTEG discharged 1225ml gastro-intestinal juice and allowed patients to drink 637ml of water. Besides it reduced grade of ileus symptom 2.4 to 0 in average and kept lower grade for 89.9% of period wearing PTEG. Conclusions: PTEG is a very useful device to improve QOL of patients in terminal stage of gastro-intestinal carcinomas by reducing ileus symptom. No significant financial relationships to disclose.
Comparative effectiveness of antiangiogenesis inhibitors for second-line therapy of metastatic colorectal cancer.
Authors: Christina Xiaoyue Chen, Sarmad Sadeghi, Heinz-Josef Lenz, Afsaneh Barzi
Journal: Journal of Clinical Oncology (2014)

9 Background: Treatment guidelines for second-line therapy of metastatic colorectal cancer (mCRC) suggest that addition of an anti-angiogenesis inhibitor to standard chemotherapy will prolong survival. Bevacizumab and aflibercept are two inhibitors that have increased survival in randomized clinical trials, but their cost-effectiveness is unclear. This study uses clinical trial data to compare the addition of aflibercept versus bevacizumab to a chemotherapy regimen in terms of incremental cost-effectiveness ratios (ICERs) in cost per month gained and treatment-related toxicities. Methods: A Markov model was used to simulate survival, toxicities, and costs for each treatment arm. Survival and adverse event probabilities were derived from published clinical trial data, and costs were estimated from the literature and the 2013 Veterans Affairs Federal Supply Schedule. Results: Aflibercept dominates bevacizumab by increasing survival by 1.06 months, while saving $3,526 in total treatment and adverse event costs combined (Table). When evaluating only adverse event-associated costs, the ICER between aflibercept and bevacizumab is $3,675 per month gained. One-way sensitivity analysis of the total cost ICER shows that aflibercept cost-savings are robust to almost all parameters varied, while similar analysis of the adverse event ICER suggests that aflibercept-associated toxicities would cost less than bevacizumab-associated toxicities in the case of a 20% decrease or increase in aflibercept or bevacizumab toxicity costs, respectively. Conclusions: Aflibercept plus chemotherapy is cost saving overall and improves survival compared with bevacizumab plus chemotherapy but results in more adverse events and associated costs. Practitioners treating mCRC patients should weigh survival outcomes against potential increased toxicity between different treatments, especially when evaluating limited survival gains. Incremental survival and costs of aflibercept versus bevacizumab. Months difference Cost difference ICER (cost/month gained) All costs combined 1.06 (-$3,526) (-$3,325) Adverse event costs only 1.06 $3,897 $3,675
Qualitative analysis of practicing oncologists’ attitudes and experiences regarding HIT-facilitated collection of patient-reported outcomes.
Authors: Reshma Jagsi, Anne C. Chiang, Bruno C. Medeiros, Blase N. Polite, Kristen McNiff, Robin Zon, Patrick J. Loehrer
Journal: Journal of Clinical Oncology (2012)

56 Background: Growing interest in incorporating widespread and routine collection of patient-reported outcomes (PROs) into a rapid-learning system for cancer care motivates consideration of stakeholder attitudes and experiences with PRO collection. Practicing oncologists are stakeholders whose views are not well characterized to date. Methods: We developed an interview guide after literature review and 6 in-depth interviews with leaders in the field. With IRB approval, we conducted 45-minute semi-structured interviews with medical oncologists identified through affiliation with QOPI or a minority-based CCOP. Purposive sampling ensured a diverse range of viewpoints. Interviews were conducted until thematic saturation. Multiple analysts independently reviewed and thematically coded verbatim transcripts. Results: 17 interviews were conducted with oncologists from diverse practice settings and types. Emergent themes included variability in understanding and experience with PRO collection; general enthusiasm for the potential value of PROs (with subthemes focused on impact on thoroughness and efficiency, and potential for coordination with quality measurement processes); and fundamental concerns (including information overload, the possibility of identifying problems for which no good interventions exist, depersonalization of the physician-patient encounter, cost, and inefficiency). Several potential barriers to the widespread implementation of PROs were identified, including need for buy-in from other stakeholders in the practice, lack of appropriate referral resources, staffing needs, and technology concerns. Respondents generally favored simple tools, format allowing for time-trending and visualization of the impact of interventions, and tailoring to the individual patient’s disease site, stage, and point in treatment trajectory. Very few identified patient compliance, data sharing/privacy, or medical liability as major barriers to implementation. Conclusions: Widespread inclusion of PROs in a rapid-learning system of oncology care will require careful consideration of the insights provided by practicing oncologists.
The influence of employer-based health insurance and job support on receipt of adjuvant chemotherapy in stage III colorectal cancer.
Authors: Christine Marie Veenstra, Scott E. Regenbogen, Sarah T. Hawley, Mousumi Banerjee, Ikuko Kato, Kevin C. Ward, Arden M. Morris
Journal: Journal of Clinical Oncology (2013)

278 Background: Approximately 15% of the U.S. population lacks health insurance. Adjuvant chemotherapy confers significant survival benefit in stage III colorectal cancer (CRC), yet many patients fail to receive recommended care. We hypothesized that access to employer-based health insurance (EBHI) and other job-related support programs influences receipt of chemotherapy. Methods: We performed a population-based survey of patients diagnosed with stage III CRC in the state of Georgia and Metropolitan Detroit SEER catchment areas. The primary outcome was receipt of adjuvant chemotherapy. Patients were queried regarding clinical, sociodemographic, and employment characteristics (EBHI and job support - e.g., sick leave, disability, flexible schedule, unpaid time off). We used χ 2 analyses to examine associations between health insurance coverage, job support availability and receipt of chemotherapy, adjusting for other characteristics. Results: To date, 630 patients have responded (preliminary response rate=56%). 257 (41%) were working for pay at diagnosis, of whom 46% had EBHI and 9% had no insurance at all. Rates of chemotherapy receipt were higher among those with EBHI than those without (97% vs. 90%, P=0.001). 26% with EBHI reported that they kept their job mainly to keep insurance. 79% of those working for pay reported some form of available job support. Rates of chemotherapy receipt were higher among employed respondents with job support compared to those without (97% vs. 85%, P&lt;0.001). Availability of job support was significantly associated with ability to retain employment; 48% of those without support stopped working altogether because of CRC vs. only 11% of those with support (P&lt;0.001). Conclusions: Patients with EBHI and job support were significantly more likely to receive recommended adjuvant chemotherapy after surgery for stage III CRC. Further, lack of job-related support for medical illness was significantly associated with loss of employment for patients undergoing treatment for CRC. These findings suggest that employer-based health insurance and job support are important contributors to receipt of recommended cancer care.
Survival after brain metastases in Asian patients with HER2+ breast cancer.
Authors: Y. S. Yap, B. C. Devi, C. Khorprasert, G. H. Cornelio, N. Sutandyo, E. Yeoh, S. Landis, M. Kobayashi, H. Moon, J. Ro
Journal: Journal of Clinical Oncology (2011)

543 Background: HER2+ breast cancer is associated with an increased risk of brain metastases (BM). In Asia there is variable utilization of anti-HER2 therapy including trastuzumab (T) and lapatinib (L). This study described anti-HER2 treatment patterns in Asia and evaluated survival after BM in relation to anti-HER2 therapy use. Methods: A retrospective cohort study of 311 Asian patients with HER2+ breast cancer diagnosed with BM between Jan 2006 and Dec 2008 across 14 medical centers in six countries was conducted. Demographics, tumor characteristics, treatment, and dates of all metastases were collected from medical records. Results: Median age was 50 years (range: 23-80). 43% were premenopausal and 43% hormone receptor positive. 76% had multiple brain lesions; 11% had both parenchymal and leptomeningeal involvement. Brain was the first site of metastases in 21%. Prior to BM, 60% (n=186) received anti-HER2 therapy, primarily T in the metastatic setting. These patients had a longer interval between breast cancer diagnosis and BM compared to non-users (median 33 vs. 22 months; p < 0.05). After BM diagnosis, 38% received therapy (N=83 that continued therapy, N=36 new initiators) including 60 T only, 30 L only and 29 that used both T and L administered as sequential (T->L) or add-on (dual blockade) therapy (T->T+L). 93% of anti-HER2 therapy after BM was given along with whole brain radiotherapy (WBRT). Use of anti-HER2 therapy after BM conferred a statistically significantly survival benefit after BM compared to no therapy (median 19 vs. 6 months; HR=0.63, 95%CI: 0.44-0.88 after adjusting for age at BM, other systemic treatment for BM, multiple BM lesions, and BM as first metastatic site). In crude analysis, use of both T and L significantly improved survival compared to T only (median 26 vs. 11 months; crude HR=0.39, 95%CI: 0.20-0.76). Use of both T and L provided a smaller, non-significant survival advantage over L only (median 26 vs. 21 months; crude HR=0.63, 95%CI: 0.29-1.37). Adjusted analyses will be presented. Conclusions: Although only 38% of these Asian patients received anti-HER2 therapy after BM, those receiving therapy had improved survival. Beyond WBRT, the use of both T and L after BM diagnosis may confer a survival benefit over T only or L only regimens.
Model-based optimization of G-CSF treatment during chemotherapy.
Authors: M. Loeffler, S. Schirm, M. Wetzler, S. Zeynalova, M. Ziepert, C. Engel, M. Scholz, M. Pfreundschuh
Journal: Journal of Clinical Oncology (2011)

e19658 Background: Optimization of G-CSF therapy during myelotoxic chemotherapy is a non-trivial task. The number of clinical trials to clarify the best G-CSF timing and dosing for each chemotherapy regimen would be too large. We designed a predictive biomathematical modelling of granulopoiesis, illustrate our predictions for the CHOP regimen and compare the results to trial data of the German DLBCL study group. Methods: We constructed a biomathematical model of human granulopoiesis under chemotherapy including a pharmacokinetic and –dynamic model of filgrastim (Fil) and pegfilgrastim (Peg). The model was established using time courses of leukocytes, granulocytes and G-CSF serum concentrations retrieved from various clinical trials. Systematic model simulations resulted in predictions regarding leucopoenia under alternative G-CSF schedules. To validate the model, we performed a prospective randomized clinical trial (PEG-Study) comparing early (d2) and late (d4) application of Peg during CHOP-14 chemotherapy (103pts) and performed a retrospective analysis of Fil (d4-d13) versus Fil (d6-d12) by matching patients of the RICOVER trial of the DSHNHL (217pts). Results: The model fits the time courses of granulocytes or leukocytes for about 50 different clinical scenarios with G-CSF and multi-cycle chemotherapy regimens. For the CHOP-14 therapy of elderly lymphoma patients, we predicted that Peg at d4 is superior to Peg at d2. This was confirmed in the PEG-Study regarding length and depth of leucopoenia, number of infections and antibiotic treatment. The model further predicts that a dose sparing application at d5 with about 30-50% lower Peg-dose would yield similar outcomes, a trial yet to be undertaken. First data regarding Fil (d4-d13) versus Fil (d6-d12) were collected in a retrospective analysis of the RICOVER trial. As predicted, there were no significant differences between Peg d4 and the Fil schedules. Conclusions: We conclude that our model is a valuable tool for the planning of G-CSF schedules in a clinical chemotherapy study resulting in verifiable predictions. Although our application was CHOP-14 therapy, the model was applied in a more general framework in order to optimize G-CSF treatments of other chemotherapies of other diseases.