tbuckley/cabot-search huggingface dataset:
Long-term outcomes of the patients with hepatocellular carcinoma after living donor liver transplantation using left lobe graft.
Authors: A. Taketomi, J. Muto, T. Motomura, Y. Mano, K. Takeishi, T. Toshima, H. Ijichi, N. Harada, H. Uchiyama, T. Yoshizumi, K. Shirabe, Y. Maehara
Journal: Journal of Clinical Oncology (2011)

e14649 Background: Adult living donor liver transplantation (LDLT) for hepatocellular carcinoma (HCC) has become a routine treatment option for patients waiting for liver transplantation. LDLT using right lobe (RL) grafts has gained widespread acceptance, whereas the use of let lobe (LL) grafts for adults has been severely limited because of their size limitation. The aim of this study was to analyze the long-term outcomes of LDLT for HCC according to the graft type. Methods: A retrospective analysis was performed of the recipients’ outcomes of LL graft (n=82) versus recipients of RL graft (n=46) between July 1995 and November 2009. The analysis endpoints were overall and recurrence-free survival after LDLT. Recipient demographics and tumor characteristics by the graft type were also analyzed. Results: No difference was found in the gender, hepatitis virus type, alpha-fetoprotein level, number of tumors, maximum tumor size, Milan classification, microscopic tumor differentiation and the presence of microvascular invasion between the two groups. The graft volume (436 ± 74 g) as well as the graft volume-standard liver volume rate (38.3 ± 6.2%) of the LL graft group was significantly less than those of RL graft group (569 ± 82 g, 46.3 ± 6.7%) (p<0.01). The 1-, 3-, 5- and 7-year overall survival rates of LL graft group were 88.2%, 80.2%, 75.7% and 72.4%, respectively, which were not significantly different compared to those of RL graft group (95.4%, 87.3%, 87.3% and 87.3%). The recurrence-free survival rates of the LL graft group (89.1% at 1-year, 78.8% at 3-year, 75.8% at 5-year and 70.3% at 7-year) were similar to that of the RL graft group (88.6%, 88.6%, 88.6% and 88.6%). As for the donors, the rate of complications over Clavien’s IIIa in LL graft procurement was 6.2%, which was significantly lower than that in RL graft group (15.6%, P<0.05).The mean peak postoperative total bilirubin levels and duration of hospital stay after surgery of LL grafting donor were significantly less than those of RL grafting donor (P<0.01). Conclusions: Since the long-term outcomes in the HCC patients with LL graft were similar to that with RL graft, LL graft should be considered more favorably when selecting donors in LDLT for HCC.
Meta-analysis examining the efficacy of serotonin and/or norepinephrine reuptake inhibitors in the treatment of women with hot flashes
Authors: S. D. Mukherjee, S. Strohm
Journal: Journal of Clinical Oncology (2008)

20606 Background: Hot flashes can be particularly troublesome in post-menopausal women, as well as those who are on medications such as tamoxifen or aromatase inhibitors for breast cancer treatment. Patients with chemotherapy-induced amenorrhea may also develop hot flashes that can impact on their quality of life. Serotonin and/or norepinephrine reuptake inhibitors have been studied to determine if they reduce the frequency or severity of hot flashes. The objective of this study is to provide a systematic review and meta-analysis of the randomised controlled trials evaluating SSRI and SNRI use in women experiencing hot flashes. Methods: Five medical literature databases were searched to identify all potential randomised placebo-controlled trials evaluating SSRI/SNRI’s in women with hot flashes. The methodological quality of the trials were also assessed. The results of all studies that met the inclusion criteria were compiled and systematically reviewed. The primary outcome for the pooled analysis was the number of patients with a 50% decrease in the hot flash frequency or hot flash score. We also evaluated the absolute reductions in hot flash frequency and hot flash score, as well as the number of withdrawals in the treatment and placebo arms. Results: A total of 11 randomised trials met the study inclusion criteria. For the primary outcome of a 50% decrease in hot flash frequency or score, an odds ratio of 0.53 (0.35, 0.90) was calculated showing a benefit of SSRI/SNRI’s over placebo. The pooled analyses also favoured treatment with SSRI/SNRI’s over placebo with regards to reducing hot flash frequency and hot flash score. There were no significant differences in study withdrawals between the SSRI/SNRI group and placebo. Most of the studies evaluated less than 3 months of SSRI/SNRI therapy. Conclusions: SSRI/SNRI’s reduced the number and severity of hot flashes in women with and without breast cancer. Whether or not the treatment effect lasts more than 2 months requires further studies to answer this question. Overall, SSRI/SNRI’s were well tolerated with only minor side effects. No significant financial relationships to disclose.
Evidence for drugs and biomarkers in oncology guidelines (GLs): A survey of the National Comprehensive Cancer Network (NCCN) colon cancer panel.
Authors: R. K. Kelley, S. J. Knight, G. Wang, K. A. Phillips, A. P. Venook
Journal: Journal of Clinical Oncology (2011)

e16578 Background: GLs influence practitioners, payers, and policy about the adoption of new cancer drugs and biomarkers. The NCCN GLs, referenced by Centers for Medicare & Medicaid Services, are the most frequently-updated oncology GLs with methodology based upon evidence review and expert consensus. The sources of evidence and weight of expert opinion in developing these GLs have not been described. Methods: We developed a multiple choice and ranking survey to examine how new drugs and biomarkers reach an NCCN panel for discussion, which sources of evidence are preferred, and the timeliness of GLs for new drugs and biomarkers according to source of evidence. Anonymous survey links were e-mailed to members of the NCCN Colon Cancer Panel with permission from the NCCN Board of Directors and Colon Cancer Panel Chair. Analysis was descriptive. Results: 69% (18 of 26) panelists responded including 56% medical oncologists, 17% surgeons, and 17% radiation oncologists. 44% were members for > 6 yrs, 22% for ≤ 2 yrs. Recent publications or presentations and new FDA approvals were the most common factors leading to discussion of a drug or biomarker at a panel meeting. The preferred supporting evidence for GLs was randomized, controlled clinical trial (RCT) data for 80% of respondents; meta-analyses (MA), non-RCT data, and expert opinion were preferred by 7% each. RCT data, systematic review (SR), and MA were reported by 87%, 67%, and 60% of respondents, respectively, as highly likely to lead to timely inclusion of a new drug or biomarker in GLs. GLs about new drugs were perceived as timely by 80%, compared to 53% for GLs about new biomarkers. Conclusions: RCT data was strongly preferred as the source of evidence for GLs about drugs and biomarkers. In contrast to GLs from other organizations which rely upon SR and MA, this preference for RCT data may be due to the dynamic, real-time development of the NCCN GLs. GLs about new biomarkers were perceived as less timely and more likely to require revision than GLs about new drugs. The findings from this pilot survey may inform future studies to improve the timeliness of GLs for rapidly-evolving technologies such as biomarkers for which RCT data may not be available.
Amrubicin monotherapy for patients with platinum-refractory gastroenteropancreatic neuroendocrine carcinoma.
Authors: Takayuki Ando, Ayumu Hosokawa, Hiroki Yoshita, Akira Ueda, Shinya Kajiura, Hiroshi Mihara, Sohachi Nanjo, Haruka Fujinami, Jun Nishikawa, Toshiro Sugiyama
Journal: Journal of Clinical Oncology (2015)

328 Background: Patients with gastroenteropancreatic neuroendocrine carcinoma (NEC) have a poor prognosis. Platinum-based combination chemotherapy is commonly used as first-line treatment; however, because studies on salvage chemotherapy are limited, its role remains unknown. This study aimed to analyze the efficacy and safety of amrubicin monotherapy in patients with platinum-refractory gastroenteropancreatic NEC. Methods: Among 22 patients with advanced gastroenteropancreatic NEC, 10 received amrubicin monotherapy between September 2006 and May 2014 after failure of platinum-based chemotherapy. The efficacy and toxicity of the treatment were analyzed retrospectively. Results: Eight males and two females ((median age, 67 years (range, 52–78)) received platinum-based chemotherapy, including cisplatin plus irinotecan (n = 7, 70%), cisplatin plus etoposide (n = 2, 20%), and carboplatin plus etoposide (n = 1, 10%) before amrubicin therapy. A total of 30 cycles of amrubicin was administered in 10 patients, with a median number of cycles per patients was 2.5 (range, 1-7). Median progression-free survival (PFS) and overall survival after amrubicin therapy were 2.6 and 5.0 months, respectively. Two patients had partial response (20% response rate), and their PFS were 6.2 months and 6.3 months, respectively. Two patients with partial response had characteristics of NEC with a high Ki-67 index (99% and 89%, respectively) and had received cisplatin and irinotecan as first-line treatment. Grade 3–4 neutropenia and anemia were observed in four (40%) and five (50%) patients, and they were manageable in all cases by careful monitoring of myelosuppression and appropriate dose reduction of amrubicin. Conclusions: Amrubicin monotherapy appears to be potentially active and well-tolerated for platinum-refractory gastroenteropancreatic NEC.
Metastatic papillary renal cell carcinoma: A retrospective study from two large academic centers in Sweden.
Authors: Maria Stenman, Andreas Demetrios Nearchou, Per Sandström, Magnus Lindskog, Ulrika Harmenberg
Journal: Journal of Clinical Oncology (2016)

535 Background: Non-clear cell renal cell carcinoma (nccRCC) constitute about 10-15% of all metastatic renal cell carcinoma (mRCC) and typically include papillary, chromophobe and collecting duct histologies. Despite differences in clinical behavior between subtypes they are often grouped as one due to small patient numbers. Hence, there is a lack of knowledge on type-specific prognosis and treatment options. Methods: Patients diagnosed with metastatic nncRRC (56 out of 526 patients; 10.8%) during the years 2005-2013 were retrospectively identified using data from medical records at two large academic centers in Sweden. The characteristics and outcome of those with papillary subtype (n = 44; 79% of nccRCC) was analyzed. Results: Metastatic papillary RCC patients were more often male (82%), had a median age of 69 years and 48% had M1 disease. 9% were type I, 41% type II, 4% mixed and 41% papillary NOS. 89% had a nephrectomy and 56% received at least one line of systemic therapy. The median overall survival (OS) of all papillary patients was 10.1 months. Factors associated with OS included performance status (PS; OS 25.8 months for ECOG PS 0-1 patients vs OS 3.1 months for ECOG PS &gt; 1 patients, p = 0.00002), and systemic therapy (OS 23.4 months vs 3.8 months for patients not treated systemically, p = 0.002). Systemic therapies (ST) included VEGF targeting agents (88%), mTOR inhibitors (50%), or interferon (21%) for all lines. The most common first line ST was VEGF targeting agents (75%). 42% received one line, 33% two lines, and 25% three or more lines of ST. Characteristics of patients treated with ST included lower age at diagnosis, higher proportion of M1 disease and better PS. The reasons for not giving systemic treatment were primarily poor performance status or comorbidities. ECOG PS &gt; 1 (p = 0.04) and poor MSKCC risk group (p = 0.02) were predictive of OS among patients treated with ST. Conclusions: Patients with metastatic papillary RCC and good performance status (ECOG PS 0-1) seem to benefit from systemic therapy using drugs primarily evaluated for clear cell RCC. However, patients not eligible for systemic therapy due to poor performance status or other reasons have a dismal prognosis.
Outcomes of patients treated with capecitabine and temozolamide (CapTem) for advanced pancreatic neuroendocrine tumors (PNETs) and non-PNETs.
Authors: Renata D'Alpino Peixoto, Krista Noonan, Hagen F. Kennecke, Howard John Lim
Journal: Journal of Clinical Oncology (2014)

343 Background: Retrospective studies have demonstrated high response rates among patients with advanced PNETs treated with CapTem while responses are infrequently seen among non-PNETs. The objective of the study was to describe progression free survival (PFS) and overall survival (OS) among sequential NET patients treated with CapTem and to identify factors associated with response. Methods: Patients who initiated therapy with CapTem between 2009 and 2013 for advanced NETs and referred to one of 6 provincial cancer treatment centers were included. Patients received Cap 2000 mg/m2 day 1-14 and TMZ 200 mg/m2 on days 10-14 every 28 days. Their characteristics and outcomes were retrospectively analyzed. Results: In our cohort, 29 patients (16 male) with a median age of 59 (range 26 – 76) received palliative CapTem, 15 of them as first-line chemotherapy and 14 as subsequent lines. Primary tumors included pancreas (48.3%), small bowel (20.7%), lung (10.3%), unknown (10.3), rectum (6.9%) and appendix (3.4%). Median number of cycles was 3. For the entire cohort, median PFS and OS were 4.7 and 20.2 months, respectively. Although pancreatic NETs (PNETs) had shorter OS (18.8 months versus not reached, p=0.37), their PFS was longer than non-PNETs (4.9 versus 2.8 months, p=0.178). There was no difference in PFS between first or subsequent lines of therapy. Patients with Ki67 above 10% had a shorter PFS when compared to lower Ki67 (3.1 versus 5.5 months, p = 0.028). Three patients had to discontinue CapTem due to poor tolerance (2 intractable nauseas and 1 myocardial infarction). There were no treatment-related deaths. Conclusions: CapTem showed good activity among NETs, especially for PNETS, who derived the greatest benefit. Effectiveness was not exclusive to first-line therapy and seems better for well-differentiated tumors.
Pegfilgrastim and filgrastim patterns of use in community oncology practices: Results of the ACCEPT study
Authors: L. A. Meza, V. Charu, L. Campos, D. Davis, F. Xie
Journal: Journal of Clinical Oncology (2005)

6113 Background: In pivotal trials, appropriate use of pegfilgrastim and filgrastim prevented neutropenic complications when initiated in cycle (C) 1, 24h after chemotherapy (CT). In practice, filgrastim initiation has varied from C1 (primary protection) to later cycles (secondary prophylaxis). Within cycle, filgrastim has been initiated within 3 days of CT (proactive), delayed until nadir (reactive), or to treat febrile neutropenia. Pegfilgrastim’s (Neulasta) patterns of use and its impact on filgrastim use are largely unknown. Methods: 99 US community practices, stratified by CT use, participated in a large retrospective chart review. Consecutive records were abstracted for adult pts receiving CT in 2001 with filgrastim support (pre-pegfilgrastim launch) or in 2003 with filgrastim or pegfilgrastim support (post-pegfilgrastim launch). CT was initiated from Jan 1 to Dec 31 in 2001 or 2003. Results: 3782 charts documented pegfilgrastim or filgrastim use; 829 pts received filgrastim in 2001, 1031 pts in 2003, and 1922 pts received pegfilgrastim in 2003. The most common cancers were breast (49%), lung (21%) and NHL (16%). CT cycle length was mostly Q3W. Pegfilgrastim was initiated in C1 in 64% of pts, 84% by C2. Pegfilgrastim was initiated within 72h of CT in 86% of cycles. Patterns of use were independent of tumor type and cycle length. Filgrastim was initiated in C1 in 54% of pts, 76% by C2. Initiation within 72h of CT occurred in 46% of cycles. Within C1, initiation occurred >10 days after CT in 48% of pts. Comparing filgrastim use in 2001 to 2003, the proportion of pts with ≥8 days of use was reduced from 32% to 20%, respectively and 1–3 days of use was increased from 31% to 46%, respectively. An additional 580 pts received both pegfilgrastim and filgrastim; most received filgrastim and converted to pegfilgrastim (61%). Conclusions: In this community practice evaluation, appropriate use of pegfilgrastim was generally observed. Appropriate use of filgrastim was inconsistently documented, appearing often to be administered after neutropenic complications. Since pegfilgrastim’s introduction, filgrastim’s pattern of use has changed. In current practice, filgrastim no longer represents the community standard. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen Amgen
Implementation of Sarah Cannon national and international multidisciplinary cancer tumor boards: Initial results.
Authors: Richard J. Geer, Andrew S. Kennedy, Howard A. Burris, Crystal Dugger, Charles Fred Lemaistre
Journal: Journal of Clinical Oncology (2014)

138 Background: Optimal cancer care is achievable when input is available from specialists in all related disciplines. To exploit the breadth and depth of clinical expertise within a large healthcare network, regularly scheduled web-based multidisciplinary tumor boards related to complex GI and breast cancers have been established. Methods: Monthly national and quarterly international multispecialty tumor boards were held in 2014. Each center presented a case for discussion and suggested management on a predetermined solid tumor subtype or clinical scenario. A web-based interface was used to show key information to the group in real time, including imaging, pathology, and laboratory results. Subspecialty participation included well known centers of excellence in radiation oncology, medical oncology, clinical research, surgical oncology and interventional oncology. A process to assure HIPPA compliance was implemented, and CME awarded. Results: Sarah Cannon centers in Nashville, Kansas City, Denver, San Antonio, Austin and London participated. An average attendance of ten physicians per center (range 4-18) was seen. Survey results demonstrated significant value as reported by participants in improving patient care leading to the development of a prospective clinical trial in one instance. Therapeutic options not available in the US but offered in the London center were discussed and a mechanism for direct referral to the London facility was developed. Improved rates of breast conservation (18% increase), breast reconstruction (31% increase) and use of AJCC staging (24% increase) were the product of breast conferences in each market. Conclusions: Physicians overwhelmingly supported and valued multidisciplinary tumor boards for GI and breast cancers. Consensus development, sharing of best practices, and promotion of the latest evidence based management led to changes in patient care. Additional centers will be invited to join meetings this year, with planned expansion to initiate similar meetings in blood and thoracic malignancies.
A phase II trial of single-agent amrubicin (AMR) in patients with extensive disease small cell lung cancer (ED-SCLC) that is refractory or progressive within 90 days of completion of first-line platinum-based chemotherapy
Authors: D. S. Ettinger, R. M. Jotte, V. Gupta, A. R. Allen, J. W. Oliver
Journal: Journal of Clinical Oncology (2008)

8041 Background: Pts with SCLC who progress while on first-line chemotherapy or relapse within 3 months are less likely to respond to additional chemotherapy treatment. Refractory patients have an expected response rate to subsequent therapy of 10%. Recent data suggest that single-agent amrubicin (AMR), a synthetic anthracycline analogue and potent DNA topoisomerase II inhibitor, may result in improved response rates and survival in refractory SCLC patients when compared to standard treatment. Methods: This is a phase 2, open-label, multicenter trial of single-agent AMR for the treatment of patients with ED-SCLC (≥18 years, ECOG performance status ≤2) refractory to prior platinum-based first-line therapy (best response to 1st-line chemotherapy is progression or response/stable disease with subsequent progression within 90 days of completion of 1st-line chemotherapy). Pts were to receive AMR 40 mg/m2 daily x 3 days IV every 21 days. Treatment was to be continued until disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was objective tumor response rate (RECIST). Secondary endpoints included progression free survival (PFS) and overall survival (OS). 63 evaluable pts were planned to be enrolled. Results: The study is closed to enrollment with 75 pts. At the time of data cut-off, 39 pts were evaluable for response. AMR was administered for a mean of 3.4 cycles (range: 1–12). To date, 13/39 AMR pts have had a response (all PR). Of these, 8 are confirmed and 5 are pending a confirmation assessment. PFS and OS data will be presented at the meeting. 55 pts are evaluable for safety. GI and hematological adverse events were the most commonly reported. Grade 3 and 4 adverse event rates were 42%, 20%, 18% and 16% for neutropenia, anemia, thrombocytopenia, and leukopenia, respectively. No trends for classical anthracycline-induced cardiotoxicity have been observed. Conclusions: AMR provides promising response rates and acceptable safety in refractory ED- SCLC patients. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Pharmion Corporation Genentech, Pharmion Corporation Pharmion Corporation Eli Lilly, Pharmion Corporation, sanofi-aventis Pharmion Corporation
Developing and implementing a balanced scorecard to improve efficiency, cost-effectiveness, and patient experience.
Authors: Gerard Colman, Julianna Grisham Moorad
Journal: Journal of Clinical Oncology (2012)

3 Background: MD Anderson Cancer Center’s Balanced Scorecard initially created in 2005 by the Office of the SVP and Chief of Operations reports key monthly financial, productivity, process and satisfaction metrics for 29 outpatient care centers on the main campus. It was developed as a management tool of standardized metrics to help align the centers’ annual operational goals with the institution’s overall strategy, goals, and processes, to improve operational efficiency, drive down costs and improve access and patient experience. Methods: The first step to develop the scorecard was to identify metrics that could be measured across all centers under each key strategic goal: financial, productivity, process, and satisfaction. The next step was to set target goals with a standard improvement percentage based on previous year’s performance. The result is a monthly overall trend score for each center. Lastly, a two-way communication process for reporting and recording the metrics was established. Results: The ultimate benefit of the scorecard is to positively impact patients and oncology care by not only delivering quality patient care, but doing it efficiently and cost effectively. The tool is transparent to all center directors and promotes accountability and sharing of best practices. Centers are actively engaged in the achievement of metrics by continuous monitoring and improving processes. The impact of improvement initiatives is easily identified via trends on the scorecard. Specific results include increased billed activity per FTE, reduced access time for new patients, increased exam room utilization and increased patient satisfaction. Within the past year, one center reduced access time for new patients by 50% from 15.59 days to 7.75 days, another center increased room turns by 5.7% from 4.01/hour to 4.25/hour. Conclusions: The value of the balanced scorecard comes from the transparent reporting and continuous owner pursuit of improvement within each of the four strategic areas. It aids in the challenge of balancing clinical care measured outcomes, patient access and throughput, and satisfaction with the business processes so that MD Anderson can continue to provide quality patient care.