tbuckley/cabot-search huggingface dataset:
Predictors of survival in patients with hepatocellular carcinoma treated with transarterial chemoembolization
Authors: P. L. Doan, B. H. O'Neil, D. T. Moore, S. A. Bernard
Journal: Journal of Clinical Oncology (2008)

15522 Introduction: Transarterial chemoembolization (TACE) is a treatment option for patients with unresectable hepatocellular carcinoma (HCC). Prior reports suggest biochemical markers (BM) and radiographic tumor characteristics (RTC) predict survival in HCC treated with TACE. We evaluated the effect of both, along with the effect of nonselective versus superselective chemoembolization on overall survival (OS) and time to progression (TTP). Methods: Patients with HCC treated with TACE between 1992 and 2006 were included in this study. Patients were eligible for TACE with MMC and doxorubicin if they had total bilirubin (TB) < 3, INR < 1.7, and albumin > 2.5. Patient demographics, BM, and RTC were assessed within 1 month prior to first TACE. Nonselective versus superselective vessel embolization were assessed based on procedure reports. Univariable Cox regression analyses were conducted for variables and their association with OS and TTP. Results: 75 patients were included. HR for OS for selected variables are listed in the table. Variables marked with an asterisk negatively impacted survival. Negative predictors of OS were elevated total bilirubin > 3 mg/dL, ≥ 3 discrete tumor foci, presence of macrovascular tumor invasion, and ascites. Tumor size, AFP, and tumor morphology (having unilobar disease and > 50% of liver with tumor) did not impact overall survival. Surprisingly, superselective TACE was associated with decreased OS, but did not impact TTP, p= 0.535, HR= 0.822. Median OS for all patients was 1.9 yrs (95% CI 1.22–3.5). Conclusions: We can predict that patients with elevated TB, ≥ 3 liver lesions, tumor vessel invasion, and ascites will have decreased OS with TACE. Further study is needed to determine whether superselective TACE is associated with decreased OS. Variable ProbChiSq Hazard Ratio total bilirubin > 3 *0.0002 3.140 ≥ 3 liver lesions *0.0015 3.308 presence of macrovascular invasion *0.0022 2.832 ascites *0.0016 2.620 superselective TACE *0.0311 2.016 INR> 1.7 0.0659 7.370 unilobar disease 0.0591 1.933 albumin 0.0568 1.480 AFP> 400 0.4535 1.271 No significant financial relationships to disclose.
Augmenting chemotherapy response through EMAP II combination in experimental pancreatic cancer.
Authors: N. Awasthi, M. A. Schwarz, P. L. Yen, R. Schwarz
Journal: Journal of Clinical Oncology (2011)

294 Background: Gemcitabine (Gem), the most active drug for locally advanced, non-operable and metastatic PDAC, has limited benefits as single agent or in combination. Endothelial monocyte activating polypeptide II (EMAP, E) enhances Gem effects in PDAC. We evaluated the antitumor activities of EMAP in combination with doxorubicin (Dox) or docetaxel (DT) in PDAC. Methods: In vitro cell proliferation, protein expression and apoptosis were analyzed by WST-1 assay, Western blotting and FACS analysis. In vivo local tumor growth and animal survival experiments were performed in murine xenografts. Results: In vitro PDAC cell proliferation was not affected by EMAP, compared to a small inhibition by Dox, DT and Gem. EMAP combination to these agents did not increase the antiproliferative effects. In endothelial cells (ECs), EMAP, Dox, DT and Gem all inhibited proliferation (59, 79, 96 and 85% at 10 μM, respectively); addition of EMAP caused additive antiproliferative effects. In PDAC cells, no agent caused measurable apoptosis, but in ECs all agents either alone or in combination increased the apoptosis. In vivo, Dox, DT, Gem and EMAP all decreased local tumor growth, and addition of EMAP enhanced inhibitory effects of DT and Gem, but not of Dox (92, 63, 60, 42, 73, 85 and 68 % inhibition after Dox, DT, Gem, E, Dox+E, DT+E and Gem+E, respectively); DT followed by Gem led to 72% inhibition without EMAP, and to 99% with EMAP (p=0.001). Inhibition of intra-tumoral proliferative activity and increase of apoptotic index were enhanced in all EMAP combination groups. Compared to controls (median survival: 21 days), EMAP (20 d) had no, but Dox (31 d) and DT (35 d) had extended survival benefit. EMAP enhanced the DT effect (44 d, p=0.009) but not that of Dox (31 d, p=0.04). In a sequential therapy experiment, median survival after controls, Gem, DT, Gem followed by DT, DT followed by Gem, Gem+E, DT+E, Gem/DT+E and DT/Gem+E was 17, 25, 29, 39, 39, 28, 35, 34 and 41 days, respectively. Conclusions: The antiendothelial agent EMAP enhances antitumor effects of not just gemcitabine. Therefore, combination approaches with EMAP-like agents could render other drugs such as taxanes or their doublets sufficiently effective for clinical applications in PDAC therapy. No significant financial relationships to disclose.
A pilot study of WCA (a Chinese Jianpi Herbal Formula) integrated to systemic chemotherapy (CT) in the first-line treatment for advanced gastric cancer (AGC).
Authors: Aiguang Zhao, Zhaoyan Li, Gang Zhao, Yong Cai, Yan Xu, Xiaohong Zhu, Nida Cao, Jinkun Yang
Journal: Journal of Clinical Oncology (2012)

143 Background: To improve survival of AGC, practitioners of traditional Chinese medicine (TCM) prescribe a combination of plant species/minerals, called formulae, based on their clinical experiences. WCA, a Chinese “Jianpi” herbal formula, could inhibit gastric cancer cells MKN-45, SGC-7901 growth in vivo on our previous studies. All the herbs formed the formula have been used for thousands of years in Chinese clinical practices. Methods: A nonrandomized concurrent control trial was performed to investigate the role of WCA for AGC. Patients (pts) with gastric adenocarcinoma (locally advanced, recurrent, or metastatic) were prospectively enrolled. All pts were assigned to receive WCA+CT q3w for 3 or more than 3 cycles or CT alone. WCA was formulated as following: Radix pseudoxtellariae 12g, Stir-fried Rhizoma atractylodis macrocephalae 12g, Poria cocos 30g, Sargentodoxa cuneata 30g, Concha ostreae 30g, Prunellae vulgaris 9g. It was given orally every day until disease progression. The primary end point was overall survival (OS). The baseline comparison was analyzed by using chi-squared test. Results: 270 eligible pts had been histologically confirmed adenocarcinoma. At the time of last follow-up, 197 pts (73.0%) had died of disease, and 67 pts (26.7%) had censored, 1 patient (0.3%) had died of unrelated cause. The median follow-up of pts was 39.9 months. Baseline characteristics (gender; age of onset; primary tumor site; histological type; initial CT scheme; cycle of CT) were well balanced across arms. Median OS was significantly improved in WCA+CT arm (n=127) compared to that in CT (n=143) alone: 19.3 vs. 13.1 months, respectively (HR 0.550; 95% CI 0.412, 0.734; p=0.000). The treatment was generally well tolerated. There were no WCA-related adverse events observed. No patient died related to WCA treatment. Conclusions: This prospectively concurrent control trial investigating Chinese herbal therapy in advanced GC showed that WCA+CT be a promising candidate treatment for GC superior to CT alone. A randomized controlled trial is needed to further evaluate the value of WCA in improving the OS of AGC.
The SSO/ASTRO Consensus on Breast Margins: Has it affected clinical practice?
Authors: Sarah P. Cate, Arielle Brooke Greenberg, Leah Bassin, Alyssa Gillego, Manjeet Chadha, Gina Aharonoff, Susan K. Boolbol
Journal: Journal of Clinical Oncology (2015)

148 Background: Adequate margin width remains a subject of much controversy in breast conserving surgery. The Society of Surgical Oncology (SSO) and the American Society for Radiation Oncology (ASTRO) presented a consensus statement on margins in December 2014. This guideline stated that re-excision is recommended only in cases where tumor is present on inked margin. In this study, we sought to determine the consensus statement’s impact on re-excision practices at our institution. We examined re-excision rates eleven months before the release and 17 months after the release of the statement. Methods: Patients included in this IRB approved study had a diagnosis of invasive breast carcinoma, underwent breast conserving surgery, and were treated with adjuvant radiotherapy. Patients with pure DCIS were excluded. Results: One hundred and two women treated from January to November 2013 were included in the pre-consensus group. One hundred and three women were treated from December 2013 to May 2015 in the post-consensus group. The women treated prior to the consensus statement (n = 102) and those women treated after the statement (n = 103) were equally matched in terms of patient age, hormone positivity, and tumor size. A close margin at our institution is defined as &lt; 2mm from the tumor edge. There were 16/102 women prior to the consensus who had close margins and 32/103 women in the post-consensus group. Of these, 68.8% (11/16) underwent re-excision for close margins in the pre-consensus group compared to 3.1% (1/32) after the consensus statement was released (p value &lt; 0.01). Conclusions: The rapid adoption of the SSO/ASTRO margin consensus statement at our institution, although not statistically significant, led to a decrease in the number of patients who underwent a re-excision for close margins. Women with a close surgical margin were less likely to undergo additional surgery for re-excision after the guidelines were released. In our institution, using a standard criterion for re-excision, the re-excision rate for close margins decreased from 68.8% to 3.1%. Further studies are needed to examine the impact of the consensus statement on re-excision practices in a larger group of patients.
Prognostic factors for survival in adult patients (pts) with metastatic cancer (MC) after the first-line chemotherapy
Authors: O. Tredan, G. Chvetzoff, A. Bajard, D. Pérol, P. Rebattu, I. L. Ray-Coquard, T. Bachelot
Journal: Journal of Clinical Oncology (2008)

9573 Background: Little is known about prognosis of MC pts after first-line treatment failure. Our group has already shown that performance status (PS) ≥ 2 and LDH >600 UI/L were independent prognostic factors in previously treated pts enrolled in phase I clinical trials (Bachelot et al. Ann Oncol. 2000). Here, we present results from a prospective study initiated to validate PS and LDH as outcome predictors and to identify other prognostic variables. Methods: We included 299 pts previously treated for MC from 12/2000 to 11/2005. Clinical assessment and blood parameters were recorded. Candidate prognostic factors for overall survival (OS) with a 0.05 significance level in univariate analysis were entered in a multivariate Cox model. Results: Median age was 59y (range: 26–85). Five percent of the pts were PS =0 and 71% were PS ≥ 2. Primary tumor sites were breast (45%), lung (15%), head and neck (6%) and others (34%). The number of metastatic sites were 1 (29%), 2 (48%), >2 (23%). After inclusion pts received second-line (49%), third-line (26%) or more than third-line chemotherapy (24%). Median follow-up and median OS were 12 months and 6 months respectively. In univariate analysis, factors associated with short OS were PS ≥ 2, weight loss >10% and abnormal blood parameters: LDH, albumin, hemoglobin (Hb), absolute neutrophil count (ANC), platelet and lymphocyte counts, CRP and IL6. The self-assessment by pts of the quality of life was not significantly correlated with OS. Multiple regression analysis confirmed that PS ≥2 and LDH >600 UI/L were independent predictors for short OS as well as other factors showed in the table. According to the presence of none (15%), 1 (19%), 2 (27%) and ≥ 3 (39%) prognostic factors, median OS were 21, 11, 6 and 3 months respectively. Conclusions: A combination of clinical and analytical parameters including PS and LDH is useful to determine prognosis in pre-treated MC pts. Explanatory variables HR 95%CI p PS ≥ 2 2.12 [1.54–2.92] <.0001 CRP >50 mg/L 1.89 [1.33–2.70] .0004 LDH >600 UI/L 1.57 [1.15–2.15] .0005 ANC, abnormal values* 1.56 [1.14–2.15] .0006 IL6 ≥ 8 pg/mL 1.47 [1.08–2.01] .015 Hemoglobin, abnormal values† 1.39 [1.03–1.90] .034 * Normal: 2–7.5 ×10^9/L † Normal <11.5 g/dL (female); <13.0 g/dL (male) No significant financial relationships to disclose.
Phase II trial of bexarotene capsules in patients with non-small-cell lung cancer (NSCLC) who have failed at least 2 prior systemic therapies for Stage IIIB/IV disease
Authors: R. Govindan, J. Crowley, L. Schwartzberg, P. Kennedy, B. C. Ekstrand, A. Sandler, D. Jaunakais, R. Ghalie
Journal: Journal of Clinical Oncology (2005)

7116 Background: Phase II studies of bexarotene (Targretin) plus chemotherapy as first line therapy for advanced NSCLC showed a potential improvement in survival. The objectives of this multicenter, single-arm study are to evaluate the effect of bexarotene on survival, quality of life (QOL), and tolerability in patients who have failed ≥ 2 prior systemic treatments for advanced NSCLC. Methods: To be eligible patients must have NSCLC Stage IV or IIIB (pleural effusion), failed ≥ 2 prior therapies including a taxane and a platinum compound, ECOG performance status (PS) 0–2, and adequate organ function. Treatment consists of oral bexarotene 400 mg/m2 daily plus supplementation with levothyroxine and a lipid-lowering agent. Tumor evaluations are performed every 8 weeks while on treatment. Bexarotene is continued in the absence of disease progression or unacceptable toxicity. Results: To date, 112 of 150 planned patients were enrolled in 31 sites. Patient characteristics: median age = 66 (range, 43–87), 52% are male, 22% have PS 2, 52% have adenocarcinoma, median prior systemic therapies = 3 (range 2–6) and 49% received gefitinib before enrollment. The median duration of bexarotene treatment = 29 days (range 1–211+). For all patients, median survival is 5 months and the estimated 1-year survival is 13%. For patients with PS 0–1, median survival is 6 months and the estimated 1-year survival is 30%. No objective responses are reported. Twelve 12 patients (11%) have stable disease with a median duration of 5.3 months (range 1.3–5.6+). The FACT-G QOL shows that 67% of patients show improvement or no decline in QOL. Eleven patients (10%) discontinued bexarotene due to an adverse event, including hypertriglyceridemia, fatigue, rash, dyspnea, heartburn, limb edema, cognitive disturbance, allergic reaction, and dysphagia. One death due to increased pulmonary infiltrate was considered possibly related to bexarotene. Conclusions: This interim analysis indicate that bexarotene is well tolerated and has encouraging activity in relapsed advanced NSCLC even in heavily pretreated patients. Enrollment continues and results on all 150 patients will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ligand Amgen, Ligand, Lilly Oncology, Pfizer Ligand Amgen, AstraZeneca, Aventis, Bristol-Myers Squibb, Genentech, Ligand, Lilly Oncology, Merck, Pfizer AstraZaneca, Aventis, Bristol-Myers Squibb, Ligand, Lilly, Pfizer
Impact of Medicare's July 2007 erythropoiesis-stimulating agent (ESA) national coverage determination (NCD) on transfusion use in chemotherapy-treated cancer patients.
Authors: T. Arneson, S. Li, D. T. Gilbertson, S. C. Dunning, K. R. Bridges, J. F. Acquavella
Journal: Journal of Clinical Oncology (2010)

6071 Background: A Medicare NCD on ESA use in cancer and related neoplastic conditions, effective July 2007, restricted payment for ESA use. We sought to assess impact of the NCD on transfusion (txfn) predicated on the assumption that hemoglobin (hgb) thresholds for txfn remained stable. Methods: Chemotherapy courses for patients (pts) with lung, breast, colorectal cancer and lymphoma were defined using Medicare 5% data. Courses initiating between Sept. 1 and Nov. 30, 2006 and Sept. 1 and Nov. 30, 2007 served as the pre- and post-NCD cohorts for comparison. Each course was studied 90 days post-initiation for evidence of ESA use and txfn. We used logistic and Poisson regression models to evaluate change in ESA, txfn use and rates after the NCD, adjusting for demographics and comorbidities. Results: The pre-NCD cohort had 1897 courses; the post-NCD cohort had 1877. Cancer types in each cohort were similar: approx. 30% lung, 28% lymphoma, 21% colorectal, and 20% breast. Overall, courses receiving any ESA dropped from 35.0% pre-NCD to 15.2% post-NCD (p<0.0001). Those receiving any txfn increased slightly, from 9.3% pre-NCD to 10.4% post-NCD (P=0.23), while txfn event rates increased from 19.0 per 100 pt-quarters to 21.8 (p=0.31). Patients with colorectal cancer had both the largest decrease in ESA use and the largest increase in txfn use. Adjusted results were similar (see Table). Conclusions: There was a modest, though not statistically significant, increase in txfn after the July 2007 NCD. A lower post-NCD threshold for txfn may have biased this comparison. Further studies need to assess differences in the hgb levels at which pts were transfused pre/post-NCD. Patient groups ESA use Txfn (Y/N) Txfn rate OR (95% C.I.) p OR (95% C.I.) p RR (95% C.I.) p All 0.44 (0.39, 0.50) <0.0001 1.16 (0.93, 1.44) 0.1791 1.17 (0.90, 1.53) 0.2383 Lung cancer 0.48 (0.40, 0.57) <0.0001 1.15 (0.83, 1.59) 0.3869 1.29 (0.88, 1.89) 0.1889 Breast cancer 0.48 (0.37, 0.62) <0.0001 1.09 (0.64, 1.86) 0.744 1.27 (0.74, 2.17) 0.384 Colorectal cancer 0.31 (0.23, 0.42) <0.0001 1.79 (0.98, 3.27) 0.0589 1.25 (0.67, 2.34) 0.4862 Lymphoma 0.44 (0.34, 0.57) <0.0001 1.04 (0.66, 1.64) 0.8635 1.09 (0.60, 1.95) 0.7826 Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen Amgen Amgen Amgen
Awareness, concern, and communication between physicians and patients on bone health in nonmetastatic prostate cancer.
Authors: Judd W. Moul, Krag S Ferenz, Beatrice Delhey Mautner
Journal: Journal of Clinical Oncology (2012)

246 Background: Little is known about physicians’ (MDs) and prostate cancer (PC) patients’ (pts) levels of awareness or concern about bone health or how/when MDs discuss bone health with at-risk pts. An online survey was conducted to explore these issues and evaluate knowledge levels and attitudes about cancer treatment-induced bone loss (CTIBL). Methods: A total of 4,403 oncologists and 4,961 urologists randomly selected from the American Medical Association master physician list, 533 oncologists from the Harris Physician Panel, and 3,400 pts from Harris’ Chronic Illness Panel were invited to participate in the survey. Surveys lasted on average 10 minutes; MD and pt surveys were weighted to be representative of the populations of interest. Descriptive statistical analyses were used. Results: Of those invited, 113 urologists and 63 oncologists completed the survey. The 186 PC pts who answered the survey (median age, 74 yrs; median time since PC diagnosis, 88 mos.) included 96 pts with nonmetastatic disease. Current or prior ADT was reported by 96% of pts. Of these pts, 48% were aware of CTIBL, 23% of whom were concerned about it and 55% of whom had discussed it with their MD. As many as 46% of pts obtained information on bone health exclusively from their healthcare team, rather than seeking information from other sources. Both oncologists and urologists (98% and 90%) considered CTIBL to be a serious issue for their patients, however, more oncologists than urologists perceived that their pts were concerned about CTIBL (71% vs 36%). More oncologists than urologists expressed concern about fractures due to CTIBL (58% vs 46%), and indicated that treatment-induced fractures would require additional intervention (91% vs 76%), treatment interruption (61% vs 43%), or change in treatment (55% vs 42%). Conclusions: Bone health is considered a serious issue for patients with nonmetastatic PC treated with ADT by both oncologists and urologists. However, there remains a gap in physician-patient communication regarding CTIBL and its clinical consequences. As primary sources of information for pts, MDs should proactively educate pts on CTIBL, its consequences, appropriate monitoring, and treatment options.
A schematic case episode format to aid in “Choosing Wisely."
Authors: J. Russell Hoverman, B. Brooke Mann, Jad Hayes, Lalan S. Wilfong, Marcus A. Neubauer
Journal: Journal of Clinical Oncology (2016)

181 Background: The recommendations of the Choosing Wisely campaign are evidence –based strategies to reduce cost without sacrificing outcomes. Yet tying the recommendations to indicators of use at the physician and case level has been challenging. As practices become responsible for total cost of care, an easy to use analytic method to determine appropriate use will be critical. We here describe a tool for rapid assessment of individual cases to achieve that objective. Methods: The population was a payer defined cohort of lung cancer patients treated at Texas Oncology (TxO). TxO maintains a payer patient list, updated daily with demographics and diagnosis details for all enrolled patients. The list of lung cancer patients was cross-referenced against billing data from TxO's financial data warehouse (FDW). The FDW data is generated monthly, based on billing details from TxO's practice management system, and includes procedure codes and dates of service. Radiation therapy, chemotherapy, and GCSF administrations for each enrolled lung cancer patient were identified in the FDW data based on CPT codes. SAS software (version 9.4 for Windows) was used to generate a time series plot for each patient, based on date of service for each procedure. The time series plots were inserted into an Excel report template, along with general patient information, using a Visual Basic script, for review by TxO's medical director and quality committees. Results: Each patient-specific time series schematic displays elapsed weeks on the x-axis, beginning with week 1 to end of treatment. Three variables are displayed on the y-axis, using distinct colors and symbols: dates of radiation therapy (orange #), dates of GCSF administration (red x), and dates of chemotherapy administration (green ^). Each of the three y-axis variables is assigned a constant value that is plotted along a straight line. A graphic representation for a patient with stage III lung cancer could look as shown in the Table. Conclusions: Treatment episodes can be distilled into a meaningful format that allows rapid case review and the opportunity for continuous learning. Additional diseases and graphics will be available for presentation. [Table: see text]