tbuckley/cabot-search huggingface dataset:
The palliative therapy of NSCLC in the medical practice.
Authors: S. Wilhelm, L. Mueller, H. W. Tessen, A. Schlichting, S. Bartels
Journal: Journal of Clinical Oncology (2011)

e18069 Background: The data of the treatment of NSCLC patients have been recorded and evaluated in a group of medical practices specialized in oncology (PIO) since January 2003. The aim is to document the general treatment and quality in Germany outside the framework of studies. Methods: Out of 1,452 registered patients, 1,057 have been documented and evaluated so far, 685 patients died. 79 medical practices specialized in oncology are involved. Results: 26 (2%) of the patients received an adjuvant chemo- or radio-/chemotherapy, 10 (1%) patients an adjuvant radiotherapy. 1,057 patients received a palliative chemo+/-immuno- resp. radiotherapy. 2,223 therapies were administered. 54% of the patients received a 2nd-line therapy, 19% a 3rd-line therapy and 6% a 4th-line therapy. As a maximum, 8 therapies were administered. The substances were applied as follows (1st-line resp. 2nd-line): Platinum: 75% resp. 23%, taxane: 38% resp. 22%, vincaalcaloids: 36% resp. 25%, antimetabolite: 22% resp. 19%, tyrosine-kinase inhibitors: 1% resp. 22%, multitarget antifolate: 0,9% resp. 10%, Bevacizumab: 2% resp. 1%. In the 1st-line therapy, 250 (24%) patients received a monotherapy, in the 2nd-line therapy 423 (73%) patients. The remission resp. response rate in the 1st-line therapy is 30% resp. 69% for the whole group, in the 2nd-line therapy 19% resp. 55%. The median overall survival as from initial metastasizing according to Kaplan-Meier is 12.0 months, the overall survival as from the initial diagnosis is 16.0 months. Conclusions: Within the framework of health services research excellent data were recorded which show that the median overall survival in everyday practice is similar to that of the survey results.
A retrospective feasibility analysis of biweekly reduced dose docetaxel in Korean patients with castration-resistant, metastatic prostate cancer.
Authors: Jinhyun Cho, Kwai Han Yoo, Ki Sun Jung, Haa-na Song, Hae Su Kim, Su Jin Lee, Ho Yeong Lim, Se Hoon Park
Journal: Journal of Clinical Oncology (2016)

e638 Background: The aim of this retrospective study was to evaluate clinical outcomes of biweekly 40 mg/m2 docetaxel plus prednisolone, as compared with standard 3-weekly regimen in Korean patients with castration-resistant prostate cancer (CRPC). Methods: We retrospectively reviewed the medical records of 48 patients with metastatic CRPC who were consecutively treated with docetaxel plus prednisolone as first-line chemotherapy between Jan 2012 and Dec 2014 at Samsung Medical Center (Seoul, Korea). Prior to the adoption of a biweekly regimen in Oct 2013, our institutional standard chemotherapy was docetaxel 75 mg/m2 every 3 weeks for patients with CRPC (n = 24). After Oct 2013, all chemotherapy-naïve CRPC patients received 40 mg/m2 biweekly regimen (n = 24). The primary end point was the PSA response, defined as a greater than 50% decline in PSA levels from baseline. Results: The baseline characteristics of the patients were similar in the two treatment groups. The most common cause of treatment discontinuation was disease progression: 17 (71%) in 3-weekly group and 20 (82%) in biweekly group. PSA responses were observed in 12 (50%) and 11 (46%) patients in the 3-weekly and biweekly groups, respectively. Time-to-failure (TTF, 4.5 versus 3.9 months) and time-to-progression (TTP, 5.0 versus 4.2 months) were statistically similar between the 3-weekly and biweekly groups, respectively. In 3-weekly group, the most commonly observed toxic effects were anemia and neutropenia. Whereas, in biweekly group, fatigue and nail changes were the most commonly observed toxic effects. Conclusions: Within the limitation of a retrospective study, biweekly reduced dose docetaxel regimen is active and well-tolerated in Korean patients with metastatic CRPC.
The characteristics and correlates of dyspnea (D) in advanced cancer patients (ACP)
Authors: S. Reddy, A. Elsayem, L. Palmer, G. Kaur, T. Zhang, E. Bruera
Journal: Journal of Clinical Oncology (2005)

8019 Background: D is a frequent and devastating symptom in advanced cancer. It results from pulmonary pathology, but other causes contribute to it. There has been a limited attempt to characterize this symptom clinically, especially breakthrough D(BTD). Methods: 74 ACP with D underwent assessment of D and other symptoms using Edmonton Symptom Assessment Scale (ESAS, 0–10), Oxygen-Cost Diagram(OCD)], Oxymetry, Pulmonary Function Tests [VC, FVC, FEV1, MIP,PFR], Hospital Anxiety and Depression [HADS], and a detailed clinical questionnaire of daily characteristics of dyspnea. Results: Two types of D were observed, constant D(CD) as well as a breakthrough D (BTD). 28/74 (37.8%) patients (pts) had continuous D(CD). 14/28 (50%) pts with CD also had episodes of BTD. BTD was the sole symptom in 46/74 (62.1%) pts. Overall BTD was found to occur in 60/74 (81%) of patients. 4/60 (6.6%) of pts had D of more than 15 minutes duration (minimal latency period of short acting opioids). 46/60 (76.6%) pts had BTD lasting less than 5 minutes. 8/60 (13.3%) patients had less than 2 BTD episodes/day, 9/60 (15%) had more than 6 BTD epiosdes/day, and 45/60 (75%) had 2–6 BTD episodes/day. In univariate analysis, D (ESAS) was associated significantly with fatigue (p<0.0001), sleep (p=0.002), anxiety(ESAS) (p=0.006), depression(ESAS) (p=0.01), feeling of well-being (p=0.03), OCD(p=0.001). D (OCD) was significantly associated with HADS depression (p=0.001), fatigue (p=0.01), and VC (p=0.04). In multivariate analysis, dyspnea was significantly associated with fatigue (p=0.001), FEV1 (p=0.004), pain (0.01), and depression (p=0.03); this model explained 34% of the variation.D (OCD) was significantly associated with depression (p=0.0006) and FEV1 (p=0.045) although the model explained only 21% of the variation (R-Square). Conclusions: D is a breakthrough symptom(BTD) of very short duration in most cancer patients, and need different treatment algorythm compared to CD. D is a multidimensional construct commonly occurring with a cluster of other symptoms, requiring a multi-modality approach. Traditional pharmacological approaches will be ineffective in most patients with BTD. This new characterization should be useful for clinical trials. No significant financial relationships to disclose.
Assessing Optimal Blood Pressure in Patients With Asymptomatic Aortic Valve Stenosis
Authors: Olav W. Nielsen, Ahmad Sajadieh, Muhammad Sabbah, Anders M. Greve, Michael H. Olsen, Kurt Boman, Christoph A. Nienaber, Y. Antero Kesäniemi, Terje R. Pedersen, Ronnie Willenheimer, Kristian Wachtell
Journal: Circulation (2016)

Evidence for treating hypertension in patients with asymptomatic aortic valve stenosis is scarce. We used data from the SEAS trial (Simvastatin Ezetimibe in Aortic Stenosis) to assess what blood pressure (BP) would be optimal.A total of 1767 patients with asymptomatic aortic stenosis and no manifest atherosclerotic disease were analyzed. Outcomes were all-cause mortality, cardiovascular death, heart failure, stroke, myocardial infarction, and aortic valve replacement. BP was analyzed in Cox models as the cumulative average of serially measured BP and a time-varying covariate.The incidence of all-cause mortality was highest for average follow-up systolic BP ≥160 mm Hg (4.3 per 100 person-years; 95% confidence interval [CI], 3.1-6.0) and lowest for average systolic BP of 120 to 139 mm Hg (2.0 per 100 person-years; 95% CI, 1.6-2.6). In multivariable analysis, all-cause mortality was associated with average systolic BP <120 mm Hg (hazard ratio [HR], 3.4; 95% CI, 1.9-6.1), diastolic BP ≥90 mm Hg (HR, 1.8; 95% CI, 1.1-2.9), and pulse pressure <50 mm Hg (HR, 1.8; 95% CI, 1.1-2.9), with systolic BP of 120 to 139 mm Hg, diastolic BP of 70 to 79 mm Hg, and pulse pressure of 60 to 69 mm Hg taken as reference. Low systolic and diastolic BPs increased risk in patients with moderate aortic stenosis. With a time-varying systolic BP from 130 to 139 mm Hg used as reference, mortality was increased for systolic BP ≥160 mm Hg (HR, 1.7; P=0.033) and BP of 120 to 129 mm Hg (HR, 1.6; P=0.039).Optimal BP seems to be systolic BP of 130 to 139 mm Hg and diastolic BP of 70 to 90 mm Hg in these patients with asymptomatic aortic stenosis and no manifest atherosclerotic disease or diabetes mellitus.URL: http://www.clinicaltrials.gov. Unique identifier: NCT00092677.
Phase II trial of sorafenib in esophageal (E) and gastroesophageal junction (GEJ) cancer: Response and prolonged stable disease observed in adenocarcinoma.
Authors: Geoffrey Y. Ku, Yelena Yuriy Janjigian, Manish A. Shah, Jessica Herrera, Laura H. Tang, Louis Fuqua, Marinela Capanu, David Ilson
Journal: Journal of Clinical Oncology (2013)

91 Background: Sorafenib is a tyrosine kinase inhibitor targeting VEGFr, PDGFr, Raf and other pathways. Encouraging response and survival were observed in a phase II trial of sorafenib with chemotherapy in GE cancer (J Clin Oncol 27:2947;2010). We performed a phase II trial of single-agent sorafenib with the primary endpoint of progression-free survival (PFS). Secondary endpoints include response and toxicity. Methods: Patients (Pts) with measurable metastatic E and GEJ cancer with ≤3 prior chemotherapy regimens were treated with sorafenib 400 mg BID. CT scans were performed monthly for the first 2 months, then every 2 months. Results: Thirty-five patients have been accrued, with 34 evaluable; median age 62, 31 male, 4 female, median KPS 80%, E 25, GEJ 10, adenocarcinoma (AC) 30 squamous 5, median no. of prior therapies 2. Of 31 response-evaluable Pts, 1 (3%) ongoing complete response was noted (34+ months) in a Pt with E AC with biopsy-proven lymph node recurrence after chemoradiation and surgery; 23 Pts (74%) had stable disease. Median PFS is 3.7 months (95% CI 1.9 to 4 months), with median overall survival 8.9 months (95% CI 6.9 to 11.6 months). Four patients remain on treatment. Significant grade 3 toxicities included hand foot reaction (3 Pts), rash (1 Pt), dehydration (3 Pts) and fatigue (2 Pts). Twenty-seven of 33 tumors (82%) tested positive for phospho-ERK by immunohistochemistry. Conclusions: Encouraging activity in terms of PFS has been noted in this heavily pre-treated population. Updated data will be presented. Supported by a grant from Bayer. Clinical trial information: NCT00917462.
A California population-based study on long-term survivors of hepatocellular carcinoma.
Authors: Somasundaram Subramaniam, Juan Yang, Daphne Lichtensztajn, Christina A Clarke
Journal: Journal of Clinical Oncology (2014)

195 Background: Hepatocellular carcinoma (HCC) is becoming increasingly common in the United States and long-term survival remains dismal, with only 15% of patients surviving more than 5 years. Little is known about the demographic and clinical characteristics of patients who survive. Methods: Using data from the California Cancer Registry, a member of the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) program, we identified all patients diagnosed with hepatocellular carcinoma between 1988 and 2007. Patients were included if they had pathological, clinical, laboratory or radiological confirmation of diagnosis. Patient’s demographic information including socio-economic status, summary stage, tumor characteristics and treatment details were included in the analysis. Hazard ratios (HR) for survival were calculated using Cox proportional hazards regression modeling. Results: We identified 19,855 patients with a median age of diagnosis of 63. Patients were predominantly male (74.4%). The majority of patients were Non-Hispanic Whites (38.1%) followed by Asian and Pacific Islander (API) (30.4%) and Hispanics (23.2%). Of the entire cohort, 3546 (17.9%) survived at least 3 years. Amongst long-term survivors, when classified by summary stage, 2552 (72%) were localized, 556 (15.7%) regional, 217 (6.1%) remote and 221 (6.2%) unknown. In a multivariate model, variables associated with survival were resection or transplant (HR 0.31), liver-directed therapies (0.53), chemotherapy (0.64), academic status of treating hospital (0.74), API race (0.832), highest socio-economic status quintile (0.88), female gender (0.93) and Hispanic race (0.94). When stratified by summary stage, API race, receipt of surgery, receipt of liver-directed therapies and treatment in an academic hospital remained significantly associated with long-term survival across all stages. Conclusions: Patients who survive for 3 years after a diagnosis of HCC have distinct demographic and clinical characteristics from patients who do not survive.
The role of partial splenic embolization (PSE) in the management of chemotherapy-induced thrombocytopenia.
Authors: Aki Ohinata, Michael J. Wallace, Michael J. Overman, Jonathan Phillips, Robert A. Wolff, Cathy Eng
Journal: Journal of Clinical Oncology (2012)

569 Background: Chemotherapy-induced splenomegaly is a relatively known treatment complication, where the clinical sequale of hypersplenism is persistent thrombocytopenia due to splenic sequestration. For cancer patients (pts) undergoing chemotherapy, thrombocytopenia may result in a dose delay or dose reduction, thus reducing dose intensity. The impact of refinement in technique with limited volume embolization (50-70%) of the spleen upon morbidity and mortality has not been well studied. Methods: A retrospective review of gastrointestinal cancer pts undergoing PSE for thrombocytopenia to facilitate the initiation or resumption of systemic chemotherapy between Jan. 2008 and March 2011 was completed. Pre- and post-PSE platelet (plt) counts within 30 days were evaluated for benefit of treatment. Objectives included the re-initiation of systemic therapy and post-PSE plt count &gt;150 (&lt; 30 days). Periprocedural laboratory values and adverse events were recorded. Results: PSE was performed in 79 pts. Median prior chemotherapy regimens = 2 (range 1-3). The median follow-up was 12M (range: 7-31). The mean plt count prior to PSE was 80 K/ UL (3-196). Post-PSE platelet count of &gt; 150 was achieved in 52 (66%) pts with a mean peak plt count of 219 K/UL. Six (8%) pts underwent repeat PSE due to recurrent thrombocytopenia after initiation of systemic therapy. Re-initiation of chemotherapy was achieved in 59 (79%) pts. The median duration of chemotherapy following PSE was 8M (95% CI: 4.2-14.2); median overall survival was 33M (95% CI: 10-47). Post-procedure fever developed in 7 (9%) pts and pleural effusion, atelectasis, or consolidation was reported in 8 (10%) pts. Seventeen (21%) pts developed reversible grade 1 hyperbilirubinemia. Median length of hospital stay was 3 days (interquartile range 1-5 days). 60-day mortality rate was 9% (7 of 79). Conclusions: Partial splenic embolization (PSE) is a safe and effective method of managing thrombocytopenia secondary to chemotherapy-induced hypersplenism to facilitate re-initiation of systemic therapy in cancer patients. PSE may be considered as a potential option in patients with good performance status to facilitate further systemic chemotherapy.
Expectations of discipline representation on multidisciplinary treatment planning (MTP) teams.
Authors: Irene Prabhu Das, Katherine Mallin, E. Greer Gay, Heather Rozjabek, Mary L. Fennell, Andrew K. Stewart, Kathleen M. Castro, Steven Clauser
Journal: Journal of Clinical Oncology (2013)

195 Background: The Commission on Cancer’s (CoC) standards require accredited cancer programs to utilize a multidisciplinary team approach for treatment planning. A recent CoC survey sought to characterize current multidisciplinary treatment planning (MTP) practice from the cancer programs’ perspective. Methods: The survey, administered to 1,261 programs, included items on team structure and process, case presentation, clinical trials and patient involvement. Each facility was designated to report on MTP for one cancer type: Breast, Gastrointestinal (GI), Lung, Head/Neck, Gynecologic (Gyn), Brain/Central Nervous System (CNS). A total of 797 (63%) facilities responded. Initial analyses highlight the disciplines expected to attend MTP meetings. Results: Forty-eight percent expected all core physician specialties (Medical Oncology, Radiation Oncology, Surgery and/or Surgical Oncology), to attend the initial case presentation. Respondents also expected affiliated specialists and professionals to attend initial case presentations, and included pathologists (90%), clinical trials nurses (46%), patient navigators (37%), primary care providers (20%), and genetic counselors (18%). Data analysis demonstrated significant variation in expected disciplinary attendance for select providers depending on type of cancer program, as illustrated below (Table). Analysis by cancer type showed that primary care physicians were expected to attend Lung MTP meetings at 25% of the facilities compared to Breast (15%). Genetic counselors were expected to attend MTP meetings for Breast (29%), Gyn (24%), and GI (18%). Additional analyses are ongoing. Conclusions: To improve cancer care quality, the CoC has put forward standards to foster multidisciplinary professional participation in the treatment of cancer care. Findings indicate expectations of attendance for key disciplines at MTP meetings vary by tumor–specific MTP and by type of cancer program. Key genetic markers for certain sites may also explain why genetic counselors are expected to attend. [Table: see text]
Impact of <i>KRAS, BRAF</i>, and <i>PIK3CA</i> mutations, PTEN, <i>AREG,</i> and <i>EREG</i> expression, and skin rash in metastatic colorectal cancer patients treated with cetuximab-containing salvage treatment.
Authors: Z. Saridaki, M. Tzardi, C. Papadaki, M. Sfakianaki, F. Pega, A. Kalikaki, E. Tsakalaki, D. Mavroudis, V. Georgoulias, I. Sougklakos
Journal: Journal of Clinical Oncology (2011)

445 Background: To investigate the predictive significance of KRAS exon 2, BRAF V600E, PIK3CA exon 9 and 20 mutational status, AREG- EREG mRNA expression, PTEN protein expression and skin rash in patients with metastatic colorectal cancer (mCRC) treated with cetuximab containing salvage chemotherapy. Methods: Primary tumors from 112 mCRC patients were analyzed. The worst skin toxicity during treatment was recorded. Results: KRAS, BRAF and PIK3CA mutations were present in 37 (33%), 8 (7.2%) and 11 (9.8%) cases, respectively, PTEN was lost in 21 (19.8%) cases, AREG and EREG were overexpressed in 48 (45%) and 51 (49%) cases. In the whole study population, time to tumor progression (TTP) and overall survival (OS) was significantly lower in patients with KRAS (p=0.001 and p=0.026, respectively) or BRAF (p=0.001 and p&lt;0.0001, respectively) mutant tumors, downregulation of AREG (p=0.018 and p=0.013, respectively) or EREG (p=0.002 and p=0.004, respectively) and in those with grade 0-1 skin rash (p&lt;0.0001 and p&lt;0.0001, respectively). In KRAS wt patients TTP and OS was significantly lower in patients with BRAF (p=0.0001 and p&lt;0.0001, respectively) mutant tumors, downregulation of AREG (p=0.021 and p=0.004, respectively) or EREG (p=0.0001 and p&lt;0.0001, respectively) and grade 0-1 skin rash (p&lt;0.0001 and p&lt;0.0001, respectively). TTP was significantly lower in patients with PIK3CA mutations (p=0.01) or lost PTEN (p=0.002). Multivariate analysis revealed KRAS (hazard ratio [HR] 4.3, p&lt;0.0001), BRAF mutation (HR: 5.1, p&lt;0.0001), EREG low mRNA expression (HR: 1.6, p=0.021) and absence of severe/moderate skin rash (HR: 4.0, p&lt;0.0001) as independent prognostic factors for decreased TTP. Similarly, KRAS (HR 2.9, p=0.01), BRAF mutation (HR: 3.0, p=0.001), EREG low mRNA expression (HR: 1.7, p=0.021), absecence of severe/moderate skin rash (HR: 3.7, p&lt;0.0001) and the presence of undifferantited tumours (HR: 2.2, p=0.001) were revealed as independent prognostic factors for decreased OS. Conclusions: These results underscore the potential of advanced CRCs genetic profiling in order to identify patients with different treatment response. No significant financial relationships to disclose.
Effect of oral ibandronate versus intravenous (i.v.) zoledronic acid on markers of bone resorption in patients with breast cancer and bone metastases: Results from a comparative phase III trial
Authors: J.-J. Body, M. Lichinitser, S. A. Tjulandin, M. Budde, B. Bergström
Journal: Journal of Clinical Oncology (2005)

534 Background: There is a correlation between suppression of bone resorption markers and the rate of reduction in skeletal-related events (SREs). Data for oral clodronate suggest that orally administered bisphosphonates may not be as effective as i.v. bisphosphonates. However, there have been no head-to-head randomized clinical trials. This multicenter, randomized, open-label, parallel group study directly compares oral ibandronate with i.v. zoledronic acid with respect to biochemical markers of bone turnover. Methods: Advanced breast cancer patients with at least one confirmed osteolytic or mixed bone lesion received oral ibandronate 50mg/day (n=114) or i.v. zoledronic acid 4mg (n=110), infused over 15 minutes every 4 weeks for 12 weeks. Eligibility criteria included: ≥18 years of age; life expectancy ≥6 months, WHO Performance Status of 0, 1 or 2; adequate renal function (serum creatinine ≤3.0 mg/dL). The primary endpoint was the mean percentage change in cross-linked C-terminal telopeptide of type I collagen in serum (S-CTX) at the end of the study. Bone specific alkaline phosphatase (BAP), the amino-terminal procollagen propeptides of type I collagen (P1NP), and osteocalcin (OC) were also measured. Results: Mean (CI) percent changes from baseline were as follows. S-CTX: ibandronate −77% (CI −82% to −73%) vs zoledronic acid −75% (CI −82% to −67%); BAP: ibandronate −35% (CI −43% to −28%) vs zoledronic acid −32% (CI −47% to −17%); P1NP: ibandronate −48% (CI −56% to −40%) vs zoledronic acid −42% (CI −55% to −29%); OC: ibandronate −35% (CI −40% to −30%) vs zoledronic acid −34% (CI −45% to −22%). Conclusion: In this head-to-head trial, oral ibandronate was statistically non-inferior to zoledronic acid for the primary endpoint of S-CTX. It also showed similar effects to that of zoledronic acid on serum BAP, P1NP and OC. Overall, a convenient oral ibandronate dose of 50mg/day is as effective as zoledronic acid in suppressing tumor induced bone resorption. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Roche Roche Roche