tbuckley/cabot-search huggingface dataset:
Head of US Mayo Clinic reconsiders comments that privately insured patients should have priority
Authors: Michael McCarthy
Journal: BMJ (2017)

The head of the prestigious Mayo Clinic in Minnesota, USA, has tried to distance himself from his remarks that patients with private insurance should have priority over those with government cover, by reassuring the public that a patient’s medical need is the center’s “top priority.”

John Noseworthy, president and CEO of the Mayo Clinic, had told staff that, when patients with similar problems seek care at the clinic, patients with commercial insurance should be given priority over those covered by Medicaid or Medicare—government run programs for poor, elderly, and disabled people.

Noseworthy was quoted as saying, “We’re asking . . . that we prioritize the commercial insured patients enough so . . . we can be financially strong at the end of the year.” State officials plan to investigate the …
Antiemetic effectiveness of palonosetron and first-generation serotonin inhibitors for high emetic risk chemotherapy in the post-aprepitant era.
Authors: Jina Yun, Young Woo Jeon, Han Jo Kim, Kyoung Ha Kim, Se Hyung Kim, Hyun Jung Kim, Sang Cheol Lee, Sang Byung Bae, Namsu Lee, Kyu Taek Lee, Sung Kyu Park, Jong-Ho Won, Dae Sik Hong, Hee Sook Park
Journal: Journal of Clinical Oncology (2012)

e19554 Background: Palonosetron(PAL) is a 5-HT3 antagonist with an approximately 100-fold higher binding affinity for the 5-HT3 receptor compared to the other serotonic antagonists(i.e., ondansetron, granisetron, and dolasetron). Several large phase III trials have demonstrated the superiority of palonosetron compared with other 5-HT3 antagonists in preventing emesis associated with both moderate and high emetic risk chemotherapy regimens. But, these studies carried out in the pre-aprepitant era. We assessed that PAL is still preferred over the other serotonin inhibitors for high emetic risk chemotherapy in the post-aprepitant era. Methods: A retrospective analysis was made of all patients who underwent serotonin inhibitor, aprepitant and dexamethaxone for high emetic risk chemotherapy between 2009 and 2011. Group A received PAL, aprepitant and dexamethaxone. Group B received first-generation serotonin inhibitors(ondansetron, granisetron or dolasetron), aprepitant and dexamethaxone. Results: Four hundred fourty patients were included in the analyses: 331 patients in the Group A and 109 patients in the Group B. No case of grade 3-4 nausea/vomiting was noted. There were no significant differences between Group A and Group B for both acute and delayed CINV. The proportion of patients with a emesis-free during the acute phase(0-24 h) was similar in both groups: 275 of 331 patients(83%) in the Group A vs 88 of 109 patients(81%) in the Group B. The proportion of patients with a emesis-free during the delayed phase(24-120h) was similar in both groups: 255 of 331(77%) vs 76 of 109 (70%). Conclusions: In aprepitant era, all of the serotonin inhibitors seems to be equally effective for high emetic risk chemotherapy.
Pomalidomide (POM) with or without low-dose dexamethasone (LoDEX) in patients (Pts) with relapsed and refractory multiple myeloma (RRMM): MM-002 phase II age subgroup analysis.
Authors: Sundar Jagannath, Craig C. Hofmeister, Rachid C. Baz, David Samuel DiCapua Siegel, Ravi Vij, Christine Chen, Sagar Lonial, Kenneth Carl Anderson, Min Chen, Mohamed H. Zaki, Paul Gerard Guy Richardson
Journal: Journal of Clinical Oncology (2013)

8532 Background: POM demonstrated clinical efficacy and favorable tolerability in RRMM pts previously treated with lenalidomide (LEN) and bortezomib (BORT), in the randomized, multicenter, open label MM-002 phase II trial. This analysis evaluated whether the efficacy and tolerability of POM+LoDEX treatment is consistent across age subgroups. Methods: Pts with RRMM who had received ≥ 2 prior therapies, including LEN and BORT, and were refractory to their last regimen were randomized to either POM+LoDEX (POM 4 mg/day, days 1–21 of a 28-day cycle; LoDEX 40 mg/week) or POM alone. End points included progression-free survival (PFS), response rate (based on EBMT criteria), response duration, and safety. A post-hoc analysis based on age (≤ 65 vs. &gt; 65 yrs) was conducted. Results: A total of 221 pts with a mean age of 64 yrs (range 34–88) were randomized to POM+LoDEX (n = 113) or POM (n = 108). The efficacy outcomes and the most common treatment emergent grade 3/4 adverse events (AEs) for the age subgroups according to treatment arm are presented in the Table. Conclusions: Regardless of age (≤ 65 vs. &gt; 65 yrs), POM with or without LoDEX was effective and generally well tolerated in heavily pretreated RRMM pts who had already received LEN and BORT. POM with or without LoDEX represents a new clinical option for pts previously treated with numerous lines of therapy. Updated data will be presented at the meeting. Clinical trial information: NCT00833833. [Table: see text]
A clinical and translational phase II trial of sequential axitinib and carboplatin/paclitaxel in advanced melanoma.
Authors: Alain Patrick Algazi, Edward Cha, Miguel H Pampaloni, Spencer Behr, Brandon Cortez, Anteo Quiroz, Fergus V. Coakley, Songling Liu, Adil Daud
Journal: Journal of Clinical Oncology (2012)

8580 Background: Several clinical trials adding VEGF signaling inhibitors to chemotherapy have not demonstrated any benefit over chemotherapy alone in advanced melanoma potentially due to decreased tumor cell proliferation induced by VEGF blockade. We tested the hypothesis that sequential administration of axitinib followed by carboplatin and paclitaxel may be more effective than chemotherapy alone in metastatic melanoma. Methods: We conducted a prospective phase II trial of this combination in previously treated metastatic melanoma patients. Patients had an ECOG PS 0-1, and normal organ function. Axitinib 5 mg PO bid was taken on days 1 through 14 of each 21-day treatment cycle, and carboplatin (AUC=5) with paclitaxel (175 mg/m 2 ) was administered on day 1 starting with cycle 2. FLT-PET scans were performed on 6 patients to assess tumor cell proliferation on days 1, 14, 17, and 20 of cycle 1. Results: Treatment has been well tolerated. The most common grade 3 AEs have been neutropenia, hypertension, and gastrointestinal events. Grade 4 non-hematologic AEs have not been observed. 4 of 5 patients completing FLT-PET scans to date showed increases (23% to 92%) in SUV values during the axitinib holiday. The fifth patient had a single, minimally FLT avid lesion at baseline (SUV=1.9). In 30 evaluable patients, there have been 4 confirmed PRs, 2 unconfirmed PRs, and 3 patients with 28.6, 29.3, and 29.5% decreases in tumor size by RECIST. Overall, 19 patients have had SD and 5 have had PD as the best response. With a median follow-up of 8.3 months and 17 patients still active, the median PFS is 6.9 months, and 23 patients (77%) are still alive. 26 of 30 evaluable patients have been wild type for BRAF-V600E/K mutations. Conclusions: Axitinib followed by carboplatin and paclitaxel has been well tolerated and effective in a largely BRAF wild-type metastatic melanoma population. Given the urgent need for effective therapies in this population, this regimen warrants phase III testing.
Geriatric oncology: Comprehensive geriatric assessment tools (CGA) implementation and interdisciplinary clinical approach for elderly patients (pts) in AC Camargo Cancer Center (ACCCC), Sao Paulo, Brazil.
Authors: Aldo A. Dettino, Barbara C M Figueroa, Ana M M Leite, Ludmilla T.D. Chinen, Ulisses Ribaldo Nicolau, Solange M. Sanches, Ana C Levy, Tiago Cordeiro Felismino, Milton Jose De Barros E. Silva, Helano C. Freitas, Katia Antunes, Marcelo Calil Machado Netto, Fábio Nasser Santos, Celso Lopes Mello, Alexandre Andre Balieiro Anastacio da Costa, Tadeu Ferreira Paiva, Milena Tariki, Adriana Regina G. Ribeiro, Joyce Maria L. Maia, Marcello Ferretti Fanelli
Journal: Journal of Clinical Oncology (2014)

9549 Background: Ageing is a global phenomenon, also in Brazil. That shift in demographics has huge impact in healthcare. Although still emerging in developing nations, there is no major national innitiative focusing on oncologic geriatric pts. The study describes a program to improve care in >70y cancer pts in A C Camargo Cancer Center, Sao Paulo. We hypothesized that incorporating CGA into daily practice can improve individualized care. Methods: aims of the study were to evaluate if: 1) CGA could be feasible in daily practice, 2) it could be useful as a tool in treatment/tx decision making, 3) analyse the impact of CGA in the selection of tx, with its ability to predict complications (such as dose reduction, hospitalization, or tx discontinuation) in a recently implemented Oncogeriatric Unit. Pts >70y, candidates to receive systemic tx, underwent CGA assessments, which included scales of: ADL (Katz, Lawton), mini-nutritional assessment, depression (GDS), comorbidities and polypharmacy. Patients were classified as fit (around 50%), borderline or frail. Fit pts received mainly full treatment; frail/borderline pts, mainly modified tx and/or specific supportive care. Results: From Mar/12-Jan/13, 620 pts were evaluated by CGA - female 56%; cancers (%): breast 30, prostate 14, colorectal 13, hematologic 12. Katz A=75%, Lawton 27=50%; polipharmacy (>=5): 49%; depression 10%, undernutrition: 28%. There was association between the choice of oncologic treatment (original vs modified: 89 vs 11%; with additional dose reduction 11%) with Katz (p=0.011, likelihood ratio[lr]=6), Lawton (p<0.001, lr=26), depression (p=0.035, lr=9) and nutrition scales (p=0.004, lr=14). The ability to complete the individualized proposed treatment (96%) was correlated with Lawton (p=0.04, lr=9) scale. Hospitalization during chemotherapy was associated with comorbidities (p=0.038), altered Katz (p=0.004, lr=4.5), Lawton (p=0.012, lr=6.5) and depression scales (p=0.032, lr=10). Conclusions: In this cohort, the incorporation of CGA in daily practice was feasible and useful to predict complications of systemic cancer tx.
Effect of the combination therapy of sorafenib and radiofrequency ablation on the survival time of advanced HCC.
Authors: Nanya Wang, Wei Li, Hengjun Zhao, Jiuwei Cui
Journal: Journal of Clinical Oncology (2013)

e15198 Background: Hepatocellular carcinoma (HCC) is one of the most common cancers in the worldwide. In China, accounts for 70% patients are in the advanced stage at the first diagnosis. Sorafenib is the only systemic therapy in adavanced HCC. Radiofrequency ablation (RFA) therapy is an new and effective minimally invasive method recent years and there are rare reports of the combination of RFA and sorafenib for the advanced HCC. This study was designed to observe the effect and security of the combination therapy with RFA and sorafenib for advanced HCC. Methods: Twenty-four advanced HCC patients treated with sorafenib for more than 3 months were divided into two groups: sorafenib alone (13 cases) and RFA/sorafenib (11 cases). The tumor status of these patients was evaluated with computed tomography (CT) every 1~2 months. Progression-free survival (PFS), Overall survival(OS) and adverse effects were observed. Results: The median PFS in sorafenib group was 3.9 (2.3-5.8) months, while median PFS in RFA/sorafenib group was 6.8 (2.5-12.8) months. The combination therapy got longer PFS than treated sorafenib only (P&lt;0.05). And the mOS in sorafenib group and RFA/sorafenib group were 16.3 vs. 22.7months (P&lt;0.05). The side effect of radiofrequency ablation are mainly included fever and pain in puncture location. And only 2 patients got pleural effusion post-operation. All the side effects are disappeared in 2 weeks. The most common adverse reactions observed in patients treated with sorafenib were: fatigue, weight loss, rash or superficial skin desquamation, hand-foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain, only 3 patients got severe hand-foot skin reaction and diarrhea, but all of them continued the sorafenib oraled after symptomatic treatment. Conclusions: RFA combined with sorafenib prolonged the PFS and OS in advanced HCC. This combination therapy is safe and effective for patients with advanced HCC. This approach could be a new choice for advanced HCC.
A phase I trial of the safety and immunogenicity of a DNA-based vaccine encoding the HER2/neu (HER2) intracellular domain in subjects with HER2+ breast cancer.
Authors: Mary L. Disis, Andrew L. Coveler, Doreen Higgins, Patricia Fintak, James Ross Waisman, Jessica Reichow, Meredith Slota, Jennifer Childs, Yushe Dang, Lupe G. Salazar
Journal: Journal of Clinical Oncology (2014)

616 Background: Vaccination with the intracellular domain (ICD) of HER2 in pre-clinical models is both immunogenic and protective against the development of mammary tumors. This study was designed to examine the safety and immunogenicity of a DNA-based vaccine encoding the HER2 ICD in subjects with HER2+ breast cancer. Methods: Sixty-six patients with stage III or IV breast cancer in remission were enrolled sequentially into three vaccine arms: 1 (10µg), 2 (100µg) and 3 (500µg). Vaccines were admixed with 100µg GM-CSF and administered i.d. monthly for three immunizations. Endpoints included safety and immunogenicity (optimum dose). Toxicity and HER2 specific IFN-gamma immune responses were evaluated and DNA persistence at the vaccine site was assessed. Results: Sixty-four of the 66 (97%) patients enrolled completed all vaccinations. Vaccination was associated with minimal toxicity. All three doses of vaccine were able to significantly induce or boost HER2-specific T cell responses to ICD, however the incidence of subjects with augmented immunity was greatest in Arm 2 (14/22, 64%) when compared to Arm 1 (9/17, 53%) and Arm 3 (8/22, 36%). Patients in Arms 2 and 3 had immune responses to HER2 ICD of higher magnitude than patients in Arm 1, however, only patients in Arm 2 retained immunity at 1 year after vaccination. DNA persistence in the vaccine site was related to dose being found most frequently in Arm 3 patients. DNA persistence was associated with a decrease in magnitude of HER2 ICD response and long term immunity. At a median follow-up of 68 months after vaccination, patients in Arm 2 demonstrate superior overall survival (p=0.02) as compared with patients in arm 3. Conclusions: Immunization with a DNA-based HER2 ICD vaccine is safe and can generate robust T-cell responses in treated patients. The resulting immune response is dose-dependent, with 100µg as the optimal dose. Higher vaccine doses may have a detrimental effect on the long term retention of immunity. Clinical trial information: NCT00436254.
A large prospective Italian population study (Project of Emilia-Romagna Region in Neuro-Oncology; PERNO) in newly diagnosed GBM patients (pts): Outcome analysis and correlations with <i>MGMT</i> methylation status in the elderly population.
Authors: Enrico Franceschi, Alicia Tosoni, Luca Morandi, Serenella Cerasoli, Giovanni Lanza, Roberta Depenni, Alessandro Gamboni, Claudio Dazzi, Gianluca Marucci, Giorgio Gardini, Eugenio Pozzati, Benedetta Urbini, Isabella Dascola, Stefania Bartolini, Claudia Biasini, Paolo Carpeggiani, Elena Zunarelli, Enrico Maria Silini, Mario Ermani, Alba Ariela Brandes
Journal: Journal of Clinical Oncology (2013)

2021 Background: The role of temozolomide concurrent with and adjuvant to radiotherapy (RT/TMZ) in elderly pts with GBM remains unclear. We therefore evaluated the efficacy of this approach in pts &gt;70 years in the context of the Project of Emilia-Romagna Region in Neuro-Oncology (PERNO), the first Italian prospective observational population-based study in neuro-oncology. Methods: The criteria for selecting pts enrolled in the PERNO study were: age &gt;70 years; PS 0-3; histologically confirmed GBM; postoperative radiotherapy after surgery; residence in the Emilia Romagna region. Data were collected prospectively. Results: Pts accrual, started on January 1 2009, was closed, as planned, on December 31 2010. In the pts enrolled (n=53), median overall survival (mOS) was 11.1 months (95% CI: 8.8 - 13.5); survival rates at 1-, 2- and 3-years were 41.5% (95% CI: 28.2 – 54.8%), 15.2% (95% CI: 4.8 – 25.6%) and 6.1% (95%CI: 0 – 15.9%), respectively. Twenty-eight pts received RT/TMZ, and 25 pts RT alone. mOS was 11.6 months (95% CI: 8.6 – 14.6) following RT/TMZ and 9.3 months (95% CI: 8.1 – 10.6) following RT alone. mOS for pts with MGMT methylated status (n = 17) was 13.5 months (95% CI: 7.7 – 19.2), being 17.2 months (95% CI: 11.5 - 22.9) in those treated with RT/TMZ (n = 6) and 8.8 months (95% CI: 2 – 15.6) in those treated with RT alone (n = 11, p = 0.09). Elderly pts with MGMT unmethylated status (n = 25) had a mOS of 8.5 months (95% CI: 6 – 11, p = 0.014), being 8.5 months (95% CI: 2.3 – 14.7) in pts treated with RT/TMZ (n =10), and 8 months (95% CI: 3 – 12.9) in those treated with RT (n = 15, p = 0.55). Conclusions: RT/TMZ appears to be more effective in prolonging the mOS of elderly pts in those with MGMT methylation status (17.2 vs 8.5 months), and seem to perform better than TMZ alone, for which mOS was 9.7 months in the Nordic phase III trial. These findings underline the value of the ongoing randomized EORTC 26062-22061/NCIC CE.6 phase III comparing RT/TMZ with short course RT alone.
CA184-240: A single-arm, open-label phase II study of vemurafenib followed by ipilimumab in patients with BRAF V600-mutated advanced melanoma (AM).
Authors: F. Stephen Hodi, Asim Amin, Yvonne M. Saenger, Gregory K. Pennock, Troy H. Guthrie, April K. Salama, Lawrence E. Flaherty, Henry B. Koon, David H. Lawson, Montaser F. Shaheen, Agnes Balogh, Cyril Konto, Steven O'Day
Journal: Journal of Clinical Oncology (2013)

TPS9103 Background: Ipilimumab (Ipi), a fully human monoclonal antibody that binds to cytotoxic T-lymphocyte antigen-4 expressed on T cells, and vemurafenib (Vem), a small molecule inhibitor of BRAF V600-mutated kinase, are both approved treatments for AM. Ipi has shown improved overall survival (OS) in two randomized phase III trials of patients with previously treated (3 mg/kg monotherapy) and previously untreated (10 mg/kg plus dacarbazine) AM. Vem has shown improved OS in a randomized phase III trial of patients that harbor the BRAF V600E mutation. The most common drug-related adverse events (AEs) with Ipi monotherapy were immune-related GI tract and skin toxicities, which were generally manageable using treatment guidelines. The most common AEs with Vem were arthralgia, rash, and fatigue. Vem can induce rapid and substantial responses, and resistance mechanisms are a focus of current investigation. This study will evaluate the safety of Vem lead-in followed by Ipi (prior to resistance) in patients with BRAF V600-mutated AM. Methods: An estimated 45 patients will be enrolled. Eligible patients include those ≥18 years old with previously untreated AM, a BRAF V600 mutation, and an ECOG PS of 0 or 1. Major exclusion criteria are primary ocular melanoma, active brain metastases, and autoimmune disease. Patients will initially receive Vem for 6 weeks (960 mg twice daily). After a washout period of 3-10 days (per protocol), patients will be initiated on Ipi at 10 mg/kg (every 3 wk for 4 doses, then once every 12 wk beginning at week 24, until disease progression or unacceptable toxicity). Vem will be restarted at the time of disease progression on Ipi (no minimum time to restart) or unacceptable toxicity on Ipi (restart minimum of 1 mo after the last dose of Ipi). Vem will be restarted at the last dose level tolerated at the end of the lead-in phase. Patients will be followed every 12 weeks for toxicity and/or disease progression, and subsequently will be followed every 12 weeks for survival. The objectives of this study are to estimate the incidence of grade 3-4 drug-related AEs. Exploratory objectives include the evaluation of efficacy (OS). Clinical trial information: NCT01673854.
Angiotensin converting enzyme inhibition in diabetic nephropathy
Authors: J. A. Breyer, L. G. Hunsicker, R. P. Bain, E. J. Lewis, J. Lachin, S. Greenhouse, T. Turlington, P. Burrows, J. Wish, J. Sheehan, M. Pohl, T. Berl, G. Santiago, J. Lemann, S. Blumenthal, B. Bresnahan, L. Hebert, N. S. Nahman, S. Goldfarb
Journal: Kidney International (1994)
The impact of pulmnary emphysema evaluated by CT on lung metastasis in rectal cancer.
Authors: Naoyuki Toyota, Masashi Tsuruta, Hirotoshi Hasegawa, Koji Okabayashi, Takashi Ishida, Takayuki Kondo, Yuko Kitagawa
Journal: Journal of Clinical Oncology (2017)

582 Background: Our previous study suggested that smoking history could be a risk factor for pulmonary metastasis following rectal cancer surgery. Smoking causes emphysematous change in the lung, however, it remains unclear how much impact of pulmonary emphysema (PE) on the pathogenesis of pulmonary metastasis in rectal cancer. The objective of this study is to clarify the influence of PE on the pulmonary metastasis. Methods: Patients with rectal cancer who underwent curative resection from September 2005 to May 2014 in our institution were enrolled and their medical records were reviewed including the percentage volume of low attenuation area in the whole lung (LAA%), which were calculated from their preoperative chest CT by using AZE virtual place. PE was defined as more than 10% in LAA% and statistically evaluated the correlation with relapse free survival for pulmonary metastasis (RFSP). Results: A total of 286 patients, who consists of 7 in stage0,102 in StageⅠ, 75 in StageⅡ, and 102 in stageⅢ, were enrolled. The median LAA% was 3.16±3.78% and 14 patients (4.9%) were diagnosed PE by LAA%. Postoperative pulmonary metastasis was observed in 22 patients, including 3 patients in PE. Five-year RFSP rate in PE was significantly poorer than non-PE (25.4% vs 7.7%, p=0.02) by log-rank test. Multivariate survival analysis using Cox’s regression model revealed that PE was an independent risk factor for RFSP (Hazard Ratio = 19.14 [3.18 – 115.20], p &lt; 0.001). Conclusions: Pulmonary emphysema may have a robust impact on pulmonary relapse after curative surgical resection of rectal cancer.