tbuckley/cabot-search huggingface dataset:
Is the informed consent (IC) to treatment truly “informed”? The use of a comprehension check tool (CCT).
Authors: R. Biamonte, S. Turano, C. Mastroianni, V. Liguori, R. De Simone, S. Conforti, G. Gadaleta-Caldarola, A. Piattelli, M. Iuvaro, S. Palazzo
Journal: Journal of Clinical Oncology (2010)

6128 Background: The IC is ethically and legally required for most medical acts involving patients. However, standardized methods for assessing the adequacy of the IC process and the level of understanding of the patient are lacking. Methods: In our Oncology Department (OD), 18 months ago we introduced a new model of structured IC comprising eight domains and designed to optimize the communication between physician and patients. This new instrument should not only to provide the necessary information, but also to assess the patient's awareness on some “key issues”: diagnosis, prognosis, potential benefits, and side effects of therapy. Therefore, our IC combines two parts: first specific, detailed, fully informative and totally performed by the patient and second, called “CCT,” to evaluate the comprehension level of received information and supervised by the physician. Since August 2008 until November 2009 we administered 447 IC in our OD. In 298 cancer patients adjuvant therapy were made, and 149 patients starting palliative care. Results: Data on the analysis performed on our sample inherent the degree ofunderstanding about the “critical issues” are listed in the Table. 14.6% of patients has difficult to know their cancer diagnosis, 25.8% do not know the potential benefits associated with the chemotherapy, 49.4% do not know the potential risks resulting associated with chemotherapy, but the most striking is related to awareness of the prognosis: the 55,1% do not have proper information on it. Conclusions: It is clear that the prognosis communication represents a crucial step, particularly in the advanced disease. The integration of the IC with CCT is indispensable to strengthen the physician-patient communication. Source insufficient information IC CCT Prognosis Diagnosis Potential benefits Side effects 245 (55.1%) 65 (14.6%) 115 (25.8%) 220 (49.4%) No significant financial relationships to disclose.
Abstract P166: Initially Healthy Cuban Immigrants Exhibit Average Increases in Waist Circumference Associated with Insulin Resistance Soon after United States Arrival
Authors: William Arguelles, Scott C Brown, Shi Huang, Tatiana Perrino, Gianna Perez-Gomez, Maria M Llabre, Ronald Goldberg, Armando Mendez, Neil Schneiderman, José Szapocznik
Journal: Circulation (2014)

U.S. Hispanics are disproportionately burdened by obesity and diabetes compared to non-Hispanic whites. While risk for these conditions appears to increase with longer U.S. residence among Hispanic immigrants, it remains unclear exactly how, when, and for whom the cardiometabolic indices underlying these disorders change upon arrival to the U.S. This study used latent growth modeling to examine change in waist circumference (WC) related to change in insulin resistance (measured via the homeostatic model assessment of insulin resistance, HOMA-IR) over an average 22-month follow-up in a sample of healthy Cuban immigrants assessed within 4 months of U.S. arrival (mean = 40.2 days). Men (n = 194, mean age = 37.1 years) and women (n = 174, mean age = 37.3 years) were analyzed separately. Analyses adjusted for age, days in U.S. prior to baseline, household income, and education. On average, WC increased in both men (0.032 cm per month, p = 0.055) and women (0.098 cm per month, p &lt; 0.001). Lower household income at baseline was associated with greater WC increase in men (B = -0.020, p = 0.043) but not women, adjusted for baseline WC. Age, days in U.S., and education were not related to WC change in either men or women. Furthermore, change in WC was positively related to change in HOMA-IR in both men (B = 0.092, p = 0.001) and women (B = 0.048, p = 0.021), adjusted for baseline WC and HOMA-IR. Findings suggest that initially healthy Cuban immigrants exhibit increases in abdominal adiposity soon after arriving in the U.S., and that this rate of change is (1) about three times higher in female compared to male immigrants, and (2) associated with concurrent increases in insulin resistance. Future research aimed at further elucidating these trends - as well as identifying important environmental and psychosocial predictors - may inform optimal intervention approaches for reducing health disparities observed among Hispanics.
Erythropoietin for anemia treatment of patients with GIST receiving imatinib
Authors: F. Duffaud, A. Lecesne, I. Ray-Coquard, E. Bompass, K. Assi, P. Berthaud, F. Ducimetiere, J.-Y. Blay
Journal: Journal of Clinical Oncology (2004)

9046 Background:Imatinib (Glivec®) is a c-kit tyrosine kinase inhibitor recently established as the standard treatment for advanced/metastatic GIST. Anemia is frequently observed in patients with advanced GIST, and is one of the most frequent side effects of imatinib (89% of patients) while this drug causes grade 3–4 anemia in 10% of patients. Whether EPO treatment is useful in the management of GIST patients receiving imatinib treatment is unknown. Methods:A retrospective study of EPO treatment in GIST patients receiving imatinib was undertaken in 4 centers. Thirty four patients received EPO treatment among the 319 GIST patients treated with imatinib in clinical trials or with compassionate use since 2001. The impact of EPO treatment on the anemia and the predictive factors of efficacy were investigated. Results:34 patients were included as follows: Male/Female=18/16; median age= 59 years; median WHO-PS= 1; metastatic/advanced GIST= 32/2. Original site of disease was mainly gastric (32%) and small bowel (29%). Sites of metastases (mets) were mainly liver (82%) and peritoneum (79%). The median delay between the initiation of imatinib treatment and EPO was 58 days (range 0–553). Median hemoglobin level (HGB) prior to EPO was 90 g/L (range 69–118) and 117 g/L (range 68–144) after 2 months. An increase of more than 2g/L was observed in 18 (53%) of patients. None of the 7 patients who had previously progressed (PD) under imatinib treatment (400 mg/day) experienced HGB response, as compared to 66% (18/27) of the remaining patients (PR+SD) (p=0,002). Primary tumor site, liver mets, peritoneal mets, age, gender did not correlate with HGB response to EPO. Response to EPO was observed in 2/11 patients receiving high-dose imatinib (800 mg/day) vs 16/23 of others. Using logistic regression, only PD before EPO treatment was retained as a predictive factor for EPO response. Conclusions:EPO increases hemoglobin level in most anaemic GIST patients who have not progressed under imatinib treatment, but not in refractory GIST patients. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen
Assay for Mutagenicity of Bile in Sprague-Dawley Rats Treated Subcutaneously With Intestinal Carcinogens
Authors: M Moriya, T Ohta, F Sugiyama, T Miyazawa, Y Shirasu
Journal: JNCI Journal of the National Cancer Institute (1979)

To investigate the mode of action of sc injected intestinal carcinogens, the mutagenicity assay of bile collected from noninbred Sprague-Dawley rats treated sc with carcinogens was conducted in the presence and absence of beta-glucuronidase. The bile samples from rats inoculated with 4-aminobiphenyl were mutagenic for Salmonella typhimurium TA100 only in the presence of beta-glucuronidase, whereas those from the 3,2'-dimethyl-4-aminobiphenyl-treated rats did not require the enzyme for mutagenicity toward strain TA100. On the contrary, the assays with S. typhimurium G46 and TA100 of bile from rats inoculated with 1,2-dimethylhydrazine, azoxymethane, or methylazoxymethanol acetate failed to reveal mutagenicity whether beta-glucuronidase was added or not, though these carcinogens were highly mutagenic for strain G46 in the Salmonella-microsome mutagenicity test and/or in the host-mediated assay.
The incidence and impact of comorbidity on survival and selection of initial treatment in elderly patients (pts) with head and neck cancer (HNC)
Authors: A. Ghobadi, M. Athar, J. Dowell
Journal: Journal of Clinical Oncology (2009)

6065 Background: Comorbidity has been shown to be a determinant of survival and treatment selection in various cancers including HNC. Higher comorbidity index is associated with higher utilization of non-curative intent treatment. Methods: In this retrospective study we analyzed 182 consecutively treated HNC pts &gt;65 years (y) old at the Dallas VAMC from January 2000 through June 2007. Comorbidity was assessed with the Charlson Comorbidity Index (CCI). Treatment was classified as curative intent versus non-curative intent. The goals were 1) to demonstrate burden of comorbidity and 2) to demonstrate the impact of comorbidity on overall survival and selection of initial treatment in elderly HNC pts. Results: Pts characteristics: 100% male; 80% white, 19.5% Black, 0.5% Hispanic; median age 72y (range 65–87); 3% stage 0, 26% stage I, 20% stage II, 18% stage III, 30% stage IV, 2% unknown; primary site - 30% oral cavity, 4% hypopharnyx, 22% oropharynx, 38% larynx, 4% other, 1% unknown; treatment - 26% radiation only, 44% surgery (S), 21% chemoradiation (CR), 9% no treatment; Median CCI -2 (range 0–11); 61% had CCI score 0–2 and 39% had CI score &gt; 3. Median overall survival was 883 days (SE 19.31 days). Rate of curative vs. non-curative intent treatment was 80% vs. 20% respectively. Pts with CCI score 0–2 had a non-significant higher rate of curative intent treatment than pts with CCI score &gt; 3 (83.8% vs. 74.6% p = 0.13). In multivariate analysis including CCI, age, race, alcohol use, primary site, treatment, and stage, only advanced clinical stage had significant prognostic importance (HR 1.66; 95% CI, 1.29 to 2.14; p &lt; 0.0005). The HR for CCI was 1.11 (95% CI, .99–1.24; p = 0.08). In separate multivariate analyses of pts treated with S and pts treated with CR, CCI was not a significant predictor of survival with HR of .88 (95% CI, .69–1.11; p = 0.29) and 1.13 (95% CI, .83–1.53; p = 0.44), respectively. Conclusions: In our population of elderly HNC pts, CCI and age had no significant impact on survival or selection of curative intent treatment. Additional study is required to better define appropriate candidates for curative intent treatment in this population. No significant financial relationships to disclose.
Progesterone receptor gene polymorphism (PROGINS) in 701 women from a mammographic breast cancer screening program (NMPOA) in Southern Brazil
Authors: J. Giacomazzi, E. Aguiar, E. I. Palmero, L. Kalakun, L. Schuler-Faccini, D. Duarte Filho, A. Bedin, M. Caleffi, R. Giugliani, P. Ashton-Prolla
Journal: Journal of Clinical Oncology (2007)

21048 Background: Several genetic polymorphisms in hormone receptor genes have been associated with breast cancer (BC) risk. Among these, a 306 base-pair insertion of the Alu subfamily in intron 7 of the progesterone receptor (PR) gene, (PROGINS), has been associated with decreased BC risk in several populations. In Brazil, BC is a significant public health problem, due to its high incidence and mortality rates. In Porto Alegre, Brazil`s southernmost capital, a multidisciplinary Breast Cancer Prevention Project - the Nucleo Mama Porto Alegre Cohort (NMPOA) was started in 2004 and includes a mammographic screening program for women ages 40–69 years. Goal: Determine the allelic and genotypic frequencies of PROGINS in women undergoing annual BC screening and correlate its presence with mammography results and presence of additional BC risk factors (family history of BC, body mass index, estimated BC risk by the Gail model and age) at baseline and after 10 years. Methods: A sample of 701 women from the NMPOA BC screening program was consecutively enrolled in the study from November/2005 until March/2006. Clinical data, mammography results (as BIRADS categories) and BC risk information was obtained by chart review. PROGINS genotyping was performed by polymerase chain reaction (PCR). Results: Of the 701 patients studied, 504 (71,0%) were wild-type homozygous, 184 (26,2%) heterozygous and 13 (1,8%) homozygous for the PROGINS polymorphism. These genotypic frequencies are similar to those of other reports in different populations. Genotype was correlated with 5-year and vital BC risk estimates (Gail model), body mass index, family history of BC and mammography findings. A statistically significant association was found between the presence of PROGINS and a positive family history of BC (p&lt; 0,05). Conclusions: The genotypic and allelic frequencies of the PROGINS polymorphism were not significantly different from those reported previously for other populations. Prospective clinical evaluation of the women followed in this program and correlation of genotype with clinical findings may be important to elucidate additional risks associated with the PROGINS polymorphism. No significant financial relationships to disclose.
R-CHOP vs R-MiniCEOP in Elderly Patients with Diffuse Large B-Cell Lymphoma (B-DLCL) Prospectively Selected by a Multidimensional Evaluation Scale: Preliminary Results of a Randomized Study Performed by Intergruppo Italiano Linfomi (IIL).
Authors: Francesco Merli, Stefano Luminari, Alessandra Tucci, Patrizia Pregno, Maurizio Musso, Maurizio Martelli, Caterina Stelitano, Luca Baldini, Patrizio Mazza, Daniele Vallisa, Flavia Salvi, Elisa Barbolini, Renato Scalone, Alice Di Rocco, Alberto Fragasso, Anna Marina Liberati, Chiara Bottelli, Lorella Orsucci, Fiorella Ilariucci, Luigi Marcheselli, Massimo Federico
Journal: Blood (2007)
Giant notochordal rests misdiagnosed and treated as chordomas. A retrospective clinical, radiological and histologic study of four cases
Authors: P. Picci, D. Vanel, M. Alberghini, J. M. Mirra, C. Errani, E. L. Staals, M. Mercuri
Journal: Journal of Clinical Oncology (2008)

21503 Background: Notochordal rests are found at autopsy on 10% of cadavers. They may well be the origin of chordomas. The differential histologic diagnosis is possible and difficult, but giant notochordal rests were often previously misdiagnosed as chordomas. Out of 350 chordomas found in the files of our institution, four were actually notochordal rests. A review of the clinical radiological and histologic data was made. Methods: Nonspecific pain was always the cause of the imaging examination. All patients had initial radiographs and CTs available, and two MR examinations. The location, size and borders were analyzed, as well as the MR signal. Histology compared the findings of rests (sheet like cells) and chordomas (chords of cells). Results: There were three rests, and one case associating both a notochordal rest and a chordoma. All lesions were limited to the posterior half of the vertebral body. They were lytic, with local destruction of bone trabeculae, and sclerotic. The posterior cortex of the vertebra was always involved and partially missing. The borders were well defined with a peripheral sclerosis. Minimal medial extension into the canal (2mm) and bulging of the posterior wall of the vertebra were found in the chordoma associated to a rest. Two patients had retrospectively another smaller rest visible on CT on another vertebra, and that was ignored at the time of the treatment. Each patient had an aggressive treatment with three vertebrectomies and one wide curettage, and radiotherapy. Conclusions: Notochordal rests must be recognized radiologically, to avoid biopsy, and then histologically to avoid a useless aggressive treatment. They should probably be followed regularly on CT or MR to discover a beginning chordoma. A biopsy should be performed, only if the soft tissues or the whole vertebral body are involved. No significant financial relationships to disclose.
Non-pegylated liposomal doxorubicin and docetaxel as first-line treatment in metastatic breast cancer
Authors: V. Heilmann, H. Eggemann, H. Sommer, G. Heinrich, J.-U. Blohmer, P.-K. Mallmann, P. Krabisch, P. Klare, J. Schilling, K. Kittel, D. Elling
Journal: Journal of Clinical Oncology (2005)

753 Background: The combination of doxorubicin and docetaxel (T) is highly effective in metastatic breast cancer. The non-pegylated liposomal formulation of doxorubicin Myocet (M) has been proven to be as effective as doxorubicin at same doses while reducing the cardiotoxicity and causing less myelosuppression and GI toxicity. The aim of this study was to evaluate the activity and tolerability of the combination of MT. Methods: M (60mg/m2) and T (75mg/m2) were administered at day 1 every 3 weeks for up to 8 cycles. To date 54 pts have been enrolled. 41 pts are evaluable for toxicity. A total of 208 cycles were given with a median of 6 (1–8). Main characteristics of pts: median age 57 yrs (37–70), median WHO PS 1 (0–2), anthracycline-pretreated 9 (22.0%), median number of metastases 2 (1–5). Results: Toxicity was mainly hematological with G3 or 4 neutropenia in 34,0% of cycles. Febrile neutropenia was encountered in 7,7%, G3 anemia in 4,4% and G3 platelets in 0.5%. Non hematological toxicities were generally mild with rare G3/G4 toxicities: diarrhea 1.0%/0.5%, nausea 2.0% G3, vomiting 1.0% G3, infection 0.5% G4. No G3 or G4 mucositis or stomatitis was observed. Skin toxicity occurred in only one cycle with G1. Of the 26 pts evaluable for response 1 had a CR, 16 achieved a PR resulting in an overall response rate of 65.4%. SD was observed in 7 pts (26,9%), PD in 2 pts (7,7%). Dose reductions were required in only 3.8% of cycles. Therapy associated dose delay was rare with 1.0% of cycles. Conclusions: This interim analysis suggests that the combination of M and T is an effective and well tolerated regimen. Updated data, including time to progression, will be presented at the time of the meeting. No significant financial relationships to disclose.
The <i>ERCC1 C8092A</i> polymorphism and grade III/IV gastrointestinal (GI) toxicity in non-small cell lung cancer (NSCLC) patients treated with chemoradiation
Authors: R. Suk, S. Gurubhagavatula, S. Park, W. Zhou, L. Su, T. J. Lynch, J. C. Wain, D. Neuberg, G. Liu, D. C. Christiani
Journal: Journal of Clinical Oncology (2004)

2014 Background: ERCC1 is the lead enzyme in nucleotide excision repair of platinum-induced DNA adducts. The ERCC1 C8092Apolymorphism may lead to an altered capacity to regenerate chemotherapy-damaged normal tissue and greater treatment-related toxicity. Methods: Using logistic regression models, we evaluated the ERCC1 C8092Apolymorphism and its association with the occurrence of Grade III or IV toxicity in 147 locally advanced and metastatic NSCLC patients treated first-line with chest radiation and platinum-based chemotherapy. Results: Median age was 62 yrs; 50% were male; 93% had ECOG PS 0/1; 6% had inoperable early stage disease, 46% were stage IIIA, 39% were stage IIIB, and 9% were stage IV. Forty-two percent received cisplatin and 58% received carboplatin. Thirty-one (21%) patients experienced Grade III/IV GI toxicity (nausea, n=10; vomiting, n=4; esophagitis, n=20). After adjusting for type of platinum agent and PS, patients carrying at least one ERCC1 variant allele (C/A, A/A) were found to have an increased risk of GI toxicity compared to patients with the C/Cgenotype (see table), with similar results in a subgroup analysis on the 125 stage IIIA/B patients. Incidence of Grade III/IV toxicity from all causes was non-significantly increased in patients carrying the variant ERCC1allele (OR=1.84, 95% CI: 0.92–3.65, p=0.08). ERCC1 polymorphism was not associated with Grade III/IV hematologic toxicity (p=0.44). Conclusions: Carrying at least one ERCC1 8092Aallele is associated with a greater than two-fold increase in Grade III/IV GI toxicity among NSCLC patients treated with chemoradiation. Supported by NIH grants CA074386, CA71345. No significant financial relationships to disclose.
Hormonal changes with anastrozole treatment in breast cancer
Authors: S. Ali, M. F. Ali, M. Mundia, A. G. Mundia
Journal: Journal of Clinical Oncology (2009)

e12026 Background: Aromatase inhibitors are a class of drugs that inhibit tumor growth in hormone receptor positive breast cancer, in postmenopausal women. They inhibit the conversion of androgens to estrogens. Both clinical benefit and side effects are believed to be due to alterations in blood hormonal levels. Methods: Clinical charts of postmenopausal women with estrogen receptor positive breast cancer, receiving anastrozole 1 mg daily, were reviewed to determine the clinical side effects and blood hormonal changes during treatments, at a community oncology practice. Hormonal levels measured were serum testosterone, serum estrogens and prolactin levels. Results: There were 31 postmenopausal women age 52–73 (median 62) years, receiving anastrozole 1 mg daily. Duration of treatment was 8 to 42 (median 24) months. Clinical side effects noted were joint pains in 4 patients; mild to moderate hot flashes in 4; temporary nausea lasting for 1 week in 3; and vaginal dryness in 2 patients. Serum estrogen levels dropped by 20% in 10 patients from baseline but remained within normal range (14–103 pg/mL), there were no changes in serum testosterone (range 14–76 ng/mL) or prolactin (2.8–29 ng/ml) levels. 2 out of 4 patients with joint pains had testosterone levels in upper range, and remained unchanged during treatments. Conclusions: Anastrozole 1 mg daily is well tolerated in clinical practice, in terms of side effects and does not cause significant blood hormonal changes. No significant financial relationships to disclose.
Reply to three letters: Dubravcsik et al, Murion et al and Fan et al The horse must come before the cart …
Authors: Tossapol Kerdsirichairat, Mustafa Arain, Martin Freeman
Journal: Endoscopy (2015)

We very much appreciate the interest generated by our recent publication in Endoscopy entitled “Urgent ERCP with pancreatic stent placement or replacement for salvage of post-ERCP pancreatitis” [1]. In the paper, we presented the second ever published case series involving placement of a pancreatic stent shortly after onset of pancreatitis, with the aim of ameliorating the course of predicted severe post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Patients included were those without a pancreatic stent, and those patients in whom a pancreatic stent had migrated out prematurely. Dramatic resolution of predicted severe pancreatitis occurred in all patients. Three letters were sent to the Editor regarding this paper, and we have been asked to respond to all three collectively.