tbuckley/cabot-search huggingface dataset:
Ductal carcinoma in situ in African American versus Caucasian American women: Analysis of clinical features and outcome.
Authors: A. Taj, I. Mohamed
Journal: Journal of Clinical Oncology (2011)

e11020 Background: Breast cancer is a commonly diagnosed malignancy in the US and remains the second leading cause of cancer death for women. The diagnosis DCIS has increased markedly because of increase in screening mammography and constitutes more than 20% of newly diagnosed breast cancer cases in the US. Methods: We retrospectively identified women newly diagnosed with DCIS between the years 1999 and 2009. Only CA and AA were included in the study. The information collected included age at diagnosis, ethnicity, family history of breast cancer, clinical presentation, treatment (hormone therapy, radiation, and chemotherapy), local recurrence data, and survival status. Results: Of the 85 patients who were included, 29 were AA and 56 were CA. The AA patients were older at the time of diagnosis than CA patients (mean 56.34 vs. 52.28). Four AA patients presented with a breast mass and three CA patients were symptomatic with a breast mass. In the remaining patients (21 AA and 44 CA), DCIS was diagnosed after a routine mammography. 15 patients (5 AA and 10 CA) had a strong family history. No significant association was found between family history of breast cancer and race. The AA patients with family history of breast cancer were younger (54.80 years vs. 63.50 years for AA, and 50.30 years vs. 56.00 years for CA) than the patients with no family history of breast cancer p= 0.02. ER status was available for 52 DCIS lesions. 26 (78.7%) of CA had ER + and 15 (78.9%) of AA were ER +. PR status was available for 52 patients. 29 (69.7%) of CA were PR + and 14 (73.6%) of AA were PR +. AA had more mastectomies 8 (28.5%) as compared to CA 5 (8.9%). More CA patients received hormonal therapy 41 (78.8%) CA vs. 16 (69.5%) AA. On follow up AA and CA patients had similar rates of tumor recurrence with DCIS. Recurrence with invasive carcinoma was not seen in any patient. Conclusions: Unlike invasive cancer DCIS is diagnosed at later age in AA patients. The AA patients with family history of breast cancer were younger than the patients with no family history of breast cancer. Except for larger size, DCIS does not have a more aggressive phenotype in AA patients. CA are more likely to receive hormone therapy. Treatment and recurrence rate were similar in both groups.
Clinical experience of intravenous temozolomide therapy for gliomas.
Authors: K. Motomura, A. Natsume, M. Fujii, H. Momota, T. Wakabayashi
Journal: Journal of Clinical Oncology (2011)

e12523 Background: Temozolomide (TMZ) is an oral alkylating agent with established antitumor activity in patients with high-grade gliomas. However, oral TMZ cannot be administered to all glioma patients, especially those with difficulty in oral intake, which makes them unable to swallow capsules. Methods: Since intravenous TMZ agent was approved as treatment for malignant gliomas by the Japanese National Ministry of Health and Welfare, we have observed its use in 5 cases and illustrated the effectiveness, toxicity, and safety associated with intravenous TMZ therapy. The primary endpoint was the incidence of adverse events. Results: The study population comprised 3 patients with diffuse intrinsic pontine glioma, 2 patients with pontine glioblastoma and 1 patients with recurrent high-grade gliomas. After intravenous TMZ therapy, 1 patients showed PR and 1 showed SD, whereas 3 patient showed PD during this time. In these 5 cases, we mainly observed hematological toxicities, with the exception of 1 occurrence of extrahematological toxicity (an itching sensation at the infusion site). Grades 2 leukocytopenia and neutropenia were observed in one patients. No grade 3 or 4 leukopenia or neutropenia events occurred in any case. In three cases of brainstem tumor patients, there were tendencies to have difficulty in oral intake of food and medication. In one case, uncontrolled tumor growth despite several treatments caused a great elevation in intracranial pressure, making oral administration difficult. Two cases were pediatric patients suffering from brainstem gliomas. In these cases, the children were not able to swallow large capsules due to esophageal immaturity. Conclusions: As a whole, intravenous TMZ administration has been found to be appropriate for patients with dysphagia resulting from a great elevation in intracranial pressure due to tumor progression, patients unable to take oral medications due to brainstem tumors, and pediatric patients who cannot swallow capsules, especially those under 7 years old. An intravenous formulation provides a useful alternative for these patients, while being generally well tolerated and relatively safe.
Assessment of metastasectomy complications in renal cell carcinoma.
Authors: Christian P Meyer, Maxine Sun, Guillermo de Velasco, Quoc-Dien Trinh, Toni K. Choueiri
Journal: Journal of Clinical Oncology (2016)

619 Background: Metastasectomy (MSx) is a viable option in patients with metastatic renal cell carcinoma (mRCC). Available information on perioperative outcomes is scarce. We assess complications of MSx in a large population-based US cohort. Methods: The Nationwide Inpatient Sample (2000-2011) was utilized to abstract all patients with a primary diagnosis of mRCC. MSx was defined as an organ-specific resection as a diagnosis of a metastasis to a corresponding site (liver; lung; brain; bones; lymph nodes; adrenal) during the same admission. All procedures concomitantly performed with radical or partial nephrectomies were excluded. Baseline characteristics and multivariable logistic regression analyzes described in-hospital complications, length of stay, and mortality following MSx. Results: Overall, 26,990 weighted patients had mRCC. Of those, 949 were treated with a MSx (3.5%). Common sites of MSx were liver (47.8%) and lung (33.2%). MSx patients were significantly younger than non-MSx patients (60 vs. 62 years, p=0.013). Overall in-hospital mortality rate was 2%. The most common in-hospital complications were prolonged length of stay, defined as ≥7 days (38.5%), respiratory complications (17.1%), vascular complications (14.8%), and blood transfusions (16.3%). In multivariable analyses neither patient nor hospital characteristics were significant predictors of overall complication rates. Conclusions: This study suggests that MSx is a sensible and safe approach for the treatment of mRCC. We did not find significant predictors of complications for MSx in mRCC patients. Nevertheless, postoperative care should be optimized to prevent unnecessary complications and prolonged length of stay.
Association of dilated main pancreatic duct with biological high proliferative activity in intraductal papillary mucious neoplasm.
Authors: Tsugio Eto, Hiromitsu Hayashi, Hideyuki Kuroki, Shigeki Nakagawa, Daisuke Hashimoto, Yoshiaki Ikuta, Akira Chikamoto, Toru Beppu, Hideo Baba
Journal: Journal of Clinical Oncology (2013)

187 Background: Intraductal papillary mucious neoplasms (IPMNs) are characterized by multifocal and malignant potential represented by an adenoma (IPMA)-carcinoma (IPMC) sequence. Biologically, accelerated cell proliferative activity play an important role in the malignant step to IPMN (IPMC). Here, we investigated the biological significance of clinically available malignant predictive markers (such as diameter of main pancreatic duct, cystic size, and a mural nodule) in cell proliferative activity. Methods: From 2002 to 2011, surgically resected pancreatic specimens of IPMN were obtained from 49 patients (IPMA in 27(55.1%) and IPMC in 22(44.9%) patients, respectively). Median age was 73 years old (range 46-86 year). Men and women were in 31 and 18 patients, respectively. Cell proliferative activity was evaluated by MIB-1 index using Ki67 immunostaininig. Results: The MIB-1 index (20.1%±13.2) in IPMC was significantly higher than that in IPMA (9.0%±6.8)(p=0.004). In the comparison between the groups with high MIB-1 index (&gt;15%) and low index (&lt;15%), the diameter of main pancreatic duct in the high MIB-1 index group was and significantly larger than that in the low MIB-1 index group (p&lt;0.05), 9mm (1-27mm) and 4.5mm(2-15mm), respectively. On the other hand, the cystic size and a mural nodule did not show any significant differences between of them. Regarding with the type of IPMNs (main- or branch-duct type), 60.9% of main duct type belongs to the high MIB-1 index group, whereas 19.2% of branch-type was in high MIB-1 index group. Conclusions: An increased diameter of pancreatic main duct showed the positive correlation with the high cell proliferative activity in IPMNs. Mucin production-induced dilatation of main pancreatic may predict the biologically high tumor proliferative activity.
Circulating tumor cells as a possible marker for micrometastatic disease in patients with localized pancreatic cancer.
Authors: Rachel D. Aufforth, Justin J. Baker, Malgorzata A. Witek, Joyce W. Kamande, Hong Jin Kim, Pei-Fen Kuan, Steven A. Soper, Jen Jen Yeh
Journal: Journal of Clinical Oncology (2013)

175 Background: Circulating tumor cells (CTCs) are cells shed into circulation from tumors. They are increasingly recognized to be important biomarkers of disease burden in patients with solid tumors. Studies in pancreatic ductal adenocarcinoma (PDAC) have been limited due in part to low sensitivity of existing assays with extremely low numbers detected (0-15 per 7.5-15ml of blood). The development of newer microfluidic platforms has resulted in the ability to detect substantially greater numbers of CTCs. Methods: 15 patients with PDAC were enrolled in an IRB-approved study. Blood was collected in EDTA tubes and processed within 3 hours. CTCs were selected from 2-3ml of whole blood using monoclonal antibodies against epithelial cell adhesion molecule (EpCAM) and enumerated using a novel microfluidic platform. CTCs were confirmed by DAPI, CK8/18/19 and CD45 staining. Results: Patients with metastatic disease (n=12) had a mean of 29.7, median of 22 (3.5-107) CTCs per 1ml of blood. Patients with localized disease (n=3) had a mean of 3.8, median of 2.9 (2.3-6.2) CTCs per 1ml of blood. 0.5-1 CTCs per 1ml were detected in normal controls (n=2). The number of CTCs was significantly different between localized, metastatic and normal patients (p=0.01). 1 patient, initially thought to have localized disease by standard imaging but found to be metastatic at time of operation, had a mean of 45.9 CTCs per 1ml of blood compared to a mean of 3.8 CTCs per 1ml in patients who underwent a curative resection (p=0.009). Conclusions: Studies of CTCs in PDAC have been very limited. Our ability to detect large numbers of CTCs with good dynamic range suggests that further investigation into CTCs as a prognostic marker in PDAC is warranted. This is the first study that we are aware of to find CTCs in patients with localized disease. The presence of CTCs in patients with localized PDAC is surprising and may be associated with findings of unexpected metastatic disease at surgery. Further follow-up will be needed to determine if the presence of CTCs in these patients is a harbinger of shorter progression-free survival and overall survival after curative operations.
Allogeneic hemopoietic stem cells donor complications: A single institution survey on sibling donors mobilized with G- CSF
Authors: M. V. Martino, G. Console, A. Dattola, I. Callea, E. Massara, F. Gatto, E. Spiniello, A. Gervasi, G. Bresolin, P. Iacopino
Journal: Journal of Clinical Oncology (2008)

19533 Healthy allogeneic donors, who were mobilized with G-CSF and underwent hemopoietic peripheral cells (HPC-A) collection at our Institution, were enrolled in a short- and long-term surveillance protocol for a 10 year period. To date, 175 donors have been assessed with a median follow-up of 56 months (1–147); for 71 subjects, the follow-up is > 60 months and for 20 subjects is > 96 months. Healthy donors received G-CSF at a median dose of 9.8 μg/kg (range 7–15). Bone pain was reported as the most common adverse event (70.2 % of donors). Common associated symptoms included fatigue (16.4 %), fevers (5 %), headache (26.3 %), nausea (12.9%), insomnia (16.4 %). Spleen size increased in 4.1 % of donors (> 2 cm exceeding the marginal cost at physical examination). All donors experienced side effect resolution within 2–4 days of G-CSF discontinuation. Leukocyte mean peak values were 49 x 109/L and the nadir of platelet counts reached mean values of 92 x 109/L and; however, such a decrease was not complicated by bleeding manifestations. Leukocyte and platelet counts returned to normal values in about one week. No vascular disorders and cardiac disease occurred. Long-term observation included adverse events in donors after 30 days from HPC-A mobilization and any neoplastic or not disease developed any time post donation. 4 donors showed persistent, slight leucocytopenia until the second month, with recovery in the fourth month of follow-up. 18 donors showed an AST and ALT result 2.5 times the upper limit of normal until the second months of follow-up. Transit ischemic attack occurred in 1 donor, (39 months post after donation). 1 autoimmune event has been reported 28 months post-G-CSF (anckylosing spondylitis); 1 donor with a history of chronic obstructive pulmonary disease developed a secondary polyglobulia (50 months post-G-CSF); 1 donor developed a gastric tumor, 19 months post-donation. No hematological malignancy was observed. In conclusion, our main findings are that the primary toxicity of G-CSF administration is bone pain and that no cardiovascular events was related to the donation. With a median follow-up near to 5 years, no hematological disease was observed in our cohort of donors. No significant financial relationships to disclose.
Effects of a unique hematology-oncology pediatric palliative care program on medical decision-making and communication between health care providers and families.
Authors: D. E. Schiff, C. Kline, J. Auger, J. Willert, W. D. Roberts, A. Reineke
Journal: Journal of Clinical Oncology (2011)

e19537 Background: In 2005, Rady Children’s Hospital San Diego (RCHSD) instituted a unique hematology-oncology palliative care program that was integrated into the existing Hematology-Oncology Program—not a consulting service. The purpose of this study was to evaluate family satisfaction with the Hematology-Oncology Supportive Care Program and its decision-making tool (DMT). A secondary aim was to identify factors that play an important role in parent/guardian medical decision-making. Methods: Parents or guardians were asked to complete the self-administered Supportive Care Survey within four weeks of participating in a Supportive Care Team Conference and receiving a DMT. Results: Twenty parents/guardians of pediatric hematology-oncology patients who had received care at RCHSD were consented to participate in this study. All of the patients had approached one of the following treatment changes requiring medical decision-making: stem cell transplantation, transition to end-of-life palliative care, or major treatment-related changes. All of the study participants had attended a Supportive Care Team medical decision-making conference and received a DMT. Ninety percent of those surveyed reported they remembered receiving the DMT and found it to be clear and straightforward. Ninety percent of the study participants reported the DMT improved communication between the family and healthcare providers. Eighty-five percent found the Supportive Care Team and physicians explained treatment options, prognosis, and risks/benefits of each treatment appropriately. Regarding treatment-related decisions, 100% of study participants reported that nurses helped guide decision-making, 95% reported physicians played a role, and 90% reported the Supportive Care Team helped guide decisions. Conclusions: The Hematology-Oncology Supportive Care Program and DMT facilitated effective communication between families and healthcare providers, and provided families with decision-making support.
Impact of pleural effusion (PE) on treatment adherence, discontinuation, switching, and dose modification in patients with chronic myelogenous leukemia (CML).
Authors: E. Q. Wu, A. Guerin, V. K. Bollu, A. Guo, M. Cloutier, D. Ponce de Leon Barido, S. Ericson, A. Quintas-Cardama
Journal: Journal of Clinical Oncology (2011)

6616 Background: CML patients may develop PE as an adverse event of some tyrosine kinase inhibitor (TKI) therapies. PE requires medical care and may compromise the course of CML treatment. The objective of this retrospective study is to estimate the impact of PE on the course of TKI therapy in CML patients. Methods: The MarketScan and Ingenix Impact databases (2001-2009) were combined to identify adult CML patients (ICD-9CM code 205.1x) who received ≥1 prescription of any TKI before the index date and had continuous enrollment ≥6 months prior to and after the index date, defined as 30 days before the first PE diagnosis (ICD-9CM code 511.9x) for PE patients and randomly selected among all the eligible calendar dates for PE-free controls. Study cohorts were matched on a 1:1 ratio using propensity score matching and followed for 6 months after the index date. Treatment adherence was measured by the proportion of days covered (PDC) and compared between PE and PE-free patients using generalized linear models where as discontinuation, switching, and dose decrease rates were compared using Cox-proportional hazard models. Treatment discontinuation was defined as a gap of ≥60 days between the last day of supply of a prescription fill and the next prescription fill of a TKI. Switching was defined as the initiation of a TKI other than the index TKI. Dose decrease was measured relative to a patient’s index dose. Results: A total of 186 matched pairs were evaluated. PE patients were significantly less adherent compared to PE-free patients with an average PDC of 0.51 vs. 0.64 (p<.05). PE patients also had significantly higher discontinuation and switching rates compared to PE-free patients and similar rates of dose decrease. Conclusions: Compared to PE-free patients, significantly more PE patients discontinued their TKI therapy or switched to another TKI, and a similar proportion had a dose decrease. Inherent limitations of the data, such as the lack of information on CML phase, preclude drawing conclusions as to whether therapy was discontinued or switched due to PE or not. PE PE-free Hazard ratio P Discontinuation 39% 27% 1.47 0.048* Switch 12% 4% 4.60 0.002* Dose decrease 10% 7% 1.67 0.323
Predictive utility of serum cytokine levels in patients with metastatic renal cell carcinoma (MRCC) treated with interferon alfa (IFNa)
Authors: A. J. Montero, C. Diaz-Montero, X. Wang, B. W. McIntyre, N. Tannir
Journal: Journal of Clinical Oncology (2006)

14503 Background: IFNa may prolong survival in MRCC patients (pts) due to stimulation of cell-mediated immunity. We hypothesized that IFNa exerts an anti-tumor effect by upregulation of Th1 cytokines and that patients (pts) with elevated serum levels of Th1 cytokines either at baseline (BL) or after treatment with IFNa would have a superior clinical outcome. Methods: Cytokine profiling was performed on 104 pts with MRCC treated in a randomized phase III trial with IFNa 0.5 million units (MU) subcutaneously (SC) twice daily or 5 MU SC daily. Serum samples were collected at BL (n = 104) and after 8 weeks of IFNa therapy (C1) (n = 89). Cytokine concentrations were determined using a 16-plex immunoassay. The linear mixed-effect model was fit to assess the change of cytokine levels from BL to C1. Cox proportional hazards model was fit to evaluate the effect of BL cytokine levels or change of cytokine levels from BL to C1 on the risk of death. Results: Of 16 cytokines evaluated (IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12 p40, IL-13, IL-15, IL-17, IFNa, IFNg, GM-CSF, TNFa, VEGF), lower BL TNFa, IL-8 (Th1), and IL-13 (Th2) levels were associated with clinical benefit (major response or progression-free status at 6 months) (p = 0.01 and 0.03, respectively). By multivariate analysis, only extremely low or high levels of IFNa (p = 0.02) and IL-12 (p = 0.002) at BL were associated with an increased risk of death. IFNa therapy after C1 produced higher levels of several Th1 cytokines (IL-8, IL-12 p40, IL-15) (p &lt; .001) and lower levels of Th2 cytokines (IL-4, IL-13). Unexpectedly, there were significantly lower levels of TNFa and GM-CSF (Th1) and higher levels of IL-10 (Th2) with IFNa. Only an increase of IL-2 levels from BL to C1 (RR 1.45; p = 0.05) correlated with an increased risk of death. Conclusions: Lower BL serum levels of TNFa, IL-8, and IL-13 were associated with clinical benefit to IFNa. Although IFNa therapy favored a shift towards a Th1 response, this effect alone did not correlate with clinical outcome. No significant financial relationships to disclose.
Health state utilities for skeletal-related events associated with bone metastases.
Authors: L. S. Matza, K. Van Brunt, K. Chung, J. Brazier, A. H. Braun, B. Currie, J. Body
Journal: Journal of Clinical Oncology (2011)

e16620 Background: Patients with solid tumors and bone metastases often experience skeletal-related events (SREs) and pain. Although cost-utility models are often used to estimate treatment outcomes for metastatic cancer, limited information is available on utilities of SREs. The purpose of this study was to estimate the disutility of 4 SREs represented by 8 health states (HS): spinal cord compression (2 HS: with and without paralysis), pathological fracture (3 HS: leg, rib, arm), radiation (2 HS: administered in 2 appointments and administered daily for 2 weeks), and surgery performed to stabilize a bone. Methods: Participants from the UK general population completed time trade-off (TTO) interviews to assess the utility of hypothetical health state vignettes describing cancer with bone metastases and SREs. The TTO task involved rating a 2-year lifespan with cancer and bone metastases. Then, the SREs were each added to this basic health state. Changes in Quality of Life Years (QALYs) were computed to estimate the decrement associated with each year in which an SRE occurs. Results: A total of 126 participants completed interviews (51.6% male, 85.7% white). Cancer with bone metastases without an SRE had a mean TTO utility score of 0.47 (SD = 0.42) on a standard utility scale (1 = full health and 0 = death). Of the SREs, spinal cord compression was associated with the greatest QALY reduction: 0.68 with paralysis and 0.44 without paralysis. Surgery was associated with a QALY reduction of 0.14, while the three fractures had a mean QALY reduction of 0.07. Two weeks and two appointments of radiation treatment had QALY reductions of 0.10 and 0.05, respectively. Conclusions: All SREs were associated with a reduction in QALYs, suggesting a substantial decrease in quality of life beyond the impact of cancer with bone metastases. The resulting QALYs may be used in cost-utility models examining the value of treatments for SREs associated with bone metastases.