tbuckley/cabot-search huggingface dataset:
Breakthrough cancer pain (BTcP) and quality-of-life outcomes.
Authors: Valeria Stati, Gian Paolo Spinelli, Elisa Gozzi, Belardino Rossi, Silverio Tomao
Journal: Journal of Clinical Oncology (2016)

61 Background: Breakthrough cancer pain (BTcP) is frequent in patients with advance solid tumors and is always associated with worsening of the quality of life (QoL). There are few studies in the literature on the effect of BTcP treatment on QoL. The aim of this analysis was to provide a qualitative evaluation of the effect of BTcP therapies considering different fentanyl formulation(nasal spray, lollipop or buccal tablets) on the QoL of treated patients. Methods: In our study, we enrolled patients with different advanced solid cancer treated with active and/or palliative therapies. All patients included have a baseline analgesis therapy and showed frequent BTcP episodes during the day. The patients were evaluated with a simultaneous care control (medical oncologist, palliativist, psychologist and nurse) every week for four consecutively weeks after initiating treatment with BtcP medicaments. A questionary about BtcP and QoL evaluation (QoL-BTcP scale) was administered. It was also completed by an interview during periodic visit. The main parameters investigated were frequency of BTcP, cancer pain value (NRSscale), fentanyl formulation for BTcP (nasal spray, lollipop or buccal tablets), time of onset of cancer pain relief and adverse events correlated with use of BTcP medicaments. At each simultaneuous care evaluation the authors evaluated the impact of BTcP medicaments on psychologic aspects using a validated Anxiety, Depression and health status Scale integrated to QoL-BTcP questionary (QoL-BTcP scale). Results: A total of 35 patients with &gt; 2 BTcP episodes/die were enrolled (50% from 2 to 4 episodes, 45% from 5 to 6 episodes and 5% for those patients with more than 6 episodes). QoL-BTcP scores showed significant improvement in the QoL in terms of depression and other psychologic aspects in the first two subgroups (from 2 to 6BTcP episodes). The QoL-BTcP scale was worse in more depressed patients and in those patients at the end of life. Conclusions: QoL-BTcP scale is a reliable and valid instrument for measuring QoL correlated to efficacy and tolerability of BTcP drugs. Results provide some suggestions for the development of programs to evaluate QoL in patient with cancer pain and implement BTcP interventions among cancer survivors.
Combination Chemotherapy with Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) Induces a High Response Rate in Previously Untreated CLL.
Authors: Francesc Bosch, A. Ferrer, N. Villamor, E. Gine, M.A. Abella, S. Gardella, J. Besalduch, M. Gonzalez, A. Altes, L. Escoda, S. Ferrer, E. Gonzalez-Barca, E. Perez-Ceballos, A. Asensi, E. Montserrat
Journal: Blood (2005)
Results from a phase 1/2 study of volociximab in combination with liposomal doxorubicin in relapsed advanced epithelial ovarian and primary peritoneal carcinoma
Authors: A. Delmonte, G. Del Conte, C. Sessa, A. Perotti, A. Fasolo, E. Williams, K. Smith, E. Dall’O’, N. Colombo, L. Gianni
Journal: Journal of Clinical Oncology (2008)

16527 Background: Preclinical studies demonstrate that the chimeric α5β1 integrin antibody volociximab inhibits tumor angiogenesis by blocking binding of activated vascular endothelial cells to fibronectin present in the extracellular matrix, thereby inducing apoptosis and inhibiting tumor growth. Volociximab also exhibits direct antitumour effects in ovarian cancer xenograft models. Methods: The Phase 1 safety lead-in portion of this study enrolled patients (pts) with advanced epithelial ovarian or peritoneal cancer who had relapsed after therapy with a platinum/taxane combination. Treatment consists of 28 day cycles of liposomal doxorubicin 40 mg/m2 d1 q4wks together with volociximab, either 7.5mg/kg qwk (Cohort 1) or 15mg/kg qwk (Cohort 2), until disease progression, in a 3+3 cohort design. DLT is defined on the basis of pre-specified hematological and non-haematological grade 3/4 toxicities related to volociximab and observed within cycle 1. Results: Nine patients were recruited from 2 centres over 5 months; 3 pts in Cohort 1 and 6 in Cohort 2. No DLTs were observed in Cohort 1 and none to date in Cohort 2 (5 of 6 pts). Preliminary safety data consisting of grade 1–2 treatment related toxicities are available on 6 pts first cycle as follows: asthenia (6), nausea (3), abdominal pain (2), flu-like syndrome (2), vomiting (1) and reduction of appetite (1). No haematological toxicity of any grade was observed in cycle 1. The median age was 51 (range 36- 72 years) with PS (ECOG) 0–1. Pharmacokinetics of both drugs in the combination are evaluated, and tumour response will be assessed by RECIST every 8 wks. Conclusions: From preliminary data, volociximab in combination with liposomal doxorubicin appears well tolerated. In the absence of DLT in the remaining pt in the first cycle of Cohort 2 and no evidence of cumulative toxicity in subsequent cycles, the adaptive-randomized multicentre Phase 2 portion of this study, comparing liposomal doxorubicin alone, with the combination of volociximab, 15 mg/kg (weekly and biweekly schedules) and liposomal doxorubicin, will begin. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Biogen Idec Inc
Costs of medical care after open or minimally invasive prostate cancer surgery: A population-based analysis.
Authors: E. B. Elkin, W. T. Lowrance, B. Denton, J. N. Mirkin, J. A. Eastham
Journal: Journal of Clinical Oncology (2011)

6016 Background: The rapid uptake of minimally-invasive radical prostatectomy (MRP) has occurred despite little evidence of better short-term functional and oncologic outcomes compared with open radical prostatectomy (ORP). MRP is generally more expensive than ORP, but it is not clear whether subsequent health care costs vary. Methods: In the SEER-Medicare dataset we identified men age 66 or older who had MRP or ORP in 2003-2006 for early-stage prostate cancer. MRP included laparoscopic and robot-assisted procedures. Total cost was estimated as the sum of Medicare payments in all claims for inpatient and outpatient care, physician services, home health and hospice care and durable medical equipment in the first year from the date of admission for surgery. Payments were adjusted for inflation and geographic variability and reported in 2006 $US. The impact of surgical approach on cost was estimated in a multivariable linear regression of log-transformed total payments. Results: Of 5,795 men who had prostate cancer surgery, 4,693 (81%) had ORP and 1,102 (19%) had MRP. The groups were similar in age, preoperative PSA, Gleason score, clinical tumor stage and comorbidity. Mean total first-year costs were $1,200 greater for men who had MRP ($16,900 vs. $15,700, p=0.08). In both groups, costs associated with the initial surgical procedure and hospitalization accounted for 65% of total first-year costs. Controlling for patient and tumor characteristics, total costs were 2% greater with MRP compared with ORP, but this difference was not statistically significant. Costs were greater for men who were older, black, lived in the Northeast, had lymph node involvement, more advanced tumor stage or greater comorbidity. Mean first-year costs decreased over time, by almost 2% per year (p<0.05). Conclusions: Mounting evidence suggests that MRP and ORP are similar with respect to complications, functional impairment and oncologic outcomes. Our analysis of prostate cancer patients in Medicare suggests that the procedures are also associated with similar costs. From a payer’s perspective, any benefits associated with MRP − including robotic procedures − do not yield net savings compared with ORP in the first year after surgery.
Signal transducer and activator of transcription 5b (STAT5b) as a novel target for anti-neoplastic therapy in human pancreatic cancer.
Authors: C. Moser, P. Ruemle, H. Schenk, E. K. Geissler, H. J. Schlitt, O. Stoeltzing, S. A. Lang
Journal: Journal of Clinical Oncology (2011)

217 Background: Activation of signal transducer and activator of transcription 5b (STAT5b) has been associated with tumor growth and metastases in various tumor entities. A number of cytokines, growth factors, and oncogenes that can induce STAT5b activity are also implicated in pancreatic cancer growth and metastases. Hence, we sought to determine STAT5b expression in human pancreatic cancer specimen and effects of selective STAT5b inhibition on pancreatic cancer cells. Methods: Expression of STAT5b in human pancreatic adenocarcinomas was determined by immunohistochemistry. For in vitro experiments, human pancreatic cancer cell lines (BxPC-3, HPAF-II, L3.6pl) were used. Cancer cells were transfected with STAT5b shRNA plasmid to create stable STAT5b knock-down. Effects of STAT5b inhibition on growth and motility of tumor cells was investigated by MTT and modified Boyden chamber assays. In vivo effects of STAT5b blockade were determined in subcutaneous mouse model. Results: Nuclear expression of STAT5b was detected in 42/80 human pancreatic adenocarcinomas. In human cancer cell lines, stable knock-down of STAT5b had no effect on growth of tumor cells in vitro. However, tumor cell motility was significantly reduced upon STAT5b blockade (p&lt;0.05). Moreover, expression of various signaling intermediates and transcription factors including c-myc was impaired upon STAT5b knock-down. In a subcutaneous tumor model, inhibition of STAT5b led to significantly reduced tumor growth (p&lt;0.05) which was also reflected by final tumor weights (p&lt;0.05). Furthermore, as revealed by immunohistochemistry, blockade of STAT5b significantly reduced tumor vascularization in vivo (p&lt;0.05). Conclusions: STAT5b is expressed in human pancreatic adenocarcinomas. Blockade of STAT5b impairs cancer cell motility in vitro, suggesting antimetastatic potential. Moreover, inhibition of STAT5b significantly reduces tumor growth and tumor vascularization in vivo. Hence, STAT5b might be an interesting target for antineoplastic therapy in human pancreatic cancer. No significant financial relationships to disclose.
Analysis of patient care in a “Palliative Medicine Day Care Unit” in a hospital in Costa Rica during its first year.
Authors: Andrea Cartin, Rosaura Benavides, Manuel Zeledon
Journal: Journal of Clinical Oncology (2015)

140 Background: A “Palliative Medicine Day Care Unit” (PMDCU) program began in January of 2014 as part of the services provided by the Department of Palliative Medicine in a national hospital in Costa Rica; the program allows patients with hemato-oncological diseases to continue as outpatients while receiving inpatient treatment for their refractory symptoms. This study analyses patient consult rates, results and the dynamics of the unit during its first year in service. Methods: The statistical information of patients attended in the PMDCU, were collected during the period between January and December of 2014. The data included: the population characteristics, the nature of the care provided and the interaction with other departments. Results: A total of 1311 patients were examined in the PMDCU, for a total of 1609 consultations; on average each patient had 3.6 consultations. The average time patients spent with physicians during consultation or receiving treatment were 115 minutes. The most common patient diagnosis was gastrointestinal, gynecological, and prostate cancers. After the initial consult, 63% of patients continued treatment in the outpatient clinic of the same hospital, 34% were scheduled for follow-up consultations in the PMDCU, 2.4% of patients were referred to the Emergency Department and less than 2% of patients were either admitted to the hospital or were referred to other palliative care units. Treatment in the PMDCU included, analgesia treatment administration, paracentesis, thoracocentesis, parenteral nutrition, blood transfusions and patient and family education. Conclusions: The PMDCU has had acceptance among patients with a high number of consultations and adequate follow up of patients. The most common types of cancer diagnosis were gastrointestinal, gynecological and prostate cancers. The majority of patients examined, continued treatment in either the outpatient clinic or follow up in the PMDCU; few were referred to the emergency department. The PMDCU provides treatment that would normally be administered either in an inpatient setting or in the emergency department, but avoiding the extra cost and inconvenience to the patients and their family.
Single institution experience with neoadjuvant chemotherapy for metaplastic breast cancer (MBC).
Authors: Anna Kaminsky, Rohit Bhargava, Kandace P McGuire, Shannon Puhalla
Journal: Journal of Clinical Oncology (2012)

1038 Background: Metaplastic breast carcinoma (MBC) is a rare subtype that accounts for &lt;1% of all breast carcinomas. MBC is frequently triple negative and neoadjuvant chemotherapy (NAC) is often used in triple negative breast cancer (TNBC). The objective of this analysis is to ascertain response rates of MBC to NAC as compared to non-metaplastic TNBC. Methods: We searched the Magee Women’s Cancer Center of UPMC IRB-approved neo-adjuvant treatment database which contains outcome data on 594 patients treated from 2004-2010. 116 patients with triple negative breast cancer (ER /PR negative or ER /PR weakly positive (H score of 10 or less) and HER2 negative or indeterminate (HER2 1+ or 2+ without amplification by FISH)), were identified. Nine of these TNBCs had metaplastic subtype and 2 groups were analyzed: metaplastic breast carcinoma (MBC) (N= 9) and non-metaplastic breast carcinoma (NMBC) (N = 107). Tumor volume reduction (TVR), pathologic complete response (pCR), recurrence and mortality were compared in both groups. Results: Mean follow up in MBC group was 43 months and no patients were lost to follow up. Mean tumor size on presentation in MBC group was 4.47 cm while in NMBC group it was 3.33 cm. pCR was noted in 0/9 MBC and 43/107 NMBC cases (p = 0.0253). 6/9 patients had mastectomy, 2/9 had breast conserving surgery (BCS) and 1/9 patients did not have a surgery yet. Average TVR was 28% in MBC cases compared to 74% in NMBCs when cases with pCR were included (p = 0.0001) and 56% when cases with pCR were excluded (p = 0.0202). Follow up on 9 MBC cases revealed 1 recurrence and subsequent death (11%). Follow up on 64 NMBC patients who failed to achieve pCR revealed 22 recurrences (34%) and 18 of them subsequently died (28%).Follow up on 43 NMBC cases that achieved pCR revealed 3 recurrences (7%) and 1 death (2%). Conclusions: MBC was characterized by larger size at baseline as compared to NMBC. There were no pCR’s seen in MBC, but some MBC did achieve response that allowed for breast conservation. Although the average tumor volume reduction was significantly less in MBC compared to NMBC, the NMBC that failed to achieve pCR fared much worse than MBC who did not achieve pCR. Therefore, the triple negative paradox is likely not applicable to MBC.
Colorectal cancer mortality among Cuban and non-Cuban Hispanics.
Authors: Daniel A. Sussman, Stacey L. Tannenbaum, Laura A. McClure, Monique N. Hernandez, D. Diane Zheng, Tulay Koru-Sengul, Olveen Carrasquillo, David J. Lee
Journal: Journal of Clinical Oncology (2015)

775 Background: We examined all-cause mortality of Floridian colorectal cancer (CRC) patients among Hispanics of Cuban and non-Cuban origin, non-Hispanic Whites (NHWs) and non-Hispanic Blacks (NHBs). We hypothesized that Cuban Hispanics would have a higher mortality risk relative to other Hispanics in Florida with CRC. Methods: We obtained data from the Florida Cancer Data System for all incident CRC cases (2007-2011) among Floridians 18+ years and linked these files with data from Florida’s Agency for Health Care Administration and the 2006-2010 American Community Survey (n=46,579). Race/ethnic groups were Cuban, non-Cuban Hispanic, NHW, and NHB. Log-rank tests were performed among race/ethnic groups with multivariable Cox proportional hazard regression models for mortality adjusting for demographic and clinical factors to produce adjusted hazard ratios (HR). Results: Cubans’ mortality were not significantly different from NHWs (p=0.8254) or NHBs (p=0.3047) but significantly different from non-Cuban Hispanics (p=0.0006). Adjusting for all covariates and compared with highest SES within each race/ethnicity, residing in lower SES neighborhoods was associated with increased mortality risk for NHWs (HR=1.19; 95%CI=1.12-1.27) and NHBs (1.33; 1.13-1.57) but not for Hispanics. Among Hispanics, Cubans with proximal CRC had a 42% higher mortality risk than those with distal disease (1.42; 1.11-1.82); however, tumor location was not predictive of mortality for other racial/ethnic groups. Single or widowed Cuban Hispanics had higher mortality risk compared to those who were married (1.42; 1.07-1.88 for both comparisons) but this was not true for non-Cuban Hispanics. Conclusions: Cuban Hispanics are a distinct and understudied population group who should not be aggregated into a general category of Hispanic with respect to CRC mortality studies. Further research to understand the Cuban Hispanic differences in CRC mortality risk is needed to reduce the burden of disease, especially in the ever growing Hispanic population.
Familial clustering of prostate cancer (Pca) cases in a nonselected south European population (sEp).
Authors: Ignacio Gil-Bazo, Eduardo Castanon, Juan Pablo Fusco, Patricia Martin, Leire Zubiri, Lucia Ceniceros, Jairo Legaspi, Isabel Gil-Aldea
Journal: Journal of Clinical Oncology (2014)

233 Background: Universal Pca screening programs (SP) are controversial. The selection of high-risk subjects might improve the efficiency of early SP. A positive family history (FH) of Pca increases its relative risk and also increases with multiple affected relatives. Pca FH is associated with earlier onset and aggressive behavior. Therefore, in this subpopulation SP would have clear advantages. This is the first study to investigate the incidence of familial Pca conducted in a sEp. Methods: Overall, 365 cancer patients (pts) of Spanish (n=342) or Portuguese (n=23) origin diagnosed at a single institution were included in the analysis. A non-selected cohort of 182 (173 with known FH) consecutive males (cases) diagnosed with Pca was studied for FH of any type of cancer including Pca. Another cohort of 183 (174 with known FH) males (controls) with similar demographic characteristics and diagnosed with other cancer types different from Pca was also studied for FH of cancer. We investigated whether Pca pts in a sEp show a higher incidence of familial Pca aggregation than subjects affected by other solid tumors. Results: Among Pca pts with a positive FH for Pca, 30.2% showed their father as the only Pca relative, 22.6% one or more brothers, 15% one or more uncles, 13.3% their father and one or more brothers, 9.4% their grandfather and 9.5% showed other combinations. Regarding the number of relatives affected, in our Pca cohort 1 relative was the most frequent finding with 41/53 pts (77.1%), 2 in 4 cases (7.6%), 3 in 3 subjects (5.8%) and 4 or more relatives in 5 cases (9.5%). We studied the overall incidence of any type of family cancer among cases and controls. No differences were found between groups (64.7% vs 67.8%; p=0.664). However, in our cohort of Pca cases, 53/173 pts (30.6%) had a FH of Pca in first or second degree whereas, among cancer control pts only 18/174 pts (10.34%) showed a Pca FH (p=0.001). Conclusions: We present the first estimation of Pca FH in a non-selected sEp with Pca. 30% of Pca cases showed a positive FH for Pca, being that incidence significantly higher (threefold) compared to cancer pts from a different origin. Therefore, the usefulness of directed SP for subjects with positive FH of Pca should be prospectively evaluated.
Sex, age, and ethnicity are associated with survival in metastatic colorectal cancer
Authors: A. E. Hendifar, G. Lurje, F. Lenz, A. Pohl, P. C. Manegold, K. Togawa, H. Husain, H. J. Lenz, D. Yang
Journal: Journal of Clinical Oncology (2008)

4015 Background: Age and ethnicity have been shown to impact the survival rates of men and women with metastatic colorectal cancer (MCRC). Previous studies have demonstrated that estrogen prevents colon cancer in postmenopausal women, indicating a role in colon cancer carcinogenesis and tumor progression. We investigated the interactions between sex, age, and ethnicity on overall survival in patients with MCRC. Methods: We screened 56,598 patients with MCRC from 1988–2003, using the Surveillance, Epidemiology, and End Results (SEER) registry. Age at diagnosis, sex, ethnicity, and overall survival were evaluated using Cox proportional hazards model. The models were adjusted for marital status, tumor site, and treatment with radiation and/or surgery. Models were stratified by SEER registry site and year of diagnosis. Results: Independent of age, there were no survival differences between men and women with MCRC. However, when age was added to our model, sex became significantly associated with survival across all ethnicities (p<0.0001). We observed that younger women (18–44 years old) with MCRC lived longer than younger men (17 months vs. 14, p<0.0001). In contrast, older women (75 and older) had significantly worse overall survival than older men (p<0.0001). In multivariate analysis, age and ethnicity were significantly associated with survival. Across all age deciles, Hispanics had the longest overall survival, followed by Whites, Asians, African Americans, and Native Americans, respectively (p<0.0001). Conclusion: Our data suggests that sex, age, and ethnicity have a significant impact on overall survival in MCRC patients. As one of the largest data sets analyzed to establish that younger women of all ethnicities survive longer than younger men, hormonal status appears to play an important role not only in the development and pathogenesis of colorectal cancer, but may be of prognostic significance. These data warrant further studies to determine the role of estrogen and ethnicity in colorectal cancer development, growth and progression. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bristol-Myers Squibb, Genentech, ImClone, Merck, Pfizer, Response Genetics Inc. Genentech, Merck, Pfizer, Roche, sanofi-aventis Dhont Family Foundation, NCI, NIH