tbuckley/cabot-search huggingface dataset:
Bevacizumab (BVZ) as second-line treatment after sorafenib (SFB) progression in patients (pts) with advanced hepatocellular carcinoma (HCC).
Authors: R. A. Pazo Cid, G. Esquerdo, T. Puertolas, V. Calderero, I. Gil, J. Lao, E. Millastre, M. Alvarez-Alejandro, J. Madani, A. Anton
Journal: Journal of Clinical Oncology (2010)

e14619 Background: Single agent SFB, a multikinase inhibitor, is the only standard systemic therapy for advanced HCC that has demonstrated a survival benefit. Data are lacking for second-line treatment post-sorafenib. BVZ, a VEGF inhibitor, has proved activity against HCC in several phase II trials. The aim of this pilot study is to assess the efficacy and safety of BVZ in HCC pts when SFB therapy fails. Methods: Advanced unresectable HCC pts, progressing both clinically and radiologically on SFB treatment, were enrolled to receive BVZ at 10 mg/Kg iv every 14 days. Additional inclusion criteria were no history of myocardial infarction, stroke, thromboenbolic event or variceal bleeding within the prior 12 months (mo). Safety wass assessed throughout the study. Efficacy endpoints were time to symptomatic progression (TTSP), time to progression (TTP) and overall survival (OS). Results: 12 pts were included. Baseline characteristics: male/female: 8/4; median age 66 (range 46-87); ECOG 0/1/2: 1/1/10 (80% ECOG 2); Child Pugh A/B: 5/7 (60% Child B); etiology of underlying chronic liver disease HBV/HCV/other: 4/3/5; esophageal varices grade 1/2/3/4: 8/3/1/0 (90% grade 1-2). Tumor characteristics: BCLC stage C: 12; vascular invasion: 1; brain metastasis: 1; lung metastasis: 5; previous treatment TACE/chemotherapy/SFB: 1/1/12; previous response to SFB PD/SD/PR/CR: 6/6/0/0 (50% of pts were primary resistant to SFB therapy); basal AFP levels: range 30-57,123. Median number of BVZ cycles: 6 (range 2-26). Treatment was well tolerated with less than 15% of grade 1-2 toxicities, such as hyperbilirrubinemia, fatigue, leucopenia and plaquetopenia and one case of grade 3 toxicity consisting in esophageal bleeding in the only pt included with grade 3 esophageal varices. Radiologic response to BVZ: PD/PR/SD: 6/2/4 (50% clinical benefit). With a median follow-up of 12 mo, median TTSP was 3.8 mo (range 1.1-13.2), TTP 3.9 mo (range 1.4-14.2) and OS 9.5 mo (range 3.1-23.0). Conclusions: BVZ was active and safe as second- line treatment in poor prognosis advanced HCC pts progressing to first-line SFB therapy. Remarkably in this series a subset of HCC pts primary resistant to SFB responded to BVZ. No significant financial relationships to disclose.
A non-comparative phase II study of bendamustine hydrochloride in patients with pretreated soft tissue sarcoma (German Sarcoma Group-AIO 001)
Authors: F. Mayer, J. Schleicher, J. Huober, I. Meisinger, J. Pintoffl, G. Kaefer, V. Gruenwald, C. Burkart, L. Kanz, J. T. Hartmann
Journal: Journal of Clinical Oncology (2006)

9525 Background: To assess the efficacy and safety of bendamustine hydrochloride, a nucleoside analogue with alkylating activity, in patients with adult type soft tissue sarcoma (STS) who have failed anthracyline-based chemotherapy. Methods: Pts with a ECOG performance status 0–2, measurable disease and adequate organ functions were eligible. All patients had inoperable locally advanced or metastatic disease and had progressive disease during or after first-line chemotherapy prior to study entry. Bendamustine was administered at a dose of 100 mg/sqm on day 1 and 2 every four weeks for a maximum of 6 cycles with tumour assessment every two cycles. The primary endpoint was overall response rate as defined by RECIST. The secondary endpoint was toxicity. A two-stage design was used (1st step: 14 pts, at least 1 PR in order to succeed with 2nd step; p0 = 5%, p1 = 25%, alpha = beta = 0.1). Results: 32 patients, median age 56 yrs (range, 18–74) with STS were recruited (3 pts not evaluable for efficacy analysis). In general the drug was well tolerated. Grade 3 toxicity was granulocytopenia in 9% and febrile neutropenia/fever in 3% of pts. No toxic death was seen in a total of 89 cycles administered. A single pt experienced a clinically significant allergic reaction (3%). Anti-tumour activity: 1 confirmed partial response (3%). A further 10 patients had progression arrest by cycle two (34%). Conclusions: The confirmed objective response rate is low. However, the incidence of progression arrest in pretreated adult type STS is in the range of other agents considered active in STS. The observed toxicity profile is favorable. Further investigation in STS appears warranted. No significant financial relationships to disclose.
Patient preferences for chemoradiation-related side effects
Authors: C. C. Sun, L. M. Ramondetta, A. Jhingran, P. J. Eifel, C. Crane, A. T. Phan, M. M. Frumovitz, L. S. Elting, D. C. Bodurka
Journal: Journal of Clinical Oncology (2009)

e20604 Background: Patients (pts) undergoing chemoradiation (CRT) face intense treatment (tx) schedules and adverse tx- related side-effects (SEs). We conducted this study to determine whether pts’ preferences (PREFs) for CRT-related SEs changed over tx duration. Methods: We used the visual analog scale (VAS) and modified time trade-off (TTO) to assess PREFs of newly diagnosed pts with gynecologic (GYN) and gastrointestinal (GI) cancers scheduled to receive CRT. Pts evaluated 16 SE health state scenarios during interviews conducted at 3 points in time: T1=prior to starting CRT; T2=2–3 weeks after starting CRT; and T3=4–6 weeks after completing CRT. Using the VAS, pts ranked SEs on a scale of 0=worst to 100=best. The TTO asked pts whether they would accept a hypothetical tx for a specified time with the SE in question or a tx for a shorter length of time that involved a worse SE profile. PREF scores were converted to 0.0=least preferred to 1.0=most preferred. Mann-Whitney and Kruskal-Wallis tests were used to analyze data. P- values were adjusted for multiple comparisons. Results: PREFs were collected from 93 pts (GYN=43; GI=50). 46/93 pts were female (3 women were GI pts). Median age was 53.7 yrs. Pts received a median of 5 chemo cycles (31/50 GI and all GYN pts received platinum) and 5.4 wks of external beam radiation. Median time between T1-T2 was 2.6 wks and T2-T3 was 9.1 wks. TTO PREFs were stable over time regardless of disease group or tx regimen. VAS scores for 7 SEs worsened significantly after initiation of CRT and remained low despite completion of CRT ( table ). Pts gave low baseline PREF scores for diarrhea, fatigue, and loss of appetite; these did not change significantly over time. Conclusions: Pts receiving CRT were willing to accept tx of longer duration with less severe SEs instead of shorter tx with more severe SEs. Relative to other SEs, pts rated GI-associated SEs lower after initiation of CRT. Ratings remained low 4–6 weeks after tx completion. Further studies are needed to determine whether pts’ experiences with and perceptions of SEs influence tx compliance. [Table: see text] [Table: see text]
Non-invasive determination of HER2-expression in metastatic breast cancer by using <sup>68</sup>Ga-ABY025 PET/CT.
Authors: Henrik Lindman, Anders Wennborg, Irina Velikyan, Joachim Feldwisch, Vladimir Tolmachev, Dan Sandberg, Helena Olofsson, Mattias Sandstrom, Mark Lubberink, Jorgen Carlsson, Jens Sorensen
Journal: Journal of Clinical Oncology (2015)

11067 Background: In contrast to biopsies, PET imaging gives a complete and quantitative image of all the patient’s tumors and all parts of individual lesions. PET imaging of HER2 could select patients for HER2-targed therapy, predict response based on uptake and be used for monitoring. In this pivotal phase I/II study the HER2-binding Affibody molecule ABY025 was labeled with 68Ga for PET to study effect of peptide mass, test-retest variability and correlation of quantified uptake in tumors to histopathology. Methods: Sixteen women with known metastatic breast cancer and on-going treatment were included and underwent FDG PET/CT to identify viable metastases. After iv injection of 212±46 MBq 68Ga-ABY025 whole-body PET was performed at 1, 2 and 4 h. In the first 10 patients, 68Ga-ABY025 PET/CT with two different doses of unlabeled peptide was performed 1 week apart. Six had HER2-positive primary tumors and 4 were included as HER2-negative controls. In the last six patients (5 HER2-pos and 1 HER2-neg primary tumor), repeated 68Ga-ABY025 PET were done as a test-retest of uptake at 2 h in individual lesions. Primary tumors and biopsies from metastases were collected for verification of HER2 expression. Results: Scanning with the higher peptide dose at 2-4h provided better discrimination of HER2-pos metastases in all tissues (p < 0.01). Sixteen metastases in 12 patients were biopsied and evaluated by immunohistochemistry and in-situ hybridization. Uptake (SUV, mean ± SD) at 2h in these metastases was 10.9 ± 5.1 in HER2-pos (n = 7) vs 3.4±2.1 in HER2-neg (n = 9) (p = 0.001). SUV at 4h was 15.0 ± 3.4 in HER2-pos (n = 6) vs 2.9±1.9 in HER2-neg (n = 6) (p < 0.001, no overlap). The test-retest intra-class correlation was R = 0.996. 68Ga-ABY025 PET led to change in HER2-targeting treatment in 3 of the 16 patients due to receptor up- or down-regulation. Moreover, the PET data indicates occurrence of intra-patient heterogeneity of HER2-expression in several cases. Conclusions: 68Ga-ABY025 PET accurately quantifies whole-body HER2-receptor status in metastatic breast cancer. Clinical trial information: NCT01858116.
Epigenetic Modulation by Vidaza™ induces Apoptosis and Overcomes In Vitro Drug Resistance in Human Multiple Myeloma Cells.
Authors: Tanyel Kiziltepe, Laurence Catley, Teru Hideshima, Noopur Raje, Hiroshi Yasui, Sonia Vallet, Hiroshi Ikeda, Yutaka Okawa, Kenneth C. Anderson
Journal: Blood (2006)
Quality of life (QOL) in patients with pancreatic and periampullary adenocarcinoma (PPAC).
Authors: Jennifer Sheng, Christina Wai, Carolyn Y Fang, Karthik Devarajan, Christine Huang, John Parker Hoffman, Crystal Shereen Denlinger
Journal: Journal of Clinical Oncology (2015)

454 Background: QOL includes perceived well-being, symptom burden, satisfaction, and enjoyment of normal activities. Limited data exist on QOL and long-term treatment effects in PPAC survivors. We evaluated factors that may impact QOL. Methods: Cross-sectional study (survey and chart review) of QOL, fear of recurrence, symptom burden, nutritional factors, and physical activity in disease free stage 0-III PPAC pts who completed treatment ≥ 12 months between 1990-2013. Pts identified via Tumor Registry and institutional database. Survey scales: FACT-Hep, Fear of Cancer Recurrence Inventory (FCRI), FACIT-AD, Hepatobiliary Symptom Index (FHSI-8), Godin Leisure Time Score (GLTS), Cancer Appetite and Symptom Scale (ASQ), and pancreatic enzyme use. Dillman mailed survey method used. Chart review yielded demographics, PPAC stage, therapy received, enzyme use, and comorbidities. Results: Of 90 identified pts, 78 mailed surveys (10 recurred; 2 died). Response rate 77% (n=60). 45 pts returned consent and survey (2 no consent, 6 opt-out, 7 ineligible). Median age at dx 65 yrs (46-87), at survey 70 yrs (51-89). Male 19/Female 26. Stage 0 (5), I (17), II (22), III (1). Median time from dx to survey 2156 days (385-6333), from surgery to survey 2134 days (343-6280). Mean scores (SD): FACT-Hep 144.5 (19.16), FCRI 51.57 (27.0), FACIT-AD 99.13 (14.47), FHSI-8 26.3 (4.15) and ASQ 34.58 (4.61), consistent with published cohorts. Pts insufficiently active with mean GLTS unit 11 (0-140, SD 25.85). Compared to those without, pts with hypertension (n=27) after surgery were less physically active (9.41 vs 13.61, p=0.046) and pts with diabetes (n=23) had poorer physical well-being (23.39 vs 25.13, p=0.017). Overall QOL was not associated with pancreatic enzyme use, time from diagnosis or surgery, primary tumor site, surgery type or physical activity. Conclusions: Despite small sample size, overall QOL, fear of recurrence, hepatobiliary cancer symptoms, and appetite in our cohort appear similar to other PPAC populations. Pts are insufficiently active, with hypertensive pts at higher risk for inactivity and diabetics with poor physical well-being. Additional evaluation of these in larger cohorts of PPAC survivors is warranted.
Characteristics of assaultive patients in private hospitals
Authors: K Tardiff
Journal: American Journal of Psychiatry (1984)

A study of two large private psychiatric hospitals showed rates and patterns of assaultive behavior by patients comparable to those found earlier in a study of public hospitals; this was especially true in the hospital that admitted involuntary patients. The targets of assault were predominantly family members other than spouses or children and persons outside the family. Seclusion was commonly used to manage assaultive patients in the private hospitals and the seclusion rates were higher than those found for public hospitals, probably reflecting a staff preference for seclusion over heavy medication. The need for staff education and support in the management of assaultive patients exists in private hospitals as well as public hospitals.
Changes on endorectal MRI during neoadjuvant hormonal therapy for prostate cancer and biochemical outcome in men managed using radiation therapy: A prospective phase II Cancer and Leukemia Group B study
Authors: A. V. D’Amico, S. Halabi, C. Tempany, R. Vollmer, M. Loffredo, B. Sanford, E. J. Small
Journal: Journal of Clinical Oncology (2007)

5072 Background: We prospectively determined whether changes in tumor volume (TV) on 1.5 Tesla endorectal magnetic resonance imaging (eMRI) during neoadjuvant androgen suppression therapy (AST) were associated with biochemical outcome after radiation and 6 months of AST. Methods: Between May, 1996 and April, 2001,180 men with T1c-T3c non-metastatic adenocarcinoma of the prostate cancer were registered. Fifteen were found to be ineligible leaving 165 men who had a eMRI TV measurement at baseline and following 2 months of neoadjuvant AST. An eMRI response was defined as &gt; 10% reduction in the volume of all lesions consistent with prostate cancer. In 32 men, the institutional MR radiologist could not completely assess the TV leaving 133 for analysis. A proportional hazards model was used to assess whether a significant association existed between eMRI response and time to prostate-specific antigen (PSA) failure following registration adjusting for PSA level (continuous), Gleason score (8 to 10 or 7 versus 6 or less) and stage (T3 versus T1, 2). PSA failure was defined as 2 consecutive rises of 0.2 above 1.0 ng/ml (PSA fail) and according to the 1997 and the 2006 American Society of Therapeutic Radiology and Oncology (ASTRO) consensus definitions. Results: The median age and PSA level of the study cohort were 70 years and 10.7 ng/ml respectively. An eMRI response was noted in 112 (84%) men and 85, 47, and 47 men experienced PSA failure based on the 1997, 2006 ASTRO consensus and PSA fail definitions respectively. After a median follow up of 6.7 years and adjusting for known prognostic factors, there was a statistically significant association between eMRI defined tumor response and time to PSA failure using the 1997 (p = 0.04) and 2006 (p = 0.009) ASTRO consensus definitions and a near significant association (p = 0.08) using PSA fail. Conclusion: Men lacking a &gt; 10% reduction in the eMRI defined TV during neoadjuvant AST are at increased risk for recurrence following radiation and AST. Therefore, eMRI enables the early documentation of androgen insensitive disease and identifies men for trials evaluating outcome when non-AST based approaches are combined with radiation and AST. No significant financial relationships to disclose.
Borderline ovarian tumors: A study of 100 cases
Authors: C. E. Taner, M. Oztekin, S. Mun, S. Sehirali, C. Büyüktosun, O. Basogul
Journal: Journal of Clinical Oncology (2006)

15069 Background: The purpose of the study was to evaluate the patients with borderline ovarian tumors. Methods: Clinical features, treatment and survival status of 100 patients with borderline ovarian tumors were retrospectively evaluated between 1998 and 2005. Results: Mean age was 37.75 (Range: 15–72) years. 22 cases were in postmenapausal status. Histopathological diagnosis was serous, musinous, endometrioid and clear cell in 54%, 41%, 2%, 3% of the patients, respectively. 19 cases underwent restaging laparotomy. In 52 cases fertility sparing surgery was performed. 70 patients had stage IA, 8 patients had stage IB, 16 cases had stage IC, 2 cases had stage IIIA, 3 cases cases had stage IIIB and a case had stage IIIC disease. 22 cases were administered chemotherapy because of advanced stage disease. All cases were alive. 5 year disease free survival of 51 cases was 100%. Conclusions: Borderline ovarian tumors have excellent prognosis and conservative surgery can be performed in young patients with early stage disease. No significant financial relationships to disclose.
Multidisciplinary management of patients with primary pulmonary artery sarcoma (PPAS).
Authors: M. S. Park, S. Patel, J. C. Trent, W. Wang, A. P. Conley, R. S. Benjamin, D. M. Araujo
Journal: Journal of Clinical Oncology (2010)

e20501 Background: PPAS is a rare sarcoma whose prognosis is often poor despite surgery. The optimal treatment strategy for the management of PPAS is unknown. Methods: We analyzed the clinical outcome and treatment responses of all patients (pts) with available records evaluated at our institution for treatment of histopathologically confirmed PPAS between 1998 and 2009. Descriptive statistics were performed from the data obtained to determine recurrence-free survival (RFS), progression-free survival (PFS), overall survival (OS), and response rate. Results: We identified 13 pts (M:F = 10:3; mean age 53 yrs [19-73]). 7 pts had completely resected or potentially resectable disease at presentation. 6 pts had metastatic disease involving the lung (n = 6), bone (n = 1), abdomen (n = 1) and brain (n = 1). All 7 pts with completely resected or potentially resectable disease underwent definitive surgery with gross total resection and also received chemotherapy (n = 3), radiotherapy (n = 1) or both (n = 3) in either neoadjuvant or adjuvant settings. Pts were treated with doxorubicin 75 mg/m2 and ifosfamide 10 gm/m2 every 3 weeks (n = 4) or doxorubicin 75 mg/m2 and dacarbazine 1,000 mg/m2 every 3 weeks (n = 2). For the 6 pts with metastatic disease, all received chemotherapy, with doxorubicin 75 mg/m2 and ifosfamide 10 gm/m2 (n = 5) or doxorubicin 75 mg/m2 and dacarbazine 1,000 mg/m2 (n = 1) as first- or second-line therapy. For pts treated with curative intent, 1/7 (17%) developed local recurrence at 55.8 months, and 1/7 (17%) developed distant disease at 6.5 months. 67% of pts remain disease free at a median follow-up period of 53.7 months (6.5-100.8). All remain alive to date. For metastatic pts treated with palliative intent, the median PFS was 7.2 months (1.5-11.2) and OS was 22.1 months (6.3-43.6). For pts with measurable disease who received doxorubicin-based chemotherapy, best response was CR 1/9 (11%), PR 1/9 (11%), SD 4/9 (44%), and PD 3/9 (33%). Conclusions: For PPAS pts with potentially resectable disease, multidisciplinary therapy with the addition of chemotherapy and/or radiotherapy can produce long-term disease control. Doxorubicin-based chemotherapy may have a potential role in the systemic management of locally advanced and metastatic PPAS. No significant financial relationships to disclose.
Ductal lavage (DL) of affected and unaffected breasts in women with newly diagnosed breast cancer: Can this technique be used for risk assessment?
Authors: M. E. Wood, M. Stanley, G. Leiman
Journal: Journal of Clinical Oncology (2006)

1024 Background: Ductal lavage (DL) is designed to obtain cellular material from breast ducts. The use of DL in risk assessment is under investigation. The aim of this study was to evaluate cytologic findings in DL of affected and unaffected breasts in women undergoing definitive surgery for breast cancer. Methods: Women with newly diagnosed breast cancer participated prior to surgery. Women with prior breast cancer or receiving neoadjuvant therapy were excluded. The study was IRB approved; all women gave written informed consent. Women underwent nipple aspiration followed by ductal lavage of fluid-producing ducts for both the affected and unaffected breast in the operating room prior to surgery. Cytology was interpreted as insufficient cells to make a diagnosis (ICMD), benign, mildly or markedly atypical, or malignant. Results: Twenty-three women aged 32–74 years underwent nipple aspiration of both breasts prior to definitive surgery; 1 had bilateral breast cancer. One woman had DCIS, 1 T1a, 3 T1b, 9 T1c, 6 T2, and 4 T3 lesions. Node status was N0 in 13, N1mic in 3, N1 in 5 and N2 in 3 (15 underwent sentinel node evaluation). Five women produced no NAF and therefore did not undergo DL; 18 underwent DL of at least one breast. Cytology samples were available for 30 breasts, 16 affected and 14 unaffected. Two samples contained malignant cells (one from a patient with pre-existing malignant nipple discharge), 3 moderate atypia, all from affected breasts. Benign cytology was found in 20 samples (8 affected breasts) and ICMD was classified in 5 samples (3 affected breasts). Age (&lt;/&gt; 50), tumor size, nodal status, or sentinel node procedure were not associated with NAF production, success or cytology of DL. Conclusion: These findings suggest that DL is not effective in identifying known breast cancer. It brings into question its ability to identify women at increased risk. Future research should focus on molecular markers of risk or other means of tissue retrieval. No significant financial relationships to disclose.
Comparison between RECIST evaluations and variations in tumor growth dynamics in patients included in phase I trials
Authors: C. A. Gomez-Roca, S. Koscielny, C. Dromain, I. Marzouk, F. Bidault, R. Bahleda, C. Ferte, C. Massard, J. Soria
Journal: Journal of Clinical Oncology (2009)

2515 Background: Monitoring of treatment efficacy is mainly based on RECIST post-treatment evaluations. We investigated the impact of pre-treatment tumor growth dynamics on the evaluation of response to treatment in phase I trials. Methods: Response at 12 weeks was evaluated using RECIST criteria in 76 patients treated in phase I trials. All patients had a scannographic evaluation at the start of the experimental treatment (D0), at least 2 evaluations before D0 and one evaluation after D0. The mean time between evaluations was 6 weeks. Tumor growth rate (GR=% change in tumor volume per month) was calculated for the pre-treatment period (from the 1 st available evaluation to D0), and the experimental period (after D0). GR was compared to RECIST and to time to progression. Disease control (DC) was defined as stable disease, partial response or complete response. We also classified patients according to the variation in GR. Results: A total of 550 evaluations were performed: 256 before D0, 76 at D0 and 218 after. Tumor GR differed according to the time period: 26.6% per month during pre-treatment period vs. 6.6% in experimental period (P&lt;0.01). The GR was significantly higher in patients without DC during pre-treatment (30% vs. 19%; P=0.003) and experimental time periods (+13% vs. -9%; P=0.0005). There was a significant association between a time to progression &gt; 12 weeks and a decrease in GR during the experimental period (P=0.01). Several discordances however were noted. Eight patients with a time to progression &gt;12 weeks (8/46=17%) had an increased GR with the experimental treatment. Thirteen patients who progressed &lt;12 weeks (13/22=59%) had a decreased GR with the experimental treatment. Conclusions: Pre-treatment growth dynamic may directly impact RECIST evaluation of tumor response and thus should be carefully documented. Patients with slow growing tumors tend to experience DC, even if treatment has little effect. The evaluation of response to treatment should take into account pre-treatment tumor GR. No significant financial relationships to disclose.