tbuckley/cabot-search huggingface dataset:
Anti-LeY monoclonal antibody (mAb) hu3S193 (Rebmab 100) in patients with advanced platinum resistant/refractory (PRR) ovarian cancer (OC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC).
Authors: O. Smaletz, M. D. P. Diz, C. C. Carmo, J. Sabbaga, G. F. Cunha, S. J. Azevedo, F. C. Maluf, C. H. Barrios, R. L. Costa, A. G. Fontana, V. A. Alves, A. M. Moro, A. M. Scott, E. W. Hoffman, L. J. Old
Journal: Journal of Clinical Oncology (2011)

5078 Background: Lewis-Y (LeY) antigen is a blood group related antigen expressed in 75% of OC. hu3S193 is a humanized anti-LeY IgG1 mAb with strong complement dependent cytotoxicity and excellent targeting characteristics with a good safety profile in Phase I studies. Methods: This phase II study accrued pts with PRR, OC, PPC or FTC, with LeY expression by IHC, ≤ 1 prior chemotherapy regimens in the PRR state, and a KPS ≥ 70%. Pts received weekly intravenous infusions (1 cycle = 8 weeks) of hu3S193 at 20mg/m2 for up to 3 cycles, until disease progression or unacceptable toxicity. Primary endpoint was clinical benefit rate [objective response (OR) + stable disease (SD) ≥ 24 weeks]. A two-stage design was utilized with H1 set at 15%, requiring at least 1 OR. Secondary objectives were safety, progression-free survival (PFS) and pharmacokinetics (PK). Results: 31 pts were enrolled. Median age: 55 yrs (range 25-78); primary site: OC-29, PPC-1 FTC-1; LeY-positive by IHC (N): 1+ (15), 2+ (5), 3+ (8), 4+ (3). Prior platinum response: refractory 8, primary resistant 8, secondary resistant 14, allergy 1; median KPS: 90% (range 70-100); median CA-125: 257 (range 18-10,041). Number of cycles of hu3S193 delivered: 32 (median 1, range <1-3). Evaluable patients: 26 (5 pts < 4 doses); Responses: OR=0; SD=11 (42%); SD ≥ 24 weeks=6 (23%). No grade 4 toxicities observed. Most frequent toxicities in all pts (N any grade/grade 3): fatigue 4/1, allergy 4/1, tremor 2/1, fever 3/0, nausea 4/0, hypertension 3/0. Median PFS was 10 weeks (95 % CI, 4-15). PK data will be presented. Conclusions: single agent hu3S193 induces disease stabilization in a significant rate in this heavily pretreated population, including long term stabilization. PFS is comparable to historic chemotherapy data with acceptable toxicity. Further studies in combination with chemotherapy are underway.
Diagnostics of pancreatic duct hypertension by the serotonin-stimulating magnetic resonance cholangiopancreatography (MRCP): A preliminary study.
Authors: Alexey Kashintsev
Journal: Journal of Clinical Oncology (2014)

196 Background: Serotonin is a neurotransmitter which stimulates the pancreatic secretion. Pancreatic and periampullary tumors can cause the dilatation of the main pancreatic duct. Its partial stenosis can remain undiagnosed on conventional MRCP. Increasing secretion of pancreatic juice after stimulation by the serotonin can help to detect the location and length of a lesion. Methods: Eighteen patients with pancreatic cancer (n=14) and tumor of papilla Vateri (n=4) were included into the study. Median age was 64.9 years with range 45-84 years. Serotonin (0,01mg/kg) was administered perorally (n=2), intramuscularly (n=2), or intravenously with dilution (n=5) and without it (n=9). MRCP was performed before the drug application and 7 minutes later. Results: In cases where serotonin was administered perorally, intramuscularly or intravenously with dilution we did not receive any significant results. The positive results were obtained in 5 (55.6%) of 9 cases when MRCP was performed 7 minutes after intravenous administration of concentrated solution. The mean increase in width of the main pancreatic duct was 1.1 mm (range 0.9-1.9 mm). Conclusions: The method of serotonin stimulating MRCP can improve the diagnosis of pancreatic ductal hypertension. In these 5 cases, a presented technique allowed us to detect the size and localization of a lesion more precisely: tumor of a papilla (n=2), cancer of a pancreatic head (n=3) including one case with involvement of the pancreatic body. In cases of primary ductal dilatation more than 5 mm (n=3), we did not receive any positive results, so these patients were excluded from the study.
Proposed Technical Guidelines for the Acquisition of Clinical Images of Skin-Related Conditions
Authors: Anna Finnane, Clara Curiel-Lewandrowski, Glen Wimberley, Liam Caffery, Chinmayee Katragadda, Allan Halpern, Ashfaq A. Marghoob, Josep Malvehy, Harald Kittler, Rainer Hofmann-Wellenhof, Ivo Abraham, H. Peter Soyer
Journal: JAMA Dermatology (2017)

Standardizing dermatological imaging is important to improve monitoring of skin lesions and skin conditions, ensure the availability of high-quality images for teledermatology, and contribute to the development of a robust archive of skin images to be used for research.To provide guidelines for the clinical application of the Standards for Dermatological Imaging set forward by the ISIC.The ISIC recommendations were developed through a hybrid Delphi methodology. The methods for achieving consensus have been described previously. The practical application of these recommendations was evaluated by 2 clinical photographers with expertise in skin imaging. Images corresponding to each recommendation were taken by a clinical photographer and provided as visual examples of how these recommendations can be implemented in clinical practice.The Standards for Dermatological Imaging developed by the ISIC members could be followed in the clinical setting. Images showing appropriate lighting, background color, field of view, image orientation, focus and depth of field, resolution, and scale and color calibration were obtained by the clinical photographer, by following the detailed recommendations for regional, close-up and dermoscopic images.Adhering to the recommendations is both feasible and achievable in practice. Adopting these Standards is the first step in achieving international standardization of skin imaging, with the potential to improve clinical outcomes and research activities.
Complete remission and survival in multiple myeloma
Authors: M. Wang, S. Giralt, B. Handy, L. Feng, K. Delasalle, J. Wang, R. Alexanian
Journal: Journal of Clinical Oncology (2008)

8523 Background: While longer survival has been the ultimate index of better treatment in multiple myeloma, earlier endpoints have included the frequencies and durations of partial (PR) and complete remission (CR). This report describes a retrospective review with multivariate analysis of outcomes among newly diagnosed patients who received the sequence of primary chemotherapy followed by intensive therapy within the first year. Methods: Clinical outcomes were assessed in 759 consecutive patients with multiple myeloma, treated between 1987–2007, of whom 406 patients also received intensive therapy supported by autologous stem cells within the first year. Response to treatment was rated according to EBMT criteria. CR required disappearance of serum myeloma protein by immunofixation on two consecutive studies. Multiple prognostic variables were assessed in order to identify features associated with long survival. All survival times were compared by landmark analyses for those alive after 1 year, in order to avoid potential bias from the guaranteed survival of patients with responsive disease. Results: The response rate among all patients was 66% (including CR in 8%) after primary chemotherapy and then 75% after including results after high-dose therapy (including CR in 20%). The median survival for all patients was 56 months. Survival comparisons dating from 12 months after start of treatment were significantly longer for 144 patients whose disease was in CR (median 9.6 years), than for those with PR or NR (median 4.0 and 2.2 years, respectively). For those patients evaluated at 12 months, Cox regression analysis indicated that the occurrence of CR, the presence of ISS Stage I disease, and provision of intensive therapy were associated independently with long survival, in that order. Median survival times from onset of CR were similar (10–15 years) for groups of patients who achieved CR after only chemotherapy or after intensive therapy for NR, PR or as consolidation of CR. Conclusions: Survival times were similar at approximately 10–12 years for different groups of patients with CR by whatever pathway that may have been achieved. Prospective clinical trials are needed for definitive evaluation of CR as a surrogate marker for long term survival. No significant financial relationships to disclose.
Comparing survival of Detroit to other registries in small and non-small cell lung cancer: SEER database study.
Authors: A. M. Eskandar, S. Sirop, M. Kojaian, J. Foreback, R. Bundesmann, E. Xie, M. Kanaan
Journal: Journal of Clinical Oncology (2011)

e12006 Background: This project compares the mortality and prevalence of SCLC and NSCLC between Detroit and other registries from the SEER database. Methods: The SEER database was analyzed for cases of SCLC and NSCLC from 1973-2007. The primary outcome was cancer specific survival between Detroit and other registries by ethnicity. The secondary outcome was determining the prevalence of SCLC and NSCLC in all registries. Statistical Analysis System (SAS) was used to analyze survival. Results: A total of 105,522 cases of SCLC and 3,094,764 cases of NSCLC were identified. Iowa has the highest prevalence of NSCLC and SCLC followed closely by Detroit for all races. In white SCLC patients, only Utah, and California excluding Los Angeles (LA), San Francisco (SF), and San Jose Monterey (SJM) have worse survival than Detroit. There is no significant difference in mortality in New Mexico, LA, rural Georgia, Alaska, Louisiana, and SF from Detroit. Connecticut, Hawaii, Seattle, SJM, Atlanta, Iowa, Kentucky, and New Jersey have better survival than Detroit There was no difference in mortality between Detroit and other registries in black and other nonwhite SCLC patients. In white NSCLC patients, rural Georgia, Kentucky, and Louisiana have worse survival than Detroit. San Francisco, Connecticut, Hawaii, Iowa, New Mexico, Seattle, Utah, Atlanta, SJM, LA, California excluding LA/SJM/SF, New Jersey have better survival than Detroit. In black NSCLC patients, Iowa had lower survival than Detroit. There was no difference in mortality comparing Detroit to New Mexico, Seattle, Utah, Alaska, or Kentucky. San Francisco, Connecticut, Hawaii, Atlanta, SJM, LA, rural Georgia, California excluding SF/SJM/LA, Louisiana, and New Jersey had better survival than Detroit. For other nonwhite NSCLC patients, Alaska had worse survival than Detroit. There was no difference in mortality between Detroit and SF, Hawaii, Iowa, Seattle, SJM, LA, rural Georgia, Kentucky, Louisiana, or California excluding LA/SJM/SF. Connecticut, New Mexico, Utah, Atlanta, and New Jersey had better survival than Detroit. Conclusions: Differences in mortality exist between registries which could reflect differences in health care access and tumor presentation.
What fixes can improve cancer care quality at safety-net hospitals?
Authors: Nina A. Bickell, Alexandra Moss, Bonnie Bellacera, Rebeca Franco, Ann Scheck McAlearney
Journal: Journal of Clinical Oncology (2014)

243 Background: Safety-net hospitals are at higher risk of poor quality cancer care and vary in levels of quality performance. Types of quality problems may differ and require different interventions. We undertook this study to identify organizational factors affecting quality and assess the early findings of the innovation’s impact on hand-offs between specialists. Methods: As part of a RCT testing a web-based tracking and feedback innovation to close referral loops, new breast cancer cases are rapidly ascertained, and post-surgical medical and radiation oncologist visits are assessed. Surgeons are alerted to patients who do not show to oncology visits to stimulate action. Of 153 enrolled women (98 Intervention/ 55 Control), 4% are white. In addition, we conducted 90 key informant interviews in 9 safety-net hospitals in the NYC metropolitan area and performed a qualitative comparative analysis (QCA), a method to assess causal complexity, to identify organizational factors associated with poor quality. Results: No-shows at oncology appointments triggering surgeon feedback occurred for 5/98 (5%) new breast cancer patients. QCA revealed 6 conditions associated with poor quality-defined as underuse of needed adjuvant treatment: information sharing; follow-up; system support; patient-centered culture; flexibility and private practice. All high-performing hospitals had a patient-centered culture, strong follow-up approaches and shared information. Some of these high-quality sites had robust system support while others had creative workarounds (flexibility) or were responsive to their private practice patients. Overall, these pathways had high consistency (.88) and coverage (.72). Only hospitals with both poor follow-up and system support activated the web-based feedback. Conclusions: Safety-net hospitals with poor follow-up capabilities may benefit from an innovation designed to improve hand-offs across specialties. This trial continues to accrue; we are monitoring the innovation’s effectiveness. Clinical trial information: NCT01544374.
Comparison of a new prognostic system and other three current staging systems in predicting the survival rate of patients with HBV-associated advanced hepatocellular carcinoma.
Authors: Ying-Fen Hong, Zhan-Hong Chen, Qu Lin, Min Dong, Xing Li, Jin-Yun Wen, Xiao-kun Ma, Li Wei, Dan-yun Ruan, Ze-xiao Lin, Jie Chen, Tian-tian Wang, Xiang-yuan Wu
Journal: Journal of Clinical Oncology (2016)

347 Background: HBV infection is one of the main reasons for hepatocellular carcinoma(HCC). Patients with advanced HBV-associated HCC have poor prognosis. Life expectancy more than 3 months is one inclusion criteria for molecular targeted drugs in clinical trials. Prediction of 3-month OS and OS survival rate of advanced HCC patients is very important. A new prognostic system called PS-JIS system (proposed Performance Status combined Japan Integrated Staging system, variables and risk classification criteria are listed below) was established in 2015 and now we want to compare this new prognostic system and other three current staging systems in predicting the survival rate of patients with advanced HBV-associated HCC. Methods: From September 2008 to June 2010, 220 patients with advanced HCC who didn’t receive anti-cancer therapy recommended by NCCN guidelines were analyzed. Data were collected to classify patients according to CLIP (Cancer of the Liver Italian Program), PS-JIS, GETCH(Groupe d’étude et de Traitement du Carcinome Hepatocellulaire) and TNM staging system at diagnosis. OS and 3-month OS were the end points used in the analysis. Results: When predicting 3-month survival, ROC analysis show AUC of CLIP, PS-JIS, GETCH and TNM is 0.806, 0.761, 0.654 and 0.643. AUC of CLIP and PS-JIS is similar (P=0.1174), both significantly higher than the other two staging system (P&lt;0.01). When predicting overall survival, likelihood ratio test show χ2 of CLIP, PS-JIS, GETCH and TNM is 74.00, 39.71, 23.09, 21.40. AIC of CLIP, PS-JIS, GETCH and TNM is 1601.46, 1635.80, 1655.06, 1654.77. The CLIP system has best performance in terms of discriminatory ability, homogeneity and monotonicity. Conclusions: The PS-JIS and CLIP systems were both the best score system in prediction of 3-month OS among the 4 systems and CLIP was still the best to predict OS analyzed for Chinese advanced HBV-associated HCC patients. [Table: see text]
Secondary resection in a general mCRC population with cetuximab-based first-line treatment: Interim analysis of the German noninterventional study ERBITAG.
Authors: Ulf P Neumann, Thomas Goehler, Gernot Reich, Michael Schwerdtfeger, Patrick Stuebs, Karsten G Stenzel, Friedrich Overkamp
Journal: Journal of Clinical Oncology (2013)

e14532 Background: Resection of liver and/or lung metastases (LM) are a potentially curative option for patients with mCRC. Cetuximab in combination with irinotecan- or oxaliplatin-based chemotherapy has shown to increase the resection rate of primarily unresectable LM in mCRC patients. After approval of cetuximab in Germany for first-line treatment of pts with unresectable mCRC, this noninterventional study was initiated to evaluate safety and efficacy of cetuximab in combination with various first-line chemotherapy regimens in patients with unresectable mCRC. Methods: We conducted an interim analysis of the first 124 fully documented pts to evaluate the response rate (RR) and resection rate of LM. Enrolment was restricted to pts with mCRC with proven KRAS wildtype mutation status without prior systemic treatment in the metastatic stage. Predefined endpoints were amongst others RR, LM resection rate, TTF, PFS, OS, and safety. Results: From May 2010 to May 2012 360 eligible pts were enrolled at 109 sites (75% office-based physicians), documentation for 124 was finalised (data cut-off for this analysis 03 May 2012) and evaluated. The median age was 68 [range 34-84] years, ECOG performance status was 0, 1, 2 in 29%, 60%, and 9% of pts, respectively, in 2% of pts ECOG performance status was missing. Resection rate was 18.5% (n=23) performed at 18 sites with 16.9% R0 resections (n=21). 42% of pts (n=52) had liver-limited disease (LLD). Resection rate in pts with LLD was 34.6% (n=18) with a 30.6% R0-resection rate (n=16). Median treatment duration from start of cetuximab-based therapy to resection of LM was 3.7 months [0.7-12.0]. Objective response rate was 46.8% (CR 4.8%, PR 41.9%) and 59.6% (CR 5.8%, PR 53.8%) for pts with LLD. Conclusions: In a clinical practice setting cetuximab-based first-line treatment of an unselected population with KRAS wildtype mCRC resulted in an R0-resection rate of 16.9% overall, and 30.6% for LLD pts. These data compare fairly well with data from clinical trials: CRYSTAL, OPUS, and CELIM.
The prognostic factor and the optimal timing of conversion surgery in unresectable stage IV gastric cancer: A retrospective analysis.
Authors: Tamotsu Sagawa, Yutaka Okagawa, Fumito Tamura, Tsuyoshi Hayashi, Koshi Fujikawa, Yasuo Takahashi, Yasushi Sato
Journal: Journal of Clinical Oncology (2016)

78 Background: Conversion surgery could be an option for unresectable stage IV gastric cancer when distant metastasis (M1) is disappeared by chemotherapy. However, the indication and the optimal timing of conversion surgery in stage IV gastric cancer remain unclear, even if metastatic lesions disappear with chemotherapy. Guideline of National Comprehensive Cancer Network also shows no principle after down-staging. Methods: This retrospective study examined 34 gastric cancer patients who underwent curative conversion surgery at our institute between 2005 and 2014. Clinicopathologic characteristics and patient outcomes were analyzed, with particular focus on the potential to select patients who might benefit from surgical resection. Results: The number of M1 factors was one in 31 patients and two in 3, including metastases to non-regional lymph node in 21, peritoneum in 8, liver in 5, and lung in 3. The regimen of chemotherapy was Docetaxel/CDDP/S-1 in 23 patients, Docetaxel/CDDP/S-1+Trastuzmab in 6, S-1/CDDP in 2, Docetaxel/S-1 in 1, CPT/CDDP in 1, and S-1 monotherapy in 1. The median duration from initiation of chemotherapy to the operation was 114 days (range 37-653 days). Total gastrectomy was performed in 27 patients and distal gastrectomy was performed in 7 patients. Complete resection with no residual tumor (R0) was achieved in 23 of 34 patients, microscopic residual tumor status (R1) in 10, and macroscopic residual tumor (R2) in 1. The 3-year overall survival (OS) rate among the patients who underwent conversion therapy was 58.0% with MST of 1190 days. Univariate analysis among the patents with conversion surgery identified intestinal differentiation, pathological response grade≧1b, R0 resection as significant prognostic factors. Patients operated on more than 91 days from initiation of chemotherapy had the 3-year survival rate of 68.2%, compared to 40.0% for patients operated on less than 90 days. Conclusions: Our data demonstrate the increased 3-year survival rate associated with delayed conversion surgery for stage IV gastric cancer. Delayed conversion surgery should be considered for patients, even if metastatic lesions disappear with chemotherapy.
Transfusion outcomes among oncology patients initiated with erythropoiesis-stimulating agents (ESAs) at baseline (BL) hemoglobin (Hb) of &lt;10 versus 10–11g/dL: Observational data from the dosing and outcomes study of erythropoiesis-stimulating therapies (DOSE) registry
Authors: T. Burton, K. Larholt, C. L. Pashos, C. Peake, B. K. Bookhart, M. Corral, C. T. Piech, R. S. McKenzie
Journal: Journal of Clinical Oncology (2008)

20637 Background: Limited real world data exist on transfusion patterns in patients initiated with ESAs at different baseline Hb levels. Transfusion outcomes in chemotherapy-treated oncology patients initiated on ESAs at BL Hb of <10g/dL vs 10–11g/dL were investigated. Methods: Observational data from an ongoing, prospective registry of ESA-treated patients in 59 US oncology clinics between 12/03–11/07 were analyzed. Hospital- and community-based outpatient practices were included. Data were analyzed from adult chemotherapy-treated oncology patients with ≥2 ESA doses. Results: 1,059 patients (ESA initiated Hb <10g/dL n=384, ESA initiated Hb 10–11g/dL n=675) from 59 sites were included. BL characteristics were similar for both groups. A significantly greater proportion of patients with BL Hb <10g/dL required transfusion. Mean number of units/transfused patient was similar between groups. However, overall blood utilization for all enrolled patients was significantly greater for patients with BL Hb <10g/dL (Table). Trends were maintained when data were analyzed from Day 28-end of study (EOS). Conclusions: Blood utilization was lower in patients with ESAs initiated at BL Hb of 10–11g/dL compared with <10g/dL. Differences were associated with the proportion of transfused patients rather than utilization in transfused patients. Baseline Hb (n = 1,059) <10 g/dL (n = 384) 10–11 g/dL (n = 675) P value Patients requiring transfusions Day 1-EOS 31% 15% < 0.0001 Patients requiring transfusions Day 28-EOS 16% 10% 0.0004 Mean (SD) units/Transfused patient Day 1-EOS 2.9 (1.8) 3.2 (2.2) 0.68 Mean (SD) units/Transfused patient Day 28-EOS 2.7 (1.5) 3.0 (2.0) 0.59 Mean (SD) units Transfused/Study patient, Day1- EOS 0.9 (1.7) 0.5 (1.4) < 0.0001 Mean (SD) units Transfused/Study patient, Day28-EOS 0.4 (1.2) 0.3 (1.1) 0.004 Mean (SD) ESA treatment duration, Days 58 (35) 58 (34) 0.88 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Ortho Biotech Ortho Biotech Ortho Biotech