tbuckley/cabot-search huggingface dataset:
Epidemiology, treatment outcome, and survival of primary gallbladder cancer in the United States: A period prevalence SEER database study 1973-2007.
Authors: A. M. Hossain, R. F. Khozouz, R. N. Rahman
Journal: Journal of Clinical Oncology (2011)

4104 Background: Primary gallbladder cancer (GBC) is an aggressive, uncommon with dismal outcomes. There has been no systemic analysis of epidemiology, outcome and survival of GBC in the past. This is the first study to examine these aspects of GBC diagnosed in last four decades (1973-2007) in USA. Methods: Frequency sessions on demographic and treatment were performed and compared among Caucasian (USW), Hispanic, African-American (AA) and Asian. Multivariate analysis and survival sessions (Kaplan-Meier, age adjusted) were performed using SEER database from 1973-2007. Results: Total of 12,993 GBC were reported in SEER from 1973-2007. It is more common in female (73% vs. 27%, p <0.0001) with incidence rate of 2 per million. Average age of diagnosis is 64 yrs but women were younger at diagnosis (59 vs. 69 years, p < 0.0001). 73% of GBC were diagnosed at advance stages. Among female USW, 39% were diagnosed at age less than 50. This is a distinctive trend and unique to GBC. Fewer USW received surgery and radiation (p < 0.01) than other groups indicating advance diseases. Differencesamong all ethnic groups in likelihood of receiving surgery, radiation andchemotherapy remained significant afteradjustment for stages, age, and year of diagnosis. Comparable 1 yr survival (28%) in different groups was observed. But 2-5 yrs survival is significantly higher in Asian (24%-17%) and Hispanics (24%-18%) than USW (19%-13%) and AA (19%-11%) (p= 0.02-0.05). Survival improvedconsiderably over time in all groups but more in Asian than others. Cox regression analysis showed that age at diagnosis, stage, marital status, and yearof diagnosis were predictors of death. Relative risk of death increased with higher stages and older ages. Chemotherapy and radiation were statisticallyassociated with poorer survival and higher RR.Persons, who did not receive surgery, had significantly worse survival and higher RR. Conclusions: GBC is rare but more common in female. 73% of the GBC were diagnosed at advance stages. More USW female were diagnosed at age younger than 50. Survival improvedconsiderably over time but remains poor. More studies are warranted to examine these epidemiological and survival trends.
Health care utilization and costs at end of life among patients with leukemia or lymphoma in a regional cancer registry-insurance claims linked database.
Authors: Cara L McDermott, Catherine R. Fedorenko, Karma L. Kreizenbeck, Ted Conklin, Bruce Smith, Gary H. Lyman, Scott David Ramsey
Journal: Journal of Clinical Oncology (2016)

184 Background: End-of-life (EOL) care for persons with hematologic malignancies is variable and often involves high-intensity services at death approaches, which may not reflect patient or family preferences. We characterized healthcare utilization and associated costs in the last 30 days of life among subjects with leukemia or lymphoma to better understand patterns of care in this population. Methods: We linked enrollment and claims records from two regional commercial insurers to Surveillance, Epidemiology, and End Results (SEER) records for patients diagnosed with leukemia or lymphoma in Western Washington state between January 1, 2007 and December 31, 2015. We developed algorithms to characterize EOL care and calculate costs from both the payer and patient perspective for the last 30 days of life. Costs are derived from paid claims for inpatient, outpatient, and pharmacy utilization. Patient out-of-pocket costs are calculated as the difference between allowed and paid claim amounts. Results: See Table. Conclusions: In this analysis, a majority of subjects usedat least one form of high intensity care in the last 30 days of life, and average out-of-pocket costs were considerable. Future research will focus on developing interventions to assess patient and family preferences for intensity of care to better inform the provision of high-value care in this population. [Table: see text]
Was it worth it (WIWI)? Patient satisfaction with clinical trial participation: Results from North Central Cancer Treatment Group (NCCTG) phase III trial N0147.
Authors: J. A. Sloan, M. R. Mahoney, D. J. Sargent, J. M. Hubbard, H. Liu, E. M. Basch, A. F. Shields, E. Chan, R. M. Goldberg, S. Gill, M. S. Kahlenberg, S. R. Alberts
Journal: Journal of Clinical Oncology (2011)

6122 Background: Despite the potential therapeutic advantage, only approximately 5% of eligible adult cancer patients enter oncology clinical trials. Knowledge of whether patients thought the clinical trial experience was beneficial may provide insights for barriers to accrual and inform future trial design. A recent phase III study in stage III colon cancer, N0147, included the 5-item "Was It Worth It" (WIWI) patient questionnaire to assess patient satisfaction. We report the results here. Methods: Patients received 12 bi-weekly cycles of FOLFOX alone or with cetuximab. WIWI was completed at treatment discontinuation. Comparisons between groups for each WIWI item was carried out via Fisher's exact tests. Results: WIWI data was provided by 1081 patients (see table). The majority said trial participation was worth it (95%), would do it again (90%), would recommend it to other people (95%), and that their QOL was improved by going on trial (65%). Over one-third of patients (37%) said their satisfaction was not related to their treatment outcome. Patients treated with Cmab were less likely to say participation was worth it and more likely to say their satisfaction was related to treatment outcome. Elderly patients were less likely to say trial participation was worth it, would do it again and would recommend it. FOLFOX-treated patients aged 70+ versus those aged <70 were more likely (76% vs 58%) to report that their satisfaction was related to their outcome (p=0.0001). Conclusions: In N0147, patients treated with Cmab and elderly patients indicated lower levels of satisfaction, due likely to the increased toxicity related to the Cmab treatment. Contrary to popular belief, patient satisfaction was not related to treatment outcome. Patient satisfaction can be assessed, is a sensitive measure to between-arm differences, and should be included in future randomized studies. Answered yes to . . . FOLFOX FOLFOX +Cmab P value Age <70 Age 70+ P value Worth it? 96% 94% 0.01 95% 92% 0.02 Do again? 93% 86% 0.0001 90% 84% 0.004 QOL improved? 67% 64% 0.13 66% 63% 0.32 Satisfaction level related to outcome? 60% 65% 0.05 60% 78% 0.0001 Recommend? 97% 94% 0.01 96% 92% 0.005
Increased time to progression and sustained PSA velocity responses in a phase II trial in advanced metastatic prostate cancer following treatment with ONY-P1, an allogeneic whole cell vaccine
Authors: A. G. Dalgleish, N. Quatan, A. Michael, F. Wushishi, H. Pandha
Journal: Journal of Clinical Oncology (2005)

4726 Background: We have shown previously that immunization with ONY-P1, a whole cell vaccine comprising 3 irradiated allogeneic prostate cancer cell lines, markedly increased time to disease progression (TTP) of 26 patients with hormone relapsed prostate cancer (HRPC) free of bone metastases. Median TTP increased from an historical 20–29 weeks to 58 weeks in this treated group. Here we report findings from the second cohort of this Phase II study: patients with asymptomatic metastatic bone lesions. Methods: All patients had HRPC, asymptomatic bone metastases and were immunocompetent (by skin Delayed Type Hypersensitivity testing). ONY-P1 was administered intradermally with BCG on weeks 0 and 2, followed by vaccine alone monthly for one year. Endpoints included safety, tolerability, TTP, PSA response, Quality of Life (QoL) and immunological profile. Results: Of 20 patients recruited, 13 were evaluable. At entry mean age was 70, mean PSA was 71ng/ml and performance status was 1 or better. A statistically significant sustained PSA velocity reduction was seen in 3 patients (23%). This was associated with a median TTP of 23 weeks, which compares favourably with published data (9–16 weeks). The vaccine was safe, well-tolerated and did not impair quality of life. The most common side-effects were mild fatigue and local injection-site reactions. Conclusion: Results from this second cohort of HRPC patients clearly demonstrate the feasibility of whole cell allogeneic vaccination in prostate cancer. As reported previously, the vaccine is a safe, rational treatment option that slows progression of disease. These data suggest that this protocol has a wide utility in HRPC, regardless of disease status and provide a strong rationale for phase III trials. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Onyvax Ltd. Onyvax Ltd. Onyvax Ltd. Onyvax Ltd.
Daily administration of MGCD265 to patients with solid tumors in a dose-escalation phase I study (study 265-101).
Authors: M. A. Drouin, C. K. Kollmannsberger, H. E. Uronis, R. E. Martell, J. Wang, M. Dubay, I. Dupont, J. M. Besterman, H. Hurwitz, G. Shapiro
Journal: Journal of Clinical Oncology (2010)

3106 Background: MGCD265 is an orally-available tyrosine kinase inhibitor that targets Met, VEGFR-1, -2, -3, Tie-2 and Ron. Methods: This is a multicenter, open-label, dose escalation study of oral MGCD265 administered once daily as a continuous 21-day cycle. Cohorts of 3-4 patients were enrolled per dose level, initially with dose doubling between cohorts, followed by smaller increments once grade 2 drug-related toxicity is observed. Response is assessed every 2 cycles by RECIST criteria and plasma makers (VEGF, HGF, shed Met and soluble VEGFR2) are being analyzed. Results: The first18 patients received capsules of MGCD265: 4 patients at 24 mg/m2; 3 patients at 48 mg/m2; 4 patients at 96 mg/m2; 3 patients at 150 mg/m2 and 4 patients at 300 mg/m2. Hypertension was observed in one patient at 300 mg/m2 during the first cycle of treatment. This event was considered to be a dose limiting toxicity. Grade 2 adverse events considered at least possibly related to the treatment included: hypertension, anemia, nausea and diarrhea. A tablet formulation was recently introduced at 150 mg/m2 (n=4) and at the 250 mg/m2 dose levels. To date, 5 patients have experienced stable disease. Available archived biopsies obtained prior to MGCD265 treatment from 3 of these 5 patients showed Met protein expression and autophosphorylation. Preliminary PK data indicate a Tmax of approximately 5 hours with a long half-life (∼26 hours). PK profile from tablets and capsules appears similar based on MGCD265 clinical studies. At 150 mg/m2, the steady state plasma concentration is anticipated to be in the range of the exposure at an efficacious dose in xenograft models of Met sensitive tumors. Preliminary PD analyses indicate modulation of VEGF by MGCD265. Conclusions: To date, daily oral administration of MGCD265 has been found to be well tolerated with early signs of activity and at 150 mg/m2, the human exposure is predicted to be in the range of an efficacious dose in preclinical Met sensitive models. In the absence of significant toxicity, this dose could be considered a phase II dose. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration MethylGene MethylGene MethylGene MethylGene
Effect of neoadjuvant treatment with gemcitabine with nab-paclitaxel on SPARC and Ki-67 in patients with resectable pancreatic adenocarcinoma.
Authors: Sarunas Sliesoraitis, Amy L. Collinsworth, Jose Gilberto Trevino, Robert Zlotecki, Xiaomin Lu, Judith L. Lightsey, Carmen Joseph Allegra, Ahmad Alkhasawneh, Long H. Dang, Karen Colleen Daily, Kevin Behrns, Chen Liu, Steven J. Hughes, Alison Marguerite Ivey, Shailendra Chauhan, Neelam Vijay Desai, Thomas J. George
Journal: Journal of Clinical Oncology (2015)

322 Background: Nab-paclitaxel (nab-P) and gemcitabine (Gem) improve survival in metastatic pancreatic cancer (PCa). We sought to determine the impact of nab-P and Gem on the primary tumor and associated microenvironment in neoadjuvant treatment (NAT). Methods: All patients in the GAIN-1 study (NCT01470417) received NAT with nab-P and Gem with or without radiation depending on risk status. A comparator group without NAT was matched for age, sex, race, resection status, smoking, primary tumor site, and tumor size. Surgical specimens of tumor, associated stroma and lymph nodes were analyzed. Routine immunohistochemistry (IHC) for Ki-67 and TUNEL was performed. Immunolabeling was assessed using anti-SPARC antibody (Invitrogen) with scoring consistent with prior reports: Negative = intensity absent to weak (+) with extent &lt;10%; Positive = intensity moderate (++) to strong (+++) with extent ≥ 10%. For Ki-67 and TUNEL, the percentage of positive tumor cells was averaged over four HPF/specimen. Study was conducted with IRB approval. Results: A total of 30 unique patients were included in this analysis, 8 NAT cases and 22 matched controls. Clinical outcomes have been previously reported. Minimal to no SPARC expression was noted in either group of tumor cells. However, stromal SPARC expression was markedly reduced in NAT group (mean 2.88 ± 0.69%) compared to controls (28.43 ± 5.80%; p = 0.0002). Ki-67 was reduced in NAT group compared to controls (10.5 ± 2.83% vs. 36.76 ± 4.32%; p = 0.0004). TUNEL stain revealed a trend toward lower levels in NAT group (mean 1.13 ± 0.30% vs. 1.62 ± 0.31%; p = 0.574). SPARC, Ki-67 and TUNEL did not correlate with survival. Conclusions: SPARC expression in pCa primary tumors is low. Neoadjuvant nab-P and Gem significantly decreased stromal SPARC and tumor Ki-67. There was no change in TUNEL expression, indicating a population of residual viable cells. Additional stromal microenvironment change analysis in response to treatment is ongoing.
Addressing patient needs through compilation of self-reported verbatim comments.
Authors: Scott Hartman, Diane Denny, Sarah Hizon, Danielle Kendrick, Maurie Markman
Journal: Journal of Clinical Oncology (2016)

111 Background: Cancer Treatment Centers of America, Inc. (CTCA) is a national network of five hospitals that specialize in the treatment of patients fighting complex or advanced-stage cancer. The Symptom Inventory Tool (SIT) is an assessment that captures the patients’ perceived symptom burden, from baseline and every 21 days thereafter. The SIT is comprised of questions utilizing the M.D. Anderson Symptom Inventory tool, with eight questions and a free text box added by CTCA. Patient comments are provided in approximately 5% of all assessments (representing 3,700 comments) since initiation of the SIT. Methods: Patients answer the question, “Is there anything else that you would like to tell us or are there additional concerns you would like addressed?” within a free text field. In addition to availability to the care team to address any identified urgent need, each comment is classified into 15 defined categories to allow trending. The report is disseminated monthly to a multi-disciplinary team for follow-up on service delivery and consideration in program development. Results: The table represents the top five patient comment categories along with “other”. In addition, a sample of last quarter's data revealed that 84% of comments required immediate follow-up that may have otherwise been missed without text data mining. Conclusions: Verbatim comments are of significant value and can be best managed via dual processes to ensure timely follow-up and to support programmatic alignment, continuously analyzing data for areas of improvement. [Table: see text]
CEA response as a predictive marker for response according to RECIST in patients with <i>KRAS</i> wild-type metastatic colorectal cancer (<i>KRAS</i> WT mCRC) (pts) treated with panitumumab monotherapy.
Authors: Irene E. G. van Hellemond, Geert-Jan Creemers, Laurence van Warmerdam, Floris A. de Jong, Rutger H. T. Koornstra
Journal: Journal of Clinical Oncology (2013)

574 Background: Panitumumab is a fully human monoclonal antibody targeting the epidermal growth factor receptor (EGFR) and is approved as treatment in KRAS WT mCRC in combination with chemotherapy and in chemotherapy-refractory pts as monotherapy. In mCRC, CEA decrease is often used as an early response predictor, but correlative studies with RECIST and formal cutoff criteria are scarcely available. Here we report on an exploratory analysis in KRAS WT mCRC pts treated with monotherapy panitumumab. Methods: A series of 29 KRAS WT mCRC pts who have been treated with panitumumab monotherapy (6 mg/kg once every 2 weeks) as second-line treatment were included (58% male; mean age 65,6 years; performance status was 0-1 in 90%). Every 12 weeks, response evaluation by CT-scan was done routinely. Responses were determined using RECIST v1.1. CEA levels were determined every 6 weeks. A CEA response was defined as two consecutive CEA decreases of ≥10% compared to the previous value. Progression was defined as two consecutive CEA increases of ≥10% compared to the previous value. Pts not meeting these criteria were defined as stable. CEA change at week 6 and CEA response at week 12 week were correlated with RECIST response at week 12 using Spearman’s correlation coefficient. Results: A 10% CEA decrease at week 6 was predictive for response according to RECIST at week 12 (r=0.71, p&lt;0.001). Likewise, at week 12, responses determined by RECIST and CEA strongly correlated (r=0.88, p&lt;0.001). Conclusions: Data from this small study suggest that CEA changes may have predictive potential as early time point response biomarker in pts treated with panitumumab monotherapy. More research is warranted to confirm these retrospective findings. [Table: see text]
Impact of mortality due to malignant melanoma versus other cancers
Authors: D. Taylor, J. Nyambose, K. Kulig, C. C. Earle, D. Thompson
Journal: Journal of Clinical Oncology (2008)

20016 Background: Rankings of different cancer types by annual numbers of deaths provide important, albeit incomplete, data on overall impact of mortality. Because some cancers primarily affect younger people and have short survival, their impact on years of life lost (YLL) and lifetime earnings lost (LEL) is greater than that suggested by raw numbers of attributable deaths. To illustrate, we compared YLL and LEL for advanced stage malignant melanoma to seven tumor types also affecting both sexes. Methods: All fatal cases of advanced-stage cancer were identified in the most recent U.S. Surveillance Epidemiology and End Results (SEER) cancer registry (1995–2004). YLL due to melanoma was compared with other advanced-stage cancers that affect both sexes, including tumors of the colon/rectum, oral cavity/pharynx, brain/other nervous system (ONS), lung/bronchus, liver/intrahepatic bile duct, pancreas, and kidney/renal pelvis. Median survival was assessed using SEER*Stat software. YLL was calculated by subtracting the median survival since diagnosis from the individual’s life expectancy without cancer at the time of diagnosis, based on the 2003 U.S. Life Tables. Total YLL was calculated by summing the products of YLL and deaths in each age group; average YLL (AYLL) by dividing total YLL by total deaths; total LEL by multiplying LEL by deaths for each tumor type; and average LEL by dividing total LEL by total deaths. LEL were based on 2005 U.S. Census Bureau Historical Income Tables. Results: Malignant melanoma had both the highest estimated AYLL (22.1 years) and average LEL ($831,000) versus other cancers (Table). Conclusions: The impact of malignant melanoma on average years of life lost and lifetime earnings lost is greater than that of the other cancers assessed. Because melanoma often strikes younger people, and because current therapies do not significantly extend survival, the humanistic and societal burden is greater than that of the other tumor types. Average years of life lost (AYLL) and average lifetime earnings lost (LEL) Cancer Site AYLL Average LEL Melanoma of the skin 22.1 $831,000 Liver and intrahepatic bile duct 21.7 $769,000 Oral Cavity & Pharynx 20.3 $784,000 Brain and Other Nervous Systems 19.7 $757,000 Kidney and Renal Pelvis 19.2 $699,000 Lung and Bronchus 18.2 $652,000 Pancreas 17.5 $612,000 Colon and Rectum 17.1 $622,000 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Pfizer, Inc Pfizer, Inc Pfizer, Inc Pfizer, Inc
Sorafenib versus cytotoxic chemotherapy for patients with advanced hepatocellular carcinoma: A retrospective, single-institution study.
Authors: S. Lee, S. Yoon, S. Shin, H. Choi
Journal: Journal of Clinical Oncology (2011)

339 Background: Prior to the sorafenib era, most of the advanced hepatocellular carcinoma (HCC) patients had to rely only on conventional cytotoxic chemotherapy. But the introduction of sorafenib in 2008 had given HCC patients additional option for their treatment. However, given that sorafenib has been a nonreimbursable drug under the Korea public health system, most of treatment strategy has largely been determined by patients' affordability of the drug rather than by difference in efficacy and toxicity of the two treatments. Therefore, we compared the efficacy and toxicity of the two treatments by observing HCC patients. Methods: From January 2002 to December 2009, 173 patients with unresectable HCC had been retrospectively analyzed. Among them, 44 (25.4%) had been treated with sorafenib and the remaining had received cytotoxic chemotherapy. We evaluated objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and toxicity profiles. Results: The median OS of sorafenib group was 23.0 weeks (95% CI, 8.1-37.9) vs. 43.6 weeks (95% CI, 34.0-37.9) for cytotoxic chemotherapy group. The median PFS for sorafenib group was 11.1 weeks (95% CI, 6.5-15.8) versus 12.4 weeks (95% CI, 8.1-16.7) for cytotoxic chemotherapy group. However, the difference in both findings had not been statistically significant (p=0.105 and p=0.496, respectively). ORR and DCR for sorafenib group were 2.3% and 52.3% versus 6.2% and 43.4% for cytotoxic chemotherapy group, respectively. Patients treated with chemotherapy had shown higher frequencies of grade 3 or 4 neutropenia, 19.7%, (vs. 0% for sorafenib). However, the group with sorafenib had reported a higher rate of all grade dermatologic toxicities such as hand-foot skin reaction, rash and pruritus. Conclusions: Our analysis indicates that efficacy of conventional chemotherapy is not inferior to that of sorafenib. Further research including novel target agent and cytotoxic chemotherapy is needed to improve clinical outcomes for advanced HCC. No significant financial relationships to disclose.