tbuckley/cabot-search huggingface dataset:
A study on the long-term survivors in an expanded access program (EAP) of gefitinib in China.
Authors: L. Longyun, G. Hui, M. Wang
Journal: Journal of Clinical Oncology (2011)

e18053 Background: Gefitinib is a kind of EGFR tyrosine kinase inhibitor (TKI) and demonstrated same efficacy in survival and better safety profile compared with standard chemotherapy for pre-treated NSCLC patients. The Expand Access Program of Iressa was initiated in 2001 in China with the objective to provide gefitinib to patients with NSCLC. It is clinically interesting to describe the QoL, tumour control status, safety and clinical/genomic feature of the long-term survivors in the EAP. Methods: The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP. Secondary objectives is to determine the clinical characteristics of long-term survivors in the EAP program. This was a descriptive observational study. A total of 934 patients were screened in EAP database. 25 of them were active long-term survivors and 34 of them were long-term survivors terminated from EAP. The data of 875 fast-progressers were extracted from the existing EAP database. Results: The mean FACT-L Score was 62.88, the mean TOI score was 36.46 and the mean LCS score was 12.79. In PWB, for question “I have a lack of energy”, 70.8% patients felt no lack of energy, and 20.8% patients felt a little bit lack of energy. In FWB, for question “I am able to enjoy life”, 50.0% patients were able to enjoy life very much, and 29.2% patients were able to enjoy life quite a bit. For question “I am content with the quality of my life right now”, 62.5% patients were content with the quality of their life very much, and 12.5% patients were content with the quality of their life quite a bit. PS 0-1 accounted for 91.66% when they were evaluated in the cross-sectional survey. Age<65 years (68.52%), adenocarcinoma (81.36%), female (55.39%) and never-smoker (70.69%) accounted for the majority of long-term survivors. For those long-term survivors, the objective response rate (CR+PR) was 37.5%, the disease control rate(CR+PR+SD) was 87.5% and the median duration of response time was almost 68 months. Conclusions: Gefitinib 250 mg offers a good QoL and efficacy for those long-term survivors even after more than 3 years treatment. Gefitinib has shown good tolerability for long-term survivors treated with gefitinib in this study.
A dendritic cell-based vaccine effects on T-cell responses compared with a viral vector vaccine when administered to patients following resection of colorectal metastases in a randomized phase II study.
Authors: H. K. Lyerly, A. Hobeika, D. Niedzwiecki, T. Osada, J. Marshall, C. R. Garrett, D. Z. Chang, M. Aklilu, T. S. Crocenzi, D. J. Cole, S. Dessureault, S. D. Hsu, A. Bulusu, B. M. Clary, R. Annechiarico, G. Devi, V. Chadaram, T. M. Clay, M. Morse
Journal: Journal of Clinical Oncology (2011)

2533 Background: CD8+ T cell responses to colorectal cancer are associated with longer survival. This has led to the hypothesis that cancer vaccines, capable of activating T cell responses, may improve clinical outcome. Vaccines based on antigen-presenting cells/dendritic cells (DC) and viral vectors, potent stimulators of adaptive immunity, have been associated with enhanced survival in prostate cancer patients. We compared rates of tumor antigen-specific T cell and antibody responses between a DC and a poxvector vaccine. The clinical outcome data is reported elsewhere. Methods: 74 patients with no evidence of disease after colorectal cancer metastasectomy and completion of peri-operative chemotherapy were randomized 1:1 to receive injections of one of either: DC mixed with PANVAC-VF (poxvectors encoding CEA, MUC1, CD54, CD58, CD80) or PANVAC-VF along with local injections of GM-CSF. Peripheral blood was drawn before and after completing the immunizations for analysis of CEA and MUC-1 immune (T cell and antibody) responses by ELISPOT and ELISA. Results: T cell responses against CEA were significantly more frequent in the DC arm (69 versus 41%, p=0.02) although the magnitude of the T cell response among responders was similar. There was a trend for improved relapse-free survival among patients with CEA-specific T cell responses (log rank p = 0.10). The antibody response to CEA was more frequent with the PANVAC alone (100% versus 67%, (p= 0.018)) and the antibodies in serum from vaccinated patients could bind to CEA-expressing tumor cells and mediated ADCC. No antibody response was induced against MUC-1. The antibody response against CEA did not correlate with clinical benefit. Few deaths were observed limiting comparison of survival by immune response. Conclusions: A dendritic cell vaccine leads to a greater frequency of CEA-specific T cell responses which is associated with enhanced RFS. Ongoing studies are evaluating the role of additional immunostimulatory cytokines and modulation of regulatory cell populations and molecules in enhancing the adaptive immune response to the DC-based vaccine.
Advance directives: Cancer patients’ preferences and family-based decision making.
Authors: Xing Li, Zhi-Huan Lin, Ying-Fen Hong, Xiao-kun Ma, Dong-hao Wu, Yan-Fang Xing, Xiang-yuan Wu, Qu Lin
Journal: Journal of Clinical Oncology (2015)

18 Background: Advance directives (ADs) are a sensitive issue among traditional Chinese people, who usually refrain from mentioning this topic until it is imperative. Medical decisions for cancer patients are made by their families, which might violate patients’ personal will. This study was aimed to examine the acceptance of ADs among Chinese cancer patients and their families and patient participation in this procedure. Finally, to analyze the moral risk involved. Methods: Participants included 412 adult cancer patients from 9 leading hospitals across China. An AD was introduced to the main decision makers for each patient; if they wished to sign it, the AD would be systematically discussed. A questionnaire was given to the oncologists in charge of each patient to evaluate the interaction between families and patients, patients’ awareness of their disease, and participation in an AD. Results: A total of 246 patients and their family members rejected systematic discussion of AD, the majority (95.5%) of whom were under anti-cancer treatment. An additional 166 patients or their families accepted the concept of an AD and signed an AD to give up invasive treatment. This decision was make shortly after termination of anti-cancer therapy. Correlational analysis revealed that patients living in villages and who were subordinate members in their families tended to accept an AD. Of these, only 24 patients participated in the decision making. Correlational analysis revealed that patients with a better financial situation, living in cities, and superordinate status in their families tended to participate in the AD discussion, as well as those who usually made medical decisions themselves. Nearly all the patients deciding their own AD knew their entire situation, including diagnosis and prognosis. For 101 patients, anti-cancer therapy was ended prematurely, with as many as 37 patients not told about their potential loss of health interests. Conclusions: ADs were widely accepted among Chinese cancer patients when anti-cancer therapy was terminated. Most cancer patients were excluded from the discussion of an AD. Thus, AD could be formally introduced to the family of Chinese cancer patients after termination of anti-cancer therapy.
The influence of CD44v6, TGF-α, COX-2, MMP-7, and MMP-9 on clinical evolution of patients with gastric cancer.
Authors: M. F. Fanelli, L. T. Chinen, M. D. Begnami, W. L. Costa, J. H. Fregnami, F. A. Soares, A. L. Montagnini
Journal: Journal of Clinical Oncology (2011)

21 Background: Gastric cancer (GC) is the fourth most common tumor worldwide. As palliative chemotherapy is a relevant approach for patients with distant metastasis, determination of prognostic parameters that are predictive of survival may allow better identification of patients who may benefit from current chemotherapy regimens. The process of GC proliferation and metastasis occurs via epithelial-mesenchymal transition (EMT), which consists on gain of motility and invasiveness by epithelial cells via the disassembly of cell-to-cell contacts and significant cytoskeletal reorganization. Molecules involved in each step have been identified, including cell-adhesion molecules, growth factors and matrix degradation enzymes. Objectives: To verify the correlation between tumor progression and the expression of some proteins (CD44v6, TGF-α, COX-2 MMP-7, MMP-9) involved on EMT, by these relation with patient overall survival (OS) and disease stage. Methods: We retrospectively examined the medical records and histopathological biopsy results of 137 patients with GC (stages I to IV), treated at the Department of Medical Oncology at Hospital do Cancer A.C. Camargo between 1998 and 2006. Included patients underwent total or subtotal gastrectomy at our hospital. Expression of proteins related to EMT was evaluated by Tissue Microarray. Results: By the analysis of protein expression according to deep of gastric wall invasion (T), no protein showed to be important. On different levels of lymphonodal commitment (N0, N1, N2, N3) and in relation to presence (M1) or absence (M0) of distant metastasis, only COX-2 expression showed to be determinant with major expression on N2 and N3 and M1 status (p = 0.017 and p = 0.011, respectively). COX-2 was also relevant for clinical stage, where its expression was higher on poor stages (p = 0.011). On 5-year OS, TGF-α (p = 0.017), COX-2 (p &lt; 0.001), MMP-7 (p = 0.020) and MMP-9 (p = 0.015) expressions revealed to be determinant, where the poor expression of these proteins were linked to better OS. Conclusions: This is the first study to correlate proteins involved on EMT with OS. We were able to show that COX-2, TGF-α, MMP-7 and MMP-9 expression on GC were related to poor patient OS. No significant financial relationships to disclose.
Understanding efficiency of chemotherapy delivery for planned chemotherapy admission at Columbia University Medical Center.
Authors: Melissa Kate Accordino, Jason Dennis Wright, Sowmya Vasan, Alfred I. Neugut, Jim Hu, Dawn L. Hershman
Journal: Journal of Clinical Oncology (2016)

206 Background: Delays in administration of planned in-patient chemotherapy can lead to prolonged length of stay (LOS), resulting in increased cost and risk of nosocomial infections and other complications. Methods: We conducted a retrospective analysis of cancer patients admitted to Columbia University Medical Center, a tertiary care center, for planned chemotherapy from January 1, 2014 through December 31, 2014. Eligible patients were identified as cancer patients (via ICD9 codes) who were admitted directly to the inpatient hematology/oncology service with intravenous chemotherapy orders submitted within 24 hours of the admission. Patients were excluded if they received oral, non-formulary, intrathecal, or high dose methotrexate therapy. For each admission, the duration of time from admission to infusion start time was recorded. We evaluated patients who were admitted to the Intensive care unit (ICU) separately. Chart review and provider interviews were conducted on a subset of patients. Results: Over 12 months, 314 unique hospital admissions involving 162 patients were included in the analysis. The median time from admission to chemotherapy infusion start was 15.8 hours (mean 31.5, IQR 3.1-41.0 hours). Of the 314 unique admissions, 299 (95.2%) did not require ICU involvement during their hospitalization. Of these patients, median admission to chemotherapy infusion start time was 15.5 hours (mean 29.9, IQR 2.9-38.9 hours). Chart review and provider interview were conducted for 22 patient admissions. In this subset, median time from admission to chemotherapy start was 13.6 hours. Top reasons for delays were: order modifications for lab abnormalities, lack of chemotherapy consent, and delay in chemotherapy delivery to inpatient units. Conclusions: In cancer patients admitted for planned chemotherapy we found a significant delay between hospital admission and infusion start time. Inefficiencies in this process are likely multifactorial on the patient, provider, and systems level, however our data suggests that they may be modifiable. Interventions devoted to reducing the time may decrease LOS, reduce cost, improve patient satisfaction, and reduce risk of complications.
Symptom clusters in patients with advanced cancers
Authors: C. Zimmermann, W. Y. Cheung, L. W. Le
Journal: Journal of Clinical Oncology (2008)

9566 Background: It has been observed that certain cancer symptoms such as pain, depression and fatigue frequently occur together. Prior research on symptom patterns has focused on inpatients, early stage cancers, or a single cancer type or metastatic site. Our aim was to explore symptom clusters among outpatients with various types of advanced cancers. Methods: Symptom scores measured by Edmonton Symptom Assessment Scale (ESAS) were routinely collected for patients attending Oncology Palliative Care Clinics at Princess Margaret Hospital from January 2004 to October 2007. Principal component analysis (PCA) was performed for the entire patient cohort and within specific disease sites to determine interrelationships of the 9 ESAS symptoms. Regression analyses were used to identify patient characteristics that were associated with symptom clusters and severity of symptom distress. Results: A total of 1,366 patients were included: 50% were male and median age was 64 years (range 18 to 74). The 3 most prevalent symptoms were fatigue, poor general well-being and decreased appetite. PCA of symptoms for the entire patient cohort revealed 2 major symptom clusters: cluster 1 (fatigue, drowsiness, nausea and decreased appetite) and cluster 2 (anxiety, depression and poor general well-being). There was high internal reliability in the clusters (Cronbach’s alpha coefficient 0.80 and total variance 10–47%). Neither patient gender nor age predicted for symptom clusters (all p>0.05). Results from PCA of symptoms within the main cancer sites were tabulated (see table). Conclusions: In patients with advanced cancers, cancer site is associated with distinct symptom clusters which are not influenced by patient demographics. Further prospective studies are warranted in order to develop cancer-specific palliative interventions for this patient population. ESAS Symptom CNS H&N Breast Lung GI GU Gyne Pain 0.70* 0.23 0.87* 0.74* 0.73* 0.71* 0.55* Fatigue 0.77* 0.64* 0.43 0.60 0.56* 0.73* 0.60* Nausea 0.22 0.10 0.28 0.41* 0.78* 0.15 0.21 Depression 0.33 0.83* 0.47 0.31 0.79* 0.17 0.14 Anxiety 0.25 0.79* 0.20 0.17 0.84* 0.20 0.16 Drowsiness 0.80* 0.24 0.57* 0.33 0.73* 0.45 0.12 Appetite 0.10 0.19 0.28 0.81* 0.03 0.77* 0.76* Well-being 0.33 0.68* 0.32 0.68* 0.39 0.73* 0.78* Dyspnea 0.65* 0.77* 0.24 0.01 0.27 0.44 0.59* Values listed represent factor loading in principal component analysis where * indicates possible symptom clustering within the disease site. CNS: central nervous system; H&N: head and neck; GI: gastrointestinal; GU: genitourinary; Gyne: gynecological. No significant financial relationships to disclose.
Characterization of urothelial carcinoma with seminal vesicle involvement in locally advanced bladder cancer.
Authors: Simpa Samuel Salami, Aaron Udager, Brady Garland Miller, Ganesh S. Palapattu, Scott Tomlins, Arul M. Chinnaiyan, Daniel Eidelberg Spratt, Felix Yi-Chung Feng, Lakshmi Priya Kunju, Angela J. Wu, Todd Matthew Morgan, Alon Z. Weizer, Jeffrey Scott Montgomery, Cheryl T. Lee, Rohit Mehra
Journal: Journal of Clinical Oncology (2016)

440 Background: Muscle-invasive bladder cancer is associated with poor clinical outcomes, especially in locally advanced (pT4) disease. There is a paucity of data, however, regarding the clinical impact of seminal vesicle (SV) involvement. Therefore, we sought to characterize clinicopathologic features of patients with urothelial carcinoma involving seminal vesicles, and evaluate clinical outcomes in patients with locally advanced (pT4) bladder cancer with or without SV involvement. Methods: After institutional review board (IRB) approval, we retrospectively identified all men with pT4 (per the 7 th edition of the AJCC Cancer Staging Manual) bladder cancer who underwent radical cystectomy between 2002 and 2013 at a single large academic institution. Clinicopathologic and follow-up data for all patients were obtained from the electronic medical record. The presence or absence of divergent differentiation, including aggressive forms (plasmacytoid, nested, micropapillary, and sarcomatoid), was recorded. Estimates of overall survival (OS) were compared by plotting Kaplan-Meier curves and using log-rank test. Results: A total of 62 patients were eligible for analysis. The median age and follow-up duration were 72 (range: 46 – 87) years and 12 (range: 0 – 141) months respectively. SV involvement was present in 17.7% (11/62) of patients. The frequency of divergent differentiation (including aggressive forms), angiolymphatic invasion, nodal disease (pN1-3), and positive soft tissue margins was relatively higher among those with SV involvement (not significant, all p &gt;0.05). The 1 and 2-year OS for patients with SV involvement were 32.7% and 0% respectively, compared with 51.0 % and 24.9% respectively for patients without SV involvement. There was no statistically significant difference between the median OS of men with and without SV involvement (9 vs. 13 months, respectively; p = 0.19). Conclusions: In this relatively limited sample size cohort, we did not observe any difference in the overall survival of locally advanced bladder cancer patients with and without SV involvement.
Docetaxel and gefitinib in the first-line treatment of elderly patients (≥70) with advanced non-small cell lung cancer (ANSCLC): Results of phase II trial
Authors: G. Bepler, C. C. Williams, A. Chiappori, S. J. Antonia, E. B. Haura, J. J. Mahany, T. Galloway, G. R. Simon
Journal: Journal of Clinical Oncology (2005)

7155
Pamidronate as adjuvant treatment for prevention of bone metastasis in breast cancer
Authors: J. Jung, G. Hwang, Y. Lee, H. Park, Y. Yang
Journal: Journal of Clinical Oncology (2005)

888 Background: Bone is the most common site of distant recurrence in breast cancer. The primary mechanism of metastatic bone disease is stimulation of osteoclastic bone resorption by factors produced by the cancer cells. Bisphosphonates are potent inhibitors of osteoclastic bone resorption with proven efficacy in reducing tumor-associated skeletal complications. Several studies have investigated the adjuvant, or preventive, use of these drugs in breast cancer. Laboratory experiments have shown that the development of bone metastases can be inhibited by Bisphosphonates. Pamidronate is an easy to use potent inhibitor of osteolysis, given in conjunction with standard anticancer therapies. We evaluated the efficacy of adjuvant pamidronate therapy for prevention of bone metastasis in women with breast cancer. Methods: We analyzed the data of 429 patients with primary operable stage I-III breast cancer that were treated at KNUH during the period January 1999-December 2002. All patients had radical local therapy and systemic therapy performed according to our guidelines at that time. 258 patients were received adjuvant pamidronate therapy(parmidronate 15mg iv every 4 weeks and oral parmidronate 100mg daily during adjuvant chemotherapy). 171 patients had no bisphosphonate therapy. The patients were perimenopausal women. The mean age of patients was 53 years and the median follow-up period was 3.5 years. The clinicopathological characteristics of the patients were well balanced. Results: The incidence of bone metastasis was 2.3% in the parmidronate group and 8.7% in control group. The incidence of other sites metastasis in pamidronate group was lower than control group but no statistically significant. Overall survival and disease-free survival rate were equal in the both groups. Bone metastasis free survival was significantly higher in the pamidronate group compared to the control group. Conclusions: In the parmidronate group, the incidence of bone metastases was significantly reduced and bone metastasis free survival was significantly higher. We conclude that adjuvant parmidronate therapy significantly reduced the development of bone metastases in perimenopausal women with primary breast cancer. No significant financial relationships to disclose.
The effect of insurance status on the stage of colorectal cancer at diagnosis.
Authors: Arieh Greenbaum, Vinay Singhal, John Morgan Cosgrove, Daniel T Farkas
Journal: Journal of Clinical Oncology (2012)

420 Background: There is currently a lot of focus on the number of uninsured patients in the country. Part of the recent healthcare debate revolved around the lack of preventative medicine and screening in such patients. The assumption is that patients without insurance present to hospitals with later stages of disease. The purpose of this study was to evaluate patients with colorectal cancer, and to see if their insurance status was related to the stage of their cancer at diagnosis. Methods: All patients in our tumor registry with a diagnosis of colorectal cancer between 2000 and 2010 were initially included. Those who did not have their complete care in our hospital, or those for whom insurance information was not available, were excluded. Patients were categorized into insured and uninsured patients. Cancer staging at the time of diagnosis was done according to the American Joint Committee on Cancer guidelines, and patients with stage 3 or 4 disease were classified as having advanced cancer. Results: There were 489 patients in the tumor registry for these ten years, of which 435 had their care in our hospital and were fully staged. Insurance information was available for 383 patients (88%). There were 360 patients (94.0%) in the insured group and 23 patients (6.0%) in the uninsured. In the insured group there were 128 patients (33.4%) with advanced cancer, while in the uninsured group there were 15 patients (65.2%). This difference was highly significant (Chi-square, p=0.007). Conclusions: Patients without insurance present with more advanced stages of colorectal cancer. In our series, uninsured patients were almost twice as likely to present with stage 3 or 4 disease. Efforts at helping more patients gain access to healthcare insurance could perhaps lead to fewer people presenting with advanced stages of cancer.