tbuckley/cabot-search huggingface dataset:
Depressive/anxiety disorders and quality of life in young adults: Survivors of childhood differentiated thyroid cancer.
Authors: M. Jarzab, A. Kropinska, A. Syska-Bielak, P. Gorczyca, R. T. Hese, D. Handkiewicz-Junak
Journal: Journal of Clinical Oncology (2010)

e19651 Background: Differentiated thyroid cancer (DTC) in children often presents at an advanced stage, but with intensive multi-modality treatment the prognosis is excellent. However, this context is not always fully realized/accepted by the patients (pts) and their families, prone to the cancer stigma phenomenon, and negatively impacts the patient adolescence. These long term effects may be important for the treatment algorithms and correct balance between over- and under-treatment. Thus, the aim of our study was to assess the psychosocial outcome of childhood DTC: frequency of anxiety and depressive disorders and quality of life in a homogenous cohort of young adults, treated in childhood and followed-up in single reference center in Poland. Methods: The study was carried out in a group of 109 pts diagnosed before age 18 years (between 1987 and 2003). Between 2006-07, these pts, after median 10 years of observation, at age 18-38 years were prospectively assessed, with full evaluation of disease status, long term physical complications and comprehensive psychiatric and psychological assessment. Anxiety, depressive symptoms and quality of life were scored, each by two independent validated tools. Results: In 18% of pts we found significant symptoms of anxiety or depressive disorders, requiring therapeutic intervention, while in approx. 40% of pts we found minor symptoms. The results were analyzed in the context of the aggressiveness of the treatment (number of surgeries or 131-I treatment courses, etc), and disease state at the moment of the examination. We did not found any association between treatment intensity and psychological outcome, with the exception of the number of surgical procedures, negatively influencing the outcome (pts treated with more than 2 surgical interventions showed significant decrease of QOL and increase in depressive/anxiety symptoms). Conclusions: The aggressive treatment of DTC does not deeply enhance the depressive or anxiety symptoms and in long term does not decrease the quality of life. It does not apply to the surgical treatment, which shall be planned to limit the number of procedures, otherwise negatively impacting the final anxiety and depressive status. No significant financial relationships to disclose.
Phase II trial of paclitaxel and nedaplatin in patients with advanced/recurrent uterine cervical cancer: A Kansai Clinical Oncology Group study.
Authors: M. Takekuma, Y. Hirashima, K. Ito, H. Tsubamoto, T. Tabata, A. Arakawa, Y. Itani, N. Furukawa, H. Murakoshi, S. Takeuchi
Journal: Journal of Clinical Oncology (2011)

5102 Background: A multicenter phase II trial was conducted to evaluate the activity and toxicity of paclitaxel and nedaplatin (cis-diammineglycolatoplatonum) in patients with advanced/recurrent uterine cervical cancer. Methods: Patients were required to have measurable disease with adequate performance status, bone marrow, hepatic, and renal function. Histologic confirmation of the primary diagnosis as uterine cervical cancer was mandatory. The treatment consisted of paclitaxel 175mg/m2 and nedaplatin 80mg/m2 intravenously on day 1 every 28 days until progressive disease or adverse effects prohibited further therapy. Results: Fifty patients were enrolled onto the study protocol from October 2007 to February 2010. 45 patients (90%) were eligible for assessment of response (RECIST) to treatment; 31 patients (68.9%) received prior radiotherapy and 23 patients (51.1%) received prior chemotherapy. A median of four cycles were administered to each patient (range: 1-16 cycles). The overall response rate was 42.2% (11 complete responses and 8 partial responses) with 26.7% of patients having stable disease.Therapeutic benefit (CR+PR+SD) was observed in 31 (68.9%) patients. Grade 3 or 4 adverse events (NCI-CTCAE ver 3) at least possibly related to paclitaxel or nedaplatin included neutropenia (n=16, 32.7%), Febrile neutropenia (n=1, 2.0%), anemia (n=9, 18.4%), elevated serum creatinie level (n=3, 6.1%), allergy (n=1, 2.0%), anorexia (n=1, 2.0%), alopecia (n=4, 8.2%), myalgia/arthralgia (n=2,4.1%) and sensory neuropathy (n=1, 2.0%). The median progression-free survival was 4.1 months (range:1.0-33.8) and overall survival was 8.0 months (range: 1.6-33.8). Conclusions: Paclitaxel 175mg/m2 and nedaplatin 80mg/m2 intravenously on day 1 every 28 days demonstrated antitumor activity and acceptable toxicity in patients with advanced/recurrence uterine cervical cancer. Evaluation of this regimen in phase III trials is warranted.
Circulating tumor cells (CTCs) and endothelial cells (CECs) in malignant pleural mesothelioma (MPM) and primary lung cancer (LC)
Authors: F. Tanaka, M. Hashimoto, T. Takuwa, S. Matsumoto, N. Kondo, Y. Okumura, S. Hasegawa, K. Fukuoka, T. Nakano
Journal: Journal of Clinical Oncology (2008)

11019 Backgrounds: CTC, a surrogate of distant metastasis, and CEC, a marker of angiogenesis, are potentially useful in diagnosis and decision-making of therapy of malignant tumors, and CTC evaluated by the “CellSearch” system has been established as a prognostic marker of metastatic breast cancer patients. The clinical significance, however, has not been examined in other malignant tumors. Methods: We quantitatively evaluated CTC/CECs in peripheral blood (7.5mL/4.0mL) taken from 36 malignant pleural mesothelioma (MPM; epithelioid-type, n=34) and 34 primary lung cancer (LC; adenocarcinoma, n=25) patients treated from October to December, 2007 by using the “CellSearch” system. In 10 patients (one with MPM and 9 with LC), CTCs in blood sampled during operation from a pulmonary vein of the primary tumor site (PV-CTC) were also examined. Results: CTC in peripheral blood was positive in 28% (10/36) of MPM and 47% (16/34) of LC patients, and CTC was not detected in any patient with non-malignant disease (n=11). The mean CTC number and the percentage of CTC-positive patients tended to increase along with advance in tumor-stage, whereas the difference did not reach a statistical significance in MPM or LC (Table). The percentage of CTC-positive patients was significantly higher in resectable-LC patients than in unresectable-LC patients (65% vs 29%; p<0.05).; among operated patients, the percentage was increased along with lymphatic and/or blood vessel invasion. Of noted, PV-CTC was positive in one stage-II MPM and two stage-I LC patients. The mean CEC number of LC patients was 100.9, which was significantly higher that of non-malignant patients (49.9; P<0.05) and was similar to that of MPM patients (86.2). The CEC number of MPM and LC patients tended to increase along with tumor progression (Table). Conclusions: CTC and CEC are potentially useful clinical marker in the diagnosis of MPM and LC. When CTC or PV-CTC is positive, adjuvant chemotherapy may be indicated even for early-stage patients. CTC/CEC in MPM and LC MPM (malignant pleural mesothelioma) LC (primary lung cancer) CTC-positive Pts Mean No. of CTCs Mean No. of CECs CTC-positive Pts Mean No. of CTCs Mean No. of CECs Stage I 50% (1/2) 0.5 (0-1) 42.0 33% (4/12) 0.7 (0-3) 48.8 Stage II 0% (0/4) 0.0 (-) 55.0 33% (1/3) 0.3 (0-1) 65.3 Stage III 31% (4/13) 2.5 (0-27) 61.0 33% (1/3) 2.3 (0-7) 180.0 Stage IV 27% (4/15) 0.4 (0-2) 100.4 63% (10/16) 5.5 (0-42) 129.0 All Pts 28% (10/36) 1.1 (0-27) 86.2 47% (16/34) 3.1 (0-42) 100.9 CTC, circulating tumor cell; CEC, circulating endothelial cell No significant financial relationships to disclose.
Improving quality assurance in clinical trials (CT) through standardization: A review of source documentation practices at a large Canadian cancer center.
Authors: L. M. Tinker, T. Panzarella, S. Sellmann, J. Brown, S. J. Webster, H. Cole, B. Fitzgerald, P. Degendorfer
Journal: Journal of Clinical Oncology (2011)

e16577 Background: Deficiencies pertaining to the accuracy, completeness and maintenance of source data remain the most prevalent regulatory finding reported during site inspections. The Princess Margaret Hospital (PMH) enrols @ 25% of patients in treatment-based CT. As a quality initiative, source documentation practices (SDP) of clinical research nurse coordinators (CRNC) were evaluated to determine compliance with institutional, professional and regulatory requirements. Methods: A review of SDP from CRNC was conducted using required criteria in 6 practice areas: informed consent (IC), adverse event (AE), concomitant medication (Con Med), drug administration, eligibility, and general documentation. Compliance was classified as yes, no, or n/a. Practice areas were reviewed to determine methods utilized: checklists (CL), clinical notes (CN), study specific templates (SPT) or other. Compliance within each practice area was summarized using the median and inter-quartile range. Group differences were tested using the non-parametric Wilcoxon test. Results: 20 reviews were conducted. Although overall median compliance was considered acceptable (table 1), the variability in each practice area varied widely, from 6% for Con Med to 69% for IC. Methods utilized also varied across the practice areas: range in frequency of use (n=20): CL(12-16), CN(4-10), SPT(6-9), other(1-3). Comparing % compliance to method use, only 3 findings were significant: Con Med: CL(100) vs. no CL(71) p = 0.03, Con Med: SPT(86) vs. no SPT(100) p = 0.01, general documentation: CN(75) vs. no CN(63) p = 0.05. Conclusions: Variation in SDP was identified as an important quality control initiative. Standardized source documentation templates and guidelines for IC, AE and Con Med have been developed and implemented across the program to improve compliance with institutional, professional and regulatory requirements. Percent compliance. Practice area Median 25th percentile 75th percentile IC 80 26 95 AE 89 75 95 Con med 89 88 94 Drug administration 83 71 100 Eligibility 84 68 84 General 90 79 100
Do nurse-navigated TSSCPs improve treatment and follow up compliance in underserved populations?
Authors: Camille Manoukian, Maria Altamirano, Kimlin Tan Ashing, Ann Falor Callahan, Virginia Sun, Nimit Sudan, Lily L. Lai
Journal: Journal of Clinical Oncology (2016)

72 Background: Multiple cancer organizations advocate for the use of treatment summaries and survivorship care plans (TSSCPs) in cancer patients. To better quantify the benefits of a nurse-navigated, culturally and linguistically responsive TSSCP in underserved breast cancer patients, we compared rates of compliance with treatment and follow up in 26 patients who were treated with TSSCPs to 38 similar controls who were treated without TSSCPs. Methods: We prospectively enrolled 26 consecutive, newly-diagnosed breast cancer patients who were given nurse-navigated TSSCPs under an IRB-approved protocol. At their first clinic visit, a trained nurse educated and assisted the patient in the use and completion of the TSSCP. Nurse-navigated TSSCPs were completed at each subsequent visit through 12 months of surveillance. Rates of compliance with treatment and follow up guidelines were compared to 38 similar control patients using a two group Fisher’s exact chi-square test. Statistical significance was set at p-value &lt; 0.05. Results: All patients were treated under Medicaid insurance and 47% were racial and/or ethnic minorities. Time from diagnosis to treatment and time from initial clinic visit to treatment were similar across groups. The rate of compliance with first treatment recommendations was 96% (25/26) in the TSSCP group compared to 79% (30/38) in the non-TSSCP group (p = 0.07). The number of patients compliant with all follow up visits was similar: 22/25 (88%) of TSSCP patients and 22/30 (73%) in non-TSSCP patients (p = 0.31). Of the recommended total follow up appointments, 6/67 in the TSSCP group and 25/120 in the no TSSCP group were “no shows” (p = 0.04). Conclusions: Although the use of nurse-navigated TSSCPs may not improve time to treatment in medically underserved patients, adherence to first treatment recommendations and follow up appointment attendance shows some improvement in patients who participate in nurse-navigated TSSCPs. Further study is needed to fully assess the role of nurse-navigated TSSCPs in improving treatment and surveillance compliance rates and how these rates impact clinical outcomes. Acknowledgement: Funded by a Community Grant from the Los Angeles County Affiliate of Susan G. Komen.
Clinical significance of genetic variations in the PI3K/PTEN/AKT/mTOR pathway in Korean patients with colorectal cancer.
Authors: S. J. Lee, J. G. Kim, Y. S. Chae, B. W. Kang, S. W. Jeon, J. S. Park, J. Y. Park, G. S. Choi, Y. J. Lee
Journal: Journal of Clinical Oncology (2011)

628 Background: Signaling through the PI3K/PTEN/AKT/mTOR pathway is responsible for balancing cell survival and apoptosis. Accordingly, the present study analyzed 14 SNPs of the PI3K/PTEN/AKT/mTOR pathway genes and their impact on the prognosis for patients with colorectal cancer. Methods: Four hundred and forty-four consecutive patients with surgically resected colorectal adenocarcinoma were enrolled in the present study. The genomic DNA was extracted from fresh colorectal tissue and 14 polymorphisms of the PI3K/PTEN/AKT/mTOR pathway genes determined using a real-time PCR genotyping assay. Results: Pathologic stages after surgery were as follows: stage 0/I (n=85, 19.1%), stage II (n=149, 33.6%), stage III (n=147, 33.1%), and stage IV (n=63, 14.2%). Univariate and multivariate survival analysis including stage, age, site of disease, adjuvant chemotherapy, and CEA level showed that these polymorphisms were not associated with progression-free or overall survival. For the clinicopathologic parameters, CEA level and TNM stage were significant prognostic factors in a Cox model for survival. Conclusions: None of the 14 SNPs of the PI3K/PTEN/AKT/mTOR pathway genes investigated in this study was found to be an independent prognostic marker for Korean patients with surgically resected colorectal cancer. No significant financial relationships to disclose.
Long-term estimate of quality-adjusted life expectancy for nilotinib and imatinib as first-line treatment for newly diagnosed patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in the chronic phase (CML-CP).
Authors: M. Botteman, J. Stephens, S. J. Snedecor, X. Ji, M. Hussein, J. Coombs
Journal: Journal of Clinical Oncology (2011)

6570 Background: In the ENESTnd study, the 12-month rates of major molecular (MMR) and complete cytogenetic (CCyR) responses were significantly higher in newly diagnosed Ph+ CML-CP patients initiating nilotinib (300 mg BID) than imatinib (400 mg QD) (MMR: 44% v. 22%, respectively; CCyR: 80% v. 65%, respectively; all P<0.001). Nilotinib patients had significantly reduced progression to accelerated phase or blast crisis v. imatinib patients (P = 0.01). The objective was to model the long-term quality-adjusted life expectancy (LE) of newly-diagnosed Ph+ CML-CP patients initiating 1st-line therapy with nilotinib or imatinib in the United States. Methods: A state-transition Markov model was developed. A central model feature was the discontinuation rate of initial therapy, which was (1) based on direct observations from ENESTnd (for the first 12 months of the model) and, (2) dependent on patients' 12-month ENESTnd treatment responses and modeled from the long-term IRIS outcomes. After initial treatment discontinuation, patients were modeled to receive an additional tyrosine kinase inhibitor (TKI). Prognosis was modeled using published literature. Uncertainty was assessed using intervals comprising 95% of 1,000 model replications generated via Monte-Carlo simulations (95% credible intervals [CI]). Results: Initiating TKI therapy with nilotinib resulted in an estimated mean (95% CI) LE of 27.80 (26.38-29.08) years and quality-adjusted LE of 24.93 (23.12-26.52) years. The corresponding estimates for imatinib first-line therapy were 25.14 (23.60-26.70) years and 22.35 (20.61-24.20) years, respectively. The differences in mean (95% CI) LE and quality-adjusted LE between nilotinib and imatinib were 2.66 (1.30-4.02) and 2.58 (1.28-3.93), respective years. Conclusions: First-line nilotinib was more efficacious than imatinib in the ENESTnd trial at 12 months. As trial data collection is ongoing, modeling can be used to estimate the long-term value of these treatments. This model suggests that nilotinib is likely to substantially increase quality-adjusted LE v. imatinib.
Electrochemotherapy (ECT) for the treatment of superficial tumor metastases
Authors: D. Galetta, M. Guida, G. Porcelli, S. Montemurro, E. Ruggiero, V. Mattioli, A. Zito, G. Colucci
Journal: Journal of Clinical Oncology (2008)

20025 Background: ECT is an effective local treatment for palliation on inoperable superficial neoplastic localizations which combines chemotherapy and electric pulses that permeabilize the cell membrane in a transient and reversible manner, allowing low-perrneant drugs to enter the cell, thus magnifying their cytotoxicity. Recent1y, a new device (Clinoporetor, IGEA S.r.l., Italy) has been developed to supply electric pulses with appropriate parameters permitting the clinical use of ECT. Methods: Until now, we treated 15 pts (median age 57 yrs, range 39–83; median ECOG I, range 1–2; disease/sites: 6 breast with nodular or infiltrating lesions in thoracic or abdominal wall; 5 melanoma, 1 with a wide infiltration of posterior thoracic wall, 4 in transit metastases; 2 head-neck cancer with a wide neck-scalp infiltration; 1 Lymphoma with two cutaneous localizations on the right leg; 1 gastric with 2 cutaneous- subc. localizations on abdominal and right arm). The areas treated ranged from 1 cm to 30 cm on diameter. 5 pts requested a prior surgery debulking and 3 pts received ECT in pre-irradiated area. Intravenous infusion of Bleomycin (15 mg/m2) were used; electric pulses were than applied to the tumor areas by needle electrodes in a time window of about 20 minutes. In total 20 procedures were performed, 6 in local anaesthesia, and 14 in general anaesthesia; 4 pts requested a second procedure because of relapse or new lesions appearing. Results: Treatment was safe and well tolerated, particularly when general anaesthesia was used. After 1 week from the treatment, 100% of the lesions showed an initial regression with a progressive necrotic and fibro-sclerotic evolution (PR 40%, CR 60%). About 50% of lesions remained in remission for a long period (median 8 months, range 3–12); in the other cases a slow relapse or peripheral new lesions occured. Concomitant systemic treatment, surgical debulking, and no rapid progression of disease outside the areas treated, were associated with a better local control. Conclusions: Our preliminary data confirm that ECT is a promising and safe treatment for the control of superficial lesions from different malignancies. No significant financial relationships to disclose.
The impact of chemotherapy use on financial strain among stage III colorectal cancer patients: A population-based survey.
Authors: Christine Marie Veenstra, Scott E. Regenbogen, Sarah T. Hawley, Mousumi Banerjee, Ikuko Kato, Kevin C. Ward, Arden M. Morris
Journal: Journal of Clinical Oncology (2014)

505 Background: Many colorectal cancer (CRC) patients suffer personal financial hardship from the disease and its treatment. We hypothesized that chemotherapy use is associated with even greater financial burden and worry. Methods: We analyzed data from a population-based survey of patients with stage III CRC in the Georgia and Detroit SEER catchment areas focusing on the effects of CRC and its treatment on personal finances. The primary outcomes were financial burden, assessed with a seven-component composite measure, and financial worry, assessed with a 5 point Likert scale. The primary independent variable was chemotherapy use. We evaluated relationships between chemotherapy use and individual components of financial burden, as well as composite financial burden and worry, using chi square analyses. Logistic regression was used to examine the effect of chemotherapy use on financial burden and worry, after controlling for patient characteristics. Results: Financial burden scores and financial worry were significantly higher among chemotherapy users (P&lt;0.001). Financial burden and worry were associated with younger age, lack of insurance, and lower education. After controlling for these factors, chemotherapy use remained significantly associated with both financial burden and financial worry. 717/844 respondents (85%) reported chemotherapy use. Chemotherapy users were more likely to use savings (34% vs 20%, P=0.001), borrow money/take out loans (14% vs 4%, P=0.001), fail to make credit card payments (14% vs 5%, P=0.003), reduce spending for food and/or clothing (31% vs 14%, P&lt;0.0001), decrease recreational activities (38% vs 15%, P&lt;0.0001), and reduce general expenses (51% vs 24%, P&lt;0.0001) than those who did not use chemotherapy. Conclusions: Adjuvant chemotherapy confers significant survival benefit in stage III colorectal cancer (CRC), but is associated with significantly increased personal financial burden and worry. Because financial stress has the potential to preclude adherence to recommended care, CRC patients who receive chemotherapy may require additional social services and economic support.
Making the case for outpatient palliative care for cancer patients at a safety-net hospital.
Authors: Heather A. Harris, Anne Kinderman, Kathleen Kerr
Journal: Journal of Clinical Oncology (2014)

310 Background: Prior research has shown that patients who receive earlier, outpatient palliative care (OP PC) have improved end-of-life care compared to patients who receive only inpatient palliative care (IP PC). We examined the need, expected impact and feasibility of providing OP PC to patients with cancer seen at our hospital, which offers IP PC but not OP PC. Methods: Retrospective cohort study of patients cared for at our urban, safety-net hospital who died of cancer between July 2010 and June 2013. We used cancer registry data to identify decedents and claims data to evaluate utilization patterns, contacts with our IP PC service, and cost of care in the final 6 months of life. Results: In the analysis period 403 patients died of cancer, 307 of whom were admitted to the hospital in the 6 months preceding death. On average patients were admitted 1.9 times, with 39% having multiple admissions. Average length of stay was 10.47 days. Nearly half of all patients were admitted to the hospital in the final month of life (181/403), and 21% of those (38/181) had multiple admissions. One third of patients died in the hospital and another 4% died within 3 days of hospital discharge. Direct costs per admission averaged $22,275. The IP PC service had contact with 178 patients; 44% of the entire decedent population and 58% of those who were hospitalized. In 60% of cases the initial contact with the PC team took place in the final month of life. We determined that 33% of patients had multiple inpatient and or outpatient encounters 90-180 days prior to death, pointing to an expected annual clinic volume of about 50 patients. Annual costs for staffing a clinic that could follow 50 patients for an average of 4 months were estimated at $88,290. We assumed that providing OP PC would reduce utilization of inpatient services by 40% (38 avoided admissions), with resulting avoided direct costs of $846,450. Conclusions: At our facility cancer patients often receive aggressive EOL care. Our IP PC team sees many of these patients, but most contacts occur days-weeks prior to death. Though many patients present very late in the course of illness, a substantial number have multiple health system contacts &gt;3 months prior to death, and could be referred to an OP PC clinic.