tbuckley/cabot-search huggingface dataset:
Incorporation of bevacizumab (B) and erlotinib (Er) with induction (I) and concurrent (C) carboplatin (Cb)/paclitaxel (P) and 74 Gy of thoracic radiotherapy in stage III non-small cell lung cancer (NSCLC)
Authors: M. A. Socinski, D. E. Morris, T. E. Stinchcombe, J. S. Halle, D. T. Moore, M. T. Tynan, M. A. Siegel, W. J. Petty, A. W. Blackstock, A. H. Khandani, J. G. Rosenman
Journal: Journal of Clinical Oncology (2008)

7517 Background: Therapies directed at both the epidermal growth factor receptor (EGFR) and the vascular endothelial growth factor (VEGF) pathways have been shown to improve survival in NSCLC and also have radiosensitizing properties. Methods: Pts receive I Cb (AUC 6), P (225 mg/m2) and B (15 mg/kg) on d1 and 22. PET scans are done pre- and post-I. On day 43, pts receive weekly Cb (AUC 2 x 7) and P (45 mg/m2 x 7) with 74 Gy (2 Gy/d) of thoracic conformal radiotherapy. Cohort I (n=5) received B at 10 mg/kg q2wks during C therapy. Cohorts II and III (both n=5) received the same dose of B as in cohort I but also received Er at 100 mg and 150 mg po Tuesday - Friday of each week of C therapy, respectively. The primary endpoint is PFS at 1 year. All histologies are allowed including squamous (SQ) (an early stopping rule is in place for pulmonary hemorrhagic complications in the SQ). Results: Thus far, 20 PS 0–1 pts have been accrued (med age 62 yrs, range 41–74, 12 non-squamous, 8 squamous, 12 IIIA, 8 IIIB). 18/20 pts have completed I CbP + B with 1 gr 3–4 non-hematologic toxicity (gr 3 hypertension). No pulmonary hemorrhage during induction has been seen (including the 8 SQ cell pts). 8/18 (44.4%) have had objective responses and none have progressed during I. Tumor volumes and PET SUVs have significantly decreased comparing pre- and post-I studies (p=0.0001 and p=0.0002, respectively). In Cohorts I and II, all 10 pts started C therapy on d43 and completed therapy to 74 Gy without interruption or missing any doses of q2wk B. In Cohort III (n=5), all 5 pts started C therapy on d43. There was 1 gr 3 pulmonary hemorrhage requiring B termination, 1 gr 3 interstitial pneumonitis and 2 gr 3 esophagitis with 4/5 pts achieving the target dose of 74 Gy. Overall, 5/15 (33%) pts had gr 3 esophagitis. One gr 5 late hemorrhage occurred in a SQ pt. Phase I has been completed; Phase II expansion is ongoing and will use an Er dose of 100 mg. Conclusions: Preliminarily, we conclude that 1) Incorporation of B and E into this treatment paradigm appears feasible, 2) Esophagitis remains the primary toxicity and appears to be more common than our prior experience at 74 Gy, 3) Phase II accrual continues and more detailed safety and efficacy data will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Genentech, OSI Oncology Genentech Genentech
Patient-reported distress in adults with myelodysplastic syndromes (MDS).
Authors: Jesse D Troy, Carlos deCastro, Mary Ruth Pupa, Greg P. Samsa, Amy Pickar Abernethy, Thomas William LeBlanc
Journal: Journal of Clinical Oncology (2016)

80 Background: MDS are hematopoietic malignancies that are incurable in most patients. The National Comprehensive Cancer Network (NCCN) defines distress as an unpleasant emotional experience associated with the psychosocial complications of cancer that may interfere with quality of life. Distress is not well described in MDS and may be useful to screen for palliative care needs. Methods: We conducted a retrospective review of distress in ambulatory adult MDS patients visiting our clinics from July 2013 to September 2015. We abstracted demographic, diagnostic, and comorbidity data from records along with the 10-point ordinal NCCN Distress Thermometer (DT) and its 39-item Problem List (PL). NCCN guidelines suggest DT scores ≥ 4 be evaluated for referral to psychosocial resources. Results: We included 119 patients (median age = 68, range = 30-88 years; 73.9% White; 67.2% male; 29.4% with prior cancer). Half were low-risk and 5 progressed to AML. Twenty-three (19.3%) had ≥ 1 hospitalization and 10.9% had &gt; = 1 emergency department visit. Ten patients died; 1 was referred to counseling and 1 used hospice. Three others were referred to counseling and no patients had a palliative care consult. There were 366 DT (median distress = 1, range = 0-10) across 580 visits and 106 patients (median = 2 DT/patient, range = 1-16). Fifty-two patients had at least 1 DT ≥ 4 and 19 had 2 or more DT ≥ 4. With patients classified by their maximum DT (median = 3, interquartile range = 1-7) ever-use of therapy (hypomethylating agents/lenalidomide/growth factors/transfusions/chelation) was associated with greater maximum DT (median = 4, range = 0-10, N = 73) compared with no therapy (median = 2, range = 0-9, N = 33; P = 0.03, 2-sample Wilcoxon test). Ninety-five patients reported 1,335 problems during 22,846 person-days of follow-up (median = 4 problems/patient/visit, range = 1-23). The 5 most frequent problems were fatigue (176 times; 76 patients), pain (92 times; 44 patients), worry (77 times; 43 patients), sleep (75 times; 39 patients), and tingling hands/feet (68 times; 33 patients). Conclusions: MDS patients experience frequent and substantial distress yet referrals to counseling and use of palliative care are rare. These findings point to unmet palliative care needs in MDS.
Long-term cause-specific mortality among 41,146 one-year survivors of Hodgkin lymphoma (HL)
Authors: G. Dores, S. Schonfeld, J. Chen, D. Hodgson, S. Fossa, H. Storm, P. Hall, E. Pukkala, E. Gilbert, L. Travis
Journal: Journal of Clinical Oncology (2005)

6511 Background: Despite high cure rates in HL, survival is compromised by deaths due to other causes. Long-term trends in cause-specific mortality are not well characterized. Methods: We identified 41,146 one-year HL survivors reported to 14 population-based cancer registries in North America and Europe (1943–2002), with 17,025, 5,899, and 1,273 patients followed for 10-, 20- and 30-years, respectively (total person-years: 374,031). Based on underlying cause of death and 8,270 deaths (excluding HL), we compared age-, gender- and calendar year-specific mortality rates to those in the general population of the 14 registries. Results: The overall relative risk (observed-to-expected ratio (O/E)) of mortality was 2.5 (95% CI 2.47–2.58; absolute excess risk (AER)=134 excess deaths/10,000 patients/year). Significant excess deaths were due to second cancers (SC) (O/E=4.1, AER= 63; O=3,107) and non-cancer (NC) causes (O/E=1.8, AER=49; O=4,202) and remained significantly elevated for more than 30 years following HL diagnosis. Significantly increased risks were observed for deaths due to cardiovascular (O/E=1.7), respiratory (O/E=2.4), infectious (O/E=8.6), and hematologic (O/E=8.2) diseases; risks were significantly elevated in both sexes, 4 age groups (<20, 20–39, 40–59, 60+ years), and 3 calendar year periods (<1970, 1970–84, 1985+). Significantly elevated risks due to SC and NC deaths (O/E=5.5 and 2.1, respectively) were highest in patients initially treated with radiation (RT) and chemotherapy (CT), but were also significantly elevated after RT alone (O/E=4.0 and 1.9) or CT alone (O/E=3.8 and 1.7). Risk of death from ischemic heart disease, pneumonia, bacterial infection, viral infection, and hematologic disorders was significantly elevated in all treatment groups. Comparable excesses of SC (AER=62) and NC (AER=62) deaths occurred in 30-year survivors, with all solid tumors (AER=54), cardiovascular disease (AER=44), and respiratory disease (AER=14) accounting for the greatest burden. Conclusions: HL patients demonstrate significant excesses of SC and NC deaths for more than 30 years after diagnosis and should be targeted for preventive measures in attempt to reduce excess mortality. No significant financial relationships to disclose.
Cost-effectiveness of a survivorship care plan for breast cancer survivors.
Authors: D. Coyle, E. Grunfeld, K. Coyle, J. A. Julian, G. R. Pond, A. Folkes, M. N. Levine
Journal: Journal of Clinical Oncology (2011)

6082 Background: Survivorship care plans (SCP) are recommended for patients who have completed primary treatment and are transitioning to routine follow-up care. However, SCPs may be costly and their effectiveness is unproven. The objective of this study was to assess the cost effectiveness of a SCP for breast cancer survivors transitioning to routine follow-up care with their own family physician (FP) using data from a recent randomized controlled trial (RCT). Methods: Analysis used resource use and utility data for 408 breast cancer patients enrolled in the RCT. In the intervention group, patients received a SCP consisting of: a 30-minute educational session with a nurse who reviewed a treatment summary, a patient-version of follow-up guidelines, brochures and information about local relevant supportive care resources; whilst FPs of intervention patients received a copy of all documents plus the full guideline and a reminder table of recommended follow-up visits and tests. Analysis assessed the societal costs and quality adjusted life years (QALYs) for both groups over the two year follow up of the RCT. Health care resources including physician visits and laboratory tests were weighted by appropriate Canadian unit costs. Analysis also considered costs to patients including travel and lost productivity assessed by the friction cost method. QALYs were assessed using the EQ5D questionnaire. Uncertainty concerning cost effectiveness was assessed through non parametric bootstrapping and deterministic sensitivity analysis. Results: The SCP was estimated to cost $59.96 per patient or $1.32 million per year in Canada given breast cancer incidence. The control group dominated the intervention group: as total costs per patient were lower for the control group ($736 versus $789) and total QALYs were higher (1.42 versus 1.41). The probability that the SCP was cost effective was 27% at a threshold value of a QALY of $50,000. Sensitivity analyses adopting a health care system perspective, using the human capital approach and including the cost of recurrences did not change the conclusions of the analysis. Conclusions: Based on the findings of this trial, SCPs would be costly to introduce and would not be cost effective.
Patient satisfaction with placement of implantable venous access devices.
Authors: K. K. Ancell, Z. Zhao, Y. Shyr, J. Berlin
Journal: Journal of Clinical Oncology (2011)

e19513 Background: Previous research surrounding implantable venous catheters (ports) has focused on surgical technique, complications, and quality of life when compared to peripheral access. Little is known about patient (pt) satisfaction regarding the placement process. Given that multiple proceduralists place ports, we also sought to determine which department’s technique led to the highest pt satisfaction. Methods: Pts with solid tumor malignancies and a recently placed port were asked to participate. Pts completed an electronic survey regarding their port experience. The ultimate goal was to determine which group of proceduralists provided the best pt satisfaction rate as determined by ranking the process on a scale of 1 through 10 (10 being highest level of satisfaction). Data was also collected regarding common port complications. Results: 90 pts participated. The majority had their ports placed by either interventional radiology (IR) (n = 38) or surgical oncology (SO) (n = 34) with the remainder placed by other groups. We considered a score of 8 out of 10 or greater to be excellent. Of the 90 pts, 81 rated the experience as an 8 or higher. Fifty-one pts rated the experience as a 10 or completely satisfied. While the original goal was to accrue 300 pts, the study was terminated as it became statistically impossible to see a difference between the proceduralist groups. One pt (1%, CI 0-0.06) reported an infected port. The charts were reviewed again at a median time of 1 year from port placement. Only one additional pt had a port infection. Pain following the procedure was significant and reported by 26 (27.8%, CI 0.189-0.382) of the 90 pts. Of those pts, 16 (18%) reported a duration of pain of > 5 days. Conclusions: Overall, pts were very satisfied with the port placement process. This was true for all of the proceduralist groups. Except for pain, rates of common complications were generally low. Despite high satisfaction, almost 30% of pts reported pain with half reporting pain for > 5 days. This is an area that should be focused on in the future as an intervention to improve the port placement process.
Plasma cell-free DNA and fraction of circulating KRAS mutations as prognostic in patients with metastatic colorectal cancer.
Authors: David Sefrioui, Nasrin Vasseur, Richard Sesboüé, France Blanchard, Alice Oden-Gangloff, Jean-Christophe Sabourin, Thierry Frébourg, Pierre Michel, Frédéric Di Fiore
Journal: Journal of Clinical Oncology (2014)

490 Background: It has been suggested that detection of circulating tumor DNA may be relevant in patients with metastatic colorectal cancer (mCRC). The main objective of the present study was to evaluate a method based on the TaqMan Mutation Detection Assay (TMDA) for the detection of circulating KRAS mutations in mCRC patients. Moreover, we also investigated the prognostic impact of the plasma cell-free DNA and the fraction of circulating KRAS mutations. Methods: The study was conducted from April to July 2013 and plasma samples were prospectively collected in a series of 35 mCRC patients treated with chemotherapy (CT). QIAamp Circulating Nucleic Acid kit was used for DNA extraction and Quant-iT High Sensitivity dsDNA Assay for cf-DNA quantification. Detection of circulating tumor DNA was based on the KRAS mutations detected in tumour and was performed in plasma by the castPCR Technology TMDA. Response to CT was assessed according to RECIST criteria. The results of plasma cf-DNA and level of mutant DNA fragments were correlated with response and 3-months survival. Results: We isolated and quantified plasma cf-DNA in all patients with a mean concentration of 106 ng/mL. Among them, 18 were wild-type and 17 mutated for KRAS in the tumour. Detection of circulating KRAS mutations was performed with TMDA in 23 patients (10 KRAS wild-type and 13 KRAS mutated). The sensitivity was 62% (8/13) and specificity 100% (0/10) with a level of circulating mutant DNA fragments ranging from 0 to 29%. Plasma cf-DNA and level of circulating mutant DNA were both significantly correlated with the 3-months survival (mean 36 versus 524 ng/mL, p=0.0015 and 2% versus 29%, p&lt;0.0001). There was a non significant trend for response to CT (respectively p=0.14 and p=0.12). Conclusions: TMDA method is a simple, accurate and non-invasive tool for the detection of circulating tumor DNA. Our preliminary results also suggest that plasma cf-DNA and fraction of mutant DNA fragments could be prognostic markers in mCRC patients.
Pilot study of focal salvage high-dose rate (HDR) prostate brachytherapy in patients with local recurrence after definitive external-beam radiotherapy (XRT).
Authors: Hans T. Chung, D. Andrew Loblaw, Laura D'Alimonte, Ananth Ravi, Masoom A. Haider, Gerard Morton
Journal: Journal of Clinical Oncology (2014)

264 Background: Studies of post-treatment biopsies of the prostate after definitive dose-escalated XRT for intermediate-risk prostate cancer suggest that approximately 20% will be positive. Salvage options include surgery, brachytherapy, cryotherapy or high-frequency ultrasound. However, the complication risk, such as fistula, incontinence or bladder neck contracture, is not insignificant. The objective of this pilot study is to explore the toxicities and efficacy of focal salvage HDR prostate brachytherapy. Methods: This study was approved by the institution’s research ethics board. Eligible patients included those with biopsy-confirmed local recurrence &gt;30 months after completing XRT, MRI of the prostate demonstrating solitary recurrence confined to the prostate, negative metastatic workup, IPSS &lt;15, post-XRT PSA &lt;10ng/mL, prostate volume ≤50cc. Salvage HDR brachytherapy was performed under transrectal ultrasound guidance with a prescription dose of 27Gy divided over two implants separated by 1 week to the target volume (TV) as seen on MRI with dose constraints to the urethra and rectum. Results: Six patients were enrolled in the study. The mean age was 73 years, all had either low- or intermediate-risk disease at presentation, and initial XRT received was 70-78Gy at least 5 years ago. The Gleason score of the local recurrence was 7 and 8-10 in 4 and 2 patients, respectively. The pre-HDR mean PSA was 5.5. The median size of the recurrence on MRI was 9mm and median size of the TV was 5.0cc (2.2-10.2), TV V100% 95.1%, urethral D10% 51.8% and rectal D1cc 39.2%. Four patients have at least 3 months of follow-up, and no acute GU/GI grade 3-5 toxicities were observed, including urinary retention. The most common acute toxicity was frequency and nocturia. Mean IPSS at baseline, 4-weeks, 3-months was 7, 9 and 7. Conclusions: Preliminary data suggests that focal salvage HDR brachytherapy was technically feasible with mild acute toxicities. Clinical trial information: NCT01583920.
Radiation oncologist density and pancreatic cancer mortality.
Authors: S. Aneja, J. B. Yu
Journal: Journal of Clinical Oncology (2011)

350 Background: Though the role of radiation oncologists (RO) in the curative treatment of pancreatic cancer (PC) is not well defined, RO are important for the multidisciplinary care of cancer patients. The impact of this variation on PC outcomes remains unexplored. The goal of this study was to determine the effect of RO density on PC mortality. Methods: Using county-level data from the 2008 Area Resource File, National Program for Cancer Registries, and U.S. Centers for Disease Control, a multivariate regression model was constructed for PC mortality, controlling for county-level categorized RO density, demographics, socioeconomic status, and existing health care facilities. Results: There was a statistically significant reduction in PC mortality (reduction ranging from 27% to 51% p&lt;.001) associated with counties that possessed at least one RO. Also there existed a statistically significant improvement in mortality in counties with a density of at least two RO per 100,000 people compared to counties with one radiation oncologist per 100,000 people. Conclusions: The presence of a RO is associated with lowered morality for PC within that county. In contrast to our other density analyses investigating the association between radiation oncology density and colorectal cancer and esophageal cancer mortality, the association between additional RO and PC mortality was equivocal. This may reflect the varying use of radiation oncology in different counties for the curative treatment of PC. Our study suggests that RO play an important role in the treatment of PC. [Table: see text] No significant financial relationships to disclose.
The analysis of management of 12 cases of primary adenocarcinoma of appendix
Authors: Z. Wang, H. Oian, Q. Yang
Journal: Journal of Clinical Oncology (2005)

4277 Background: To study the characteristics of primary adenocarcinoma of appendix and methodology of treatment. Methods: We retrospectively analyse the total of 12 cases of primary carcinoma of appendix of all cases of primary malignant of appendix in our hospital from 1958 to 2003 in terms of clinical characteristics, treatment and prognosis. Results: the incidence of primary adenocarcinoma of appendix is very low. The median age at time of presentation is 56 (19∼68), male vs. female is 4 vs. 8. Operation were performed in all patients, most were appenctomy, and remainders were right hemilcolectomy and palliative operation. Six of patient experienced adjuvant chemotherapy, non for radiotherapy. The longest Time To Progression (TTP) is 22 months. Conclusions: primary adenocarcinoma of appendix is an uncommon entity. It is very difficult to diagnose exactly, and is important to perform the differential diagnosis for middle-aged and elderly patients presenting with acute appendicitis. Right hemicolectomy should be performed for colonic type of primary adenocarcinoma of appendix, which has a tendency of metastasise. The role of adjuvant chemotherapy needs to be evaluated in future. No significant financial relationships to disclose.
Evaluation of insulin resistance among endometrial cancer patients.
Authors: J. K. Burzawa, K. M. Schmeler, M. W. Bevers, T. B. Pustilnik, J. Brown, M. L. Anderson, L. M. Ramondetta, D. Urbauer, G. Tortolero-Luna, K. H. Lu
Journal: Journal of Clinical Oncology (2010)

5026 Background: Obesity and unopposed estrogen are well-known risk factors for endometrial cancer. While diabetes also independently increases the risk of this cancer, little is known about the risk related to the insulin-resistant, prediabetic state. The purpose of this study was to determine the prevalence of insulin resistance (IR), and factors associated with increased IR, in endometrial cancer patients. Methods: A geographically-limited, case-case study was conducted, and women with endometrial cancer were prospectively enrolled. Participants completed a structured questionnaire, and height and weight were measured. Fasting serum samples were analyzed for glucose, insulin, and adiponectin. Insulin resistance was defined by a history of diabetes or a QUICKI (1/([og fasting insulin + log fasting glucose]) value of < 0.357. Results: Of the 100 study patients, diabetes was present in 30 women, and pre-diabetes was found in an additional 36 patients. Among the 40 non-obese women (Body Mass Index [BMI] < 30kg/m2), 17 (43%) demonstrated IR. In a multivariate analysis, increased odds of IR was independently and significantly associated with increasing BMI (p = 0.001), decreasing socioeconomic status (p = 0.041), and nulliparity (p = 0.046). Mean adiponectin levels were significantly lower among women with IR (p = 0.02). Additionally, adiponectin levels showed a moderate correlation with QUICKI values among nondiabetics (R = 0.58, p < 0.001). Conclusions: IR was highly prevalent in this population of endometrial cancer patients. Overall, more than half of insulin-resistant women had no prior history of diabetes. Unsurprisingly, IR was present in an overwhelming percentage of obese women; however, a high proportion of non-obese women were also insulin-resistant. Better characterization of metabolic risks in addition to obesity, including the spectrum of insulin resistance and altered cytokines such as adiponectin, may provide avenues for targeted cancer prevention in the future. No significant financial relationships to disclose.