tbuckley/cabot-search huggingface dataset:
Using a QOPI-based template to monitor appropriate evaluation of constipation.
Authors: Joshua Michael Gulvin, Bruce S. Lin, Nanette Robinson, Thomas William Malpass, Vincent J. Picozzi, Prakash Vishnu, Lynne Patricia Taylor, Gurkamal S. Chatta, Cathleen M. Goetsch, David Michael Aboulafia, Joseph K Rosales
Journal: Journal of Clinical Oncology (2016)

94 Background: A common symptom in patients being treated with opioid analgesics is constipation, which is often underreported by patients and therefore undertreated by providers. The Quality Oncology Project Initiative (QOPI) has identified constipation as one of the benchmark symptoms to be monitored in order to obtain certification. At Virginia Mason Medical Center, we had previously identified constipation as a symptom which was not adequately addressed in the medical record, and implemented a template-based initiative to increase its evaluation. Methods: We identified consecutive patients with advanced cancer undergoing systemic therapy who were also receiving opioid analgesic treatments. These patients were surveyed for constipation, and answered a questionnaire regarding its severity and whether they felt it was adequately handled. We then reviewed the encounter notes for the visit to correlate the provider’s documentation of constipation and its treatment and the patient experience. Results: Results will be presented at the symposium. Conclusions: We aim to describe whether or not the symptom of constipation was adequately captured and/or treated in patients receiving opioid therapy.
PANOVA: A pilot study of TTFields concomitant with gemcitabine for front-line therapy in patients with advanced pancreatic adenocarcinoma.
Authors: Fernando Rivera, Javier Gallego, Carmen Guillen, Manuel Benavides, Jose A. Lopez-Martin, Daniel C. Betticher, Marc Kueng
Journal: Journal of Clinical Oncology (2016)

269 Background: TTFields are alternating electric fields delivered to the region of the tumor by means of non-invasive transducer arrays. TTFields interfere with mitotic spindle formation, thus having an anti-mitotic activity. In pancreatic cancer, TTFields decreased proliferation and clonogenic potential in vitro, and reduced tumor volume in vivo. The PANOVA trial was designed to test TTFields, combined with chemotherapy, in pancreatic cancer. Methods: Twenty patients with advanced pancreatic adenocarcinoma were enrolled in a prospective, single arm study of TTFields at 150 kHz, concomitant with standard weekly gemcitabine. All patients had histologically-confirmed unresectable tumors, with an ECOG performance score of 0-1 and no prior chemotherapy or radiation therapy. The primary endpoint was incidence and severity of treatment emergent adverse events (AEs). Secondary endpoints included progression free survival (PFS), PFS rate at 6 months, overall survival (OS) and response rate. Results: The median age was 73 (range – 49-81) and 60% of the patients were females. Most patients (80%) had an ECOG score of 1. Twelve patients (60%) had distant metastases, while the others had locally advanced disease. Median compliance with TTFields was 78% (14 hours/day), with median duration of 5 months. Fourteen patients (70%) had serious (grade 3-5) AEs during the study period. Six patients (30%) had hematological, 45% gastrointestinal and 15% pulmonary AEs. Ten patients (50%) had treatment-related skin toxicity, of which only 2 were grade 3, both resolved with appropriate treatment. No TTFields-related serious AEs were reported. The median PFS was 8.3 months (95% CI 4.3, 10.3). PFS rate at 6 months was 56%. Of the evaluable tumors, 30% had partial response and another 30% stable disease. The median OS was 14.9 months and 1-year survival rate was 55%. Conclusions: TTFields concomitant to gemcitabine are tolerable and safe for advanced pancreatic cancer patients. The efficacy results are promising and support further research in this indication. An extension of the PANOVA protocol, including 20 additional patients who receive gemcitabine, nab-paclitaxel and TTFields is ongoing. Clinical trial information: NCT01971281.
Chemotherapy-enhanced accelerated radiotherapy for intermediate-volume hypopharyngeal cancer.
Authors: M. Kawashima, R. Hayashi, M. Tahara, T. Ogino
Journal: Journal of Clinical Oncology (2010)

5576 Background: To evaluate the safety and efficacy of accelerated radiotherapy (RT) with delayed concomitant, low dose chemotherapy as a radiosensitizer in patients with squamous cell carcinoma of the hypopharynx that was judged as amenable to margin-free resection with curative surgery necessitating total laryngectomy. Methods: Patients aged 20-75 years with previously untreated, histologically proven T2 – 4 disease were eligible for the study. Those who have unresectable and/or bilateral lymph node metastasis or distant organ metastasis were ineligible. A total dose of 40 Gy/4 weeks using 2 Gy once daily fractionation to the entire neck followed by boost RT administering 30 Gy/2 weeks (1.5 Gy twice daily fractionation) to the primary tumor was administered. Cisplatin 80 mg/m2 bolus followed by 4-day continuous infusion of 5-fluorouracil (FU) 400 mg/m2/day was administered concomitantly during boost RT. Primary endpoint was completeness of the protocol within overall treatment time of less than 49 days. Results: Thirty-five patients were enrolled between October 2002 and March 2008. Volume of the primary tumor was estimated as 5–49 mL (median 15 mL) and 29 patients (83%) had that of 10-40 mL. Acute adverse events were acceptable, and grade >=3 acute reactions were observed in 13 (37%) of patients. All patients could complete this protocol as planned within 49 days (39–48 days, median 44 days). After median follow-up period for surviving patients of 54 months (22–86 months), overall and local recurrence-free survival rate at 3 years were 91% (95% confidence interval, 81%-100%), and 86% (74%-97%), respectively. All of the patients who were alive and free from local failure retained their normal understandable speech, and all surviving patients maintained their normalcy of diet without feeding tube dependency at the time of last follow-up. Conclusions: This regimen was feasible with encouraging oncological and functional outcomes in selected patients with intermediate-volume hypopharyngeal cancer. Further study is warranted to scrutinize adequate patient selection and outcomes to maximize therapeutic ratio using this strategy. No significant financial relationships to disclose.
How do palliative care needs vary across the disease trajectory in patients with gynecologic cancer?
Authors: Rachel Ruskin, Michelle Renee Rowland, Katherine N Moore, Carolyn Lefkowits, Adam Walter, Katrina Slaughter, Lisa Michelle Landrum, Joan L. Walker, Marianne Matzo
Journal: Journal of Clinical Oncology (2015)

106 Background: The WHO’s integrated model emphasizes that palliative care (PC) should be provided concurrently with curative and life-prolonging care, with disease-directed treatments decreasing and PC increasing over time. This study aimed to understand how accurately this theoretical model matches the PC needs of gynecologic cancer (GC) patients. Methods: GC patients at a comprehensive cancer center completed a symptom and needs assessment questionnaire as part of routine care. Needs were divided into physical, emotional, social, practical, and informational domains. Patients reporting at least one symptom score ≥ 4/10 made the physical need domain positive. For the remainder of the categories, patients endorsing at least one need in a given domain made that domain positive. Time points in the illness trajectory were categorized as diagnosis, primary treatment, remission, and progression/recurrence. Univariate analyses were utilized to assess differences in needs at various time points. Results: Questionnaires from 1348 patient visits over 3 months were included. Patients had ovarian (39%), uterine (36%), cervical (16%), and vulvar (5%) cancer. Visits occurred around the time of diagnosis (6%), during primary therapy (28%), during remission (42%), and during disease progression or recurrence (23%). Physical needs were most common at diagnosis and during progression/recurrence (p &lt; 0.01). Emotional needs (p &lt; 0.01), social needs (p &lt; 0.01), and informational needs (p &lt; 0.01) all varied throughout the course of disease and were highest at diagnosis. At each time point, at least 65% of patients had one or more PC needs. Having needs in multiple domains ( ≥ 3) was associated with time point, with patients around the time of diagnosis having the highest rate of need in multiple domains (p &lt; 0.01). Conclusions: GC patients have a broad range of PC needs across the trajectory of their illness. The WHO schema fails to capture the full scope of these needs and under-appreciates their prevalence earlier in the course of the disease. These results underscore the importance of training gynecologic oncologists in primary PC as well as increasing referrals to specialist PC providers.
TBCRC 018: Phase II study of iniparib plus chemotherapy to treat triple-negative breast cancer (TNBC) brain metastases (BM).
Authors: C. K. Anders, R. Nanda, M. C. Liu, K. L. Blackwell, C. H. Van Poznak, V. G. Abramson, A. M. Storniolo, N. U. Lin, V. Stearns, A. Melhem, S. Puhalla, J. T. Carpenter, M. E. Melisko, A. M. Deal, C. Hudis, E. P. Winer, C. M. Perou, C. R. Bradley, A. C. Wolff, L. A. Carey
Journal: Journal of Clinical Oncology (2011)

TPS127 Background: TNBC is an aggressive subset of BC with high rates of BM and poor survival. Iniparib, an anticancer agent with poly (ADP-ribose) polymerase (PARP) inhibitory activity, in combination with DNA-damaging chemotherapy appears to be effective in advanced TNBC. Iniparib penetrates the blood brain barrier. We are evaluating the efficacy and safety of iniparib plus irinotecan, a topoisomerase I inhibitor with activity in primary and secondary central nervous system (CNS) tumors, in pts with TNBC BM. Methods: Pts with TNBC BM measuring > 0.5cm are eligible for enrollment. There are no limits to prior therapies, including iniparib; stable or decreasing steroids ≥ 7 days prior to study entry. Pts with leptomeningeal disease are excluded. Cohort 1: new and/or progressive BM following CNS radiation; Cohort 2: asymptomatic, CNS-radiation therapy naïve patients. Pts receive irinotecan (125 mg/m2 IV D 1, 8) prior to iniparib (5.6mg/kg IV D 1, 4, 8, 11) of a 21 day cycle. Intra- and extracranial disease is assessed every 9 weeks (wks) by gadolinium-enhanced brain MRI and CT chest/abdomen/pelvis, respectively. The primary endpoint is time to progression (TTP) (intracranial by modified RECIST or extracranial by RECIST 1.1). Secondary objectives include CNS and non-CNS response rates, progression free survival, overall survival, quality of life, and correlative science endpoints. Statistical considerations: A sample size of 32 evaluable pts has 80% power to detect a difference between the null (2.0 months TTP) and the alternative hypothesis (3.15 months TTP) at a 0.05 significance level. Assuming a 20% drop-out rate, 40 pts will be enrolled. Correlative studies: Brain magnetic resonance angiography pre- and 9 wks post-therapy to determine if intracranial vasculature dynamics predict response. Archival primary and/or metastatic tissues are required from all pts to evaluate intrinsic BC subtype and alterations in DNA repair genes. Among pts who consent for testing, BRCA1/2 status will be correlated with response. Optional pre- and post-therapy (non-CNS) biopsies are expected from 25% of pts to assess in vivo effects on proliferation, apoptosis, and gene expression (NCT01173497).
What we know from the semiannually repeated CT screening in a high-risk cohort over 15 years: Update of Anti-Lung Cancer Association project.
Authors: N. Seki, K. Eguchi, M. Kaneko, H. Ohmatsu, R. Kakinuma, E. Matsui, M. Kusumoto, T. Tsuchida, H. Nishiyama, N. Moriyama
Journal: Journal of Clinical Oncology (2011)

1595 Background: The National Lung Screening Trial showed mortality benefit of twenty percent fewer lung cancer deaths with low-dose helical CT (LDCT). Based on this result, we summarized what we could know from 15 years of experience with Anti-Lung Cancer Association project, which was regarded as a longer-term study with LDCT performed at shorter intervals and with a larger number of detected cancers than any other single-armed studies. Methods: Among 2,302 participants (mean age 63 years, 87% male, and 83% smoker) at baseline screening, 2,063 underwent semiannually repeated screening from 1993 to 2009. We investigated (1) survival of patients with screening detected lung cancers, (2) presence of a stage shift, (3) appropriate duration of repeated screening, (4) identification of high-risk group, (5) appropriate screening intervals, and (6) tumor size necessary for early-stage detection. Results: (1) The 10-year survival rates were 84.5% in repeated screening group (n == 74) and were 38.1% in initial screening group (n == 21) (P == 0.208). (2) Only in invasive adenocarcinoma, both proportion of stage II to IV and tumor size were negatively correlated with duration of repeated screening (r ==−0.77, P == 0.007 and r ==−0.60, P == 0.029, respectively). (3) Detection rate of all incidence cancers were positively correlated with duration of repeated screening (r == 0.50, P == 0.020). However, detection rate and stage sift remained unchanged until 5 years of repeated screening. (4) Female sex (HR 2.9, P == 0.015) and smoking (HR 2.7, P == 0.046) were demographic risk factors for lung cancer detection at repeated screening. The accumulated 10-year detection rates for female smokers (n == 91), male smokers (n == 1557), and non-smokers (n == 229) were 15.1%, 6.2%, and 4.3%, respectively (P == 0.002). (5) The estimated relative cancer detection powers of annual screening to semiannual screening were 50% and 57% for female and male smokers with lung cancer, respectively. (6) Tumor size of 15 mm or less was necessary for the detection of early-stage (N0M0) lung cancer. Conclusions: When seeking counsel about initiation of CT screening for lung cancer, above estimations for individualized benefit can be provided.
<i>RAS</i> mutational status and CEA production at initial presentation in metastatic colorectal cancer.
Authors: May Thet Cho, Leanne Goldstein, Chie Akiba, S. Cecilia Lau, Milhan Telatar, Michelle Afkhami, Stephen Sentovich, Kurt Melstrom, Dean Lim, Joseph Chao, Vincent M. Chung, Marwan Fakih
Journal: Journal of Clinical Oncology (2016)

542 Background: Serial CEA testing is recommended in the surveillance of patients with resected stage II-IV colorectal cancer. However, the sensitivity of CEA in identifying metastatic disease has not been evaluated in the settings of RAS mutant (MT) and RAS/BRAF wild-type tumors (WT). In order to evaluate the impact of RAS mutational status on CEA production, we retrospectively evaluated a single-institute metastatic colorectal cancer (mCRC) population. Methods: We retrospectively reviewed, in a single center, all cases with mCRC with known RAS mutational status based on next generation sequencing (ONCO44 and ONCO48). These assays identify clinically relevant mutations in BRAF, KRAS, and NRAS. Additional eligibility criteria included the availability of CEA levels and imaging studies at first diagnosis of mCRC. Patient demographics, primary tumor location and sites of metastatic disease at 1 st diagnosis were captured. CEA levels were stratified as normal or elevated based on a cut point of 5ng/ml. Results: 139 mCRC patients satisfied the eligibility criteria (75 RAS-MT, 59 RAS/BRAF-WT, and 5 BRAF-MT). BRAF-MT patients were excluded from the analysis due to their small sample size. Patients with RAS/BRAF-WT tumors were more likely to present with metastatic disease to the liver, but this did not reach statistical significance (p = 0.056). There was no difference in the incidence of normal CEA at presentation in RAS-MT (30%) and RAS/BRAF-WT (28%) cohorts. CEA production was dependent on the pattern of metastatic disease. Elevated CEA was associated with the presence of liver metastases versus no metastases among RAS-MT (92% vs 47% p &lt;.0001) and RAS/BRAF-WT patients (82% vs 50% p = 0.0101). RAS status did not impact the likelihood of CEA production within the hepatic metastases and non-hepatic metastases groups. Conclusions: RAS status does not appear to influence CEA production in patients with mCRC. CEA elevations are highly associated with liver metastases and are less prevalent in patients without hepatic involvement. These findings confirm the limited predictive value of CEA for non-hepatic recurrence, irrespective of RAS status.
Evaluation of efficacy and safety of neoadjuvant chemotherapy with weekly paclitaxel in patients with locally advanced and large operable breast cancer
Authors: A. V. Bakshi, R. Bharath, S. Gupta, R. Nair, T. Shet, N. S. Ghadyalpatil, R. Kaushal, K. Gaikwad, S. Kannan, P. M. Parikh
Journal: Journal of Clinical Oncology (2008)

11593 Background: Taxanes have been shown to induce high pathologic response rates in patients with early breast cancer. We studied the use of single agent weekly paclitaxel as anterior chemotherapy in large operable (tumour size >5 cm) breast cancer (LOBC) and locally advanced breast cancer (LABC). Methods: In this prospective study, we enrolled women above 18 years with T3–4 any N and N2- 3 any T with nonmetastatic disease. Patients with inadequate organ function were excluded. Tumor size was documented at baseline and after completion of neoadjuvant chemotherapy. After diagnostic biopsy, patients were given paclitaxel (100 mg/m2) weekly for 8 weeks. This was followed by breast conservative surgery or mastectomy (as per surgeon’s discretion) and adjuvant chemotherapy with 4 cycles of FEC (5-fluorouracil 500 mg/m2, epirubicin 90 mg/m2, cyclophosphamide 500 mg/m2), radiotherapy and hormone therapy (if indicated). The primary objectives included assessment of clinical and pathologic response after primary chemotherapy and to assess toxicity profile of weekly paclitaxel. Results: A total of 30 patients - stage IIA-2, stage IIB-1, stage IIIA-8, stage IIIB-18, stage IIIC-1 between the ages of 30–67 were included. All 30 patients were assessable for clinical response and 28 patients were assessable for pathologic response. A total of 239 out of planned 240 cycles were administered. Clinical complete response was seen in 12/30 patients and clinical partial response in 16/30 patients (overall response = 28/30). One patient each had stable and progressive disease. Complete pathologic response was observed in 4 patients. Two patients received second-line chemotherapy owing to suboptimal response. Side effects were mild in the form of myalgia, nausea and vomiting. Eight patients developed Grade I-II neuropathy and 1 patient developed Grade IV neuropathy. No incidence of neutropenic fever was noted during the weekly paclitaxel schedule. One patient suffered from myelotoxicity in the form Grade III leucopenia, Grade IV neutropenia and grade III thrombocytopenia. Conclusions: Single agent weekly paclitaxel is safe and effective as neoadjuvant chemotherapy in patients with LOBC and LABC with modest pathologic responses. No significant financial relationships to disclose.
The TREPP as alternative technique for recurrent inguinal hernia after Lichtenstein's repair: A consecutive case series
Authors: W.J.V. (Willem) Bökkerink, A.M. (Alexandra) Persoon, W.L. (Willem) Akkersdijk, C.J.H.M. (Kees) van Laarhoven, G.G. (Giel) Koning
Journal: International Journal of Surgery (2017)
Obesity and peritoneal surface disease: Outcomes following cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC).
Authors: Konstantinos I Votanopoulos, Katrina R Swett, Doug S Swords, Perry Shen, John Stewart, Edward A. Levine
Journal: Journal of Clinical Oncology (2013)

533 Background: It is estimated that 35% of the US population is obese. It is unknown how obesity influences the operative and survival outcomes of CRS/HIPEC procedures. Methods: A retrospective analysis of a prospective database of 1,000 procedures was performed. Type of malignancy, ECOG, resection status, hospital and ICU stay, Clavien-Dindo morbidity, mortality and survival were reviewed. Results: 242 patients with BMI&gt;30 (30-63.3) underwent 264 CRS/HIPEC procedures between 1991-2012. 94(38.8%) of those had a BMI&gt;35. 136(51.7%) obese patients had appendiceal and 59(22.4%) colon cancer. Median follow up for obese patients was 52 months. Major (III /IV) and minor morbidity (I/II) was 36.6% and 28.8% for obese and 36.5% and 25.7% for non-obese patients. The 30 day mortality for obese and non-obese was 5.5% and 7.3% respectively. Median ICU and hospital stay was 1 and 9 days for both obese and non-obese. The 30 day readmission rate was similar between obese and non-obese patients 35.2% vs 30.8%. When patients were grouped by primary (colon or appendix), resection status, and grade of disease (for appendiceal) and stratified by BMI (not obese, 30-&lt;35, ≥35) there was no difference in 30 day postoperative morbidity and mortality. When the interaction of obesity with the biology of the underlying primary was studied there was no obesity related survival differences. For obese and non-obese patients, median survival for low grade appendiceal cancer was 76 months and 107 months respectively (p=0.38) and for colon cancer was 18.1 months and 19.8 months. 5 and 10 year survival for the low grade appendiceal group was 60.5% and 33.1% for obese and 69.1% and 46.5% for non obese (p=0.38). Conclusions: Obesity does not influence postoperative morbidity and mortality of patients with peritoneal surface disease (PSD) regardless of primary. Obesity does not influence long term survival for appendiceal and colon cancer patients with PSD, and should not be considered a contraindication for the procedure.
Patterns of care and patient characteristics in postmenopausal women with HER2+ and hormone receptor-positive (HR+) metastatic breast cancer (MBC).
Authors: P. P. Sharma, K. Sail, T. E. Delea, M. T. Forsyth, M. Halm, Y. M. Nagarwala, W. Lopez, D. A. Patt
Journal: Journal of Clinical Oncology (2011)

e11107 Background: Treatment of women who are HER2+/ HR+ is challenging due to the complexity of regimens including chemotherapy (CT), hormonal therapy (HT), and targeted therapy (TT). This study evaluated patient characteristics and treatment patterns in women with HER2+/HR+ MBC initiating 1st line therapy in community oncology setting. Methods: We conducted a retrospective observational study utilizing data from US Oncology’s iKnowMed electronic medical record system. Post-menopausal female patients with HER2+/ HR+ MBC from January 2007 to June 2010 were identified and followed through September 2010 to observe treatment patterns. Patients were stratified by presence or absence of visceral crisis (VC), which was identified by chart reviews. For patients without VC, subgroup analyses were conducted by ECOG performance status (PS), year of diagnosis and location of metastasis. Results: The study population consisted of 347 patients; 258 without VC and 89 with VC. Patients with VC were more likely to have multiple sites of metastasis and lower PS than patients without VC. Irrespective of VC status, the most frequently used treatment regimen was CT+ TT followed by HT (without VC: 32%; VC: 37%). In patients without VC, the next most frequently used regimen was HT+TT (20%), compared to CT+TT in women with VC (21%). Trastuzumab, paclitaxel and letrozole were the most frequently used TT, CT and HT, respectively. In patients without VC, better ECOG PS was a predictor of TT and HT; bone only metastasis was a predictor of HT; whereas non-bone metastasis, a predictor of receipt of CT. Approximately 25% of patients without VC did not receive TT, and 35% did not receive HT. Treatment patterns were relatively stable over observation period. Conclusions: When medically appropriate, there may be opportunities to improve patient outcomes (with minimal toxicity) through increased use of TT +/- HT.