tbuckley/cabot-search huggingface dataset:
Persistence with adjuvant hormone therapy in older breast cancer survivors.
Authors: T. Hedin, C. Guo, A. Nattinger
Journal: Journal of Clinical Oncology (2011)

6032 Background: Breast cancer survivors with hormone receptor positive disease are typically prescribed tamoxifen or an aromatase inhibitor (AI) as adjuvant hormonal therapy (HT) for a 5-year course to reduce the likelihood of recurrence. Despite its benefit in breast cancer patients, prior studies on tamoxifen have found sub-optimal rates of adherence to a 5-year course. This study aims to identify the extent of non-persistence to adjuvant HT among older breast cancer survivors as well as examine self-reported reasons for non-persistence. Methods: We recruited 3083 Medicare breast cancer patients who underwent initial surgery in 2003 and resided in California, Florida, New York, or Illinois. Four survey waves between 2005 and 2008 assessed receipt of HT as well as demographic and treatment information. Stage 1 or 2 subjects who initiated HT within 1 year of surgery (n=1402) were included. A multinomial model was constructed to determine which demographic factors were associated with which self-reported reasons for non-persistence. Results: Of the 1402 breast cancer survivors studied, 325 (23%) discontinued their HT within 5 years of their surgery. Reasons for non-persistence were provided by 280 (86%) of those discontinuing therapy early. The most common reason for non-persistence was side effects (47% of subjects), followed by belief they had finished therapy (17%), physician-directed discontinuation (15%), and cost (8%). Thirteen percent had other reasons for discontinuation and were excluded from the multinomial analysis. Factors associated with reasons for non-persistence were age (p=0.025), marital status (p=0.015), household income (p=0.045), and supplemental insurance in addition to Medicare (p=0.047). Compared to side effects, older subjects (>75 years) were more likely to discontinue treatment due to physician direction (p=0.01) or completion of treatment (p=0.04), married subjects were less likely to discontinue due to cost (p=0.05), and higher income subjects were less likely to discontinue due to cost or completion of treatment (p=0.04). Conclusions: Most women discontinued due to perceived side effects. Cost was a particular issue for those who were older, unmarried, poorer, and with poorer insurance coverage.
Symptom burden in hospitalized patients with advanced cancer.
Authors: Samantha M.C. Moran, Areej El-Jawahri, William F. Pirl, Lara Traeger, Pallavi Kumar, David P. Ryan, Inga Tolin Lennes, Barbara J. Cashavelly, Holly S Martinson, Harry VanDusen, Ephraim P. Hochberg, Vicki A. Jackson, Joseph A. Greer, Jennifer S. Temel, Ryan David Nipp
Journal: Journal of Clinical Oncology (2015)

100 Background: Patients with advanced cancer experience high rates of both physical and psychological morbidity, but data describing patients’ symptoms during hospital admissions are lacking. We sought to describe symptom burden in hospitalized patients with incurable solid and hematologic malignancies. Methods: We prospectively enrolled patients with incurable cancers admitted to the Massachusetts General Hospital from 9/1/2014 through 5/1/2015. Within the first week of their admission, we assessed physical and psychological symptoms using the Edmonton Symptom Assessment System-revised (ESAS-r). Beginning 11/15/2015, we also administered the Patient Health Questionnaire 4 (PHQ-4), scored categorically. Results: We enrolled 457 of 547 (84%) eligible patients. Participants (mean age=63.8 years; n=231, 51% female) had the following malignancies: gastrointestinal (n=149, 33%), lung (n=77, 17%), genitourinary (n=52, 11%), breast (n=33, 7%), hematologic (n=24, 5%), and other solid tumors (n=122, 27%). Using the ESAS-r, tiredness, drowsiness, anorexia, and pain were the most common severe symptoms. Using the PHQ-4, approximately one-third of participants screened positive for depression (91/271, 34%) and anxiety (86/273, 32%). Conclusions: Hospitalized patients with incurable solid and hematologic malignancies experience substantial physical and psychological symptoms. Most patients reported at least moderate tiredness, drowsiness, anorexia and pain. Additionally, a concerning proportion reported depression and anxiety. Our data demonstrate the need for efforts to alleviate the physical symptoms experienced by this population, while also seeking to understand and address their psychological needs. [Table: see text]
Adherence to anti-emetic guidelines with a newly approved chemotherapy agent, trifluridine/tipiracil (TAS-102): A single-institution study.
Authors: Daniel Childs, Aminah Jatoi
Journal: Journal of Clinical Oncology (2016)

221 Background: To our knowledge, no study has examined adherence to antiemetic guidelines with soon-to-be-approved or newly approved chemotherapy agents. In 2015, the Food and Drug Administration approved 18 cancer drugs, underscoring the timeliness of this topic. Here, we hypothesize that patients prescribed new drugs are at risk for poor guideline adherence, and we report on antiemetic prescribing practices and outcomes with TAS-102, a recently approved drug for metastatic colorectal cancer. Methods: This study focused on all patients prescribed TAS-102 in 2015 at the Mayo Clinic in Rochester, MN for compassionate use or routine care within 3 months of FDA approval. First-cycle antiemetic prophylaxis was examined for adherence to National Comprehensive Cancer Network Guidelines, version 1.2015, for chemotherapy of low emetogenic potential based on TAS-102 phase 3 data. Results: Among 44 patients, 28 (64%) had nausea and vomiting with prior chemotherapy. With the first cycle of TAS-102, 25 (57%) were prescribed antiemetics in a guideline-adherent manner; 15 (34%) in a non-guideline-adherent/more aggressive manner; and 4 (9%) in a non-guideline-adherent/less aggressive manner. In guideline-adherent patients, rates of nausea and vomiting were 52% and 24%, respectively, with one patient requiring an unscheduled clinic visit and another an emergency department visit and hospital admission - all for nausea and vomiting. In non-guideline-adherent/more aggressive patients (who received more prophylaxis than called for), these rates were 33% and 27%, respectively, with one patient requiring a clinic visit and emergency department visit and another an emergency department visit. In non-guideline-adherent/less aggressive patients, no nausea or vomiting was reported. Conclusions: Poor adherence to antiemetic guidelines occurred often. However, because adherence was not associated with better control of nausea and vomiting, clinical judgment should complement guidelines in patients about to receive new cancer drugs, particularly with drugs of low emetogenic potential and also in patients with a history of chemotherapy-induced nausea and vomiting.
Psychosocial distress screening and the survivorship care plan in the community oncology setting.
Authors: Milana V. Dolezal, Mary Prishtina, Luanne Ridgley, Beverly Hart-Inkster, Kimberly Christensen, Dana Orange
Journal: Journal of Clinical Oncology (2016)

206 Background: Alta Bates Summit Medical Center (ABSMC) is a Commission on Cancer (CoC) accredited comprehensive community oncology program in the San Francisco Bay Area with an annual adult cancer program of approximately 1700 patients. To satisfy CoC accreditation standards 3.2 (Psychosocial Distress Screening) and 3.3 (Survivorship) the cancer survivorship program has a collaborative nurse-led and primary oncologist-led model utilizing Journey Forward software for survivorship care plans (SCP) and the Distress Tool (DT). National standards include distress screening as an important assessment in cancer care, in order to provide interventions Methods: The self reporting DT was sent to adult cancer patients prior to a survivorship visit. Oncology nurse navigator and oncologist reviewed the DT and discussed concerns with the patient. Patients scoring 5 or greater on DT were referred to psychosocial services. Interventions based on patients’ needs include the Cancer Transitions Program(CTP), support groups and classes. Results: 100 patient charts were reviewed for DT and SCP. 95% of patients were female; 5% were male. Patients ranged in age from 22 to 92 years. 36 patients were enrolled in the 2015 CTP and 63% of those participants had completed SCP. Conclusions: The prevalence of psychosocial distress in our community oncology practice was lower than expected, in part due to the robust supportive care environment that patients actively partake in at the Cancer Center. Implementing the DT also improved patient and clinician communication resulting in more timely intervention. [Table: see text]
Circulating microRNAs as dynamic biomarkers of response to treatment with FOLFIRINOX combination therapy in advanced pancreatic ductal adenocarcinoma
Authors: Laura L Meijer, Adam E Frampton, Ingrid Garajová, Chiara Caparello, Tessa Y S Le Large, Niccola Funel, Enrico Vasile, Justin Stebbing, Jonathan Krell, Geert Kazemier, Elisa Giovannetti
Journal: The Lancet (2017)
A phase I, open-label, dose-escalation study of the novel oral proteasome inhibitor (PI) ONX 0912 in patients with advanced refractory or recurrent solid tumors.
Authors: K. P. Papadopoulos, D. S. Mendelson, A. W. Tolcher, A. Patnaik, H. A. Burris, D. W. Rasco, J. C. Bendell, M. S. Gordon, G. Kato, H. Wong, D. Bomba, S. Lee, H. H. Gillenwater, T. Woo, J. R. Infante
Journal: Journal of Clinical Oncology (2011)

3075 Background: ONX 0912 is a potent, irreversible, orally bioavailable peptide epoxyketone PI. It is a structural analog of carfilzomib (CFZ), an intravenously administered PI in ph III trials. ONX 0912 has demonstrated preclinical antitumor activity in human solid and hematologic tumor models, similar to that observed with CFZ. The objectives of this first-in-human ph I dose escalation study are to determine the safety and bioavailability of ONX 0912. Methods: This open-label, multicenter, study is enrolling adult pts with recurrent or refractory advanced solid tumors. ONX 0912 is administered orally as a single agent on a 14-day cycle (C), once daily for 5 days with 9 days rest. Beginning with 30 mg/day, ONX 0912 doses are escalated in 30 mg increments in sequential groups of 3 pts with expansion to 6 pts if a dose limiting toxicity (DLT) is observed. The primary objectives of the study are to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of ONX 0912. Samples for pharmacokinetics and pharmacodynamics are also collected at various time points during C 1 and 2. Results: To date, 18 pts (median age 64.5 y) have received 1-14 C of ONX 0912 (n=3 for each dose from 30-180 mg). Exposure in plasma was observed in all pts with maximum concentrations of up to 3.8 µM, exceeding the IC50 for proteasome inhibition by >50-fold. Inhibition >80% in whole blood and peripheral blood mononuclear cells was observed in 2/3 pts receiving ≥90 mg of ONX 0912, comparable to levels achieved with CFZ. There were 2 grade (G) 3 drug-related AEs (1 each at 90 and 180 mg), and 1 DLT (G3 nausea/vomiting) at 180 mg. Expansion at this dose is ongoing. Similar to toxicities observed in animal studies, the most frequent treatment-related AEs observed in this ph I study were nausea (61%), vomiting (56%), and diarrhea (33%). Stable disease of >3 mo duration has been observed in 3 pts (prostate cancer, liposarcoma, non-small cell lung cancer) who have remained on study. Conclusions: ONX 0912, an orally bioavailable PI, achieves levels of proteasome inhibition >80% when given daily for 5 days every 2 weeks in pts with advanced solid tumors and has an acceptable safety profile.
A phase Ib trial of mushroom powder in biochemically recurrent, hormone-naive prostate cancer.
Authors: Przemyslaw Twardowski, Paul Henry Frankel, Sumanta Kumar Pal, Timothy W. Synold, Christopher Ruel, Maribel Junqueira, Tina Nguyen, Melanie R. Palomares, Pamela Renee Tryon, Shiuan Chen
Journal: Journal of Clinical Oncology (2013)

142 Background: Biochemically recurrent prostate cancer (PC) is a common presentation of relapse after primary local therapies. Strategies to delay disease progression and defer initiation of androgen deprivation therapy and associated side effects are needed. White button mushroom (WBM, Agaricus bisporus) extract suppresses prostate cancer tumor growth in animals, and prior human experience indicates favorable toxicity profile. Methods: Patients (pts) with rising PSA of ≥0.2 ng/mL after prostatectomy (RP) and/or radiation (RT) and no radiographic evidence of metastases were treated with WBM powder tablets at 4, 6, 8, 10, 12 and 14 grams po daily. Dose escalation was conducted in cohorts of 6 and continued as long as no more than 1 patient per cohort experienced dose limiting toxicity (DLT). Therapy continued until PSA increased by ≥100% and by ≥1 ng/mL, or clinically detectable metastases or unacceptable toxicity occurred. Primary objective was feasibility and toxicity, secondary objective was the effect of WBM on serum PSA and androgen levels. Results: Thirty six pts were treated. Median age was 68 (53-80).Thirty three pts (92%) had prior RP and all underwent previous RT. Median PSA was 1.9 (0.2-22.2). Mean compliance was 98.6 %. No DLT’s were encountered. The most common side effect was grade 1 abdominal bloating (39%); one patient experienced asymptomatic grade 3 hyponatremia. Overall PSA response rate was 11% (95% CI: 4%-27%). Two pts receiving 8 and 14 gm/day demonstrated a PSA complete response (CR), defined as a decline in PSA to undetectable levels that continues for 26 and 7 months respectively. Two pts, receiving 8 and 14 gm/day, experienced confirmed PSA partial responses (PR), defined as a ≥50% PSA decline on treatment. After 3 months of therapy 36% of pts (13/36) demonstrated some PSA decrease below baseline. No association between PSA response and serum testosterone, DHT or DHEA levels was observed. Median duration on therapy is 10.2 months (0.9 – 35.3). Ten pts remain on therapy. Conclusions: Therapy with WBM was well tolerated. Our data suggest that WBM intake results in durable decreases in PSA level in some patients with biochemically recurrent PC. Further studies to clarify mechanism of action are warranted. Clinical trial information: NCT00779168.
MAVERICC, a phase 2 study of mFOLFOX6-bevacizumab (BV) vs FOLFIRI-BV with biomarker stratification as first-line (1L) chemotherapy (CT) in patients (pts) with metastatic colorectal cancer (mCRC).
Authors: Heinz-Josef Lenz, Fa-Chyi Lee, Linda Yau, Han A. Koh, James A. Knost, Edith P. Mitchell, Ivan Bosanac, Christoph Mancao, Aparna Parikh
Journal: Journal of Clinical Oncology (2016)

493 Background: Standard 1L mCRC treatment (tx) includes a CT backbone (e.g., modified leucovorin [LV]/5-fluorouracil [5-FU]/oxaliplatin [mFOLFOX6] or LV/ 5-FU/ irinotecan [FOLFIRI]) and biologic therapy (e.g., BV). The preferred CT backbone for anti VEGF tx is unknown. MAVERICC (NCT01374425), a global, randomized, open-label, phase 2 trial, assessed tx efficacy and safety of mFOLFOX6-BV vs FOLFIRI-BV in pts with mCRC. Intratumoral ERCC1 and plasma VEGF-A were studied as biomarkers for oxaliplatin- and BV-containing tx, respectively. Methods: Pts with mCRC (≥1 measurable metastatic lesion, ECOG performance status ≤1) were randomized 1:1 to receive BV (5 mg/kg) + mFOLFOX6 or FOLFIRI every 2 weeks, stratified by ERCC1 level (low [£1.7] vs high [&gt;1.7]) and region. VEGF-A levels were measured at baseline. Primary objectives were to evaluate: ERCC1 as a biomarker of progression-free survival (PFS) in 1L mCRC tx (mFOLFOX-BV vs FOLFIRI); and VEGF-A as a biomarker for BV and as a biomarker in combination with ERCC1 for PFS following CT + BV. Secondary objectives were to evaluate: the effect of ERCC1 and VEGF-A on overall survival (OS), objective response rate, hepatic metastases resection, and safety. PFS and OS were estimated by Kaplan–Meier methods, hazard ratios (HR) were estimated by Cox regression, and p-values were based on stratified log-rank tests. ERCC1 biomarker analyses are presented here. Results: A total of 376 pts were randomized: median age, 61 yr; white race, 83%; US region, 85%. Baseline characteristics: ERCC1 high, 35%; KRAS mutant, 34%. Efficacy results are shown (see Table). Conclusion: Consistent with previous findings, PFS and OS were comparable in pts treated with either 1L mFOLFOX6-BV or FOLFIRI-BV. Exploratory analyses within pts with high ERCC1 levels suggest consistent results. VEGF-A analyses are ongoing. Clinical trial information: NCT01374425. [Table: see text] [Table: see text]
Real-world use of epic for clinical practice (EPIC-CP) to assess patient-reported prostate cancer quality of life in the clinical setting.
Authors: Peter Chang, Arie Carneiro, Ostap Dovirak, Kimberly Taylor, Catrina Crociani, Martin G. Sanda, Andrew Percy, Kyle McAnally, Andrew A Wagner
Journal: Journal of Clinical Oncology (2015)

18 Background: Prostate cancer practitioners tend to underestimate patients’ treatment-related side effects. We developed the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) to facilitate patient-reported health-related quality of life (HRQOL) assessment at the point-of-care (Chang P et al, J Urol Sep 2011). We sought to demonstrate the feasibility of EPIC-CP use in routine clinical care, and to compare longitudinal patient-reported and practitioner-reported prostate cancer outcomes. Methods: We reviewed practitioner- and patient-reported HRQOL outcomes in 482 patients who underwent radical prostatectomy at our institution from 2010 to 2014. All EPIC-CP questionnaires were administered and interpreted without research personnel. Practitioner-reported outcomes were assessed using chart review. We used the paired t-test and Wilcoxon signed-rank test to compare pre- and post-treatment EPIC-CP domain scores, and Fisher’s exact test to compare patient-reported and practitioner-reported outcomes. We considered p-values &lt; 0.05 statistically significant. Results: 708 total EPIC-CP questionnaires were completed. Mean urinary incontinence domain scores increased (worsened) significantly from baseline (0.6±0.2) to 3 (3.1±2.3) and 6 months (2.2±2.1) post-treatment, but were not statistically changed from baseline at 12 months (1.6±1.7). Patient-reported incontinence pad-free rates using EPIC-CP at 3, 6, and 12 months were 47%, 76%, and 78%, respectively, which were consistent with practitioner-reported rates. Mean sexual domain scores were significantly worse at 12 months (5.9±3.3) compared to baseline (2.4±2.8). Practitioners significantly overestimated the rate of functional erections compared to patients’ EPIC-CP-reported rates at 3 months (18% vs 12%, p &lt; 0.05) and 12 months (45% vs 23%, p &lt; 0.05). Bowel and vitality/hormonal scores were unchanged, and urinary irritation/obstruction scores improved after surgery. Conclusions: EPIC-CP is feasible to use in the routine clinical care of prostate cancer patients, and can help practitioners more accurately assess patients’ post-treatment symptom severity.
A phase II trial of radiotherapy for patients 80 years of age or older with squamous cell carcinoma of the thoracic esophagus
Authors: M. Kawashima, Y. Kagami, M. Oguchi, H. Ikeda
Journal: Journal of Clinical Oncology (2005)

8026 Backgrounds: Few data is available regarding the safety and efficacy of RT for elderly patients with this disease. Methods: A multi-institutional prospective trial for previously untreated SqCC of TE in patients 80 years of age or older was performed. Patient eligibility criteria were: biopsy-proven squamous cell carcinoma; no evidence of tumor invasion of adjacent structures (cT1–3); no regional lymphadenopathy of more than 1 cm in maximum diameter (cN0); no evidence of distant metastasis (cM0); Zubrod performance status (PS) is 0∼2; no history of thoracic RT; no serious co-morbidities. Planned total dose was 66 Gy/33 fractions/6.5 weeks using external beam RT alone. Planning target volume was limited to the primary tumor with margin, and neither chemotherapy nor brachytherapy was combined. Primary endpoint was complete response rate. Results: From Jan 1999 to Dec 2002, 51 evaluable patients were enrolled from 22 institutions in Japan. There were 16 females and 35 males with median age of 83 years (80 ∼ 91y). PS was classified as 0 in 21 (41%), 1 in 25 (49%), and 2 in 5 (10%) patients. Eighteen patients (35%) had T1, 6 (12%) had T2, and 27 (53%) had T3 disease. RT was completed as planned in 47 (92%) patients with median overall treatment time of 49 days (43 ∼58 days). Three (6%) patients died of pulmonary complication during or immediately after RT, however, other acute adverse events were well tolerated. Complete response was achieved in 31 (61%) patients: 15/18 (83%) in T1; 3/6 (50%) in T2; 13/25 (52%) in T3. All patients were followed-up for ≥2 years and median survival time and actuarial overall survival rate at 2 years were 30 months and 53% (95% confidence interval, 39% ∼ 67%). Actuarial incidence of ≥Grade 3 cardiopulmonary complication was significantly correlated with size of RT field. Conclusion: RT alone for cT1–3N0 squamous cell carcinoma of the thoracic esophagus is effective with acceptable acute and late adverse effect. However, it was suggested that the planning target volume should be minimized in order to prevent cardiopulmonary complications. No significant financial relationships to disclose.
Epidemiology of the head and neck carcinoma of northern Portugal between 1986-2009.
Authors: A. F. Martins Ferreira Castro, M. P. Alves, I. Azevedo, J. D. Silva, H. Rodrigues
Journal: Journal of Clinical Oncology (2011)

e16035 Background: Few cancers translate functional and physical damage as severe as those of head and neck carcinomas (HNC). Whether the damage caused to the ability of speech, swallowing or breathing, or by changes to the image of the patient, or motivated by surgical mutilations often necessary (eg tracheostomy, nasogastric tube), probes that HNC has great personal and social impact. Methods: Epidemiological retrospective, not interventional, study. Data were obtained and collected retrospectively from crossing database from the cancer registry, the computer records and clinical files from patients. For survival, the cases were analyzed from date of diagnosis (up to December 2009) until the last available assessment. Descriptive analysis of data treatment and follow-up, which shows the absolute and relative frequencies of various neoplasms, stratified by year, diagnosis and stage. Results: From 7321 patients admitted between 1986 and 2009 with a diagnosis of HNC, there were 3889 deaths. The majority (35.6%) cases occurred in the pharynx, larynx followed (31.3%), oral cavity (25.2%), nasal cavity and sinuses (4.3%), and finally, salivary glands (3.6%). While among men the most important locations are the larynx and pharynx in women oral cavity and pharynx assume these positions. The survival analysis by Kaplan-Meier, stratifying patients by location and gender, showed statistically significant differences emerged between genders in HNC of the oral cavity, pharynx and salivary glands. Through a direct analysis, we noticed that our sample is representative of Portugal reality. The different incidence of HNC in both sexes, with regard to age group, shows that these cancers arise in women at older ages and in men at younger ages. Conclusions: The promotional campaigns, prevention and screening to detect early lesions are widely disseminated to diseases such as breast, cervical, colorectal and prostate cancer. We thought that more actions should be performed for public information, in order to do more earlier diagnosis of HNC, ensuring that treatments should had more curative intent and be less aggressive.