bluuebunny/crossref_metadata_2025_split huggingface dataset:
Risk for dose-limiting chemotherapy-induced peripheral neuropathy in black women with breast cancer.
Authors: Speck Rebecca M , Farrar John T , Sammel Mary D , Mao Jun J , Stineman Margaret G , Hennessy Sean , DeMichele Angela 
Published: March 2020

6560 Background: Chemotherapy induced peripheral neuropathy (CIPN) is a potentially dose-limiting toxicity. Recent data from early stage breast cancer clinical trials has suggested that black women are at increased risk for CIPN. We examined whether black race was a risk factor for dose-limiting CIPN events in a general academic practice. Methods: This retrospective cohort study included 260 women, (27.3% black) that received neoadjuvant or adjuvant paclitaxel for non-metastatic breast cancer. The primary outcome was a dose-limiting (DL) event (dose delay, dose reduction, or treatment discontinuation) attributed to CIPN (DL-CIPN). Cox proportional hazards models were used to analyze patient level and treatment level factors related to DL-CIPN. Survival time was represented by cumulative dose in milligrams of paclitaxel received. The final model included independent risk factors (p<0.05) of DL-CIPN and confounders that when adjusted for altered the crude estimate by 10% or more. Results: There were 39 DL-CIPN events; 5 were excluded from analyses for being a subsequent event. For the 34 DL-CIPN events, the median cumulative dose received at time of DL-CIPN event was 925 mg (range=256-1520 mg), which differed significantly (p<0.001) from the 188 women who had no dose-limiting event of any cause (median=1272, range=928-2136 mg). Black race was the only statistically significant independent risk factor for DL-CIPN. Compared to whites, black women had a greater than two-fold increased risk of DL-CIPN (HR=2.29, 95%CI=1.17-4.50). After adjusting for oncologist, menopausal status, obesity (BMI≥30), and regimen (80mg/m2 weekly for 12 cycles vs. 175mg/m2 bi-weekly for 4 cycles) the risk of DL-CIPN for blacks compared to whites was HR=3.35 (95%CI=1.54-7.28). Conclusions: Our findings contribute to the growing body of evidence that black race is associated with CIPN symptom onset and severity. Efforts to elucidate mechanisms, increase clinicians’ awareness of the greater susceptibility of black women to CIPN, and the development of symptom management strategies, effective in ensuring adequate adherence to chemotherapy, are crucial.
Uptake and disparities of neoadjuvant therapy for stage III non-small cell lung cancer.
Authors: Becker Daniel Jacob , Levy Benjamin Philip , Grossbard Michael L. 
Published: March 2020

6571 Background: The optimal use and sequence of radiation therapy (RT), chemotherapy, and surgery for patients with stage III non-small cell lung cancer (NSCLC) is unknown. We conducted a cross-sectional study using the Surveillance Epidemiology and End Results (SEER) population-based cancer registry to examine the relationship between year of diagnosis and receipt of neoadjuvant RT for patients with stage III NSCLC diagnosed in the United States from 2000 to 2008, with additional focus on the role of race and treatment location. Methods: Thirteen SEER registries were used for data analysis. Patients diagnosed with stage III NSCLC treated with both surgery and RT between the years 2000 and 2008 were included. We used multiple logistic regression to describe the relationship between type of therapy for lung cancer and year of diagnosis. Covariates identified for analysis included age, grade, sex, race, ethnicity, and SEER registry. Results: The total sample size was 393,711 of which 5,949 patients met our inclusion criteria. The cohort had a mean age of 64, was predominantly white (85.8%) and had predominantly high grade tumors (50.9%). Use of neoadjuvant RT for stage III NSCLC was lowest in 2000 and higher in every year from 2002 to 2008 (OR 1.325 in 2002, p= 0.035; 1.921 in 2007, p<0.0001). Substantial heterogeneity among registries existed, with more neoadjuvant RT use in Seattle and San Francisco-Oakland (OR 1.83, 1.698 p<0.0001 and 0.0002 respectively) and less use in Metropolitan Detroit, New Jersey and Louisiana (OR 0.754, 0.570, 0.493, p=0.25, <0.0001, and <0.0001 respectively). Black race was significantly associated with lack of neoadjuvant therapy without controlling for registry, but the association weakened after controlling for registry (OR 0.81, p=0.072). Conclusions: The use of neoadjuvant RT for stage III NSCLC substantially increased from 2000 to 2008. Location of treatment was strongly associated with receipt of neoadjuvant therapy and outweighed the association of race and therapy. The effort to equitably distribute care should focus additional study on the important role of regional and local medical culture in determination of medical care.
Achieving quality: Comparing recommendations for cancer care between NCCN and ESMO.
Authors: Gao Jennifer , Calkins Geoffrey , Birrer Michael J. , Dizon Don S. 
Published: March 2020

6579 Background: Guidelines for the treatment of cancer are in place in both the United States and Europe. However, specific recommendations that can be utilized as measures of quality care have not been evaluated in either guideline set, nor have they have been compared against one another. Our aim was to delineate the number of concrete treatment recommendations made using the PICO model for evidence-based medicine. Methods: Three authors (JG, GC, DD) independently reviewed treatment guidelines of the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) for three common cancers: 1) breast cancer; 2) colon cancer; 3) non-Hodgkin lymphoma (specifically diffuse large B-cell lymphoma and follicular lymphoma). The primary objective was to differentiate the concordant versus discordant recommendations. Recommendations were identified by first identifying all category 1 and 2 guidelines in ESMO, then finding the equivalent NCCN recommendations, and finally assessing their fulfillment of the PICO model (Patient/Problem – Intervention – Comparison – Outcome). Each recommendation was separately analyzed by the three aforementioned authors of this abstract. The results reflect the unanimous agreement of all three reporters. Results: Using PICO criteria, we identified a total of 46 recommendations (10 colon cancer, 22 breast cancer, and 14 in NHL). Concordance between NCCN and ESMO was 80, 86, and 100 percent, respectively. Discordance between NCCN and ESMO were noted in first line chemotherapy regimens in localized colon cancer and fluoropyridine as maintenance therapy in unresectable colon cancer; patients who should receive partial breast irradiation and chemotherapy regimens in the elderly with breast cancer. Conclusions: The number of actual recommendations that meet the PICO evidence-based medicine criteria is relatively small. However, comparing NCCN and ESMO, there is a high rate of agreement between guidelines reviewed regarding treatment recommendations. Our data suggest that it may be possible to identify specific measures of quality treatment as defined by evidence based medicine criteria.
A pilot study of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in a phase I clinical trial.
Authors: Qin Rui , Dueck Amylou C. , Satele Daniel , Molina Julian R. , Erlichman Charles , Basch Ethan M. , Sloan Jeff A. 
Published: March 2020

6587 Background: Recently the Patient-Reported Outcomes version of the CTCAE was developed to augment clinically graded adverse events with information reported directly by patients on clinical trials (Basch, 2009). The validation and potential application of PRO-CTCAE in phase I clinical trials are of great interest as toxicity is the primary endpoint. Methods: Selected PRO-CTCAE items (21 items measuring 12 symptomatic adverse events) corresponding to the major adverse events required to be graded clinically were collected in an ongoing phase I clinical trial of weekly cilengitide and paclitaxel in patients with advanced solid malignancies (NCT01276496). PRO-CTCAE was administered in a paper booklet by a clinical research associate prior to treatment on days 1, 8 and 15 of their regular visits. These PRO-CTCAE items were summarized descriptively in comparison to clinician-assessed CTCAE ver 4.0 (NCI, 2009) during the first cycle. As a pilot study to assess feasibility of PRO-CTCAE in phase I trials, PRO-CTCAE was not intended for determination of dose-limiting toxicity. Results: Twelve patients were accrued to two separate doses of cilengitide and paclitaxel. The median age was 56 (range 36—67) and half of patients were female. All patients had an ECOG performance score <= 1. Over 90% of patients had received prior surgery and chemotherapy. All but one patient completed weekly PRO-CTCAE during the first cycle, the only patient refused to complete weeks 2 and 3 did not give a reason. PRO-CTCAE captured most of the symptomatic adverse events reflected in clinician-assessed CTCAE. Some symptomatic adverse events were not reported clinically by CTCAE but were reported by patients by PRO-CTCAE. Overall, PRO-CTCAE items indicated slightly more severe degree of symptoms experienced by patients than those reported in CTCAE. Conclusions: This is the first study that PRO-CTCAE items were integrated within regular study visits in a phase I trial. The administration of PRO-CTCAE has been proved feasible and fruitful, providing consistent and enhanced symptomatic toxicity from the patient point of view. The addition of PRO-CTCAE did not significantly increase patient burden. Clinical trial information: NCT01276496.
How oncologists adhere to evidence-based G-CSF-guidelines to prevent febrile neutropenia: A sample survey in hospitals and practices in Germany.
Authors: Link Hartmut , Nietsch Josef , Kerkmann Markus , Ortner Petra Angelika ,   Supportive Care Working Group (ASORS) of the German Cancer Society (DKG)
Published: March 2020

6591 Background: Primary G-CSF prophylaxis after chemotherapy is recommended in evidence based guidelines (GL), if the risk of febrile neutropenia (FN) is high (≥20%), or intermediate (≥ 10% - 20%) in case of risk factors. The aim was to evaluate, if G-CSF is used as proposed by GL, to identify determinants of GL implementation and adherence. Methods: The sample size was calculated at 2% of the incidence of malignant lymphoma, breast and lung cancer in Germany. Pts who had received 3-9 cycles of chemotherapy with a FN risk ≥10% between 5/2011 to 4/2012 were documented retrospectively. Results: 286 lymphoma, 666 lung cancer and 976 breast cancer pts were collected from 87 hospitals and 59 oncology practices with 195 physicians participating. Adherence to GL was higher in physicians up to 10 than over 10 years of experience. Conclusions: The adherence to and acceptance of GL for G-CSF may not be sufficient. Patient risk factors are underestimated therefore resulting in a possible underuse of G-CSF. Physicians may underestimate FN risk in pts who have an intermediate risk of FN and they overestimate their adherence to the GL. [Table: see text]
Impact of cetuximab on chemoradiation use in older patients with locally advanced head and neck cancer.
Authors: Baxi Shrujal S. , Sherman Eric Jeffrey , Atoria Coral L , Lee Nancy Y. , Pfister David G. , Elkin Elena B. 
Published: March 2020

6594 Background: The benefit of chemoradiation (CTRT) in the treatment of locally advanced head and neck cancer (LAHNC) declines in older and sicker patients. In 2006, the FDA approved cetuximab in LAHNC. Cetuximab with radiation has a perceived lower side effect profile compared to standard chemotherapies used in CTRT. Our objective was to examine the impact of cetuximab on the use of CTRT in elderly patients with LAHNC. Methods: We identified adults aged 66 and older diagnosed with LAHNC between 1999 and 2007 in the Surveillance Epidemiology and End Results (SEER)-Medicare linked database. Treatment was categorized as CTRT or other based on Medicare claims within 6 months of diagnosis. We excluded patients who did not receive definitive treatment. In patients who had CTRT, we identified use of cetuximab based on drug-specific billing codes. We assessed trends in the use of CTRT over the entire study period and in the use of cetuximab since 2006. We examined the influence of age and comorbidity on the likelihood of receiving CTRT before and after 2006 adjusting for clinical and demographic factors. Results: We identified 4,809 patients with LAHNC. One-fourth were ≥80 years and almost a fifth had a Charlson comorbidity score (CCS) of ≥2. Overall more than 20% of patients received CTRT. The use of CTRT more than tripled over time, from 10% of patients diagnosed in 1999 to 38% in 2007 (p<0.0001 for trend). Of the 336 patients who had CTRT since 2006, 45% received cetuximab. Prior to 2006, patients ≥80 years or those with a CCS of ≥2 were significantly less likely to be treated with CTRT compared to younger patients or those with a CCS of 0. In patients diagnosed in 2006 or later, age and comorbidity no longer predicted the likelihood of receiving CTRT. Conclusions: In this population-based cohort of older adults, the use of CTRT increased substantially over time. The availability of cetuximab, with a perceived gentler side effect profile, may have increased the use of CTRT, especially in older and sicker patients. [Table: see text]
Survival of non-small cell lung cancer (NSCLC) patients with and without diabetes mellitus (DM): Findings from the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS).
Authors: Abu Hejleh Taher , Chrischilles Elizabeth A. , Pendergast Jane F , Porter Aaron T , Wallace Robert B ,   Cancer Care Outcomes Research and Surveillance Consortium (CanCORS)
Published: March 2020

6602 Background: DM increases all-cause mortality in the general population. It is also associated with more complications from chemotherapy, increased risk of radiation pneumonitis and worse surgical-wound healing. In this study, we explored the effect of DM on NSCLC overall survival. Methods: This study utilized the surveys and abstracted medical record resources of NSCLC patients studied by CanCORS, an inception cohort of newly diagnosed lung and colon cancer patients from the United States. Patients with NSCLC stage I-IV were included. The log-rank test was used to compare the survival curves of patients with and without DM. Cox proportional hazard models were used to adjust for other variables in the survival model. Results: Of the 2243 NSCLC patients, 359 (16%) had DM. Survival for patients diagnosed with DM was significantly worse than patients without DM [hazard ratio (HR) 1.28; 95% confidence interval (CI) 1.13-1.45]. The median overall survival for patients with and without DM was 561 and 833 days, respectively. DM was also associated with poorer survival (HR 1.20; 95% CI 1.05, 1.36) after adjusting for age, smoking status, stage, treatment (radiation, chemotherapy), brain metastasis, severity of respiratory symptoms at diagnosis, and comorbidities. While a significant interaction between stage and DM was not detectable after adjusting for the above, the estimated Kaplan-Meier plots present more prominent differences in stages I-III, with virtually overlapping plots in stage IV. Conclusions: DM was associated with worse survival in NSCLC patients. Although this finding can be utilized when counseling diabetic NSCLC patients, it is unknown if improving DM care will result in a better survival. The effect of DM on survival in the various stages of NSCLC needs further study.
Updated use of first-line chemotherapy for advanced pancreatic cancer: FOLFIRINOX versus gemcitabine.
Authors: Cartwright Thomas H. , Arlen Aimee Ginsburg , Wilfong Lalan S. , Harrell Robyn K. , Hoverman J. Russell , Beveridge Roy A. 
Published: March 2020

6607 Background: Pancreatic cancer (PC) is the fourth leading cause of death in the United States. It is estimated that 45,220 patients will be diagnosed in 2013 and 38,460 will die (Siegel, CA Cancer J Clin 2013). Gemcitabine has long been the standard of care chemotherapy. Recent advances in treatment created a combination regimen (oxaliplatin, irinotecan, leucovorin, fluorouracil [FOLFIRINOX]) for patients with good Karnofsky performance status (PS) (Conroy, NEJM 2011). This retrospective analysis was conducted as an update to results reported at ASCO 2012 (Ginsburg Arlen, JCO 2012) to evaluate characteristics and overall survival (OS) of patients receiving FOLFIRINOX and gemcitabine-based treatments in a large outpatient community setting. This is the largest study describing FOLFIRINOX patients to date. Methods: Patients with advanced PC treated within The US Oncology Network entered into the iKnowMed (iKM) database between June 2010 and November 2012 were included. Patterns of treatment were characterized by the median age at diagnosis, sex, PS, and first-line metastatic chemotherapy prescribed. The primary endpoints of the analysis were OS and uptake of FOLFIRINOX within the network. Results: Compared to ASCO 2012 results, 1,000 additional patients were identified in iKM. Of the 1,714 total patients, 24% received FOLFIRINOX (up from 13% in 2012) and 76% gemcitabine-based therapy (87% in 2012). Increased utilization of FOLFIRINOX for patients with good PS began in June 2010. For all patients (55% male), the median age at diagnosis was 67 years and the majority (85%) had a PS of 70% or greater. The OS was significantly longer for FOLFIRINOX (9.6 mos) versus gemcitabine (6.3 mos) (p<0.0001). This held true for PS of 70% or greater patient given FOLFIRINOX (9.6 mos) versus gemcitabine (7 mos) (p<0.0001). Conclusions: Utilization of FOLFIRINOX has continued to expand after the publication of phase III trials. Our data in a community setting supports a survival advantage for FOLFIRINOX. Although the magnitude of benefit may be smaller in the community, we agree that FOLFIRINOX should become a standard of care for good PS patients.
Impact of center case volume on cardiotoxicity during adjuvant trastuzumab in breast cancer.
Authors: Chin-Yee Nicolas J. , Yan Andrew , Tomlinson George A. , Earle Craig , Trudeau Maureen E. , Krahn Murray , Ko Dennis , Krzyzanowska Monika , Pal Raveen , Brezden Christine B. , Chan Kelvin K. 
Published: March 2020

6625 Background: A recent study suggested that cardiotoxicity from trastuzumab (T) was associated with regional variation and insufficient cardiac monitoring (Ng et al.SABCS 2012). Few studies have examined the impact of centre or physician (MD) case volume (vol) on outcomes in systemic therapy. Methods: All breast cancer patients who were diagnosed in 2003-2009 in Ontario and treated with adjuvant T were identified through a provincial drug funding program, and linked to administrative databases to ascertain patient demographics, hospitalizations, cardiac risk factors, cardiac imaging, comorbidities, and treating centre and MD. For each year, we calculated case vol as the number of patients treated with adjuvant T by each MD and by each centre. Cardiotoxicity was defined as receiving less than 16 out of 18 doses of T because of heart failure (HF) admission, HF diagnosis by physician claims, or discontinuation after cardiac imaging. Insufficient cardiac monitoring was defined as per recent guideline and per Ng et al. Logistic regression and mixed models were constructed to examine factors associated with cardiotoxicity. Results: Our cohort consisted of 3,777 patients, 214 MDs and 68 centres. For patients, 16.5% were over age 65; 30.3%, 9.4%, and 1.2% had previous diagnoses of hypertension, diabetes, and HF, respectively; 16.9% had cardiotoxicity. Univariate analyses found that high centre vol, but not MD vol, was associated with lower cardiotoxicity. Cardiotoxicity rates by centre vol quintiles (Q) were 23.4% (Q1-3), 18.2% (Q4), and 15.2% (Q5). Multivariable analyses found that lower cardiotoxicity was associated with higher centre vol (OR=0.85 per Q, p=0.02) and diagnosis in recent years (2008-2009 vs. before 2008; OR=0.50, p<0.001), after adjusting for age, previous HF, comorbidities, regional variation, and cardiac monitoring. Accounting for clustering within centres, there remained a strong trend of lower cardiotoxicity with higher centre vol (OR=0.77 per Q, p=0.06) and recent diagnosis (OR=0.50, p<0.001). Conclusions: Our findings suggest a reduction in cardiotoxicity with experience and over time, and support the notion of centralization of systemic therapy in high vol centres to optimize outcomes.
Effect of breakthrough pain on functional status, pain interference, and disability in cancer patients: Findings from the national breakthrough pain survey.
Authors: Narayana Arvind , Katz Nathaniel , Shillington Alicia , Stephenson Judith J , Frye Carla B , Portenoy Russell 
Published: March 2020

6627 Background: Few studies have evaluated the epidemiology of breakthrough pain (BTP) in community-dwelling populations with cancer and chronic pain. The National Breakthrough Pain Survey (NBTPS) assessed the prevalence, characteristics, and impact of BTP in a large commercially-insured population and determined the BTP-associated functional impairments and disability in cancer patients with controlled, persistent pain. Methods: Administrative claims from the HealthCore Integrated Research Database were utilized to identify commercially-insured adult patients with ≥2 medical claims at an interval ≥3 months with an ICD-9-CM code indicating a chronic pain condition (cancer or noncancer) and ≥3 opioid prescription claims. Patients were called and, after consent, completed the Brief Pain Inventory (BPI), Sheehan Disability Scale (SDS), and 12-Item Short-Form Health Survey (SF-12) by interview. Data from patients with cancer and controlled, persistent pain were included in this subanalysis. Results: Of 2198 patients surveyed, 1279 had controlled, persistent pain. Of these, 145 had cancer pain, 77.2% of whom reported BTP (BTP, 112; no BTP, 33). Compared to those without BTP, cancer patients with BTP had significantly higher total BPI pain interference scores (mean±SD 34.7±14.5 vs 23.4±16.7, P=.001) and significantly greater global functional impairment on the SDS (mean±SD 16.8±8.3 vs 12.4±8.3, P=.028). There also was a non-significant finding of decreased quality of life, as assessed by SF-12 physical and mental component scale scores, among cancer patients with BTP vs no BTP (mean±SD 27.8±9.1 vs 32.2±10.1, P=.11, and 47.0±11.9 vs 49.4±11.6, P=1.0, respectively). Conclusions: In a sample of commercially-insured patients, cancer patients with controlled, persistent pain and BTP had greater pain-related functional impairments and disability than those with controlled, persistent pain and no BTP. These data suggest that BTP is clinically important among populations receiving cancer care in the community.