bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of hormone receptor (HR) status on clinicopathological features, patterns of recurrence, and clinical outcomes among patients (pts) with human epidermal growth factor receptor-2 positive (HER2) breast cancer (BC) in the National Comprehensive Cancer Network (NCCN).
Authors: Luis Ines Maria Vaz Duarte , Ottesen Rebecca A , Hughes Melissa E , Marcom P. Kelly , Moy Beverly , Rugo Hope S. , Theriault Richard L. , Wilson John , Niland Joyce C. , Weeks Jane C. , Lin Nancy U.
Published: March 2020

599

Background: According to gene expression profiling, HER2+ BC is heterogeneous and appears to diverge by HR status. Methods: We evaluated 3394 pts who presented to NCCN centers with stage I-III HER2+ BC between 2000-07. Pts were classified as HR+ (ER+ and/or PR+) and HR- (ER- and PR-). Chi-square, univariate logistic regression, log-rank test, and Cox hazard proportional regression were used for analysis. Results: Median follow-up was 51 months. 59% of patients had HR+ and 41% HR- disease respectively. Pts with HR- BC were more likely to be postmenopausal and to present with higher stage and high grade disease (p<0.001). Most pts received adjuvant or neoadjuvant therapy; 44% received adjuvant trastuzumab. Recurrences were recorded for 458 pts. HR- patients were more likely to recur first in the central nervous system (CNS) (OR: 1.8, 95% CI: 1.1, 2.9; p= 0.03) and less likely to recur in bone (OR: 0.5, 95% CI: 0.3, 0.8; p<0.01). No differences in risk of lung or liver recurrence were observed. Combining first and subsequent sites of recurrence, the difference in CNS involvement was lost (p=0.107) but HR- were more likely to experience lung involvement (OR: 1.5, 95% CI: 1.0, 2.2; p= 0.05). After adjusting for age, year of diagnosis (y), race, stage, and grade, HR- had worse survival after initial BC diagnosis than HR+ pts (Hazard Ratio of death [HRd] 1.4, 95% CI: 1.14, 1.7; p<0.01). However, the risk of death was not proportional over time with HR- having significantly increased hazard in the first five years: HRd 0-2 y 1.9 [1.3, 2.9]; p< 0.01; HRd 2-5y 1.5, [1.2, 2.0]; p<0.01; HRd 5+ y, 0.8, [ 0.6, 1.2], p=0.29. Conclusions: Clinicopathological features, sites of recurrence, and risk of death over time for HER2+ BC differed by HR status. This suggests that HR status in HER2+ BC is clinically relevant. These differences should be further explored from a mechanistic and therapeutic standpoint.
Cancer patient acceptance, understanding, and willingness to pay for pharmacogenetic testing (PGT).
Authors: Hon Henrique , Qiu Xin , Tobros Kimberly , Wong Chung-Kwun Amy , De Souza Bradley , McFarlane Graham , Masroor Sohaib , Azad Abul Kalam , Hasani Ekta , Rozanec Natalie , Leighl Natasha B. , Alibhai Shabbir M.H. , Xu Wei , Issa Amalia M. , Liu Geoffrey , Cuffe Sinead
Published: March 2020

6005

Background: PGT offers the potential to improve cancer therapy through the use of specialized tests that can predict the level of efficacy and/or toxicity of specific treatments in an individual. However, there is currently little knowledge concerning cancer patient attitudes towards such testing in the clinical setting. Methods: We interviewed a broad cross-section of 278 cancer patients (20% lung, 19% breast, 20% colorectal, 40% other) using hypothetical time, efficacy, toxicity and willingness-to-pay trade-off PGT scenarios. Results: 153 potentially curable patients and 125 incurable patients received a separate series of trade-off scenarios. For curative patients, 70% accepted chemo that had a 5% absolute improvement in cure rate and <5% of severe toxicity. Of these, 99% wanted PGT where the test identifies a subset of patients benefiting from chemo; the same individuals were willing to pay a median $2,000 (range: $0-25,000) for PGT and would accept a median wait time for PGT results of 21 days (0-90). Patient preferences were insensitive to variation of fractions of individuals carrying the genetics associated with lack of benefit. In the incurable scenario, 90% of patients accepted palliative chemo with an 80% response rate and a severe side effect rate of 5%. Of these, 98% wanted PGT, where there test identifies individuals at highest risk of severe toxicity; the same individuals were willing to pay a median $1,000 ($0-15,000) for PGT, and would accept PGT turnaround times of 14 days (1-90). Patient preferences were insensitive to variation of fractions of individuals carrying the genetics associated with severe toxicity. The majority of patients (76% adjuvant; 87% metastatic) wanted to be involved in decision making regarding PGT; however, one in five patients (20% adjuvant; 22% metastatic) admitted that they lacked a basic understanding of what PGT means and its clinical implications. Conclusions: Among cancer patients willing to undergo chemo, almost all wanted PGT and were willing to pay for it, waiting several weeks for results. While patients had a strong desire to be involved in decision making for PGT, a considerable proportion lacked the necessary knowledge to make informed choices.
A comparison of primary care providers’ and oncologists’ preferences for different models of cancer survivorship care.
Authors: Cheung Winson Y. , Noone Anne Michelle , Aziz Noreen , Rowland Julia Howe , Potosky Arnold L. , Ayanian John , Virgo Katherine S. , Ganz Patricia A. , Stefanek Michael Edward , Earle Craig
Published: March 2020

6006

Background: There is increasing interest in developing more efficient and effective strategies for coordinating and delivering cancer and non-cancer related follow-up care to survivors. The objectives of this nationwide survey were to describe and compare US physician preferences for different cancer survivorship care models. Methods: The Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) was mailed to PCPs and oncologists in order to evaluate their views regarding physician responsibilities, knowledge levels about survivorship, and cancer follow-up testing. Using weighted univariate and multivariate models, we analyzed PCPs’ and oncologists’ preferences for different cancer survivorship care models (PCP/shared vs. oncologist vs. non-physician provider) and examined how physician attitudes towards and self-efficacy with their own skills during breast and colorectal cancer follow-up affected these preferences. Results: Of 3,434 physicians surveyed, 2,202 (64%) responded of whom 2,026 (59%) provided eligible outcomes for this study: 938 (46%) PCPs and 1,088 (54%) oncologists. In unadjusted analyses, most PCPs (51%) supported a PCP/shared care system whereas the majority of specialists (59%) strongly endorsed an oncologist-based model (p<0.001). A number of PCPs and oncologists (23% for both) preferred to involve non-physician providers. A significant proportion of cancer specialists (87%) did not feel that PCPs can take on the primary role for cancer follow-up. Many PCPs believed that they have the skills to perform breast and colorectal cancer follow-up (57%), detect recurrent cancers (74%), and offer psychosocial support (50%), but only a minority (32%) were willing to assume exclusive responsibility. In adjusted analyses, PCPs already involved with cancer surveillance (43%) were more likely to prefer a PCP/shared care system than an oncologist-based survivorship care model (OR 2.08, 95%CI 1.34-3.23, p<0.001). Conclusions: PCPs and oncologists have different preferences for models of cancer survivorship care. Prior involvement with cancer follow-up was one of the strongest predictors of PCPs' willingness to assume this responsibility.
Insurance status and cancer disparities in adolescents and young adults age 15 to 39: National Cancer Data Base, 1998-2003.
Authors: Robbins Anthony , Lerro Catherine C. , Barr Ronald
Published: March 2020

6011

Background: Since the mid-1970s there has been little progress in improving cancer survival for adolescents and young adults (AYAs, defined by the National Cancer Institute as individuals 15 to 39 years of age), in contrast to the substantial improvements for children and older adults. The association between insurance status and cancer disparities (stage at diagnosis, survival, and treatment) in AYA patients has not been examined in a national sample. Methods: The National Cancer Data Base, a national hospital-based cancer registry, was used to examine insurance status and cancer disparities in 177,359 AYA cancer patients. Cases were diagnosed during 1998−2003 and followed for vital status through 2008. We examined the association between insurance status and stage at diagnosis, stage-specific survival, and receipt of the most frequently used stage-specific treatments for common AYA sites (thyroid, female breast, non-Hodgkin lymphoma, and acute myeloid leukemia). Results: Insurance status was strongly related to cancer disparities in AYA patients. For example, compared to patients with private insurance, uninsured patients were 1.71 times more likely to be diagnosed at stage IV (95% confidence interval [CI], 1.63−1.79), had higher risk of death within every stage [stage I, hazard ratio (HR) (95% CI), 2.43 (2.13−2.76); stage II, 1.87 (1.70−2.06); stage III, 1.55 (1.43−1.68); stage IV, 1.39 (1.31−1.48); and unstaged (leukemias, CNS tumors, etc.), 1.67 (1.58−1.76), and for the four sites listed above, were less likely to receive the most frequently used stage-specific treatments. Insurance status remained a strong independent predictor for each of these outcomes in multivariate models adjusting for patient, hospital, and tumor factors. Conclusions: In a large national sample, insurance status was a strong independent predictor of cancer disparities in AYA patients. The Affordable Care Act of 2010 should facilitate the acquisition of adequate health insurance by AYA, who are the most under- and uninsured age group in the US population, and should contribute to remediation of such disparities.
Racial differences in the impact of financial hardship on the intensity of end-of-life cancer care.
Authors: Tucker-Seeley Reginald D , Abel Gregory Alan , Prigerson Holly Gwen
Published: March 2020

6012

Background: Research suggests that Black cancer patients have higher end-of-life (EOL) medical costs than White patients; and that Black, compared with White, families are more likely to use all or most of their savings to pay for EOL care. Although Black cancer patients receive more intense EOL care than Whites, research has yet to determine the effect of financial hardship on receipt of intensive EOL care, and whether the effect varies by the patient’s race. Methods: Coping with Cancer (CwC) is a longitudinal, multi-site cohort study of advanced cancer patients and their informal caregivers recruited from September 2002-February 2008. CwC was designed to investigate Black/White differences in EOL care. The purpose of this analysis was to determine the association between baseline financial hardship and receipt of intensive EOL care in the last week of life (CwC deceased cohort N=342), and to identify racial differences in this association. Financial hardship was defined as whether the household had to use all or most of their savings due to the family member’s illness (response =yes/no). Intensive EOL care was defined as the receipt of ventilation or resuscitation in the last week of life assessed by medical record review and patient’s caregiver. Results: Patients reporting financial hardship had higher odds of receiving intensive EOL care (OR = 2.83, CI: 1.33, 6.05). After adjusting for socio-demographic characteristics the significant association remained (OR = 2.55, CI: 1.13, 5.81). Race-stratified fully adjusted models revealed no statistically significant association between financial hardship and intensive EOL care for Whites; however, for Blacks, those reporting financial hardship had over five times higher odds of receiving intensive EOL care (OR = 5.21, CI: 1.51, 17.99) compared to those not reporting financial hardship. Conclusions: Financial hardship was associated with greater likelihood of receiving intensive EOL care. The intensity of EOL care received by White patients was insensitive to financial hardship; in contrast Black patients reporting depletion of life savings for cancer care were much more likely to die receiving intensive EOL care than their non-financially strained counterparts.
Toxicity of chemotherapy dosing using actual body weight in obese versus normal-weight patients: A systematic review and meta-analysis.
Authors: Hourdequin Kathryn Cunningham , Schpero William Lewis , Piazik Breanne Lee , McKenna Dorothy R , Larson Robin Joyce
Published: March 2020

6013

Background: Because weight-based chemotherapy calculations can be very large in obese patients, oncologists often empirically reduce doses due to fear of excess toxicity. The resulting underdosing may negatively impact survival. We performed a systematic review and meta-analysis to determine whether, among adults receiving chemotherapy dosed by actual body weight (ABW), obese patients experience differing toxicity or survival compared to normal-weight patients. Methods: We searched MEDLINE, Cochrane Library, Web of Science, and ClinicalTrials.gov through October 2011 and reviewed reference lists. We included studies that compared outcomes of obese versus normal-weight adults receiving chemotherapy dosed according to ABW (+/- 5% variability). Studies followed subjects for at least one cycle of chemotherapy and reported at least one pre-specified outcome. Two authors independently abstracted data from eligible studies. We used random effects models to pool odds ratios (OR) for hematologic and non-hematologic toxicities. We summarized survival qualitatively. Results: Of 3,921 studies, five met inclusion criteria, for a total of 6,877 subjects. Based on three studies, Grade 3/4 hematologic toxicity occurred less often in obese patients than normal-weight patients (OR 0.68, 95% CI 0.51-0.89, I2=29%). A fourth study comparing leukocyte nadirs had variable results depending on the regimen, dosing, and patient co-morbidities. Based on two studies, Grade 3/4 non-hematologic toxicity occurred less often in obese patients than normal-weight patients (OR 0.74, 95% CI 0.63-0.87, I2=0%). A third study found rates of infection did not significantly differ. Three of four studies reported reduced overall survival in obese patients (statistical significance not reported). Conclusions: Contrary to common belief, obese patients receiving chemotherapy based on ABW appear to have lower rates of both hematologic and non-hematologic toxicities compared to normal-weight patients. These results do not support the practice of empiric dose reduction in obese patients. Further research should explore etiologies for the reduced survival in this group.
Use of palliative chemotherapy and targeted agents in elderly patients with metastatic colorectal cancer (mCRC).
Authors: Chan Matthew , Renouf Daniel John , Speers Caroline , Cheung Winson Y.
Published: March 2020

6018

Background: Elderly patients are increasingly diagnosed with advanced cancers, but they are consistently underrepresented in clinical trials, which may lead to undertreatment. Our aims were to 1) evaluate the impact of advanced age on patterns of first-line chemotherapy and bevacizumab use in mCRC, 2) examine the reasons for treatment choices and 3) compare adverse events and treatment discontinuations in elderly vs young patients. Methods: A random sample of mCRC patients diagnosed from 2006 to 2007 and referred to any 1 of 5 regional cancer centers in British Columbia, Canada was reviewed. Summary statistics were used to describe treatment patterns between the elderly (>/=70 years) and young (<70 years). Cox regression was used to determine the effect of systemic therapy on overall survival, controlling for age and confounders. Results: We identified 800 patients: 43% elderly and 57% young; 56% men; and 26 / 36 / 38% ECOG 0 / 1 / 2+, respectively. Fewer elderly patients were given chemotherapy (52% vs 79%, p<0.001). Among those treated, most common first-line palliative regimens for elderly vs young included: capecitabine (50 vs 15%), FOLFIRI (26 vs 38%), and FOLFOX (15 vs 37%) (all p<0.001). Those aged >/=70 were also less likely to receive bevacizumab in their regimens (22 vs 50%, p<0.001). The most frequent reasons for no systemic therapy were similar between age groups: patient choice (31 vs 28%), poor ECOG (16 vs 17%), and significant co-morbidity (11 vs 13%). Risk of chemotherapy (p=0.30) and bevacizumab (p=0.39) adverse events were comparable between elderly and young as were rates of early chemotherapy (p=0.07) and bevacizumab (p=0.79) discontinuation. Receipt of systemic therapy +/- bevacizumab was associated with improved survival from mCRC (HR for death 0.50, 95% CI 0.31-0.62, p<0.001), regardless of advanced age (p interaction for age and treatment = 0.33). Conclusions: Elderly patients with mCRC are more likely to receive no chemotherapy, capecitabine monotherapy, or a regimen without bevacizumab. However, in carefully selected elderly patients, adverse events, treatment discontinuations, and overall survival benefit from treatment appear similar to those observed for younger patients.
Bias in reporting of endpoints of efficacy and toxicity in randomized clinical trials (RCTs) for women with breast cancer (BC).
Authors: Vera Badillo Francisco Emilio , Shapiro Roman , Ocana Alberto , Amir Eitan , Tannock Ian
Published: March 2020

6043

Background: Phase III RCTs are designed to assess clinically important differences in endpoints that reflect benefit to patients. Accurate and unbiased reporting is essential to guide rational therapy. Here we evaluate the quality of reporting of the primary endpoint (PE) and of toxicity in RCTs for BC. Methods: PUBMED was searched from 1995-2011 to identify RCTs for BC. Scales for assessing bias in reporting of the PE and of toxicity were developed. For the PE, scales assessed whether the concluding statement of the abstract (CSAbs) was (a) based on the PE, (b) described appropriately a statistically positive or negative result for the PE, or (c) was based on secondary endpoints. Bias and completeness of reporting of toxicity was assessed using a hierarchy scale of whether reporting occurred in the CSAbs, elsewhere in the abstract, in the discussion of the article or only in the results. Association of bias with Journal Impact Factor (JIF); changes in the PE compared to protocol information in clinicaltrials.gov and funding source was also evaluated. Results: 164 trials were evaluated; 33% showed bias in reporting of the PE. The PE was more likely to be reported in the CSAbs if statistically significant [OR 5.2, 95% CI 1.9-14.3, p=0.001]. A statistically negative PE was not reported in the CSAbs in 27% of trials. Of the 30 trials where protocol information was available in clinicaltrials.gov, there were non-significant associations for the PE to show a positive result if had been changed, and for greater bias in reporting the PE if it was unchanged. 67% of studies showed bias in reporting of toxicity. Only 14% mentioned toxicity in CSAbs. When the PE was positive, bias in reporting of toxicity was more common [OR 2.0, 95% CI 1.0-3.9, p=0.04]. There was no apparent association between bias in reporting of either the PE or toxicity and JIF or funding source, but a non-significant association between change in the PE and industry funding. Conclusions: Bias in reporting of the PE is common especially for studies with a negative PE. Reporting of toxicity is poor especially for studies with a positive PE. Changing of the PE appears to be a strategy to increase the likelihood of observing a statistically significant result.
Treatment and treatment outcomes of advanced NSCLC patients in routine clinical care: Results of the retrospective LUCEOR study.
Authors: Agulnik Jason Scott , Chouaid Christos , Herder Judith , Ziske Carsten , Mitchell Paul , Vansteenkiste Johan F. , Eriksson Jennifer , Finnern Henrik W. , Lungershausen Juliane , Lester Jason ,   LUCEOR Study Group
Published: March 2020

6058

Background: Although NSCLC is the most common type of lung cancer, published data on both treatment patterns and outcomes in routine clinical care are scarce. Collecting this data systematically across countries will help to understand, compare and improve patient care. Methods: 1,490 patient charts were reviewed retrospectively from 40 sites in Australia, Belgium, Canada, France, Germany, Italy, Sweden, Turkey, the Netherlands and the UK, 1436 of those evaluable. Patients deceased before April 2010 were eligible if ≥18 years, diagnosed with advanced stage IIIb/IV NSCLC and had received active 1st line anti-cancer treatment. Demographic data, disease and, treatment history and resource use were collected from start of first line treatment until death. Results: Mean age at NSCLC diagnosis was 64 years [SD=10.6], 67% of patients had stage IV disease at diagnosis and 66% were male. Confirmed tumor histology was adenocarcinoma in 50% of patients, squamous and large cell carcinoma in 23% and 14%, respectively. Tumour histology was not available in 13% of patients. Mean number of treatment lines was 1.7 [range 1-8]. Biomarker analysis was performed in 19% of patients (of those 26% and 13% tested for EGFR and KRAS mutation, respectively) within less than one month of diagnosis. 1st line therapy included mainly platinum doublets (86%, mostly carboplatine/gemcitabine [23%]), 2nd line included erlotinib (35%) and pemetrexed (18%), and 3rd line included erlotinib (38%) and docetaxel (17%). Most treated patients had ECOG performance status of 1. Stable disease (based on RECIST) was highest during 1st line therapy with 30%. Median PFS from start of 1st line treatment was 3.8 months [SD=7.1], with a median OS of 7.1 months [SD=11.6]. Conclusions: The majority of patients were diagnosed with an adenocarcinoma and a number of patients were tested for EGFR or KRAS mutation. Overall treatment outcomes observed in routine care seem lower than those observed in clinical trials. Also current therapeutic options for NSCLC seem to provide limited clinical benefit, underpinning the need for new treatment alternatives to prolong PFS and OS.
The use of the word “cure” in oncology.
Authors: Miller Kenneth David , Abraham Joseph , Joshi Brijen L
Published: March 2020

6067

Background: Use of the word “cure” in cancer care reflects a balance of physician and patient optimism, realism, medico-legal concerns, and even superstition. The purpose of this study was to survey a group of clinicians regarding the frequency and determinants of using the word “cure” in their practice. Methods: In 2011, 180 oncology clinicians at the Dana-Farber Cancer Institute were invited to complete a survey regarding the word “cure” in cancer care. Participants completed a 19 question survey regarding how commonly their patients are cured, how often they use the word cure, in what circumstances they would tell a patient that they are cured, the timing of telling a patient that they are cured, and hesitancy in using the word cure. Three patient case scenarios were presented to elicit participants’ views regarding whether patients were cured and whether they need continued follow-up. Results: The 117 participants who provided answers to the cure questions (65% of the original 180 invitees), were evenly divided between males and females,73% were medical doctors, and 56% had 10 or more years of experience since their training. Eighty-one percent of respondents were hesitant to tell a patient that they are cured and 63% would never tell a patient that they are cured. Only 7% feel that greater than 75% of their patients are, or will be, cured. This varied significantly by subspecialty (p<0.001). The participating clinicians reported that only 34% (sd: 30%) of patients ask if they are cured. In considering 20-year survivors of seminoma, large cell lymphoma, and estrogen positive breast cancer, 81%, 73%, and 47% of clinicians, respectively, believed that the patients were cured and 33%, 38%, and 52% recommended annual oncology follow-up of the patients. Twenty-three percent of clinicians believed that patients should never be discharged from the cancer center. Conclusions: Oncologists report that patients are hesitant to ask whether they are cured, and the clinicians are hesitant to tell, although this varied by cancer subspecialty. Annual oncology follow-up was frequently endorsed, even after 20 years in remission.
Correlation of quantitative p95HER2 and HER2 protein expression with pathologic complete response (pCR) in HER2-positive breast cancer patients (pts) treated with neoadjuvant (NEO) trastuzumab-containing therapy.
Authors: Villasboas Jose Caetano , Hurley Judith , Weidler Jodi Marie , Paquet Agnes , Fernandez Carmen Gomez , Cioffi Lavina Maureen , Sperinde Jeff , Chenna Ahmed , Haddad Mojgan , Lie Yolanda , Winslow John William , Huang Weidong , Petropoulos Christos J. , Pegram Mark D.
Published: March 2020

608

Background: Elevated p95 [HER2-M611-CTF (carboxy-terminal-fragment) also known as p110 or p95HER2] expression has been correlated with poor outcomes in HER2+ pts with metastatic breast cancer treated with trastuzumab (T); however, limited data have been presented on the correlation between p95 and pCR to T in the NEO setting, where p95 was measured by immunohistochemistry. In the current study, we sought to determine whether quantitative p95 and HER2 expression correlated with pCR in pts treated with T + chemotherapy in the NEO setting. Methods: HER2 expression (H2T) was quantified by HERmark in 47 breast tumors using formalin-fixed, paraffin-embedded sections. Tissue remained in 40 cases to measure p95 by VeraTag and compare to a previously published cutoff (Clin Cancer Res 16:4226, 2010). pCR data were available for 45 cases. pCR was defined as the absence of invasive disease in the breast. Results: The overall pCR rate was 46.7% (ER+: 14.3% vs. ER-: 75%; Wilcoxon rank p<0.0001) and was significantly associated with higher H2T levels (p=0.02). In ER- subjects (N=24), no difference in H2T levels was observed between pCR vs non-pCR groups [median H2T=111.5 (IQR 63.4-162.2) vs 150.5 (IQR 43 – 226.2), respectively; p=0.721]. However, within the ER+ group (N=21), H2T levels were significantly higher in the pCR group vs non-pCR group [median H2T=254 (IQR 181.5-584.5) vs 37.3 (IQR 16.4-89); p=0.024]. Using multivariate logistic regression, increasing log(H2T) (p = 0.011), ER-negativity (p = 0.027) and low p95 (p = 0.074) were found to correlate or trend with pCR. Conclusions: pCR was significantly associated with high H2T expression in ER+ HER2+ breast cancer pts who received NEO therapy with T + chemotherapy. A trend towards pCR was seen in tumors that had low p95. These data suggest that quantitative H2T and p95 may provide additional information on response to T-based regimens in breast cancer, particularly ER+ breast cancer. Additional investigation into the possible relationship between quantitative levels of HER2 and p95 expression and T response in the NEO setting in larger cohorts is warranted.
Does drug cost drive drug adherence? The designer drug phenomenon.
Authors: Ebrahim Jalal , Han Dolly , Hogeveen Sophie , Trinkaus Martina , Fadhel Ehab , Hon Henrique , Kassam Zahra , Liu Geoffrey , Simmons Christine E.
Published: March 2020

6084

Background: Cancer patients (pts) are on many medications, both for malignancy and supportive therapies. The cost of oral medications are funded by either the pt, public, or private mechanisms. Low adherence rates are observed in oral treatments, and non-adherence is the primary cause of treatment failures. To our knowledge, cost-related adherence to oral therapy in the context of malignancy has not been studied extensively in the existing literature. We assessed the relationships between oral medication costs and adherence rates. Methods: This cohort study enrolled 453 pts at 3 outpatient heme/onc clinics in the Greater Toronto Area. A 7-item survey was designed to assess pt demographics, self-reported adherence to oral medication, type of drug coverage (private payer, public payer, self payer) and patients' perceived cost of oral drugs. Oral medications were recorded and actual monthly costs were calculated. Descriptive statistics were used to describe frequencies. Spearman Rank Order Correlations and Chi-Square Analyses were used to examine relationships between variables. Results: Of 453 pts, 50% had a private drug plan, 24% paid out of pocket, 44% had government funding and 4% reported their physician had arranged funding. 51% of pts had oral drug costs of ≥ $100/month. Self reported adherence to prescribed oral medications was 80%. As the cost of prescribed medications increased, so did self reported adherence (r=0.144, p=0.002). There was also a significant relationship between drug coverage and oral drug costs (c²=23.78, df=12, p=0.02). Pts paying out of pocket were significantly less likely than all other pts to have oral drug costs of ≥$500/month (11% vs 19%) Conclusions: As oral drug costs increase, so does likelihood of adhering to prescribed regimen. This implies that further pt education about the efficacy and importance of medications may help with adherence, regardless of cost. It is possible that pts are provided with more education regarding newer and more expensive agents than they are regarding older and cheaper agents, regardless of efficacy. Disparities observed in medication costs between those with private drug plans vs. those without suggests financial restrictions may affect prescription patterns in this group.
Involvement of low- and middle-income countries (LMCs) in oncology randomized controlled trials (RCTs).
Authors: Wong Janice C. , Fernandes Kimberly A. , Amin Shubarna , Lwin Zarnie , Krzyzanowska Monika K.
Published: March 2020

6087

Background: Lower costs and fewer regulatory barriers make clinical trials in LMCs attractive, but little is known about characteristics of such trials and roles of investigators from LMCs. We describe trends in participation of investigators from LMCs in oncology RCTs over a decade. Methods: We used Medline to identify all RCTs published in English between January 1 1998 and December 31 2008 evaluating treatment in five solid tumours (lung, breast, colorectal, stomach, liver) with high mortality in LMCs as per GLOBOCAN 2002. Data on author affiliations and roles (first, middle or corresponding author), trial characteristics, funding and study interventions were abstracted using an electronic form. Countries were stratified into low-, middle- and high-income using World Bank data. Interventions were categorized as requiring basic, limited, enhanced or maximal resources as per the Breast Health Global Initiative classification. Logistic regression identified factors associated with investigator participation from LMCs. Results: 454 trials were identified: lung (n=177), breast (n=165), colorectal (n=82), stomach (n=29), liver (n=7). The annual number of trials published increased from 10 trials in 1998 to 86 in 2008. The proportion of trials with at least one LMC author also increased over time from 20% in 1998 to 29% in 2008 (p=0.01), but almost all LMC authors were from middle-income countries. In 17% of trials involving LMC authors, they were first or corresponding authors. 67% of trials involving LMC investigators evaluated interventions requiring enhanced or maximal resources for implementation. Factors associated with LMC participation included industry funding (OR=3.57, p<0.0001), use of placebo arm (OR=2.59, p=0.02) and metastatic setting (OR=3.87, p=0.0003). Conclusions: An increasing number of oncology RCTs involve LMC investigators primarily in non-leadership roles. These trials are commonly industry-funded and often test interventions that require at least enhanced resources for implementation. To minimize concerns of exploitation and facilitate future collaboration it is crucial that interventions are locally feasible and investigators receive appropriate authorship.
Recruitment of cancer patients to National Institute for Health research cancer research network portfolio studies between 2001 and 2011.
Authors: Cooper Matthew , Poole Karen , Cameron David A. , Haward Robert , Selby Peter John , Kaplan Richard S. , Parmar Mahesh , Moser Rachel , Seymour Matthew T.
Published: March 2020

6091

Background: The National Institute for Health Research Cancer Research Network (NCRN) was established in 2001 in England, United Kingdom to improve cancer patient outcomes by improving the coordination, integration and speed of cancer research. Methods: Baseline recruitment of cancer patients in England to clinical studies was around 4% of incident population. Research Networks were established initially in England (NCRN) and then across the UK, co-terminus with clinical cancer service networks, and a per capita based funding model used to provide a research infrastructure to support recruitment to a nationally defined research portfolio. Results: Within 3 years, as the networks were established, recruitment of patients to studies doubled from 10,000 to 20,000 cancer patients per year. Recruitment has continued to increase year on year, supported initially by underspend that had accrued from earlier years in the life of NCRN, and more recently from additional resources invested via the NIHR comprehensive networks. Data for 2010/11 show that over 45,000 cancer patients are now recruited into portfolio studies in England each year, with over 50,000 across the whole of the UK. Conclusions: Dedicated, targeted, clinician-led National Health Service investment into supporting national portfolio studies, has delivered an unprecedented five-fold increase in recruitment of cancer patients into clinical trials across the United Kingdom. This required coordinated research infrastructure, close cooperation with research funders, particularly Cancer Research UK and the National Cancer Research Institute, and the enthusiasm and hard work of many clinicians, patients and others working to deliver clinical cancer care in the National Health Service in the United Kingdom.
Utilization of bone densitometry and administration of bisphosphonates to prevent osteoporosis in patients with nonmetastatic prostate cancer receiving anti-androgen therapy.
Authors: Khan Muhammad Atif , Holt Abby E , Gujja Swetha , Govindarajan Rangaswamy
Published: March 2020

6099

Background: Prostate cancer subjects with PSA relapse who are treated with androgen deprivation therapy (ADT) are recommended to have baseline and serial bone densitometry (BD) and receive intravenous bisphsphonates (BP). Utilization of BD and BP therapy was evaluated in a retrospective SEER Medicare database analysis. Methods: A cohort study of men aged aged ≥ 65 years with a nonmetastatic incident diagnosis of prostate cancer between 2004 and 2008 was conducted. Data were obtained from the Surveillance, Epidemiology and End Results (SEER) linked Medicare claims. Medicare claims were used to select prostate cancer cases who had ever received ADT and intravenous BP as part of their treatment. ADT was defined as an orchiectomy, goserelin, leuprolide, leuprolide implant, or triptorelin. BD and treatment with pamidronate or zoledronic acid were identified using Medicare HCPCS codes. One-sided exact binomial test of proportion was used to determine if the physician compliance rate is consistent with 80%; meaning equal to or higher than 80%. Results: 157,974 newly diagnosed prostate cancer cases were identified. Of those, 100,865 were age 65 and above and had no bone metastases. Subjects who did not have ADT claims were excluded. 30,846 patients were eligible for analysis. Cases were further stratified by use of BD and BP therapy. Results revealed 86.8% (N=26,774) on ADT did not receive either a BD or intravenous BP therapy. Approximately 2.9% (N=885) of the cases on ADT received BP treatment without ever receiving a BD. 9.3% (N=2,863) of the cases on ADT received a BD without receiving intravenous BP, while only 1.05% (N=324) of the cases on ADT received both a BD and BP. A compliance rate of 1.05%, those patients receiving both bone densitometries to screen for bone loss and preventive therapy, was well below the expected rate of 80%. Conclusions: Contrary to the recommendations, BD assessment and BP use is under utilized in men receiving ADT for non metastatic prostate cancer. Education of practicing physicians regarding better screening and preventative measures for osteoporosis in this population is warranted.
Advanced gastrointestinal cancer patients' perceptions of prognosis and goals of treatment.
Authors: El-Jawahri Areej , Traeger Lara , Park Elyse R. , Greer Joseph A. , Pirl William F. , Lennes Inga Tolin , Jackson Vicki A. , Gallagher Emily R. , Temel Jennifer S.
Published: March 2020

6106

Background: Patients with advanced cancer require accurate perception of their illness in order to make informed decisions regarding their care. However, little is known about the accuracy of these patients’ illness and prognostic understanding. The objectives of this study are to 1) examine prognostic understanding in patients with advanced gastrointestinal (GI) cancers, 2) assess patient preferences for prognostic information, and 3) explore associations of perceptions with quality of life (QOL) and mood. Methods: Cross-sectional study of 50 patients within 6-12 weeks post diagnosis of advanced GI cancers (gastric, esophageal, pancreatic, and hepatobiliary). We assessed patients’ perceptions of prognosis with a 15-item questionnaire, the Perception of Treatment and Prognosis Questionnaire. QOL and mood were assessed using the Functional Assessment of Cancer Therapy-General (FACT-G) and hospital anxiety and depression scales (HADS), respectively. Results: We enrolled 50/62 (80%) consecutive eligible patients within an 11-month period. 50% (25/50) of participants responded that the primary goal of their cancer treatment was to “cure their cancer.” Similarly, 54% (27/50) reported that they were “somewhat” to “extremely likely” to be cured from their cancer. Only 22% (10/49) reported having a discussion about their end-of-life care preferences with their oncologist. 76% (38/50) reported wanting to know as many details as possible about their cancer diagnosis and treatment and 64% (32/50) rated this information as “extremely important.” Patients who perceived knowing about their prognosis as “extremely helpful” reported a better QOL (p = 0.009), lower symptoms of anxiety (p = 0.02) and depression (p = 0.02). Conclusions: Although the majority of patients report that they desire detailed information about their prognosis, half incorrectly perceived their cancer as curable and the majority did not discuss their end-of-life care preferences with their oncologist. Patients who found learning about their prognosis to be extremely helpful reported better QOL and mood. Studies of interventions to increase advanced cancer patients’ knowledge of their prognosis and to encourage end-of-life discussions are warranted.
Association between baseline physical function and comorbidity status with patient-reported quality of life after prostate cancer treatments: Combined analysis of two prospective cohort studies.
Authors: Chen Ronald C. , Reeve Bryce B. , Deal Allison Mary , Moore Dominic T , Talcott James Austin
Published: March 2020

6107

Background: Treatment-related bowel, urinary, and sexual dysfunction in prostate cancer patients varies by treatment type, baseline function and other patient factors. To better predict patient outcomes after treatment, we examined the impact of comorbidity on these quality of life (QOL) outcomes in a secondary data analysis of two pooled, prospective cohort studies. Methods: A total of 697 patients from 3 academic hospitals who received radical prostatectomy, external beam radiation, or brachytherapy were included. Using a validated instrument, patients reported bowel, urinary, and sexual symptoms pretreatment, and at 3, 12, 24, and 36 months after treatment. Baseline physical function was measured by the physical component summary score (PCS) of the SF-12 using patient report. Comorbidity as measured by the Index of Co-Existent Disease (ICED) was obtained from medical record review. Repeated QOL measurements were analyzed using a mixed modeling method, by random coefficient modeling. Separate models were built for each outcome using bowel, urinary, and sexual scale scores at each time point.Covariates in all models included baseline age, education, ICED, and PCS. Results: Approximately 70% of patients had one or more comorbid conditions at baseline. After adjusting for age and education in mixed-models, we found baseline comorbidity was independently associated with more sexual dysfunction (p<.001) and urinary incontinence (p=.03). Worse baseline physical functioning was independently associated with more bowel problems (p<.001) and sexual dysfunction (p<.001). There were no treatment by comorbidity or physical functioning interactions. Conclusions: Comorbidity and worse physical functioning at baseline are significantly associated with poorer bowel, urinary, and sexual function after treatment for prostate cancer, but the associations do not appear to differ by treatment. Patients with comorbidity recovered more slowly. This information may help patients and their physicians anticipate outcomes after surgical and radiation treatments.
Pregnancy outcomes in women with cancer.
Authors: Milbourne Andrea , Sun Charlotte C. , Fanale Michelle A. , Theriault Richard L. , Rimes Sue A , Litton Jennifer Keating , Ramirez Mildred M.
Published: March 2020

6116

Background: Parenthood after cancer is a critical concern for many cancer patients (pts). Pregnancy (prg) during cancer is an emotional time for about 1/1000 pregnant women. No randomized controlled studies exist examining the impact of cancer treatment (tx) on the developing fetus nor on the woman with cancer. Methods: From 2002-2011, women presenting for cancer tx during prg were approached for this IRB-approved prospective database study. All pts provided written consent. Results: To date 143 pts are evaluable. The median age at diagnosis was 32.1 years and median gestational age (GA) at enrollment was 18.2 weeks. 95/143 (66.4%) are White, 19 (13.3%) are African American, 17 (11.9%) are Hispanic and 12 (8.4%) are Asian/Other. Primary cancers included breast (n=59, 41.3%), hematologic (n=29, 20.3%), melanoma (n=13, 9%), GYN (n=11, 8%), GI (n=8, 5.6%), head/neck (n=7, 6%) and other (n=16, 11%) (brain=4, GU=1, thyroid=3, head/neck=7, thoracic=1, sarcoma=6, unknown primary=1). 111/143 (77.6%) of prgs resulted in live births. Median birth weight was 6.5 lbs. Median follow-up time for pts was 32.3 months. To date, 3/19 pts who terminated prgs have died (1.6%). Most terminations occurred in the 1st trimester. To date, 79 pts (55.2%) are NED and 23 pts have died; of these 19 (1.7%) had live births. No major malformations were observed in the 74/143 (52%) of pts who received chemotherapy (CTx) during pregnancy. 57% received FAC/FEC; other regimens included ABVD (n=5), cytarabine (n=5), CHOP/R-CHOP, and platinum-based regimens. Median GA at the start of CTx was 19.7 wks. Median number of CTx cycles during prg was 4. Other pts underwent surgery (n=32), no tx (n=14), deferred tx until after delivery (n=17), radiation (2), transplant (3), other (1). Conclusions: Cancer diagnosis during prg is compatible with successful tx and prg outcome. Cancer tx during the 2nd and 3rd trimester can be safely given and in our pts did not result in adverse prg outcomes. Tx during the 1st trimester is usually not recommended. Thus cancer pts in their 1st trimester need to be extensively counseled about their disease as well as about the risks to the prg. In our pts continuation or termination of prg were not associated with an increased risk of death.
Influence of hospital characteristics on immediate breast reconstruction following mastectomy.
Authors: Richards Catherine A. , Wright Jason Dennis , Neugut Alfred I. , Ascherman Jeffrey , Hershman Dawn L.
Published: March 2020

6118

Background: Immediate breast reconstruction (IBR) following mastectomy is underutilized in the U.S. Racial, economic and geographic factors are associated with lower rates of IBR. Prior research has explored the association of individual and surgeon-level factors with the use of IBR, with little attention paid to hospital characteristics. Methods: We analyzed data from the 2008 Nationwide Inpatient Sample (NIS), a 20% random sample of academic, public and private U.S. hospitals. We used ICD-9 codes to identify women diagnosed with invasive breast cancer or DCIS who underwent mastectomy, and IBR (natural or expander/implant). If a hospital performed at least one IBR during 2008, they were classified as performing reconstruction. Relative risk regression was used to assess the hospital factors associated with a hospital performing IBR. Results: Of the 3,518 hospitals that performed mastectomy in 2008 only 50.4% performed at least one IBR. For hospitals that did not perform IBR, the average number of mastectomies was 5, compared to 35 at hospitals that did perform IBR (p<0.01). Among hospitals that did perform IBR, the mean proportion of mastectomy patients that had IBR was 34% (SD=20). In a multivariable adjusted model, urban/teaching (RR=3.47) and urban/non-teaching (RR=2.86) hospitals were significantly more likely to perform IBR compared to rural hospitals. Hospitals with a high proportion of privately insured patients (RR=1.10) were significantly more likely to perform IBR compared to hospitals with a low proportion of privately insured patients. In contrast, hospitals with a high proportion of publically insured patients (RR=0.24) and hospitals with a high proportion of female patients ≥ 70 years old (RR=0.75) were significantly less likely to perform IBR. Hospital region, hospital ownership status and the proportion of nonwhite patients were not significantly associated with IBR. Conclusions: Almost half of all U.S. hospitals where mastectomies are performed do not have any patients who have undergone IBR. The likelihood a hospital will perform IBR varies significantly by hospital characteristics.