bluuebunny/crossref_metadata_2025 huggingface dataset:
A pilot study of individualised monitoring of patients with metastatic melanoma using plasma and urine DNA.
Authors: Wan Jonathan , Murphy Suzanne , Gale Davina Gillian , Morris James Anthony , Mouliere Florent , Gill Andrew , Marass Francesco , Heider Katrin , Parkinson Christine , Gallagher Ferdia Aidan , Durrani Amer J , McDermott Ultan , Massie Charles , Corrie Philippa , Rosenfeld Nitzan
Published: September 2018

e21032

Background: Circulating tumour DNA (ctDNA) is released by cancer cells into the bloodstream and can be analysed via liquid biopsy, providing a real-time snapshot of tumour burden. After treatment, ctDNA concentrations may be low, making detection challenging, and collecting larger sample volumes may be impractical. Our study aims to achieve high-sensitivity monitoring of melanoma patients melanoma on therapy, maximising the number of mutations targeted per patient by individualised sequencing. Methods: 72 patients with stage 3 or 4 melanoma have so far been recruited to MelResist, a translational research study. 235 plasma, urine, tumour and buffy coat samples have been analysed for 10 BRAF mutant metastatic melanoma patients receiving systemic therapies, and 30 matched CT scans were analysed for RECIST response. Exome or targeted sequencing were carried out on tumour samples and plasma at baseline and progression and mutations identified were used to design individualised amplicon and hybrid-capture sequencing panels targeting hundreds to thousands of mutations per patient. Results: Baseline ctDNA allele fraction predicted for overall survival ( r = -0.56, p < 0.05). Longitudinal analysis of ctDNA showed that mutant allele fractions significantly correlated with tumour burden from CT imaging ( r = 0.79, p < 0.0001) and ctDNA changes were concordant with 20/22 (90%) of RECIST response events. ctDNA allele fractions increased with a lead time of 70 days relative to serum lactate dehydrogenase, a standard measure of disease burden (IQR = 42-142 days). Targeting multiple mutations per patient enabled detection of less than one mutant genome copy per sample and allowed comprehensive monitoring of clonal evolution on therapy, even using limited sample volumes. Conclusions: Analysis of an initial cohort of BRAF mutant metastatic melanoma patients has confirmed feasibility to apply an individualised targeted sequencing panel on both plasma and urine DNA. For a given sample volume, monitoring multiple mutations improves detection sensitivity compared to targeting individual loci, has predictive value and can be applied to all melanoma patients, irrespective of BRAF mutation status.
Clinical characteristics of melanoma in an ethnically diverse population of adolescents and young adults.
Authors: Miller Kimberly Ann , Pham Anthony , Thomas Jacob Stephen , Cockburn Myles G , Freyer David Robert , Hu James , Milam Joel , Wojcik Katherine , In Gino Kim
Published: September 2018

e21043

Background: Melanoma is the third most common cancer among adolescents and young adults (AYAs; aged 15-39). Disease characteristics have not been well-described in this age group, particularly among diverse populations. We describe clinical features of AYAs diagnosed with melanoma at a large public hospital serving an ethnically diverse population. Methods: We reviewed medical chart data from patients diagnosed with melanoma between 2001-2016 at Los Angeles County + USC Medical Center. We describe clinical characteristics of AYA patients and compare to non-AYAs (aged ≥40) using Fisher’s exact test. A p-value < 0.05 was considered statistically significant. Results: Of the 273 melanoma patients identified, 47 (17.3%) were AYAs (mean age 32.3; SD±4.45; lower age range 18). The majority of patients were Hispanic (AYA, 53.2%; non-AYA, 51.1%), followed by non-Hispanic whites (AYA, 38.3%; non-AYA, 38.7%). A greater proportion of AYA patients were female (59.6%) compared to non-AYAs (38.2%) (p < 0.01). No AYA patients reported prior skin cancer compared to 19.9% of non-AYAs; 8.5% of AYAs reported family history of melanoma compared to 6.3% of non-AYAs. For all patients, superficial spreading melanoma was the most common histological subtype (AYA, 21.3%; non-AYA, 20.9%). Nodular melanoma was the second most common subtype in AYAs (17.02%) in contrast to acral lentiginous melanoma among non-AYAs (20.9%). Median Breslow depth was 3.0 mm for AYAs and 2.55 mm among non-AYAs. A slightly higher percentage of AYAs were diagnosed with regional disease (31.9%) than non-AYAs (24.4%), and a greater proportion of non-AYAs presented with distant metastases (AYA, 6.4%; non-AYA, 18.7%). The most common site of diagnosis were the extremities for all patients (AYA, 45.0%; non-AYA, 29.3%). Conclusions: We found similar clinical characteristics between AYA and non-AYA melanoma patients. However, we found a statistically significant difference for gender. The increased incidence of melanoma in female AYAs may be driven by biological factors such as sex hormones or genotype, or tanning behaviors. Further research is warranted to identify predictive and prognostic factors of melanoma among diverse AYAs, particularly females.
Non-progression during avelumab treatment is associated with clinically relevant improvements in health-related quality of life in patients with Merkel cell carcinoma.
Authors: Bharmal Murtuza , Fofana Fatoumata , Mahnke Lisa , Schlichting Michael , Kaufman Howard
Published: September 2018

e21070

Background: There is little data on quality of life (QoL) for patients (pts) with Merkel cell carcinoma (MCC). To better understand how new treatments might impact QoL in MCC, pts with stage IV chemotherapy-treated MCC from a single-arm, open-label, multicenter, international phase 2 trial (NCT02155647) of a novel immunotherapy were followed for QoL and clinical outcomes. Methods: Because there is no MCC-specific QoL instrument, the FACT-Melanoma (FACT-M), a validated QoL questionnaire including multiple subscales and summary scores (Trial Outcome Index [TOI], FACT-G total and FACT-M total) was used. Pts completed the FACT-M at baseline (BL), week 7, every 6 weeks until disease progression (PD) and at end of treatment (EOT). Linear mixed models (LMM) were fitted for change from BL for each scale including the time-varying covariate PD vs non-PD. Established minimal important differences (MID) were used to interpret meaningfulness of changes. Sensitivity analyses explored the effects of missing data. Results: 70 pts were analyzed. Overall, no meaningful changes from BL were observed for each scale during treatment. Moderate correlations between reduction in tumor size and improvements in FACT-M were observed at week 7 for Functional Well-being (-0.47), TOI (-0.36), FACT-M total (-0.36), and FACT-G total (-0.34), suggesting improvements in QoL with tumor shrinkage. LMM showed differences between PD vs non-PD groups in the range of MIDs for Functional Well-being (2.23, p = 0.018), Melanoma (3.19, p = 0.012), Surgery (1.95, p = 0.109), TOI (6.36, p = 0.012) and FACT-G total (3.89, p = 0.105). These models showed improvement for the non-PD group in Emotional Well-being (1.55, p = 0.004) and worsening for the PD group in Physical Well-being (-1.63, p = 0.041), Surgery (-2.09, p = 0.044) and TOI (-4.56, p = 0.036). As expected, all scales worsened in the range of MIDs at EOT, mostly due to PD. Sensitivity analyses were consistent, with modest increases in estimated differences. Conclusions: In pts with metastatic MCC, non-progression during avelumab treatment contributed to statistically and clinically meaningful improvements in health-related QoL. Clinical trial information: NCT02155647.
Evaluation of the risk of relapse of patients with stage III cutaneous melanoma at event-free survival time points.
Authors: Weppler Alison M. , Lee Derrick G , van Niekerk Dirk , Savage Kerry J.
Published: September 2018

e21074

Background: The prognosis of patients (pts) with stage III cutaneous melanoma is typically estimated at the time of diagnosis. Recent studies in other malignancies have reported the utility of estimating outcome using a conditional survival approach. Herein, we evaluated the risk of melanoma relapse at event-free survival (EFS) time points in pts with stage III cutaneous melanoma in British Columbia (BC). Methods: The Cancer Surveillance & Outcomes Database and Co Path Database were screened to identify pts diagnosed between 1998 and 2013 in BC with completely resected stage III cutaneous melanoma. A competing risk model was used to estimate 5-year (y) risk of recurrence at pre-specified EFS time points, with non-melanoma related deaths considered competing risks. Results: In total, 513 patients were identified: 329 males (64%); median age at diagnosis 58 y (16-99); median follow-up 5.6 y (0.2-17.5) for living pts. In total, 330 pts (64%) had a melanoma recurrence and most were distant metastases (n=194, 59% v regional n=79, 24% v local n= 57, 17%). The median time to first recurrence of any type was 11.6 months. The 5-y risk of any relapse was 63.8% at EFS 0, which decreased to 11.4% by EFS 5 y (Table 1). Full staging information was available for 423 pts (83%); the risk of relapse was lower for stage IIIA compared to IIIB and IIIC at EFS 0 (48%, 68% and 77%, respectively, p<0.001). By EFS 2 y, there was no difference between the groups; however, the 5-y risk of relapse was still moderate (IIIA 40%, IIIB 41%, IIIC 36%, p=0.46). Conclusions: While the risk of melanoma relapse decreases over time, it remains moderate up until 5 y, with distant recurrence as the most frequent event. This data can help inform surveillance guidelines and serves as a benchmark to compare the impact of novel therapies in the adjuvant setting. [Table: see text]
The stability of treatment preferences of advanced cancer patients over time.
Authors: Jabbarian Lea Jasmina , Maciejewski Renee , Maciejewski Paul K , Prigerson Holly Gwen
Published: September 2018

e21501

Background: The stability of patient treatment preferences has important implications for the optimal timing of advance care planning. Nevertheless, longitudinal data on cancer patients in real-life settings have not examined stability of treatment preferences over time. This study examines the stability of treatment preferences of advanced cancer patients over time and the potential influence of changes in physical functioning. Methods: The patient sample (N = 104) was drawn from a multi-institutional, longitudinal cohort study of patients recruited between 2010 and 2015. Patients with metastatic solid tumor cancer that had progressed on prior chemotherapy regimens were interviewed after an initial clinic meeting in which their most recent scan results were discussed (baseline) and, subsequently, completed monthly follow-ups. Patients reported their treatment preferences (i.e., comfort versus life-extending care) and physical functioning at each assessment. Results: The treatment preferences of the majority of patients (80.8%) remained stable within the first month of follow-up. Patient characteristics, such as age or type of cancer, were not significantly associated with treatment preference stability. The proportion of patients whose preferences changed in favor of comfort care (10.6%) was only slightly higher than the proportion of patients whose preferences changed in favor of life-extending care (8.7%). The same pattern held for the two- and three-month follow-up assessments. Improvement in physical functioning was significantly associated with change in treatment preferences. However, the vast majority of patients (72.2%) had stable or declining physical functioning. Conclusions: Most advanced cancer patients have stable treatment preferences regarding comfort versus life-extending care in the months leading up to their death. Thus, advance care planning earlier in the course of illness may not be premature for the vast majority of patients. As physical functioning changes, treatment preferences should be re-evaluated.
Documenting goals of care (GOC) and prognosis of patients with advanced cancer: A tertiary cancer centre review of internal and external correspondence.
Authors: Hamid Anis , Ha Francis , Das Oindrila , Weickhardt Andrew
Published: September 2018

e21512

Background: Patients with advanced cancer require clear communication and documentation of GOC and prognosis to inform optimal care planning between the patient, family, specialist and primary healthcare providers. Such documentation may be lacking despite multiple inpatient and outpatient (OP) interactions prior to death. We aimed to review the frequency, content and timing of GOC/prognosis documentation during the last year of life of advanced cancer patients. Methods: All patients who died during palliative care admission at our tertiary centre in 2015 were identified. Patients with incurable solid cancer and reviewed ≥1 times in oncology OP clinic were included. We reviewed all oncology OP consultation notes and letters, oncology discharge summaries and advanced care plans (ACP) over a 12 month period before death. Both internal (OP notes) and external documents (OP letters; discharge summaries) were reviewed in detail for documentation of GOC and prognosis (qualitative/quantitative description). Results: 147 patients were included in the analysis. There was a median of 6 OP consultations and 6 hospital encounters (including admissions) per patient. Median time from first OP consultation to death was 7.7 months. Most patients had documentation of GOC in OP notes (61%) however only 24% had prognosis documented. 63% of OP visits resulted in a letter to external doctors. 58% of patients had ≥1 OP letter documenting GOC (median time before death, 3.9 months) and 16% had a letter documenting prognosis (median time before death, 2.8 months). 73% of patients had a ward admission yet 5% of discharge summaries specified prognosis. Only 15% of patients had an accessible ACP on record. Conclusions: We observed a lack of documentation of GOC and particularly prognosis in internal and external hospital correspondence despite multiple interactions prior to patient death. Although discussion of GOC and prognosis may occur within a consultation, lack of documentation in correspondence reduces insight into patient clinical trajectory and may result in differing care between providers. There is a need for improved communication and documentation in advanced cancer care.
Association of multidimensional comorbidities with survival in elderly patients with metastatic colorectal cancer treated with chemotherapy.
Authors: Kim Ki Hyang , Lee Jae Jin , Kim Jongphil , Morgado Gomes Fabio Renato , Sehovic Marina , Extermann Martine
Published: September 2018

e21530

Background: In geriatric assessments, comorbidity is often assessed with tools such as the Charlson comorbidity index (CCI) and the Cumulative Illness Rating Scale-Geriatrics (CIRS-G). In studies of older patients with colorectal cancer (CRC), comorbidity was mainly measured using the CCI, and inconsistent results about the correlation comorbidity with overall survival (OS) were found. In order to refine our understanding of the impact of comorbidity, we evaluated its correlation with OS using the CIRS-G and heat maps to elicit the subgroups with the highest impact. Methods: We retrospectively reviewed 153 consecutive patients from the Total Cancer Care database, aged ≥65 with stage 4 CRC, who underwent chemotherapy at Moffitt Cancer Center from 2000 to 2015. The association between CIRS-G scores and OS was examined by the Cox proportional hazards regression model. Results: Median age at diagnosis was 71 years. Forty-eight % of patients had an ECOG PS of 0. Median MAX2 score of chemotherapies was 0.119. Median total score of CIRS-G was 8 (1-20) and median severity index was 0.57 (0.07-1.43). The most common comorbidities were vascular, EENT and larynx, and respiratory diseases. Eleven patients had 1 comorbidity and 1 patient had 2 comorbidities at level 4 severity. Median OS of all patients was 25.1 months (95% CI 21.2-27.6). In univariate analysis, the number of CIRS-G level 4 comorbidities was a significant worse prognostic factor for OS (0 vs 1 or 2, HR 2.16, p = 0.017). In multivariate analysis, ECOG PS ≥2, poorly differentiated histology, age at diagnosis and numbers of CIRS-G level 4 comorbidities were significant worse prognostic factors for OS. ECOG PS ≥2 and age at diagnosis were significant worse prognostic factors for unplanned hospitalization. Conclusions: The OS in the elderly metastatic CRC patients was good and similar to the general population with this disease. The number of CIRS-G level 4 comorbidities was associated with worse OS but no specific CIRS-G category was individually associated with OS.
Development of 3-item questionnaire for preoperative evaluation of older cancer patients.
Authors: Shahrokni Armin , Tin Amy , Aiken William N. , Vickers Andrew J. , Korc-Grodzicki Beatriz
Published: September 2018

e21543

Background: Our study aims at developing a very short screening questionnaire for the preoperative evaluation of older cancer patients in the surgical clinics. Methods: Our study was based on 47-item electronic Rapid Fitness Assessment (eRFA) data presented last year (Shahrokni, et al. (J Clin Oncol 34, 2016 (suppl; abstr 10011). Frail patients were defined as having any of these criteria: Cognitive impairment (Mini-Cog < 3), basic or instrumental activities of daily living dependency, Karnofsky Performance Score ≤80, occurrence of fall in the past year, high level of distress (distress thermometer score ≥7), or Timed Up and Go test ≥ 10 seconds. The dataset was split 2/3 for training set and 1/3 for validation set. The sets were matched based on age and gender. Decision Curve Analysis (DCA) was preformed to assess the clinical utility of different models. Results: Based on a dataset of 1076 older cancer patients who completed the eRFA for preoperative evaluation in the geriatrics clinic, five models of 3 or 4-items showed to have the highest accuracy ( > 78%). For example, one 3-item questionnaire (difficulty with bladder and bowel control, fall in the past year, limitation of walking outside home) was able to identify 100% of non-frail patients and 73% of frail patients. If we use this model in the surgical clinic with a presumed 36% incidence of frailty among 1000 potential patients, the model can correctly indentify 266 out of 363 frail patients and all 637 fit patients who may and may not benefit from referral to geriatrics clinic, respectively. Using the validation set, the sensitivity and specificity of the model remained high and we confirmed the utility of the 3-item questionnaire on decision analysis. Conclusions: We identified a 3-item questionnaire to be used as a screening tool to identify frail and fit older cancer patients. Implementation of the tool is needed to evaluate whether it is useful in distinguishing older cancer patient in surgical clinic for geriatric referral. If effective, further studies should look into correlation between this questionnaire and surgical outcomes.
Comparative nocebo effects in older patients enrolled in cancer therapeutic trials: Observations from a 446-patient cohort—NCCTG 97-24-51 and ACOSOG Z9001 (Alliance A151602).
Authors: Le-Rademacher Jennifer , Foster Jared C. , Feliciano Josephine Louella , Gajra Ajeet , Seisler Drew K. , DeMatteo Ronald P. , Lafky Jacqueline M. , Hurria Arti , Muss Hyman B. , Cohen Harvey Jay , Jatoi Aminah
Published: September 2018

e21545

Background: A nocebo is an inert substance that causes adverse events. Although previous studies have examined the favorably positive (placebo) effects of an inert substance, few studies have examined negative (nocebo) effects, particularly in older patients who sometimes experience frequent and severe adverse events from cancer therapy. Methods: This study focused on placebo/nocebo-exposed patients who participated in two double-blind, placebo-controlled, cancer therapeutic studies, namely, North Central Cancer Treatment Group (NCCTG) 97-24-51 and American College of Surgeons Oncology Group (ACOSOG) Z9001, with the goal of reporting comparative, age-based adverse event rates. Results: Among the 446 patients who received placebo/nocebo exclusively, 161 were 65 years of age or older at the time of respective trial entry; 5234 adverse events occurred. Unadjusted adverse event rates did not differ significantly between patients 65 years of age or older and those younger: rate ratio (99% confidence intervals (CI): 1.01 (0.47, 2.02) with similar findings for grade 2 or worse adverse events and for all symptom-driven adverse events (for example, pain, loss of appetite, anxiety). Adjustment for sex, ethnicity, baseline performance score, and trial resulted in no significant age-based rate differences in adverse event rates. Similar findings were observed with an age threshold of 70. Conclusions: A nocebo effect appears to occur irrespective of age. This observation suggests that adverse events should be taken no less seriously in older than in younger cancer patients and that education to manage patients’ expectations from cancer therapy might improve tolerability. [Table: see text]
The importance of evaluation and taking care of the patient and caregiver in the oncological disease experience: A multicentre study.
Authors: Ratti Maria monica , Portaluppi Alessandra , Bertin Federica , Franchini Eleonora , Verusio Claudio
Published: September 2018

e21551

Background: Caregiver and patient are a dyad in which the hardship of one inevitably results in a worsening of the other’s condition. Supporting caregivers so they can deal with their relatives’ cancerous condition is useful to improve both patient care and collaboration with medical teams (Zavagli et al., 2012). Burden of caregivers has psychological and physical negative impact on patients (Gritti et al., 2011). This research matches the effects of the oncological disease on the patients and the caregivers, to find similarities and differences in order to better understand their specific needs and optimizing the support provided to them in hospital setting. Methods: Two different sets of tests are composed of a particular registry paper, SF-36, MAC, BDI-II, STAI-Y, addressed to patients, and SF-36, ZBI, COPE, addressed to caregivers. The samples are made up of 250 patients (M = 107; W = 143) and 143 caregivers (M = 54; W = 89). 34% of the sample had changes in job life due the illness process (C1), while 69% of caregivers had changes in their social, working or familiar life due taking care patients (CC1). 40% of patients in sample of caregivers had received the diagnosis since less than 3 months (CD3), 23% from 3 to 6 months (CD3-6), 14% from 6 to 12 months (CD6-12) and 22% over 12 months (CD12). Results:C1 reported worse levels of “Mental Health Index” (t = 2,016; p = ,045), depression (t = -3,949; p = ,000) and anxiety (t = -3,363; p = ,001) than patients had not changes in job. CC1 had worse levels of “Mental Health Index” (t = 4,276; p = ,045) and burden (t = -6,402; p = ,000) than caregivers without changes in life. Patients who received the diagnosis since less than 3 months reported less “Fighting Spirit” coping style (F(210;8) = 2,76; p = ,006) and worse levels of “Role Limitations due to Emotional Problems” (F(211;8) = 2,346; p = ,020) than in other periods. CD12 reported worse levels of burden than CD3, CD3-6 and CD6-12 (F(136;3) = 3,67; p = ,014). Conclusions:The results suggest that patients and caregivers share a similar suffering related to life changes, but underscore a difference in the adaptation to the disease condition with increasing time from diagnosis.
Cancer clinical trials education: Insights from patient experiences and preferences.
Authors: Saxton Claire
Published: September 2018

e21554

Background: Clinical trials offer cancer patients access to innovative treatments, quality care, and hope for a better future. Yet, participation rates across adult cancers remain low. Education is a target intervention. The following research examines patient experiences, beliefs, and preferences related to cancer clinical trial participation. Methods: In 2015-16, the Cancer Support Community conducted an online survey with the goal of developing an educational program that would increase clinical trial awareness and participation. Survey responses from 506 cancer patients were collected. Most respondents were female (85.5%) and Caucasian (84.8%). The average age was 58.7 years old. Nearly half (47.2%) were diagnosed with breast cancer. Of the respondents, 48.3% were currently receiving treatment. Results: Most (81.4%) had heard of clinical trials prior to diagnosis. While 36.3% had participated in trials, 52.5% never considered it. Results found that 56.7% had discussed clinical trials with their healthcare team during treatment, but only 20.2% felt that their goals and concerns were meaningfully addressed. Additionally, 93.1% reported that more time with their doctors to discuss clinical trials would be “somewhat” or “very” helpful. Websites with clinical trial information were shared with just 34.4% of respondents. Survey results indicated that 91.9% felt that a website including clinical trial information would be “somewhat” or “very” helpful. Specifically, 60.2% of respondents reported that a website with patient narratives would be “very” helpful. While, 60.9% felt that tools to help locate clinical trials would be “very” helpful. Most had not been offered or couldn’t independently locate videos (80.7%) or illustrations/images (73.8%) explaining clinical trials. Of the respondents, 94.0% reported that speaking directly with a clinical trial participant would be helpful. Yet, this was only offered to 10.3% of patients. Conclusions: Findings were used to develop content for educational products and programs delivered by CSC for those potentially eligible for clinical trials. Survey data highlight the importance of providing information relevant to eligible participants across multiple formats.
Incidence of permanent alopecia following adjuvant chemotherapy in women with early stage breast cancer.
Authors: Crown John P , Sills Emer , Ballot Jo , McDonnell Deirdre , Walshe Janice Maria , Fennelly David , Kearney Susan , Long Jessica Claire , Collison Deirdre , Gullo Giuseppe
Published: September 2018

e21576

Background: Alopecia is one of the most distressing toxicities of adjuvant chemotherapy for patients with breast cancer. Historically, oncologists have reassured patients (pts) that chemotherapy-induced alopecia is temporary, and followed by full hair recovery. More recently there have been troubling reports of permanent alopecia following adjuvant taxanes (Tax). We studied the incidence of long-term hair loss in patients treated on adjuvant trials in our institution. Patients who were enrolled on clinical trials involving Tax (D-Docetaxel, P-Paclitaxel) and/or Anthracyclines (A) were included. Methods: We conducted a telephone interview survey of pts who had completed adjuvant or neo adjuvant A and/or T chemotherapy on clinical trials more than one year before. Ongoing alopecia was graded as 0 (full hair recovery), 1 (mild hair loss) or 2(severe/total). The study was approved by the hospital audit committee. Results: We studied 295 pts who has been treated on 12 studies. Drug exposure: D-260 pts (D nonA-185, D+A-75); A-nonTax-12 pts ; A+P 23 pts. The overall incidence of alopecia was 15% (11% grade 1 and 4% grade 2). For all D the incidence was 15% (12% Grade 1 and 3% Grade 2). For D+A-24% (19% Grade 1 and 5% Grade 2). For D non A the incidence was 13% ( 8% grade 1 and 5% grade 2). For A non T 8% (Grade 2-8%). For PA-13% ( 4% grade 1 and 9% grade 2). For patients receiving D non-A regimens, there were two levels of D exposure, 300mg/m2 (90 pts) or 450 mg/m 2 (95 pts). The incidence of alopecia was significantly D dose dependent: D300- 7% (all grade 1) and D 450-19% (14% grade 1, 5% grade 2) (p = .02 chi2 ). Among the higher dose D group, the companion drug choices carboplatin for HER2 positive, (55 pts) or cyclophosphamide (40 pts) were associated with similar incidences of permanent alopecia (22% v 16%). Conclusions: Permanent alopecia is a common complication of adjuvant chemotherapy. The risk appears to be highest in regimens which contain A and Tax, but it is also seen in AP and in A non-Tax. For patients receiving D non A, the risk is dose-dependent. Our data set contains few P pts, and does not contain any pts undergoing low dose weekly P. Oncologists should warn all patients undergoing adjuvant therapy of the risk of permanent alopecia.
Feasibility intervention to increase exercise outcome expectations among breast cancer survivors.
Authors: Hirschey Rachel , Pan Wei , Kimmick Gretchen Genevieve , Hockenberry Marilyn , Shaw Ryan , Lipkus Isaac
Published: September 2018

e21584

Background: Exercise is associated with decreased mortality and recurrence risk and improved quality of life for breast cancer survivors (BCS). Roughly 1/3 of BCS exercise enough to experience these benefits. A promising strategy to increase exercise among BCS is to target outcome expectations (OEs), or what one expects to obtain or avoid from a behavior. OE dimensions include 1) importance – value placed on the outcome(s); 2) certainty - perceived probability outcome(s) will occur; and 3) accessibility – the frequency with which outcome(s) are considered. Methods: This RCT tested the feasbility and effects of a self-directed booklet designed to increase OEs and exercise. It was created in collaboration with BCS who successfully use exercise to manage long term side effects. OEs were measured through online surveys and exercise was measure with a Fitbit accelerometer. Data was collected at baseline, 4, 8 and 12 weeks post intervention. Feasibility was defined as the extent to which participants made use of intervention materials and was assessed through 9 researcher related questions. Results: The sample is mean age of 58, 74% white, 26% black, an average 2.5 years post treatment and about 1/3 take an AI or SERM. The booklet “somewhat” (mean = 3.24, SD = 1.8 on 1-5 Likert scale) made use of the booklet, as intended. OEs increased 0.01 points over time in the intervention arm, compared to the control arm ( p = 0.3555); 0.4 points more for black participants compared to white ( p = 0.0003); 0.2 points per every unit of increased exercise self-efficacy ( p < 0.0001), and 0.01 points per month participants were closer to their time of cancer surgery ( p = 0.0037). Intervention arm participants increased their weekly steps by 970, every 4 weeks, compared to participants in the control arm ( p = 0.0283). Conclusions: Overall the intervention was well received by participants, had positive effects on OEs and exercise and can easily be translated into practice with need for minimal resources. Significant differences were noted for black compared to white participants, thus it is necessary to understand racial differences in exercise beliefs when designing future exercise interventions. Clinical trial information: NCT02348710.
Patient attitudes toward oncofertility care in male cancer patients receiving targeted and immune therapies.
Authors: Tsai Katy K. , Kamal Puneet , Ramstein Joris , Algazi Alain Patrick , Daud Adil , Smith James F
Published: September 2018

e21593

Background: Tyrosine kinase inhibitors (TKI) and immune checkpoint inhibitors (ICI) have resulted in durable response for many cancer patients. The impact of these agents on future fertility are not well described, and patients are often committed to long-term treatment without adequate oncofertility counseling. We sought to better characterize patient attitudes toward oncofertility and challenges faced by male cancer patients undergoing treatment with TKI or ICI. Methods: Men receiving TKI/ICI at the UCSF Helen Diller Family Comprehensive Cancer Center were retrospectively identified. Eligible men had received at least one dose of TKI/ICI. Detailed questionnaires addressing cancer history, possible effects of treatment on fertility, and obstacles to fertility preservation were completed. Results: Between January 2013 to September 2016, 51 men with a mean age of 46 years (SD 12, range 21-72), 65% white, completed questionnaires. Most (61%) were CML patients, with 12% RCC, 10% GIST, 6% melanoma, and NET, oligodendroglioma, and HCC comprising remaining histologies. 96% were treated with TKI, and 4% with ICI. At the time of diagnosis, 35% of patients indicated a desire to father future children, and 53% believed that cancer treatment might affect their fertility. Despite this, 45% were not asked whether having children was important to them, and 47% did not receive information from any provider on their oncology care team about the possible risks of TKI/ICI to future fertility. The majority of patients felt there was inadequate discussion of how treatment might affect testosterone levels (73%) and their ability to father a child (53%), yet only 14% recalled adequate referrals to a fertility specialist. Conclusions: These data demonstrate that male cancer patients perceive treatment-related infertility risks as important, yet have few opportunities to discuss these concerns with providers. Care plans to address oncofertility needs, especially as TKI/ICI are increasingly used in multiple cancer types, are needed as part of the diagnosis, treatment, and follow up of these patients. Larger retrospective and prospective studies are ongoing to further characterize this patient cohort.
Survivor feedback on a late effects-oriented survivorship care plan for head and neck cancer.
Authors: Salz Talya , McCabe Mary S. , Oeffinger Kevin C. , Schnall Rebecca B , Corcoran Stacie , Vickers Andrew J. , Salner Andrew L. , Dornelas Ellen A , Raghunathan Nirupa Jaya , Fortier Elizabeth , Finitsis David , Baxi Shrujal S.
Published: September 2018

e21596

Background: Survivorship care plans (SCPs) typically include generic advice for the management of late effects (LEs) that can occur, rather than addressing LEs that the survivor actually has. We developed a platform called HN-STAR that uses electronic patient-reported outcomes (ePROs) and evidence-based LE management to generate a personalized SCP for survivors of head and neck cancer (HNC), a population vulnerable to various LEs. We assessed HNC survivors’ experiences with HN-STAR to ensure its acceptability and usefulness. Methods: Disease-free HNC survivors at two cancer hospitals used HN-STAR in conjunction with a routine survivorship visit. Prior to the visit, survivors used a validated ePRO measure (PRO-CTCAE) to report up to 22 physical LEs. Based on clinic visit discussions, HN-STAR generated an SCP that included a treatment summary and LE management plans. Survivors indicated their level of agreement to statements regarding the ease of use of the ePROs, content of the SCP, and intentions to adhere to LE management recommendations. Results: 47 survivors completed surveys (mean 5.4 years from treatment completion). Most were white (89%), male (85%), had an oropharynx tumor (58%), and received multimodality therapy (81%). More than half (51%) experienced at least 9 of the 22 LEs in the last 30 days (mean 8.2 per person). Most survivors reported that completing ePROs improved the discussions with their provider (98%), the quality of their care (96%), and their communication with their provider (98%). 91% agreed the SCP was the right length, and 98% agreed it was easy to follow. 98% intended to follow at least some of the recommendations for LEs management, and 98% reported feeling confident that they could follow the recommendations. The majority agreed that the SCP accurately summarized the clinic visit (98%), they would refer back to the SCP (98%), they trust the SCP (100%), and they plan to share the SCP with a primary care provider (87%). Conclusions: Among HNC survivors, an automatically generated SCP that was tailored to their LEs was acceptable, was trusted, and provided recommendations they intended to follow. Patient-centered SCPs that focus on existing LEs hold promise as a means to help survivors manage LEs.
Long term peripheral neuropathy symptoms in breast cancer survivors.
Authors: Mustafa Ali Moaath Khader , Moeller Machelle , Rybicki Lisa A. , Moore Halle C. F.
Published: September 2018

e21599

Background: Peripheral neuropathy (PN) is a common complication from chemotherapy (CTX), associated with significant morbidity, and may improve with time. The prevalence of long-term PN symptoms in breast cancer survivors is not well known. We sought to explore PN symptoms and associated risk factors among breast cancer survivors at least 2 years out from diagnosis. Methods: We performed a cross-sectional retrospective study investigating the prevalence of patient-reported numbness/tingling symptoms as a surrogate for PN in breast cancer survivors at our institution. We included patients with stage 0-III breast cancer who completed a questionnaire about symptoms and life-style habits at a survivorship visit that occurred 2 or more years after initial diagnosis. We evaluated the prevalence of PN and associated risk factors using univariable and multivariable logistic regression analysis; results are shown as odds ratio (OR) and 95% confidence interval (CI). Results: 605 patients assessed between April 2009 and October 2016 met eligibility for analysis. Median age was 60 (31-93) years. Median number of years from diagnosis to assessment was 6.3 (2-21). All patients had surgery and 62% had CTX. Twenty-seven percent reported PN. On univariable analysis, obesity, stage II & III, mastectomy, PN before diagnosis, and receipt of taxane CTX were associated with PN (all p < 0.05). Patients who were older, exercised before diagnosis, had ER/PR-positive disease and who received endocrine therapy reported less PN (all p < 0.05). On multivariable analysis, only receipt of docetaxel (OR: 2.18, CI: 1.22- 3.88) or paclitaxel (OR: 4.07, CI: 2.54-6.50) and reporting PN symptoms before diagnosis (OR: 3.28, CI: 1.49-7.21) were associated with PN. Among patients without pre-existing PN symptoms, 15%, 19%, 28% and 43% reported long-term PN after no CTX, non-taxane CTX, docetaxel CTX and paclitaxel CTX respectively. Conclusions: At a median follow-up of 6.3 years from diagnosis, 28% of survivors in our cohort who had received docetaxel and 43% who had received paclitaxel report long-term PN symptoms compared with 15-19% in those who received no or non-taxane CTX. These data can help inform patients and clinicians regarding long-term PN risk following CTX.
Cancer survivorship in the rural U.S. Columbia Pacific: A pilot study.
Authors: Lycette Jennifer L. , Cockrum Paulina , Fromwiller Venus , Winters-Stone Kerri M.
Published: September 2018

e21614

Background: We provide the only fully staffed cancer center in the rural Columbia Pacific, serving multiple counties in OR and WA. Rural areas can lack resources to provide comprehensive survivorship care. Higher rates of medical comorbidities and socioeconomic barriers add challenges to rural survivorship. We conducted a pilot study to 1) develop a program for lifestyle and behavior modifications to fit the needs of our patients in our rural community and 2) determine feasibility and preliminary efficacy of a survivorship program for breast cancer patients. Methods: 9 women with stage I-III breast cancer completed a 12-week program consisting of 1:1 meetings every 2 weeks with a physical therapist and registered dietician; health coach support; and access to a social worker. The following pre-post measures of physical health were taken: fasting lipids and glucose, HbA1C, waist circumference, blood pressure, BMI, 3-day physical activity log and food journal, joint range of motion, and muscle strength. Pre-post well-being was assessed by EORTC QLQC30 and focus groups. Results: Decreases in systolic BP, weight, waist circumference, fasting glucose, and HbA1c were seen in a majority of participants; however, only decreases in waist circumference reached statistical significance (p = .043). On post-program survey using a 0-10 rating scale, program acceptability was rated at an average of 7, and likelihood to continue at an average of 9.4; however, overall QOL rating had no change. Focus group feedback indicated participants valued dietician visits, but requested more social work support, exercise customization, and group support to foster mentoring, education, and sense of community. Conclusions: Developing a rural comprehensive survivorship care program locally is feasible. More work is needed to translate physical health goals into enhancement of well-being and improved QOL of rural cancer survivors.
Effect of hypoglycemic agents on survival outcomes of patients with lung cancer and diabetes mellitus: A systematic review and meta-analysis.
Authors: Huang Ping , Xin Wenxiu , Fang Luo , Ding Haiying , Zheng Xiaowei ,   Zhejiang Caner Hospital
Published: September 2018

e21617

Background: Although hypoglycemic agents (metformin, insulin, sulfonylureas [SUs] and thiazolidinediones [TZDs]) may influent prognosis of cancer at several sites, very little is known about their effects on clinical outcomes of lung cancer patients with diabetes mellitus (DM) and results from clinical trials are often inconsistent. Methods: To assess the association between hypoglycemic agents and clinical outcomes of lung cancer, we performed a systematic review of published studies from PubMed, EMBASE, Web of Science and The Cochrane Library up to January, 2016. Meta-analysis was performed to calculate the pooled hazard ratio (HR) and 95% confidence interval (95% CI). Results: The pooled HRs favoring metformin users was 0.77 for overall survival (OS) (n = 12, 95% CI: 0.66-0.89) and 0.59 for disease-free survival (DFS) (n = 6, 95% CI: 0.47-0.72). Only one study assessed the relation between metformin and cancer-specific survival (CSS) in lung cancer patients, reporting no statistically significant results. No significant association between insulin use and OS (n = 2, HR: 0.95, 95% CI: 0.79-1.13) or CSS (n = 2, HR: 1.03, 95% CI: 0.76-1.41) was noted. Only one study evaluated the effect of SUs in patients with lung cancer and reported no statistically clinical benefit (HR: 1.10; 95% CI: 0.87-1.40). Likewise, one study evaluated the effect of TZDs on OS in patients of lung cancer and reported no significant difference between TZDs and non-TZDs groups (HR: 1.04, 95% CI: 0.65-1.66). Conclusions: This meta-analysis demonstrated that metformin could improve survival outcomes of patients with lung cancer and DM. No association between insulin, TZDs or SUs and lung cancer outcomes was found.
Antiangiogenetic-induced hypertension and improved outcome in cancer patients.
Authors: Barni Sandro , Dognini Giuseppina Patrizia , Petrelli Fausto , Borgonovo Karen , Ghilardi Mara , Cabiddu Mary , Destro Maurizio
Published: September 2018

e21651

Background: Hypertension (HTN) is one of the most common adverse events observed during treatment with antiangiogenetic drugs (AAG) inhibiting the Vascular Endothelial Growth Factor Pathway. It may rise few days after anti-AAG starting, is dose dependent and reversible after its withdrawal. Some reports seem to suggest an improved outcome in patients (pts) developing HTN after AAG initiation (AAG-HTN). The aim of this study was to evaluate the impact of AAG-HTN on ORR, OS and EFS in pts receiving AAG, particularly tyrosine kinase inhibitors. Methods: All consecutive pts referred to ASST Bergamo Ovest between March 2012 and January 2017, and receiving sunitinib, sorafenib, regorafenib, pazopanib or axitinib, were evaluated. AAG- HTN was defined either as ex novo HTN or worsening of a pre-existing and pharmacologically controlled HTN, arising after AAG starting, and graded according to the NCI CTCAE 4.03. Overall survival was estimated using the Kaplan-Meyer method and hazard ratio with 95% CI was calculated, the primary endpoint was analyzed with a stratified log-rank test. Overall response rates were compared applying the chi-square test. Results: Overall 43 pts (male/female = 30/13, median age = 65yrs, range: 49-84) were evaluated. The AAG used were: sunitinib (n = 20), sorafenib (14), regorafenib (4), axitinib (3), pazopanib (2). Hypertension was present and pharmacologically controlled before AAG in 35 pts. Antiangiogenetic-related hypertension was developed in 27 pts (62.8%). Thirty-four pts were evaluable for ORR, which was observed in 44% of pts developing AAG-HTN versus 9% of those not developing AAG-HTN (p = 0.045). A trend to improved OS (hazard ratio [HR] 0.71 95%CI 0.33-1.5; P = 0.33) and EFS (HR 0.7, 95%CI 0.33-1.49; P = 0.29) in pts developing HTN was observed too. Conclusions: the development of AAG-HTN is related to an increased ORR. An improvement in OS and EFS has been postulated too, but the small number of this series did not allow to find a statistical correlation. For its potential impact on pts’ prognosis, further studies to better explore this issue should be performed and, importantly, AAG-HTN should be early recognized and properly managed.
Characteristics and outcomes of oncology patients requiring admission to an Australian intensive care unit.
Authors: Tan Aaron , Freyberg Sarah , Oatley Meredith , Guminski Alexander David
Published: September 2018

e21653

Background: Patients with advanced malignancies have historically been considered poor candidates for the intensive care unit (ICU), however survival and prognosis is continually improving and requirements for use of intensive care services is increasing. This study aimed to understand the characteristics and outcomes of oncology patients admitted to an Australian ICU and identify potential prognostic factors. Methods: A single-centre, retrospective, cohort study was conducted at Royal North Shore Hospital, a tertiary public hospital in Sydney, Australia with a 58-bed quaternary ICU. All patients aged > 18 years, admitted under the medical oncology team requiring ICU admission between June 2014 and June 2016 were evaluated. Data collected included basic demographics, cancer type and status, performance status (ECOG) and co-morbidities (ACE-27 score). Clinical outcomes were determined including ICU and hospital mortality, requirements (ventilation, dialysis, vasopressors, infection) and APACHE II scores. Results: There were 96 patients admitted to the ICU during the study period. Mean age was 61 years, 58% were male and 76% had metastatic disease. Most patients were receiving palliative treatment (89%), with recent chemotherapy (43%), immunotherapy (10%) and other therapies (5%). Of the 10 patients with recent immunotherapy, three (all melanoma) required ICU admission due to immunotoxicity with all three alive at time of data collection (mean 222 days follow-up). 13% were admitted due to an oncological emergency. Most common primary tumour site was thoracic (20%), genitourinary (11%), breast (10%) and melanoma (10%). Mean APACHE II score was 17 (SD 5.33), mean SOFA score was 4 (SD 2.70), ICU mortality was 5% and hospital mortality was 22%. For the 75 patients (78%) discharged from hospital, 42 (56%) were still alive at time of data collection (mean 321 days follow-up). Conclusions: Our patient population had good short-term outcomes for survival despite most receiving palliative treatment, although prognostic scores were also favourable. This suggests cancer patients can achieve positive outcomes after ICU admission with appropriate selection of patients crucial.