SWOG S1820: A pilot randomized trial of the Altering Intake, Managing Bowel Symptoms Intervention in Survivors of Rectal Cancer.

BACKGROUND: Survivors of rectal cancer experience persistent bowel dysfunction after treatments. Dietary interventions may be an effective approach for symptom management and posttreatment diet quality. SWOG S1820 was a pilot randomized trial of the Altering Intake, Managing Symptoms in Rectal Cancer (AIMS-RC) intervention for bowel dysfunction in survivors of rectal cancer. METHODS: Ninety-three posttreatment survivors were randomized to the AIMS-RC group (N = 47) or the Healthy Living Education attention control group (N = 46) after informed consent and completion of a prerandomization run-in. Outcome measures were completed at baseline and at 18 and 26 weeks postrandomization. The primary end point was total bowel function score, and exploratory end points included low anterior resection syndrome (LARS) score, quality of life, dietary quality, motivation, self-efficacy, and positive/negative affect. RESULTS: Most participants were White and college educated, with a mean age of 55.2 years and median time since surgery of 13.1 months. There were no statistically significant differences in total bowel function score by group, with the AIMS-RC group demonstrating statistically significant improvements in the exploratory end points of LARS (p = .01) and the frequency subscale of the bowel function index (p = .03). The AIMS-RC group reported significantly higher acceptability of the study. CONCLUSIONS: SWOG S1820 did not provide evidence of benefit from the AIMS-RC intervention relative to the attention control. Select secondary end points did demonstrate improvements. The study was highly feasible and acceptable for participants in the National Cancer Institute Community Oncology Research Program. Findings provide strong support for further refinement and effectiveness testing of the AIMS-RC intervention.

Modifiable fall risk factors among older adults with advanced cancer: Secondary analysis of a cluster-randomized clinical trial.

INTRODUCTION: Older adults with cancer have unique fall risk factors related to their disease and treatment such as polypharmacy and neurotoxic treatments. In this secondary analysis, we identified modifiable risk factors associated with future falls among older adults with advanced cancers. MATERIALS AND METHODS: Data were from the COACH study (ClinicalTrials.gov: NCT02107443; PI: Mohile). Patients were age ≥ 70, had stage III/IV solid tumor or lymphoma, ≥1 geriatric assessment impairment, and were receiving palliative intent treatment. Falls were self-reported at baseline (in the past six months), four to six weeks, three months, and six months. We generated inverse probability weights to account for mortality-related loss to follow-up and applied these in generalized linear mixed models to estimate incidence rate ratios. RESULTS: Of 541 patients (mean age: 77, standard deviation [SD]: 5.27), 140 (26%) reported prior falls at baseline, and 467 (86%) had falls data for ≥1 follow-up timepoint. Of those, 103 (22%) reported at least one fall during the follow-up period, and 112 (24%) had incomplete follow-up due to death. In fully adjusted models, prior falls and impaired Timed Up and Go score were associated with higher incidence of falls over 6 months. DISCUSSION: We identified several potentially modifiable fall risk factors in older adults with advanced cancers. Future studies should consider ways to integrate fall risk assessment into ongoing cancer care and intervene to reduce falls in this population.

Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Prospective Randomized Trial of Docetaxel Versus Best Supportive Care in Patients With Non-Small-Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy.

PURPOSE: To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with non-small-cell lung cancer who had previously been treated with platinum-based chemotherapy. Secondary end points included assessment of response (docetaxel arm only), toxicity, and quality of life.PATIENTS AND METHODS: Patients with performance statuses of 0 to 2 and stage IIIB/IV non-small-cell lung cancer with either measurable or evaluable lesions were eligible for entry onto the study if they had undergone one or more platinum-based chemotherapy regimens and if they had adequate hematology and biochemistry parameters. They were excluded if they had symptomatic brain metastases or if they had previously been treated with paclitaxel. Patients were stratified by performance status and best response to cisplatin chemotherapy and were then randomized to treatment with docetaxel 100 mg/m2 (49 patients) or 75 mg/m2 (55 patients) or best supportive care. Patients in both arms were assessed every 3 weeks. RESULTS: One hundred four patients (103 of whom were eligible for entry onto the study) were well balanced for prognostic factors. Of 84 patients with measurable lesions, six (7.1%) achieved partial responses (three patients at each dose level). Time to progression was longer for docetaxel patients than for best supportive care patients (10.6 v 6.7 weeks, respectively; P < .001), as was median survival (7.0 v 4.6 months; log-rank test, P = .047). The difference was more significant for docetaxel 75 mg/m2 patients, compared with corresponding best supportive care patients (7.5 v 4.6 months; log-rank test, P = .010; 1-year survival, 37% v 11%; χ2 test, P = .003). Febrile neutropenia occurred in 11 patients treated with docetaxel 100 mg/m2, three of whom died, and in one patient treated with docetaxel 75 mg/m2. Grade 3 or 4 nonhematologic toxicity, with the exception of diarrhea, occurred at a similar rate in both the docetaxel and best supportive care groups. CONCLUSION: Treatment with docetaxel is associated with significant prolongation of survival, and at a dose of 75 mg/m2, the benefits of docetaxel therapy outweigh the risks.

Feasibility and acceptability of an online intervention to enhance hopefulness among oncology professionals.

BACKGROUND: Patients prefer medical communication including both hopefulness and realism, though health-care professional (HCPs) struggle to balance these. Providers could thus benefit from a detailed personal understanding of hope, allowing them to model and convey it to patients. Additionally, given that hope is associated with lower levels of burnout, HCPs may benefit from tools designed to enhance their own personal hopefulness. Several investigators have proposed offering HCPs interventions to augment hope. We developed an online workshop for this purpose. METHODS: Feasibility and acceptability of the workshop were assessed in members of the SWOG Cancer Research Network. Three measures were used: the Was-It-Worth-It scale, a survey based on the Kirkpatrick Training Evaluation Model, and a single item prompting participants to rate the degree to which they believe concepts from the workshop should be integrated into SWOG studies. RESULTS: Twenty-nine individuals signed up for the intervention, which consisted of a single 2-hour session, and 23 completed measures. Results from Was-It-Worth-It items indicate that nearly all participants found the intervention relevant, engaging, and helpful. Mean ratings for Kirkpatrick Training Evaluation Model items were high, ranging from 6.91 to 7.70 on 8-point scales. Finally, participants provided a mean rating of 4.44 on a 5-point scale to the item "To what degree do you believe it may be useful to integrate concepts from this workshop into SWOG trials/studies?" CONCLUSIONS: An online workshop to enhance hopefulness is feasible and acceptable to oncology HCPs. The tool will be integrated into SWOG studies evaluating provider and patient well-being.

Combination Dabrafenib and Trametinib Versus Combination Nivolumab and Ipilimumab for Patients With Advanced BRAF-Mutant Melanoma: The DREAMseq Trial-ECOG-ACRIN EA6134.

PURPOSE: Combination programmed cell death protein 1/cytotoxic T-cell lymphocyte-4-blockade and dual BRAF/MEK inhibition have each shown significant clinical benefit in patients with BRAFV600-mutant metastatic melanoma, leading to broad regulatory approval. Little prospective data exist to guide the choice of either initial therapy or treatment sequence in this population. This study was conducted to determine which initial treatment or treatment sequence produced the best efficacy. PATIENTS AND METHODS: In a phase III trial, patients with treatment-naive BRAFV600-mutant metastatic melanoma were randomly assigned to receive either combination nivolumab/ipilimumab (arm A) or dabrafenib/trametinib (arm B) in step 1, and at disease progression were enrolled in step 2 to receive the alternate therapy, dabrafenib/trametinib (arm C) or nivolumab/ipilimumab (arm D). The primary end point was 2-year overall survival (OS). Secondary end points were 3-year OS, objective response rate, response duration, progression-free survival, crossover feasibility, and safety. RESULTS: A total of 265 patients were enrolled, with 73 going onto step 2 (27 in arm C and 46 in arm D). The study was stopped early by the independent Data Safety Monitoring Committee because of a clinically significant end point being achieved. The 2-year OS for those starting on arm A was 71.8% (95% CI, 62.5 to 79.1) and arm B 51.5% (95% CI, 41.7 to 60.4; log-rank P = .010). Step 1 progression-free survival favored arm A (P = .054). Objective response rates were arm A: 46.0%; arm B: 43.0%; arm C: 47.8%; and arm D: 29.6%. Median duration of response was not reached for arm A and 12.7 months for arm B (P < .001). Crossover occurred in 52% of patients with documented disease progression. Grade ≥ 3 toxicities occurred with similar frequency between arms, and regimen toxicity profiles were as anticipated. CONCLUSION: Combination nivolumab/ipilimumab followed by BRAF and MEK inhibitor therapy, if necessary, should be the preferred treatment sequence for a large majority of patients.

Development of a measure of clinicians' self-efficacy for medical communication (SEMC).

OBJECTIVES: Studies of clinician-patient communication have used varied, ad hoc measures for communication efficacy. We developed and validated the Self-Efficacy for Medical Communication (SEMC) scale as a standard, quantitative measure of clinician-reported skills in communicating difficult news. METHODS: Using evidence-based scale development guidelines, we created two 16-item forms of the SEMC, one assessing communication with patients and one assessing communication with families. Clinicians providing oncological care in four organisations were invited to participate and provided consent. Participant demographics, responses to the SEMC items and responses to convergent and discriminant measures (those expected to relate strongly and weakly to the SEMC) were collected online. We performed analyses to determine the convergent and discriminant validity of the SEMC as well as its reliability and factor structure. RESULTS: Overall, 221 oncology clinicians (including physicians, residents, fellows, medical students, nurses, nurse practitioners and physician assistants) participated. The patient and family forms both demonstrated high internal consistency reliability (alpha=0.94 and 0.96, respectively) and were strongly correlated with one another (r=0.95, p<0.001). Exploratory factor analysis demonstrated that the SEMC measures a unitary construct (eigenvalue=9.0), and its higher mean correlation with convergent (r=0.46) than discriminant (r=0.22) measures further supported its validity. CONCLUSIONS: Our findings support the SEMC's validity and reliability as a measure of clinician-rated communication skills regarding conducting difficult conversations with patients and families. It provides a useful standard tool for future research in oncology provider-patient serious illness communication.

Association of Prognostic Understanding With Health Care Use Among Older Adults With Advanced Cancer: A Secondary Analysis of a Cluster Randomized Clinical Trial.

Importance: A poor prognostic understanding regarding curability is associated with lower odds of hospice use among patients with cancer. However, the association between poor prognostic understanding or prognostic discordance and health care use among older adults with advanced incurable cancers is not well characterized. Objective: To evaluate the association of poor prognostic understanding and patient-oncologist prognostic discordance with hospitalization and hospice use among older adults with advanced cancers. Design, Setting, and Participants: This was a post hoc secondary analysis of a cluster randomized clinical trial that recruited patients from October 29, 2014, to April 28, 2017. Data were collected from community oncology practices affiliated with the University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program. The parent trial enrolled 541 patients who were aged 70 years or older and were receiving or considering any line of cancer treatment for incurable solid tumors or lymphomas; the patients' oncologists and caregivers (if available) were also enrolled. Patients were followed up for at least 1 year. Data were analyzed from January 3 to 16, 2021. Main Outcomes and Measures: At enrollment, patients and oncologists were asked about their beliefs regarding cancer curability (100%, >50%, 50%, <50%, and 0%; answers other than 0% reflected poor prognostic understanding) and life expectancy (≤6 months, 7-12 months, 1-2 years, 2-5 years, and >5 years; answers of >5 years reflected poor prognostic understanding). Any difference between oncologist and patient in response options was considered discordant. Outcomes were any hospitalization and hospice use at 6 months captured by the clinical research associates. Results: Among the 541 patients, the mean (SD) age was 76.6 (5.2) years, 264 of 540 (49%) were female, and 486 of 540 (90%) were White. Poor prognostic understanding regarding curability was reported for 59% (206 of 348) of patients, and poor prognostic understanding regarding life expectancy estimates was reported for 41% (205 of 496) of patients. Approximately 60% (202 of 336) of patient-oncologist dyads were discordant regarding curability, and 72% (356 of 492) of patient-oncologist dyads were discordant regarding life expectancy estimates. Poor prognostic understanding regarding life expectancy estimates was associated with lower odds of hospice use (adjusted odds ratio, 0.30; 95% CI, 0.16-0.59). Discordance regarding life expectancy estimates was associated with greater odds of hospitalization (adjusted odds ratio, 1.64; 95% CI, 1.01-2.66). Conclusions and Relevance: This study highlights different constructs of prognostic understanding and the need to better understand the association between prognostic understanding and health care use among older adult patients with advanced cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02107443.

S1417CD: A Prospective Multicenter Cooperative Group-Led Study of Financial Hardship in Metastatic Colorectal Cancer Patients.

BACKGROUND: Financial toxicity is a growing problem in oncology, but no prior studies have prospectively measured the financial impact of cancer treatment in a diverse national cohort of newly diagnosed cancer patients. S1417CD was the first cooperative group-led multicenter prospective cohort study to evaluate financial hardship in metastatic colorectal cancer (mCRC) patients. METHODS: Patients aged 18 years or older within 120 days of mCRC diagnosis completed quarterly questionnaires for 12 months. We estimated the cumulative incidence of major financial hardship (MFH), defined as 1 or more of increased debt, new loans from family and/or friends, selling or refinancing home, or 20% or more income decline. We evaluated the association between patient characteristics and MFH using multivariate cox regression and the association between MFH and quality of life using linear regression. RESULTS: A total of 380 patients (median age = 59.9 years) were enrolled; 77.7% were White, 98.0% insured, and 56.5% had annual income of $50 000 or less. Cumulative incidence of MFH at 12 months was 71.3% (95% confidence interval = 65.7% to 76.1%). Age, race, marital status, and income (split at $50 000 per year) were not statistically significantly associated with MFH. However, income less than $100 000 and total assets less than $100 000 were both associated with greater MFH. MFH at 3 months was associated with decreased social functioning and quality of life at 6 months. CONCLUSIONS: Nearly 3 out of 4 mCRC patients experienced MFH despite access to health insurance. These findings underscore the need for clinic and policy solutions that protect cancer patients from financial harm.

Association Between Health-Related Quality of Life and Progression-Free Survival in Patients With Advanced Cancer: A Secondary Analysis of SWOG Clinical Trials.

PURPOSE: Health-related quality of life (HRQOL) is an established prognostic factor for mortality; however, it is unclear if HRQOL is predictive of time to disease progression, a particularly meaningful outcome for patients. We examined the association between HRQOL and progression-free survival (PFS) in SWOG Cancer Research Network clinical trials. METHODS: For this secondary analysis, we reviewed all completed SWOG clinical trials to identify those for patients with advanced cancer that incorporated Functional Assessment of Cancer Therapy (FACT) questionnaires at baseline. FACT-Trial Outcome Index (FACT-TOI) was the primary independent variable. Associations between FACT-TOI and other FACT subscores with PFS and overall survival were evaluated via log-rank test and multivariable Cox regression analysis. RESULTS: Three clinical trials met our inclusion criteria: S0027 and S9509 for advanced non-small-cell lung cancer and S0421 for hormone-refractory prostate cancer. Of the 1,527 enrolled patients, 1,295 (85%) had both HRQOL and survival outcomes data available and were included in this analysis. In univariable analysis, we observed a statistically significant gradient effect in all three trials, with higher baseline FACT-TOI scores corresponding to better PFS (S0027, P < .001; S9509, P = .02; and S0421, P < .001). In multivariable analysis, FACT-TOI was significantly associated with PFS in S0027 (hazard ratio [HR] = 0.64; 95% CI, 0.42 to 1.00) but not in S9509 (HR = 0.77; 95% CI, 0.56 to 1.05) or S042 (HR = 0.86; 95% CI, 0.73 to 1.01). FACT-TOI was significantly associated with overall survival in multivariable analysis (P < .005 in all three trials). CONCLUSION: The association between baseline FACT-TOI scores and survival underscores their potential as a stratification factor in clinical trials.

Using Geriatric Assessment to Guide Conversations Regarding Comorbidities Among Older Patients With Advanced Cancer.

PURPOSE: Older patients with advanced cancer often have comorbidities that can worsen their cancer and treatment outcomes. We assessed how a geriatric assessment (GA)-guided intervention can guide conversations about comorbidities among patients, oncologists, and caregivers. METHODS: This secondary analysis arose from a nationwide, multisite cluster-randomized trial (ClinicalTrials.gov identifier: NCT02107443). Eligible patients were ≥ 70 years, had advanced cancer (solid tumors or lymphoma), and had impairment in at least one GA domain (not including polypharmacy). Oncology practices (n = 30) were randomly assigned to usual care or intervention. All patients completed a GA; in the intervention arm, a GA summary with recommendations was provided to their oncologist. Patients completed an Older Americans Resources and Services Comorbidity questionnaire at screening. The clinical encounter following GA was audio-recorded, transcribed, and coded for topics related to comorbidities. Linear mixed models examined the effect of the intervention on the outcomes adjusting for practice site as a random effect. RESULTS: Patients (N = 541) were 76.6 ± 5.2 years old; 94.6% of patients had at least one comorbidity with an average of 3.2 ± 1.9. The intervention increased the average number of conversations regarding comorbidities per patient from 0.52 to 0.99 (P < .01). Moreover, there were a greater number of concerns acknowledged (0.52 v 0.32; P = .03) and there was a 2.4-times higher odds of having comorbidity concerns addressed via referral, handout, or other modes (95% CI, 1.3 to 4.3; P = .004). Most oncologists in the intervention arm (76%) discussed comorbidities in light of the treatment plan, and 41% tailored treatment plans. CONCLUSION: Providing oncologists with a GA-guided intervention enhanced communication regarding comorbidities.

Dispositional hope as a potential outcome parameter among patients with advanced malignancy: An analysis of the ENABLE database.

BACKGROUND: Hopefulness, whether inherently present (dispositional hope) or augmented (by enhancement techniques), may affect outcomes. This study was performed to determine the association of dispositional hope with survival among patients diagnosed with advanced cancer. METHODS: Data from ENABLE (Educate, Nurture, Advise, Before Life Ends), a palliative care intervention, were reanalyzed to determine the association of higher dispositional hope and patient survival. This was a secondary analysis of data combined from the ENABLE II and ENABLE III randomized controlled trials (RCTs) with respect to dispositional hope and survival. A dispositional hope index was created from 3 hope items from 2 validated baseline questionnaires. Dispositional hope and survival data were collected during the 2 RCTs. In ENABLE II, participants were randomly assigned to the ENABLE intervention or to usual care. In ENABLE III, participants were randomly assigned to receive the intervention immediately or 12 weeks after enrollment. RESULTS: In all, 529 persons were included in Cox proportional hazards regression analyses to model the effects of dispositional hope on survival. An initial analysis without covariates yielded a significant effect of hope (Wald statistic, 8.649; hazard ratio, 0.941; confidence interval, 0.904-0.980; P = .003), such that higher dispositional hope was associated with longer survival. In a subsequent analysis that included all covariates, the effect of dispositional hope approached statistical significance (Wald statistic, 2.96; hazard ratio, 0.933; confidence interval, 0.863-1.010; P = .085). CONCLUSIONS: Higher levels of dispositional hope were associated with longer survival in patients with advanced cancer. Prospective trials are needed to determine the effects of dispositional and augmented hope on the outcomes of patients with advanced cancer.

The Relationship Between Frailty and Emotional Health in Older Patients with Advanced Cancer.

BACKGROUND: Aging-related deficits that eventually manifest as frailty may be associated with poor emotional health in older patients with advanced cancer. This study aimed to examine the relationship between frailty and emotional health in this population. METHODS: This was a secondary analysis of baseline data from a nationwide cluster randomized trial. Patients were aged ≥70 years with incurable stage III/IV solid tumors or lymphomas, had ≥1 geriatric assessment (GA) domain impairment, and had completed the Geriatric Depression Scale, Generalized Anxiety Disorder-7, and Distress Thermometer. Frailty was assessed using a Deficit Accumulation Index (DAI; range 0-1) based on GA, which did not include emotional health variables (depression and anxiety), and participants were stratified into robust, prefrail, and frail categories. Multivariate logistic regression models examined the association of frailty with emotional health outcomes. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were reported. RESULTS: Five hundred forty-one patients were included (mean age: 77 years; 70-96). DAI ranged from 0.04 to 0.94; 27% of patients were classified as robust, 42% prefrail, and 31% frail. Compared with robust patients, frail patients had an increased risk of screening positive for depression (aOR = 12.8; 95% CI = 6.1-27.0), anxiety (aOR = 6.6; 95% CI = 2.2-19.7), and emotional distress (aOR = 4.62; 95% CI = 2.9-8.3). Prefrail compared with robust patients also had an increased risk of screening positive for depression (aOR = 2.22; 95% CI = 1.0-4.8) and distress (aOR = 1.71; 95% CI = 1.0-2.8). CONCLUSION: In older patients with advanced cancer, frailty is associated with poorer emotional health, which indicates a need for an integrated care approach to treating these patients. IMPLICATIONS FOR PRACTICE: A relationship exists between frailty and poor emotional health in older adults with advanced cancer. Identifying areas of frailty can prompt screening for emotional health and guide delivery of appropriate interventions. Alternatively, attention to emotional health may also improve frailty.

Multilevel predictors of guideline concordant needle biopsy use for non-metastatic breast cancer.

PURPOSE: Persistent breast cancer disparities, particularly geographic disparities, may be explained by diagnostic practice patterns such as utilization of needle biopsy, a National Quality Forum-endorsed quality metric for breast cancer diagnosis. Our objective was to assess the relationship between patient- and facility-level factors and needle biopsy receipt among women with non-metastatic breast cancer in the United States. METHODS: We examined characteristics of women diagnosed with breast cancer between 2004 and 2015 in the National Cancer Database. We assessed the relationship between patient- (e.g., race/ethnicity, stage, age, rurality) and facility-level (e.g., facility type, breast cancer case volume) factors with needle biopsy utilization via a mixed effects logistic regression model controlling for clustering by facility. RESULTS: In our cohort of 992,209 patients, 82.96% received needle biopsy. In adjusted models, the odds of needle biopsy receipt were higher for Hispanic (OR 1.04, Confidence Interval 1.01-1.08) and Medicaid patients (OR 1.04, CI 1.02-1.08), and for patients receiving care at Integrated Network Cancer Programs (OR 1.21, CI 1.02-1.43). Odds of needle biopsy receipt were lower for non-metropolitan patients (OR 0.93, CI 0.90-0.96), patients with cancer stage 0 or I (at least OR 0.89, CI 0.86-0.91), patients with comorbidities (OR 0.93, CI 0.91-0.94), and for patients receiving care at Community Cancer Programs (OR 0.84, CI 0.74-0.96). CONCLUSION: This study suggests a need to account for sociodemographic factors including rurality as predictors of utilization of evidence-based diagnostic testing, such as needle biopsy. Addressing inequities in breast cancer diagnosis quality may help improve breast cancer outcomes in underserved patients.

Randomized Phase III Trial Evaluating Radiation Following Surgical Excision for Good-Risk Ductal Carcinoma In Situ: Long-Term Report From NRG Oncology/RTOG 9804.

PURPOSE: To our knowledge, NRG/RTOG 9804 is the only randomized trial to assess the impact of whole breast irradiation (radiation therapy [RT]) versus observation (OBS) in women with good-risk ductal carcinoma in situ (DCIS), following lumpectomy. Long-term results focusing on ipsilateral breast recurrence (IBR), the primary outcome, are presented here. PATIENTS AND METHODS: Eligible patients underwent lumpectomy for DCIS that was mammogram detected, size ≤ 2.5 cm, final margins ≥ 3 mm, and low or intermediate nuclear grade. Consented patients were randomly assigned to RT or OBS. Tamoxifen use was optional. Cumulative incidence was used to estimate IBR, log-rank test and Gray's test to compare treatments, and Fine-Gray regression for hazard ratios (HRs). RESULTS: A total of six hundred thirty-six women were randomly assigned from 1999 to 2006. Median age was 58 years and mean pathologic DCIS size was 0.60 cm. Intention to use tamoxifen was balanced between arms (69%); however, actual receipt of tamoxifen varied, 58% RT versus 66% OBS (P = .05). At 13.9 years' median follow-up, the 15-year cumulative incidence of IBR was 7.1% (95% CI, 4.0 to 11.5) with RT versus 15.1% (95% CI, 10.8 to 20.2) OBS (P = .0007; HR = 0.36; 95% CI, 0.20 to 0.66); and for invasive LR was 5.4% (95% CI, 2.7 to 9.5) RT versus 9.5% (95% CI, 6.0 to 13.9) OBS (P = .027; HR = 0.44; 95% CI, 0.21 to 0.91). On multivariable analysis, only RT (HR = 0.34; 95% CI, 0.19 to 0.64; P = .0007) and tamoxifen use (HR = 0.45; 95% CI, 0.25 to 0.78; P = .0047) were associated with reduced IBR. CONCLUSION: RT significantly reduced all and invasive IBR for good-risk DCIS with durable results at 15 years. These results are not an absolute indication for RT but rather should inform shared patient-physician treatment decisions about ipsilateral breast risk reduction in the long term following lumpectomy.

Association of Fatigue and Outcomes in Advanced Cancer: An Analysis of Four SWOG Treatment Trials.

PURPOSE: Patient-reported outcomes may be associated with cancer outcomes. We evaluated clinically significant fatigue (CSF), overall survival, adverse events (AEs), and quality of life (QOL) during cancer treatment. METHODS: We compared outcomes in four phase II or III chemotherapy trials, two advanced non-small-cell lung cancer and two advanced hormone-refractory prostate cancer, with or without baseline CSF. CSF was defined as a rating of two or greater on the Functional Assessment of Cancer Therapy fatigue question or a European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 fatigue symptom score of 50% or greater. Survival was compared according to CSF using Kaplan-Meier estimates and Cox regression models. Differences in AE rates by CSF were assessed via chi-squared tests, and QOL changes from baseline to 3 months via linear regression. RESULTS: Of 1,994 participants, 1,907 (median age 69 years, range: 32-91) had complete baseline QOL survey data, with 52% reporting CSF at baseline. For the two hormone-refractory prostate cancer studies, baseline CSF was associated with higher mortality rates, with adjusted hazard ratios of (95% CI, P value) 1.32 (1.13 to 1.55, P < .001) and 1.31 (1.02 to 1.67, P = .03) and with increased incidence of grade 3-5 constitutional (16.5% v 9.4%, P = .002; 13.9% v 6.3%, P = .002) and neurologic (11.7% v 6.1%, P = .006; 9.0% v 3.9%, P = .01) AEs, respectively. Baseline CSF was associated with a higher mortality rate in one non-small-cell lung cancer study: hazard ratio 1.44 and 1.04 to 2.00, P = .03. CONCLUSION: Oncology trial participants with baseline CSF had poorer survival and experienced more AEs than participants without CSF. This indicates fatigue as an important baseline prognostic factor in oncology treatment trials.

Association Between Caregiver-Oncologist Discordance in Patient's Life Expectancy Estimates and Caregiver Perceived Autonomy Support by the Oncologist.

BACKGROUND: Caregiver perceived autonomy support by the oncologist is important for caregiver well-being and may be affected by the patient's survival. We determined the association of caregiver-oncologist discordance in patient's life expectancy estimates with perceived autonomy support over time and whether the association differed by patient survival status. MATERIALS AND METHODS: We used data from a geriatric assessment cluster-randomized trial (URCC 13070) that recruited patients aged at least 70 years with incurable cancer considering or receiving treatment, their caregivers, and their oncologists. At baseline, caregivers and oncologists were asked to estimate patient's life expectancy (0-6 months, 7-12 months, 1-2 years, 2-5 years, and >5 years; any difference in response was considered discordant). At 4-6 weeks, 3 months, and 6 months, caregivers completed the Health Care Climate Questionnaire (HCCQ), which measured perceived autonomy support by the oncologist. Generalized estimating equation modeling was conducted to assess the association of baseline caregiver-oncologist discordance with longitudinal HCCQ scores, stratified by patient 6-month survival status. RESULTS: Discordant life expectancy estimates were present in 72.0% of dyads. In multivariate analyses, caregiver-oncologist discordance in patient's life expectancy estimates was associated with higher caregiver HCCQ scores. In stratified analysis, caregiver-oncologist discordance was associated with lower caregiver HCCQ scores (ß = -3.46; 95% CI, -4.64 to -2.29) among patients who died within 6 months but with higher caregiver HCCQ scores (ß = 1.33; 95% CI, 0.63-2.04) among patients who survived beyond 6 months. CONCLUSION: Interventions aimed at mitigating discordance need to consider its association with caregiver perceived autonomy support and patient's survival in order to better inform caregiver expectations. IMPLICATIONS FOR PRACTICE: Among patients who died within the first 6 months, caregivers who estimated a different length of life for the patient compared with oncologists were more likely to report lower support from the oncologist, whereas the opposite relationship was seen within patients who survived beyond the first 6 months. When designing interventions to improve caregiver understanding of the patient's prognosis, its relationship with caregiver-perceived support and patient's survival needs to be considered.