Antineoplastic Therapy Administration Safety Standards for Adult and Pediatric Oncology: ASCO-ONS Standards.

PURPOSE: To update the ASCO-Oncology Nursing Society (ONS) standards for antineoplastic therapy administration safety in adult and pediatric oncology and highlight current standards for antineoplastic therapy for adult and pediatric populations with various routes of administration and location. METHODS: ASCO and ONS convened a multidisciplinary Expert Panel with representation of multiple organizations to conduct literature reviews and add to the standards as needed. The evidence base was combined with the opinion of the ASCO-ONS Expert Panel to develop antineoplastic safety standards and guidance. Public comments were solicited and considered in preparation of the final manuscript. RESULTS: The standards presented here include clarification and expansion of existing standards to include home administration and other changes in processes of ordering, preparing, and administering antineoplastic therapy; the advent of immune effector cellular therapy; the importance of social determinants of health; fertility preservation; and pregnancy avoidance. In addition, the standards have added a fourth verification. STANDARDS: Standards are provided for which health care organizations and those involved in all aspects of patient care can safely deliver antineoplastic therapy, increase the quality of care, and reduce medical errors.Additional information is available at www.asco.org/standards and www.ons.org/onf.

The DISCO App: A pilot test of a multi-level intervention to reduce the financial burden of cancer through improved cost communication.

Objective: Financial toxicity affects 30-50% of people with cancer in the US. Although experts recommend patients and physicians discuss treatment cost, cost discussions occur infrequently. We pilot-tested the feasibility, acceptability and influence on outcomes of the DIScussions of COst (DISCO) App, a multi-level communication intervention designed to improve cost discussions and related outcomes. Methods: While waiting to see their physician, patients (n = 32) used the DISCO App on a tablet. Physicians were given a cost discussion tip sheet. Clinic visits were video recorded and patients completed pre- and post-intervention measures of self-efficacy for managing costs, self-efficacy for interacting with physicians, cost-related distress, and perceptions of the DISCO App. Coders observed the recordings to determine the presence of cost discussions, initiators, and topics. Results: Most patients reported needing ≤15 min to use the DISCO App, and that it made it easier to ask cost-related questions. Findings showed increased self-efficacy for managing treatment costs (p = .02) and for interacting with physicians (p = .001). All visits included a cost discussion. Conclusions: Prompting patients to discuss costs may improve cost treatment discussions and related outcomes. Innovation: An app-based and tailorable treatment-cost communication intervention is feasible, acceptable, and demonstrates promise in prompting cost discussions and improving outcomes.Trial registration: Clinical Trials.gov registration number: NCT03676920 (September 19, 2018).

DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population.

BACKGROUND: Financial toxicity, the material and psychological burden of the cost of treatment, affects 30-50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adherence and, ultimately, mortality. Financial toxicity is a health equity issue, disproportionately affecting patients who are racial/ethnic minorities, have lower incomes, and are < 65 years old. Patient education about treatment cost and patient-oncologist cost discussions are recommended as ways to address financial toxicity; however, research shows cost discussions occur infrequently (Altice et al. J Natl Cancer Inst 109:djw205, 2017; Schnipper et al. J Clin Oncol 34:2925-34, 2016; Zafar et al. Oncologist 18:381-90, 2013; American Cancer Society Cancer Action Network 2010). Our overall goal is to address the burden of financial toxicity and work toward health equity through a tailorable education and communication intervention, the DISCO App. The aim of this longitudinal randomized controlled trial is to test the effectiveness of the DISCO App on the outcomes in a population of economically and racially/ethnically diverse cancer patients from all age groups. METHODS: Patients diagnosed with breast, lung, colorectal, or prostate cancer at a NCI-designated comprehensive cancer center in Detroit, MI, will be randomized to one of three study arms: one usual care arm (arm 1) and two intervention arms (arms 2 and 3). All intervention patients (arms 2 and 3) will receive the DISCO App before the second interaction with their oncologist, and patients in arm 3 will receive an intervention booster. The DISCO App, presented on an iPad, includes an educational video about treatment costs, ways to manage them, and the importance of discussing them with oncologists. Patients enter socio-demographic information (e.g., employment, insurance status) and indicate their financial concerns. They then receive a tailored list of questions to consider asking their oncologist. All patients will have up to two interactions with their oncologist video recorded and complete measures at baseline, after the recorded interactions and at 1, 3, 6, and 12 months after the second interaction. Outcome measures will assess discussions of cost, communication quality, knowledge of treatment costs, self-efficacy for treatment cost management, referrals for support, short- and longer-term financial toxicity, and treatment adherence. DISCUSSION: If effective, this intervention will improve awareness of and discussions of treatment cost and alleviate the burden of financial toxicity. It may be especially helpful to groups disproportionately affected by financial toxicity, helping to achieve health equity. TRIAL REGISTRATION: ClinicalTrials.gov NCT04766190. Registered on February 23, 2021.

Assessment of Financial Toxicity Among Older Adults With Advanced Cancer.

Importance: Financial toxicity (FT), unintended and unanticipated financial burden experienced by cancer patients undergoing cancer care, is associated with negative consequences and increased risk of mortality. Older patients (≥70 years) with cancer are at risk for FT, yet data are limited on FT and whether oncologists discuss FT with their patients. Objective: To examine the prevalence of FT in older adults with advanced cancer, its association with health-related quality of life (HRQoL), and cost conversations between oncologists and patients. Design, Setting, and Participants: This cross-sectional secondary analysis was performed on baseline data from the Improving Communication in Older Cancer Patients and Their Caregivers study, a cluster randomized trial from 31 community oncology practices across the US that was conducted from October 29, 2014, to April 28, 2017. Participants included 536 patients with advanced cancer who answered 3 questions regarding financial toxicity. Data were analyzed from September 1, 2019, to May 1, 2020. Exposure: Older patients undergoing cancer care treatments. Main Outcomes and Measures: The main outcome looked at FT and its association with HRQoL. Three questions were used to identify patients 70 years or older experiencing FT. Multivariable linear regression models were used to assess the independent associations of FT with HRQoL. A single audio-recorded clinic transcript was analyzed within 4 weeks of enrollment for patients with FT. The framework method was used to identify frequency and themes related to cost conversations. Results: This study evaluated 536 patients 70 years or older with advanced cancer. Ninety-eight patients (18.3%) reported FT; mean (SD) age was 76.4 (5.4) years; 59 (60.2%) were female, 14 (14.3%) were Black/African American, 91 (92.9%) were not employed, and 29 (29.6%) had Medicare as their sole insurance coverage. On multivariate regression analyses, FT was associated with higher levels of depression (ß = 0.81; 95% CI, 0.15-1.48), anxiety (ß = 1.67; 95% CI, 0.74-2.61), and distress (ß = 0.73; 95% CI, 0.08-1.39) and lower HRQoL (ß = -5.30; 95% CI, -8.92 to -1.69). Among those who reported FT, 49% had a conversation with their health care professional about costs. Most conversations (79%) were initiated by oncologists or patients. Four themes were generated from cost conversations: statements regarding cost of care, ability to afford medical prescriptions, indirect consequences associated with inability to work and provide for family, and cost burden in nontreatment domains. Conclusions and Relevance: In this study, among older adults with advanced cancer, FT is associated with worse HRQoL. Almost half of conversations among patients reporting FT demonstrated costs are being actively discussed. Resources and interventions are needed to manage FT.

Unpacking Trial Offers and Low Accrual Rates: A Qualitative Analysis of Clinic Visits With Physicians and Patients Potentially Eligible for a Prostate Cancer Clinical Trial.

PURPOSE: Cancer clinical trial accrual rates are low, and information about contributing factors is needed. We examined video-recorded clinical interactions to identify circumstances under which patients potentially eligible for a trial at a major cancer center were offered a trial. METHODS: We conducted a qualitative directed content analysis of 62 recorded interactions with physicians (n = 13) and patients with intermediate- or high-risk prostate cancer (n = 43). Patients were screened and potentially eligible for a trial. We observed and coded the interactions in 3 steps: (1) classification of all interactions as explicit offer, offer pending, trial discussed/not offered, or trial not discussed; (2) in interactions with no explicit offer, classification of whether the cancer had progressed; (3) in interactions classified as progression but no trial offered, identification of factors discussed that may explain the lack of an offer. RESULTS: Of the 62 interactions, 29% were classified as explicit offer, 12% as offer pending, 18% as trial discussed/not offered, and 39% as trial not discussed. Of those with no offer, 57% included information that the cancer had not progressed. In 68% of the remaining interactions with patients whose cancer had progressed but did not receive an offer, reasons for the lack of offer were identified, but in 32%, no explanation was provided. CONCLUSION: Even in optimal circumstances, few patients were offered a trial, often because their cancer had not progressed. Findings support professional recommendations to broaden trial inclusion criteria. Findings suggest accrual rates should reflect the proportion of eligible patients who enroll.

Nurse-Delivered Symptom Assessment for Individuals With Advanced Lung Cancer.

OBJECTIVES: To assess an intervention derived from self-regulation theory (SRT) to promote well-being for individuals with advanced lung cancer. SAMPLE & SETTING: 45 adults with advanced lung cancer who were receiving chemotherapy at an ambulatory cancer center. METHODS & VARIABLES: Participants were randomized to the intervention group or usual care control group. Feasibility assessment focused on recruitment, retention, design, methods, and fidelity. Outcome measures of quality of life, symptoms, and distress were collected at four time points. The main research variables were symptoms, quality of life, and distress. RESULTS: The participation rate was 79%, and the retention rate was 62%. Participant loss was most often because of progressive disease and occurred early in the study. High fidelity was noted for delivery of the intervention as planned and outcome data collection by telephone. The mean number of interventions delivered was 5.5 of a planned 8. A high level of acceptability was reported for participants completing the intervention. IMPLICATIONS FOR NURSING: Although delivering the SRT-derived intervention with fidelity was possible, feasibility findings do not warrant intervention replication in this population.

Risk of thromboembolism in cisplatin versus carboplatin-treated patients with lung cancer.

INTRODUCTION: Carboplatin is widely used to treat lung cancer in the United States as an alternative to cisplatin. Several studies have demonstrated that cisplatin-based regimen is associated with a high frequency of thromboembolic complications. However, there has been limited investigation directly comparing the risk of thromboembolic events (TEEs) between cisplatin- and carboplatin-treated patients with lung cancer. METHODS: All lung cancer patients treated with cisplatin or carboplatin at Wilmot Cancer Center, University of Rochester between 2011 and 2014 were included. Patient characteristics including exposure (cisplatin vs. carboplatin) and outcome (TEEs between the time of the first dose of cisplatin or carboplatin and 4 weeks after the last dose) were collected by reviewing electronic medical records. A Fisher's exact test was used to compare the proportion of incident TEEs between cisplatin and carboplatin groups. The risk of TEE associated with carboplatin compared to cisplatin was assessed using multiple logistic regression. RESULTS: Among 415 subjects, 317 patients (76.4%) received carboplatin and 98 (23.6%) patients received cisplatin. In the carboplatin group, 10.9% (33/302) of evaluable patients developed treatment-related TEEs vs. 14.7% (14/95) in the cisplatin group. There was no significant difference in the risk of developing TEEs between the two groups (P = 0.32). However, 15.2% of carboplatin-related TEEs were arterial thromboses compared to none in the cisplatin group. CONCLUSIONS: The incidence of carboplatin-related TEEs was high in lung cancer patients without significant difference in the risk of developing TEEs between cisplatin and carboplatin groups. Potential use of prophylactic anticoagulation in all platinum-treated patients should be further investigated.

Significant activity of single agent vinorelbine against small-cell cancer of the bladder as second line chemotherapy: a case series and review of the literature.

Small-cell carcinoma of the urinary bladder is an extremely uncommon form of urologic malignancy, accounting for less that 1% of new cases of bladder cancer. It is an aggressive malignancy which, like its pulmonary counterpart, tends to spread with distant metastases. This malignancy is generally chemotherapy and radiotherapy sensitive. Metastatic disease is typically treated with regimens active against small-cell carcinoma of the lung, such as cisplatin and etoposide. There are no data regarding second-line treatment of this cancer. We report our experience in 3 patients using the second generation vinca alkaloid, vinorelbine, in refractory metastatic small-cell carcinoma of the bladder. These 3 patients had extensive prior therapy but all 3 responded to weekly vinorelbine, with a complete response (CR) in 1, near CR in the second, and partial response in the third. Of note, the patient who sustained a CR has remained without disease and with excellent quality of life for nearly 4 years since starting vinorelbine. Indeed, the therapy was very well tolerated in all 3 patients with grade 2 cytopenia being the only toxicity. We conclude that vinorelbine is well tolerated and has activity in this case series in the second-line treatment of metastatic small-cell carcinoma of the bladder.

Gemcitabine and other new cytotoxic drugs: will any find their way into primary therapy?

Primary treatment for classic Hodgkin lymphoma (HL) remains highly effective with chemotherapy alone or combined-modality therapy. The limitations of therapy have been related to toxicity and efficacy in subsets of patients. The introduction of a number of new and novel cytotoxic agents has provided opportunities for investigating their use in the treatment of HL. This article briefly reviews current primary treatment strategies for HL and examines the existing data for both new cytotoxic agents and other selected novel agents in the treatment of HL.

Superficial bladder cancer metastatic to the lungs: two case reports and review of the literature.

Bladder cancer remains a significant cause of morbidity and mortality in the United States, with mortality related predominantly to metastasis. Approximately 70% of newly diagnosed cases of bladder cancer represent superficial disease that, despite a high risk of local recurrence, rarely progress to invasive or metastatic disease. The present cases demonstrate isolated pulmonary metastases associated with low-grade superficial bladder cancer, without previous evidence of muscle-invasive disease. Distant spread of low-grade superficial tumors is extremely unusual, and we review the literature and discuss the management of this rare entity.