The Advanced Practitioner's Role in the Rapidly Evolving Landscape of Precision Medicine.

The advent of precision medicine targeting oncogenic mutations and other alterations has led to a paradigm shift in the treatment of many solid tumors and hematologic malignancies. For many of these agents, predictive biomarker testing is necessary to determine the presence of such alterations in order to select patients who are most likely to respond, and to avoid the use of ineffective and potentially harmful alternative therapy. Recent technological advances such as next-generation sequencing have facilitated the identification of targetable biomarkers in patients with cancer and thus help inform treatment decisions. Moreover, new molecular-guided therapies and associated predictive biomarkers continue to be discovered. For some cancer therapeutics, regulatory approval requires the use of a companion diagnostic to ensure proper patient selection. Advanced practitioners therefore need to be aware of current biomarker testing guidelines regarding who should be tested, how and when to test, and how these results can guide treatment decisions using molecular-based therapies. They should also recognize and address potential barriers and disparities in biomarker testing to ensure equitable care for all patients, and assist in educating patients and colleagues alike on the importance of testing and integration into clinical practice to enhance outcomes.

Biomarker-Driven Oncology Clinical Trials: Novel Designs in the Era of Precision Medicine.

Oncology drug development historically has followed a path of sequential phase I, II, and III clinical trials using traditional trial designs, with the goal of achieving regulatory approval. These studies are often conducted with inclusion criteria that limit enrollment to a single tumor type or tumor site of origin, excluding other patients who might also respond. Increased use of precision medicine targeting biomarkers or specific oncogenic mutations has led to novel clinical trial designs that can evaluate these therapies in a less limited fashion. Master protocols such as basket trials, umbrella trials, and platform trials can, for example, evaluate histology-specific therapies targeting a common oncogenic mutation across multiple tumor types or screen for the presence of multiple different biomarkers rather than a single one. In other cases, they can lead to more rapid evaluation of a drug and evaluate targeted therapies in tumor types for which they are not yet currently indicated. As the use of complex biomarker-based master protocols increases, advanced practitioners must understand these novel trial designs, their advantages and disadvantages, and how their use may advance drug development and maximize the clinical benefits of molecular precision therapy.

The Role of Biomarkers in Guiding Clinical Decision-Making in Oncology.

Recent advances in molecular diagnostics have led to the characterization of an increasing number of actionable genomic alterations and immune-based signatures, which have facilitated the development of many highly effective cancer therapies. In addition to their prognostic value, some of these biomarkers have been shown to have predictive value and have had a significant impact on clinical decision-making. The presence of these therapeutic targets can thus aid health-care professionals to select the optimal therapies and avoid use of ineffective, potentially toxic ones. Earlier agents were generally approved for only one or a limited number of malignancies and/or stages, but more recent approvals encompass multiple tumor types that bear a common molecular alteration regardless of tumor type (i.e., tumor-agnostic indications). The expanding use of tumor-agnostic biomarkers has the potential to greatly broaden the use of these therapies to a wider patient population. Yet the rapidly increasing number of tumor-specific and tumor-agnostic biomarkers, and the continually changing treatment guidelines regarding the use of targeted agents and associated testing requirements, present challenges for advanced practitioners to remain current on these topics and their ability to apply these advances to clinical care. Here, we review predictive oncology biomarkers currently in use and their role in clinical decision-making, including those specified in product prescribing information and clinical practice guidelines. Current clinical guidelines regarding recommended targeted therapies for selected malignancies, and when molecular testing should be performed, are discussed.

Revolutionizing Cancer Treatment: Harnessing the Power of Biomarkers to Improve Patient Outcomes.

There has been an increasing number of approvals for targeted therapies and immunotherapies in oncology in the past decade. This has changed the treatment paradigm for many solid tumors and hematologic malignancies, and therefore the outcomes of patients with cancer. Advanced practitioners should be up to date with advances in cancer biomarker testing and its implications for the use of targeted therapy and immunotherapy to integrate this information into clinical decision-making.

Uncovering and Addressing Implicit Bias in Oncology.

Implicit bias affects patient care every day, and not just in oncology. It impacts decision-making in already vulnerable populations such as the historically marginalized racial and ethnic groups, the LGBTQI+ population, patients with disabilities, and patients with low socioeconomic status or low health literacy. At JADPRO Live 2022 in Aurora, Colorado, panelists took a deep look at implicit bias and its impact on health inequities. They then discussed best practices for increasing equity and representation in clinical trials, ways to facilitate equitable communication and interactions with patients, and finally shared steps that advanced practitioners can take to minimize the impact of implicit bias.

Advanced Practitioner Leadership in Times of Crisis.

JADPRO Live Virtual kicked off with the opening panel on advanced practitioner leadership during the COVID-19 pandemic. The group discussed their institutional emergency protocols, how they leveraged advanced practitioners (APs) to provide care during the crisis peak, and how they responded to the personal issues and anxieties of their AP colleagues.

The Elevator Pitch: Communicating Your Expertise, Experience, and Value to Patients, Co-Workers, and Prospective Employers in an Instant.

During JADPRO Live Virtual 2020, Andrew S. Guinigundo, MSN, RN, CNP, ANP-BC, provided guidance to advanced practitioners on creating their elevator pitch and communicating their role.

A Randomized, Single-Blind Study Evaluating the Effect of a Bone Pain Education Video on Reported Bone Pain in Patients with Breast Cancer Receiving Chemotherapy and Pegfilgrastim.

BACKGROUND: Mild-to-moderate bone pain is the most commonly reported adverse event associated with pegfilgrastim. AIMS: To investigate the effect of bone pain education on pegfilgrastim-related bone pain in patients with breast cancer receiving chemotherapy and pegfilgrastim. DESIGN: Randomized, single-blind study. SETTINGS: Forty-eight community oncology clinics throughout the United States. PARTICIPANTS: Three hundred women ≥18 years of age with newly diagnosed stage I -III breast cancer, who were planning ≥4 cycles of neoadjuvant or adjuvant chemotherapy with pegfilgrastim support starting in cycle 1. METHODS: Patients were randomized 1:1 to view a general education DVD on chemotherapy side effects (GE-DVD) or a DVD on bone pain following chemotherapy and pegfilgrastim (BP-DVD). Patients recorded severity of bone pain on a scale of 0-10, location of pain, and use of bone pain medications (i.e., analgesics, antihistamines, and nonsteroidal anti-inflammatory drugs) for 5 days, beginning on the day of pegfilgrastim administration, in each of the first four chemotherapy cycles. RESULTS: Patient-reported maximum bone pain was similar in the two groups (GE-DVD vs BP-DVD: cycle 1, 3.2 vs. 3.5, p = .3479; across all cycles, 4.1 vs. 4.6, p = .2196). Other measures of bone pain were also similar between the groups. Bone pain was highest in cycle 1 but decreased and then remained stable in subsequent cycles. Bone pain medication use was similar in both groups and was highest in cycle 1. CONCLUSIONS: The bone pain-specific education evaluated here did not improve perceptions of bone pain reported in this patient population.

NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim.

PURPOSE: Mild-to-moderate bone pain is a commonly reported adverse event (AE) associated with pegfilgrastim. We evaluated the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on pegfilgrastim-associated bone pain. METHODS: In this open-label study (NCT01712009), women ≥ 18 years of age with newly diagnosed stage I-III breast cancer and an ECOG performance status ≤ 2 who were planning ≥ 4 cycles of adjuvant or neoadjuvant chemotherapy with pegfilgrastim support starting in cycle 1 were randomized 1:1:1 to receive naproxen, loratadine, or no treatment to prevent pegfilgrastim-associated bone pain. The primary endpoint was all-grade bone pain in cycle 1 from AE reporting. Secondary endpoints included bone pain in cycles 2-4 and across all cycles from AE reporting and patient-reported bone pain by cycle and across all cycles. RESULTS: Six hundred patients were enrolled. Most patients (83.0%) were white, and mean (SD) age was 54.2 (11.1) years. The percentage of patients with all-grade bone pain in cycle 1 from AE reporting in the naproxen, loratadine, and no prophylaxis groups was 40.3, 42.5, and 46.6%, respectively; differences between the treatment groups were not statistically significant. Maximum, mean, and area under the curve for patient-reported bone pain were consistently lower in the naproxen and loratadine groups than in the no prophylaxis group; some of these differences were significant. Loratadine was associated with fewer treatment-related AEs and discontinuations than naproxen. CONCLUSIONS: Given its tolerability, its ease of administration, and its potential benefit, treatment with loratadine should be considered to help prevent bone pain in patients receiving chemotherapy and pegfilgrastim. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ; NCT01712009.