Disparities in care of older adults of color with cancer: A narrative review.

This review describes the barriers and challenges faced by older adults of color with cancer and highlights methods to improve their overall care. In the next decade, cancer incidence rates are expected to increase in the United States for people aged ≥65 years. A large proportion will be older adults of color who often have worse outcomes than older White patients. Many issues contribute to racial disparities in older adults, including biological factors and social determinants of health (SDOH) related to healthcare access, socioeconomic concerns, systemic racism, mistrust, and the neighborhood where a person lives. These disparities are exacerbated by age-related challenges often experienced by older adults, such as decreased functional status, impaired cognition, high rates of comorbidities and polypharmacy, poor nutrition, and limited social support. Additionally, underrepresentation of both patients of color and older adults in cancer clinical research results in a lack of adequate data to guide the management of these patients. Use of geriatric assessments (GA) can aid providers in uncovering age-related concerns and personalizing interventions for older patients. Research demonstrates the ability of GA-directed care to result in fewer treatment-related toxicities and improved quality of life, thus supporting the routine incorporation of validated GA into these patients' care. GA can be enhanced by including evaluation of SDOH, which can help healthcare providers understand and address the needs of older adults of color with cancer who face disparities related to their age and race.

Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline BRCA-Mutated Advanced HER2-Negative Breast Cancer.

BACKGROUND: Talazoparib is a poly (adenosine diphosphate-ribose) polymerase inhibitor approved for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative, locally advanced or metastatic breast cancer (LA/mBC), with approval based on the EMBRACA trial. To date, there are no published data on talazoparib use in the real-world United States (USA) setting. PATIENTS AND METHODS: Characteristics, treatment patterns, and clinical outcomes of real-world US patients with gBRCAm HER2-negative LA/mBC treated with talazoparib monotherapy were collected via retrospective chart review and summarized using descriptive statistics. RESULTS: Among 84 eligible patients, 35.7% had hormone receptor-positive tumors and 64.3% had triple-negative LA/mBC (TNBC). At talazoparib initiation, 29.8% had ECOG PS of ≥2 and 19.0% had brain metastasis. Mutations in gBRCA1 or 2 were detected among 64.3% and 35.7% of patients, respectively. Talazoparib was given as 1st-line therapy in 14.3% of patients, 2nd-line in 40.5%, and 3rd- or 4th-line in 45.2%. Median time to talazoparib treatment failure was 8.5 months (95% CI, 8.0-9.7), median progression-free survival was 8.7 months (95% CI, 8.0-9.9), the median time from initiation to chemotherapy was 12.2 months (95% CI, 10.5-20.1), and the overall response rate was 63.1%. No differences in clinical outcomes were observed between patients with HR-positive/HER2-negative LA/mBC and patients with TNBC by using unadjusted statistical comparisons. Brain metastasis and ECOG PS ≥2 at talazoparib initiation were associated with treatment failure and progression or mortality. CONCLUSION: Overall, talazoparib clinical outcomes in this real-world population are consistent with findings from EMBRACA.

Timely Genetic Testing and Therapy Management in Patients With gBRCA-Mutated Metastatic Breast Cancer Receiving Talazoparib.

Talazoparib is a poly(ADP-ribose) polymerase (PARP) inhibitor that has demonstrated strong efficacy with manageable side effects for patients with germline breast cancer susceptibility genes 1 or 2 (gBRCA1/2)- mutated, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer (mBC) in the EMBRACA and ABRAZO trials. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer recommend genetic testing for all patients with recurrent or metastatic BC to identify those with a gBRCA1/2 mutation who would benefit from treatment with a PARP inhibitor. However, many patients who meet these criteria do not receive genetic testing for a variety of reasons. Advanced practitioners (APs) can play a key role in the care of these patients by guiding them through the genetic testing process and explaining how the results impact treatment choices. A hypothetical case study highlighting a 42-year-old woman who received a diagnosis of triple-negative mBC provides an example of genetic testing strategies, as well as management considerations, with the use of talazoparib that can be implemented by APs. The efficacy and safety of talazoparib are reviewed along with practical guidance on its use (i.e., managing adverse events and drug interactions) to optimize patient outcomes. The patient case described in this publication is fictional and does not represent actual events or a response from an actual patient. The authors developed this fictional case for educational purposes only.

Practical Strategies for Advanced Practitioners Streamlining the Integration of Oncology Biosimilar Therapies Into Practice.

In oncology practices across the United States, biosimilars-highly similar versions of licensed, innovator (reference) biological medicines-are currently emerging as more affordable therapeutic options. Only after a rigorous product development program, during which a proposed biosimilar is analyzed and compared with its reference biologic to demonstrate comparable clinical efficacy, safety, and tolerability, is biosimilarity supported and licensure granted by the US Food and Drug Administration. Coincidentally, many advanced practitioners (APs) are finding themselves at the forefront of introducing monoclonal antibody (mAb) biosimilars in their oncology practice. Advanced practitioners are often tasked with building the confidence of colleagues and patients who may be unfamiliar with biosimilars, skeptical about integrating them, or have yet to consider mAb biosimilars as a viable and more sustainable cancer treatment option. With this responsibility comes a number of challenges that require APs to become knowledgeable about biosimilars and approaches to their implementation. This review aims to highlight the practical implications of streamlining the integration of biosimilar therapies in an oncology practice.

Glasdegib plus low-dose cytarabine for acute myeloid leukemia: Practical considerations from advanced practitioners and pharmacists.

OBJECTIVE: Acute myeloid leukemia (AML) is primarily a disease of older adults. These patients may not be candidates for intensive treatment, and there has been an ongoing need for treatment options for this group. We review the use of glasdegib, a hedgehog-pathway inhibitor available for use in combination with low-dose cytarabine (LDAC).Data Sources: PubMed and relevant congress abstracts were searched using the term "glasdegib". In addition, based on our experience with glasdegib, we considered treatment aspects of particular relevance to pharmacists and advanced practitioners.Data Summary: In a randomized phase II study, the combination of glasdegib plus LDAC demonstrated superior overall survival versus LDAC alone (hazard ratio 0.51, 80% confidence interval 0.39-0.67, p = 0.0004). The trial reported adverse events (AEs) of special relevance for older patients, such as hematologic events, gastrointestinal toxicity, and fatigue, as well as AEs associated with Hh-pathway inhibitors (alopecia, muscle spasms, dysgeusia). Educating patients about typical AEs can facilitate adherence as well as early AE identification and proactive management. For LDAC, which is a long-established therapy in AML, various stages of delivery need consideration, with attention to individual circumstances. Practical measures such as dispensing a longer supply can reduce the number of return clinic visits, providing a meaningful difference for many patients. CONCLUSIONS: Pharmacists and advanced practitioners play important roles in treatment with glasdegib plus LDAC. Ultimately, framing plans for treatment delivery within the individual circumstances of each patient may enable them to stay on therapy longer, giving them the greatest potential to achieve benefit.

Understanding the adverse event experience in the S-TRAC adjuvant trial of sunitinib for high-risk renal cell carcinoma.

Until recently, the sole treatment for patients with nonmetastatic renal cell carcinoma (RCC) was nephrectomy followed by observation. As metastatic RCC (mRCC) remains largely incurable (5-year survival rate ∼12%), adjuvant treatment, with potential to prevent/delay disease recurrence, is needed. In November 2017, sunitinib was approved in the USA as the first adjuvant therapy for patients at high risk for recurrent RCC postnephrectomy based on results from the S-TRAC trial. Patients eligible for adjuvant treatment have no evidence of disease and may be less willing to tolerate side effects. Therefore, proactive adverse event management is critical for keeping patients on adjuvant treatment and requires understanding the subtle differences in the adverse event profile of sunitinib in the adjuvant versus metastatic RCC setting.

Optimizing Palbociclib Therapy Across the Age Spectrum: Hypothetical, Illustrative Case Scenarios in HR+, HER2-Metastatic Breast Cancer.

Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors in combination with endocrine therapy are a preferred treatment option for premenopausal and postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). Palbociclib is a potent, first-in-class oral inhibitor of CDK4/6. To provide optimal care to patients with HR+/HER2- mBC receiving palbociclib, advanced practitioners require a thorough understanding of the efficacy and adverse event (AE) profile of palbociclib as well as the diverse characteristics and support needs of patients eligible for palbociclib treatment. This Grand Rounds uses two hypothetical patient scenarios to illustrate core issues in the management of premenopausal and postmenopausal patients receiving palbociclib-based therapy for mBC. In addition to providing an overview of key efficacy and safety data, each case offers practical guidance on providing individualized, patient-centered care, the identification and management of treatment-related AEs, management of concomitant medications, and best practices to promote adherence to therapy.

Therapy Management Using Modified 2-Weeks-On/1-Week-Off Dosing Schedule in Patients With Metastatic Renal Cell Carcinoma Receiving Sunitinib: A Hypothetical, Illustrative Case Scenario.

This patient case is fictional and does not represent events or a response from an actual patient. The authors developed this fictional case for educational purposes only. Brady, a 54-year-old white male, was diagnosed with metastatic renal cell carcinoma (mRCC). Two and a half years prior, he had undergone a complete left nephrectomy for clear-cell RCC, with clean margins and negative lymph nodes. Post nephrectomy, he was routinely surveyed (every 3-6 months) by radiologic imaging. After 15 months of monitoring, a CT scan revealed small nodules in the left lung. Repeated scans were ordered to be taken in 6 weeks to assess growth kinetics, wherein an increase in the size of a number of nodules was detected. Of particular concern was the location of one of the larger nodules very close to a bronchus. Consequently, a needle biopsy was performed, which recovered malignant cells consistent with mRCC. It was then decided to begin systemic treatment for mRCC. Prior to starting treatment, Brady's Eastern Cooperative Oncology Group performance status (ECOG PS) was 0, and he had a Karnofsky score of 90, as he had only slightly diminished stamina that was considered disease related. Accordingly, he was classified as favorable risk by both Memorial Sloan Kettering Cancer Center and International Metastatic Renal Cell Carcinoma Database Consortium criteria (Table 1). Brady is married and lives with his wife. He drinks alcohol occasionally but does not have a history of smoking. For the past 22 years, he has been employed full time as a factory assembly line worker, performing skilled, light assembly. In this capacity, Brady works with his hands and must remain on his feet approximately 30% of the working day. As Brady is eligible for early retirement in 11 months, he intends to continue working full time during treatment, if possible. Brady's medical history includes nonvalvular atrial fibrillation, which is treated with apixaban; hypertension that is adequately controlled (blood pressure 137/79 mm Hg) with lisinopril at 20 mg/day; coronary artery disease; and hyperlipidemia that is treated with atorvastatin at 20 mg/day. He is also taking daily low-dose aspirin (81 mg).

Management of Older Patients With Metastatic Renal Cell Carcinoma Receiving Sunitinib: A Hypothetical, Illustrative Case Scenario.

CASE STUDY Tom, a 75-year-old white male, was recently diagnosed with metastatic renal cell carcinoma (RCC; Tom's case is not an actual clinical case but has been developed by the authors as an exemplar). Two years prior, he had undergone a left partial (laparoscopic) nephrectomy for clear cell RCC. At that time, he had a stage 3 disease (the tumor extended into perinephric tissues but not into the ipsilateral adrenal gland and not beyond Gerota's fascia [Cancer.net, 2016]), and regularly (every 3-6 months) scheduled surveillance imaging did not show metastatic disease. Recent imaging with a computed tomography (CT) of the chest/abdomen/pelvis revealed small bilateral pulmonary nodules that did not have the radiographic appearance of a primary lung tumor, but rather that of metastatic disease. Therefore, a decision was made to repeat CT scans in a shorter interval (in 6 weeks) to assess growth kinetics. Subsequent CT scan showed an increase in size and number of pulmonary nodules, so the decision was made to begin systemic treatment. At the time of Tom's metastatic evaluation, his Eastern Cooperative Oncology Group performance status was 0 as he was asymptomatic and fully active (Table 1). He was classified as favorable risk according to Heng criteria (Table 2). Tom is married and lives with his wife. He is independent in his self-care but also relies on his wife for health-care decision-making. He does not drink alcohol and is a former smoker with a history of 30 pack-years. Tom's medical history includes hypertension that is adequately controlled with lisinopril (20 mg/day), coronary artery disease (on daily aspirin 81 mg) with left ventricular ejection fraction (LVEF) of > 50%, which is within the normal range (50%-75%), benign prostatic hyperplasia for which he is treated with finasteride, and hyperlipidemia that is treated with atorvastatin.

Updates on managing advanced breast cancer with palbociclib combination therapy.

BACKGROUND: The objective of this study was to review the pharmacology, efficacy, and safety of palbociclib, a first-in-class cyclin-dependent kinase 4/6 inhibitor, for the management of advanced breast cancer (ABC). METHODS: Pharmacokinetics and drug interactions associated with palbociclib are described. Recent clinical trial data are reviewed, including patient-reported outcomes and subgroup analyses. RESULTS: Palbociclib is indicated in combination with an aromatase inhibitor as initial endocrine therapy (ET) or with fulvestrant for patients with disease progression following ET for hormone receptor positive, human epidermal growth factor receptor 2 negative ABC or metastatic breast cancer. Palbociclib inhibits cyclin-dependent kinases 4/6, resulting in a blockade of phosphorylation of the retinoblastoma protein, which hinders the activation of transcription factors involved in S-phase entry, thereby arresting cell cycle progression at G1 phase. The efficacy and safety of palbociclib in combination with ET was established in three randomized trials (PALOMA-1, -2, and -3); all studies met their primary endpoint of significantly prolonging investigator-assessed progression-free survival versus ET alone. Findings were similar in subgroup analyses of the three PALOMA studies. Palbociclib plus ET also maintained health-related quality of life (QoL) compared with ET alone in PALOMA-2 and -3. A long-term safety profile for palbociclib, up to 3 years, has been established. Neutropenia, the most common any-grade and grade 3 or higher adverse event associated with palbociclib, is consistent with the drug's mechanism of action and can be effectively managed with dose interruption, dose reduction, or delay in starting treatment cycles. CONCLUSIONS: Palbociclib in combination with ET improved progression-free survival and QoL in patients with ABC, including in several patient subgroups.

Palbociclib Plus Letrozole for the Treatment of Metastatic Breast Cancer: An Illustrative Case Scenario.

CASE STUDY Betty, a 66-year-old white female, was diagnosed with stage IIB, T2N1M0, estrogen receptor/progesterone receptor-positive, HER2-negative breast cancer in 2007. It was detected on screening mammography when she was age 59, and she was confirmed to be postmenopausal at the time. She has no family history of breast cancer. Betty has never smoked but enjoys drinking alcohol, normally with dinner and typically limited to 1 drink of hard liquor per day. Her medical history includes type 2 diabetes mellitus and hypertension, which are adequately controlled with metformin and lisinopril. Betty is married and a retired teacher. She has four healthy adult children and five grandchildren. She noted that although she was always thin as a child, she was never able to lose the weight she gained during her pregnancies. Currently, her body mass index (BMI) is around 29 kg/m2. She enjoys ballroom dancing with her husband, gardening, and walking her dog and she is an active member at her church. Betty and her family were shocked to hear about her diagnosis. After a discussion with her oncologist, a treatment plan was devised. Her Eastern Cooperative Oncology Group performance status at diagnosis was 0. Initial treatment consisted of neoadjuvant chemotherapy with dose-dense doxorubicin/cyclophosphamide (AC) × 4 cycles followed by weekly paclitaxel × 12 cycles. Betty tolerated treatment relatively well. However, she was hospitalized once after cycle 3 of AC for neutropenic fever. Her subsequent cycle was followed with pegfilgrastim. Repeat imaging after AC treatment revealed a good overall response. Other adverse effects from treatment included fatigue and nausea for a few days after each cycle. Residual grade 1 neuropathy secondary to her treatment with paclitaxel, with a potential contribution from her history of diabetes, was a long-term complication. Following completion of her neoadjuvant therapy, she had a lumpectomy and then radiation therapy. Adjuvant endocrine therapy with the aromatase inhibitor (AI) anastrozole was given for 5 years, which she completed in late 2012. Bone health was monitored with dual-energy x-ray absorptiometry screening. Mild osteopenia was noted during AI therapy, and she was given twice-daily calcium plus vitamin D supplementation. Annual surveillance diagnostic breast mammography along with biannual history and physical examinations showed no signs of disease recurrence.

Predictors of practice patterns for lymphedema care among oncology advanced practice nurses.

Lymphedema, a debilitating and chronic condition, is considered to be one of the most distressing adverse effects of cancer treatment. The purpose of this study was to understand the practice patterns in lymphedema care and identify predictors influencing those patterns among oncology nurses, with a focus on advanced practice nurses. Random and purposive sampling was utilized to recruit 238 oncology nurses who completed the Web-based study. Participants included advanced practice nurses (nurse practitioners and clinical nurse specialists), nurse navigators/case managers, staff nurses, and directors/managers/coordinators. Data focused on perceived knowledge of and perceived competence in risk reduction, treatment, and self-management of lymphedema and practice patterns in lymphedema care. Actual knowledge of lymphedema care was evaluated. Descriptive, comparative, and regression analyses were performed. The study showed that perceived knowledge and perceived competence were highly correlated. Perceived competence was a predictor of practicing lymphedema care. Advanced practice nurses scored in the midrange for perceived knowledge and perceived competence in risk reduction and self-management, but obtained lower scores in perceived knowledge and perceived competence for treatment. The odds of advanced practice nurses delivering lymphedema care were less than those of staff nurses. This study identifies gaps and opportunities for advanced practice nurses to play an important role in providing lymphedema care, an essential aspect of cancer survivorship.