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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 (g BRCA m), 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 g BRCA m 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 g BRCA1 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Cancer survivorship is a continuum spanning diagnosis, treatment, and recovery. Oncology nurse navigators educate and support cancer survivors who face long-term adverse effects of cancer treatment such as lymphedema. This Web-based study investigated the knowledge, perceived competence, and practice patterns of lymphedema care of oncology nurse navigators. Invitation to the study was sent to 2510 randomly selected nurses who were likely to provide lymphedema care. A total of 238 nurses in clinical practice constituted the final sample for analysis. Oncology nurses were grouped according to primary nursing role: oncology nurse navigators, advanced practice nurses, directors/ managers/coordinators, and staff nurses. Perceived knowledge and perceived competence in lymphedema risk reduction, treatment, and self-management were evaluated as well as practice patterns of lymphedema care and actual lymphedema knowledge. Analyses included descriptive, comparative, and logistic regression. A strong relationship between perceived knowledge and perceived competence for all 3 areas of lymphedema care was identified. Oncology nurse navigators demonstrated the highest perceived knowledge and perceived competence in lymphedema risk reduction and had increased odds of providing education regarding lymphedema risk reduction compared with the other nurse groups. Overall, actual knowledge of lymphedema was relatively low, but oncology nurse navigators had more actual knowledge than other nurses. Oncology nurse navigators also had increased odds of delivering lymphedema risk reduction when compared with other nurses. Through education and support, oncology nurse navigators can make valuable contributions to cancer survivors and positively impact cancer survivors' quality of life. [ABSTRACT FROM AUTHOR]

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 (g BRCA1/2 )- 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 g BRCA1/2 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., Competing Interests: Dr. Martinez and Ms. Donahue have no conflicts of interest to disclose. Ms. Jones has served on speakers bureaus for AstraZeneca, Bristol Myers Squibb, Merck, and Pfizer, and served on an advisory board for Pfizer. Dr. Ryan, Dr. Barnett, and Dr. Soussou are employees of Pfizer., (© 2022 Harborside™.)

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., Competing Interests: Dr. Mayden has received payment for service on speakers bureaus from Pfizer, Amgen, and Puma outside the submitted work. Dr. McBride has received payment from Pfizer and Amgen for consultancy work, and payment for lectures including service on speakers bureaus from Pfizer and Coherus, all outside the submitted work. Dr. Kelton and Dr. Ryan are full-time employees of and hold stock or options in Pfizer Inc., (© 2022 Harborside™.)

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., Competing Interests: Ms. Podsada has served on speakers bureaus for AstraZeneca, Novartis, and Pfizer, Inc. Ms. Ryan is an employee of Pfizer, Inc. Ms. Orbaugh has served on speakers bureaus for Bristol Myers Squibb, Novartis, Pfizer, Inc, and TEVA., (© 2020 Harborside™.)

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)., Competing Interests: Ms. Allman is a consultant for Exelixis and a speaker for Exelixis, Pfizer, and Sanofi. Ms. Wood received consulting fees from Exelixis and was a speaker for Pfizer and Exelixis. Dr. Ryan and Dr. Clair are employees of and hold stock in Pfizer., (© 2019 Harborside™.)

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.

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.

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.