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Disparities in Adjuvant Endocrine Therapy

Elizabeth J. Cathcart-Rake and Kathryn J. Ruddy

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Calcium and Magnesium Use for Oxaliplatin-Induced Neuropathy: A Case Study to Assess How Quickly Evidence Translates Into Practice

Deirdre R. Pachman, Kathryn Ruddy, Lindsey R. Sangaralingham, Axel Grothey, Nilay D. Shah, Andreas S. Beutler, Joleen M. Hubbard, and Charles L. Loprinzi

Substantial research efforts have focused on methods of treating and preventing oxaliplatin-associated neuropathy, the dose-limiting toxicity associated with this drug. Administration of intravenous calcium and magnesium (CaMg) before and after oxaliplatin has been the most studied approach to preventing oxaliplatin-induced neuropathy. Although early reports demonstrated potential benefit, subsequent larger trials failed to confirm the efficacy of CaMg in preventing this adverse effect. This article explores how accumulating evidence for and against the use of CaMg for preventing oxaliplatin-induced neuropathy has impacted clinical practice.

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What the HEC? Clinician Adherence to Evidence-Based Antiemetic Prophylaxis for Highly Emetogenic Chemotherapy

Eric J. Roeland, Kathryn J. Ruddy, Thomas W. LeBlanc, Ryan D. Nipp, Gary Binder, Silvia Sebastiani, Ravi Potluri, Luke Schmerold, Eros Papademetriou, Lee Schwartzberg, and Rudolph M. Navari

Background: Clinician adherence to antiemetic guidelines for preventing chemotherapy-induced nausea and vomiting (CINV) caused by highly emetogenic chemotherapy (HEC) remains poorly characterized. The primary aim of this study was to evaluate individual clinician adherence to HEC antiemetic guidelines. Patients and Methods: A retrospective analysis of patients receiving HEC was conducted using the IBM Watson Explorys Electronic Health Record Database (2012–2018). HEC antiemetic guideline adherence was defined as prescription of triple prophylaxis (neurokinin-1 receptor antagonist [NK1 RA], serotonin type-3 receptor antagonist, dexamethasone) at initiation of cisplatin or anthracycline + cyclophosphamide (AC). Clinicians who prescribed ≥5 HEC courses were included and individual guideline adherence was assessed, noting the number of prescribing clinicians with >90% adherence. Results: A total of 217 clinicians were identified who prescribed 2,543 cisplatin and 1,490 AC courses. Patients (N=4,033) were primarily women (63.3%) and chemotherapy-naïve (92%) with a mean age of 58.6 years. Breast (36%) and thoracic (19%) cancers were the most common tumor types. Guideline adherence rates of >90% were achieved by 35% and 58% of clinicians using cisplatin or AC, respectively. Omission of an NK1 RA was the most common practice of nonadherence. Variation in prophylaxis guideline adherence was considerable for cisplatin (mean, 71%; SD, 29%; coefficient of variation [CV], 0.40) and AC (mean, 84%; SD, 26%; CV, 0.31). Conclusions: Findings showed substantial gaps in clinician adherence to HEC CINV guidelines, including a high variability across clinicians. Clinicians should review their individual clinical practices and ensure adherence to evidence-based CINV guidelines to optimize patient care.

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Ten-Year Trends in Antiemetic Prescribing in Patients Receiving Highly Emetogenic Chemotherapy

Ciara C. O'Sullivan, Holly K. Van Houten, Lindsey R. Sangaralingham, Alexis D. Leal, Shivani Shinde, Hongfang Liu, David Ettinger, Charles L. Loprinzi, and Kathryn J. Ruddy

Purpose: Prevention of chemotherapy-induced nausea and vomiting is essential to preserve quality of life in patients with cancer receiving highly emetogenic chemotherapy (HEC). Recently, new drugs (eg, fosaprepitant, and the newer neurokinin-1 receptor antagonists [NK1RAs] rolapitant and netupitant) and updated antiemetic guidelines have emerged. However, trends in real-world antiemetic use are understudied. Methods: We identified patients treated with an initial dose of HEC (either cisplatin or doxorubicin/cyclophosphamide) from January 2006 to June 2016 using administrative claims data from a US commercial insurance database (OptumLabs). Antiemetic use was determined by identifying intravenous/oral/transdermal administration within ±1 day of the chemotherapy dose and/or prescription fill from 14 days before to 7 days after chemotherapy. We used descriptive statistics to present patient demographics, chemotherapy drugs administered, presence/absence of a central intravenous access device, and antiemetics used. Results: A total of 23,030 patients (67.3%) received doxorubicin/cyclophosphamide and 11,206 (32.7%) received cisplatin. Dexamethasone and 5-hydroxytryptamine 3 receptor antagonists (5-HT3RAs) were consistently used by 85% to 95% of patients, consistent with guideline recommendations. NK1RAs were underused early on, but use increased to approximately 80% in the most recently evaluated year. Fosaprepitant use increased precipitously starting in 2009, preceding a sharp decrease in aprepitant use beginning in 2011. Receipt of olanzapine, rolapitant, and netupitant was minimal throughout the study period. Conclusions: Dexamethasone and 5-HT3RAs were used by most patients receiving HEC, in accordance with guideline recommendations. NK1RA use was less adherent with guidelines.

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BPI22-021: Surveillance Mammography in Elderly Breast Cancer Survivors (Project Funded by Breast Cancer Research Foundation)

Dhauna Prasad Karam, Robert A. Vierkant, Shawna Ehlers, Rachel A. Freedman, Jessica Austin, Sadia Choudhery, Nicole Larson, Charles Loprinzi, Janet E. Olson, Fergus Couch, and Kathryn J. Ruddy

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BPI19-019: Avoidable Acute Care Use Associated With Nausea and Vomiting Among Patients Receiving Highly Emetogenic Chemotherapy or Oxaliplatin

Eric J Roeland, Thomas W. LeBlanc, Kathryn J. Ruddy, Ryan Nipp, Rebecca Clark-Snow, Rita Wickham, Gary Binder, William L. Bailey, Ravi Potluri, Luke M. Schmerold, Eros Papademetriou, and Rudolph M. Navari

Background: Avoiding acute care services can improve cancer care and reduce cost. The US Centers for Medicare and Medicaid Services’ (CMS) new oncology outcome measure (OP-35) defines 30-day post-chemotherapy inpatient (IP) and/or emergency department (ED) events (IP/ED) as “potentially avoidable” if involving any of 10 toxicities, including nausea or vomiting (NV). Evidence demonstrates meaningful gaps in oncologists’ adherence to antiemetic prophylaxis guidelines for highly emetogenic chemotherapy (HEC), and that NV-related IP use costs >$10,000; yet the incidence of avoidable acute care events involving NV is not well studied. Methods: We assessed chemotherapy courses using IBM Explorys electronic health records (4Q 2012–1Q 2018). We identified rates of IP/ED ≤30 days post-chemotherapy, and OP-35 toxicities (NV, anemia, dehydration, diarrhea, fever, neutropenia, pain, pneumonia, or sepsis) by ICD-9, ICD-10, procedure codes, and CMS criteria. We evaluated cisplatin, anthracycline + cyclophosphamide (AC), carboplatin (>14 days apart, as a proxy for AUC ≥4), oxaliplatin (OX), and other non-HEC chemotherapy. We assessed guideline adherence, defined as triple prophylaxis (NK1 RA + 5HT3 RA +dexamethasone) rates at HEC initiation. Results: In 17,609 HEC and 56,624 non-HEC courses, we observed 30-day IP/ED utilization in 29% and 19% of courses, respectively (). For HEC, 76% of IP/ED use involved ≥1 of the 10 CMS toxicities, most often anemia (42%), pain (41%), dehydration (24%), and NV (24%). Rates of all-cause IP/ED, IP/ED with OP-35 toxicity, and NV-related IP/ED were consistent for HEC and OX. Gaps in triple prophylaxis were common in HEC. Conclusion: Roughly one-third of patients receiving HEC or OX experienced IP/ED events ≤30 days after chemotherapy. Three-quarters of IP/ED events involved ≥1 of 10 OP-35 toxicities linked by CMS to potentially avoidable acute care; of these, one-third involved NV. NV-associated acute care use is considerable, costly, and potentially avoidable with better adherence to antiemesis guidelines.

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Adherence to Guidelines for Breast Surveillance in Breast Cancer Survivors

Kathryn J. Ruddy, Lindsey Sangaralingham, Rachel A. Freedman, Sarah S. Mougalian, Heather Neuman, Caprice Greenberg, Ahmedin Jemal, Narjust Duma, Tufia C. Haddad, Valerie Lemaine, Karthik Ghosh, Tina J. Hieken, Katie Hunt, Celine Vachon, Cary P. Gross, and Nilay D. Shah

Background: Guidelines recommend annual mammography after curative-intent treatment for breast cancer. The goal of this study was to assess contemporary patterns of breast imaging after breast cancer treatment. Methods: Administrative claims data were used to identify privately insured and Medicare Advantage beneficiaries with nonmetastatic breast cancer who had residual breast tissue (not bilateral mastectomy) after breast surgery between January 2005 and May 2015. We calculated the proportion of patients who had a mammogram, MRI, both, or neither during each of 5 subsequent 13-month periods. Multinomial logistic regression was used to assess associations between patient characteristics, healthcare use, and breast imaging in the first and fifth years after surgery. Results: A total of 27,212 patients were followed for a median of 2.9 years (interquartile range, 1.8–4.6) after definitive breast cancer surgery. In year 1, 78% were screened using mammography alone, 1% using MRI alone, and 8% using both tests; 13% did not undergo either. By year 5, the proportion of the remaining cohort (n=4,790) who had no breast imaging was 19%. Older age was associated with an increased likelihood of mammography and a decreased likelihood of MRI during the first and fifth years. Black race, mastectomy, chemotherapy, and no MRI at baseline were all associated with a decreased likelihood of both types of imaging. Conclusions: Even in an insured cohort, a substantial proportion of breast cancer survivors do not undergo annual surveillance breast imaging, particularly as time passes. Understanding factors associated with imaging in cancer survivors may help improve adherence to survivorship care guidelines.

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Real-World Implementation of Best-Evidence Cancer Distress Management: Truly Comprehensive Cancer Care

Shawna L. Ehlers, Lisa M. Gudenkauf, Elizabeth L. Kacel, Sherrie M. Hanna, Pam S. Sinicrope, Christi A. Patten, Eleshia L. Morrison, Jill Snuggerud, Danielle Bevis, Janae L. Kirsch, Jeffrey P. Staab, Katharine A.R. Price, Andrea E. Wahner-Hendrickson, and Kathryn J. Ruddy

Background: Cancer distress management is an evidence-based component of comprehensive cancer care. Group-delivered cognitive behavioral therapy for cancer distress (CBT-C) is the first distress treatment associated with replicated survival advantages in randomized clinical trials. Despite research supporting patient satisfaction, improved outcomes, and reduced costs, CBT-C has not been tested sufficiently within billable clinical settings, profoundly reducing patient access to best-evidence care. This study aimed to adapt and implement manualized CBT-C as a billable clinical service. Patients and Methods: A stakeholder-engaged, mixed-methods, hybrid implementation study design was used, and the study was conducted in 3 phases: (1) stakeholder engagement and adaptation of CBT-C delivery, (2) patient and therapist user testing and adaptation of CBT-C content, and (3) implementation of practice-adapted CBT-C as a billable clinical service focused on evaluation of reach, acceptability, and feasibility across stakeholder perspectives. Results: A total of 40 individuals and 7 interdisciplinary group stakeholders collectively identified 7 primary barriers (eg, number of sessions, workflow concerns, patient geographic distance from center) and 9 facilitators (eg, favorable financial model, emergence of oncology champions). CBT-C adaptations made before implementation included expanding eligibility criteria beyond breast cancer, reducing number of sessions to 5 (10 total hours), eliminating and adding content, and revising language and images. During implementation, 252 patients were eligible; 100 (40%) enrolled in CBT-C (99% covered by insurance). The primary reason for declining enrollment was geographic distance. Of enrollees, 60 (60%) consented to research participation (75% women; 92% white). All research participants completed at least 60% of content (6 of 10 hours), with 98% reporting they would recommend CBT-C to family and friends. Conclusions: CBT-C implementation as a billable clinical service was acceptable and feasible across cancer care stakeholder measures. Future research is needed to replicate acceptability and feasibility results in more diverse patient groups, test effectiveness in clinical settings, and reduce barriers to access via remote delivery platforms.

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Impact of Anti-HER2 Therapy Alone and With Weekly Paclitaxel on the Ovarian Reserve of Young Women With HER2-Positive Breast Cancer

Matteo Lambertini, Marcello Ceppi, Richard A. Anderson, David A. Cameron, Marco Bruzzone, Maria Alice Franzoi, Claudia Massarotti, Sarra El-Abed, Yingbo Wang, Christophe Lecocq, Paolo Nuciforo, Rebecca Rolyance, Lajos Pusztai, Joohyuk Sohn, Maria Maddalena Latocca, Luca Arecco, Barbara Pistilli, Kathryn J. Ruddy, Alberto Ballestrero, Lucia Del Mastro, Fedro A. Peccatori, Ann H. Partridge, Cristina Saura, Michael Untch, Martine Piccart, Serena Di Cosimo, Evandro de Azambuja, and Isabelle Demeestere

Background: The potential gonadotoxicity of anti-HER2 agents remains largely unknown, and limited, conflicting evidence exists for taxanes. Antimüllerian hormone (AMH) is an established biomarker of ovarian reserve that may aid in quantifying anticancer treatment–induced gonadotoxicity. Patients and Methods: The present biomarker analysis of the randomized phase III neoadjuvant NeoALTTO trial included premenopausal women aged ≤45 years at diagnosis of HER2-positive early breast cancer with available frozen serum samples at baseline (ie, before anticancer treatments), at week 2 (ie, the “biological window” of anti-HER2 therapy alone), and/or at the time of surgery (ie, after completing paclitaxel + anti-HER2 therapy, before starting adjuvant chemotherapy). Results: The present analysis included 130 patients with a median age of 38 years (interquartile ratio [IQR], age 33–42 years). AMH values at the 3 time points differed significantly (P<.001). At baseline, median AMH levels were 1.29 ng/mL (IQR, 0.56–2.62 ng/mL). At week 2, a small but significant reduction in AMH levels was observed (median, 1.10 ng/mL; IQR, 0.45–2.09 ng/mL; P<.001). At surgery, a larger significant decline in AMH levels was observed (median, 0.01 ng/mL; IQR, 0.01–0.03 ng/mL; P<.001). Although the type of anti-HER2 treatment (trastuzumab and/or lapatinib) did not seem to impact the results, age and pretreatment ovarian reserve had a major influence on treatment-induced gonadotoxicity risk. Conclusions: This NeoALTTO biomarker analysis showed that anti-HER2 therapies alone had limited gonadotoxicity but that the addition of weekly paclitaxel resulted in marked AMH decline with possible negative implications for subsequent ovarian function and fertility.

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Survivorship, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology

Crystal S. Denlinger, Tara Sanft, K. Scott Baker, Gregory Broderick, Wendy Demark-Wahnefried, Debra L. Friedman, Mindy Goldman, Melissa Hudson, Nazanin Khakpour, Allison King, Divya Koura, Robin M. Lally, Terry S. Langbaum, Allison L. McDonough, Michelle Melisko, Jose G. Montoya, Kathi Mooney, Javid J. Moslehi, Tracey O'Connor, Linda Overholser, Electra D. Paskett, Jeffrey Peppercorn, William Pirl, M. Alma Rodriguez, Kathryn J. Ruddy, Paula Silverman, Sophia Smith, Karen L. Syrjala, Amye Tevaarwerk, Susan G. Urba, Mark T. Wakabayashi, Phyllis Zee, Nicole R. McMillian, and Deborah A. Freedman-Cass

The NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for common physical and psychosocial consequences of cancer and cancer treatment to help healthcare professionals who work with survivors of adult-onset cancer in the posttreatment period. This portion of the guidelines describes recommendations regarding the management of anthracycline-induced cardiotoxicity and lymphedema. In addition, recommendations regarding immunizations and the prevention of infections in cancer survivors are included.