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Pooja Ghatalia and Elizabeth R. Plimack

Five new PD-1/PD-L1 checkpoint inhibitors have been approved for the treatment of metastatic urothelial carcinoma (UC): pembrolizumab, atezolizumab, durvalumab, nivolumab, and avelumab. Although cisplatin-based chemotherapy remains the recommended frontline option for cisplatin-eligible patients with metastatic UC, immunotherapy is now an available option in the second-line setting as well as the frontline setting for selected cisplatin-ineligible patients who are either unable to tolerate chemotherapy or PD-L1–positive. This review describes the updated clinical efficacy of these checkpoint inhibitors in the treatment of advanced UC and suggests how they can be sequenced in the context of available chemotherapeutic options.

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Estanislao Arana, Francisco M. Kovacs, Ana Royuela, Beatriz Asenjo, Fatima Nagib, Sandra Pérez-Aguilera, María Dejoz, Alberto Cabrera-Zubizarreta, Yolanda García-Hidalgo, Ana Estremera and for the Spanish Back Pain Research Network Task Force for the Improvement of Inter-Disciplinary Management of Spinal Metastasis

Background: MRI is assumed to be valid for distinguishing metastatic vertebral fractures (MVFs) from osteoporotic vertebral fractures (OVFs). This study assessed (1) concordance between the image-based diagnosis of MVF versus OVF and the reference (biopsy or follow-up of >6 months), (2) interobserver and intraobserver agreement on key imaging findings and the diagnosis of MVF versus OVF, and (3) whether disclosing a patient’s history of cancer leads to variations in diagnosis, concordance, or agreement. Patients and Methods: This retrospective cohort study included clinical data and imaging from 203 patients with confirmed MVF or OVF provided to 25 clinicians (neurosurgeons, radiologists, orthopedic surgeons, and radiation oncologists). From January 2018 through October 2018, the clinicians interpreted images in conditions as close as possible to routine practice. Each specialist assessed data twice, with a minimum 6-week interval, blinded to assessments made by other clinicians and to their own previous assessments. The kappa statistic was used to assess interobserver and intraobserver agreement on key imaging findings, diagnosis (MVF vs OVF), and concordance with the reference. Subgroup analyses were based on clinicians’ specialty, years of experience, and complexity of the hospital where they worked. Results: For diagnosis of MVF versus OVF, interobserver agreement was fair, whereas intraobserver agreement was substantial. Only the latter improved to almost perfect when a patient’s history of cancer was disclosed. Interobserver agreement for key imaging findings was fair or moderate, whereas intraobserver agreement on key imaging findings was moderate or substantial. Concordance between the diagnosis of MVF versus OVF and the reference was moderate. Results were similar regardless of clinicians’ specialty, experience, and hospital category. Conclusions: When MRI is used to distinguish MVF versus OVF, interobserver agreement and concordance with the reference were moderate. These results cast doubt on the reliability of basing such a diagnosis on MRI in routine practice.

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John A. Thompson, Bryan J. Schneider, Julie Brahmer, Stephanie Andrews, Philippe Armand, Shailender Bhatia, Lihua E. Budde, Luciano Costa, Marianne Davies, David Dunnington, Marc S. Ernstoff, Matthew Frigault, Benjamin H. Kaffenberger, Matthew Lunning, Suzanne McGettigan, Jordan McPherson, Nisha A. Mohindra, Jarushka Naidoo, Anthony J. Olszanski, Olalekan Oluwole, Sandip P. Patel, Nathan Pennell, Sunil Reddy, Mabel Ryder, Bianca Santomasso, Scott Shofer, Jeffrey A. Sosman, Yinghong Wang, Ryan M. Weight, Alyse Johnson-Chilla, Griselda Zuccarino-Catania and Anita Engh

The NCCN Guidelines for Management of Immunotherapy-Related Toxicities provide interdisciplinary guidance on the management of immune-related adverse events (irAEs) resulting from cancer immunotherapy. These NCCN Guidelines Insights describe symptoms that may be caused by an irAE and should trigger further investigation, and summarize the NCCN Management of Immunotherapy-Related Toxicities Panel discussions for the 2020 update to the guidelines regarding immune checkpoint inhibitor–related diarrhea/colitis and cardiovascular irAEs.

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William R. Kennedy, Christopher Tricarico, Prashant Gabani, Ashley A. Weiner, Michael B. Altman, Laura L. Ochoa, Maria A. Thomas, Julie A. Margenthaler, Souzan Sanati, Lindsay L. Peterson, Cynthia X. Ma, Foluso O. Ademuyiwa and Imran Zoberi

Background: Pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) for triple-negative breast cancer (TNBC) predicts decreased distant metastasis. However, most patients do not experience pCR, and other risk factors for distant metastasis after NAC are poorly characterized. This study investigated factors predictive of distant metastasis in TNBC without pCR after NAC. Methods: Women with TNBC treated with NAC, surgery, and radiation therapy in 2000 through 2013 were reviewed. Freedom from distant metastasis (FFDM) was compared between patients with and without pCR using the Kaplan-Meier method. In patients without pCR, univariate and multivariable Cox analyses were used to determine factors predictive of distant metastasis. Results: We identified 153 patients with median follow-up of 4.0 years (range, 0.5–14.0 years). After NAC, 108 had residual disease (pCR, 29%). Five-year FFDM was 98% and 55% in patients with and without pCR, respectively (P<.001). Factors independently predicting FFDM in patients without pCR were pathologic nodal positivity (hazard ratio, 3.08; 95% CI, 1.54–6.14; P=.001) and lymphovascular space invasion (hazard ratio, 1.91; 95% CI, 1.07–3.43; P=.030). Patients with a greater number of factors had worse FFDM; 5-year FFDM was 76.5% for patients with no factors (n=38) versus 54.9% and 27.5% for patients with 1 (n=44) and 2 factors (n=26), respectively (P<.001). Conclusions: Lack of pCR after NAC resulted in worse overall survival and FFDM, despite trimodality therapy. In patients with residual disease after NAC, pathologic lymph node positivity and lymphovascular space invasion predicted worse FFDM.

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Thomas A. D’Amico, Lindsey A.M. Bandini, Alan Balch, Al B. Benson III, Stephen B. Edge, C. Lyn Fitzgerald, Robert J. Green, Wui-Jin Koh, Michael Kolodziej, Shaji Kumar, Neal J. Meropol, James L. Mohler, David Pfister, Ronald S. Walters and Robert W. Carlson

Although oncology care has evolved, outcome assessment remains a key challenge. Outcome measurement requires identification and adoption of a succinct list of metrics indicative of high-quality cancer care for use within and across healthcare systems. NCCN established an advisory committee, the NCCN Quality and Outcomes Committee, consisting of provider experts from NCCN Member Institutions and other stakeholders, including payers and patient advocacy, community oncology, and health information technology representatives, to review the existing quality landscape and identify contemporary, relevant cancer quality and outcomes measures by reevaluating validated measures for endorsement and proposing new measure concepts to fill crucial gaps. This manuscript reports on 22 measures and concepts; 15 that align with existing measures and 7 that are new.

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Amanda Putri Rahmadian, Seanthel Delos Santos, Shruti Parshad, Louis Everest, Matthew C. Cheung and Kelvin K. Chan

Background: Restricted mean survival time (RMST) overcomes limitations of current measures of survival benefits because it directly captures information of the entire area under Kaplan-Meier survival curves. Using RMST difference (absolute survival benefit) and RMST ratio (relative survival benefit), we quantified the magnitude of survival benefits of recent oncology drugs and compared immunotherapies with nonimmunotherapies. Methods: Kaplan-Meier curves were extracted from phase II/III randomized controlled trials used by the FDA for oncology drug approvals from January 2011 through November 2017 with overall survival (OS) or progression-free survival (PFS) as primary endpoints. RMST differences, ratios, and their 95% confidence intervals were meta-analyzed to estimate absolute and relative survival benefits of contemporary oncology drugs and to compare immunotherapies with nonimmunotherapies. Meta-regression was conducted to adjust for potential confounders. Results: Ninety-four trials with a total of 51,639 patients were included. Overall absolute survival benefits (RMST differences) were 1.55 months for OS (95% CI, 1.32–1.77) and 2.99 months for PFS (95% CI, 2.65–3.33). Overall relative survival benefits (RMST ratios) were 1.11 for OS (95% CI, 1.09–1.13) and 1.42 for PFS (95% CI, 1.36–1.48). Immunotherapy absolute PFS benefit was less than that of nonimmunotherapy (1.56 vs 3.23 months), whereas immunotherapy absolute OS benefit was larger than that of nonimmunotherapy by 0.59 months (2.02 vs 1.43 months). Adjusted OS RMST difference was 0.91 months greater for immunotherapy than for nonimmunotherapy after adjusting for confounders. Conclusions: Absolute survival benefits of recent oncology drugs are modest. Survival benefits of immunotherapies are not dramatically superior to those of nonimmunotherapies. Routine reporting and use of RMST may help patients, physicians, and payers make more informed and responsible decisions regarding the care of patients with cancer.

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Ryan D. Nipp, Leah L. Thompson, Brandon Temel, Charn-Xin Fuh, Christine Server, Paul S. Kay, Sophia Landay, Daniel E. Lage, Lara Traeger, Erin Scott, Vicki A. Jackson, Nora K. Horick, Joseph A. Greer, Areej El-Jawahri and Jennifer S. Temel

Background: Oncologists often struggle with managing the complex issues unique to older adults with cancer, and research is needed to identify patients at risk for poor outcomes. Methods: This study enrolled patients aged ≥70 years within 8 weeks of a diagnosis of incurable gastrointestinal cancer. Patient-reported surveys were used to assess vulnerability (Vulnerable Elders Survey [scores ≥3 indicate a positive screen for vulnerability]), quality of life (QoL; EORTC Quality of Life of Cancer Patients questionnaire [higher scores indicate better QoL]), and symptoms (Edmonton Symptom Assessment System [ESAS; higher scores indicate greater symptom burden] and Geriatric Depression Scale [higher scores indicate greater depression symptoms]). Unplanned hospital visits within 90 days of enrollment and overall survival were evaluated. We used regression models to examine associations among vulnerability, QoL, symptom burden, hospitalizations, and overall survival. Results: Of 132 patients approached, 102 (77.3%) were enrolled (mean [M] ± SD age, 77.25 ± 5.75 years). Nearly half (45.1%) screened positive for vulnerability, and these patients were older (M, 79.45 vs 75.44 years; P=.001) and had more comorbid conditions (M, 2.13 vs 1.34; P=.017) compared with nonvulnerable patients. Vulnerable patients reported worse QoL across all domains (global QoL: M, 53.26 vs 66.82; P=.041; physical QoL: M, 58.95 vs 88.24; P<.001; role QoL: M, 53.99 vs 82.12; P=.001; emotional QoL: M, 73.19 vs 85.76; P=.007; cognitive QoL: M, 79.35 vs 92.73; P=.011; social QoL: M, 59.42 vs 82.42; P<.001), higher symptom burden (ESAS total: M, 31.05 vs 15.00; P<.001), and worse depression score (M, 4.74 vs 2.25; P<.001). Vulnerable patients had a higher risk of unplanned hospitalizations (hazard ratio, 2.38; 95% CI, 1.08–5.27; P=.032) and worse overall survival (hazard ratio, 2.26; 95% CI, 1.14–4.48; P=.020). Conclusions: Older adults with cancer who screen positive as vulnerable experience a higher symptom burden, greater healthcare use, and worse survival. Screening tools to identify vulnerable patients should be integrated into practice to guide clinical care.

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Margaret Tempero