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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

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Zhiyuan Zheng, Ahmedin Jemal, Reginald Tucker-Seeley, Matthew P. Banegas, Xuesong Han, Ashish Rai, Jingxuan Zhao and K. Robin Yabroff

Background: A cancer diagnosis can impose substantial medical financial burden on individuals and may limit their ability to work. However, less is known about worry for nonmedical financial needs and food insecurity among cancer survivors. Methods: The National Health Interview Survey (2013–2017) was used to identify cancer survivors (age 18–39 years, n=771; age 40–64 years, n=4,269; age ≥65 years, n=7,101) and individuals without a cancer history (age 18–39 years, n=53,262; age 40–64 years, n=60,141; age ≥65 years, n=30,261). For both cancer survivors and the noncancer group, adjusted proportions were generated for (1) financial worry (“very/moderately/not worried”) about retirement, standard of living, monthly bills, and housing costs; and (2) food insecurity (“often/sometimes/not true”) regarding whether food would run out, the fact that food bought did not last, and the inability to afford balanced meals. Further adjusted analyses examined intensity measures (“severe/moderate/minor or none”) of financial worry and food insecurity among cancer survivors only. Results: Compared with individuals without a cancer history, cancer survivors aged 18 to 39 years reported consistently higher “very worried” levels regarding retirement (25.5% vs 16.9%; P<.001), standard of living (20.4% vs 12.9%; P<.001), monthly bills (14.9% vs 10.3%; P=.002), and housing costs (13.6% vs 8.9%; P=.001); and higher “often true” levels regarding worry about food running out (7.9% vs 4.6%; P=.004), food not lasting (7.6% vs 3.3%; P=.003), and being unable to afford balanced meals (6.3% vs 3.4%; P=.007). Findings were not as consistent for cancer survivors aged 40 to 64 years. In contrast, results were generally similar for adults aged ≥65 years with/without a cancer history. Among cancer survivors, 57.6% (age 18–39 years; P<.001), 51.9% (age 40–64 years; P<.001), and 23.8% (age ≥65 years; referent) reported severe/moderate financial worry intensity, and 27.0% (age 18–39 years; P<.001), 14.8% (age 40–64 years; P<.001), and 6.3% (age ≥65 years; referent) experienced severe/moderate food insecurity intensity. Lower income and higher comorbidities were generally associated with greater intensities of financial worry and food insecurity in all 3 age groups. Conclusions: Younger cancer survivors experience greater financial worry and food insecurity. In addition to coping with medical costs, cancer survivors with low income and multiple comorbidities struggle to pay for daily living needs, such as food, housing, and monthly bills.

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William G. Wierda, John C. Byrd, Jeremy S. Abramson, Syed F. Bilgrami, Greg Bociek, Danielle Brander, Jennifer Brown, Asher A. Chanan-Khan, Julio C. Chavez, Steve E. Coutre, Randall S. Davis, Christopher D. Fletcher, Brian Hill, Brad S. Kahl, Manali Kamdar, Lawrence D. Kaplan, Nadia Khan, Thomas J. Kipps, Megan S. Lim, Shuo Ma, Sami Malek, Anthony Mato, Claudio Mosse, Mazyar Shadman, Tanya Siddiqi, Deborah Stephens, Suchitra Sundaram, Nina Wagner, Mary Dwyer and Hema Sundar

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are characterized by a progressive accumulation of leukemic cells in the peripheral blood, bone marrow, and lymphoid tissues. Treatment of CLL/SLL has evolved significantly in recent years because of the improved understanding of the disease biology and the development of novel targeted therapies. In patients with indications for initiating treatment, the selection of treatment should be based on the disease stage, patient’s age and overall fitness (performance status and comorbid conditions), and cytogenetic abnormalities. This manuscript discusses the recommendations outlined in the NCCN Guidelines for the diagnosis and management of patients with CLL/SLL.

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Jaideep Sandhu, Chongkai Wang and Marwan Fakih

HER2 amplification has been identified in 2% to 3% of all colorectal cancers (CRCs). Although the prognostic role of HER2 amplification in metastatic CRC (mCRC) is unclear, studies have highlighted it as a therapeutic target. In addition, several studies have shown that HER2 amplification is implicated in the resistance to EGFR-targeted therapies. Other studies have provided scientific evidence to support the use of HER2-directed therapies in HER2-amplified CRC; however, thus far this benefit has been limited to the RAS wild-type population. There is an ongoing clinical need to identify novel means of targeting HER2 amplifications in the rare settings of HER2-amplified, RAS-mutated CRC. This case report presents a 58-year-old man with HER2-amplified mCRC and a KRAS G12D mutation whose disease progressed on all standard cytotoxic therapies as well as dual HER2 targeting using trastuzumab and pertuzumab. He subsequently derived a clinical benefit with metastatic lung disease regression on trastuzumab emtansine (T-DM1). He eventually experienced disease progression in the liver after 6 every-3-week cycles. The patient’s response and disease progression were associated with ongoing decline in the HER2 copy number on the circulating tumor DNA assay, suggesting that the mechanism of resistance was related to the loss of HER2 amplification or the emergence of non–HER2-amplified CRC clones. This represents the first report of clinical benefit with T-DM1 in KRAS-mutated HER2-amplified CRC.