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Emily J. Martin, Andrew R. Bruggeman, Vinit V. Nalawade, Reith R. Sarkar, Edmund M. Qiao, Brent S. Rose and James D. Murphy

Background: Patients with advanced esophageal cancer often experience pain and dysphagia, yet the optimal palliative management remains unclear. This retrospective study evaluated outcomes and adverse effects of palliative radiotherapy (RT) compared with esophageal stenting among a cohort of U.S. veterans with metastatic esophageal cancer. Patients and Methods: We identified 1,957 veterans in the United States with metastatic esophageal cancer who received palliative RT to the esophagus or esophageal stenting, and assessed the risks of severe adverse effects, including esophageal fistula formation, perforation, obstruction, hemorrhage, and esophagitis. We determined palliative efficacy by evaluating pain and dysphagia scores before and after intervention. Multivariable analyses were used to control for potential confounding factors. Results: In our cohort, 1,593 patients underwent RT and 364 underwent esophageal stenting. The cumulative incidence of any severe adverse effect at 6 months was higher among patients who received stents compared with those who received RT (21.7% vs 12.4%; P<.0010). In multivariable analysis, patients who received stents had an increased risk of any severe adverse effect, including fistula, perforation, and hemorrhage (all P<.0500). Multivariable analysis also showed that, compared with stenting, RT was associated with more rapid and durable pain relief (P<.0010) with no difference in relief of dysphagia over time when accounting for pretreatment dysphagia scores (P=.1029). Conclusions: Compared with esophageal stenting, RT was associated with a decreased risk of adverse effects, greater pain relief, and equivalent relief of moderate to severe dysphagia over time. Unmeasured patient- or tumor-related factors could have influenced the choice of intervention, thereby impacting our study outcomes. To our knowledge, this is the largest study to date analyzing the comparative risks and benefits of palliative RT and esophageal stenting among patients with metastatic esophageal cancer.

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Ryan D. Nipp, Brandon Temel, Charn-Xin Fuh, Paul Kay, Sophia Landay, Daniel Lage, Esteban Franco-Garcia, Erin Scott, Erin Stevens, Terrence O’Malley, Supriya Mohile, William Dale, Lara Traeger, Ardeshir Z. Hashmi, Vicki Jackson, Joseph A. Greer, Areej El-Jawahri and Jennifer S. Temel

Background: Oncologists often struggle with managing the unique care needs of older adults with cancer. This study sought to determine the feasibility of delivering a transdisciplinary intervention targeting the geriatric-specific (physical function and comorbidity) and palliative care (symptoms and prognostic understanding) needs of older adults with advanced cancer. Methods: Patients aged ≥65 years with incurable gastrointestinal or lung cancer were randomly assigned to a transdisciplinary intervention or usual care. Those in the intervention arm received 2 visits with a geriatrician, who addressed patients’ palliative care needs and conducted a geriatric assessment. We predefined the intervention as feasible if >70% of eligible patients enrolled in the study and >75% of eligible patients completed study visits and surveys. At baseline and week 12, we assessed patients’ quality of life (QoL), symptoms, and communication confidence. We calculated mean change scores in outcomes and estimated intervention effect sizes (ES; Cohen’s d) for changes from baseline to week 12, with 0.2 indicating a small effect, 0.5 a medium effect, and 0.8 a large effect. Results: From February 2017 through June 2018, we randomized 62 patients (55.9% enrollment rate [most common reason for refusal was feeling too ill]; median age, 72.3 years; cancer types: 56.5% gastrointestinal, 43.5% lung). Among intervention patients, 82.1% attended the first visit and 79.6% attended both. Overall, 89.7% completed all study surveys. Compared with usual care, intervention patients had less QoL decrement (–0.77 vs –3.84; ES = 0.21), reduced number of moderate/severe symptoms (–0.69 vs +1.04; ES = 0.58), and improved communication confidence (+1.06 vs –0.80; ES = 0.38). Conclusions: In this pilot trial, enrollment exceeded 55%, and >75% of enrollees completed all study visits and surveys. The transdisciplinary intervention targeting older patients’ unique care needs showed encouraging ES estimates for enhancing patients’ QoL, symptom burden, and communication confidence.

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Wei Nie, Jie Qian, Mi-Die Xu, Kai Gu, Fang-Fei Qian, Jun Lu, Xue-Yan Zhang, Hui-Min Wang, Bo Yan, Bo Zhang, Shu-Yuan Wang, Fang Hu, Chang-Hui Li, Hua Zhong and Bao-Hui Han

Background: Biomarkers for chemotherapy efficacy in non–small cell lung cancer (NSCLC) are lacking. This retrospective study assesses the association between blood-based tumor mutational burden (bTMB) and clinical benefit of chemotherapy. Methods: Clinical and targeted next-generation sequencing data from the OAK trial (training set; n=318) and POPLAR trial (validation set; n=106) in the docetaxel arm were analyzed. The cutoff value of bTMB for outcome prediction was determined based on a time-dependent receiver operating characteristic curve in the training set, and propensity score matching (PSM) was conducted. The primary outcome was overall survival (OS). Durable clinical benefit (DCB) was defined as OS lasting >12 months. Interaction between treatment and bTMB was assessed in the combined set. Results: A lower bTMB was observed in patients with DCB compared with no durable benefit, and in those with a partial response and stable disease compared with progressive disease. The optimized cutoff value of bTMB for predicting OS was 7 single-nucleotide variants per megabase. In the training set, a low bTMB was significantly associated with longer OS and progression-free survival (PFS). The prognostic value of bTMB was confirmed in the validation set and PSM set. The interaction between bTMB and treatment was significant for PFS (interaction P=.043) in the combined set. Mutations in KEAP1 were associated with high bTMB and a lack of benefit from chemotherapy. Conclusions: Low bTMB is associated with a survival advantage in patients with NSCLC treated with docetaxel, suggesting the prognostic and predictive potential of bTMB for determining chemotherapy efficacy.

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Pelin Cinar, Timothy Kubal, Alison Freifeld, Asmita Mishra, Lawrence Shulman, James Bachman, Rafael Fonseca, Hope Uronis, Dori Klemanski, Kim Slusser, Matthew Lunning and Catherine Liu

The novel coronavirus, SARS-CoV-2, was first detected as a respiratory illness in December 2019 in Wuhan City, China. Since then, coronavirus disease 2019 (COVID-19) has impacted every aspect of our lives worldwide. In a time when terms such as social distancing and flattening the curve have become a part of our vernacular, it is essential that we understand what measures can be implemented to protect our patients and healthcare workers. Undoubtedly, healthcare providers have had to rapidly alter care delivery models while simultaneously acknowledging the crucial unknowns of how these changes may affect clinical outcomes. This special feature reviews strategies on how to mitigate transmission of COVID-19 in an effort to reduce morbidity and mortality associated with the disease for patients with cancer without infection, for patients with cancer with COVID-19 infection, and for the healthcare workers caring for them, while continuing to provide the best possible cancer care. [Editor’s Note: This article includes the most current information available at time of publication; however, recommendations regarding public safety and practice may change rapidly in this situation. Individuals should get the most up to date information from the CDC website.]

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William J. Gradishar, Benjamin O. Anderson, Jame Abraham, Rebecca Aft, Doreen Agnese, Kimberly H. Allison, Sarah L. Blair, Harold J. Burstein, Chau Dang, Anthony D. Elias, Sharon H. Giordano, Matthew P. Goetz, Lori J. Goldstein, Steven J. Isakoff, Jairam Krishnamurthy, Janice Lyons, P. Kelly Marcom, Jennifer Matro, Ingrid A. Mayer, Meena S. Moran, Joanne Mortimer, Ruth M. O'Regan, Sameer A. Patel, Lori J. Pierce, Hope S. Rugo, Amy Sitapati, Karen Lisa Smith, Mary Lou Smith, Hatem Soliman, Erica M. Stringer-Reasor, Melinda L. Telli, John H. Ward, Jessica S. Young, Jennifer L. Burns and Rashmi Kumar

Several new systemic therapy options have become available for patients with metastatic breast cancer, which have led to improvements in survival. In addition to patient and clinical factors, the treatment selection primarily depends on the tumor biology (hormone-receptor status and HER2-status). The NCCN Guidelines specific to the workup and treatment of patients with recurrent/stage IV breast cancer are discussed in this article.

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Alyssa A. Schatz, Thomas K. Oliver, Robert A. Swarm, Judith A. Paice, Deepika S. Darbari, Deborah Dowell, Salimah H. Meghani, Katy Winckworth-Prejsnar, Eduardo Bruera, Robert M. Plovnick, Lisa Richardson, Neha Vapiwala, Dana Wollins, Clifford A. Hudis and Robert W. Carlson

Opioids are a critical component of pain relief strategies for the management of patients with cancer and sickle cell disease. The escalation of opioid addiction and overdose in the United States has led to increased scrutiny of opioid prescribing practices. Multiple reports have revealed that regulatory and coverage policies, intended to curb inappropriate opioid use, have created significant barriers for many patients. The Centers for Disease Control and Prevention, National Comprehensive Cancer Network, and American Society of Clinical Oncology each publish clinical practice guidelines for the management of chronic pain. A recent JAMA Oncology article highlighted perceived variability in recommendations among these guidelines. In response, leadership from guideline organizations, government representatives, and authors of the original article met to discuss challenges and solutions. The meeting featured remarks by the Commissioner of Food and Drugs, presentations on each clinical practice guideline, an overview of the pain management needs of patients with sickle cell disease, an overview of perceived differences among guidelines, and a discussion of differences and commonalities among the guidelines. The meeting revealed that although each guideline varies in the intended patient population, target audience, and methodology, there is no disagreement among recommendations when applied to the appropriate patient and clinical situation. It was determined that clarification and education are needed regarding the intent, patient population, and scope of each clinical practice guideline, rather than harmonization of guideline recommendations. Clinical practice guidelines can serve as a resource for policymakers and payers to inform policy and coverage determinations.

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Helmneh M. Sineshaw, K. Robin Yabroff, V. Liana Tsikitis, Ahmedin Jemal and Timur Mitin

Background: Elderly patients with rectal cancer have been excluded from randomized studies, thus little is known about their early postoperative mortality, which is critical for informed consent and treatment decisions. This study examined early mortality after surgery in elderly patients with locally advanced rectal cancer (LARC). Methods: Using the National Cancer Database, we identified patients aged ≥75 years, diagnosed with clinical stage II/III rectal cancer who underwent surgery in 2004 through 2015. Descriptive analyses determined proportions and trends and multivariable logistic regression analyses were performed to determine factors associated with early mortality after rectal cancer surgery. Results: Among 11,794 patients with rectal cancer aged ≥75 years, approximately 6% underwent local excision and 94% received radical resection. Overall 30-day, 90-day, and 6-month postoperative mortality rates were 4.2%, 7.8%, and 11.5%, respectively. Six-month mortality varied by age (8.4% in age 75–79 years to 18.3% in age ≥85 years), and comorbidity score (10.1% for comorbidity score 0 to 17.7% for comorbidity score ≥2). Six-month mortality declined from 12.3% in 2004 through 2007 to 10.2% in 2012 through 2015 (Ptrend=.0035). Older age, higher comorbidity score, and lower facility case volume were associated with higher 6-month mortality. Patients treated at NCI-designated centers had 30% lower odds of 6-month mortality compared with those treated at teaching/research centers. Conclusions: Six-month mortality rates after surgery among patients aged ≥75 years with LARC have declined steadily over the past decade in the United States. Older age, higher comorbidity score, and care at a low-case-volume facility were associated with higher 6-month mortality after surgery. This information is necessary for informed consent and decisions regarding optimal management of elderly patients with LARC.

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Ami M. Vyas, Hilary Aroke and Stephen Kogut

Background: It is crucial to identify whether women with HER2-positive (HER2+) metastatic breast cancer (MBC) are treated according to treatment guidelines and whether treatment disparities exist. This study examined guideline-concordant treatment among women with HER2+ MBC and determined the magnitude of differences in treatment between those with positive and negative hormone receptor (HR) status using a nonlinear decomposition technique. Methods: A retrospective observational cohort study was conducted using the SEER-Medicare linked database. The study cohort consisted of women aged ≥66 years diagnosed with HER2+ MBC in 2010 through 2013 (n=241). Guideline-concordant initial treatment after cancer diagnosis was defined based on the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer. A multivariable logistic regression was performed to identify significant predictors of guideline-concordant treatment. A postregression decomposition was conducted to identify the magnitude of disparities in treatment by HR status. Results: Of 241 women included in the study, a total of 76.8% received guideline-concordant treatment. These women were significantly more likely to have positive HR status (P=.0298), have good performance status (P=.0009), and more oncology visits (P<.0001). With 1-year increments in age at cancer diagnosis, the likelihood of receiving guideline-concordant treatment reduced by 5% (P=.0356). The decomposition analysis revealed that 19.0% of the disparity in guideline-concordant treatment between women with positive and negative HR status was explained by differences in their characteristics. Enabling characteristics (marital status, income, and education) explained the highest (22.8%) proportion of the disparity. Conclusions: Nearly one-quarter of the study cohort did not receive guideline-concordant treatment. Our findings suggest opportunities to improve cancer care for elderly women with negative HR status who are unpartnered or have lower socioeconomic status. The high unexplained portion of the disparity by HR status can be due to patient treatment preferences, propensity to seek care, and organizational and physician-level characteristics that were not included in the study.

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Margaret Tempero