Background: This study evaluated the effectiveness of a screening and stepped care program (the TES program) in reducing psychological distress compared with care as usual (CAU) in patients with metastatic colorectal cancer starting with first-line systemic palliative treatment. Patients and Methods: In this cluster randomized trial, 16 hospitals were assigned to the TES program or CAU. Patients in the TES arm were screened for psychological distress with the Hospital Anxiety and Depression Scale and the Distress Thermometer/Problem List (at baseline and 10 and 18 weeks). Stepped care was offered to patients with distress or expressed needs, and it consisted of watchful waiting, guided self-help, face-to-face problem-solving therapy, or referral to specialized mental healthcare. The primary outcome was change in psychological distress over time, and secondary outcomes were quality of life, satisfaction with care, and recognition and referral of distressed patients by clinicians. Linear mixed models and effect sizes were used to evaluate differences. Results: A total of 349 patients were randomized; 184 received the TES program and 165 received CAU. In the TES arm, 60.3% of the patients screened positive for psychological distress, 26.1% of which entered the stepped care program (14.7% used only watchful waiting and 11.4% used at least one of the other treatment steps). The observed low use of the TES program led us to pursue a futility analysis, which showed a small conditional power and therefore resulted in halted recruitment for this study. No difference was seen in change in psychological distress over time between the 2 groups (effect size, −0.16; 95% CI, −0.35 to 0.03; P>.05). The TES group reported higher satisfaction with the received treatment and better cognitive quality of life (all P<.05). Conclusions: As a result of the low use of stepped care, a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer did not improve psychological distress. Our results suggest that enhanced evaluation of psychosocial concerns may improve aspects of patient well-being.
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Claudia S.E.W. Schuurhuizen, Annemarie M.J. Braamse, Aartjan T.F. Beekman, Pim Cuijpers, Mecheline H.M. van der Linden, Adriaan W. Hoogendoorn, Hans Berkhof, Dirkje W. Sommeijer, Vera Lustig, Suzan Vrijaldenhoven, Haiko J. Bloemendal, Cees J. van Groeningen, Annette A. van Zweeden, Maurice J.D.L. van der Vorst, Ron Rietbroek, Cathrien S. Tromp-van Driel, Machteld N.W. Wymenga, Peter W. van der Linden, Aart Beeker, Marco B. Polee, Erdogan Batman, Maartje Los, Aart van Bochove, Jan A.C. Brakenhoff, Inge R.H.M. Konings, Henk M.W. Verheul and Joost Dekker
Samuel L. Aitken, Jerod L. Nagel, Lilian Abbo, William Alegria, Jason N. Barreto, Sanjeet Dadwal, Alison G. Freifeld, Rupali Jain, Steven A. Pergam, Frank P. Tverdek, Susan K. Seo and on behalf of the Antimicrobial Stewardship in Cancer Consortium ASCC
Zi-Xian Wang, Hao-Xiang Wu, Ming-Ming He, Ying-Nan Wang, Hui-Yan Luo, Pei-Rong Ding, Dan Xie, Gong Chen, Yu-Hong Li, Feng Wang and Rui-Hua Xu
Background: Previous meta-analyses have suggested primary tumor location as a predictive factor for efficacy of anti–epidermal growth factor receptor (EGFR) therapies in patients with metastatic colorectal cancer (mCRC). However, the recent phase III TAILOR trial addressing this issue was not included in those analyses. This meta-analysis incorporated data from the TAILOR trial to evaluate the efficacy of chemotherapy plus anti-EGFR agents (cetuximab [Cet] or panitumumab [Pani]) versus chemotherapy alone for RAS wild-type (wt) right- and left-sided mCRC. Patients and Methods: A PubMed-based literature search was conducted to identify randomized controlled trials (RCTs) studying the additional efficacy of Cet/Pani in combination with chemotherapy versus chemotherapy alone in RAS wt left- and right-sided mCRC. Study-level pooled analyses of hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS) and odds ratios (ORs) for objective response rate (ORR) were performed. Results: Three first-line RCTs (CRYSTAL, PRIME, and TAILOR) and one second-line RCT (20050181) were included. Significant OS benefits from Cet/Pani were observed in the left-sided (HR, 0.76; 95% CI, 0.66–0.86) but not right-sided subgroups (HR, 0.99; 95% CI, 0.78–1.27). However, the addition of Cet/Pani to chemotherapy significantly improved PFS and ORR in both the left-sided (HR, 0.70; 95% CI, 0.57–0.86, and OR, 3.28; 95% CI, 1.95–5.51, respectively) and right-sided subgroups (HR, 0.76; 95% CI, 0.59–0.99, and OR, 1.78; 95% CI, 1.08–2.93, respectively). Conclusions: The addition of Cet/Pani to chemotherapy significantly benefits PFS and ORR in patients with RAS wt right-sided mCRC, indicating that anti-EGFR therapies may remain an option for selected patients.
Suneel D. Kamath, Sheetal M. Kircher and Al B. Benson III
Background: Nonprofit organizations (NPOs) in oncology are vital for patient advocacy and funding research for rare cancers, young investigators, and innovative projects. However, some cancers may be underfunded relative to their burden. This study examined the alignment of cancer burden by histology with NPO funding for each histology. Patients and Methods: This nationwide, cross-sectional study conducted from October 2017 through February 2018 included all oncology NPOs with >$5 million in annual revenue. Total revenue from NPOs supporting individual cancer types with the incidence, mortality, and person-years of life lost (PYLL) for each cancer type was compared using scatter plots and Pearson correlation coefficients. Correlation of expenditure types (eg, fundraising, patient education) with revenue was assessed using Pearson correlation coefficients. Effect of disease association with a stigmatized behavior (eg, lung cancer and smoking) was evaluated using descriptive statistics. Results: A total of 119 cancer-related NPOs were included, generating approximately $6 billion in annual revenue in 2015. Cancers with the largest revenue were breast cancer ($460 million; 33.2%), leukemia ($201 million; 14.5%), pediatric cancers ($177 million; 12.8%), and lymphoma ($145 million; 10.5%). Breast cancer, leukemia, lymphoma, and pediatric cancers were all well funded compared with their incidence, mortality, and PYLL. Gastrointestinal (colorectal, pancreas, and hepatobiliary), gynecologic (ovarian, cervical, and endometrial), brain, and lung cancers were poorly funded in all 3 metrics. All cancers associated with a stigmatized behavior were poorly funded in at least 2 metrics. Increased spending on fundraising, administrative costs, patient education, and treatment was highly correlated with increased revenue (Pearson correlation coefficients all >0.92). Conclusions: NPO funding by cancer type is not proportionate with individual cancer burden on society. Disease stigma negatively impacts funding. A significant need exists to increase awareness and funding for many undersupported but common and highly lethal cancers.
Ang Li, Qian Wu, Suhong Luo, Greg S. Warnick, Neil A. Zakai, Edward N. Libby, Brian F. Gage, David A. Garcia, Gary H. Lyman and Kristen M. Sanfilippo
Background: Although venous thromboembolism (VTE) is a significant complication for patients with multiple myeloma (MM) receiving immunomodulatory drugs (IMiDs), no validated clinical model predicts VTE in this population. This study aimed to derive and validate a new risk assessment model (RAM) for IMiD-associated VTE. Methods: Patients with newly diagnosed MM receiving IMiDs were selected from the SEER-Medicare database (n=2,397) to derive a RAM and then data from the Veterans Health Administration database (n=1,251) were used to externally validate the model. A multivariable cause-specific Cox regression model was used for model development. Results: The final RAM, named the “SAVED” score, included 5 clinical variables: prior surgery, Asian race, VTE history, age ≥80 years, and dexamethasone dose. The model stratified approximately 30% of patients in both the derivation and the validation cohorts as high-risk. Hazard ratios (HRs) were 1.85 (P<.01) and 1.98 (P<.01) for high- versus low-risk groups in the derivation and validation cohorts, respectively. In contrast, the method of stratification recommended in the current NCCN Guidelines for Cancer-Associated Venous Thromboembolic Disease had HRs of 1.21 (P=.17) and 1.41 (P=.07) for the corresponding risk groups in the 2 datasets. Conclusions: The SAVED score outperformed the current NCCN Guidelines in risk-stratification of patients with MM receiving IMiD therapy. This clinical model can help inform providers and patients of VTE risk before IMiD initiation and provides a simplified clinical backbone for further prognostic biomarker development in this population.
Jenna F. Borkenhagen, Daniel Eastwood, Deepak Kilari, William A. See, Jonathan D. Van Wickle, Colleen A. Lawton and William A. Hall
Background: Prostate cancer clinical stage T2 (cT2) subclassifications, as determined by digital rectal examination (DRE), are a historic method of staging prostate cancer. However, given the potential discomfort associated with prostate examination and the wide availability of other prognostic tests, the necessity of DRE is uncertain. This study sought to determine the prognostic value of the prostate cancer cT2 subclassifications in a contemporary cohort of patients. Methods: The National Cancer Database was used to identify a cohort of men with high-risk clinical T2N0M0 prostate cancer treated with external-beam radiotherapy and androgen deprivation therapies ± surgery from 2004 to 2010. We assessed overall survival from a landmark time of 10 months using Kaplan-Meier and log-rank test analysis. A multivariate proportional hazards model was used to estimate the simultaneous effects of multiple factors, including cT2 subclassification and other well-established prognostic indicators of overall survival in prostate cancer. Results: A total of 5,291 men were included in the final analysis, with a median follow-up of 5.4 years. The cT2a, cT2b, and cT2c subclassifications demonstrated increasing hazard ratios of 1.00 (reference), 1.25 (95% CI, 1.07–1.45; P=.0046), and 1.43 (95% CI, 1.25–1.63; P<.0001), respectively, reflecting a higher probability of death with each incremental increase in cT2 subclassification. This finding was independent of other known prognostic variables on multivariate analysis. Conclusions: Results show that cT2 subclassifications had independent prognostic value in a large and contemporary cohort of men. cT2 classification remains an important, low-cost prognostic tool for men with prostatic adenocarcinoma. The clinical relevance of this test should be appreciated and accounted for by providers treating prostate adenocarcinoma.
Daniëlle D. Huijts, Onno R. Guicherit, Jan Willem T. Dekker, Julia T. van Groningen, Leti van Bodegom-Vos, Esther Bastiaannet, Johannes A. Govaert, Michel W. Wouters and Perla J. Marang-van de Mheen
Background: Previous studies showing higher mortality after elective surgery performed on a Friday were based on administrative data, known for insufficient case-mix adjustment. The goal of this study was to investigate the risk of adverse events for patients with colon and rectal cancer by day of elective surgery using clinical data from the Dutch ColoRectal Audit. Patients and Methods: Prospectively collected data from the 2012–2015 Dutch ColoRectal Audit (n=36,616) were used to examine differences in mortality, severe complications, and failure to rescue by day of elective surgery (Monday through Friday). Monday was used as a reference, analyses were stratified for colon and rectal cancer, and case-mix adjustments were made for previously identified variables. Results: For both colon and rectal cancer, crude mortality, severe complications, and failure-to-rescue rates varied by day of elective surgery. After case-mix adjustment, lower severe complication risk was found for rectal cancer surgery performed on a Friday (odds ratio, 0.84; 95% CI, 0.72–0.97) versus Monday. No significant differences were found for colon cancer surgery performed on different weekdays. Conclusions: No weekday effect was found for elective colon and rectal cancer surgery in the Netherlands. Lower severe complication risk for elective rectal cancer surgery performed on a Friday may be caused by patient selection.
Jaffer A. Ajani, Thomas A. D’Amico, David J. Bentrem, Joseph Chao, Carlos Corvera, Prajnan Das, Crystal S. Denlinger, Peter C. Enzinger, Paul Fanta, Farhood Farjah, Hans Gerdes, Michael Gibson, Robert E. Glasgow, James A. Hayman, Steven Hochwald, Wayne L. Hofstetter, David H. Ilson, Dawn Jaroszewski, Kimberly L. Johung, Rajesh N. Keswani, Lawrence R. Kleinberg, Stephen Leong, Quan P. Ly, Kristina A. Matkowskyj, Michael McNamara, Mary F. Mulcahy, Ravi K. Paluri, Haeseong Park, Kyle A. Perry, Jose Pimiento, George A. Poultsides, Robert Roses, Vivian E. Strong, Georgia Wiesner, Christopher G. Willett, Cameron D. Wright, Nicole R. McMillian and Lenora A. Pluchino
Esophageal cancer is the sixth leading cause of cancer-related deaths worldwide. Squamous cell carcinoma is the most common histology in Eastern Europe and Asia, and adenocarcinoma is most common in North America and Western Europe. Surgery is a major component of treatment of locally advanced resectable esophageal and esophagogastric junction (EGJ) cancer, and randomized trials have shown that the addition of preoperative chemoradiation or perioperative chemotherapy to surgery significantly improves survival. Targeted therapies including trastuzumab, ramucirumab, and pembrolizumab have produced encouraging results in the treatment of patients with advanced or metastatic disease. Multidisciplinary team management is essential for all patients with esophageal and EGJ cancers. This selection from the NCCN Guidelines for Esophageal and Esophagogastric Junction Cancers focuses on recommendations for the management of locally advanced and metastatic adenocarcinoma of the esophagus and EGJ.
Featured Updates to the NCCN Guidelines
Tara Sanft, Crystal S. Denlinger, Saro Armenian, K. Scott Baker, Gregory Broderick, Wendy Demark-Wahnefried, Debra L. Friedman, Mindy Goldman, Melissa Hudson, Nazanin Khakpour, Divya Koura, Robin M. Lally, Terry S. Langbaum, Allison L. McDonough, Michelle Melisko, Kathi Mooney, Halle C.F. Moore, Javid J. Moslehi, Tracey O’Connor, Linda Overholser, Electra D. Paskett, Lindsay Peterson, William Pirl, M. Alma Rodriguez, Kathryn J. Ruddy, Sophia Smith, Karen L. Syrjala, Amye Tevaarwerk, Susan G. Urba, Phyllis Zee, Nicole R. McMillian and Deborah A. Freedman-Cass
The NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for consequences of cancer and cancer treatment to aid healthcare professionals who work with survivors of adult-onset cancer. Guidance is also provided to help promote physical activity, weight management, and proper immunizations in survivors and to facilitate care coordination to ensure that all needs are addressed. These NCCN Insights summarize some of the topics discussed by the NCCN Survivorship Panel during the 2019 update of the guidelines, including the survivorship population addressed, ways to improve care coordination, and pain management.