The aim of the NCCN Guidelines for Management of Immunotherapy-Related Toxicities is to provide guidance on the management of immune-related adverse events resulting from cancer immunotherapy. The NCCN Management of Immunotherapy-Related Toxicities Panel is an interdisciplinary group of representatives from NCCN Member Institutions and ASCO, consisting of medical and hematologic oncologists with expertise in a wide array of disease sites, and experts from the fields of dermatology, gastroenterology, neuro-oncology, nephrology, emergency medicine, cardiology, oncology nursing, and patient advocacy. Several panel representatives are members of the Society for Immunotherapy of Cancer (SITC). The initial version of the NCCN Guidelines was designed in general alignment with recommendations published by ASCO and SITC. The content featured in this issue is an excerpt of the recommendations for managing toxicity related to immune checkpoint blockade and a review of existing evidence. For the full version of the NCCN Guidelines, including recommendations for managing toxicities related to chimeric antigen receptor T-cell therapy, visit NCCN.org.
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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, Brianna Hoffner, Christopher J. Hoimes, Mario Lacouture, Frederick Locke, Matthew Lunning, Nisha A. Mohindra, Jarushka Naidoo, Anthony J. Olszanski, Olalekan Oluwole, Sandip P. Patel, Sunil Reddy, Mabel Ryder, Bianca Santomasso, Scott Shofer, Jeffrey A. Sosman, Momen Wahidi, Yinghong Wang, Alyse Johnson-Chilla and Jillian L. Scavone
Stefanie L. Thorsness, Azael Freites-Martinez, Michael A. Marchetti, Cristian Navarrete-Dechent, Mario E. Lacouture and Emily S. Tonorezos
Background: Radiotherapy (RT) is a risk factor for nonmelanoma skin cancer (NMSC), specifically basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), but whether features, histology, or recurrence of NMSC after RT resemble those observed in the general population is unknown. Methods: A retrospective review (1994–2017) was performed within the Adult Long-Term Follow-Up Program and Dermatology Service at Memorial Sloan Kettering Cancer Center. Demographics, clinical features, histology, treatment, and recurrence were collected for this patient cohort that was under close medical surveillance. Pathology images were reviewed when available. Results: A total of 946 survivors (mean age, 40 years [SD, 13]) were assessed for NMSC. The mean age at first cancer diagnosis was 16 years (range, 0–40 years ), and the most common diagnosis was Hodgkin lymphoma (34%; n=318). In 63 survivors, 281 primary in-field lesions occurred, of which 273 (97%) were BCC and 8 (3%) were SCC. Mean intervals from time of RT to BCC and SCC diagnosis were 24 years (range, 2–44 years) and 32 years (range, 14–46 years), respectively. The most common clinical presentation of BCC was macule (47%; n=67), and the most common histologic subtypes were superficial for BCC (48%; n=131) and in situ for SCC (55%; n=5). Mohs surgery predominated therapeutically (42%; n=117), the mean duration of follow-up after treatment was 6 years (range, 12 days–23 years), and the 5-year recurrence rate was 1% (n=1). Conclusions: Most NMSCs arising in sites of prior RT were of low-risk subtypes. Recurrence was similar to that observed in the general population. Current guidelines recommend surgical intervention for tumors arising in sites of prior RT because they are considered to be at high risk for recurrence. These findings suggest that an expanded role for less aggressive therapy may be appropriate, but further research is needed.
Michael Karass, Rohan Bareja, Ethan Shelkey, Panagiotis J. Vlachostergios, Brian D. Robinson, Francesca Khani, Juan Miguel Mosquera, Douglas S. Scherr, Andrea Sboner, Scott T. Tagawa, Ana M. Molina, Olivier Elemento, David M. Nanus and Bishoy M. Faltas
Urothelial carcinoma (UC) is a common and frequently lethal cancer. Despite the presence of genomic alterations creating dependency on particular signaling pathways, the use of targeted therapies in advanced and metastatic UC has been limited. We performed an integrated analysis of whole-exome and RNA sequencing of primary and metastatic tumors in a patient with platinum-resistant UC. We found a strikingly high ERBB2 mRNA expression and enrichment of downstream oncogenic ERBB2 signaling in this patient’s tumors compared with tumors from an unselected group of patients with UC (N=17). This patient had an exceptional sustained response to trastuzumab. Our findings show that oncogenic addiction to ERBB2 signaling potentially predicts response to ERBB2-directed therapy of UC.
Julia C. Shih and Anthony J. Olszanski
Jamie M. Jacobs, Molly E. Ream, Nicole Pensak, Lauren E. Nisotel, Joel N. Fishbein, James J. MacDonald, Joanne Buzaglo, Inga T. Lennes, Steven A. Safren, William F. Pirl, Jennifer S. Temel and Joseph A. Greer
Background: Oral therapies are increasingly common in oncology care. However, data are lacking regarding the physical and psychologic symptoms patients experience, or how these factors relate to medication adherence and quality of life (QoL). Materials and Methods: From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center. Patients completed baseline assessments of adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment. Relationships among these factors were examined using Pearson product-moment correlations and multivariable linear regression. Results: At baseline, the mean electronic pill cap adherence rate showed that patients took 85.57% of their oral therapy. The most commonly reported cancer-related symptoms were fatigue (88.60%), drowsiness (76.50%), disturbed sleep (68.20%), memory problems (63.10%), and emotional distress (60.80%). Patients who reported greater cancer-related symptom severity had lower adherence (r= −0.20). In a multivariable regression, greater depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction with clinicians and treatment, and higher symptom burden were associated with worse QoL (F[10, 146]=50.53; adjusted R 2=0.77). Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= −7.10; SE=0.22). Conclusions: Patients prescribed oral therapies struggle with adherence, and cancer-related symptom burden is high and related to worse adherence and QoL. Given perceptions that oral therapies are less impairing, these data underscore the strong need to address adherence issues, symptom burden, and QoL for these patients.
Naresh Ramarajan, Farzana Begum and Gitika Srivastava
Background: Availability of care is an important characteristic of effective primary healthcare systems. Imbalanced oncologist to patient ratios (∼1600: 1.8 M in India, ∼23,000: 15 M in USA), impedes access to expertise. On average it takes a week or more to get an online expert review from leading cancer hospitals in the United States and in India. Such delays have an important psychosocial impact on the patient and caregivers. Patients worldwide often race to start treatments at non-expert centers and may experience worse health outcomes from lack of expert tumor board review of their cases. This study aimed to examine the impact of Navya, a health services technology, on reducing the patient wait time in real-time treatment decision making. Methods: Navya generates personalized treatment plans that maps 98.8% within NCCN Resource Stratified Guidelines [SABCS 2017, NCCN 2018]. This is vetted on mobile by oncologists at tertiary centers like TMC NCG to provide expert opinion reports to patients. Since 2015, approximately 25,775 patients from 60 countries have reached out for an online opinion. On the ground, 78% of patients received evidence-based treatments recommended by Navya [ASCO 2017]. The Navya system releases preliminary system-generated opinions for patients whose treatment plans fit high confidence based on NCCN Guidelines and prior expert reviews. The mean reduction in time between a system-generated opinion and an expert-reviewed opinion was studied in a prospective cohort of patients between July 1, 2017, and August 30, 2018. Results: 313 patients received a system-generated treatment plan in the study period. Only approximately 10% of these plans were modified by experts to add additional treatment details since these were cases with high confidence in treatment decision-making. Navya delivered a preliminary treatment plan on an average of 86 hours (SD, 153 hours) prior to the expert response time. Of the 313 patients studied, 44% of patients would have waited an additional 3 days longer to receive an expert-reviewed recommendation. Conclusions: Navya’s NCCN and evidence-based treatment plans reduce the patient waiting times for an expert opinion average by 86 hours. This rapid confirmation of the right treatment plan at the time of patient need has potential to relieve patient anxieties at critical junctures in treatment decision-making and helps improve the treatment-planning process.
Surbhi Agarwal, Ruta Rao and David Ansell
Background: NCCN quality measures for breast cancer include (1) radiation therapy administered within 1 year of diagnosis for women under age 70 receiving breast-conserving surgery; (2) chemotherapy considered in 4 months of diagnosis for women under 70 with T1c or stage II/III ER/PR- tumors; (3) endocrine therapy administered within 1 year of diagnosis for women with AJCC T1 or stage II/III ER/PR+ breast cancer. These evidence-based measures promote accountability for providers and allow transparency in quality of care. Black women are less likely than white women to receive these therapies that are associated with a survival benefit. Improving adherence to guidelines can decrease the gap in mortality rates for minority women with breast cancer. Methods: We performed a retrospective chart review on patients with breast cancer between April 2010 and October 2015 at Rush University. Information collected included time of diagnosis, clinical stage, ER/PR status, surgical procedures, radiation, chemotherapy, endocrine therapy, and demographics. Chi-squared analysis was done to compare percent of black versus white women who met each quality guideline. Results: In total, 2,436 women were analyzed, of whom 30.3% were black, 66% were white, and 3.7% were other. Of this cohort, 779 women met inclusion criteria for quality guideline 1, and there was no significant difference between black and white women who did not receive radiation therapy (P=.21; 24.7% vs 20.4%). For quality guideline 2 (n=382), there was also no significant difference between black and white women who did not get chemotherapy within 4 months of diagnosis (P=.32; 36.6% vs 31.4%). However, for quality guideline 3 (n=1,222), there was a statistically significant difference between black and white women who did not get hormone therapy within a year of diagnosis (P=.0008; 36.9% vs 26.1%). Conclusions: Endocrine therapy reduces risk of recurrence and mortality in women with ER/PR positive breast cancer; however, there is a disparity between black versus white women who meet this NCCN quality measure. Further studies are needed to understand the reason for this gap in quality of care so that specific interventions can be implemented to eliminate this disparity.