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Background: The oncologic safety of transanal total mesorectal excision (TaTME) for rectal cancer has recently been questioned, with high local recurrence (LR) rates reported in Dutch and Norwegian experiences. The objective of this study was to evaluate the oncologic safety of TaTME in a large cohort of patients with primary rectal cancer, primarily in terms of LR, disease-free survival (DFS), and overall survival (OS). Patients and Methods: This was a prospective international registry cohort study, including all patients who underwent TaTME for primary rectal adenocarcinoma from February 2010 through December 2018. The main endpoints were 2-year LR rate, pattern of LR, and independent risk factors for LR. Secondary endpoints included 2-year DFS and OS rates. Kaplan-Meier survival analysis was used to calculate actuarial LR, DFS, and OS rates. Results: A total of 2,803 patients receiving primary TaTME were included, predominantly men (71%) with a median age of 65 years (interquartile ratio, 57–73 years). After a median follow-up of 24 months (interquartile ratio, 12–38 months), the 2-year LR rate was 4.8% (95% CI, 3.8%–5.8%) with a unifocal LR pattern in 99 of 103 patients (96%). Independent risk factors for LR were male sex, threatened resection margin on baseline MRI, pathologic stage III cancer, and a positive circumferential resection margin on final histopathology. The 2-year DFS and OS rates were 77% (95% CI, 75%–79%) and 92% (95% CI, 91%–93%), respectively. Conclusions: This largest TaTME cohort to date supports the oncologic safety of the TaTME technique for rectal cancer in patients treated in units that contributed to an international registry, with an acceptable 2-year LR rate and a predominantly unifocal LR pattern.

Background: The oncologic safety of transanal total mesorectal excision (TaTME) for rectal cancer has recently been questioned, with high local recurrence (LR) rates reported in Dutch and Norwegian experiences. The objective of this study was to evaluate the oncologic safety of TaTME in a large cohort of patients with primary rectal cancer, primarily in terms of LR, disease-free survival (DFS), and overall survival (OS). Patients and Methods: This was a prospective international registry cohort study, including all patients who underwent TaTME for primary rectal adenocarcinoma from February 2010 through December 2018. The main endpoints were 2-year LR rate, pattern of LR, and independent risk factors for LR. Secondary endpoints included 2-year DFS and OS rates. Kaplan-Meier survival analysis was used to calculate actuarial LR, DFS, and OS rates. Results: A total of 2,803 patients receiving primary TaTME were included, predominantly men (71%) with a median age of 65 years (interquartile ratio, 57–73 years). After a median follow-up of 24 months (interquartile ratio, 12–38 months), the 2-year LR rate was 4.8% (95% CI, 3.8%–5.8%) with a unifocal LR pattern in 99 of 103 patients (96%). Independent risk factors for LR were male sex, threatened resection margin on baseline MRI, pathologic stage III cancer, and a positive circumferential resection margin on final histopathology. The 2-year DFS and OS rates were 77% (95% CI, 75%–79%) and 92% (95% CI, 91%–93%), respectively. Conclusions: This largest TaTME cohort to date supports the oncologic safety of the TaTME technique for rectal cancer in patients treated in units that contributed to an international registry, with an acceptable 2-year LR rate and a predominantly unifocal LR pattern.

Background: Chemotherapy-induced febrile neutropenia (FN) is prevented or minimized with granulocyte colony-stimulating factors (G-CSFs). Several G-CSF biosimilars are approved in the United States. The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is a nonprofit initiative whose objective is to provide scientific evidence on real-world use and comparative safety and effectiveness of biologics and biosimilars using the BBCIC distributed research network (DRN). Patients and Methods: We describe real-world G-CSF use in patients with breast or lung cancer receiving first-cycle chemotherapy associated with high FN risk. We assessed hospitalizations for FN, availability of absolute neutrophil counts, and G-CSF–induced adverse events to inform future observational comparative effectiveness studies of G-CSF reference products and their biosimilars. A descriptive analysis of 5 participating national health insurance plans was conducted within the BBCIC DRN. Results: A total of 57,725 patients who received at least one G-CSF dose were included. Most (92.5%) patients received pegfilgrastim. FN hospitalization rates were evaluated by narrow (<0.5%), intermediate (1.91%), and broad (2.99%) definitions. Anaphylaxis and hyperleukocytosis were identified in 1.15% and 2.28% of patients, respectively. This analysis provides real-world evidence extracted from a large, readily available database of diverse patients, characterizing G-CSF reference product use to inform the feasibility of future observational comparative safety and effectiveness analyses of G-CSF biosimilars. We showed that the rates of FN and adverse events in our research network are consistent with those reported by previous small studies. Conclusions: Readily available BBCIC DRN data can be used to assess G-CSF use with the incidence of FN hospitalizations. Insufficient laboratory result data were available to report absolute neutrophil counts; however, other safety data are available for assessment that provide valuable baseline data regarding the effectiveness and safety of G-CSFs in preparation for comparative effectiveness studies of reference G-CSFs and their biosimilars.

Background: Racial disparities in breast cancer mortality in the United States are well documented. Non-Hispanic Black (NHB) women are more likely to die of their disease than their non-Hispanic White (NHW) counterparts. The disparity is most pronounced among women diagnosed with prognostically favorable tumors, which may result in part from variations in their receipt of guideline care. In this study, we sought to estimate the effect of guideline-concordant care (GCC) on prognosis, and to evaluate whether receipt of GCC modified racial disparities in breast cancer mortality. Patients and Methods: Using the Georgia Cancer Registry, we identified 2,784 NHB and 4,262 NHW women diagnosed with a stage I–III first primary breast cancer in the metropolitan Atlanta area, Georgia, between 2010 and 2014. Women were included if they received surgery and information on their breast tumor characteristics was available; all others were excluded. Receipt of recommended therapies (chemotherapy, radiotherapy, endocrine therapy, and anti-HER2 therapy) as indicated was considered GCC. We used Cox proportional hazards models to estimate the impact of receiving GCC on breast cancer mortality overall and by race, with multivariable adjusted hazard ratios (HRs). Results: We found that NHB and NHW women were almost equally likely to receive GCC (65% vs 63%, respectively). Failure to receive GCC was associated with an increase in the hazard of breast cancer mortality (HR, 1.74; 95% CI, 1.37–2.20). However, racial disparities in breast cancer mortality persisted despite whether GCC was received (HR_GCC: 2.17 [95% CI, 1.61–2.92]; HR_non-GCC: 1.81 [95% CI, 1.28–2.91] ). Conclusions: Although receipt of GCC is important for breast cancer outcomes, racial disparities in breast cancer mortality did not diminish with receipt of GCC; differences in mortality between Black and White patients persisted across the strata of GCC.

Background: Racial disparities in breast cancer mortality in the United States are well documented. Non-Hispanic Black (NHB) women are more likely to die of their disease than their non-Hispanic White (NHW) counterparts. The disparity is most pronounced among women diagnosed with prognostically favorable tumors, which may result in part from variations in their receipt of guideline care. In this study, we sought to estimate the effect of guideline-concordant care (GCC) on prognosis, and to evaluate whether receipt of GCC modified racial disparities in breast cancer mortality. Patients and Methods: Using the Georgia Cancer Registry, we identified 2,784 NHB and 4,262 NHW women diagnosed with a stage I–III first primary breast cancer in the metropolitan Atlanta area, Georgia, between 2010 and 2014. Women were included if they received surgery and information on their breast tumor characteristics was available; all others were excluded. Receipt of recommended therapies (chemotherapy, radiotherapy, endocrine therapy, and anti-HER2 therapy) as indicated was considered GCC. We used Cox proportional hazards models to estimate the impact of receiving GCC on breast cancer mortality overall and by race, with multivariable adjusted hazard ratios (HRs). Results: We found that NHB and NHW women were almost equally likely to receive GCC (65% vs 63%, respectively). Failure to receive GCC was associated with an increase in the hazard of breast cancer mortality (HR, 1.74; 95% CI, 1.37–2.20). However, racial disparities in breast cancer mortality persisted despite whether GCC was received (HR_GCC: 2.17 [95% CI, 1.61–2.92]; HR_non-GCC: 1.81 [95% CI, 1.28–2.91] ). Conclusions: Although receipt of GCC is important for breast cancer outcomes, racial disparities in breast cancer mortality did not diminish with receipt of GCC; differences in mortality between Black and White patients persisted across the strata of GCC.

Background: Lung cancer is the leading cause of cancer-related death in the United States and globally, and many questions exist about treatment options. Harmonizing data across registries and other data collection efforts would yield a robust data infrastructure to help address many research questions. The purpose of this project was to develop a minimum set of patient and clinician relevant harmonized outcome measures that can be collected in non–small cell lung cancer (NSCLC) patient registries and clinical practice. Methods: Seventeen lung cancer registries and related efforts were identified and invited to submit outcome measures. Representatives from medical specialty societies, government agencies, health systems, health information technology groups, patient advocacy organizations, and industry formed a stakeholder panel to categorize the measures and harmonize definitions using the Agency for Healthcare Research and Quality’s supported Outcome Measures Framework (OMF). Results: The panel reviewed 66 outcome measures and identified a minimum set of 8 broadly relevant measures in the OMF categories of patient survival, clinical response, events of interest, and resource utilization. The panel harmonized definitions for the 8 measures through in-person and virtual meetings. The panel did not reach consensus on 1 specific validated instrument for capturing patient-reported outcomes. The minimum set of harmonized outcome measures is broadly relevant to clinicians and patients and feasible to capture across NSCLC disease stages and treatment pathways. A pilot test of these measures would be useful to document the burden and value of the measures for research and in clinical practice. Conclusions: By collecting the harmonized measures consistently, registries and other data collection systems could contribute to the development research infrastructure and learning health systems to support new research and improve patient outcomes.

Background: Most breast cancer clinicians lack training to counsel patients about sexual concerns. The purpose of this study was to assess the feasibility, acceptability, and preliminary effects of a mobile learning (mLearning) intervention (improving Sexual Health and Augmenting Relationships through Education [iSHARE]) aimed at enhancing breast cancer clinicians’ knowledge of, beliefs about, and comfort with discussing patients’ sexual health concerns. Methods: Clinicians listened to a 2-part educational podcast series offering information on breast cancer–related sexual health concerns and effective communication on the topic, which consisted of interviews with expert guests. Intervention feasibility was assessed through rates of enrollment, retention, and intervention completion, with benchmarks of 40%, 70%, and 60%, respectively. Acceptability was assessed through program evaluations, with 75% of clinicians rating the intervention favorably (eg, relevance, satisfaction) signifying acceptability. Clinicians self-reported their knowledge about breast cancer–related sexual health concerns, beliefs (ie, self-efficacy for discussing sexual health concerns), and comfort with discussing sexual concerns measured at preintervention and postintervention. Qualitative analysis examined clinicians’ perceptions of lessons learned from the intervention. Results: A total of 32 breast cancer clinicians enrolled (46% of those invited; 97% of those who responded and screened eligible), 30 (94%) completed both the intervention and study surveys, and 80% rated the intervention favorably, demonstrating feasibility and acceptability. Results showed positive trends for improvement in clinician knowledge, beliefs, and comfort with discussing sexual health concerns. Clinicians reported key lessons learned, including taking a proactive approach to discussing sexual health concerns, normalizing the topic, addressing vaginal health, sending the message that help is available, and assessing sexual health concerns with patients from different backgrounds. Conclusions: Breast cancer clinicians were amenable to participating in the iSHARE intervention and found it useful. iSHARE showed promise for improving clinician’s knowledge and comfort discussing patients’ sexual health concerns. A larger trial is required to demonstrate efficacy. Future studies should also examine whether iSHARE can improve patient–clinician communication and address patients’ sexual concerns.

Background: Optimal treatment of nonoperative patients with large, node-negative non–small cell lung cancer (NSCLC) is poorly defined. Current NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) recommend definitive radiotherapy (RT) with or without sequential chemotherapy and do not include concurrent chemoradiotherapy (chemoRT) as a treatment option. In this study, we identified factors that predict nonadherence to NCCN Guidelines. Patients and Methods: Patients who received definitive RT for nonmetastatic, node-negative NSCLC with tumor size of 5 to 7 cm were identified in the National Cancer Database from 2004 through 2016. Patients were evaluated by RT type (stereotactic body RT [SBRT], hypofractionated RT [HFRT], or conventionally fractionated RT [CFRT]) and chemotherapy use (none, sequential, or concurrent with RT). Patients were classified as receiving NCCN-adherent (RT with or without sequential chemotherapy) or NCCN-nonadherent (concurrent chemoRT) treatment. Demographic and clinical factors were assessed with logistic regression modeling. Overall survival was evaluated with Kaplan-Meier, log-rank, and univariable/multivariable Cox proportional hazards regression analyses. Results: Among 2,020 patients in our cohort, 32% received NCCN-nonadherent concurrent chemoRT, whereas others received NCCN-adherent RT alone (51%) or sequential RT and chemotherapy (17%). CFRT was most widely used (64% CFRT vs 22% SBRT vs 14% HFRT). Multivariable analysis revealed multiple factors to be associated with NCCN-nonadherent chemoRT: age ≤70 versus >70 years (odds ratio [OR] , 2.72; P<.001), treatment at a nonacademic facility (OR, 1.65; P<.001), and tumor size 6 to 7 cm versus 5 to 6 cm (OR, 1.27; P=.026). Survival was similar between the NCCN-nonadherent chemoRT and NCCN-adherent groups (hazard ratio, 1.00; P=.992) in multivariable analysis. Conclusions: A substantial proportion of inoperable patients with large, node-negative NSCLC are not treated according to NCCN Guidelines and receive concurrent chemoRT. Younger patients with larger tumors receiving treatment at nonacademic medical centers were more likely to receive NCCN-nonadherent therapy, but adherence to NCCN Guidelines was not associated with differences in overall survival.

Background: Psychological distress is common in patients with cancer. Distress can affect patients’ engagement with treatment. We examined the relationship between psychological distress and treatment timeliness in a sample of adult oncology patients at a safety-net hospital. Methods: A retrospective review was conducted of all patients screened for distress at a first outpatient oncology visit between March 1, 2014, and December 31, 2015 (n=500). The analytic sample (n=96) included patients with a new cancer diagnosis and a curative-intent treatment plan for lymphoma (stage I–IV), solid tumor malignancy (stage I–III), or head and neck cancer (stage I–IVb). Distress was measured using the Hospital Anxiety and Depression Scale. Using Poisson regression, we determined the effects of depression and anxiety on treatment timeliness. Patient age, sex, race/ethnicity, insurance type, cancer site, and cancer stage were included as covariates. Results: Mean patient age was 54 years. The median treatment initiation interval was 28 days. Clinically significant anxiety was present in 34% of the sample, and clinically significant depression in 15%. Greater symptom severity in both anxiety and depression were associated with a longer treatment initiation interval after controlling for demographics and disease factors. The average days to treatment (DTT) was 4 days longer for patients with elevated anxiety scores and for those with elevated depression scores compared with those without. Overall survival was not associated with anxiety, depression, or DTT. Conclusions: In this safety-net patient sample, greater psychological distress was associated with slower time to treatment. As of writing, this is a new finding in the literature, and as such, replication studies utilizing diverse samples and distress measurement tools are needed.

Background: Breast cancer care requires coordination between multiple diagnostic and treatment modalities. Disparities such as age, race/ethnicity, and socioeconomic status are associated with delays in care. This study investigates whether primary language is associated with delays in breast cancer diagnosis and treatment before and through radiotherapy (RT). Patients and Methods: This study was an institutional retrospective matched-cohort analysis of women treated with breast RT over 2 years. A total of 65 non–English-speaking (NES) patients were matched with 195 English-speaking (ES) patients according to stage, age, and chemotherapy delivery. Key time intervals along the breast cancer care path from initial findings through RT were recorded. Data were analyzed in a mixed model with matching as the random effect. The impact of race and insurance status was analyzed in addition to language. Results: Significant delays were found for NES patients, which varied by race. NES Latina patients experienced the longest delay, with a mean total care-path time of 13.53 months (from initial findings to end of RT) versus 8.18 months for all ES patients (P<.0001). Specifically, their mean total care-path time was 5.97 months longer than that of ES Latina patients (P=.001) and 5.80 months longer than that of ES White patients (P<.0001). In addition, NES Latina patients had a significantly longer total care-path time than NES patients of other races/ethnicities (P=.001). Delays were specifically seen between initial clinical or radiographic findings and diagnostic mammogram (P=.001) and between biopsy and resection (P=.044). Beyond language, race/ethnicity was itself associated with delays between resection and start of RT (P=.032) and between start and end of RT (P=.022). Conclusions: Language is associated with pre-RT delays in breast cancer care, especially for NES Latina patients. Delays are most pronounced before diagnostic mammograms, but they also exist before resection and RT. Future work should target NES patients to assist their progress along the care path.