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Purpose Family/caregiver visitation provides critical support for patients confronting cancer and is associated with positive outcomes. However, the COVID-19 pandemic brought historic disruptions including widespread visitation restrictions. Here, we characterize in-depth the visitor policies of NCI-designated comprehensive cancer centers (CCCs) and analyze geographic/temporal patterns across CCCs. Methods The public-facing CCC websites, including archived webpages, were reviewed to abstract initial visitation policies and revisions, including end-of-life (EoL) exceptions and timing of visitation restrictions relative to regional lockdowns. Chi-squared and Fisher’s exact tests were employed to analyze associations between geographic region, timing, and severity of restrictions. Results Most CCCs (n=43, 86%) enacted visitation restrictions between March 15 and April 15, 2020. About half barred all visitors for COVID-negative inpatients (n=24, 48%) or outpatients (n=26, 52%). Most (n=36, 72%) prohibited visitors for patients with confirmed/suspected COVID-19. Most (n=40, 80%) published EoL exceptions but the specifics were highly variable. The median time from initial restrictions to government-mandated lockdowns was 1 day, with a wide range (25 days before to 26 days after). There was no association between timing of initial restrictions and geographic location (p=0.14) or severity of inpatient policies (p=1.0), even among centers in the same city. Outpatient policies published reactively (after lockdown) were more restrictive than those published proactively (p=0.04). Conclusion CCCs enacted strict but strikingly variable COVID-19 visitation restrictions, with important implications for patients/families seeking cancer care. A unified, evidence-based approach to visitation policies is needed to balance proven infection control measures with the needs of patients and families.

Emerging efficacy data have led to the emergency use authorization or approval of COVID-19 vaccines in several countries worldwide. Most trials of COVID-19 vaccines excluded patients with active malignancies, and thus data on the safety, tolerability and efficacy of the vaccines in patients with cancer are currently limited. Given the risk posed by the COVID-19 pandemic, decisions regarding the use of vaccines against COVID-19 in patients participating in trials of investigational anticancer therapies need to be addressed promptly. Patients should not have to choose between enrolling on oncology clinical trials and receiving a COVID-19 vaccine. Clinical trial sponsors, investigators and treating physicians need operational guidance on COVID-19 vaccination for patients with cancer who are currently enrolled or might seek to enrol in clinical trials. Considering the high morbidity and mortality from COVID-19 in patients with cancer, the benefits of vaccination are likely to far outweigh the risks of vaccine-related adverse events. Herein, we provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials. In our perspective, continued quality oncological care requires that patients with cancer, including those involved in trials, be prioritized for COVID-19 vaccination, which should not affect trial eligibility., Patients with cancer have a high risk of morbidity and mortality from COVID-19. The rapid development of COVID-19 vaccines has provided new hope of mitigating the disease. Herein, the COVID19 and Cancer Clinical Trials Working Group calls for prioritization of patients with cancer, importantly including those participating in oncology clinical trials, for COVID-19 vaccination. The authors also provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials.

Context Coronavirus Disease 2019 (COVID-19) has caused unprecedented disruptions to cancer care, including through strict hospital visitation policies. Since a substantial proportion of the U.S. population report a non-English language as their primary language, it is critical that information is disseminated in multiple languages. Objectives To examine the availability of language translations of visitation restrictions on adult National Cancer Institute-designated comprehensive cancer centers (CCCs) Web sites. Methods Cross-sectional analysis of visitation policies abstracted from public-facing Web sites of CCCs in June 2020. Using U.S. Census data, CCC's city and state proportions of self-identifying Hispanic/Latinx population were categorized into three cohorts: low (20%). Results As of June 2020, all 50 CCCs published a COVID-19 visitation policy on their Web site. Of these, 33 (66%) posted policies only in English, whereas 17 (34%) included one or more non-English translations. A minority of CCCs published Spanish language resources, which did not differ based on state or city demographics: for example, only 42% (8 of 19), 10% (1 of 10), and 38% (8 of 21) of CCCs published Spanish language resources in cities with low, moderate, and high Hispanic/Latinx populations, respectively. Conclusion Most CCC's did not publish non-English language translations of their visitor policies. Even in cities and states with larger Hispanic/Latinx populations, most CCCs did not publish resources in Spanish. This study highlights a key opportunity to mitigate communication barriers and deliver culturally competent, patient-centered care.

Emerging efficacy data have led to the emergency use authorization or approval of COVID-19 vaccines in several countries worldwide. Most trials of COVID-19 vaccines excluded patients with active malignancies, and thus data on the safety, tolerability and efficacy of the vaccines in patients with cancer are currently limited. Given the risk posed by the COVID-19 pandemic, decisions regarding the use of vaccines against COVID-19 in patients participating in trials of investigational anticancer therapies need to be addressed promptly. Patients should not have to choose between enrolling on oncology clinical trials and receiving a COVID-19 vaccine. Clinical trial sponsors, investigators and treating physicians need operational guidance on COVID-19 vaccination for patients with cancer who are currently enrolled or might seek to enrol in clinical trials. Considering the high morbidity and mortality from COVID-19 in patients with cancer, the benefits of vaccination are likely to far outweigh the risks of vaccine-related adverse events. Herein, we provide operational COVID-19 vaccine guidance for patients participating in oncology clinical trials. In our perspective, continued quality oncological care requires that patients with cancer, including those involved in trials, be prioritized for COVID-19 vaccination, which should not affect trial eligibility.

// Ishwaria M. Subbiah 1 , Chad Tang 2 , Arvind Rao 3 , Gerald S. Falchook 4 , Vivek Subbiah 5 , Apostolia M. Tsimberidou 5 , Daniel Karp 5 , Razelle Kurzrock 6 and David S. Hong 5 1 Department of Palliative, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA 2 Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA 3 Department of Bioinformatics and Computational Biology, University of Texas MD Anderson Cancer Center, Houston, TX, USA 4 Sarah Cannon Research Institute at HealthONE, Denver, CO, USA 5 Department of Investigational Cancer Therapeutics (Phase I Program), University of Texas MD Anderson Cancer Center, Houston, TX, USA 6 Center for Personalized Cancer Therapy and Clinical Trials Office, Moores Cancer Center, University of California, San Diego, CA, USA Correspondence to: Ishwaria M. Subbiah, email: isubbiah@mdanderson.org Keywords: geriatric oncology; elderly; VEGF inhibitors; older adults; phase I trials Received: May 19, 2018 Accepted: May 24, 2018 Published: June 22, 2018 ABSTRACT Background: Older adults aged 65 years and above remain underrepresented in cancer clinical trials. We hypothesized that older participation in early phase trials with VEGF/VEGFR (VEGF/R) inhibitors was lower than cancer prevalence in this group and lower than other age groups (middle age, adolescent/young adults [AYA]). Results: Of 1489 patients, 278 were older adults (18%, median age 68.9y), 220 AYA (15%, median age 32.6 y), 991 middle age (67%, median age 53.8 y). Common malignancies included gastrointestinal ( n = 438, 29%), gynecologic ( n = 234, 16%), and thoracic/head/neck ( n = 216, 15%). Median time to treatment failure did not vary significantly between the 3 age-based cohorts (3m in older adults, 3.5 m middle age, 3.3 m AYA). OR of achieving clinical benefit in older adults vs middle age (OR 1.10, p 0.19 [two-tailed], p 0.09 [one-tailed]) and AYA vs middle age (OR 0.85, p 0.31 [proportions z -test, two tailed], p 0.15 [one-tailed]) showed no significant differences. Conclusions: Older adults accounted for

// Ishwaria M. Subbiah 1 , Shanda H. Blackmon 2,4 , Arlene M. Correa 2 , Bryan Kee 3 , Ara A. Vaporciyan 2 , Stephen G. Swisher 2 and Cathy Eng 3 1 Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas 2 Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas 3 Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas 4 Department of Surgery, The Methodist Hospital and Weill Cornell College of Medicine, Houston, Texas Correspondence: Cathy Eng, email: // Keywords : colorectal, carcinoma, neoadjuvant, chemotherapy, metastasectomy Received : May 10, 2014 Accepted : July 7, 2014 Published : July 8, 2014 Abstract Background: The benefit of preoperative chemotherapy prior to pulmonary metastasectomy for patients with colorectal carcinoma (CRC) is unknown. Here, we identify outcomes of preoperative chemotherapy in patients with resected primary CRC who then underwent pulmonary metastasectomy. Methods: We queried a prospective database to identify treatment characteristics. Multivariate analyses identified predictors of overall survival (OS) and progression-free survival (PFS). Results: 229 patients underwent lung metastasectomy, of whom 115 proceeded to surgery without chemotherapy while 114 received preoperative regimen based on oxaliplatin (32%), irinotecan (46%), capecitabine (16%), or other (6%). Median PFS in preoperative chemotherapy vs. surgery alone arms were comparable (p=0.004). Patients on oxaliplatin-based therapy had an improved OS vs. an irinotecan, capecitabine, or alternate regimen (p=.019). On multivariate analysis, the irinotecan subset had a worse OS (HR 1.846; 95% CI 1.070, 3.185) vs. surgery alone arm (p=0.028). The OS of an oxaliplatin-based regimen vs. no chemotherapy was inconclusive (HR 0.57; 95% CI 0.237 to 1.389, p=0.218). Multivariate analysis demonstrated a worse PFS and OS for the male gender and an incomplete resection (R2). Conclusion: Prospective trials on specific preoperative regimens and criteria for patient selection may identify a role for preoperative chemotherapy prior to a curative pulmonary metastasectomy.

Purpose Several indices have been developed to predict overall survival (OS) in patients with breast cancer with brain metastases, including the breast graded prognostic assessment (breast-GPA), comprising age, tumor subtype, and Karnofsky performance score. However, number of brain metastases—a highly relevant clinical variable—is less often incorporated into the final model. We sought to validate the existing breast-GPA in an independent larger cohort and refine it integrating number of brain metastases. Patients and Methods Data were retrospectively gathered from a prospectively maintained institutional database. Patients with newly diagnosed brain metastases from 1996 to 2013 were identified. After validating the breast-GPA, multivariable Cox regression and recursive partitioning analysis led to the development of the modified breast-GPA. The performances of the breast-GPA and modified breast-GPA were compared using the concordance index. Results In our cohort of 1,552 patients, the breast-GPA was validated as a prognostic tool for OS (P < .001). In multivariable analysis of the breast-GPA and number of brain metastases (> three v ≤ three), both were independent predictors of OS. We therefore developed the modified breast-GPA integrating a fourth clinical parameter. Recursive partitioning analysis reinforced the prognostic significance of these four factors. Concordance indices were 0.78 (95% CI, 0.77 to 0.80) and 0.84 (95% CI, 0.83 to 0.85) for the breast-GPA and modified breast-GPA, respectively (P < .001). Conclusion The modified breast-GPA incorporates four simple clinical parameters of high prognostic significance. This index has an immediate role in the clinic as a formative part of the clinician's discussion of prognosis and direction of care and as a potential patient selection tool for clinical trials.