Citations 69

Living systematic reviews: A novel mechanism for improving efficiency and quality of evidence synthesis in oncology.

Journal of Clinical Oncology | October 16, 2019 | Volume: 37 | Issue: 27_suppl | Pages: 241-241

10.1200/jco.2019.37.27_suppl.241

241 Background: In a rapidly moving field, such as cancer immunotherapy, where immune checkpoint inhibitors (ICIs) are used across 14 different tumor types, patients may receive suboptimal treatment or even be harmed if information on toxicity is not readily translated for use in clinical practice. Every single systematic review and meta-analysis which attempted to summarize toxicity of immune checkpoint inhibitors (ICIs) quickly became outdated. A living systematic review, which is defined as a systematic review that is continually updated to incorporate relevant new evidence as it becomes available, is necessary in this situation. Methods: The process of creating a living systematic review started with the creation of a comprehensive search designed by a librarian experienced in systematic reviews in collaboration with the study’s principle investigator. Search was constantly updated every 3 months and evidence is synthesized in a series of steps (microtasks) using a combination of human and augmented intelligence. A complete infrastructure is being developed and it includes automated cumulative meta-analysis and an online reporting platform which will constantly update information for clinicians and patients in a live manner. Results: We screened 6746 studies during Sep 2018-March 2019 and identified 6746 studies and we were able to successfully maintain up-to-date toxicity estimates for immune mediated adverse events over this period while maintaining the rigor of a conventional systematic review. Eventually, we will integrate the steps of LSR into one, user-friendly, semi-automated format which can independently provide accurate estimates and feed into and support a living guidelines platform through shared Application Programing Interface (APIs). Conclusions: LSRs are feasible, efficient, and when fully developed can reduce redundancy and waste in medical research, improve the quality of evidence, reduce human effort and support living and dynamic guidelines to facilitate truly informed shared decision making.
Querying Patients With Cancer About Sexual Health and Sexual and Gender Minority Status: A Qualitative Study of Health-Care Providers

American Journal of Hospice and Palliative Medicine® | October 10, 2019 | Volume: 37 | Issue: 6 | Pages: 418-423

10.1177/1049909119879129 | PMID 31601116

Background: Although national organizations advocate that health-care providers ask patients about sexual health and sexual and gender minority status—to learn, for example, about side effects of treatment and to understand patients’ social support—these conversations often do not occur. This study explored health-care providers’ reasons for having/not having these conversations. Methods: This single-institution study recruited health-care providers from medical oncology, hematology, radiation oncology, and gynecology. Face-to-face interviews were recorded, transcribed, and analyzed qualitatively. Results: Three main themes emerged: (1) patient-centric reasons for discussing/not discussing sexual health and sexual and gender minority status (“So I think just the holistic viewpoint is important”); (2) health-care provider–centric reasons for discussing/not discussing these issues (“That’s going to take more time to talk about and to deal with…” or “I was raised orthodox, so this is not something we talk about…”; and (3) reasons that appeared to straddle both of the above themes (eg, acknowledgment of the sometimes taboo nature of these topics). Conclusion: Although many health-care providers favor talking with patients with cancer about sexual health and sexual and gender minority status, limited time, personal reluctance, and the taboo nature of these topics appear at times to hamper the initiation of these conversations.
Acupuncture: Real-world patient-reported outcomes of treatment-related symptoms in breast cancer survivors.

Journal of Clinical Oncology | May 28, 2019 | Volume: 37 | Issue: 15_suppl | Pages: e23111-e23111

10.1200/jco.2019.37.15_suppl.e23111

e23111 Background: Acupuncture has been shown to reduce aromatase inhibitor-induced arthralgias, as well as possibly hot flashes and fatigue, but research has been limited. The purpose of this study was to evaluate real world perceived benefit of acupuncture for commonly experienced symptoms among breast cancer survivors. Methods: Breast cancer survivors who had used acupuncture for cancer- or treatment-related symptoms were identified using an ongoing prospective Mayo Clinic Breast Disease Registry (MCBDR) cohort. In addition, Mayo Clinic electronic health records (EHR) were queried to identify additional participants. All identified patients were mailed a survey with acupuncture-related questions. Respondents were also asked to recall their severity of arthralgia, myalgia, post-surgical pain, hot flashes, nausea/vomiting, fatigue, depression, anxiety, insomnia, lymphedema, headache, and neuropathy from 1 to 5 (1 = mild, 5 = severe) before and after acupuncture treatment. Results: Acupuncture use was reported among 413 participants in MCBDR (12% of all enrollees) and 73 patients were identified in the Mayo EHR. 241 eligible women returned surveys (median age at diagnosis 50 yrs). Mean symptom severity scores decreased from before to after acupuncture by at least 1 point for all queried symptoms (Table). Conclusions: Acupuncture is frequently used by patients for a variety of breast cancer-related symptoms. Those who do pursue acupuncture usually perceive few toxicities and substantial benefits. Cost may be a barrier to treatment for some. [Table: see text]
A living systematic review of immune checkpoint inhibitors in cancer patients: A novel platform for evidence synthesis in oncology.

Journal of Clinical Oncology | May 27, 2019 | Volume: 37 | Issue: 15_suppl | Pages: 6596-6596

10.1200/jco.2019.37.15_suppl.6596

6596 Background: Several previous systematic reviews and meta-analyses have attempted to summarize toxicity of Immune checkpoint inhibitors (ICIs). However, very soon after each one of these reviews has been published, it became outdated. ICIs are currently used in 14 different cancers and data is rapidly evolving from new clinical trials. A living Systematic review, which is defined as a systematic review that is continually updated to incorporate relevant new evidence as it becomes available, is necessary in this situations. Therefore, we performed an updated systematic review and a meta-analysis which will serve as a foundation of a living Systematic review. Methods: MEDLINE, EMBASE and Cochrane were searched to identify phase 2 and 3 RCTs of PD-1/PD-L1 ICIs. Included studies compared either immunotherapy alone or combination with existing standard of care treatment and reported data for AE’s of interest. DerSimonian-Laird random effects Meta-Analysis was performed to derive pooled odds Ratio (OR) estimates for AE’s of interest. An infrastructure of a living systematic review is being developed and it includes monthly literature searches, cumulative meta-analysis and an online reporting platform. Results: We screened 6746 studies and 31 phase 3 and 2 phase 2 RCTs (n = 21,421) were included in the analysis. 22 RCTs used PD-1/PD-L1 ICIs as a single agent and 11 as a combination therapy. Selected toxicity estimates are summarized in a table. Conclusions: The meta-analysis updates previously published toxicity estimates and provides additional information about the risk of toxicities in single versus combination regimens. We have initiated the first living systematic review in oncology that will be continuously updated, incorporating relevant new evidence as it becomes available, and will provide accurate and up to date toxicity estimates to support clinical decision making. [Table: see text]
We Need to Educate Young Lung Cancer Patients About Menopause Risk

Lung Cancer Management | February 12, 2019 | Volume: 8 | Issue: 1 | Pages: No page available

10.2217/lmt-2018-0018 | PMID 31044017

Teaching Health-Care Providers to Query Patients With Cancer About Sexual and Gender Minority (SGM) Status and Sexual Health

American Journal of Hospice and Palliative Medicine® | January 1, 2019 | Volume: 36 | Issue: 6 | Pages: 533-537

10.1177/1049909118820874 | PMID 30599758

End of life is difficult for all patients but sexual and gender minorities (SGM) are prone to isolation and loneliness, especially if their SGM status is unknown or unaccepted. In oncology clinics, where goals of care discussions about end of life are integral and frequent, querying patients about their SGM status and sexual health is of particular importance. The American Society of Clinical Oncology recently released a position statement that called for greater focus on SGM populations with the goal of reducing and eventually eliminating disparities in cancer care within this group. An important first step in addressing such disparities is learning how best to train cancer health-care providers to ask patients about their SGM status and about sexual health in general. This article summarizes the mandate for understanding cancer issues in SGM populations and the dearth of cancer-related data within this group. This article also describes an ongoing 3-part study intended to build a mini curriculum with the goal of helping cancer health-care providers to ask patients with cancer about SGM status and to ask all patients with cancer about sexual health issues. The results of this ongoing study could potentially improve end-of-life care for subgroups of patients.
Acquisition of sexual orientation and gender identity data among NCI Community Oncology Research Program practice groups

Cancer | December 18, 2018 | Volume: 125 | Issue: 8 | Pages: 1313-1318

10.1002/cncr.31925 | PMID 30561776

Background Sexual and gender minority individuals face numerous cancer‐related inequities, many of which appear to be underreported. However, to the best of the authors’ knowledge, no one has assessed rates of acquisition of sexual orientation and gender identity (SOGI) data within community oncology settings. Methods Community oncology practices that were part of the NCI Community Oncology Research Program (NCORP) network were asked whether they routinely collected SOGI information and coded this information in their electronic medical records. The proportion of practice groups reporting routine collection of sexual and/or gender minority information was calculated. Potential associations between the collection of SOGI information and practice group–level and state‐level characteristics (from Gallup poll data) were also provided. Results Twenty‐four percent of the responding NCORP practice groups reported routine collection of sexual orientation information, and 10% reported collection of gender identity information. Practices located in western regions of the United States, practices in states with higher proportions of sexual and gender minority–identifying individuals, and practices with lower proportions of non‐Hispanic patients were more likely to ask patients about sexual orientation and/or gender identity. Conclusions US oncology practices that participate in research do not frequently collect SOGI information from patients with cancer. Educational initiatives should inform oncology staff and providers about the importance of collecting gender identity and sexual orientation information to improve existent disparities faced by sexual and gender minority patients.
Immunotherapy-related toxicities: More common than originally reported?

Journal of Clinical Oncology | November 28, 2018 | Volume: 36 | Issue: 34_suppl | Pages: 184-184

10.1200/jco.2018.36.34_suppl.184

184 Background: Population level data regarding incidence of immune-related adverse events (irAE) is lacking. This study evaluated the frequency of irAEs among a large population of patients with non-small cell lung cancer (NSCLC) who received immune checkpoint inhibitors. Methods: Administrative claims data from a large U.S. commercial insurance database (OptumLabs Data Warehouse) were used to retrospectively identify patients with NSCLC who received PD-1 or PD-L1 inhibitors between January 1, 2015 to December 31, 2017. The frequencies of irAEs were reported, identified by having a new medical claim with a corresponding ICD-9 or ICD-10 code during the time period in which the patient was on immunotherapy. Results: Of 2,798 patients with NSCLC (median age at PD-(L)1 initiation: 69 years, interquartile range: 60-75, 1558 male [55.7%], 1240 [44.3%] female), 1,998 (71.4%) received nivolumab, 699 (25.0%) received pembrolizumab, and 101 (3.6%) received atezolizumab. Most patients (1463, 52.3%) received a PD-(L)1 inhibitor as second line therapy; the majority of patients (744) received alkylating agents and antimetabolites prior to receiving PD-(L)1 therapy. See Table 1 for frequencies of irAEs. Conclusions: The current study suggests that the frequencies of some irAEs related to immune checkpoint inhibitor therapies may be higher than those which were reported in the initial trials that led to the FDA approvals for immunotherapies. For example, hypophysitis was noted to occur in 0.6% of patients in the KEYNOTE-024 trial, but was identified in 2.4% of patients in this large cohort. Real world data may refine provider and patient expectations for outcomes beyond what is observed in clinical trials. [Table: see text]
Novel germline missense DDX41 variant in a patient with an adult-onset myeloid neoplasm with excess blasts without dysplasia

Leukemia & Lymphoma | November 8, 2018 | Volume: 60 | Issue: 5 | Pages: 1337-1339

10.1080/10428194.2018.1522443 | PMID 30407884

Amenorrhea in lung cancer patients.

Journal of Clinical Oncology | September 6, 2018 | Volume: 35 | Issue: 15_suppl | Pages: e20092-e20092

10.1200/jco.2017.35.15_suppl.e20092

e20092 Background: More than 5,000 premenopausal women are diagnosed (dx’d) with lung cancer annually in the United States. Improvements in treatment are contributing to a growing population of young survivors. Limited data exist regarding the risk of treatment-related amenorrhea, a surrogate for infertility and early menopause, after systemic therapies for lung cancer. Methods: Since 1997, we mailed annual surveys to patients seen at Mayo Clinic for lung cancer who consented to join a research cohort. Surveys queried menopausal status and age of menopause. Those who were dx’d under age 50, who were treated with curative intent, and who reported that they were premenopausal at the time of the cancer dx were included in this analysis. “Immediate” treatment-related menopause was defined as reporting age of menopause as the same as the age at diagnosis or 1 year (yr) older. Results: Of 182 survey respondents to date (mean time from dx to 1st survey: 26 mos, SD 24 mos, range 12-202 mos), 85 (mean age 44 yrs, SD 5, range 34-48) received chemo during the yr after diagnosis, 26 of whom also received targeted therapy during that yr. Lung cancer dx occurred 1958-2016. Platinum drugs, taxanes, and etoposide were the most common chemotherapies. 46% of chemo recipients (mean age 47, SD 2, range 41-49) experienced immediate menopause, 9% (mean age 43 yrs, SD 5, range 35-48) experienced menopause at least 2 yrs after the age of dx, and 45% (mean age 40 yrs, SD 5, range 25-48) remained pre- or peri-menopausal at their final survey (on average 3 years after dx, SD 2, range 1-10). Only 3 patients received targeted therapy alone, and the remaining 94 (mean age 42 yrs, SD 6 years) received no systemic therapy within a year of diagnosis. 15% of these 94 (mean age 45 yrs, SD 3, range 41-49) experienced immediate menopause, 16% (mean age 43 yrs, SD 4, range 36-49) experienced menopause 2+ yrs after the age of diagnosis, and 69% (mean age 41 yrs, SD 7, range 20-49) remained pre- or perimenopausal at their final survey (on average 4 yrs after dx, SD 3, range 1-10). Conclusions: Chemotherapy for lung cancer causes amenorrhea in a substantial proportion of women dx’d with lung cancer while premenopausal. Further research on fertility and menopausal symptoms after lung cancer treatment, and on differences between regimens, is warranted.