between girls and boys. We call for a gendered perspective in developing policy responses by tackling the sexual and reproductive health and socioeconomic issues addressed here to bring girls back to school after the measures to contain the COVID-19 pandemic end. We also ask governments to collect data specifically on non-paid housework and childcare respon sibilities frequently ignored when investigating the consequences of child labour. Addressing the health and socioeconomic issues girls might face during this pandemic, as well as collecting data to quantify their effects, are important in honouring the commitment to the Sustainable Development Goals.We declare no competing interests.

Context. Immune checkpoint inhibitors (ICIs) are increasingly used to treat a variety of cancers, but comparatively little is known about patient-reported outcomes (PROs) and health-related quality of life (HRQoL) among patients receiving these novel therapies.Objectives. We performed a systematic review to examine PROs and HRQoL among cancer patients receiving ICIs as compared to other anticancer therapies.Methods. We systematically searched PubMed, CINAHL, Embase, Web of Science, and Scopus, using search terms representing ICIs, PROs, and HRQoL on August 10, 2018. Eligible articles were required to involve cancer patients treated with ICIs and to report PROs and/or HRQoL data.Results. We screened 1453 references and included 15 publications representing 15 randomized controlled trials in our analysis. Studies included several cancer types (melanoma, lung cancer, genitourinary cancer, and head/neck cancer), used four different ICIs (nivolumab, pembrolizumab, atezolizumab, and ipilimumab), and compared ICIs to a wide range of therapies (chemotherapy, targeted therapies, other immunotherapy strategies, and placebo). Studies used a total of seven different PROs to measure HRQOL, most commonly the European Organisation for the Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) (n ¼ 12, 80%). PRO data were reported in a variety of formats and at a variety of time points throughout treatment, which made direct comparison challenging. Some trials (n ¼ 11, 73%) reported PROs on specific symptoms. In general, patients receiving ICIs had similar-to-improved HRQoL and experiences when compared to other therapies.Conclusion. Despite the broad clinical trials experience of ICI therapies across cancer types, relatively few randomized studies reported PROs and patient HRQoL data. Available data suggest that ICIs are well tolerated in terms of HRQoL compared to other anticancer therapies although the conclusions are limited by the heterogeneity of trial designs and outcomes. Currently used instruments may fail to capture important symptomatology unique to ICIs, underscoring a need for PROs designed specifically for ICIs.

BackgroundTreatment of metastatic melanoma patients with immune checkpoint inhibitors is an important standard of care. Side effects are due to immune activation, can affect virtually all organ systems, and are occasionally severe. Although hematologic toxicity has been reported, we present a case of hemophagocytic lymphohistiocytosis (HLH) due to immune checkpoint inhibitor therapy.Case presentationA patient with metastatic melanoma was treated with one course of ipilimumab + nivolumab and presented 3 weeks later with severe anemia and hyperferritinemia. A bone marrow biopsy revealed necrotic tumor cells, infiltrating T cells, and hemophagocytosis. The patient was treated with high-dose steroids; 12 months later, the patient remains off all therapy and in complete remission of both HLH and metastatic melanoma.ConclusionsThe hemophagocytic syndromes are attributable to dysregulated immune activation and share pathophysiologic mechanisms with immune activation from checkpoint inhibitors. Increasing use of regimens that include immune checkpoint inhibition require vigilant monitoring for immune-activating side effects as they can occasionally be life threatening, as in this case of HLH.

11579 Background: PROs are increasingly used as a key tool in patient-focused treatment decisions. However, many cancer PROs were designed to capture the patient experience of those treated with chemotherapeutic agents. Less is known about the utility of PRO instruments in assessing symptoms from ICIs. Methods: We systematically searched the literature to identify peer-reviewed publications that reported PROs for patients receiving ICIs. We excluded case reports/series, narrative reviews, and publications without original data. We then selected the studies that compared ICIs to cytotoxic chemotherapy. Clinician-documented adverse events (AEs) occurring in at least 10% of patients in a study arm were extracted and examined for concordance with symptoms included in the PROs administered to study patients. Results: Of 1,450 identified studies, eight met criteria for inclusion. Seven assessed PROs with the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), six used the EuroQOL EQ-5D, and one used the Lung Cancer Symptom Scale (LCSS). Across the studies, fatigue, nausea, vomiting, appetite loss, diarrhea, constipation, pruritus, rash, and pyrexia were among the most common clinician-documented AEs. Of these AEs, six are directly correlated with questions on the PRO instruments, and three (pruritus, rash, and pyrexia) are not. AEs with corresponding PRO questions were more common in chemotherapy patients. Pruritus, rash, and pyrexia – AEs without corresponding PRO questions – were more common in patients treated with ICIs (see Table). Conclusions: Existing PRO instruments do not specifically query important symptoms associated with ICIs, underscoring the need to revise the instruments to more appropriately reflect the toxicity profiles of novel agents. [Table: see text]

e23160 Background: Immune checkpoint inhibitors (ICIs) have been met with a wave of excitement due to their novel mechanism. We hypothesized that this may impact how patients (via PROs) report treatment tolerability in comparison to traditional therapies. We sought to examine if there was a notable difference in PROs in blinded vs unblinded trials of ICIs. Methods: We systematically searched PubMed, CINAHL, Embase, Web of Science, and Scopus in August 2018 for publications with quantitative PRO data comparing ICIs to cytotoxic chemotherapy. Case series, narrative reviews, and publications lacking original data were excluded. Eligible publications were reviewed to assess if patients were blinded to the agent received, and a comparison for common PRO metrics was performed. Results: Of the 1,450 unique references identified, eight met inclusion criteria: 1 double blinded placebo-controlled trial and 7 trials where patients were aware of the assigned arm. The blinded trial had quantitative PRO data in the form of the European Organisation for Research and Treatment of Cancer (EORTC) global health status (GHS) score and patient reported symptom burden at week 12. Most (6 of 7; 86%) unblinded trials reported the GHS at either week 12 or 15, and patient symptom burden at these time points as well (5 of 7; 71%). For the EORTC GHS, the blinded trial showed no inter-arm difference at week 12. 4 of 6 (67%) open label trials noted statistically significant differences in GHS favoring the ICI arm. For symptom burden at week 12 or 15, there was no difference found in the blinded study. In unblinded trials, there were domains where patients receiving ICIs reported a statistically significant lower symptom burden than those receiving chemotherapy: fatigue (4 of 5 trials favoring ICIs; 80%), dyspnea (2 of 5; 40%), insomnia (1 of 4; 25%), appetite loss (1 of 4; 25%), and diarrhea (1 of 5; 20%). There were no differences in pain (n = 5), nausea/vomit (n = 5), and constipation (n = 5). Conclusions: We found a trend towards more favorable reporting on common symptoms in unblinded studies of patients receiving ICIs. Our analysis is limited by the lack of available comparisons in the published literature.