ObjectivesTo quantify the risk of pneumococcal pneumonia (PP) and invasive pneumococcal disease (IPD) in adults aged ≥19 years with underlying medical conditions compared with healthy adults of the same age in Japan.DesignAn observational, retrospective, cohort study using two healthcare claims databases in Japan: Japan Medical Data Center (JMDC) and Medical Data Vision (MDV) databases.ParticipantsA total of 10.4 million individuals, representing 9.3 million person-years of follow-up, were included in the analysis. Eleven medical conditions as well as PP and IPD were identified by the International Statistical Classification of Diseases and Related Health Problems version 10 diagnostic codes and/or local disease codes used in Japan.Primary outcome measuresAdjusted rate ratios (RRs) for PP and IPD in adults with a medical condition versus adults without any medical condition were calculated using multivariate Poisson regression models with age and/or sex as covariates.ResultsIn the JMDC and MDV databases, respectively, adults ≥19 years with a medical condition (RRs for PP: 3.3 to 13.4, 1.7 to 5.2; RRs for IPD: 12.6 to 43.3, 4.4 to 7.1), adults with two or more medical conditions (PP: 11.6, 2.8; IPD: 18.7, 5.8) and high-risk adults (PP: 12.9, 1.8; IPD: 29.7, 4.0) were at greater risk of PP and IPD compared with their healthy counterparts. Adults aged 50–64 years with an underlying medical condition (PP rate: 38.6 to 212.1 per 100 000 person-years) had a higher rate of PP than those aged ≥65 years without any condition (PP rate: 13.2 to 93.0 per 100 000 person-years).ConclusionsAdults of all ages with an underlying medical condition are at greater risk of PP and IPD compared with adults without any medical condition. This risk increases with the number of underlying medical conditions. Our results support extending pneumococcal vaccination to younger adults with an underlying medical condition, especially those aged 50–64 years.

More than half of persons living with HIV infection in the United States (U.S.) will be ≥50 years of age by 2020, including postmenopausal women. We conducted a systematic literature review about the effects of (1) HIV infection on age at menopause and (2) menopause on antiretroviral therapy (ART) response, in order to inform optimal treatment strategies for menopausal women living with HIV infection. We used the Ovid Medline database from 1980 to 2012. We included studies that focused on HIV-infected persons, included postmenopausal women, and reported outcome data for either age at menopause or response to ART across menopause. We identified six original research articles for age at menopause and five for response to ART across menopause. Our review revealed that current data were conflicting and inconclusive; more rigorous studies are needed. Disentangling the effects of menopause requires well-designed studies with adequate numbers of HIV-infected and HIV-uninfected women, especially disproportionately affected women of color. Future studies should follow women from premenopause through menopause, use both surveys and laboratory measurements for menopause diagnoses, and control for confounders related to normal aging processes, in order to inform optimal clinical management for menopausal women living with HIV.

ObjectivesTo investigate the prevalence of chronic comorbidities and the use of comedications in people living with HIV (PLWH) and on antiretrovirals in Japan, by using a hospital claims database.DesignObservational, retrospective, cross-sectional study.SettingA hospital claims database of Japanese hospitals that have advanced medical treatment capabilities (ie, advanced treatment hospitals, general hospitals, acute care hospitals), which include those providing acute and chronic care (excluding nursing homes or hospices).ParticipantsA total of 1445 PLWH aged ≥18 years and with a prescription record of antiretrovirals between January 2010 and December 2015 were identified from the database.Outcome measuresThe number and types of chronic comorbidities, as well as the number and types of comedications, in different age groups of the PLWH.ResultsThe median (range) age of patients was 45 (18–90) years, and 90.4% were men. Of the 1445 patients, 972 (67.3%) had at least one chronic comorbidity. Common chronic comorbidities included lipid disorders (31.6%), diabetes (26.8%), hypertension (18.2%) and hepatitis B/C coinfection (18.2%). Patients in the older age groups had greater numbers of chronic comorbidities. The most common chronic comorbidities in the older age groups were hypertension, diabetes and lipid disorders. The majority of patients used at least one comedication, and those in the older age groups used greater numbers of comedications. The most common therapeutic category of comedication included antacids, antiflatulents and antiulcerants (31.7%). Of 151 malignancies reported in 117 patients, 84 were AIDS-defining cancers and 67 were non-AIDS-defining cancers.ConclusionsChronic comorbidities and comedications were common among PLWH in Japan taking antiretrovirals; particularly among older patients, who more frequently used comedications. This suggests the need for giving special attention to the appropriate management of this patient population.

4561 Background: Frontline cisplatin-based chemotherapy improves survival in patients (pts) with UC, but ̃50% are cisplatin-ineligible owing to poor performance status or comorbidity. The definition of platinum ineligibility is not standardized; hence, treatment decisions are almost solely made by clinical judgment. Pembrolizumab (pembro) showed antitumor activity and manageable toxicity as frontline therapy in 370 cisplatin-ineligible pts in the single arm, phase 2 KEYNOTE-052 trial (NCT02335424). We present effects of pembro on HRQoL of pts in KEYNOTE-052 who were potentially platinum ineligible in this exploratory analysis. Methods: Eligible pts for KEYNOTE-052 were adults with no prior systemic chemotherapy for advanced/metastatic UC, ECOG PS ≤2, and measurable disease per RECIST v1.1 by blinded independent central review. Pembro 200 mg IV was administered Q3W for up to 2 y. Clinical characteristics of frail pts (platinum ineligible) were identified by extensive review of real-world treatment patterns and relevant literature. Consequently, platinum ineligibility was defined as having an ECOG PS ≥2 plus ≥1 of the following: visceral disease, creatinine clearance < 60 mL/min, or age ≥80 y. HRQoL was assessed using the EORTC QLQ-C30 and EQ-5D-3L during the first 4 cycles, then every 2 cycles for 1 year or until treatment discontinuation (whichever occurred first), and at least 30 days after treatment discontinuation. Key end points were change from baseline per the QLQ-C30 global health status (GHS)/QoL score, QLQ-C30 physical functioning subscale, and EQ-5D visual analog scale (VAS). The minimum important difference (MID) was 10 for QLQ-C30 score change (improved: ≥10; stable: –10 to 10; deteriorated: –10 or less); MID for VAS score change was 7 (improved: ≥7; stable: –7 to 7; deteriorated: –7 or less). Results: Median age for 143 pts was 75 y (range, 34-91); 129 pts (90.2%) had visceral disease; 142 (99.3%) had ECOG PS 2; 1 had ECOG PS 3 (enrolled in error). Compliance rate for HRQoL questionnaires was 93.7% at baseline. At the prespecified analysis time of week 9, 77.6% of pts had improved (n = 51) or stable (n = 60) QLQ-C30 GHS/QoL scores, 64.3% had improved (n = 35) or stable (n = 57) QLQ-C30 physical functioning scores, and 62.2% had improved (n = 56) or stable (n = 33) EQ-5D VAS scores. These scores were stable throughout the HRQoL assessment period for pts who continued pembro. Conclusions: In this exploratory analysis, pembro maintained HRQoL for pts with advanced/metastatic UC in KEYNOTE-052 who were potentially platinum-ineligible per the above criteria. Together with the efficacy and safety data from KEYNOTE-052, these data suggest that pembro monotherapy is a valuable treatment option for select pts with advanced UC who are more senior and/or deemed medically frail. Clinical trial information: NCT02335424.

635 Background: Although a handful of studies have elicited treatment preferences in renal cell carcinoma (RCC), most focused on advanced disease. This study elicited United States patients’ and physicians’ preferences for adjuvant treatment characteristics. Methods: Patients with physician-confirmed RCC and (physician-defined) intermediate high or high risk of recurrence and physicians who treat such patients completed online surveys in Q1-Q2 2022 with a discrete-choice experiment. Hypothetical treatments were described by median disease-free survival (DFS); 5-year overall survival (OS) rate; mode and frequency of administration; need for concomitant daily pill; treatment duration; and the risks of severe diarrhea, fatigue, and dizziness. Preference weight estimates from random parameter logit analysis were used to calculate the conditional relative importance of attributes and risk tolerance measures. Results: 250 patients (50% post-nephrectomy) and 250 physicians (64% oncologists; 36% urologists) completed the survey. OS was the most important attribute to both patients and physicians, but DFS was also important (Table). OS had a greater influence on physicians’ choices than on patients’ choices. On average, OS was 3.2 and 2.5 times as important as DFS and 5.8-9.1 and 2.4-3 times more important than the evaluated risks for physicians and patients, respectively. Further, DFS was 1.8-2.9 times more important to physicians than the evaluated risks, while the importance of DFS and risks were nearly equivalent for patients. The need for concomitant oral medication was the least important attribute to patients and physicians. Both groups were willing to accept more than a 25-percentage-point increase in the risks of severe diarrhea, fatigue, and dizziness for improvements (from 45% to 60% or 85%) in OS. Conclusions: While both patients and physicians weighted OS improvements more than the other treatment attributes, including risks, physicians tended to place lower importance on changes in risk and administration than patients. Physicians and patients should discuss potential benefits and harms when considering adjuvant RCC therapies. [Table: see text]