Search

Background: The efficacy and safety of lenalidomide plus low-dose dexamethasone (Rd) in Chinese patients with relapsed/refractory multiple myeloma (RRMM) was demonstrated in a phase 2, multicenter trial (MM-021). MM-024 was an Extended Access Program (EAP) that allowed responding patients in the MM-021 trial to continue to receive Rd, and to provide additional safety and efficacy data with longer follow-up.Methods: Chinese patients with RRMM who completed ≥ 1 year of Rd therapy in MM-021 and who remained progression-free under Rd entered the Treatment Phase of the MM-024 EAP, continuing Rd at the same dose and schedule. Patients in MM-021 who discontinued Rd treatment or progressed were allowed to enroll in the Safety Follow-Up Phase of the MM-024 EAP. Safety data, including the incidence of second primary malignancies (SPMs), were collected for ≥ 5 years from the time the last on-study patient enrolled in the MM-021 trial (primary end point). Efficacy outcomes (time to progression [TTP], progression-free survival [PFS], and overall survival [OS]) were secondary end points.Results: Median follow-up was 38.4 months for the safety population (n = 80) and 43.3 months for the treatment cohort (n = 41). In the safety population, Grade 3-4 adverse events (AEs) occurred in 60.0 % of patients; the most common grade 3-4 AEs were neutropenia (20.0%), decreased neutrophil count (13.8%), and anemia (11.3%). There was no evidence of cumulative toxicity, and no patients discontinued Rd due to AEs; 2 patients had SPMs. In the treatment cohort, median duration of response was 35.1 months, median TTP was 36.9 months, and median PFS was 36.0 months; median OS was not reached due to the low number of deaths (n = 5).Conclusion: Long-term treatment with Rd has a predictable and manageable safety profile and provides sustained efficacy in Chinese patients with RRMM.Trial Registration: China State Food and Drug Administration (SFDA) registration (CTA reference numbers: 209L10808; 209L10809; 209L10810; and 209L10811) and ClinicalTrials.gov Identifier: NCT02348528. First received January 23, 2015; last updated November 12, 2015; last verified November 2015; study start date September 2012. [ABSTRACT FROM AUTHOR]

Problematic internet use (PIU) has been shown to be closely associated with suicidality and self-injurious behavior (SSIB), but the mechanism to help explain this association is understudied. The aim of the present study is to test mediating effects of negative affectivity between PIU and SSIB and whether social support moderates this mediating effect. A sample of 2173 middle and high school students (M age = 14.66, SD age = 1.87) in central China were recruited. All participants completed a self-report questionnaire assessing PIU, SSIB, negative affectivity, and social support. Simple mediation analysis and moderated mediation analysis were conducted to examine the roles of negative affectivity and social support in the association between PIU and SSIB. PIU was positively associated with SSIB, and negative affectivity mediated this association (β = 0.255, Boot 95 % CI: 0.219 to 0.296). The indirect effect of negative affectivity was moderated by social support, with a stronger association between PIU and SSIB for adolescents with lower social support (β = 0.228, Boot 95 % CI: 0.178 to 0.282) than their counterparts (β = 0.098, Boot 95 % CI: 0.068 to 0.133). Cross-sectional design with self-report measures. PIU is a detrimental risk factor for SSIB, as it is associated with high negative affectivity and increased SSIB, which was more robust for adolescents with lower social support. These results highlight the importance of helping adolescents regulate negative affectivity and improving social support-based preventative interventions to reduce SSIB. • Problematic internet use was a detrimental risk factor for suicidality and self-injurious behavior. • Problematic internet use increased suicidality and self-injurious behavior via high negative affectivity. • The mediation of negative affectivity was more robust for adolescents with lower social support. [ABSTRACT FROM AUTHOR]

Objective: Rapid, high-volume screening programs are needed as part of cervical cancer prevention in China. Methods: In a 5-day screening project in Inner Mongolia, 3345 women volunteered following a community awareness campaign, and self-swabbed to permit rapid HPV testing. Two AmpFire™ HPV detection systems (Atila Biosystems) were sufficient to provide pooled 15-HPV type data within an hour. HPV+ patients had same-day digital colposcopy (DC) performed by 1 of 6 physicians, using the EVA™ system (MobileODT). Digital images were obtained and, after biopsy of suspected lesions for later confirmatory diagnosis, women were treated immediately based on colposcopic impression. Suspected low- grade lesions were offered treatment with thermal ablation (Wisap), and suspected high-grade lesions were treated with LLETZ. Results: Of 3345 women screened, 624 (18.7%) were HPV+. Of these, 88.5% HPV+ women underwent same-day colposcopy and 78 were treated. Later consensus histology results obtained on 197 women indicated 20 CIN2+, of whom 15 were detected and treated/referred at screening (10 by thermal ablation, 4 by LLETZ, 1 by referral). Conclusions: Global control of cervical cancer will require both vaccination and screening of a huge number of women. This study illustrates a cervical screening strategy that can be used to screen-and-treat large numbers of women. HPV self-sampling facilitates high-volume screening. Specimens can be tested rapidly, promoting minimal loss-to-follow-up. Specifically, the AmpFire™ system used in this study is highly portable, simple, rapid (92 specimens per 65 min per unit), and economical. Visual triage can be performed on HPV+ women with a portable digital colposcope that provides magnification, lighting, and a recorded image. Diagnosis and appropriate treatment remain the most subjective elements. The digital image is under study for deep-learning based automated evaluation that could assist the management decision, either by itself or combined with HPV typing. [ABSTRACT FROM AUTHOR]