Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE).

BACKGROUND: Pertuzumab combined with trastuzumab and docetaxel is the standard first-line therapy for HER2-positive metastatic breast cancer, based on results from the phase III CLEOPATRA trial. PERUSE was designed to assess the safety and efficacy of investigator-selected taxane with pertuzumab and trastuzumab in this setting. PATIENTS AND METHODS: In the ongoing multicentre single-arm phase IIIb PERUSE study, patients with inoperable HER2-positive advanced breast cancer (locally recurrent/metastatic) (LR/MBC) and no prior systemic therapy for LR/MBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab [8\u2009mg/kg loading dose, then 6\u2009mg/kg every 3\u2009weeks (q3w)] and pertuzumab (840\u2009mg loading dose, then 420\u2009mg q3w) until disease progression or unacceptable toxicity. The primary end point was safety. Secondary end points included overall response rate (ORR) and progression-free survival (PFS). RESULTS: Overall, 1436 patients received at least one treatment dose (initially docetaxel in 775 patients, paclitaxel in 589, nab-paclitaxel in 65; 7 discontinued before starting taxane). Median age was 54\u2009years; 29% had received prior trastuzumab. Median treatment duration was 16\u2009months for pertuzumab and trastuzumab and 4\u2009months for taxane. Compared with docetaxel-containing therapy, paclitaxel-containing therapy was associated with more neuropathy (all-grade peripheral neuropathy 31% versus 16%) but less febrile neutropenia (1% versus 11%) and mucositis (14% versus 25%). At this preliminary analysis (52 months' median follow-up), median PFS was 20.6 [95% confidence interval (CI) 18.9-22.7] months overall (19.6, 23.0 and 18.1\u2009months with docetaxel, paclitaxel and nab-paclitaxel, respectively). ORR was 80% (95% CI 78%-82%) overall (docetaxel 79%, paclitaxel 83%, nab-paclitaxel 77%). CONCLUSIONS: Preliminary findings from PERUSE suggest that the safety and efficacy of first-line pertuzumab, trastuzumab and taxane for HER2-positive LR/MBC are consistent with results from CLEOPATRA. Paclitaxel appears to be a valid alternative taxane backbone to docetaxel, offering similar PFS and ORR with a predictable safety profile. CLINICALTRIALS.GOV: NCT01572038

Validation and utilization of an internally controlled multiplex Real-time RT-PCR assay for simultaneous detection of enteroviruses and enterovirus A71 associated with hand foot and mouth disease

BACKGROUND: Hand foot and mouth disease (HFMD) is a disease of public health importance across the Asia-Pacific region. The disease is caused by enteroviruses (EVs), in particular enterovirus A71 (EV-A71). In EV-A71-associated HFMD, the infection is sometimes associated with severe manifestations including neurological involvement and fatal outcome. The availability of a robust diagnostic assay to distinguish EV-A71 from other EVs is important for patient management and outbreak response. METHODS: We developed and validated an internally controlled one-step single-tube real-time RT-PCR in terms of sensitivity, linearity, precision, and specificity for simultaneous detection of EVs and EV-A71. Subsequently, the assay was then applied on throat and rectal swabs sampled from 434 HFMD patients. RESULTS: The assay was evaluated using both plasmid DNA and viral RNA and has shown to be reproducible with a maximum assay variation of 4.41 % and sensitive with a limit of detection less than 10 copies of target template per reaction, while cross-reactivity with other EV serotypes was not observed. When compared against a published VP1 nested RT-PCR using 112 diagnostic throat and rectal swabs from 112 children with a clinical diagnosis of HFMD during 2014, the multiplex assay had a higher sensitivity and 100 % concordance with sequencing results which showed EVs in 77/112 (68.8 %) and EV-A71 in 7/112 (6.3 %). When applied to clinical diagnostics for 322 children, the assay detected EVs in throat swabs of 257/322 (79.8 %) of which EV-A71 was detected in 36/322 (11.2 %) children. The detection rate increased to 93.5 % (301/322) and 13.4 % (43/322) for EVs and EV-A71, respectively, when rectal swabs from 65 throat-negative children were further analyzed. CONCLUSION: We have successfully developed and validated a sensitive internally controlled multiplex assay for rapid detection of EVs and EV-A71, which is useful for clinical management and outbreak control of HFMD. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12985-015-0316-2) contains supplementary material, which is available to authorized users

Pollution minimizing at traditional craft village by micro-credit program - case study from Tan Phu Dong rice flour production village: Event report

This paper introduces the results of a project initiated by Cantho University (CTU) on the introduction of micro-credits for addressing the environmental pollution in Vietnam’s craft villages. At Tan Phu Dong, a traditional rice powder production village in Sa Dec, Dong Thap, all wastes from domestic and production activities and animal husbandry were freely disposed into open water sources. This practice led to a negative impact on the local environment. With the financial support provided by the Bread for the World (BfdW), a micro-credit program was initiated in which farmers could borrow money to construct a biogas plant to treat animal husbandry and domestic wastes. In addition, the staff transferred biogas plant construction technology to the local masons and organized training courses on biogas plant operation and maintenance and biogas usage for the farmers and the local officials. 61 farmers borrowed money from the program to construct their biogas plants, followed by more than 250 farmers that constructed their biogas plants by their own finance after realizing the positive benefits of biogas plants. As result, the environmental pollution issue was solved step-by-step, thereby helping enhance the living conditions of the local community.Bài báo này trình bày biện pháp sử dụng nguồn quỹ tín dụng nhỏ để các hộ dân cải thiện tình trạng ô nhiễm môi trường ở các làng nghề Việt Nam. Tại làng nghề làm bột Tân Phú Đông - Sa Đéc - Đồng Tháp, các loại chất thải sinh hoạt, chất thải sản xuất và chăn nuôi xả thải bừa bãi đã gây ô nhiễm môi trường nghiêm trọng. Với kinh phí tài trợ từ tổ chức Bánh mỳ cho thế giới (BfdW), các cán bộ trường Đại học Cần Thơ đã tổ chức cho người dân luân phiên vay vốn để xây dựng hầm ủ khí sinh học xử lý chất thải chăn nuôi và chất thải sinh hoạt. Bên cạnh đó còn tổ chức các lớp tập huấn chuyển giao công nghệ xây hầm ủ khí sinh học cho thợ xây địa phương, hướng dẫn vận hành và bảo dưỡng hầm ủ cho người dân và cán bộ địa phương. Thông qua nguồn vốn vay của dự án, có 61 hộ dân đã xây dựng hầm ủ khí sinh học và trên 250 hộ dân khác đã tự đầu tư xây dựng khi thấy được lợi ích của hầm ủ. Nhờ đó tình trạng ô nhiễm môi trường từng bước được giải quyết góp phần cải thiện điều kiện sống của người dân tại địa phương

Pollution minimizing at traditional craft village by micro-credit program - case study from Tan Phu Dong rice flour production village: Event report

This paper introduces the results of a project initiated by Cantho University (CTU) on the introduction of micro-credits for addressing the environmental pollution in Vietnam’s craft villages. At Tan Phu Dong, a traditional rice powder production village in Sa Dec, Dong Thap, all wastes from domestic and production activities and animal husbandry were freely disposed into open water sources. This practice led to a negative impact on the local environment. With the financial support provided by the Bread for the World (BfdW), a micro-credit program was initiated in which farmers could borrow money to construct a biogas plant to treat animal husbandry and domestic wastes. In addition, the staff transferred biogas plant construction technology to the local masons and organized training courses on biogas plant operation and maintenance and biogas usage for the farmers and the local officials. 61 farmers borrowed money from the program to construct their biogas plants, followed by more than 250 farmers that constructed their biogas plants by their own finance after realizing the positive benefits of biogas plants. As result, the environmental pollution issue was solved step-by-step, thereby helping enhance the living conditions of the local community.Bài báo này trình bày biện pháp sử dụng nguồn quỹ tín dụng nhỏ để các hộ dân cải thiện tình trạng ô nhiễm môi trường ở các làng nghề Việt Nam. Tại làng nghề làm bột Tân Phú Đông - Sa Đéc - Đồng Tháp, các loại chất thải sinh hoạt, chất thải sản xuất và chăn nuôi xả thải bừa bãi đã gây ô nhiễm môi trường nghiêm trọng. Với kinh phí tài trợ từ tổ chức Bánh mỳ cho thế giới (BfdW), các cán bộ trường Đại học Cần Thơ đã tổ chức cho người dân luân phiên vay vốn để xây dựng hầm ủ khí sinh học xử lý chất thải chăn nuôi và chất thải sinh hoạt. Bên cạnh đó còn tổ chức các lớp tập huấn chuyển giao công nghệ xây hầm ủ khí sinh học cho thợ xây địa phương, hướng dẫn vận hành và bảo dưỡng hầm ủ cho người dân và cán bộ địa phương. Thông qua nguồn vốn vay của dự án, có 61 hộ dân đã xây dựng hầm ủ khí sinh học và trên 250 hộ dân khác đã tự đầu tư xây dựng khi thấy được lợi ích của hầm ủ. Nhờ đó tình trạng ô nhiễm môi trường từng bước được giải quyết góp phần cải thiện điều kiện sống của người dân tại địa phương

Lasianthus kbangensis V. S. Dang, Vuong & Naiki 2022, sp. nov.

Lasianthus kbangensis V.S.Dang, Vuong & Naiki, sp. nov. (Figures 1, 2) TYPE:— VIET NAM. Gia Lai province, K’Bang district, Kon Chu Rang Nature Reserve, in primary evergreen forests, 14°29’17.00”N, 108°32’16.14”E, 1015 m elevation, 20 April 2021, Van-Son Dang, Ba Vuong Truong, Ngoc Minh Tam Thao Duong, Ngan Thi Kim Le & Dinh Hiep Nguyen, Dang 463 (holotype VNM! [barcode VNM00045839]; isotypes HN! VNM! [barcode VNM00045840]). Diagnosis: — Lasianthus kbangensis is similar to L. oblongilobus H. Zhu (2002: 400) in their shrub habit (to 2.5 m tall), smooth on branches and branchlets, and glabrous leaves, but differs in having larger leaf blades (13–20 × 3–5 cm vs. 7–9 × 2–3 cm), longer petioles (10–13 mm long vs. 5–10 mm long), calyx lobes 4 and 0.5–1 mm long (vs. 5 or 6 and 2 mm long), corolla tubes 3–3.5 mm long (vs. ca. 5 mm long), and blue (vs. yellowish-orange) fruits when ripe (Table 1). Shrubs, evergreen, up to 2.5 m tall; branches and branchlets terete, 2–4 mm in diam., glabrous, blackish when dry; internodes 2–4 cm long. Leaves opposite; petioles 10–13 mm long, smooth, glabrous; blade elliptic, ellipticoblong to elliptic-lanceolate, 13–20 × 3–5 cm, coriaceous, glabrous on both surfaces, base cuneate, margin entire, apex acuminate and mucronately cuspidate; midrib flat adaxially, prominent abaxially; secondary veins 5–7 pairs, ascending at an angle of 45–50° from the midrib, curved to the margin, flat adaxially, slightly abaxially; tertiary veins subparallel to reticulate, flat on both surface. Stipules narrowly triangular, 0.8–1 mm long, glabrous except barbate margin. Inflorescences axillary, cymose, 5–13-flowered; bracts inconspicuous. Flowers sessile or subsessile; calyx campanulate, 2–3 mm long, white to purple, subglabrous, calyx tube 1.5–2 mm long, calyx lobes 4, linear to oblong, 0.5–1 mm long, sparsely strigose outside, glabrous inside; corolla salverform, 4–5 mm long, white, corolla tube 3–3.5 mm long, glabrous to sparsely strigose, lobes 4, triangular-lanceolate, 1–1.5 mm long, sparsely strigose outside, villous at throat inside; stamens 4, filaments short, anthers linear to oblong, 0.7–1 mm long; ovary with 4 locules, style linear, 2–3 mm long, glabrous, stigma with 4 lobed, 0.5 mm long. Fruit drupaceous, obovoid to subglobose, 8–10 mm long, 6–8 mm in diam., glabrous, crowned by 4 calyx lobes, blue when ripe; pyrenes 2(–4). Seeds ovoid, 5–5.5 mm long, 3–4 mm in diam., irregular sulcate on the abaxial face, blackish brown when dry. Distribution and habitat: — Lasianthus kbangensis is currently known only from the type locality Kon Chu Rang Nature Reserve, Gia Lai province, Vietnam. It grows under the shade of the primary evergreen forest at elevation of 1000–1100 m, where Elaeocarpus kontumensis Gagnep., Castanopsis harmandii Hickel & A.Camus, Lithocarpus pierrei (Hickel & A.Camus) A.Camus, Cinnamomum verum J.Presl, Garcinia sp., Litsea elongata (Nees) Hook. f., Ardisia conspersa E.Walker, Antidesma montanum Blume are dominant. Phenology: —Flowering and fruiting specimens were collected in April. Etymology: —The new species “ kbangensis ” derives its name from the type locality Kbang District of the Gia Lai Province, where this species was discovered. Vernacular name: —Xú hƯƠng kbang. Preliminary conservation assessment: — Lasianthus kbangensis was only discovered in Kon Chu Rang Nature Reserve, Gia Lai Province. The Extent of Occurrence (EOO) is less than 150 km 2 and the known Area of Occupancy (AOO) is less than 20 km 2. About 500 individuals were observed from our field. Therefore, we propose a status of Endangered (EN) according to the IUCN Red List Categories (IUCN 2019). Discussion:— Lasianthus kbangensis is also similar to Paralasianthus hainanensis (Merrill) H. Zhu (2015: 277), which was a combination based on Lasianthus hainanensis Merrill (1922: 355) (synonym: Saprosma merrillii H.S. Lo (1993: 15)) by Zhu (2015), in the shape of leaves and axillary inflorescences, but differs from the latter by having less secondary veins (5–7 pairs vs. 14–15 pairs), shorter stipules (0.8–1 mm long vs. 2–3 mm long), calyx tube 1.5–2 mm long (vs. ca. 1 mm long), corolla tube 3–3.5 mm long (vs. 4–4.5 mm long), and ovary with 4 locules (vs. 2 locules) (Table 1).Published as part of Nguyen, Dinh Hiep, Dang, Minh Quan, Le, Ngan Thi Kim, Quach, Van Toan Em, Pham, Van Ngot, Le, Van Tho, Truong, Ba Vuong, Naiki, Akiyo & Dang, Van-Son, 2022, A new species of Lasianthus (Rubiaceae) from Kon Chu Rang Nature Reserve in central highlands of Vietnam, pp. 291-296 in Phytotaxa 541 (3) on pages 292-295, DOI: 10.11646/phytotaxa.541.3.9, http://zenodo.org/record/639269

Assessing feasibility of establishing antimicrobial stewardship programmes in two provincial-level hospitals in Vietnam: an implementation research study

Objectives To investigate the feasibility of establishing hospital-based antimicrobial stewardship (AMS) programmes comprising action-planning, educational interventions and data feedback in two provincial-level hospitals in Viet Nam. Design and setting This was an implementation research using participatory action process and existing resources from the Duke Antimicrobial Stewardship Outreach Network with local adjustments. A national stakeholder meeting and Strengths-Weaknesses-Opportunities-Threats (SWOT) analysis were conducted to identify gaps and potential interventions. Participants Hospital AMS staff implemented activities throughout the study phases. Routinely collected patient data were analysed to support planning, implementation and evaluation. Interventions Hospitals were considered as a complex adaptive system and leveraged their unique characteristics and interconnections to develop 1-year plans containing core interventions (data use, educational training, prospective audit with feedback (PAF) and evaluations). Outcome measures We assessed feasibility using outputs from stakeholder meeting, SWOT analysis, baseline data, planning process and implementation. Results The stakeholder meeting identified three gaps for AMS at national level: supportive policies, AMS training and core competencies and collaboration. At the hospitals, AMS programmes took 1 year for planning due to lack of hospital-specific procedures and relevant staff competencies. Baseline data (January–December 2019) showed variations in antibiotic consumption: 951 days of therapy (DOT) per 1000 days present in the control and 496 in the intervention wards in hospital 1, and 737 and 714 in hospital 2, respectively. During 1-year implementation, clinical pharmacists audited 1890 antibiotic prescriptions in hospital 1 (June 2020–May 2021) and 1628 in hospital 2 (July 2020–July 2021), and will continue PAF in their daily work. Conclusion Our data confirmed the need to contextualise AMS programmes in low-income and middle-income countries (LMICs) and demonstrated the usefulness of implementation research design in assessing programme feasibility. Developing staff competencies, using local data to stimulate actions and integrating programme activities in routine hospital work are key to success in LMICs

A rigorous methodology for specification and verification of business processes

10.1007/s00165-009-0106-yFormal Aspects of Computing215495-510FACM