ABSTRACT
BACKGROUND: Concurrent chemoradiotherapy (CCRT) is the standard treatment for locally advanced esophageal squamous cell carcinoma (ESCC). However, the optimal radiotherapy regimen, particularly in terms of total dose and planned range of irradiation field, remains unclear. This phase III clinical trial aimed to compare the survival benefits between different radiation doses and different target fields. METHODS: This trial compared two aspects of radiation treatment, total dose and field, using a two-by-two factorial design. The high-dose (HD) group received 59.4 Gy radiation, and the standard-dose (SD) group received 50.4 Gy. The involved field irradiation (IFI) group and elective nodal irradiation (ENI) group adopted different irradiation ranges. The participants were assigned to one of the four groups (HD+ENI, HD+IFI, SD+ENI and SD+IFI). The primary endpoint was overall survival (OS), and the secondary endpoints included progression-free survival (PFS). The synergy indexwas used to measure the interaction effect between dose and field. RESULTS: The interaction analysis did not reveal significant synergistic effects between the dose and irradiation field. In comparison to the target field, patients in IFI or ENI showed similar OS (hazard ratio [HR] = 0.99, 95% CI: 0.80-1.23, p = 0.930) and PFS (HR = 1.02, 95% CI: 0.82-1.25). The HD treatment did not show significantly prolonged OS compared with SD (HR = 0.90, 95% CI: 0.72-1.11, p = 0.318), but it suggested improved PFS (25.2 months to 18.0 months). Among the four groups, the HD+IFI group presented the best survival, while the SD+IFI group had the worst prognosis. No significant difference in the occurrence of severe adverse events was found in dose or field comparisons. CONCLUSIONS: IFI demonstrated similar treatment efficacy to ENI in CCRT of ESCC. The HD demonstrated improved PFS, but did not significantly improve OS. The dose escalation based on IFI (HD+IFI) showed better therapeutic efficacy than the current recommendation (SD+ENI) and is worth further validation.
ABSTRACT
OBJECTIVES: Cardiac rehabilitation (CR) improves outcomes after myocardial infarction (MI), but it is underused in China. The purpose of this study was to develop a set of quality indicators (QIs) to improve clinical practices and to confirm the measurability and performance of the developed QIs for CR in Chinese patients after MI. DESIGN AND SETTING: The QIs were developed by a Chinese expert consensus panel during in-person meetings. The five QIs most in need of improvement were selected using a national questionnaire. Finally, the completion rate and feasibility of the QIs were verified in a group of MI survivors at university hospitals in China. PARTICIPANTS: Seventeen professionals participated in the consensus panel, 89 personnel in the field of CR participated in the national questionnaire and 165 MI survivors participated in the practice test. RESULTS: A review of 17 eligible articles generated 26 potential QIs, among which 17 were selected by the consensus panel after careful evaluation. The 17 QIs were divided into two domains: (1) improving participation and adherence and (2) CR process standardisation. Nationwide telephone and WeChat surveys identified the five QIs most in need of improvement. A multicenter practice test (n=165) revealed that the mean performance value of the proposed QIs was 43.9% (9.9%-86.1%) according to patients with post-MI. CONCLUSIONS: The consensus panel identified a comprehensive set of QIs for CR in patients with post-MI. A nationwide questionnaire survey was used to identify the QIs that need immediate attention to improve the quality of CR. Although practice tests confirmed the measurability of the proposed QIs in clinical practice, the implementation of the QIs needs to be improved. TRIAL REGISTRATION NUMBER: This study is part of a study registered in ClinicalTrials.gov (NCT03528382).
