Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2022
Late toxicity within a Phase III clinical trial of IG-IMRT in cervix cancer (PARCER): Reanalysis with time weighted adverse event reporting (MOSES).
Клиническое исследование III фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Supriya Chopra, Nilesh Ranjan, Mayuri Charnalia, Sadhana Kannan, Reena Engineer, Tapas Dora, Lavanya Gurram, Prachi Mittal, Amita Maheshwari, Shylasree T S, Shyam Shrivastava, Sudeep Gupta
Аннотация
BACKGROUND AND PURPOSE: This post-hoc analysis was performed to report the impact of Image guided intensity modulated radiotherapy (IG-IMRT) and three-dimensional conformal radiotherapy (3D-CRT) across organ system and grades of toxicity within PARCER trial (NCT01279135). Primary endpoint of PARCER focused on grade ≥ 2 late gastrointestinal (GI) toxicity using Common Terminology Criteria for Adverse Events (CTCAE). We now analyze all adverse events using CTCAE and time and severity weighted toxicity reporting method (MOSES).
MATERIALS AND METHODS: MOSES was calculated separately for GI, genitourinary (GU)/GI, and any late toxicities (GI, GU, lymphedema, fatigue, vaginal stenosis, fibrosis and constitutional symptoms) by imputing proportionate time weightage to CTCAE. Cumulative MOSES (C-MOSES) for multiple system and multiorgan toxicity was determined. Difference in arms was analyzed as time-to-event and intention-to-treat analysis using CTCAE grade ≥ 1 and C-MOSES ≥ 0.70.
RESULTS: We observed no difference in the 3-year cumulative incidence of CTCAE grade ≥ 1 GI, GI or GU, or any late toxicity between treatment arms. However, while using C-MOSES, HR of 0.59 (95% CI 0.38-0.92, p = 0.017), 0.68 (95% CI: 0.44-1.05, p = 0.08) and 0.72 (95% CI: 0.52-0.99, p = 0.04) was observed for GI, GI or GU, or any late toxicity within IG-IMRT respectively.
CONCLUSION: This demonstrates superior discrimination of intervention effects using MOSES which demonstrates superiority of IG-IMRT.
MATERIALS AND METHODS: MOSES was calculated separately for GI, genitourinary (GU)/GI, and any late toxicities (GI, GU, lymphedema, fatigue, vaginal stenosis, fibrosis and constitutional symptoms) by imputing proportionate time weightage to CTCAE. Cumulative MOSES (C-MOSES) for multiple system and multiorgan toxicity was determined. Difference in arms was analyzed as time-to-event and intention-to-treat analysis using CTCAE grade ≥ 1 and C-MOSES ≥ 0.70.
RESULTS: We observed no difference in the 3-year cumulative incidence of CTCAE grade ≥ 1 GI, GI or GU, or any late toxicity between treatment arms. However, while using C-MOSES, HR of 0.59 (95% CI 0.38-0.92, p = 0.017), 0.68 (95% CI: 0.44-1.05, p = 0.08) and 0.72 (95% CI: 0.52-0.99, p = 0.04) was observed for GI, GI or GU, or any late toxicity within IG-IMRT respectively.
CONCLUSION: This demonstrates superior discrimination of intervention effects using MOSES which demonstrates superiority of IG-IMRT.