Zoledronic Acid Add-on Therapy for Standard-Risk Ewing Sarcoma Patients in the Ewing 2008R1 Trial.
Обработка статьи · этапы, ошибки и управление
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.
Koch Raphael, Haveman Lianne, Ladenstein Ruth, Brichard Benedicte, Jürgens Heribert, Cyprova Sona, van den Berg Henk, Hassenpflug Wolf, Raciborska Anna, Ek Torben, Baumhoer Daniel, Egerer Gerlinde, Kager Leo, Renard Marleen, Hauser Peter, Burdach Stefan, Bovee Judith V M G, Hong Angela M, Reichardt Peter, Kruseova Jarmila, Streitbürger Arne, Kühne Thomas, Kessler Torsten, Bernkopf Marie, Butterfaß-Bahloul Trude, Dhooge Catharina, Bauer Sebastian, Kiss János, Paulussen Michael, Bonar Fiona, Ranft Andreas, Timmermann Beate, Rascon Jelena, Vieth Volker, Kanerva Jukka, Faldum Andreas, Hartmann Wolfgang, Hjorth Lars, Bhadri Vivek A, Metzler Markus, Gelderblom Hans, Dirksen Uta
Аннотация
PATIENTS AND METHODS: Eligible patients had localized EWS with either good histologic response to induction chemotherapy and/or small tumors (<200 mL). Patients received six cycles of VIDE induction and eight cycles of VAI (male) or eight cycles of VAC (female) consolidation. ZOL treatment started parallel to the sixth consolidation cycle. Randomization was stratified by tumor site (pelvis/other). The two-sided adaptive inverse-normal four-stage design (planned sample size 448 patients, significance level 5%, power 80%) was changed after the first interim analysis using the Müller-Schäfer method.
RESULTS: Between April 2010 and November 2018, 284 patients were randomized (142 ZOL/142 no add-on). With a median follow-up of 3.9 years, EFS was not significantly different between ZOL and no add-on group in the adaptive design (HR, 0.74; 95% CI, 0.43-1.28, P = 0.27, intention-to-treat). Three-year EFS rates were 84.0% (95% CI, 77.7%-90.8%) for ZOL vs. 81.7% (95% CI, 75.2%-88.8%) for no add-on. Results were similar in the per-protocol collective. OS was not different between groups. The 3-year OS was 92.8% (95% CI, 88.4%-97.5%) for ZOL and 94.6% (95% CI, 90.9%-98.6%) for no add-on. Noticeable more renal, neurologic, and gastrointestinal toxicities were observed for ZOL (P < 0.05). Severe renal toxicities occurred more often in the ZOL arm (P = 0.003).
CONCLUSIONS: In patients with standard-risk localized EWS, there is no additional benefit from maintenance treatment with ZOL.