Results from neoadjuvant chemotherapy followed by surgery compared to chemoradiation for stage Ib2-IIb cervical cancer, EORTC 55994.

• DOI: 10.1200/jco.2019.37.15_suppl.5503
• Publication Date: 2019-05-27T16:09:53Z
• Authors: Gemma Kenter; Stefano Greggi; Ignace Vergote; Dionyssios Katsaros; Juliusz Kobierski; Leon Massuger; H. C. van Doorn; Fabio Landoni; Jacobus Van Der V...; Nicholas Simon Reed; Corneel Coens; Iske van Luijk; P. B. Ottevanger; Antonio Casado
• Keywords: Chemoradiotherapy; Concomitant; Clinical endpoint; Radical surgery

5503 Background: Conflicting evidence on the value of neoadjuvant chemotherapy followed by surgery compared to concomitant chemoradiation in Stage IB2-IIB cervical carcinoma led this multinational multicenter trial. As trial is approaching completion its follow-up, preliminary results are presented. Methods: Between May 2002 and June 2014 a total 620 patients with FIGO stage Ib2-IIb were randomized between (NACTS, arm 1, N=311) standard chemoradiotherapy (CCRT, 2, N=309) . In radical hysterectomy was required within 6 weeks after cisplatin-based cumulative minimum 225mg/m2, radiation consisted 45-50 Gy plus boost concurrent weekly cisplatin (40 mg/m2 per week). Primary endpoint 5-yrs overall survival (OS). Results: Median follow-up time 8.2 years ( 95% CI = 7.8 yrs – 8.6 yrs)) similar both arms. A 191 deaths (31%) occurred. Age, histological cell type balanced Protocol treatment completed 459 (74%) (71% for NACTS; 82% CCRT). 1 238 (76%) underwent surgery. Main reasons not having as protocol, toxicity (25/74, 34%), progressive disease (18/74, 24%) insufficient response NACT (12/74, 16%). Additional radiotherapy given 113 (36.3%) 1; additional performed 9 (2.9%) 2. Short term severe adverse events (≥G3) occurred more frequently than 2 (35% vs 21%, p < 0.001). The 5 year OS 72% 76% (not statistically significant, difference 4.0% (95%CI: -4% - 12%); HR 0.87, 95%CI: 0.65-0.15, p=0.332). Conclusions: These revealed no 5-year NACTS CCRT, indicating that quality life long important decide optimal treatment. final will be available April 2019, including long-term effect across prognostic factors. Clinical information: NCT00039338.