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Results from neoadjuvant chemotherapy followed by surgery compared to chemoradiation for Stage IB2-IIB cervical cancer: EORTC55994
  1. S Greggi1,
  2. G Kenter2,
  3. I Vergote3,
  4. D Katsaros4,
  5. J Kobierski5,
  6. LFAG Massuger6,
  7. PA van Doorn7,
  8. F Landoni8,
  9. J van de Velden9,
  10. N Reed10,
  11. C Coens11,
  12. I van Luijk12,
  13. P Ottevanger6,
  14. N Colombo13 and
  15. A Casado Herraez14
  1. 1Gynecologic Oncology Surgery, Istituto Nazionale Tumori IRCCS ‘Fondazione G. Pascale’, Naples, Italy
  2. 2Center Gynaecologic Oncology Amsterdam, Amsterdam, The Netherlands
  3. 3University Hospitals, Leuven, Belgium
  4. 4AOU Citta della Salute, PO S. Anna and University of Torino, Torino, Italy
  5. 5Medical University of Gdansk, Gdansk, Poland
  6. 6Radboud University Medical Center, Nijmegen
  7. 7Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands
  8. 8Milano Bicocca University, Ospedale San Gerardo, Monza, Italy
  9. 9Amsterdam University Medical Center, Amsterdam, The Netherlands
  10. 10Gartnavel General Hospital, Glasgow, UK
  11. 11European Organization on Research and Treatment of Cancer EORTC, Brussels, Belgium
  12. 12MC Haaglanden, The Hague, The Netherlands
  13. 13University of Milan Bicocca and European Institute of Oncology, Milan, Italy
  14. 14University Hospital San Carlos, Madrid, Spain


Introduction/Background Within EORTC-GCCG we conducted a randomized multinational multicenter trial in order to compare the value of neoadjuvant chemotherapy followed by radical surgery with standard concomitant chemoradiation in Stage IB2-IIB cervical carcinoma. As the trial (55994) is approaching completion of its follow-up, preliminary results are presented here.

Methodology Between May 2002 and June 2014 a total of 620 patients with FIGO stage Ib2-IIb were randomized between neoadjuvant chemotherapy followed by surgery (NACTS, arm1, N=311) with standard concomitant chemoradiotherapy (CCRT, arm2, N=309). In arm1, radical hysterectomy was required within 6 weeks after completion of cisplatin-based chemotherapy with a cumulative minimum of 225 mg/m2, in arm2, radiation consisted of 45-50Gy plus boost concurrent with weekly cisplatin chemotherapy (40 mg/m2 per week). Primary endpoint was 5-yr overall survival (OS).

Results Median follow-up time was 8.2 years (95%CI =7.8 yrs–8.6 yrs) and similar between both arms. A total of 191 deaths (31%) occurred. Age, stage and histological cell type were balanced in both arms. Protocol treatment was completed in 459 (74%) patients (71% for NACTS; 82% for CCRT). In arm1 238 (76%) patients underwent surgery. Main reasons for not having surgery as per protocol, were toxicity (25/74, 34%), progressive disease (18/74, 24%) and insufficient response to NACT (12/74, 16%). Additional radiotherapy was given to 113 patients (36.3%) in arm1; additional surgery performed in 9 patients (2.9%) in arm2. Short term severe adverse events (≥G3) occurred more frequently in arm1 than in arm2 (35% vs 21%, p<0.001). The 5 year OS was 72% in arm1 and 76% in arm2 (not statistically significant, difference =4.0% (95%CI: -4%–12%); HR 0.87, 95%CI: 0.65–0.15, p=0.332).

Conclusion These preliminary results revealed no difference in 5-year OS between NACTS and CCRT, indicating that quality of life and long term toxicity across prognostic factors are important to decide on optimal treatment.

Disclosure Nothing to disclose.

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