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154 A randomized phase III trial of induction chemotherapy followed by chemoradiation compared with chemoradiation alone in locally advanced cervical cancer. The GCIG INTERLACE trial
  1. Mary Mc Cormack1,
  2. Dolores Gallardo Rincon2,
  3. Gemma Eminowicz1,
  4. Patricia Diez3,
  5. Laura Farrelly4,
  6. Christopher Kent5,
  7. Emma Hudson6,
  8. Miguel Panades7,
  9. Tony Mathew8,
  10. Anjana Anand9,
  11. Mojca Persic10,
  12. Jennifer Forrest11,
  13. Rajanee Bhana12,
  14. Nicholas Reed13,
  15. Anne Drake14,
  16. Hilary Stobart15,
  17. Asima Mukhopadhyay16,
  18. Anne-Marie Hacker4,
  19. Allan Hackshaw4 and
  20. Jonathan Ledermann4
  1. 1University College London Hospital, London, UK
  2. 2The National Cancer Institute, Ciudad De Mexico, Mexico
  3. 3National Radiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, London, UK
  4. 4University College London, London, UK
  5. 5Leicester Royal Infirmary, Leicester, UK
  6. 6Velindre Cancer Centre, Cardiff, UK
  7. 7United Lincolnshire Hospitals NHS Trust, Lincoln, UK
  8. 8Sheffield Teaching Hospitals NHS Trust, Sheffield, UK
  9. 9Nottingham University Hospitals NHS Trust, Nottingham, UK
  10. 10University of Derby and Burton NHS Foundation Trust, Derby, UK
  11. 11Royal Devon and Exeter NHS Foundation Trust, Exeter, UK
  12. 12University Hospital of North Midlands NHS Trust, Stoke-On-Trent, UK
  13. 13Beatson West of Scotland Cancer Centre, Glasgow, UK
  14. 14Belfast Health and Social Care Trust, Belfast, UK
  15. 15Independent Cancer Patients’ Voice, London, UK
  16. 16Kolkata Gynaecological Oncology Trials and Translational Research Group, Kolkata, India

Abstract

Introduction/Background Locally advanced cervical cancer (LACC) is treated with chemoradiation (CRT). However, many patients relapse and die from metastatic disease. A feasibility study demonstrated a good response rate to 6 weeks of induction chemotherapy (IC) delivered before standard CRT. INTERLACE trial investigated whether this approach improves both progression free survival (PFS) and overall survival (OS).

Methodology Patients with locally advanced squamous, adeno or adenosquamous carcinoma were randomised (1:1) to either CRT alone (5 weeks cisplatin) or IC (6 weeks carboplatin AUC2 and paclitaxel 80mg/m2) followed by the same CRT in week 7. Mandated minimum total EQD2 dose 78Gy to Point A. All centers underwent radiation quality assurance. Primary endpoints PFS (target hazard ratio [HR] 0.65) and OS (target HR 0.65–0.70).

Results 500 Patients recruited from 32 centres 5 countries. Median age 46 Majority of the patients were stage IIB (70%) and IIIB (11%) 57% node negative .82% squamous subtype. Arms were balanced.

92% of IC patients had 5/6 cycles of carboplatin/paclitaxel. Median interval IC to CRT 7 days. 85% IC/CRT vs. 90% (CRT alone) had 4/5 cycles cisplatin. Over 92% received external beam and brachytherapy in both arms. Median overall treatment time 45days.

Grade ³3 adverse events in 59% (IC/CRT) vs. 48% (CRT alone).

Median follow up 64 months. 5-year PFS rate 73% IC/CRT and 64% CRT alone (HR 0.65; 95%CI:0.46–0.91, p=0.013). The corresponding 5-year OS rates are 80% and 72% (HR 0.61:95%CI:0.40–0.91, p=0.04). Local and pelvic relapses occurred in 16% in both arms whilst distant relapses occurred in 12% and 20% of IC/CRT and CRT arms respectively.

Conclusion Induction chemotherapy followed by CRT significantly improves PFS and OS in LACC and should be considered a new standard of care. INTERLACE recruited patients from diverse health care settings demonstrating that IC followed by CRT is feasible in all countries.

Disclosures See attached document for COI- presenting author.

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