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

医学诱导化疗宫颈癌随机对照试验肿瘤科化疗内科学癌症妇科癌症放化疗卵巢癌

作者

Michael Mc Cormack,Dolores Gallardo Rincón,Gemma Eminowicz,Patricia Díez,Laura Farrelly,Christopher Kent,Emma Hudson,Miguel Panades,Tony Mathew,Anjana Anand,Mojca Persic,Jennifer Forrest,Rajanee Bhana,Nicholas S. Reed,Anne Drake,Hilary Stobart,Asima Mukhopadhyay,Anne-Marie Hacker,Allan Hackshaw,Jonathan A. Ledermann

标识

DOI：10.1136/ijgc-2024-esgo.2

摘要

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¬ ¬≥3 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.