Hysterectomy after Chemoradiotherapy for Stage Ib2 and IIb Cervical Cancer Vivek Nama UHBT

Existing Evidence: Keys trial  Cervical Cancers > 4cm  RCT post radiotherapy  30cGy to point A the hysterectomy arm  40cGy to Point A in the non hysterectomy arm  256 (123 in each arm)

Results Hysterectomy did not increase the grade 3 and 4 adverse effects 46% progressed among the radiation group and 37% progressed in the adjuvant hysterectomy group 5 years local relapse was 27% in radiation only group and 14% in combined treatment group Overall survival not different - distant relapses

Changes Chemoradiotherapy  Significant decrease in local and distant recurrence (CD008285) MRI  Combined histology  Negative histology Negative histology had higher distant recurrence

Post Chemo-radiotherapy MRI showing complete response Intervention Arm – Simple Hysterectomy Control Arm – Routine follow up Routine follow up 3 months after completion of treatment for 2 years Routine follow up 6 monthly for 3 years

Outcomes: Primary outcome: Overall Survival Secondary Outcome measures:  Progression free survival,  Treatment related morbidity (CTACE 4.0)  Quality of life (EORTC/FACT)

Has any one tried? French Difficulty recruiting Surgeons felt that randomization into a non intervention arm was harmful to their patients

Funding? NIHR agenda Charity organizations NIHR CRN funds

Why us? Centre  Bristol  Bath  Taunton  Exeter  Cheltenham  Truro 10 cases each

Thank you