Chemo-conization in Early-sTage cERvical caNcer >2 cm scheduled for fertilItY-sparing approach: an analysis of the ETERNITY project.

Abstract

Objective: To investigate the safety of neoadjuvant chemotherapy and conization in early-stage cervical cancer with a tumor size >2 cm using a fertility-sparing approach.

Methods: The ETERNITY project is a retrospective, multi-institutional study that collected data from patients with early-stage cervical cancer undergoing fertility-sparing treatment. In the present study, we report the outcomes of stage IB2 to IB3 cervical cancer undergoing nodal assessment, neoadjuvant chemotherapy, and conization. A propensity-matching algorithm was used to compare patients who underwent upfront radical surgery.

Results: A total of 395 patients were included in the ETERNITY project. Among these, 25 underwent a fertility-sparing attempt with nodal assessment, neoadjuvant chemotherapy, and conization. The median (range) patient age was 37 (24-41) years. Four (16%) patients with positive nodes required definitive chemo-radiation. Twenty-one (84%) patients received neoadjuvant chemotherapy. Two (8%) patients with stable disease underwent radical hysterectomy, whereas the remaining 19 (76%) patients who achieved a clinical response underwent cervical conization. Three (12%) patients underwent radical hysterectomy owing to persistent positive margins, leaving 16 (64%) patients who completed the planned fertility-sparing attempt. After a median (range) follow-up of 36.2 (21.9-88) months, 3 recurrences occurred. Two patients with cervical recurrence underwent hysterectomy, while 1 patient who received definitive chemoradiotherapy owing to the presence of positive nodes developed distant recurrence. Regarding obstetric outcomes, 6 patients attempted to conceive, and 4 (66.7%) pregnancies were achieved (1 was achieved with assisted reproductive technology). In a propensity-matched group of patients who underwent upfront radical surgery, no differences in morbidity or survival rates were recorded.

Conclusions: Neoadjuvant chemotherapy followed by conization should be investigated in selected patients with cervical cancer who wish to preserve their childbearing potential. Further prospective studies are needed to assess the long-term safety and identify predictors of response.

Clinical trial identifier: NCT06351228.