ESMO Congress 2024 | OncologyPRO

Abstract 728P

Background

Cervical function damage from fertility-sparing surgery reduces pregnancy success rate. Recently, immunotherapy has made significant advances in treating cervical cancer (CC). Herein, we conducted this study to evaluate the efficacy and safety of chemo + tislelizumab (TIS, a PD-L1 inhibitor) in young pts with CC who required fertility preservation.

Methods

In this trial, FIGO2018 stage IB1-IB3 or IIIC1r (localized cervical lesions) CC and having fertility needs were enrolled. Pts received 4 cycles chemo (175 mg/m² paclitaxel + 70 mg/m² cisplatin/AUC 5-6 carboplatin, Q3W) + TIS (200 mg, Q3W), followed by surgery-diagnostic cervical conization and sentinel lymph node (SLN) biopsy (IIIC1r stage with pelvic lymph node [PLN] systematic dissection)-upon achieving radiographic complete response (CR). After surgery, pts with pathological complete response (pCR) in all samples will undergo 2-cycle chemo + TIS, followed by TIS maintenance therapy (MT) for 1 year. If the first conization did not achieve pCR for localized cervical lesion only, a second conization was performed after 2-cycle chemo + TIS, followed by 1 year of TIS MT upon achieving pCR. Primary endpoint was pCR (SLN/PLNs + cervical conization) after surgery.

Results

Between Mar. 2022 and Apr. 2024, 8 pts (mean age 31 years) were enrolled, with 2 having stage IIIC1r disease. All 8 pts received chemo + TIS; of these, 6 pts completed 4 cycles, CR rate was 83.3%(5/6), and patients with CR received surgery. The pCR was 100% (5/5) in pts who underwent surgery, with 1 reaching a pCR after the second conization. Amenorrhea occurred in 3 of 5 pts, with 2 recovering normal menstruation post-chemo, and 1 had not returned after 3 weeks post-last chemo+TIS. During 4 cycles of chemo+TIS therapy (n=7), common TEAEs included rash (62.5%), neutropenia (62.5%), and leukopenia (62.5%), alanine aminotransferase increased (50.0%). At data cutoff (median follow-up, 9 months, range 2-25), 1 pt developed progression during MT, and 1 pt got pregnant 3 months post-MT.

Conclusions

Chemo + TIS could mediate tumor regression and eliminate micro-metastases with a tolerable safety profile, potentially preserving fertility in many pts previously considered ineligible.