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.
Chemo-conization in Early-sTage cERvical caNcer >2 cm scheduled for fertilItY-sparing approach: an analysis of the ETERNITY project / Bogani, G.; Scambia, G.; Malzoni, M.; Casarin, J.; Vizzielli, G.; Amant, F.; Raspagliesi, F.; Scambia, G.; Fagotti, A.; Fanfani, F.; De Vincenzo, R.; Ciavattini, A.; Sopracordevole, F.; Clemente, N.; Del Fabro, A.; Buttignol, M.; Cianci, S.; Sarpietro, G.; Matarazzo, M. G.; Malzoni, M.; Falcone, F.; Casarin, J.; Ghezzi, F.; Vizza, E.; Berretta, R.; Petrillo, M.; Capobianco, G.; Scarfone, G.; Casaccia, F.; Fichera, M.; Leo, L.; Sozzi, G.; Colalillo, A.; Cosentino, F.; Gardella, B.; Serrachioli, R.; Raimondo, D.; Chiantera, V.; Ercoli, A.; Dominoni, M.; Zupi, E.; Centini, G.; Uccella, S.; Franchi, M.; Ferrari, F. A.; Perrone, A. M.; De Iaco, P.; Multinu, F.; Zanagnolo, V.; Schivardi, G.; De Vitis, L. A.; Cuccu, I.; Ferrari, F.; Vizzielli, G.; Restaino, S.; Driul, L.; Arcieri, M.; Sorbi, F.; Fambrini, M.; Aguzzoli, L.; Mandato, V. D.; Murina, F.; Solima, E.; Vignali, M.; Vercellini, P.; Ceccaroni, M.; Di Donato, V.; Giannini, A.; Muzii, L.; Chiappa, V.; Palladino, S.; Tozzi, R.; Amant, F.; Raspagliesi, F.. - In: INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER. - ISSN 1048-891X. - 35:4(2025). [10.1016/j.ijgc.2025.101643]
Chemo-conization in Early-sTage cERvical caNcer >2 cm scheduled for fertilItY-sparing approach: an analysis of the ETERNITY project
Berretta R.;
2025-01-01
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.