Rosa de Vincenzo, M.D., Ph.D., Caterina Ricci, M.D., Ph.D., Francesco Fanfani, M.D., Benedetta Gui, M.D., Valerio Gallotta, M.D., Anna Fagotti, M.D., Gabriella Ferrandina, M.D., Giovanni Scambia, M.D.
To evaluate feasibility of neoadjuvant chemotherapy (NACT) followed by cold-knife conization (CKC) in patients with 2018 FIGO stage IB2–IIA1 cervical cancer who desired to maintain fertility.
Pilot study of conization after chemotherapy in stage IB2–IIA1 >2 cm cervical cancer.
From 2014 to 2018, 25 patients, <40 years of age, were enrolled.
After laparoscopic pelvic lymph-node assessment, NACT with cisplatin/paclitaxel q21 was administered to eligible patients. Responsive patients were treated with CKC.
Main Outcome Measure(s)
Obstetrical outcome: pregnancy rate. Oncologic outcome.
Thirteen out of 25 patients were eligible for fertility-sparing treatment. Oncologic outcome: The clinical overall response rate was 84.5% (11 out of 13 patients). One patient achieved stable disease, was managed by radical surgery, and is still alive; another one experienced progression of disease and died after 15 months. The optimal pathologic response was 69.1%. In the setting of fertility preservation patients, the median follow-up was 37 months (range 18–76). In this group we registered one distant recurrence, 12 months after CKC, in the liver; the patient is still alive and without evidence of disease. Obstetrical outcome: Among the nine patients amenable, three tried to conceive, and two spontaneous pregnancy occurred a few months after the end of treatment, for a pregnancy rate of 66.7%.
This pilot study supports the feasibility of CKC after NACT as conservative treatment in stage IB2–IIA1 cervical cancer, with oncologic outcomes similar to those reported for trachelectomy in the same stage and with potential benefits in terms of obstetrical outcomes.
Clinical Trial Registration Number