Rosa de Vincenzo1, Caterina Ricci2, Francesco Fanfani3, Benedetta Gui4, Valerio Gallotta2, Anna Fagotti1, Gabriella Ferrandina1, Giovanni Scambia1. 1. Università Cattolica del Sacro Cuore, Rome, Italy; Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy. 2. Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy. 3. Università Cattolica del Sacro Cuore, Rome, Italy; Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy. Electronic address: francesco.fanfani74@gmail.com. 4. Dipartimento di Diagnostica per immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.
Abstract
OBJECTIVE: 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. DESIGN: Pilot study of conization after chemotherapy in stage IB2-IIA1 >2 cm cervical cancer. SETTING: University hospital. PATIENT(S): From 2014 to 2018, 25 patients, <40 years of age, were enrolled. INTERVENTIONS(S): 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. RESULT(S): 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%. CONCLUSION(S): 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: NCT02323841.
OBJECTIVE: 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. DESIGN: Pilot study of conization after chemotherapy in stage IB2-IIA1 >2 cm cervical cancer. SETTING: University hospital. PATIENT(S): From 2014 to 2018, 25 patients, <40 years of age, were enrolled. INTERVENTIONS(S): 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. RESULT(S): 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%. CONCLUSION(S): 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: NCT02323841.
Authors: Carlo Ronsini; Maria Cristina Solazzo; Nicolò Bizzarri; Domenico Ambrosio; Marco La Verde; Marco Torella; Raffaela Maria Carotenuto; Luigi Cobellis; Nicola Colacurci; Pasquale De Franciscis Journal: Ann Surg Oncol Date: 2022-09-05 Impact factor: 4.339