TY - JOUR
T1 - ConCerv
T2 - a prospective trial of conservative surgery for low-risk early-stage cervical cancer
AU - Schmeler, Kathleen M.
AU - Pareja, Rene
AU - Blanco, Aldo L.
AU - Fregnani, Jose Humberto
AU - Lopes, Andre
AU - Perrotta, Myriam
AU - Tsunoda, Audrey T.
AU - Cantú-De-León, David F.
AU - Ramondetta, Lois M.
AU - Manchana, Tarinee
AU - Crotzer, David R.
AU - McNally, Orla M.
AU - Riege, Martin
AU - Scambia, Giovanni
AU - Carvajal, Juan Manuel
AU - Di Guilmi, Julian
AU - Rendon, Gabriel J.
AU - Ramalingam, Preetha
AU - Fellman, Bryan M.
AU - Coleman, Robert L.
AU - Frumovitz, Michael
AU - Ramirez, Pedro T.
N1 - Funding Information:
Funding This research was supported in part by the National Institutes of Health (NIH) through MD Anderson’s Cancer Center Support Grant P30CA016672 and the MD Anderson Sister Institution Network Fund.
Funding Information:
The authors would like to thank the following research personnel and collaborators for their assistance in recruiting patients, collecting/ entering data, and working across different countries, languages, and time zones to complete this study: MD Anderson Cancer Center, Houston, Texas, USA: Cindy Melendez, Jessica Gallegos, Juana Rayo, Ana Lopez, Keiry Paiz, and Mark Munsell; Instituto de de Cancerología - Las Américas - AUNA, Medellín, Colombia: Natalia Escobar; Instituto Nacional de Enfermedades Neoplásicas (INEN), Lima, Perú: Ninoska Macavilca; Barretos Cancer Hospital, Barretos, Brazil: Talita Garcia, Julio Cesar Souza, Ligia Zampieri, Carlos Andrade, Georgia Fontes-Cintra, Marcelo Viera, Ricardo dos Reis, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina: Mariana Prada, Marina Lamm, and Ana Jaen; Instituto Nacional de Cancerologia, México City, México: Lenny Gallardo, Instituto Brasileiro de Controle do Cancer (IBCC), São Paulo, Brazil: Alayne Domingues Yamada; Hospital Erasto Gaertner, Curitiba, Brazil: Nathalia Carneiro, Fernanda Schamne; Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand: Patou Tantbirojn, MD; Nebraska Methodist Health System, Omaha, Nebraska, USA: Kathryn Bartz, RN; Royal Women’s Hospital, Melbourne, Australia: Julie Silvers; Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome, Italy: Luigi Carlo Turco, Anna Fagotti, Francesco Cosentino, Instituto de Ginecología de Rosario, Rosario, Argentina: Gabriela Santillan, and Jeronimo Costa. The authors would also like to thank all the women who entrusted us with their care and participated in the study in order to improve the care of women with cervical cancer globally. This research was supported in part by the National Institutes of Health (NIH) through MD Anderson’s Cancer Center Support Grant P30CA016672 and the MD Anderson Sister Institution Network Fund.
Publisher Copyright:
© IGCS and ESGO 2021.
PY - 2021/10
Y1 - 2021/10
N2 - Objective The objective of the ConCerv Trial was to prospectively evaluate the feasibility of conservative surgery in women with early-stage, low-risk cervical cancer. Methods From April 2010 to March 2019, a prospective single-arm, multicenter study evaluated conservative surgery in participants from 16 sites in nine countries. Eligibility criteria included: (1) FIGO 2009 stage IA2–IB1 cervical carcinoma; (2) squamous cell (any grade) or adenocarcinoma (grade 1 or 2 only) histology; (3) tumor size <2 cm; (4) no lymphovascular space invasion; (5) depth of invasion <10 mm; (6) negative imaging for metastatic disease; and (7) negative conization margins. Cervical conization was performed to determine eligibility, with one repeat cone permitted. Eligible women desiring fertility preservation underwent a second surgery with pelvic lymph node assessment, consisting of sentinel lymph node biopsy and/or full pelvic lymph node dissection. Those not desiring fertility preservation underwent simple hysterectomy with lymph node assessment. Women who had undergone an ‘inadvertent’ simple hysterectomy with an unexpected post-operative diagnosis of cancer were also eligible if they met the abov inclusion criteria and underwent a second surgery with pelvic lymph node dissection only. Results 100 evaluable patients were enrolled. Median age at surgery was 38 years (range 23–67). Stage was IA2 (33%) and IB1 (67%). Surgery included conization followed by lymph node assessment in 44 women, conization followed by simple hysterectomy with lymph node assessment in 40 women, and inadvertent simple hysterectomy followed by lymph node dissection in 16 women. Positive lymph nodes were noted in 5 patients (5%). Residual disease in the post-conization hysterectom specimen was noted in 1/40 patients—that is, an immediate failure rate of 2.5%. Median follow-up was 36.3 months (range 0.0–68.3). Three patients developed recurrent disease within 2 years of surgery—that is, a cumulative incidence of 3.5% (95% CI 0.9% to 9.0%). Discussion Our prospective data show that select patients with early-stage, low-risk cervical carcinoma may be offered conservative surgery.
AB - Objective The objective of the ConCerv Trial was to prospectively evaluate the feasibility of conservative surgery in women with early-stage, low-risk cervical cancer. Methods From April 2010 to March 2019, a prospective single-arm, multicenter study evaluated conservative surgery in participants from 16 sites in nine countries. Eligibility criteria included: (1) FIGO 2009 stage IA2–IB1 cervical carcinoma; (2) squamous cell (any grade) or adenocarcinoma (grade 1 or 2 only) histology; (3) tumor size <2 cm; (4) no lymphovascular space invasion; (5) depth of invasion <10 mm; (6) negative imaging for metastatic disease; and (7) negative conization margins. Cervical conization was performed to determine eligibility, with one repeat cone permitted. Eligible women desiring fertility preservation underwent a second surgery with pelvic lymph node assessment, consisting of sentinel lymph node biopsy and/or full pelvic lymph node dissection. Those not desiring fertility preservation underwent simple hysterectomy with lymph node assessment. Women who had undergone an ‘inadvertent’ simple hysterectomy with an unexpected post-operative diagnosis of cancer were also eligible if they met the abov inclusion criteria and underwent a second surgery with pelvic lymph node dissection only. Results 100 evaluable patients were enrolled. Median age at surgery was 38 years (range 23–67). Stage was IA2 (33%) and IB1 (67%). Surgery included conization followed by lymph node assessment in 44 women, conization followed by simple hysterectomy with lymph node assessment in 40 women, and inadvertent simple hysterectomy followed by lymph node dissection in 16 women. Positive lymph nodes were noted in 5 patients (5%). Residual disease in the post-conization hysterectom specimen was noted in 1/40 patients—that is, an immediate failure rate of 2.5%. Median follow-up was 36.3 months (range 0.0–68.3). Three patients developed recurrent disease within 2 years of surgery—that is, a cumulative incidence of 3.5% (95% CI 0.9% to 9.0%). Discussion Our prospective data show that select patients with early-stage, low-risk cervical carcinoma may be offered conservative surgery.
UR - http://www.scopus.com/inward/record.url?scp=85116511831&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85116511831&partnerID=8YFLogxK
U2 - 10.1136/ijgc-2021-002921
DO - 10.1136/ijgc-2021-002921
M3 - Article
C2 - 34493587
AN - SCOPUS:85116511831
SN - 1048-891X
VL - 31
SP - 1317
EP - 1325
JO - International Journal of Gynecological Cancer
JF - International Journal of Gynecological Cancer
IS - 10
ER -