RESUMO
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 above 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 hysterectomy 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.
Assuntos
Adenocarcinoma/cirurgia , Carcinoma de Células Escamosas/cirurgia , Tratamento Conservador/métodos , Neoplasias do Colo do Útero/cirurgia , Adulto , Idoso , Conização/métodos , Conização/estatística & dados numéricos , Estudos de Viabilidade , Feminino , Humanos , Histerectomia/métodos , Histerectomia/estatística & dados numéricos , Laparoscopia , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos RetrospectivosRESUMO
Introducción La variante pleomórfica del carcinoma lobulillar infiltrante es considerada más agresiva y con peor pronóstico que la variante clásica, según se ve reflejado en numerosos trabajos que muestran una menor sobrevida global en pacientes con carcinoma lobulillar infiltrante pleomórfico (CLP) en comparación con el carcinoma lobulillar infiltrante clásico (CLC). El objetivo del presente trabajo fue comparar las características clínicas, anatomo-patológicas, la sobrevida global y libre de enfermedad entre el carcinoma lobulillar infiltrante pleomórfico y el carcinoma lobulillar infiltrante clásico. Material y método Estudio comparativo, descriptivo, retrospectivo, llevado a cabo en el Instituto de Ginecología de Rosario, donde de un total de 562 pacientes con diagnóstico de cáncer de mama, se hallaron 112 pacientes con diagnóstico de cáncer lobulillar infiltrante, de las cuales un grupo de 94 pacientes tuvo diagnóstico de carcinoma lobulillar infiltrante clásico (19,9%) y 18 pacientes fueron diagnosticadas con carcinoma lobulillar infiltrante pleomórfico (3,2%), de acuerdo al informe anatomopatológico. Se compararon las características clínico-patológicas de presentación, el tratamiento quirúrgico y los resultados oncológicos a largo plazo. Resultados No hubo diferencias significativas en la edad de presentación entre el CLC y el CLP (Mediana: 55 años vs 55 años), tamaño tumoral (Promedio: 2,4 cm vs 3,1 cm), multicentricidad (17% vs 11.1%), receptores hormonales positivos (93,3% vs 97,1%), y tratamiento quirúrgico conservador (70.6% vs 79.4%). Se encontró diferencia estadísticamente significativa en cuanto a estadificación ganglionar (N3: 2.8% vs 44.5% p=0,004), Her2neu positivo (p=0,012) e indicación de quimioterapia en el grupo de carcinoma lobulillar infiltrante pleomórfico (43,2% vs 75% p=0,028). Con respecto al seguimiento, en el grupo CLP se observó menor sobrevida global (p=0,006) y libre de enfermedad (p=0,004) durante 151 meses de seguimiento promedio. Hallamos concordancia con las publicaciones que reportan al CLP como una variante con peor evolución en comparación al CLC. Conclusión Hallamos que el CLP tuvo mayor compromiso ganglionar, indicación de quimioterapia adyuvante, mayor porcentaje de Her2neu positivo y peor evolución, lo que se vio reflejado en una menor sobrevida global y libre de enfermedad.
Introduction According to what is reflected in numerous studies showing a lower global survival in patients with pleomorphic infiltrating lobular carcinoma (PLC) rather than in those with classical infiltrating lobular carcinoma (CLC), the pleomorphic variant of infiltrating lobular carcinoma is considered an aggressive tumor which has a worst prognosis than the classical type. The aim of the present study was to compare the clinical, pathological characteristics, the global and disease-free survival between the pleomorphic infiltrating lobular carcinoma and the classical infiltrating lobular carcinoma. Material and method Comparative, descriptive, retrospective study, conducted at the Instituto de Ginecología de Rosario, where a total of 562 patients diagnosed with breast cancer. 112 patients of them were found diagnosed with infiltrating lobular carcinoma, of which a group of 94 patients had a diagnosis of classic lobular carcinoma (19.9%) and 18 (3.2%) patients were diagnosed with pleomorphic infiltrating lobular carcinoma, according to the pathological report. The clinical-pathological characteristics of presentation, surgical treatment and long-term outcomes were compared. Results There were no significant differences in the age of presentation between the CLC and the CLP (Median: 55 years vs 55 years), tumor size (Mean: 2.4 cm vs. 3.1 cm), multicentricity (17% vs. 11.1%), positive hormonal receptors (93.3% vs. 97.1%), and surgical treatment (70.6% vs. 79.4% in conservative surgery). A statistically significant difference was found in terms of lymph node status (N3: 2.8% vs. 44.5% p=0.004), Her2neu positive (p=0.012) indication of chemotherapy in the group of pleomorphic infiltrating lobular carcinoma (43.2% vs. 75% p=0.028). Regarding the follow-up, in the CLP group, lower overall survival (p= 0.006) and disease-free (p=0.004) noticed during 151 months of average follow-up. We found ourselves in agreement with the publications that report to the CLP as a variant with worse evolution compared to the CLC. Conclusion We found that CLP had a greater lymph node involvement, an indication for adjuvant chemotherapy, a higher percentage of positive Her2 neu and worse evolution, which was reflected in a lower overall and disease-free survival.