[High-risk endometrial carcinoma in early stages: Hospital Italiano de Buenos Aires, oncological results]. / Carcinoma de endometrio de alto riesgo en estadios iniciales: resultados oncológicos, Hospital Italiano de Buenos Aires

Introduction: Endometrial cancer is the second most frequent gynecological tumor in Argentina, representing 6% of all cancers in women. The objective of this study is to evaluate the oncological and perioperative results in patients with high-risk endometrial cancer (HREC) limited to the uterus, treated at the Hospital Italiano de Buenos Aires, between January 2010-2018. Methods: Retrospective cohort study that evaluated perioperative results, disease-free survival at 2, 4 years in patients with HREC. Results: Of a total of 123 patients, 74 met the inclusion criteria. Serous tumors were the most frequent histological type, n=38 (51%), while dedifferentiated tumors were the least frequent, n=2 (3%). Of all the patients included, 56 (76%) received at least one adjuvant treatment. Taxol platinum-based chemotherapy was implemented in 28 patients (38%), while 24 (33%) received a combination of chemotherapy and radiotherapy. The median follow-up time was 2.9 years. Disease-free survival in patients with stage IA at 2 and 4 years was 71% (95% CI 55-82) and 63% (CI 46-76), respectively, while those with stage IB were 53 (95% CI 33-70) and 38 (95% CI 19-58). Regarding the surgical approach, no significant differences were found in disease-free or overall survival when comparing the laparoscopic with the laparotomy approach (p=0.06). Conclusion: Only the FIGO stage showed an increased probability of death or relapse regardless of the type of adjuvant treatment and the type of surgery approach. Perioperative complications were similar in both approaches.

Introducción: En Argentina el cáncer de endometrio es el segundo tumor ginecológico más frecuente, representando el 6% de todos los cánceres en mujeres. El objetivo de este trabajo es evaluar los resultados oncológicos y perioperatorios, en pacientes con cáncer de endometrio de alto riesgo (CEAR) limitados al útero tratadas en el Hospital Italiano de Buenos Aires entre enero 2010-2018. Métodos: Estudio de cohorte retrospectivo que evaluó los resultados perioperatorios, la supervivencia libre de enfermedad a los 2, 4 años en pacientes con CEAR. Resultados: 74 pacientes cumplieron con los criterios de inclusión. Los tumores serosos fueron los más frecuente n=38 (51%), mientras que los desdiferenciados, los de menor frecuencia, n=2 (3%). 56 (76%) pacientes recibieron al menos un tratamiento adyuvante. El tratamiento sistémico fue implementado en 28 pacientes (38%), mientras que 24 (33%) recibieron una combinación de quimioterapia y radioterapia.  La mediana de seguimiento fue de 2,9 años. La supervivencia libre de enfermedad, en pacientes con estadio IA a los 2 y 4 años fue de 71% (IC 95% 55-82) y 63 % (IC 46 -76) respectivamente, mientras que aquellas que presentaban un estadio IB fue de 53 (IC 95% 33-70) y 38 (IC 95% 19-58). En cuanto a la vía quirúrgica de abordaje, no se encontraron diferencias significativas en la supervivencia libre de enfermedad ni en las complicaciones perioperatorias. Conclusión: Sólo el estadio FIGO mostró un aumento en la probabilidad de muerte o recaída independientemente del tipo de tratamiento adyuvante realizado y de la vía de abordaje seleccionada.

Conservative treatment of cervical cancer: A single center experience over a two-decade period.

Objective: To report the surgical, oncological, and obstetrical outcomes of the different surgical techniques used for the fertility-sparing treatment of patients with early-stage cervical cancer. Methods: We retrospectively analyzed all fertility-sparing procedures performed between 2004 and 2020. The study included patients desiring to preserve fertility who had squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma histology, all grades, and FIGO 2009 stage IA2-IB1 tumors. Results: 48 patients met the inclusion criteria. Eight patients (16.7%) had stage IA2, and 40 (83.3%) had stage IB1 tumors. Conization with pelvic lymph node assessment was performed in 5 (10.4%) patients, an open radical trachelectomy in 21 (43.8%), and a laparoscopic radical trachelectomy in 22 (45.8%). No major intraoperative complications were registered. Two patients required surgery due to an early postoperative complication. Late postoperative complications were seen in 15 patients (31.2%), with cervical stenosis being the most frequent (60%). The rate of DFS at 2 and 5 years was 89% (95% CI, 76-95%), and the 5- year OS was 96% (95% CI, 83-98%). Univariate analysis demonstrated a relationship between tumor size and recurrence, but not for other prognostic tumor factors or surgical approach. One patient (4.8%) developed recurrent disease in the open radical trachelectomy group, and five (22.7%) in the laparoscopic radical trachelectomy group. The pregnancy rate was 41.4%, and the live birth rate 88.2%. Conclusion: Fertility-sparing treatment for patients with early-stage cervical cancer is ever-evolving. This study adds information to the literature about the outcomes of these quite uncommon procedures, and allows a critical analysis of many of the topics which are under discussion.

Minimally invasive surgery versus laparotomy in women with high risk endometrial cancer: A multi-center study performed in Argentina.

Objective: Compare the perioperative outcomes and disease-free survival between minimally invasive and open surgery in women with stage I-II high-risk endometrial cancer. Methods: A retrospective, cohort study was performed involving twenty-four centers from Argentina. Patients with grade 3 endometrioid, serous, clear cell, undifferentiated carcinoma or carcinosarcoma who underwent hysterectomy, bilateral salpingo-oophorectomy, and staging between January 2010-2018 were included. Cox hazard regression analysis and Kaplan-Meier curves evaluated the association of surgical technique with survival. Results: Of 343 eligible patients, 214 (62 %) underwent open surgery and 129 (38 %) underwent laparoscopic surgery. No significant differences were seen between the two groups with respect to greater or equal grade III Clavien-Dindo postoperative complications (11 % in the open surgery group vs 9 % minimally invasive surgery group; P = 0.34) Minimally invasive surgery was not associated with worse disease-free survival at four years (79.14 % [95 % CI 69.42- 86.08] vs 78.80 % [95 % CI 70.61-84.96]), (p = 0.25), even after creating a Cox proportional model (hazard ratio [HR] 1.08 95 % CI 0.63-1.84); (p = 0.76). Conclusion: There was no difference between postoperative complications nor oncologic outcomes comparing minimally invasive and open surgery among patients with high-risk endometrial cancer.

Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study.

BACKGROUND: Minimally invasive radical trachelectomy has emerged as an alternative to open radical hysterectomy for patients with early-stage cervical cancer desiring future fertility. Recent data suggest worse oncologic outcomes after minimally invasive radical hysterectomy than after open radical hysterectomy in stage I cervical cancer. OBJECTIVE: We aimed to compare 4.5-year disease-free survival after open vs minimally invasive radical trachelectomy. STUDY DESIGN: This was a collaborative, international retrospective study (International Radical Trachelectomy Assessment Study) of patients treated during 2005-2017 at 18 centers in 12 countries. Eligible patients had squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma; had a preoperative tumor size of ≤2 cm; and underwent open or minimally invasive (robotic or laparoscopic) radical trachelectomy with nodal assessment (pelvic lymphadenectomy and/or sentinel lymph node biopsy). The exclusion criteria included neoadjuvant chemotherapy or preoperative pelvic radiotherapy, previous lymphadenectomy or pelvic retroperitoneal surgery, pregnancy, stage IA1 disease with lymphovascular space invasion, aborted trachelectomy (conversion to radical hysterectomy), or vaginal approach. Surgical approach, indication, and adjuvant therapy regimen were at the discretion of the treating institution. A total of 715 patients were entered into the study database. However, 69 patients were excluded, leaving 646 in the analysis. Endpoints were the 4.5-year disease-free survival rate (primary), 4.5-year overall survival rate (secondary), and recurrence rate (secondary). Kaplan-Meier methods were used to estimate disease-free survival and overall survival. A post hoc weighted analysis was performed, comparing the recurrence rates between surgical approaches, with open surgery being considered as standard and minimally invasive surgery as experimental. RESULTS: Of 646 patients, 358 underwent open surgery, and 288 underwent minimally invasive surgery. The median (range) patient age was 32 (20-42) years for open surgery vs 31 (18-45) years for minimally invasive surgery (P=.11). Median (range) pathologic tumor size was 15 (0-31) mm for open surgery and 12 (0.8-40) mm for minimally invasive surgery (P=.33). The rates of pelvic nodal involvement were 5.3% (19 of 358 patients) for open surgery and 4.9% (14 of 288 patients) for minimally invasive surgery (P=.81). Median (range) follow-up time was 5.5 (0.20-16.70) years for open surgery and 3.1 years (0.02-11.10) years for minimally invasive surgery (P<.001). At 4.5 years, 17 of 358 patients (4.7%) with open surgery and 18 of 288 patients (6.2%) with minimally invasive surgery had recurrence (P=.40). The 4.5-year disease-free survival rates were 94.3% (95% confidence interval, 91.6-97.0) for open surgery and 91.5% (95% confidence interval, 87.6-95.6) for minimally invasive surgery (log-rank P=.37). Post hoc propensity score analysis of recurrence risk showed no difference between surgical approaches (P=.42). At 4.5 years, there were 6 disease-related deaths (open surgery, 3; minimally invasive surgery, 3) (log-rank P=.49). The 4.5-year overall survival rates were 99.2% (95% confidence interval, 97.6-99.7) for open surgery and 99.0% (95% confidence interval, 79.0-99.8) for minimally invasive surgery. CONCLUSION: The 4.5-year disease-free survival rates did not differ between open radical trachelectomy and minimally invasive radical trachelectomy. However, recurrence rates in each group were low. Ongoing prospective studies of conservative management of early-stage cervical cancer may help guide future management.

ConCerv: a prospective trial of conservative surgery for low-risk early-stage cervical cancer.

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.

[Treatment of advanced epithelial ovarian tumor. Hospital Italiano de Buenos Aires experience]. / Tratamiento de tumores malignos epiteliales de ovario en estadios avanzados. Experiencia del Hospital Italiano de Buenos Aires.

Ovarian cancer represents the third gynecological cancer in frequency in Argentina. There is a lack of information on this pathology in our country regarding the treatment and evolution of patients who suffer it. The aim of this study was to evaluate the perioperative and oncological results in patients with advanced epithelial ovarian tumor. We present a retrospective cohort in which we evaluated disease-free survival and overall survival in patients with epithelial ovarian tumor treated at the Hospital Italiano de Buenos Aires between June 2009 and June 2017. Of 170 patients included in the study, 72 (42.4%) received primary debulking surgery (CCP), while 98 (57.6%) received neoadjuvant therapy and interval surgery (CI). The optimal cyto-reduction rate was 75% and 79% respectively. No differences were found in perioperative outcomes, or in severe complications between the two groups. The median disease-free survival in the CCP group was 2.5 years (95% CI 1.6-3.1) while in the CI group it was 1.4 (95% CI 1.2-1.7) p < 0.001. The median overall survival was 5.8 years in CPP, and 3.5 years in CI. Faced with a meticulous selection by a group of experts, patients with advanced ovarian cancer treated with CCP present better oncological results than those who received neoadjuvant therapy and CI.

El cáncer de ovario ocupa el tercer lugar en frecuencia entre los cánceres ginecológicos en Argentina. Existe un déficit de información de esta enfermedad en nuestro país respecto al tratamiento y evolución oncológica de las pacientes. El objetivo de nuestro trabajo fue evaluar los resultados perioperatorios y oncológicos, en pacientes con tumor epitelial de ovario con estadios avanzados. Presentamos una cohorte retrospectiva en la que se evaluó la supervivencia libre de enfermedad y la supervivencia global en pacientes con tumores epiteliales de ovario tratadas en el Hospital Italiano de Buenos Aires entre junio del 2009 a junio del 2017. De 170 pacientes incluidas en el estudio, 72 (42.4%) fueron tratadas con una cirugía de citorreducción primaria (CCP), mientras que 98 (57.6%) recibieron neoadyuvancia y luego cirugía del intervalo (CI). La tasa de citorreducción óptima fue de 75% y de 79% respectivamente. No se encontraron diferencias en los resultados perioperatorios, ni en las complicaciones graves entre ambos grupos. La mediana de SLE en el grupo de CCP fue de 2.5 años (IC 95% 1.6-3.1) mientras que en el grupo de CI fue de 1.4 (IC 95% 1.2-1.7) p < 0.001. La mediana de supervivencia global fue de 5.8 años en CCP, y de 3.5 años en CI. En pacientes adecuadamente seleccionadas la CCP presenta mejores resultados oncológicos a la neoadyuvancia y CI. La selección correcta de las pacientes para tratamiento primario es fundamental para definir la conducta terapéutica.

Tratamiento de tumores malignos epiteliales de ovario en estadios avanzados. Experiencia del Hospital Italiano de Buenos Aires / Treatment of advanced epithelial ovarian tumor. Hospital Italiano de Buenos Aires experience

Resumen El cáncer de ovario ocupa el tercer lugar en frecuencia entre los cánceres ginecológicos en Argentina. Existe un déficit de información de esta enfermedad en nuestro país respecto al tratamiento y evolución oncológica de las pacientes. El objetivo de nuestro trabajo fue evaluar los resultados perioperatorios y oncológicos, en pacientes con tumor epitelial de ovario con estadios avanzados. Presentamos una cohorte retrospectiva en la que se evaluó la supervivencia libre de enfermedad y la supervivencia global en pacientes con tumores epiteliales de ovario tratadas en el Hospital Italiano de Buenos Aires entre junio del 2009 a junio del 2017. De 170 pacientes incluidas en el estudio, 72 (42.4%) fueron tratadas con una cirugía de citorreducción primaria (CCP), mientras que 98 (57.6%) recibieron neoadyuvancia y luego cirugía del intervalo (CI). La tasa de citorreducción óptima fue de 75% y de 79% respectivamente. No se encontraron diferencias en los resultados perioperatorios, ni en las complicaciones graves entre ambos grupos. La mediana de SLE en el grupo de CCP fue de 2.5 años (IC 95% 1.6-3.1) mientras que en el grupo de CI fue de 1.4 (IC 95% 1.2-1.7) p < 0.001. La mediana de supervivencia global fue de 5.8 años en CCP, y de 3.5 años en CI. En pacientes adecuadamente seleccionadas la CCP presenta mejores resultados oncológicos a la neoadyuvancia y CI. La selección correcta de las pacientes para tratamiento primario es fundamental para definir la conducta terapéutica.

Abstract Ovarian cancer represents the third gynecological cancer in frequency in Argentina. There is a lack of information on this pathology in our country regarding the treatment and evolution of patients who suffer it. The aim of this study was to evaluate the perioperative and oncological results in patients with advanced epithelial ovarian tumor. We present a retrospective cohort in which we evaluated disease-free survival and overall survival in patients with epithelial ovarian tumor treated at the Hospital Italiano de Buenos Aires between June 2009 and June 2017. Of 170 patients included in the study, 72 (42.4%) received primary debulking surgery (CCP), while 98 (57.6%) received neoadjuvant therapy and interval surgery (CI). The optimal cyto-reduction rate was 75% and 79% respectively. No differences were found in perioperative outcomes, or in severe complications between the two groups. The median disease-free survival in the CCP group was 2.5 years (95% CI 1.6-3.1) while in the CI group it was 1.4 (95% CI 1.2-1.7) p < 0.001. The median overall survival was 5.8 years in CPP, and 3.5 years in CI. Faced with a meticulous selection by a group of experts, patients with advanced ovarian cancer treated with CCP present better oncological results than those who received neoadjuvant therapy and CI.

Measurement of tumor size in early cervical cancer: an ever-evolving paradigm.

The major tenets in accurately assessing tumor size in patients with early stage cervical cancer currently include physical examination, imaging studies, and pathologic evaluation. It is estimated that when comparing clinical stage based on physical examination and final pathology, the concordance diminishes as stage increases: 85.4%, 77.4%, 35.3%, and 20.5% for stage IB1, IB2, IIA, and IIB, respectively. Vaginal involvement and larger tumor diameter are considered the main causes of stage inaccuracy. When considering imaging studies, magnetic resonance imaging (MRI) provides the highest level of accuracy in the assessment of cervical tumor size. Its accuracy in determining tumor location within the cervix is approximately 91% and in predicting tumor size 93%. MRI imaging is also significantly more accurate in measuring tumor size, delineating cervical tumor boundaries, and local tumor extension when compared with computed tomography (CT) scan. When comparing with pelvic ultrasound, the accuracy of both imaging techniques (MRI and pelvic ultrasound) in the assessment of tumor size in small versus large tumors is comparable. Pertaining to pathology, the depth of invasion should be measured by convention from the nearest surface epithelium, which equates to tumor thickness. In the setting where tumor is found both in the conization and hysterectomy specimen, the horizontal extent should be measured by summing the maximum horizontal measurement in the different specimens and the depth of invasion measured as the maximum depth in either specimen. A new pattern-based classification for endocervical adenocarcinomas recommends the description of patterns of invasion for human papillomavirus (HPV)-related adenocarcinomas as this is associated with differing risks of lymph node involvement.

Experience with concurrent chemoradiotherapy treatment in advanced cervical cancer: results from a hospital in Argentina.

OBJECTIVE: To describe our experience with concurrent chemoradiotherapy using three-dimensional conformal radiotherapy (3D-CRT) and high-dose-rate intracavitary brachytherapy with weekly cisplatin in the treatment of patients with locally advanced cervical cancer. METHODS: Forty-three patients were identified between January 2009 and December 2015. Their medical records were retrospectively reviewed, and data on patient characteristics, tumour, treatment and toxicities were collected and analysed. RESULTS: The median age was 45 years (interquartile range (IQR): 26) The median tumour size was 45 mm (IQR: 20). Thirty-eight patients (88%) had a cervical tumour with a size of ≥ 40 mm. The median cervical tumour size evaluated by magnetic resonance imaging (MRI) was 52 mm (IQR: 17). Twenty-two patients (51%) had enlarged lymph nodes on MRI (≥ 10 mm). MRI demonstrated the involvement of the parametrium in 29 patients (67%). Fifteen patients had positive para-aortic nodes (36%). The median total treatment time was 58 days (IQR: 20). Sixteen patients (39%) received extended-field radiotherapy. Cisplatin was administered simultaneously for a median of five courses. The median follow-up period was 32 months (IQR: 28 months). Grade 3 acute toxicity was observed at the gastrointestinal level in seven patients (16%). Late grade 3/4 toxicity was observed in 14 patients (33%). Seven patients (16%) persisted with the disease and five died. The local relapse rate was 9%. Eleven patients underwent a hysterectomy after treatment. The disease-free interval was 24.2 months. The 2-year global survival rate was 82.9%. CONCLUSION: Concurrent chemo-radiotherapy appears to be an effective regimen, with acceptable toxicity, for patients with locally advanced cervical cancer.

Minimally invasive radical hysterectomy: an analysis of oncologic outcomes from Hospital Italiano (Argentina).

BACKGROUND: The Laparoscopic Approach to Cervical Cancer (LACC) trial demonstrated a higher rate of disease recurrence and worse disease-free survival in patients who underwent minimally invasive radical hysterectomy. OBJECTIVES: To evaluate surgical and oncological outcome of laparoscopic radical hysterectomy performed at Hospital Italiano in Buenos Aires, Argentina. METHODS: This retrospective study included all patients with cervical cancer, 2009 FIGO stage IA1, with lymphovascular invasion to IB1 (<4 cm) who underwent a laparoscopic radical hysterectomy between June 2010 and June 2015. Patients were eligible if they had squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, and no lymph node involvement by imaging. Patients must have undergone a type C1 radical hysterectomy. Only patients who were treated by a laparoscopic approach were included. Patients were excluded if histopathology showed a component of neuroendocrine carcinoma before or after surgery; if they had synchronous primary tumors, history of abdominal or pelvic radiotherapy, or were operated on at an outside institution; and if they had only surgery and no follow-up in our institution. Relapse rate and disease-free survival were evaluated using the Kaplan-Meier method. RESULTS: A total of 108 patients were evaluated. The median age was 41 years (range 27-70). Distribution of histologic sub-types was squamous carcinoma in 77 patients (71%), adenocarcinoma in 27 patients (25%), and adenosquamous carcinoma in four patients (4%). Ninety-nine patients (92%) had stage IB1 tumors and 58 (54%) patients had tumors ≤2 cm. The median surgical time was 240 min (range 190-290), the median estimated blood loss was 140 mL (range 50-500) and the transfusion rate was 3.7%. The median length of hospital stay was 2 days (range 1-11). The median follow-up time was 39 months (range 11-83). The global recurrence rate after laparoscopic radical hysterectomy was 15% (16/108). According to tumor size, the recurrence rate was 12% in patients with tumors ≤2 cm (7/58) and 18% in patients with tumors >2 cm (9/50) (OR=0.76; 95% CI 0.26 to 2.22; p=0.62) The 3- and 5-year relapse rate was 17% (95% CI 11% to 27%). The 3- and 5-year disease-free survival was 81% (95% CI 71% to 88%) and 70% (95% CI 43% to 86%), respectively. Overall survival at 3 years was 87% (95% CI 76% to 93%). CONCLUSION: The recurrence rate after laparoscopic radical hysterectomy was 15%, and in tumors ≤2 cm it was 12%. The 3-year disease-free survival was 81%. Given these results our hospital has changed the approach to open radical hysterectomy.

International radical trachelectomy assessment: IRTA study.

BACKGROUND: Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy. PRIMARY OBJECTIVE: To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy. STUDY HYPOTHESIS: We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach. STUDY DESIGN: This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data. INCLUSION CRITERIA: Patients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both). EXCLUSION CRITERIA: Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach. PRIMARY ENDPOINT: The primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy. SAMPLE SIZE: An estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group.

[Laparoscopic Surgery for isolated lymph nodes recurrence in gynecology. Experience in Argentina.] / Citoreducción Ganglionar Laparoscópica en recidiva única por cánceres ginecológicos. Experiencia en Argentina.

Objectives: to describe the perioperative and oncological outcomes of a serie of cases treated with laparoscopic surgery for isolated nodal metastasis of gynecologic malignancies at the Gynecology Service of Hospital Italiano de Buenos Aires and conduct a literature review on the surgical treatment provided to patients with this condition. Methods: A search was conducted in the surgery records of the Gynecology Service of Hospital Italiano of patients who underwent laparoscopic cytoreductive surgery for isolated nodal recurrence of a gynecologic primary tumor in the period 2009-2015. The medical records were reviewed and data on the patients' characteristics, the tumor, the surgery and its complications were collected and analyzed. A literature search was conducted in Pubmed by the term "isolated nodal recurrence in gynecology" and a subsequent snowball search was performed. Results: As results, nine patients are presented. The median age was 66 years old (RI 7). The initial cancer location was: ovary (n=3), endometrium (n=3), cervix (n=2) and breast (n=1). The location site of the single nodal recurrence was the para-aortic area (n=8) and the pelvic area (n=1). The median of the disease-free interval to recurrence was 42.8 months (RI 40.2). Either the retroperitoneal or the transperitoneal approach was used based on the location of the recurrence. The median surgery time was 120 minutes (RI 36). No conversion to laparotomy was performed in any patient. No intraoperative or postoperative complications were reported, nor any requirement for blood transfusion. The median hospital stay was 36 hours. Adjuvant treatment with chemotherapy was applied to 8/9 patients. Only one patient recurred in para-aortic lymph nodes and peritoneal carcinomatosis after eight months and died of her disease. The literature review confirms the possibility of laparoscopic resection of the single nodal recurrence with low complication rate. Conclusion: The laparoscopic lymph node cytoreductive surgery is a valid and safe treatment option considering the perioperative and oncological outcomes in our hospital.

Objetivos: Describir los resultados perioperatorios y oncológicos de una serie de casos operados con laparoscopía por metástasis única ganglionar de cánceres ginecológicos en el Servicio de Ginecología del Hospital Italiano de Buenos Aires y realizar una revisión bibliográfica sobre el tema. Métodos: Se llevó a cabo una búsqueda de pacientes en los registros de cirugía del servicio de Ginecología del Hospital que hayan recibido tratamiento quirúrgico de citoreducción laparoscópica por recurrencia ganglionar aislada de un tumor primario ginecológico en el período 2009-2015. Se revisaron las historias clínicas y se recolectaron y analizaron datos referidos a características de las pacientes, del tumor, de la cirugía y sus complicaciones. Se realiza una búsqueda bibliográfica en Pubmed con el concepto "isolated nodal recurrence in gynecology" y posterior búsqueda en bola de nieve. Resultados: Se presentan 9 pacientes. La mediana de edad fue de 66 años (RI 7). La localización del cáncer inicial fue ovario (n=3), endometrio (n=3), cuello (n=2) y mama (n=1). El sitio de localización de la recurrencia ganglionar única fue el área lumboaórtica (n=8) y el área pelviana (n=1). La mediana de intervalo libre de enfermedad a la recurrencia fue de 42.8 meses (RI 40.2). Se utilizó un abordaje retroperitoneal o transperitoneal según la localización de la recurrencia. La mediana de tiempo operatorio fue de 120 minutos (RI 36). No se realizó conversión a laparotomía en ninguna paciente. No se reportaron complicaciones intraoperatoria o postoperatorias, así como tampoco requerimiento de transfusión sanguínea. La mediana de estadía hospitalaria fue de 36 horas. Realizaron tratamiento adyuvante con quimioterapia 8/9 pacientes. Solo 1 paciente recurrió a nivel lumboaórtico y peritoneal luego de 8 meses y falleció de su enfermedad.La revisión de la literatura confirma la posibilidad de realizar la resección de la recurrencia ganglionar única por vía laparoscópica con baja tasa de complicaciones. Conclusión: la citorreducción ganglionar laparoscópica es una opción de tratamiento válida y segura en relación a los resultados perioperatorios y oncológicos en nuestra institución.

Patterns of cervical cancer care in Argentina: Applying ASCO recommendations adjusted by local resources.

There are significant differences in cervical cancer incidence and mortality between low-middle and high-income countries. The American Society of Clinical Oncology (ASCO) resource-stratified clinical practice guideline was designed to provide an appropriate cervical cancer treatment based on the best available evidence in scenarios with different diagnostic and therapeutic resources. Argentina, a Latin American high middle income country, shows however, that cervical cancer rates are similar to those of low-income countries. In addition, significant disparities in incidence and mortality are described throughout the country. The present article describes the current pattern of care of cervical cancer in Argentina and establishes recommendations adjusted to local resources in different regions of the country according to the ASCO guideline.

Four Surgical Approaches to Cervical Excision During Laparoscopic Radical Trachelectomy for Early Cervical Cancer.

STUDY OBJECTIVE: To compare the clinical and oncological outcomes of four different approaches of cervical excision (CE) during radical trachelectomy (RT) for early cervical cancer. DESIGN: A retrospective comparative observational study was performed at Gynecology Department of the Hospital Italiano de Buenos Aires in Buenos Aires, Argentine. The study was composed of all consecutive women who had undergone laparoscopic RT for early cervical cancer between May 2011 and July 2016. They were divided in four groups according with different surgical approaches to perform the CE during RT; which are also detailed. (Canadian Task Force Classification III). SETTING: Tertiary care hospital. INTERVENTION: CE during radical trachelectomy for early cervical cancer. MEASUREMENT AND MAIN RESULTS: A total of 7, 6, 6 and 3 patients undergone Type A, B, C and D cervical excision during RT, respectively. No significant differences in terms of age, BMI, surgical time and length of hospital stay were found according with different types of CE. Patients in Type D had, however, a significantly higher EBL, p =.006. Similar histology characteristics in terms of histology type, tumor grade and size, as well as lymph node count were observed among groups. Only grade 1-2 postoperative complications were noted in 9 patients. One local recurrence after Type B CE was treated with radical surgery plus chemoradiaton; while other patient after Type A CE relapsed with peritoneal carcinomatosis managed with chemotherapy. CONCLUSION: Different types of cervical excision that are here described should be used according to each case based on specific clinical factors.

Laparoscopic surgical staging in women with early stage epithelial ovarian cancer performed by recently certified gynecologic oncologists.

OBJECTIVE: To compare the surgical and oncological outcomes of laparoscopic versus open surgical staging in patients with early stage ovarian cancer performed by recently certified gynecologic oncologists. STUDY DESIGN: A retrospective comparative observational study was performed, which included women who had undergone laparoscopic comprehensive surgical staging for early stage epithelial ovarian cancer between June, 2008 and January, 2014. Patients were compared with women who had undergone laparotomic staging between June, 2006 and January, 2014. RESULTS: A total of 50 and 58 patients underwent, laparoscopic and laparotomy surgical staging, respectively. The patients' baseline characteristics were similar in both groups. Women in the laparoscopy group had a significantly lower preoperative CA-125 value (p=0.01). The operative time was similar between groups. The patients in the laparotomy group had significantly higher estimated blood loss (p≤0.001) and larger ovarian masses (p=0.001). Estimated blood loss was significantly higher in laparotomy versus laparoscopy; median (IQ range) 200 (200-225) ml and 500 (300-1000) ml (p≤0.0001). Intraoperative complications and postoperative complication rate was similar in both groups regardless of the type of surgical procedure; and laparoscopy was associated with a significantly shorter length of the hospital stay (p≤0.001). The number of lymph node retrieved and upstaging rate, as well as progression free survival and overall survival rates, were similar in both groups. CONCLUSIONS: Laparoscopic surgical staging of apparent early stage ovarian cancer has similar surgical and oncological outcomes to laparotomy when recently certified gynecologic oncologists perform the procedures.

Laparoscopic radical trachelectomy: technique, feasibility, and outcomes.

BACKGROUND AND OBJECTIVES: Our objectives are to describe our surgical technique for laparoscopic radical trachelectomy, to evaluate its feasibility, and to present the perioperative results at Hospital Italiano de Buenos Aires, Argentina. METHODS: We analyzed 4 patients who underwent laparoscopic radical trachelectomy for early-stage cervical cancer between December 2011 and May 2013. RESULTS: Four patients were included in this study. Total laparoscopic radical trachelectomy was performed in all cases. The mean age was 26 years (range, 19-32 years), the mean body mass index was 21 (range, 18-23), and the mean length of hospital stay was 33 hours (range, 24-36 hours). The mean operative time was 225 minutes (range, 210-240 minutes), and no complications were reported. During the postoperative period, only 1 patient presented with left vulvar edema, which resolved spontaneously. The pelvic and parametrial lymph nodes, as well as the vaginal cuff and cervical resection margins, were negative for malignancy in all cases. On average, 18 pelvic lymph nodes (range, 15-20) were removed. The tumor stage was IB in all 4 patients, and the mean tumor size was 17 mm (range, 12-31 mm). No patient required conversion to laparotomy. CONCLUSION: We consider laparoscopic radical trachelectomy, performed by trained surgeons, a feasible and safe therapeutic option as a fertility-sparing surgical technique, with good perioperative outcomes for women with early-stage cervical cancer with a desire to preserve their fertility. Minimally invasive surgery provides the widely known benefits of this type of approach.