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.

Oncological and obstetrical outcomes after neo-adjuvant chemotherapy followed by fertility-sparing surgery in patients with cervical cancer ≥2 cm.

OBJECTIVE: There is significant debate between up-front radical trachelectomy versus neo-adjuvant chemotherapy before fertility-sparing surgery in patients with tumors ≥2 cm. The aim of this study was to report on the oncological and obstetrical outcome of neo-adjuvant chemotherapy followed by fertility-sparing surgery, in patients diagnosed with cervical cancer ≥2 cm. METHODS: This was a retrospective review of patients diagnosed with cervical cancer measuring ≥2 cm to ≤6 cm, who were scheduled to undergo neo-adjuvant chemotherapy before fertility-sparing surgery, at six institutions from four Latin American countries between February 2009 and February 2019. Data collected included: age, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage, histology, tumor size, pre-treatment imaging work-up, chemotherapy agents and number of cycles, toxicity, clinical and imaging response rate, type of fertility-sparing surgery, pathology results, timing of lymphadenectomy, follow-up time, and obstetrical and oncological outcomes. RESULTS: A total of 25 patients were included, with a median age of 27 years (range 20-37): 17 patients had stage IB1, 7 had stage IB2 cervical cancer, and 1 patient had stage IIA1 (FIGO 2009); 23 patients had squamous cell carcinoma and 2 patients had adenocarcinoma. The median number of chemotherapy cycles was 3 (range 3-6) and no toxicity grade 3-4 was reported. Lymphadenectomy was performed before chemotherapy in 6 (24%) patients. After neo-adjuvant chemotherapy 20 patients were scheduled for radical trachelectomy (11 abdominal and 9 laparoscopic) and 5 patients for conization. After surgery, no residual disease was found in 11 patients (44%). Fertility was preserved in 23 patients (92%) and 10 patients became pregnant (43.5%). After a median follow-up time of 47 months (13-133), 3 patients had recurrent disease (3/23=13%), 2 were alive without disease, and 1 patient had disease at last contact. CONCLUSION: Neo-adjuvant chemotherapy followed by fertility-sparing surgery is feasible in well selected patients with cervical tumors ≥2 cm. Future studies should focus on the timing of lymphadenectomy and type of cervical surgery.

Alternative management for gynecological cancer care during the COVID-2019 pandemic: A Latin American survey.

OBJECTIVE: To determine the acceptance rate of treatment alternatives for women with either preinvasive conditions or gynecologic cancers during the COVID-19 pandemic among Latin American gynecological cancer specialists. METHODS: Twelve experts in gynecological cancer designed an electronic survey, according to recommendations from international societies, using an online platform. The survey included 22 questions on five topics: consultation care, preinvasive cervical pathology, and cervical, ovarian, and endometrial cancer. The questionnaire was distributed to 1052 specialists in 14 Latin American countries. A descriptive analysis was carried out using statistical software. RESULTS: A total of 610 responses were received, for an overall response rate of 58.0%. Respondents favored offering teleconsultation as triage for post-cancer treatment follow-up (94.6%), neoadjuvant chemotherapy in advanced stage epithelial ovarian cancer (95.6%), and total hysterectomy with bilateral salpingo-oophorectomy and defining adjuvant treatment with histopathological features in early stage endometrial cancer (85.4%). Other questions showed agreement rates of over 64%, except for review of pathology results in person and use of upfront concurrent chemoradiation for early stage cervical cancer (disagreement 56.4% and 58.9%, respectively). CONCLUSION: Latin American specialists accepted some alternative management strategies for gynecological cancer care during the COVID-19 pandemic, which may reflect the region's particularities. The COVID-19 pandemic led Latin American specialists to accept alternative management strategies for gynecological cancer care, especially regarding surgical decisions.

Outpatient laparoscopic nerve-sparing radical hysterectomy: A feasibility study and analysis of perioperative outcomes.

OBJECTIVE: The goal of our study was to report on the feasibility of outpatient laparoscopic radical hysterectomy in patients with early-stage cervical cancer. METHODS: We included all patients who underwent a laparoscopic radical hysterectomy at the Instituto de Cancerología - Las Americas in Medellin, Colombia, between January 2013 and July 2015. The control group was a similar cohort of patients who were admitted after their surgery. RESULTS: Seventy-six patients were included [outpatient (31) and admitted (45)]. There were no statistically significant differences between groups regarding age, clinical stage, histology, nodal count, need of adjuvant treatment, visual pain scores at discharge or follow up time. All patients underwent a transversus abdominis plane block. The median operative time was 150min (range, 105-240) in the outpatient group vs. 170min (range, 97-300) in the admitted group (p=0.023). The median estimated blood loss was 50ml (range, 20-150) in the outpatient group vs. 120ml (range, 20-1000) in the admitted group (p=0.001). All patients were able to void spontaneously and tolerate a diet before discharge. In patients who were admitted, the median hospital stay was 1day, (range; 1-6), and 39 (87%) were discharged at postoperative day 1. There were 6 postoperative complications, 3 in each group. There were no recurrences in the follow-up period in the outpatient group, and there were 3 (6.6%) recurrences in the admitted group. CONCLUSION: Outpatient laparoscopic radical hysterectomy is feasible and can be performed safely in a developing country in well-selected patients.

Radical trachelectomy in early-stage cervical cancer: A comparison of laparotomy and minimally invasive surgery.

OBJECTIVES: Radical trachelectomy is considered standard of care in patients with early-stage cervical cancer interested in future fertility. The goal of this study was to compare operative, oncologic, and fertility outcomes in patients with early-stage cervical cancer undergoing open vs. minimally invasive radical trachelectomy. METHODS: A retrospective review was performed of patients from four institutions who underwent radical trachelectomy for early-stage cervical cancer from June 2002 to July 2013. Perioperative, oncologic, and fertility outcomes were compared between patients undergoing open vs. minimally invasive surgery. RESULTS: A total of 100 patients were included in the analysis. Fifty-eight patients underwent open radical trachelectomy and 42 patients underwent minimally invasive surgery (MIS=laparoscopic or robotic). There were no differences in patient age, body mass index, race, histology, lymph vascular space invasion, or stage between the two groups. The median surgical time for MIS was 272min [range, 130-441min] compared with 270min [range, 150-373min] for open surgery (p=0.78). Blood loss was significantly lower for MIS vs. laparotomy (50mL [range, 10-225mL] vs. 300mL [50-1100mL]) (p<0.0001). Nine patients required blood transfusion, all in the open surgery group (p=0.010). Length of hospitalization was shorter for MIS than for laparotomy (1day [1-3 days] vs. 4days [1-9 days]) (p<0.0001). Three intraoperative complications occurred (3%): 1 bladder injury, and 1 fallopian tube injury requiring unilateral salpingectomy in the MIS group and 1 vascular injury in the open surgery group. The median lymph node count was 17 (range, 5-47) for MIS vs. 22 (range, 7-48) for open surgery (p=0.03). There were no differences in the rate of postoperative complications (30% MIS vs. 31% open surgery). Among 83 patients who preserved their fertility (33 MIS vs. 50 open surgery), 34 (41%) patients attempted to get pregnant. Sixteen (47%) patients were able to do so (MIS: 2 vs. laparotomy: 14, p=0.01). The pregnancy rate was higher in the open surgery group when compared to the MIS group (51% vs. 28%, p=0.018). However, median follow-up was shorter is the MIS group compared with the open surgery group (25months [range, 10-69] vs. 66months [range, 11-147]). To date, there has been one recurrence in the laparotomy group and none in the MIS group. CONCLUSIONS: Our results suggest that radical trachelectomy via MIS results in less blood loss and a shorter hospital stay. Fertility rates appear higher in patients undergoing open radical trachelectomy.

Immediate radical trachelectomy versus neoadjuvant chemotherapy followed by conservative surgery for patients with stage IB1 cervical cancer with tumors 2cm or larger: A literature review and analysis of oncological and obstetrical outcomes.

Radical trachelectomy is the treatment of choice in women with early-stage cervical cancer wishing to preserve fertility. Radical trachelectomy can be performed with a vaginal, abdominal, or laparoscopic/robotic approach. Vaginal radical trachelectomy (VRT) is generally not offered to patients with tumors 2cm or larger because of a high recurrence rate. There are no conclusive recommendations regarding the safety of abdominal radical trachelectomy (ART) or laparoscopic radical trachelectomy (LRT) in such patients. Several investigators have used neoadjuvant chemotherapy in patients with tumors 2 to 4cm to reduce tumor size so that fertility preservation may be offered. However, to our knowledge, no published study has compared outcomes between patients with cervical tumors 2cm or larger who underwent immediate radical trachelectomy and those who underwent neoadjuvant chemotherapy followed by radical trachelectomy. We conducted a literature review to compare outcomes with these 2 approaches. Our main endpoints for evaluation were oncological and obstetrical outcomes. The fertility preservation rate was 82.7%, 85.1%, 89%; and 91.1% for ART (tumors larger than >2cm), ART (all sizes), NACT followed by surgery and VRT (all sizes); respectively. The global pregnancy rate was 16.2%, 24% and 30.7% for ART, VRT, and NACT followed by surgery; respectively. The recurrence rate was 3.8%, 4.2%, 6%, 7.6% and 17% for ART (all sizes), VRT (all sizes), ART (tumors>2cm), NACT followed by surgery, and VRT (tumors>2cm). These outcomes must be considered when offering a fertility sparing technique to patients with a tumor larger than 2cm.

Management of low-risk early-stage cervical cancer: should conization, simple trachelectomy, or simple hysterectomy replace radical surgery as the new standard of care?

The standard treatment for women with early-stage cervical cancer (IA2-IB1) remains radical hysterectomy with pelvic lymphadenectomy. In select patients interested in future fertility, the option of radical trachelectomy with pelvic lymphadenectomy is also considered a viable option. The possibility of less radical surgery may be appropriate not only for patients desiring to preserve fertility but also for all patients with low-risk early-stage cervical cancer. Recently, a number of studies have explored less radical surgical options for early-stage cervical cancer, including simple hysterectomy, simple trachelectomy, and cervical conization with or without sentinel lymph node biopsy and pelvic lymph node dissection. Such options may be available for patients with low-risk early-stage cervical cancer. Criteria that define this low-risk group include: squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma, tumor size <2 cm, stromal invasion <10mm, and no lymph-vascular space invasion. In this report, we provide a review of the existing literature on the conservative management of cervical cancer and describe ongoing multi-institutional trials evaluating the role of conservative surgery in selected patients with early-stage cervical cancer.

Surgical, oncological, and obstetrical outcomes after abdominal radical trachelectomy - a systematic literature review.

OBJECTIVE: Radical trachelectomy is a standard treatment for selected patients with early-stage cervical cancer. Outcomes are well established for vaginal radical trachelectomy (VRT), but not for abdominal radical trachelectomy (ART). METHODS: We searched MEDLINE, EMBASE, and CINAHL (October 1997 through October 2012) using the terms: uterine cervix neoplasms, cervical cancer, abdominal radical trachelectomy, vaginal radical trachelectomy, fertility sparing, and fertility preservation. We included original articles, case series, and case reports. Excluded were review articles, articles with duplicate patient information, and articles not in English. RESULTS: We identified 485 patients. Ages ranged from 6 to 44 years. The most common stage was IB1 (331/464; 71%), and the most common histologic subtype was squamous cell carcinoma (330/470; 70%). Operative times ranged from 110 to 586 min. Blood loss ranged from 50 to 5568 mL. Three intraoperative complications were reported. Forty-seven patients (10%) had conversion to radical hysterectomy. One hundred fifty-five patients (35%) had a postoperative complication. The most frequent postoperative complication was cervical stenosis (n=42; 9.5%). The median follow-up time was 31.6 months (range, 1-124). Sixteen patients (3.8%) had disease recurrence. Two patients (0.4%) died of disease. A total of 413 patients (85%) were able to maintain their fertility. A total of 113 patients (38%) attempted to get pregnant, and 67 of them (59.3%) were able to conceive. CONCLUSION: ART is a safe treatment option in patients with early-stage cervical cancer interested in preserving fertility.

Laparoscopic radical trachelectomy.

INTRODUCTION: The standard treatment for patients with early-stage cervical cancer has been radical hysterectomy. However, for women interested in future fertility, radical trachelectomy is now considered a safe and feasible option. The use of minimally invasive surgical techniques to perform this procedure has recently been reported. CASE DESCRIPTION: We report the first case of a laparoscopic radical trachelectomy performed in a developing country. The patient is a nulligravid, 30-y-old female with stage IB1 adenocarcinoma of the cervix who desired future fertility. She underwent a laparoscopic radical trachelectomy and bilateral pelvic lymph node dissection. The operative time was 340 min, and the estimated blood loss was 100mL. There were no intraoperative or postoperative complications. The final pathology showed no evidence of residual disease, and all pelvic lymph nodes were negative. At 20 mo of follow-up, the patient is having regular menses but has not yet attempted to become pregnant. There is no evidence of recurrence. CONCLUSION: Laparoscopic radical trachelectomy with pelvic lymphadenectomy in a young woman who desires future fertility may also be an alternative technique in the treatment of early cervical cancer in developing countries.