Int J Gynecol Cancer 2021 Sep 07
ConCerv: a prospective trial of conservative surgery for low-risk early-stage cervical cancer.
Abstract
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.
Related Questions
In the context of the ConCerv and SHAPE trials, how would you approach a patient with endometrioid adenocarcinoma within an excised 1.2 cm cervical polyp (negative for LVSI) who has no suspicious lymph nodes on CT scan?
I would ensure that the polyp was fully removed and attempt to determine whether it is of cervical or endometrial origin. Either way, however, I would discuss fertility-preserving surgery versus definitive surgery. If fertility-preserving, then I would consider a CKC with sentinel lymph nodes, versu...
Do the results of the ConCerv and SHAPE trials alter how you might counsel a patient incidentally found to have ≤IB1 after simple hysterectomy?
The ConCerv and SHAPE trials have demonstrated that selected patients with low-risk, less than or equal to stage IB1 cervical cancers can be safely treated with simple, extrafascial hysterectomy with lymph node assessment. Given those findings, if a patient met the criteria for inclusion in the ConC...
If a patient meets criteria for extrafascial hysterectomy for early-stage cervical cancer, how do you determine your surgical approach (abdominal vs laparoscopic)?
For FIGO 1A1-1A2 (i.e., microinvasion which means no visible lesion) - I would perform a vaginal hysterectomy with bilateral salpingectomy (IA1) or robotic hysterectomy with bilateral salpingectomy-nodes (IA2); for FIGO 1B1 with no visible lesion (eg., post-conization), I would perform a robotic cys...
What post-treatment surveillance strategy do you employ for patients who undergo conservative fertility-sparing surgery for early-stage cervical cancer?
For patients undergoing fertility-sparing surgery for early-stage cervical cancer not dissimilarly to any other patient treated for early-stage cervical cancer. I would recommend that the patient undergo a history and exam, including a pelvic exam, every 3 months for the first 2 years, then every 6 ...
What are your top takeaways in Gynecologic Cancers from ASCO 2023?
Gynecologic oncology research was strong at ASCO 2023. Results of the following 3 pivotal studies are practice changing. Marie Plante, MD: SHAPE trial: This non-inferiority CCTG (Canadian Cancer Trials Troup) trial enrolled 700 patients with low-risk squamous cell carcinoma, adenocarcinoma or adenos...
When would you offer extra-fascial hysterectomy to patients with low-risk early-stage cervical cancer in light of data from the ConCerv trial?
Stage 1A1 and 2
How would you treat a woman who has had a simple, extrafascial hysterectomy for a clinically occult, pathologically FIGO stage IB1 cervical cancer?
Standard would be to do some form of radical hysterectomy and if not done add adjuvant RT. That being said, the absolute risk of parametrial involvement for that size of disease is very low, and the benefit of RT if at all, is very small and requires a discussion of the pros and cons of intervention...