While no difference was shown in disease-free survival rates between surgical and non-surgical staging methods, laparoscopy benefits patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer. Surgical staging also has a cancer-specific survival benefit, according to a study published in the International Journal of Gynecological Cancers.
Surgical staging is superior to imaging staging for disease-free and cancer-specific survival benefits in locally advanced cervical cancer, according to the Uterus-11 prospective international multicenter study. This study was conducted by Simone Marnitz, MD, PhD, of the department of radio oncology and medical faculty at the University of Cologne in Germany and colleagues. It is the only randomized study comparing surgical and non-surgical staging before primary chemoradiation to date.
The study’s purpose was to evaluate how surgical staging prior to treatment, including enlarged lymph node removal, affects disease-free survival in patients with locally advanced cervical cancer. The authors said that while clinical examination, imaging, and potential surgical findings are used for revised staging, imaging is often limited because it can result in understaging.
Two hundred forty patients were randomized 1:1 to an experimental surgical staging group (121 patients) or a control clinical staging group (119 patients). Marnitz and colleagues reported that randomization took place between February 2009 and August 2013. The authors reported that patients in the two groups had comparable characteristics.
Patients with confirmed adenocarcinoma, squamous cell carcinoma, or adenosquamous cancer FIGO 2009 stage IIB-IVA had a gynecological exam and pre-treatment imaging that included abdominal magnetic resonance imaging and/or abdominal computed tomography (CT). They also had chest imaging via X-ray, CT, or positron emission tomography-CT.
Transperitoneal, extraperitoneal, or open transperitoneal laparoscopic methods were used for surgical staging in the experimental group. Suspicious areas were biopsied and frozen. Transperitoneal laparoscopy was used in 96.6% of patients in the surgical staging group.
The authors reported laparoscopy resulted in upstaging in 39 of 120 (33%) patients. Surgical staging is also better than clinical staging when examining disease-free survival (HR 0.51, 95% CI 0.30 to 0.86, p=0.011), the authors said. It was associated with better cancer-specific survival in the post-hoc analysis as well (HR 0.61, 95% CI 0.40 to 0.93, p=0.020).
After a median 90-month follow-up, the authors reported “no difference in disease-free survival between surgical staging and clinical staging in patients with locally advanced cervical cancer,” (p=0.084).
Marnitz and colleagues highlighted several strengths in the study: that this is the largest of its kind, and that nearly all patients received minimally invasive surgical approaches and modern radiation techniques. They also noted strength in long-term follow up and high levels of data completeness. They acknowledged study challenges that included PET-CT scans not being routinely done pre-operatively due to lack of reimbursement funding, and study power being reduced from 80% to 70% due to 102 instead of 129 observed events. In addition, the protocol could not include patients with stage IB2 (FIGO 2009) cervical cancer.
The authors concluded that staging with laparoscopy “was safe, did not delay primary chemoradiation, and led to 33% upstaging in patients with locally advanced cervical cancer.” They also said that after surgical staging, primary chemoradiation was not delayed or associated with higher early complication rates.
As a result of these findings, the authors recommended that “further studies in patients with FIGO stage IIB tumors should be considered. The fact that in cases of recurrence there were >85% distant metastases underlines the need for more effective systemic (maintenance) treatments such as sequential chemotherapy following primary chemoradiation, immunotherapy, or a combination of both.”