Oncologic outcome after completing or abandoning (radical) hysterectomy in patients with cervical cancer and intraoperative detection of lymph node positivity; ABRAX (ABandoning RAd hyst in cerviX cancer)

Abstract

BackgroundThe management of patients with intraoperative detection of lymph node involvement remains controversial. The most significant aspect is the decision regarding the completion of the cervical procedure, such as hysterectomy, radical hysterectomy, or a fertility sparing procedure.Primary objectiveThe primary objective of the ABandoning RAd hyst in cerviX cancer (ABRAX) trial is to determine whether the completion of the cervical procedure (ie, radical hysterectomy) improves oncological outcome in patients with intraoperatively detected lymph node involvement before they are referred for definitive chemoradiation.Study hypothesisWe hypothesize that, in patients with intraoperative lymph node involvement, completion of radical hysterectomy or other cervical procedure does not improve the oncological outcome of definitive chemoradiation.Trial designThe ABRAX trial is a multicenter, retrospective, cohort study. Patients with negative lymph nodes in clinical staging, in whom lymph node involvement is detected intraoperatively, are included. Completion or abandonment of the planned cervical procedure stratifies the cohort into two subgroups in which oncological outcome and morbidity will be compared.Major Inclusion/Exclusion criteriaPatients with early stage (pT1a–pT2b) cervical cancer, who did not have positive lymph nodes on preoperative imaging, who were scheduled for primary surgical treatment, and in whom metastatic involvement of pelvic lymph node was found during surgery either as a grossly (macroscopically) involved or on intraoperative pathology assessment will be enrolled. Patients can be included irrespective of surgical approach (minimal invasive surgery or laparotomy) and type of cervical procedure performed (hysterectomy, radical hysterectomy, or a fertility sparing procedure).Primary endpointThe primary endpoint of this retrospective study is a progression free survival in two subgroups with abandoned or completed cervical procedure followed by definitive chemoradiation in both groups.Sample sizeThe assumed sample size is 718 patients (in total for both groups).Estimated dates for completing accrual and presenting resultsEstimated end of data collection: December 2019; estimated date of presenting results: Q2/3 2020.Trial registrationClinicaltrials.gov: NCT04037124.

Completion of radical hysterectomy does not improve survival of patients with cervical cancer and intraoperatively detected lymph node involvement: ABRAX international retrospective cohort study

“…Proponents of completing radical hysterectomy highlight a lower risk of central pelvis recurrence and a lower morbidity if brachytherapy is avoided. By contrast, proponents for abandoning radical surgery believe it reduces morbidity associated with the combination of radical surgery and adjuvant radiotherapy [18]. Several authors have attempted to address the role of completing radical hysterectomy in patients with lymph node involvement in the last 30 years, although the studies are subject to a variety of limitations and inconsistent conclusions (Supplementary Table S4).…”

“…Patients were retrospectively enrolled if they met the following inclusion criteria: (i) intraoperatively detected lymph node involvement; (ii) confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma; (iii) pretreatment disease stage IAeIIB [17]; (iv) primary surgery with a curative intent performed between January 2005 and December 2015 [18]. Lymph node involvement was defined as the presence of macrometastases (lesions !2 mm) or micrometastases (0.2e2 mm) according to the TNM classification of malignant tumours [17,19].…”

Tumor Volume Predicts High-Risk Patients and Guides Initial Chemoradiotherapy for Early Cervical Cancer

“…Combining surgery with chemoradiotherapy leads to a serious issue that patients experience not only surgical complications but also have various short-and long-term chemoradiotherapy toxicities (8,9). Recently, the ABandoning RAd hyst in cerviX cancer (ABRAX) trial, the biggest retrospective analysis of 515 patients to date, conducted by Cibula et al (10), showed that there is no difference in the oncologic outcome of patients where a lymph node involvement was diagnosed intraoperatively if the hysterectomy was completed or abandoned before initial chemoradiotherapy. This data supports the importance of avoiding hysterectomy when there is a clear indication for initial chemoradiotherapy.…”

Diagnostic value of frozen section examination of sentinel lymph nodes in early-stage cervical cancer at the time of ultrastaging

“…If ITCs were excluded, only 22 of 39 patients with positive SLNs (56.4%) were identified in our study and these 17 patients (5.5%) would have combined treatment. In addition, it is still highly debatable whether to abort radical surgery in setting of positive nodes and the results of the ABRAX study will soon answer to this question [42].…”