medwireNews: Simple hysterectomy is noninferior to radical hysterectomy with respect to the 3-year incidence of pelvic recurrence in women with early-stage, low-risk cervical cancer, show phase 3 data.
The procedure was also associated with fewer urologic complications, report Marie Plante (Centre Hospitalier Universitaire de Québec, Quebec City, Canada) and co-investigators in The New England Journal of Medicine.
The author of an accompanying editorial says that “[t]hese findings challenge our current standards and provide evidence that simple hysterectomy, in selected patients, appears to be safe, yielding oncologic outcomes similar to those of radical hysterectomy.”
Pedro Ramirez (Houston Methodist Hospital Neal Cancer Center, Texas, USA) continues: “However, it is critical to ensure that the use of simple hysterectomy is limited to patients who have low-risk tumors and who meet the criteria for eligibility for this conservative approach.
“Patients who do not meet such inclusion criteria should continue to be offered radical hysterectomy.”
The SHAPE trial enrolled 700 women who had FIGO stage IA2 (8.3%) or IB1 (91.7%) cervical cancer with lesions measuring no more than 2 cm and limited stromal invasion. The majority of participants had squamous histology (61.7%) and grade 1 or 2 disease (59.3%).
During a median follow-up of around 4.5 years, there were 11 pelvic recurrences among patients who were randomly assigned to undergo simple hysterectomy, which involved removal of the uterus and cervix, and 10 among those who had radical surgery, involving removal of the uterus, cervix, medial one-third of parametria, 2 cm of the uterosacral ligaments, and upper 1–2 cm of the vagina (type II).
The incidence of pelvic recurrence at 3 years, the study’s primary endpoint, was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group, equating to a difference of 0.35 percentage points. The upper limit of the 90% confidence interval was 2.32, which was below the noninferiority margin of 4.0 percentage points.
“The results of a prespecified per-protocol analysis including 317 patients in the simple hysterectomy group and 312 in the radical hysterectomy group were similar to those of the intention-to-treat analysis,” say Plante and colleagues.
And they add that the groups were comparable with respect to the secondary outcomes, such as extrapelvic recurrence-free survival, recurrence-free survival, and overall survival.
The proportion of patients with intraoperative surgical complications was also similar in the simple and radical hysterectomy group, at 7.1% and 6.4%, respectively. But the incidence of surgery-related adverse events within 4 weeks of the procedure was significantly lower in the simple hysterectomy study arm, at 42.6% versus 50.6%.
Moreover, significantly fewer women who underwent simple hysterectomy had urinary incontinence than their counterparts who had radical surgery, both within and after 4 weeks of surgery, at rates of 2.4% versus 5.5%, and 4.7% versus 11.0%, respectively.
This was also the case for urinary retention, with rates within 4 weeks of surgery of 0.6% versus 11.0%, and after 4 weeks of 0.6% versus 9.9%.
The editorialist says that the trial “provides compelling evidence” for the use of simple hysterectomy in selected patients, but cautions that “the trial cannot inform decisions about the surgical approach (open vs. minimally invasive), because the choice of approach was at the discretion of participating surgeons.”
He adds: “[A]lthough patients with tumors of any grade and with lymphovascular invasion were eligible for inclusion, only 14.0% of patients had grade 3 disease and only 12.9% had lymphovascular invasion; thus, whether the findings are generalizable to patients who have tumors with these features is unclear.”
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