Simple, radical hysterectomies for low-risk cervical cancer yield similar recurrence rate

Simple hysterectomy shows noninferiority over radical hysterectomy for patients with low-risk cervical cancer, with no significant difference in the 3-year incidence of pelvic recurrence, while reducing the risk of urinary incontinence or retention, according to the phase III CX.5 SHAPE trial.

CX.5 SHAPE included 700 patients with low-risk cervical cancer (lesions of ≤2 cm with limited stromal invasion). Of these, 350 were assigned randomly to undergo simple hysterectomy and 350 to undergo radical hysterectomy.

Baseline characteristics showed that most patients had tumours that were stage IB1 based on the 2009 International Federation of Gynecology and Obstetrics (FIGO) criteria (91.7 percent), that had squamous-cell histologic features (61.7 percent), and that were grade 1 or 2 (59.3 percent).

Over a median follow-up of 4.5 years, the primary outcome of cancer recurrence in the pelvic area at 3 years occurred in 2.52 percent in the simple hysterectomy group and in 2.17 percent in the radical hysterectomy group (an absolute difference of 0.35 percentage points, 90 percent confidence interval, −1.62 to 2.32). Per-protocol analysis yielded consistent results.

Safety data showed that compared with the radical hysterectomy group, the simple hysterectomy group had a lower incidence of urinary incontinence within 4 weeks after surgery (2.4 percent vs 5.5 percent; p=0.048) and beyond 4 weeks (4.7 percent vs 11.0 percent; p=0.003). The same was true for the incidence of urinary retention within 4 weeks after surgery (0.6 percent vs 11.0 percent; p<0.001) and beyond 4 weeks (0.6 percent vs 9.9 percent; p<0.001).