Literature
Clinical Pearls & Morning Reports
Published February 28, 2024
How did simple hysterectomy compare with radical hysterectomy in the SHAPE trial?
In developed countries, owing to effective screening programs, a high proportion of cervical cancers are diagnosed in early stages. Radical hysterectomy remains the standard of care for the treatment of early-stage cervical cancer. Plante et al. designed the SHAPE trial to evaluate the safety of simple hysterectomy as compared with radical hysterectomy in patients with low-risk early-stage cervical cancer. Read the NEJM Original Article here.
Clinical Pearls
Q: What were the entry criteria for the trial?
A: Patients were eligible for the trial if they had squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix; International Federation of Gynecology and Obstetrics 2009 stage IA2 or IB1 tumors with lesions measuring no more than 2 cm; limited depth of cervical stromal invasion, as indicated by invasion of tumor tissue to a depth of less than 10 mm on the sample obtained by a diagnostic loop electrosurgical excision procedure or conization or by preoperative pelvic magnetic resonance imaging showing invasion of less than 50% of cervical stromal tissue; a tumor of any histologic grade; and no evidence of lymph-node metastasis on preoperative imaging. Lymphovascular invasion was not an exclusion criterion.
Q: How did simple hysterectomy compare with radical hysterectomy in the SHAPE trial?
A: The primary outcome of this randomized, noninferiority trial was cancer recurrence in the pelvic area (pelvic recurrence) within 3 years after randomization. The incidence of pelvic recurrence at 3 years was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group. The difference was 0.35 percentage points (90% confidence interval, -1.62 to 2.32); the upper limit of the confidence interval was consistent with noninferiority of simple hysterectomy.
Morning Report Questions
Q: Were urological complications less common among patients who underwent simple hysterectomy, as expected?
A: Intraoperative surgical complications occurred in 7.1% of the patients (24 of 338) who underwent simple hysterectomy as compared with 6.4% (22 of 344) who underwent radical hysterectomy. Bladder injuries occurred in 0.9% of the patients (3 of 338) who underwent simple hysterectomy as compared with 2.6% (9 of 344) who underwent radical hysterectomy, and ureteral injuries occurred in 0.9% of the patients (3 of 338) as compared with 1.5% (5 of 344). The incidence of surgery-related adverse events was lower in the simple hysterectomy group than in the radical hysterectomy group within 4 weeks after surgery (42.6% vs. 50.6%; P = 0.04). The incidence of urinary incontinence was 2.4% in the simple hysterectomy group as compared with 5.5% in the radical hysterectomy group within 4 weeks after surgery (P = 0.048) and 4.7% as compared with 11.0% beyond 4 weeks (P = 0.003). The incidence of urinary retention was lower in the simple hysterectomy group than in the radical hysterectomy group within 4 weeks after surgery (0.6% vs. 11.0%; P<0.001) and beyond 4 weeks (0.6% vs. 9.9%; P<0.001).
Q: Describe some of the limitations of the trial.
A: Limitations of the trial included the small number of events (disease recurrence or death) that occurred during the follow-up period, which resulted in wide confidence intervals around hazard ratios for time-to-event outcomes. The median follow-up time was 4.5 years (range, 3 to 10 years); disease recurrence beyond this time frame is possible. Results cannot be generalized to patients who do not meet the criteria for low-risk disease that was used in the trial. The trial was conducted largely in Western Europe, South Korea, and Canada. Black women and Native Americans were underrepresented in the trial, and therefore, results cannot be generalized to these populations or to populations in developing nations.