OK to Skip Pelvic Lymph Node Dissection in Cervical Cancer?

Results from the PHENIX-I trial support skipping pelvic lymphadenectomy in women with early cervical cancer who have a negative sentinel lymph node biopsy.

Omitting pelvic lymphadenectomy in these patients “did not compromise disease-free survival and potentially [led to] improved overall survival,” reported lead investigator Jihong Liu, MD, gynecologic oncologist, Sun Yat-sen University Cancer Center, Guangzhou, China.

Forgoing the additional procedure also decreased the incidence of retroperitoneal lymph node recurrence and adverse events and demonstrated superior surgical outcomes including shorter operative duration, reduced blood loss, and a lower morbidity.

Liu reported the PHENIX-I results at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancers (SGO) 2src25.

Pelvic lymphadenectomy has been part of standard care for early-stage cervical cancer for over a century, even though the incidence of lymph node metastasis in early-stage cervical cancer is relatively low. Overtreatment and increased morbidity have been notable drawbacks of the procedure.

It may be possible to forgo pelvic lymphadenectomy in early-stage cervical cancer when sentinel lymph node biopsy findings are negative, but evidence from randomized controlled trials are lacking, Liu explained.

The PHENIX-I trial prospectively assessed survival outcomes among patients who received pelvic lymphadenectomy and those who did not. More specifically, all patients underwent sentinel lymph node biopsy and patients with negative lymph nodes were then intraoperatively randomized (1:1) to undergo pelvic lymphadenectomy (417 patients) or not (416 patients).

The multicenter, randomized controlled trial involved patients undergoing radical hysterectomy for stage IA1 (lymphovascular invasion), IA2, IB1, IB2 or IIA1 cervical cancer with tumor size not exceeding 3 cm.

“The only difference between the two groups was that patients in the experimental arm did not have pelvic lymphadenectomy,” Liu said.

Liu and colleagues reported that 23 patients (2.8%) had a positive lymph node on postoperative pathology examination. The rate of false-negative sentinel lymph node biopsy was <1%. About half the patients in both groups received postoperative adjuvant therapy, and there was no significant between-group difference in the rates and time to initiate adjuvant therapy.

Overall, about 3.85% of patients (n=16) in the biopsy-only group had a recurrence compared with 6.24% (n=26) in the pelvic lymphadenectomy group at a median follow-up of 5src months.

But no patients in the biopsy-only group had a recurrence in the retroperitoneal lymph nodes compared with 9 patients in the pelvic lymphadenectomy group.

The 3-year disease-free survival (primary endpoint) rates were similar between the two groups — 96.8% in the biopsy-only group and 94.5% in the lymphadenectomy group (hazard ratio [HR], src.61; P =.12). However, the 3-year overall survival was significantly higher in biopsy-only group — 1srcsrc% vs 97.8% in the lymphadenectomy group (HR, src.21; P= .srcsrc7). Overall, three patients (19%) in the biopsy-only group died from cervical cancer vs 14 (54%) in the lymphadenectomy group.

As for surgical complications, pelvic lymphadenectomy was associated with a higher incidence of pain (5.8% vs 1.7%), lymphocyst (22.1% vs 8.4%), and lymphedema (1src.1% vs 2.4%), as well as longer operating time and more blood loss.

Offering perspective on PHENIX-I, discussant Premal Thaker, MD, noted that this is the first randomized trial to report on the use of sentinel lymph node biopsy alone vs biopsy plus pelvic lymphadenectomy after radical hysterectomy.

Key takeaways are the “equivalent” 3-year disease-free outcomes but “lower” overall survival in the pelvic lymphadenectomy group as well as more adverse events, said Thaker, gynecologic oncologist and surgeon, Siteman Cancer Center, Washington University, St Louis.

Although quality of life data was not presented in the trial, patients who skipped pelvic lymphade