Radical hysterectomy and bilateral pelvic lymphadenectomy with or without total pelvic radiation therapy plus chemotherapy

An Italian group randomly assigned 343 women with stage IB and IIA cervical cancer to surgery or radiation therapy. The radiation therapy included EBRT and one 137Cs LDR insertion, with a total dose to point A from 70 to 90 Gy (median 76 Gy). Patients in the surgery arm underwent a class III radical hysterectomy, pelvic lymphadenectomy, and selective, para-aortic lymph–node dissection. Adjuvant radiation therapy was given to patients with high-risk pathological features in the uterine specimen or positive lymph nodes. Adjuvant radiation therapy was EBRT to a total dose of 50.4 Gy over 5 to 6 weeks.[2][Level of evidence A1]

An Italian group randomly assigned 343 women with stage IB and IIA cervical cancer to surgery or radiation therapy. The radiation therapy included EBRT and one 137Cs LDR insertion, with a total dose to point A from 70 to 90 Gy (median 76 Gy). Patients in the surgery arm underwent a class III radical hysterectomy, pelvic lymphadenectomy, and selective, para-aortic lymph–node dissection. Adjuvant radiation therapy was given to patients with high-risk pathological features in the uterine specimen or positive lymph nodes. Adjuvant radiation therapy was EBRT to a total dose of 50.4 Gy over 5 to 6 weeks.[2][Level of evidence A1]

The primary outcome was 5-year OS, with secondary measures of rate of recurrence and complications. With a median follow-up of 87 months, the OS rate was the same in both groups at 83% (hazard ratio [HR], 1.2; 95% confidence interval [CI], 0.7–2.3; P = .8).

An Italian group randomly assigned 343 women with stage IB and IIA cervical cancer to surgery or radiation therapy. The radiation therapy included EBRT and one 137Cs LDR insertion, with a total dose to point A from 70 to 90 Gy (median 76 Gy). Patients in the surgery arm underwent a class III radical hysterectomy, pelvic lymphadenectomy, and selective, para-aortic lymph–node dissection. Adjuvant radiation therapy was given to patients with high-risk pathological features in the uterine specimen or positive lymph nodes. Adjuvant radiation therapy was EBRT to a total dose of 50.4 Gy over 5 to 6 weeks.[2][Level of evidence A1]

Complications were highest among the patients who received adjuvant radiation after surgery.

An Italian group randomly assigned 343 women with stage IB and IIA cervical cancer to surgery or radiation therapy. The radiation therapy included EBRT and one 137Cs LDR insertion, with a total dose to point A from 70 to 90 Gy (median 76 Gy). Patients in the surgery arm underwent a class III radical hysterectomy, pelvic lymphadenectomy, and selective, para-aortic lymph–node dissection. Adjuvant radiation therapy was given to patients with high-risk pathological features in the uterine specimen or positive lymph nodes. Adjuvant radiation therapy was EBRT to a total dose of 50.4 Gy over 5 to 6 weeks.[2][Level of evidence A1]

In general, radical hysterectomy should be avoided in patients who are likely to require adjuvant therapy.

A multicenter, international, randomized trial, the Laparoscopic Approach to Cervical Cancer (LACC [NCT00614211]) trial, explored the efficacy of radical hysterectomy and staging via open abdominal surgery (open) versus MIS for patients with early-stage cervical cancer.[22] Patients with stages IA1 (with lymphovascular space invasion), IA2, and IB1 disease and histological subtypes of squamous cell, adenocarcinoma or adenosquamous carcinoma were eligible for inclusion. The primary end point was noninferiority of MIS compared with open surgery; the metric used was the percent of disease-free patients at 4.5 years postsurgery. The secondary end points were a comparison of the recurrence and survival rates between the two groups.Of the planned 740 patients, 632 were accrued when the study was stopped early because of an imbalance in deaths between the two groups. Of 631 eligible patients, 319 were assigned to MIS and 312 to open surgery.The study concluded that MIS was inferior to an open abdominal approach and should not replace open surgery as the standard for cervical cancer patients.

A multicenter, international, randomized trial, the Laparoscopic Approach to Cervical Cancer (LACC [NCT00614211]) trial, explored the efficacy of radical hysterectomy and staging via open abdominal surgery (open) versus MIS for patients with early-stage cervical cancer.[22] Patients with stages IA1 (with lymphovascular space invasion), IA2, and IB1 disease and histological subtypes of squamous cell, adenocarcinoma or adenosquamous carcinoma were eligible for inclusion. The primary end point was noninferiority of MIS compared with open surgery; the metric used was the percent of disease-free patients at 4.5 years postsurgery. The secondary end points were a comparison of the recurrence and survival rates between the two groups.Of the planned 740 patients, 632 were accrued when the study was stopped early because of an imbalance in deaths between the two groups. Of 631 eligible patients, 319 were assigned to MIS and 312 to open surgery.The study concluded that MIS was inferior to an open abdominal approach and should not replace open surgery as the standard for cervical cancer patients.

The DFS rate at 4.5 years was 86% for the MIS group and 96.5% for the open-surgery group (95% CI, -16.4 to -4.7). At 3 years, the MIS group had a DFS rate of 91.2% versus 97.1% for the open-surgery group (HR for disease recurrence or death, 3.74; 95% CI, 1.63–8.58).

A multicenter, international, randomized trial, the Laparoscopic Approach to Cervical Cancer (LACC [NCT00614211]) trial, explored the efficacy of radical hysterectomy and staging via open abdominal surgery (open) versus MIS for patients with early-stage cervical cancer.[22] Patients with stages IA1 (with lymphovascular space invasion), IA2, and IB1 disease and histological subtypes of squamous cell, adenocarcinoma or adenosquamous carcinoma were eligible for inclusion. The primary end point was noninferiority of MIS compared with open surgery; the metric used was the percent of disease-free patients at 4.5 years postsurgery. The secondary end points were a comparison of the recurrence and survival rates between the two groups.Of the planned 740 patients, 632 were accrued when the study was stopped early because of an imbalance in deaths between the two groups. Of 631 eligible patients, 319 were assigned to MIS and 312 to open surgery.The study concluded that MIS was inferior to an open abdominal approach and should not replace open surgery as the standard for cervical cancer patients.

The MIS group also had a lower 3-year OS rate (93.8% vs. 99.0% for the open-surgery group; HR for death from any cause, 6.0; 95% CI, 1.77–20.30).[22][Level of evidence A1]

An epidemiological study using two large U.S. databases (National Cancer Database [NCDB] and Surveillance, Epidemiology, and End Results [SEER] Program database) confirmed a reduction in OS in patients undergoing MIS radical hysterectomy for stage IA2 and stage IB1 cervical cancer from 2010 to 2013. Additionally, among women who underwent radical hysterectomy in the years 2000 to 2010, there was a decrease in OS after 2006, coincident with the widespread adoption of MIS for cervical cancer.[23][Level of evidence C1]