VANCOUVER – Follow-up oncologic data from the UTERUS-11 trial shows advantages to surgical staging over clinical staging in stage IIB-IVA cervical cancer, with little apparent risk.
Compared with clinical staging using CT, laparoscopic staging led to an improvement in cancer-specific survival, with no delays in treatment or increases in toxicity. It also prompted surgical up-staging and led to treatment changes in 33% of cases. There was no difference in overall survival, but progression-free survival trended towards better outcomes in the surgical-staging group.
The new study presents 5-year follow-up data from patients randomly assigned to surgical (n = 121) or clinical staging (n = 114). The original study, published in 2017 (), reported that 33% of surgical-staging patients in the surgical staging were up-staged as a result, compared with 6% who were revealed to have positive paraaortic lymph nodes through a CT-guided core biopsy after suspicious CT results. After a median follow-up of 90 months in both arms, overall survival was similar between the two groups, and progression-free survival trended towards an improvement in the surgical-staging group (P = .088). Cancer-specific survival was better in the surgical-staging arm, compared with clinical staging (P=.028), Audrey Tsunoda, MD, PhD, reported.
Surgical staging didn’t impact the toxicity profile, said Dr. Tsunoda, a surgical oncologist focused in gynecologic cancer surgery who practices at Hospital Erasto Gaertner in Curitiba, Brazil.
The mean time to initiation of chemoradiotherapy following surgery was 14 days (range, 7-21 days) after surgery: 64% had intensity-modulated radiotherapy and 36% had three-dimensional radiotherapy. There were no grade 5 toxicities during chemoradiotherapy and both groups had similar gastrointestinal and genitourinary toxicity profiles. About 97% of the surgical staging procedures were conducted laparoscopically. Two patients had a blood loss of more than 500 cc, and two had a delay to primary chemoradiotherapy (4 days and 5 days). One patient had to be converted to an open approach because of obesity and severe adhesions, and there was no intraoperative mortality.
Previous retrospective studies examining surgical staging in these patients led to confusion and disagreements among guidelines. Surgical staging is clearly associated with increased up-staging, but the oncologic benefit is uncertain. Theattempted to address the question with prospective data, but failed to accrue enough patients and was later abandoned. That leaves the UTERUS-11 study, the initial results of which were published in 2017, as the first prospective study to examine the benefit of surgical staging.
The new follow-up results suggest a benefit to surgical staging, but they leave an important question unanswered, according to Lois Ramondetta, MD, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, Houston, who served as a discussant at the meeting sponsored by AAGL. “Paraaortic lymph node status does connect to clinical benefit, but the question is really [whether] the removal of the lymph nodes accounts for the benefit, or is the identification of them and the change in treatment plan responsible? [If the latter is the case], a PET scan would have done a better job,” said Dr. Ramondetta. “The question remains unanswered, but I think this was huge progress in trying to answer it. Future studies need to incorporate a PET scan.”
Dr. Tsunoda has received honoraria from AstraZeneca and Roche. Dr. Ramondetta has no relevant financial disclosures.