Effect of Positron Emission Tomography Imaging in Women With Locally Advanced Cervical Cancer: A Randomized Clinical Trial

Abstract

Importance: In women with locally advanced cancer of the cervix (LACC), staging defines disease extent and guides therapy. Currently, undetected disease outside the radiation field can result in undertreatment or, if disease is disseminated, overtreatment.

Objective: To determine whether adding fludeoxyglucose F 18 positron emission tomography-computed tomography (PET-CT) to conventional staging with CT of the abdomen and pelvis affects therapy received in women with LACC.

Design, setting, and participants: A randomized clinical trial was conducted. Women with newly diagnosed histologically confirmed International Federation of Gynecology and Obstetrics stage IB to IVA carcinoma of the cervix who were candidates for chemotherapy and radiation therapy (CRT) were allocated 2:1 to PET-CT plus CT of the abdomen and pelvis or CT alone. Enrollment occurred between April 2010 and June 2014 at 6 regional cancer centers in Ontario, Canada. The PET-CT scanners were at 6 associated academic institutions. The median follow-up at the time of the analysis was 3 years. The analysis was conducted on March 30, 2017.

Interventions: Patients received either PET-CT plus CT of the abdomen and pelvis or CT of the abdomen and pelvis.

Main outcomes and measures: Treatment delivered, defined as standard pelvic CRT vs more extensive CRT, ie, extended field radiotherapy or therapy with palliative intent.

Results: One hundred seventy-one patients were allocated to PET-CT (n = 113) or CT (n = 58). The trial stopped early before the planned target of 288 was reached because of low recruitment. Mean (SD) age was 48.1 (11.2) years in the PET-CT group vs 48.9 (12.7) years in the CT group. In the 112 patients who received PET-CT, 68 (60.7%) received standard pelvic CRT, 38 (33.9%) more extensive CRT, and 6 (5.4%) palliative treatment. The corresponding data for the 56 patients who received CT alone were 42 (75.0%), 11 (19.6%), and 3 (5.4%). Overall, 44 patients (39.3%) in the PET-CT group received more extensive CRT or palliative treatment compared with 14 patients (25.0%) in the CT group (odds ratio, 2.05; 95% CI, 0.96-4.37; P = .06). Twenty-four patients in the PET-CT group (21.4%) received extended field radiotherapy to para-aortic nodes and 14 (12.5%) to common iliac nodes compared with 8 (14.3%) and 3 (5.4%), respectively, in the CT group (odds ratio, 1.64; 95% CI, 0.68-3.92; P = .27).

Conclusions and relevance: There was a trend for more extensive CRT with PET-CT, but the difference was not significant because the trial was underpowered. This trial provides information on the utility of PET-CT for staging in LACC.

Trial registration: ClinicalTrials.gov Identifier: NCT00895349.

Conflict of interest statement

Conflict of Interest Disclosures: The trial was coordinated by the Ontario Clinical Oncology Group (OCOG), which is an academic trials group affiliated with McMaster University. Dr Levine is also director of OCOG. The trial had no industry support. Dr Elit reported grants from Cancer Care Ontario during the conduct of the study. Dr Pond reported grants from Cancer Care Ontario during the conduct of the study. Dr Whelan reported grants from Genomic Health outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram

aExclusion criteria (can be multiple per patient) were Eastern Cooperative Oncology Group performance status less than 2 (n = 2), other cervical cancer type (n = 9), carcinoma of the cervical stump (n = 2), prior hysterectomy (n = 4), already undergone positron emission tomography–computed tomography (PET-CT) (n = 1), previous CT of abdomen or pelvis (n = 8), inability to lie supine (n = 4), contraindication to radiotherapy (n = 1), contraindication to cisplatin (n = 2), inadequate bone marrow function (n = 4), inadequate renal function (n = 1), inadequate hepatic function (n = 2), history of other malignancy (n = 1), other medical condition (n = 3), known pregnancy or lactating (n = 4), and inability to complete study (n = 2). CRT indicates chemotherapy and radiation therapy; EFRT, extended field radiotherapy; and MRI, magnetic resonance imaging.

Figure 2.. Event-Free and Overall Survival

A, Event-free survival was calculated from the date of randomization to the date of objective disease recurrence, progression (positive result on a biopsy or radiologic imaging), or death due to any cause. B, overall survival was calculated from the date of randomization to the date of death due to any cause. CT indicates computed tomography; PET, positron emission tomography.