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In women with locally advanced carcinoma of the cervix who are candidates for chemotherapy and radiotherapy, does adding fludeoxyglucose F 18 positron emission tomography–computed tomography (PET-CT) to staging with CT of the abdomen and pelvis detect more extensive disease and influence therapy?
In a randomized clinical trial, 44 of 112 patients receiving PET-CT compared with 14 of 56 patients receiving CT alone received more extensive chemotherapy and radiotherapy or palliative treatment, a nonsignificant difference. Five percent of patients in each group were treated with palliative intent.
In this trial among women with locally advanced carcinoma of the cervix, there was no significant difference between PET-CT plus CT vs CT alone, possibly because the trial was underpowered.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT00895349
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Accepted for Publication: June 10, 2018.
Published: September 14, 2018. doi:10.1001/jamanetworkopen.2018.2081
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2018 Elit LM et al. JAMA Network Open.
Corresponding Author: Mark N. Levine, MD, MSc, FRCPC, Juravinski Hospital, 711 Concession St, Room 104, G Wing, First Floor, Hamilton, ON L8V 1C3, Canada (firstname.lastname@example.org).
Author Contributions: Dr Levine had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Elit, Fyles, Gu, Pond, Metser, Levine.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Elit, Fyles, Pond, Filion, Whelan, Gulenchyn, Metser, Dhamanaskar, Levine.
Critical revision of the manuscript for important intellectual content: Elit, Fyles, Gu, Pond, D'Souza, Samant, Anthes, Thomas, Filion, Arsenault, Dayes, Gulenchyn, Metser, Levine.
Statistical analysis: Gu, Pond.
Obtained funding: Levine.
Administrative, technical, or material support: Elit, Fyles, D’Souza, Samant, Filion, Gulenchyn, Metser, Levine.
Supervision: Elit, Samant, Metser, Levine.
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.
Funding/Support: This study was supported by the Ministry of Health and Long-Term Care/Cancer Care Ontario.
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: Dr Levine is an associate editor of JAMA Network Open but was not involved in the editorial review of or decision to publish this article.
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