|
|
PET or PET/CT for Ovarian Cancer | |
|
|
Description: |
Positron Emission Tomography (PET) imaging uses radiotracers that can reveal both anatomical and physiological information. The glucose analog, 2-[fluorine-18]-Fluoro-2-deoxy-D-glucose (FDG) is useful in cancer imaging because it has been found that tumor cells show increased utilization of glucose compared to non-malignant tissue and is the most common radiotracer that is utilized. For certain malignancies PET scans have been shown to be more accurate than other non-invasive tests in detecting malignant disease. However, as with all diagnostic tests, PET scans do not detect cancer 100% of the time that cancer is present (a false negative test), nor do all positive PET scans represent the presence of malignant disease (a false positive test). A false negative test may occur because a critical volume of malignant cells is necessary for a PET scan to be positive. PET scans may be false positive in the presence of inflammation or granulomatous disease.
The sensitivity of PET in detecting disease averages only 77% and the specificity averages only 83%. Studies which were clearly designed to study recurrent disease showed an average sensitivity of only 74%, and an average specificity of only 88%.
Definitions
Screening – testing in the absence of an established or clinically suspected diagnosis
Diagnosis - testing based on a reasonable clinical suspicion of a particular condition or disorder
Diagnostic Workup – initial staging of documented malignancy
Management – testing to direct therapy of an established condition, which may include preoperative or postoperative imaging, or imaging performed to evaluate the response to nonsurgical intervention. In oncologic imaging, management applies to patients with measurable disease and to imaging performed before or after planned treatment intervention, therapy response, restaging or clinically suspected recurrence.
Surveillance – periodic assessment following completion of therapy. In oncologic imaging, surveillance applies to asymptomatic patients in remission and/or without measurable disease
Cannot be performed or is nondiagnostic – applies when the test:
Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.
|
|
|
Policy/ Coverage: |
EFFECTIVE MARCH 13, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
FDG-PET/CT scanning for Ovarian Cancer (all variants) scanning meets primary coverage criteria for effectiveness and is covered for:
For all fully insured contracts, all self-funded church-sponsored health plans and all self-funded government-sponsored health plans other than the Arkansas State and Public School Employees program, the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of Positron emission tomography (PET) scanning for Ovarian Cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
For members with contracts without primary coverage criteria, the use of Positron emission tomography (PET) scanning for Ovarian Cancer is considered investigational and is not covered for any indication or any circumstance other than those listed above including but not limited to:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
*For all fully insured contracts, all self-funded church-sponsored health plans and all self-funded government-sponsored health plans other than the Arkansas State and Public School Employees program, the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
Note: Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.
Effective Prior to March 13, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
PET for ovarian cancer meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered:
Note: The decision to administer salvage therapy should be made after the positive PET finding has been confirmed by biopsy. The decision to treat based solely on PET results in not recommended in most studies.
For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans (e.g., state and public-school employee plans), other than the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
PET do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for women with ovarian cancer for:
For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans (e.g., state and public-school employee plans), other than the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
For contracts without primary coverage criteria, PET scanning for ovarian cancer is not covered:
For members with contracts without primary coverage criteria, the use of PET in women with ovarian cancer, when used for any reason other than that in the coverage statement, is considered investigational and not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Note: PET scanning should not be done for staging or re-staging of tumors that are known not to be 18FDG-avid. (Juweid ME, Cheson BD. NEJM, 2006;354:496-507)
|
|
|
Rationale: |
2012 Update
A literature search was performed on PubMed for PET imaging and ovarian cancer.
Fischerova and colleagues(2012) reported on imaging techniques for the diagnosis of ovarian tumors. PET/CT is not recommended for primary ovarian cancer detection because of its lower sensitivity in comparison to ultrasound and its high false positive rates as well. According to the results of the largest multicenter International Ovarian Trial Analysis (IOTA), ultrasound if performed by an experienced sonologist is an ideal diagnostic method in diferential diagnosis between benign and malignant ovarian tumors. The experienced examiner is also able to detect extraovarian tumor spread and to assess tumor operability. Magnetic resonance imaging (MRI) is used only to complement ultrasound in cases when high tissue resolution is needed. Computed tomography (CT) is a useful method for detection of extraovarian spread, especially in cases when an ultrasound examiner experienced in abdominal scanning is not available. Similarly, fusion of positron emission tomography with CT (PET/CT) is a highly accurate method for the detection of abdominal and extraabdominal tumor spread, but its use is limited by cost and the low availability of this method.
Kitajima and colleagues (2012) published the results of a study performed to evaluate low-dose non-enhanced CT (ldCT) and full-dose contrast-enhanced CT (ceCT) in integrated (18)F-fluorodeoxyglucose (FDG)-PET/CT studies for restaging of ovarian cancer. One hundred and twenty (120) women who had undergone treatment for ovarian cancer underwent conventional PET/CT scans with ldCT, and then ceCT. Final diagnoses were obtained by histopathological examinations, or clinical follow-up for at least 6 months. The authors concluded that PET/ceCT is a more accurate imaging modality with higher confidence for assessing ovarian cancer recurrence than PET/ldCT. Patient-based analysis showed that the accuracy of PET/ceCT was 92.5% (111/120), whereas those of PET/ldCT was 88.3% (106/120).
Kumar and colleagues (2012) published an article on an evidence-based approach on the impact of FDG-PET and -PET/CT imaging in the clinical decision-making of ovarian carcinoma They concluded that surveillance and detecting recurrence in patients who have completed primary therapy but demonstrate a rising serum tumor marker (e.g., CA-125 levels) is the most definitive role of fluorodeoxyglucose (FDG)-PET/computed tomography (CT). PET/CT demonstrates high sensitivity and accuracy in detecting lesions that are otherwise challenging, and appears superior (with less interobserver variability) compared with CT alone. Even though peritoneal deposits may be missed by PET/CT, the overall performance is better than CT alone. FDG-PET does not play a significant additional role in the primary diagnosis of ovarian cancers; however, because PET/CT can pick up small unsuspected lesions and thereby provide a better disease assessment of the whole body in a single examination, the role of combined PET/CT modality has recently begun to be re-explored for initial disease staging. The baseline PET/CT also offers an important role for future monitoring of therapy response. Monitoring therapy with PET may help to optimize neoadjuvant therapy protocols and might prevent ineffective therapy in nonresponders early in its course; however,additional study needs to be done on the cost-effectiveness of PET/CT.
Clinical Trials
NCT01276574 – “Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT” - A prospective study to determine whether there is clinical benefit of using fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial ovarian cancer (EOC). Estimated enrollment 60 and completion date of 12/2016.
NCT00959582 – “A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients” – Study sponsored by Merck, has been completed, results have not been published. Estimated enrollment 42. Purpose was to characterize FDG-PET (18F-Fluorodeoxyglucose-Positron Emission Tomography) as an early response marker in recurrent, platinum-sensitive ovarian cancer treated with platinum-based therapy.
2014 Update
A literature search conducted through October 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2013 meta-analysis found PET-CT was useful in detecting ovarian cancer recurrence (Limei, 2013). American College of Radiology Appropriateness Criteria also issued in 2013 indicates PET-CT is appropriate for detecting and restaging ovarian cancer recurrence (Mitchell, 2013). NCCN guidelines for ovarian cancer indicate PET-CT may be appropriate “for indeterminate lesions if results will alter management” (NCCN, 2014). PET-CT may also be appropriate if clinically indicated after complete remission for follow-up and monitoring for recurrence.
2015 Update
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2017 meta-analysis by Xu et al evaluated the diagnostic value of PET and PET/CT for recurrent or metastatic ovarian cancer (Xu, 2017). The literature search, conducted through August 2014, identified 64 studies for inclusion: 15 studies (n=657 patients) using PET and 49 studies (n=3065 patients) using PET/CT. The pooled sensitivity and specificity for PET were 89% (95% CI, 86% to 92%) and 90% (95% CI, 84% to 93%), respectively. The pooled sensitivity and specificity for PET/CT were 92% (95% CI, 90% to 93%) and 91% (95% CI, 89% to 93%), respectively. Subgroup analyses were conducted by study region (Asia, Europe, and America). For PET/CT, sensitivities in the Asia and Europe studies were significantly higher compared with the sensitivity in the America studies.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
A literature search was conducted through February 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement. .
November 2021 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
DIAGNOSTIC WORKUP
Ovarian cancer is most commonly staged using the FIGO system, although the American Joint Committee on Cancer TNM system may also be utilized. Until more conclusive data is available, CT abdomen and pelvis with contrast remains the preferred imaging modality for staging. CT abdomen and pelvis has a reported accuracy of 77%. The positive predictive value for cancer nonresectability was 100% and the negative predictive value was 92%. Results of CT are comparable to MRI in terms of accuracy, positive predictive value, and negative predictive value: 78%, 91%, and 99%. In one study, no difference was seen between MRI and CT in detection of abdominal disease. (1) In a second prospective
study comparing ultrasound, CT, and MRI, CT and MRI were again found to be equivalent in detecting stage III/IV disease. (2) In a smaller study, MRI outperformed CT for detection of small tumors in extrahepatic sites and was particularly advantageous for evaluating the peritoneum, mesentery, and bowel. (3)
FDG-PET/CT or MRI may be useful for indeterminate lesions if results will alter management. (4) The use of PET for initial staging is not universally supported; sensitivity and specificity have been reported at 86% and 54%, respectively. False negatives can be seen with borderline tumors, early carcinomas, and adenocarcinomas and false positives occur in some benign conditions. (5) A small prospective trial (N =50) found PET/CT had a 69% correlation with final pathologic staging while the correlation for CT was 53%. CT imaging missed 11% of patients with distant metastasis in the liver, pleura, mediastinum, and in left supraclavicular lymph nodes. (6) In a review of 18 studies, PET was superior to both CT and MRI at detecting involved lymph nodes. PET had a sensitivity of 73.2% and specificity of 96.7%. (7)
MANAGEMENT
If treated with neoadjuvant therapy, reassessment should be performed using the same imaging modality that was used in the original assessment (CT, MRI, PET/CT or PET as clinically indicated without modality preference per NCCN, level of evidence category 2A). (4) However, in patients with suspected recurrence, PET may be more accurate at detecting recurrence than CT; in one prospective, multicenter cohort study, PET/CT detected additional sites of disease in 68% of patients compared to conventional imaging and led to a change in management in 60%. (8) A second study in patients with suspected recurrence showed that PET detected recurrence in 66% of patients while CT only detected 50%. The sensitivities of CT and PET/CT for diagnosing recurrence were 81% and 97%, respectively, and the specificity was 90% for both modalities. (9) These findings have been validated in 2 large meta-analyses. (10, 11)
SURVEILLANCE
Based on a review of the Surveillance Epidemiology & End Results database, up to 95% of recurrences are detected by physical exam or rising cancer antigen (CA) 125.12 Studies using radiographic surveillance for ovarian cancer have reported the sensitivity and specificity of CT 40%-93% and 50%-98%, respectively.13 In a retrospective Italian study, recurrence in asymptomatic patients was detected by physician exam in 14.8%, by serum CA 125 in 23%, and by imaging in 27.2%. No difference was seen in survival with symptomatic or asymptomatic presentation at time or relapse.14 In a post-hoc analysis of the AURELIA trial (Avastin [Bevacizumab] Use in Platinum-Resistant Epithelial Ovarian Cancer), progression-free survival was improved with earlier recurrence detection, but no difference in overall
survival was demonstrated. (15) Additionally, Rustin et al. reported in a randomized trial that there was no evidence of a survival benefit with early treatment of relapse on the basis of a raised CA 125 concentration alone. (16) While the Society of Gynecologic Oncology and the NCCN do not recommend routine use of surveillance imaging, it may be indicated when tumor markers are considered unreliable, the physical exam is unreliable, and/or there is a high risk of recurrence. (4, 13)
Current References
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement.
MANAGEMENT
For stage I-IV after primary treatment, the NCCN recommends CT, MRI, PET/CT or PET as
clinically indicated without modality preference (level of evidence category 2A). (4) Imaging should be
performed with oral and IV contrast (unless contraindicated) and rectal contrast as needed.
New Reference
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer (Version 1.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.
|
|
|
CPT/HCPCS: | |
|
|
References: |
Bristow RE, Giuntoli RL II, et al.(2005) Combined PET/CT for detecting recurrent ovarian cancer limited to retroperitoneal nodes. Gynecol Oncol 2005; 99:294-300. Cho S, Ha H, Byun J, et al.(2002) Usefulness of FDG PET for assessment of early recurrent epithelial ovarian cancer. Am J Roentgenol 2002; 179:391-5. Fenchel S, Grab D, Nuessle K, et al.(2002) Asymptomatic Adnexal Masses: Correlation of FDG PET and Hisopathologic Findings. Radiology 2002; 223:780-788. Fischerová D, Zikán M, Pinkavová I, et al.(2012) [The rational preoperative diagnosis of ovarian tumors - imaging techniques and tumor biomarkers (review)]. Ceska Gynekol. 2012 Aug;77(4):272-87. Juweid ME, Cheson BD.(2006) Positron Emission Tomography and assessment of cancer therapy. NEJM 2006; 354:496-507. Kitajima K, Ueno Y, Suzuki K, et al.(2012) Low-dose non-enhanced CT versus full-dose contrast-enhanced CT in integrated PET/CT scans for diagnosing ovarian cancer recurrence. Eur J Radiol. 2012 Nov;81(11):3557-62. Epub 2012 Apr 23. Kumar Dhingra V, Kand P, Basu S.(2012) Impact of FDG-PET and -PET/CT imaging in the clinical decision-making of ovarian carcinoma: an evidence-based approach. Womens Health (Lond Engl). 2012 Mar;8(2):191-203. Kurosaki H, Oriuchi N, et al.(2006) Prognostic value of FDG-PET in patients with ovarian cancer following surgical treatment. Ann Nucl Med 2006; 20:171-4. Limei Z, Yong C, Yan X et al.(2013) Accuracy of positron emission tomography/computed tomography in the diagnosis and restaging for recurrent ovarian cancer: a meta-analysis. Int J Gynecol Cancer 2013; 23(4):598-607. Makhija S, Howden N, Edwards R, et al.(2002) Positron Emission Tomography/Computed Tomography Imaging for the Detection of Recurrent Ovarian and Fallopian Tube Carcinoma: A Retrospective Review. Gynecol Oncol 2002; 85:53-8. Markman, M.(2002) The use of PET scanning in ovarian cancer (Ltr). Gynecol Oncol 2002; 85:391-2. Mitchell DG, Javitt MC, Glanc P et al.(2013) ACR appropriateness criteria staging and follow-up of ovarian cancer. J Am Coll Radiol 2013; 10(11):822-7. Murakami M, Miyamoto T, et al.(2006) Whole-body positron emission tomography and tumor marker CA125 for detection of recurrence in epithelial ovarian cancer. Int J Gynecol Cancer 2006; 16 Suppl 1:99-107. Nanni C, Rubello D, et al.(2005) 18F-FDG PET/CT in the evaluation of recurrent ovarian cancer: a prospective study on forty-one patients. Eur J Surg Oncol 2005; 31:792-97. National Comprehensive Cancer Network(2013) Clinical Practice Guidelines in Oncology. Ovarian Cancer V2.2013. Available online at: http://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Last accessed January, 2014. National Comprehensive Cancer Network(2022) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer (Version 1.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022. NCT00959582.(2012) A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients. www.clinicaltrials.gov; last accessed 11/14/2012. NCT01276574.(2012) Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT. www.clinicaltrials.gov; last accessed 11/14/2012. Takekuma M, Maeda M, et al.(2005) Positron emission tomography with 18F-fluoro-2-deoxyglucose for the detection of recurrent ovarian cancer. Int J Clin Oncol 2005; 10:177-81. Torizuka T, Nobezawa S, et al.(2002) Ovarian cancer recurrence: role of whole-body positron emission tomography using 2-[fluorine-18]-fluoro-2-deoxy-D-glucose. Eur J Nucl Med 2002; 29:797-803. Xu B, Ma J, Jiang G, et al.(2017) Diagnostic value of positron emission tomography (PET) and PET/computed tomography in recurrent/metastatic ovarian cancer: A meta-analysis. J Obstet Gynaecol Res. Feb 2017;43(2):378-386. PMID 28150407 Zimny M, Siggelkow W, Schroder W, et al.(2001) 2-[Fluorine-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography in the Diagnosis of Recurrent Ovarian Cancer. Gynecol Oncol 2001; 83:310-315. |
|
|
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2023 American Medical Association. |