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MP 6.01.51 Interim PET Scanning in Oncology to Detect Early Response during Treatment

Medical Policy    
Section
Radiology 
Original Policy Date
04/24/09
Last Review Status/Date
Reviewed with literature search/8:2014
Issue
8:2014
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

Positron emission tomography (PET) scan has many established roles in oncology. Another potential use of PET scanning is early in the course of treatment to assess treatment response, with the intent of altering therapy if the PET scan shows inadequate response.

Background

Positron emission tomography (PET) scans are based on the use of positron emitting radionuclide tracers coupled to other molecules, such as glucose, ammonia, or water. The radionuclide tracers simultaneously emit 2 high-energy photons in opposite directions that can be simultaneously detected (referred to as coincidence detection) by a PET scanner, consisting of multiple stationary detectors that encircle the area of interest.

A variety of tracers are used for PET scanning, including oxygen-15, nitrogen-13, carbon-11, and fluorine-18. The radiotracer most commonly used in oncology imaging has been fluorine-18, coupled with fluorodeoxyglucose (FDG), which has a metabolism related to glucose metabolism. FDG has been considered potentially useful in cancer imaging, because tumor cells show increased metabolism of glucose.

This policy focuses on the use of PET to determine early treatment response for cancer, that is, assessment of therapy response during cancer treatment. The purpose of the PET scan at this particular interval is to determine whether the treatment being given should be maintained or changed. Such a treatment strategy has been called “risk-adapted” or “response-adapted” treatment. This policy addresses detecting early response during short-term therapy, e.g., during cycle(s) of chemotherapeutic agents and/or a course of radiation therapy, and not on assessing response during use of long-term agents, such as tamoxifen.

This use is to be distinguished from all uses of PET in the initial diagnosis and staging of cancer and other uses after treatment, such as routine surveillance or detection of recurrence. This is also different from what has been called “response assessment” or “treatment response” in some reports but clearly refers to imaging done after completion of therapy for the purpose of prognosis and future treatment planning. Some reports differentiate between PET during treatment and PET after treatment by referring to PET during cancer treatment as “interim treatment response” or “interim staging” and PET at the conclusion of treatment as “restaging.”

The technique of using PET for early treatment response assessment involves comparing PET images before treatment and at some interval after the initial course of treatment. Many intervals have been used in various studies, and there appears to be no standard interval. Comparison of the pre-treatment and mid-treatment PET images can either be performed qualitatively or quantitatively. If a quantitative technique is used, a quantity called the standardized uptake value (SUV) is calculated for a specific region of the image. Various methods are used to compare the SUV between the 2 images, and a specific cut-off value is selected to determine whether the patient is responding or not responding to therapy. A change in SUV between 40% and 60% has often been used in studies of early treatment response.

Summary

Positron emission tomography (PET) scanning has many established roles in oncology. Another potential use of PET scanning is early in the course of treatment to assess treatment response, with the intent of altering therapy if the PET scan shows inadequate response.
High-quality evidence on the use of PET scans in various cancers to determine early response to treatment is lacking. PET scans may provide additional information on risk prediction and/or prognosis, but the effect of these scans on net health outcome is unknown. Comparative trials would be necessary to determine if health outcomes are improved with treatment changes based on early PET scans. A randomized controlled trial in patients with stage 1 or 2 Hodgkin lymphoma was halted for futility after interim results indicated that PET-directed therapy was inferior to standard therapy. PET scanning during a planned course of cancer treatment for the purpose of altering the treatment plan is therefore considered investigational.
Regulatory Status

 

Initial FDA 510(k) approval for the Penn-PET scanner (UGM Medical Systems Inc.) was obtained in 1989. Several PET scanners have been approved subsequently (FDA product code: KPS). The most recent approval was in 2009 for the Attrius™, Attrius L™, and Truesight PET scanners (K090178) from Neusoft Positron Medical Systems (Shenyang, China).

 


Related Policies:
6.01.06 Miscellaneous Applications of Positron Emission Tomography (PET)
6.01.20 Cardiac Applications of PET Scanning
6.01.26 Oncologic Applications of PET Scanning

 


Policy
The use of positron emission tomography (PET) scans to determine early response to treatment (PET scans done during a planned course of chemotherapy and/or radiation therapy) in patients with cancer is considered investigational. 

Policy Guidelines

There is no specific coding for positron emission tomography (PET) scans to determine early response to treatment. The CPT codes for PET or PET/computed tomography (CT) imaging (78811-78816) would be used.

Effective in July 2009, there is a HCPCS modifier created by Medicare that might be helpful:

Modifier PS: Positron emission tomography (PET) or PET/computed tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary’s treating physician determines that the PET study is needed to inform subsequent anti-tumor strategy.


Benefit Application
BlueCard/National Account Issues

 

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

Rationale

This policy was created in April 2009 and has been updated periodically with literature review. The most recent update with literature review covers the period through July 13, 2014.

Literature Review

The use of positron emission tomography (PET) during treatment to detect early treatment response and as a trigger to potentially change treatment at that time makes this imaging procedure more closely tied to treatment than is usually the case with diagnostic tests, and thus, risk-adapted treatment using PET could be evaluated in randomized clinical trials (RCTs). However, no such clinical trials have been completed, although at least 11 studies have been described in clinical trial registries. (1-11) Most of these registered RCTs address Hodgkin and non-Hodgkin lymphomas, although one trial includes patients with adenocarcinoma of the esophagus and gastroesophageal junction. Published case series, in which outcomes are reported for patients whose treatment has been directed by interim PET scans, appear to be rare. A comprehensive review of PET published by the National Health Service (NHS) in the United Kingdom in 2007 specifically looked for but did not find any studies reporting outcomes of patients whose treatment had been altered by interim PET. (1) However, according to a study generated from the National Oncologic PET Registry, which collected data on PET scans to develop evidence for Medicare coverage policy, PET is often used during treatment to change therapy, most often to a different therapy when the PET scan indicates progressive disease. (2) No patient outcomes were reported in this study, however.

The lack of studies showing impact on clinical outcomes based on PET-directed treatment makes it difficult to determine whether using PET during treatment will result in improved patient outcomes. Most studies that evaluate PET during treatment have analyzed PET in relation to various findings such as pathologic or clinical response at the end of treatment, PET at the end of treatment, or long-term results. Although associations between PET and all these findings have consistently been found for a number of cancers, whether such associations can lead directly to improved patient outcomes depends on the specific context of the treatment being used and the alternatives available. For example, if PET during treatment is highly specific for non-response to chemotherapy, and the alternative treatment for non-response is withdrawal of therapy, then treatment-directed PET could lead to withdrawal of ineffective treatment (and its adverse effects) for a subset of patients. If the alternative treatment is a different chemotherapeutic agent, then outcomes would be improved only if the alternative agent results in better outcomes. Use of PET during treatment may not improve outcomes compared to a PET performed after treatment or more than using a different method of response assessment. Interim PET could possibly simply advance the timing of alternative therapies, producing a lead-time bias effect without actually improving outcomes.

Other types of treatment protocols using PET-directed treatment that could potentially improve patient outcomes are possible. For example, treatment with less toxic agents that are less efficacious could be tried initially and changed quickly if PET showed that the initial agents were ineffective; thus allowing that subset of patients for whom a treatment is working to be treated successfully with less toxic treatment.

Evaluation of these types of treatment protocols would seem to require direct evidence from clinical trials, and conclusions about efficacy could not follow directly from current observational studies of PET. The following sections summarize the literature on PET during treatment for several major cancers in which its use has been proposed or is apparently being used.

Lymphoma

Standard therapy for patients with clinical stage 1 or 2 (above the diaphragm) Hodgkin lymphoma comprises combination chemotherapy followed by radiation therapy.(3) In 2014, Raemaekers et al published a preplanned interim futility analysis of the European Organization for Research and Treatment of Cancer/Lymphoma Study Association/Fondazione Italiana Linfomi (EORTC/LYSA/FIL) Intergroup H10 randomized trial.(3) The trial randomized patients who had previously untreated stage 1/2 Hodgkin lymphoma to PET-directed therapy or standard therapy; patients in the PET-directed therapy arm who had a negative early (after 2 chemotherapy cycles) PET scan did not receive radiation therapy. Patients with favorable or unfavorable prognostic factors were analyzed separately. Favorable prognostic factors are age younger than 50 years with less than 4 involved nodal areas, nonbulky disease (mediastinum-to-thorax ratio, <0.35), and erythrocyte sedimentation rate (ESR) less than 30 mm/h with B symptoms (unexplained fevers, >38°C [98.6°F], drenching night sweats, or weight loss >10% of body weight within 6 months before diagnosis) or ESR less than 50 mm/h without B symptoms; unfavorable prognostic factors are age 50 years or older with more than 4 involved nodal areas, bulky disease (mediastinum-to-thorax ratio, ≥0.35), and ESR 30 mm/h or greater with B symptoms or 50 mm/h or greater without B symptoms. The primary end point was progression-free survival. The interim analysis included 1124 randomized patients (favorable group, n=441; unfavorable group, n=683) with median follow-up of 1.1 years. Progression or death was more common among patients in PET-guided therapy arms than standard therapy arms of both groups (5% vs 0.5%, respectively, in the favorable group; 6% vs 3%, respectively, in the unfavorable group). Estimated hazard ratios for progression or death were 9.4 (80% confidence interval [CI], 2.5 to 35.7) and 2.4 (80% CI, 1.4 to 4.4), in the favorable and unfavorable groups, respectively. Based on these findings, futility was declared, and accrual to the early PET-negative experimental arm was discontinued. (Accrual to an experimental treatment escalation protocol for early PET-positive patients continued.)

A 2007 National Comprehensive Cancer Network (NCCN) Task Force report on PET scanning in cancer makes no specific recommendation, but the language seems to indicate that the benefits of PET during treatment are not proven. (14) “Study results suggest that therapy does not need to be changed when the PET scan is negative, but a separate trial is needed to determine whether a positive PET scan should prompt an alternative therapy and whether this alternative therapy can improve outcomes.” A consensus statement released in 2007 by the Imaging Subcommittee of the International Harmonization Project in Lymphoma stated that use of PET for treatment monitoring during a course of therapy should only be done in a clinical trial or as part of a prospective registry. (15) This statement also comments on the need for clinical trials to demonstrate improved patient outcomes. The document otherwise proposes a strong endorsement for PET at the conclusion of therapy.

A comprehensive review of PET for lymphoma by the British National Health Service (NHS) identified 9 studies evaluating PET during treatment. (12) PET during treatment was highly associated with either patient survival or progression, such that patients who had positive PET scans during treatment were more likely to have progressed or have shorter survival. The 9 studies reviewed all had fewer than 100 patients, and different methods were used to analyze the PET scans. Cut-off values to differentiate a positive from a negative PET scan were invariably derived post hoc, possibly leading to an overestimate of discriminative capability.

A 2007 comprehensive review of PET for lymphoma by NHS identified 9 studies evaluating interim PET.(1) Interim PET was highly associated with either patient survival or progression, such that patients who had positive PET scans during treatment were more likely to have progressed or have shorter survival. The 9 studies reviewed all had fewer than 100 patients, and different methods were used to analyze the PET scans. Cutoff values to differentiate a positive from a negative PET scan were invariably derived post hoc, possibly leading to an overestimate of discriminative capability.

In a case series of risk-adapted treatment using mid-treatment PET to alter therapy in lymphoma, 33 of 59 patients with positive mid-treatment PET scans had therapy changed to more aggressive therapy with platinum-based salvage chemotherapy, high-dose therapy, and autologous stem-cell transplantation. (16)These patients had a 2-year event-free survival of 67%, which is better than is historically associated with such patients who have positive mid-treatment PET scans. However, such case series data are not definitive in establishing the benefit of such a treatment strategy.

Some single-arm studies that assess outcomes of patients receiving treatment changes based on interim PET/CT (computed tomography) scans suggest that some chemotherapeutic regimens can be intensified or switched to less-toxic regimens without harm. (17, 18) The conclusions of single-arm studies may be biased by selection and lead-time bias. Imperfect prediction of poor prognosis may lead to some low-risk patients being classified as high risk, improving the group’s survival. Earlier treatment using salvage therapies may result in a lead-time bias, which would also give an apparent survival improvement. Given the potential for selection and lead-time biases, comparative trials would be necessary to determine the efficacy of such a strategy.

Subsequent studies in patients with Hodgkin or non-Hodgkin lymphoma (total N=380) have shown an association between early interim PET (after 1 or 2 chemotherapy cycles) and survival outcomes.(9-12) Strength of association varied by radioactive tracer and method of image interpretation. Neither study demonstrated the impact of early interim PET on net health outcome.

Current NCCN guidelines on Hodgkin lymphoma (version 2.2014) include several statements on the use of interim PET.(13) Initial studies suggested that for early-stage Hodgkin lymphoma (stage 1 to 2 favorable disease), interim PET imaging was not considered to be of important prognostic significance. However, the guideline cites two 2012 studies (Kostakaglu et al14 and Zinzani et al15) that found PET scans after 2 cycles of chemotherapy were significant predictors of progression-free survival. For more advanced disease, interim PET imaging predicts long-term outcomes. Although interim PET has prognostic capability, the document states that “guiding therapy based on the results of interim PET imaging is considered investigational and is not recommended outside the context of a clinical trial.” However, if interim PET imaging is to be performed in patients with stage 1 to 2 unfavorable (bulky or nonbulky) disease or stage 3 to 4 disease, it may be performed after 2 to 4 cycles of chemotherapy. Interim staging with diagnostic CT was recommended for certain patients receiving certain treatment regimens. For non-Hodgkin lymphoma, current NCCN guidelines (version 2.2014) do not support interim PET for altering treatment (see Table 1).(16)

Lung Cancer

The 2007 NCCN Task Force report discussed studies examining the role of PET in determining early treatment response for non-small-cell lung cancer but made no statement recommending such use.(4) Three studies were cited that showed that interim PET scans during neoadjuvant therapy were associated with pathologic findings at surgery or with median time to cancer progression. A 2009 NCCN Task Force report did not cite evidence for the use of interim PET in small-cell lung cancer.(17) Current NCCN guidelines for small-cell lung cancer (version 1.2015)(18) and for non-small-cell lung cancer (version 4.2014)(19) do not recommend interim PET scanning.

No studies were identified that evaluated outcomes of patients whose treatments were altered with mid- treatment PET. The 2007 British NHS review identified several studies that evaluated PET for posttreatment assessment and only 1 study that evaluated PET during treatment.1 In that study, PET findings during chemotherapy were associated with clinical measures of best response evaluated at the.

Ovarian Cancer

Ovarian cancer was the most common type of cancer in which PET was used during treatment in the U.S. National Oncologic PET registry.(2) Neither the 2007 NCCN Task Force nor the British NHS review included ovarian cancer among the uses of PET considered in their reports.(1,4) The 2009 NCCN Task Force report cited no evidence for interim PET in ovarian cancer.(17) Current NCCN guidelines for ovarian cancer (version 3.2014)25 do not recommend interim PET scanning.

No case series or comparative trials of risk-adapted treatment for ovarian cancer were identified. One study evaluated the use of PET during chemotherapy to predict patient outcomes in 33 patients, without making management changes.(26) Using various thresholds of change in standardized uptake value (SUV), median survival was worse among those who had a smaller change in SUV. For example, at a threshold of decrease in SUV of 20% after the first cycle of chemotherapy, overall survival was 38.3 months in responders and 23.1 months in nonresponders. Clinical response, CA-125 response, and histopathologic response did not correlate with overall survival. Although PET during treatment appears to be associated with response and may be better than other methods of prognosis, whether such improved prediction leads to improved patient outcomes is not demonstrated in this type of study.

Gastrointestinal Stromal Tumors

The 2009 NCCN Task Force report identified a small retrospective study of 20 patients with gastrointestinal stromal tumors (GIST) who were treated with imatinib and underwent PET, CT, and PET/CT imaging.17 PET/CT was more accurate than either PET or CT alone for detecting tumor response at 1, 3, and 6 months after initiation of imatinib. Based on this study, the Task Force recommended PET for response assessment to targeted GIST therapy. Current NCCN guidelines for soft tissue sarcoma (version 2.2014) state that for patients with GIST, “PET may give an indication of imatinib activity after 2-4 weeks of [primary or preoperative] therapy when rapid readout of activity is necessary.”27 However, this statement is a footnote to GIST treatment recommendations and is uncited.

A 2012 review of studies of PET for evaluating treatment response to imatinib and other drugs in GIST included the retrospective study identified by the NCCN Task Force.(28) Review authors concluded that “FDG PET allows an early assessment of treatment response and is a strong predictor of clinical outcome.” This conclusion was based on several studies (total N=192) that showed associations between PET as early as 1 week after initiation of imatinib therapy and survival outcomes, and 2 studies (total N=44) that did not show this association. None of the reviewed studies assessed the impact of PET-directed treatment changes on net health outcome.

Other Cancers

The 2007 and 2009 NCCN Task Force Reports assessed other cancers for interim PET. The 2007 report cited 1 small study of patients with colorectal cancer that showed an association between PET and tumor response to 5-fluorouracil after 1 month of therapy.(4) In their summary recommendation, the Task Force concluded that PET scans are not routinely indicated to monitor response to chemotherapy or radiation therapy. The report cited several studies of breast cancer patients and early PET, and commented on promising data but included this indication among several potential uses in breast cancer that need further research.

The British NHS review also assessed other cancers for PET during treatment.(1) The report identified a previous systematic review and 3 primary studies that demonstrated associations between PET during treatment and responses in breast cancer. No studies showing outcomes of PET-directed treatment for breast cancer were identified. For colorectal cancer, 1 study showed that PET after 1 month of chemotherapy predicted outcome, but predictive accuracy was low. For head and neck cancer, esophageal cancer, and melanoma, only studies that evaluated PET performed after treatment were identified.

In total, the British NHS review found 22 studies of PET during treatment. The authors concluded that many studies were small and evaluated different treatments using a diversity of response targets and monitoring methods. There was little evidence of change in patient management, even anecdotally, and no published evidence of successful applications to drug development.

The 2009 NCCN Task Force report reviewed cancers not discussed in the 2007 report.(17) For most cancers (eg, bladder, prostate, thyroid), evidence for interim PET was not cited. Although the Task Force included a recommendation for PET to assess response to liver-directed therapies in patients with localized hepatocellular carcinoma, the recommendation was based on studies of PET after transcatheter chemo-embolization and/or radiofrequency ablation (ie, not interim PET).

Subsequent studies in patients with colon cancer(29,30) or breast cancer in the neoadjuvant setting(31-35) have demonstrated associations between early or interim PET and recurrence or survival outcomes. Evidence in rectal cancer was mixed,36,37 and studies of early (during or after 1 or 2 neoadjuvant chemotherapy cycles) PET to predict axillary lymph node response reported conflicting results.(38,39) Cut-point thresholds for PET positivity varied across studies. No study demonstrated the impact of PET-directed treatment on net health outcome.

Others studies have reported associations between early or interim PET during treatment and recurrence or survival outcomes in bladder cancer,(40) malignant pleural mesothelioma,(41,42) squamous cell carcinomas of the head and neck,43,44 and bone or soft tissue sarcoma.(45) Conversely, evidence suggests that early or interim PET during treatment does not add prognostic information for patients with esophageal cancer(46,47); evidence for advanced renal cell carcinoma was mixed.(48-50) However, the impact of PET-directed treatment on net health outcome has not been demonstrated in any of these cancers.

Current NCCN recommendations for interim PET scanning in the various cancers discussed in this policy are summarized in Table 1.

Clinical Input Received through Physician Specialty Societies and Academic Medical Centers

In response to requests, input was received from one physician specialty society and 5 academic medical centers while this policy was under review in 2011. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. In general, there was agreement with the conclusions of this policy from those providing input. Most of the disagreement related to use of PET scans during a planned course of treatment for patients with Hodgkin lymphoma. Some reviewers felt current data were sufficient to show benefit, others commented that additional studies needed to evaluate this issue.

Summary

There is a lack of high-quality literature on the use of positron emission tomography (PET) scans in various cancers to determine early response to treatment. These scans may provide some additional information on risk prediction and/or prognosis, but the effect of these scans on the net health outcome is not known. Comparative trials would be necessary to determine if health outcomes are improved based on treatment changes instituted based on early PET scans. Therefore, PET scanning done during a planned course of cancer treatment for the purpose of altering the treatment plan is considered investigational.

Table 1. Current NCCN Recommendations for Interim PET Scanning

Guideline

Version

Recommendation

Bladder cancer(51)

 2.2014

Interim PET for assessing response to ongoing treatment is not addressed.

Breast Cancer(52)

3.2014

“Studies of functional imaging [for monitoring metastatic disease], such as radionuclide bone scans and PET imaging, are particularly challenging when used to assess response…PET imaging is challenging because of the absence of a reproducible, validated, and widely accepted set of standards for disease activity assessment.”

CNS Cancers(53)

1.2014

Interim PET for assessing response to ongoing treatment is not addressed.

Cervical Cancer(54)

1.2014

Interim PET for assessing response to ongoing treatment is not addressed.

Colon Cancer(55)

3.2014

“PET-CT should not be used to monitor progress of therapy.a CT with contrast or MRI is recommended.”

Esophageal and EGJ Cancers (56)

1.2014

Interim PET for assessing response to ongoing treatment is not addressed.b

GIST(27)

2.2014

PET may give an indication of imatinib activity after 2-4 weeks of [primary or preoperative] therapy when rapid readout of activity is necessary.”c

Head and neck cancers(57)

2.2014

Interim PET for assessing response to ongoing treatment is not addressed.

Hepatobiliary cancers(58)

2.2014

Interim PET for assessing response to ongoing treatment is not addressed.

HL(13)

2.2014

“Guiding therapy based on the results of interim PET scans is considered investigational and is not recommended outside the context of a clinical trial.”

Melanoma(59)

4.2014

Interim PET for assessing response to ongoing treatment is not addressed.

MPM(60)

1.2014

Interim PET for assessing response to ongoing treatment is not addressed.

Rectal cancer(61)

3.2014

“PET-CT should not be used to monitor progress of therapy. CT with contrast or MRI is recommended.”

Multiple myeloma(62)

2.2014

Interim PET for assessing response to ongoing treatment is not addressed.

NHL(16)

2.2014

“Interim PET scan is not recommended to be used to guide changes in therapy” for DLBCL.a,d “If treatment modifications are considered based on interim PET scan results [in DLBCL or in PTCLe], a repeat biopsy of residual masses is  recommended to confirm true positivity.”

NSCLC(19)

4.2014

Interim PET for assessing response to ongoing treatment is not addressed.

Ovarian cancer(25)

3.2014

Interim PET for assessing response to ongoing treatment is not addressed.

Pancreatic adenocarcinoma(63)

2.2014

Interim PET for assessing response to ongoing treatment is not addressed.

Prostate cancer(64)

2.2014

Interim PET for assessing response to ongoing treatment is not addressed.

SCLC(18)

1.2015

Interim PET for assessing response to ongoing treatment is not addressed.

Thyroid carcinoma(65)

2.2013

Interim PET for assessing response to ongoing treatment is not addressed.

Uterine neoplasms(66)

1.2014

Interim PET for assessing response to ongoing treatment is not addressed.

CNS: central nervous system; DLBCL: diffuse large B-cell lymphoma; EGJ: esophagogastric junction; GIST: gastrointestinal stromal tumor; HL: Hodgkin lymphoma; MPM: malignant pleural mesothelioma; MRI: magnetic resonance imaging; NHL: non-Hodgkin lymphoma; NSCLC: non-small-cell lung cancer; PTCL: peripheral T-cell
lymphoma; SCLC: small-cell lung cancer
a Both false-negative and false-positive results can occur.
b NCCN recommends consideration of PET to assess treatment response after completion of preoperative or definitive chemotherapy and/or radiation therapy.
c This statement is a footnote to GIST treatment recommendations and is uncited.
d When planned treatment for stage 1 or 2 DLBCL involves short course chemotherapy followed by radiation therapy, NCCN recommends repeat PET scan before initiating radiation therapy to determine radiation dose.
e Except for patients with ALK-positive anaplastic large cell lymphoma.

Ongoing and Unpublished Clinical Trials

An online search of ClinicalTrials.gov in July 2014 found 22 ongoing trials of interim PET-directed treatment. They are listed in Table 2. Table 2 also includes 1 unpublished trial in patients with Hodgkin lymphoma.

Table 2. Ongoing Clinical Trials of Early or Interim PET-Directed Cancer Therapy

NCT Number

Title

Enrollment

Completion dateb

Esophageal Cancer

NCT01065818

Early Prediction of Pathologic Complete Response (pathCR) With Fluoro-L-Thymidine (FLT) Positron Emission Tomography (PET)

100

Aug 2012

NCT02125448

PReoperative Identification Of Response to Neoadjuvant

Chemoradiotherapy for Esophageal Cancer (PRIOR)

30

Apr 2015

NCT02139488

Organ Motion and Early Tumor Response Measurement

54

Jan 2016

Hodgkin Lymphoma

NCT00515554

HD18 for Advanced Stages in Hodgkins Lymphoma

1500

Sep 2014

NCT00678327

Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to 1200 Sep 2012 Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin Lymphoma

1200

Sep 2012

NCT00736320

HD16 for Early Stage Hodgkin Lymphoma

1100

Nov 2015

NCT00784537

High-dose Chemotherapy and Stem Cell Transplantation, in Patients PET-2 Positive, After 2 Courses of ABVD and Comparison of RT Versus no RT in PET-2 Negative Patients (HD0801)

300

Jun 2014

NCT00795613

Positron Emission Tomography (PET)-Adapted Chemotherapy In

Advanced Hodgkin Lymphoma (HL) (HD0607)

450

Jul 2012

NCT00822120

S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination

Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma

230

Dec 2014

NCT00943423

PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma (RAPID)

602

Dec 2015

NCT01118026

Response-Based Therapy Assessed By PET Scan in Treating

Patients With Bulky Stage I and Stage II Classical Hodgkin

Lymphoma

123

Jul 2017

NCT01132807

Chemotherapy Based on Positron Emission Tomography Scan in

Treating Patients With Stage I or Stage II Hodgkin Lymphoma

149

Jun 2016

NCT01356680

HD17 for Intermediate Stage Hodgkin Lymphoma

1100

Dec 2019

NCT01390584

Chemotherapy Based on PET Scan in Treating Patients With Stage I

or Stage II Hodgkin Lymphoma

200

Jun 2021

NCT01508312

Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With

Relapsed or Refractory Hodgkin Lymphoma

46

Jan 2015

NCT02166463

Brentuximab Vedotin and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Hodgkin  Lymphoma

600

Nov 2019

Unpublished trial

Involved Field Radiotherapy Versus No Further Treatment in 602 Completed Patients with Clinical Stages IA and IIA Hodgkin Lymphoma and a ‘Negative’ PET Scan After 3 Cycles ABVD. Results of the UK NCRI RAPID Trial

602

Completed

Non-Hodgkin lymphoma

NCT00554164

Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas (PETAL)

696

Jun 2014

NCT01285765

Study Evaluating the Non-inferiority of a Treatment Adapted to the Early Response Evaluated With 18F-FDG PET Compared to a Standard Treatment, for Patients Aged From 18 to 80 Years With Low Risk (aa IPI = 0) Diffuse Large B-cell Non Hodgkin's Lymphoma CD 20+

420

Jan 2018

NCT01478542

OPTIMAL>60, Improvement of Therapy of Elderly Patients With

CD20+ DLBCL Using Rituximab Optimized and Liposomal

Vincristine

1152

Oct 2016

NCT01659099

GA In NEwly Diagnosed Diffuse Large B-Cell Lymphoma (GAINED)

670

Oct 2015

NCT02063685

Study to Evaluate the Efficacy of Response-adapted Strategy in

Follicular Lymphoma

602

Jul 2016

SCC of the Head and Neck

NCT01287390

Adaptive, Image-guided, Intensity-modulated Radiotherapy for Head

and Neck Cancer in the Reduced Volumes of Elective Neck

100

Sep 2015

aa: age-adjusted; ABVD: doxorubicin, bleomycin, vinblastine, dacarbazine; IPI: International Prognostic Index; SCC: squamous cell cancer.
a Expected.
b Estimated.

Clinical Input Received from Physician Specialty Societies and Academic Medical Centers

In response to requests, input was received from 1 physician specialty society and 5 academic medical centers while this policy was under review in 2011. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. In general, there was agreement with the conclusions of this policy from those providing input. Most of the disagreement related to use of PET scans during a planned course of treatment for patients with Hodgkin lymphoma. Some reviewers felt current data were sufficient to show benefit; others commented that
additional studies needed to evaluate this issue.

Summary of Evidence

High-quality evidence on the use of positron emission tomography (PET) scans in various cancers to determine early response to treatment is lacking. PET scans may provide additional information on risk prediction and/or prognosis, but the effect of these scans on net health outcome is unknown. Comparative trials would be necessary to determine if health outcomes are improved with treatment changes based on early PET scans. A randomized controlled trial in patients with stage 1 or 2 Hodgkin lymphoma was halted for futility after interim results indicated that PET-directed therapy was inferior to standard therapy. PET scanning during a planned course of cancer treatment for the purpose of altering the treatment plan is therefore considered investigational.

Practice Guidelines and Position Statements
American College of Radiology/Society for Pediatric Radiology

The American College of Radiology and the Society for Pediatric Radiology issued a 2012 practice guideline for performing FDG-PET/CT in oncology.67 The guideline states that FDG-PET/CT imaging in oncology patients “should only be performed when there is reasonable expectation that the results will have an impact on patient care.” Examples of indications for imaging included “guiding initial or subsequent treatment strategy in patients with known malignancy” and “monitoring therapeutic efficacy.” Further clarification was not provided.

National Comprehensive Cancer Network
Current National Comprehensive Cancer Network recommendations for interim PET scanning during treatment to assess early response in a variety of cancers are summarized in Table 1.

International Harmonization Project in Lymphoma

A consensus statement released in 2007 by the Imaging Subcommittee of the International Harmonization Project in Lymphoma stated that use of PET for treatment monitoring during a course of therapy should only be done in a clinical trial or as part of a prospective registry.(5) This statement also comments on the need for clinical trials to demonstrate improved patient outcomes. The document otherwise proposes a strong endorsement for PET at the conclusion of therapy.

U.S. Preventive Services Task Force Recommendations

PET scan for the purpose of detecting early response to cancer treatment is not a preventive service.

Medicare National Coverage

There is no national coverage determination (NCD) for PET during ongoing treatment to assess treatment response. In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

 

References:
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Codes

Number

Description

CPT  78811, 78812, 78813  Positron emission tomography (PET) imaging, coding range
  78814, 78815, 78816 Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging, coding range
ICD-9 Diagnosis    Investigational for all diagnoses when used to determine early response to treatment.
HCPCS  Modifier - PS Positron emission tomography (PET) or PET/computed tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary’s treating physician determines that the PET study is needed to inform subsequent anti-tumor strategy
ICD-10-CM (effective 10/1/15)    Investigational for all diagnoses when used to determine early response to treatment.
   C00.0-C14.8 Malignant neoplasm of lip, oral cavity and pharynx code range
   C15.3-C15.9 Malignant neoplasm of esophagus code range
   C18.0-C18.9 Malignant neoplasm of colon code range
   C19 Malignant neoplasm of rectosigmoid junction (includes colon with rectum)
   C25.0-C25.9 Malignant neoplasm of pancreas code range
    C30.0-C31.9 Malignant neoplasm of nasal cavities, middle ear and accessory sinuses code range
    C32.0-C32.9 Malignant neoplasm of larynx code range
   C34.0-C34.92 Malignant neoplasm of bronchus and lung code range
   C43.0-C43.9 Malignant melanoma of skin code range
   C50.011-C50.929 Malignant neoplasm of breast code range
   C53.0-C53.9 Malignant neoplasm of cervix uteri code range
    C56.0-C56.9 Malignant neoplasm of ovary code range
   C62.00-C62.92 Malignant neoplasm of testis code range
   C73 Malignant neoplasm of thyroid gland
   C76.0 Malignant neoplasm of head, face and neck NOS
   C80.0-C80.1 Malignant neoplasm without specification of site (unknown primary)
   C81.00-C81.99 Hodgkin’s disease code range
   C82.00-C88.9 Other malignant neoplasm of lymphoid tissue (other lymphomas)
ICD-10-PCS (effective 10/1/15)   ICD-10-PCS is for use only on inpatient services. There are a few specific PET ICD-10-PCS codes such as the following:
   CB32KZZ, CB32YZZ Nuclear medicine, respiratory system, positron emission tomographic (PET) imaging, lungs and bronchi, code by radionuclide
   CB3YYZZ Nuclear medicine, respiratory system, positron emission tomographic (PET) imaging, respiratory system

 


Index

 

Positron Emmision Tomography, Early Treatment Response
Policy History
Date Action Reason
04/24/09 Add to Radiology section Policy created with literature search through April 2009;
considered investigational when performed to determine early response to treatment.
12/09/10 Replace policy Policy updated with literature search; references 9 and 10 added. No change to policy statement
5/12/11 Replace policy Policy updated with review of clinical input. No change in policy statement
08/09/12 Replace policy Policy updated with literature review, reference 9 deleted, reference 10 added. No change in policy statement.
8/08/13 Replace policy Policy updated with literature review through July 2013; reference 1 deleted, references 2 through 11, 20, and 21 added. Old reference 11 replaced with new reference 19. No change in policy statement.
8/14/14 Replace policy Policy updated with literature review through July 13, 2014; references 3, 9-12, 17-25, and 27-67 added; references 13, 16, and 68 updated; references 1-11 (trial registrations) deleted. No change to policy statements.