| Coverage Policy Manual | |
| Policy #: | 2011071 |
| Category: | Radiology |
| Initiated: | June 2011 |
| Last Review: | August 2023 |
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| Intensity Modulated Radiation Therapy (IMRT), Abdomen and Pelvis | |
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| Description: |
Radiotherapy may be an integral component of the treatment of cancers of the abdomen and pelvis. Intensity-modulated radiotherapy (IMRT) has been proposed as a method that allows adequate radiation to the tumor while minimizing the radiation dose to surrounding normal tissues and critical structures.
Radiation therapy may be administered externally (i.e., a beam of radiation is directed into the body) or internally (i.e., a radioactive source is placed inside the body, near a tumor) (Misher, 2022). External radiotherapy (RT) techniques include "conventional" or 2-dimensional (2D) RT, 3-dimensional (3D) conformal RT, and intensity-modulated radiation therapy (IMRT).
Methods to plan and deliver RT have evolved that permit more precise targeting of tumors with complex geometries. Conventional 2D treatment planning utilizes X-ray films to guide and position radiation beams (Misher, 2022). Bony landmarks visualized on X-ray are used to locate a tumor and direct the radiation beams. The radiation is typically of uniform intensity.
Radiation treatment planning has evolved to use 3D images, usually from computed tomography (CT) scans, to more precisely delineate the boundaries of the tumor and to discriminate tumor tissue from adjacent normal tissue and nearby organs at risk for radiation damage. Three-dimensional conformal RT (3D-CRT) involves initially scanning the patient in the position that will be used for the radiation treatment (Misher, 2022). The tumor target and surrounding normal organs are then outlined in 3D on the scan. Computer software assists in determining the orientation of radiation beams and the amount of radiation the tumor and normal tissues receive to ensure coverage of the entire tumor in order to minimize radiation exposure for at risk normal tissue and nearby organs. Other imaging techniques and devices such as multileaf collimators may be used to "shape" the radiation beams. Methods have also been developed to position the patient and the radiation portal reproducibly for each fraction and to immobilize the patient, thus maintaining consistent beam axes across treatment sessions.
IMRT is the more recent development in external radiation. Treatment planning and delivery are more complex, time-consuming, and labor-intensive for IMRT than for 3D-CRT. Similar to 3D-CRT, the tumor and surrounding normal organs are outlined in 3D by a scan and multiple radiation beams are positioned around the patient for radiation delivery (Misher, 2022). In IMRT, radiation beams are divided into a grid-like pattern, separating a single beam into many smaller "beamlets". Specialized computer software allows for “inverse” treatment planning. The radiation oncologist delineates the target on each slice of a CT scan and specifies the target's prescribed radiation dose, acceptable limits of dose heterogeneity within the target volume, adjacent normal tissue volumes to avoid, and acceptable dose limits within the normal tissues. Based on these parameters and a digitally reconstructed radiographic image of the tumor, surrounding tissues, and organs at risk, computer software optimizes the location, shape, and intensities of the beam ports to achieve the treatment plan's goals.
Increased conformality may permit escalated tumor doses without increasing normal tissue toxicity and is proposed to improve local tumor control, with decreased exposure to surrounding, normal tissues, potentially reducing acute and late radiation toxicities. Better dose homogeneity within the target may also improve local tumor control by avoiding underdosing within the tumor and may decrease toxicity by avoiding overdosing.
Other advanced techniques may further improve RT treatment by improving dose distribution. These techniques are considered variations of IMRT. Volumetric modulated arc therapy delivers radiation from a continuous rotation of the radiation source. The principal advantage of volumetric modulated arc therapy is greater efficiency in treatment delivery time, reducing radiation exposure and improving target radiation delivery due to less patient motion. Image-guided RT involves the incorporation of imaging before and/or during treatment to more precisely deliver RT to the target volume.
Regulatory Status
In general, IMRT systems include intensity modulators which control, block, or filter the intensity of radiation; and RT planning systems which plan the radiation dose to be delivered.
A number of intensity modulators have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Intensity modulators include the Innocure Intensity Modulating Radiation Therapy Compensators (Innocure), cleared in 2006, and the decimal tissue compensator (Southeastern Radiation Products), cleared in 2004. FDA product code: IXI. Intensity modulators may be added to standard linear accelerators to deliver IMRT when used with proper treatment planning systems.
RT planning systems have also been cleared for marketing by the FDA through the 510(k) process. They include the FOCUS Radiation Treatment Planning System (Computerized Medical Systems) cleared in 2002, Prowess Panther™ (Prowess) cleared in 2003, TiGRT (LinaTech) cleared in 2009, the RayDose (RaySearch Laboratories) cleared in 2008, and the Eclipse Treatment Planning System (Varian Medical Systems) cleared in 2017. FDA product code: MUJ.
Fully integrated IMRT systems also are available. These devices are customizable and support all stages of IMRT delivery, including planning, treatment delivery, and health record management. Varian Medical Systems has several 510(k) marketing clearances for high-energy linear accelerator systems that can be used to deliver precision RT such as IMRT. FDA product code: IYE.
Related Policies:
2003015 Intensity Modulated Radiation Therapy (IMRT)
2009036 Intensity Modulated Radiation Therapy (IMRT), Breast
2009035 Intensity Modulated Radiation Therapy (IMRT), Lung
2009034 Intensity Modulated Radiation Therapy (IMRT), Prostate
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Policy/ Coverage: |
Effective August 1, 2021, for members of plans that utilize a radiation oncology benefits management program, Prior Approval is required for this service and is managed through the radiation oncology benefits management program.
Effective April 14, 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Anorectal, Gynecological, Bladder
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
Stomach, Hepatobiliary, Pancreas
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
Penile and Testicular
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness (may be considered medically necessary):
Colon Cancer
Intensity Modulated Radiation Therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for colon cancer when EITHER of the following conditions are met:
Image Guided Radiation Therapy (IGRT)
Image guidance or image-guided radiation therapy (IGRT), any modality, used with IMRT meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
Effective November 6, 2022 to April 13, 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Anorectal, Gynecological, Bladder
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
Stomach, Hepatobiliary, Pancreas
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
Penile, Testicular, Colon
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
Effective Prior to November 6, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Anorectal, Gynecological, Bladder
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
Stomach, Hepatobiliary, Pancreas
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness
Penile, Testicular, Colon
Intensity modulated radiation therapy (IMRT) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness
Effective Prior to August 2020
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Intensity modulated radiation therapy (IMRT) to treat squamous cell or adenocarcinoma of the anus/anal canal meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
Intensity modulated radiation therapy (IMRT) to treat adenocarcinoma of the rectum meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
Effective Prior to July 2020
Intensity modulated radiation therapy (IMRT) to treat squamous cell carcinoma of the anus/anal canal meets Primary Coverage Criteria.
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| Rationale: |
Much of the reported literature describes case series. Two of them describe results achieved with IMRT in patients with squamous cell carcinoma of the anal canal. The first is a single-institution series that included 17 patients with stage I/II cancer who underwent IMRT alone (n=3) or concurrent with 5-FU alone (n=1) or 5-FU with mitomycin C (MMC, n=13) (Milan0, 2005). Patients generally received 45 Gy to the PTV at 1.8 Gy per fraction, followed by a 9 Gy boost to the gross tumor volume. Thirteen of 17 (76%) patients completed treatment as planned. None experienced acute or late grade 3 or above nonhematologic (GI or GU) toxicity. Grade 4 acute hematologic toxicity (leukopenia, neutropenia, thrombocytopenia) was reported in 5 of 13 (38%) patients who received concurrent chemoradiotherapy. At a median follow-up of 20.3 months, the 2-year OS rate was 91%.
A second multicenter series included a cohort of 53 consecutive patients who received concurrent chemotherapy and IMRT (Salama,2007). Forty-eight (91%) received 5-FU plus MMC, the rest received other regimens not including MMC. Radiation was delivered at 45 Gy to the PTV. Thirty-one (58%) patients completed therapy as planned, with breaks in the others because of grade 4 hematologic toxicities (40% of patients), painful moist desquamation, or severe GI toxicities. At the18-month follow-up, the local tumor control rate was 83.9% (range: 69.9–91.6%), with an OS rate of 93.4% (range: 80.6–97.8%). Univariate analyses did not reveal any factors significantly associated with tumor control or survival rates, whereas a multivariate analysis showed patients with stage IIIB disease experienced a significantly lower colostomy-free survival (hazard ratio 4.18; 95% CI: 1.062–16.417; p=0.041).
The authors of these series suggest that their tumor control, survival, and toxicity results are similar to those achieved in earlier trials with concurrent chemoradiotherapy using non-IMRT methods.
Three case series reports were identified in the 2010 update. One was a gastrointestinal toxicity study in 45 patients who received concurrent chemotherapy and IMRT for anal cancer (Devisetty, 2009). Chemo-radiotherapy is becoming the standard treatment for anal cancer, in part due to preservation of sphincter function. Patients had T1 (n=1), T2 (n=24), T3 (n=16), and T4 (n=2) tumors; N stages included Nx (n=1), N0 (n=31), N1 (n=8), N2 (n=3), and N3 (n=2). Concurrent chemotherapy primarily comprised 5FU plus mitomycin C (MMC). IMRT was administered to a dose of 45 Gy in 1.8 Gy fractions, with areas of gross disease subsequently boosted with 9–14.4 Gy. Acute genitourinary toxicity was grade 0 in 25 (56%) cases, grade 1 in 10 (22%) patients, grade 2 in 5 (11%) patients, with no grade 3 or 4 toxicities reported; 5 (11%) patients had no genitourinary tract toxicities reported. Grades 3-4 leukopenia was reported in 26 (56%) cases, neutropenia in 14 (31%), and anemia in 4 (9%). Acute GI toxicity included grade 0 in 2 (4%) patients, grade 1 in 11 (24%), grade 2A in 25 (56%), grade 2B in 4 (95), grade 3 in 3 (7%) and no grade 4 toxicities. Univariate analysis of data from these patients suggests a statistical correlation between the volume of bowel that received 30 Gy or more of radiation and the risk for clinically significant (grade 2 or higher) GI toxicities.
Pepek et al. (2010) reported a retrospective analysis of toxicity and disease outcomes associated with IMRT in 47 patients with anal cancer. Thirty-one patients had squamous cell carcinoma (SCC). Patients had AJCC stage I (n=6, 13%), stage II (n=16, 36%), stage III (n=14, 31%), stage IV (n=6, 13%), or recurrent disease (n=3, 7%). IMRT was prescribed to a dose of at least 54 Gy to areas of gross disease at 1.8 Gy per fraction. Forty patients (89%) received concurrent chemotherapy with a variety of agents including MMC, 5FU, capecitabine, oxaliplatin, etoposide, vincristine, doxorubicin, cyclophosphamide, and ifosfamide in various combinations. The 2-year actuarial OS for all patients was 85%. Eight patients (18%) required treatment breaks. Toxicities included grade 4 leukopenia (7%) and thrombocytopenia (2%); grade 3 leukopenia (18%) and anemia (4%); and, grade 2 skin (93%). These rates were much lower than previous trials of chemoradiation, where grade 3 to 4 skin toxicity was noted in about 50% of patients and grade 3 to 4 GI toxicity noted in about 35%. In addition, the rate of treatment breaks was lower than in many studies; and some studies of chemoradiation include a break from radiation therapy. Some investigators believe that treatment breaks reduce the efficacy of this combined approach. The authors concluded IMRT is emerging as a standard therapy for anal cancer.
A small (n=6) case series of IMRT and concurrent infusional 5FU plus cisplatin in patients in patients with anal cancer with para-aortic nodal involvement was reported by Hodges et al. in 2009. IMRT was delivered to a median dose of 57.5 Gy to the CTV, with nodal areas of involvement treated to a median dose of 55 Gy. Five of 6 completed the entire prescribed course of IMRT. The 3-year actuarial OS rate was 63%. Four patients developed grade 3 acute toxicities that included nausea and vomiting, diarrhea, dehydration, small bowel obstruction, neutropenia, anemia, and leukopenia. Five of 6 had grade 2 skin toxicity.
Bazan et al. reported a retrospective study, single center, 17 receiving conventional radiotherapy 1993-2002, compared to 29 receiving IMRT 2003-2009. Each group received 54 Gy to the primary tumor and involved nodes. Thirty-nine pts received concurrent 5FU & mitomycin C, 9 received 5FU & cisplatin. The CRT group, compared to the IMRT group: required longer treatment duration – 57 vs 40 days; more treatment breaks – 88% vs 34.5 %; longer breaks – 12 vs 1.5 day; 65% experienced grade >2 nonhematologic toxicity vs 21%. The 3-year overall survival (OS), locoregional control )LRC), and progression free survival (PFS) were 87.8%, 91.9% and 84.2% respectively for the IMRT group vs 51.8%, 56.7% and 56.7% for the CRT group.
DeFoe and colleagues report clinical outcomes in a group of 78 patients with anal cancer who received concurrent chemotherapy and IMRT at 13 community cancer centers. All IMRT planning was done at one central location. Median follow-up for the entire cohort was 16 mos (range 0-72 months). Acute grade 3 toxicity occurred in 27.7% (GI) and 29.0% (dermatological). Acute grade 4 hematological toxicity occurred in 12.9% of patients. Sixty-four (88.9%) of patients experienced a complete response. The 2-year colostomy free survival, overall survival, freedom from local failure, and freedom from distant failure rates were 82.1, 86.9, 83.6 and 81.8%, respectively.
October 2012 Update
No new randomized controlled trials were identified in a PubMed search through September 2012. There were a few dosimetric comparison including an article by Brooks and colleagues in 2012.
There were reports of a few case series. Call et al, 2011, did a retrospective review of 34 patients who received IMRT delivered to clinically negative nodal regions in patients receiving chemoradiotherapy for anal cancer. Median follow-up duration was 22 months. Three-year freedom from relapse was 80% and 3-year overall survival was 87% , estimated using Kaplan-Meier curves.
Kachnic et al., 2012, reported acute toxicity and response to therapy for 43 patients treated with dose-painted IMRT (DP-IMRT) and chemotherapy at two academic centers. Median follow-up was 24 months. Sixty percent completed chemoradiation without interruption while median interruption for the others was 2 days (range 2-24 days). Acute grade 3 toxicity included: hematologic 51%, dermatologic 10%, gastrointestinal 7% and genitourinary 7%. Two-year local control, overall survival, colostomy-free survival, and metastasis-free survival were 95%, 94%, 90%, and 92%, respectively.
Vieillot et al., 2012, reported on the first 39 of 72 patients treated with IMRT, 1.8 Gy per fraction for 45 fractions, to the primary tumor and the risk area including pelvic and inguinal nodes. A second plan delivered 1.8 – 2.0 Gy per fraction for a total of 14.4 – 20 Gy to the primary tumor. Thirty-three of the patients also received chemotherapy. Six patients required a treatment break of 3 days or longer with a median 8 day break. Grade 3 gastrointestinal toxicity was seen in 10% of patients while 5% of patients had genitourinary toxicity. Twelve percent of patients had grade 4 hematologic toxicity and those patients received CRT. With 24-month follow-up there was no late grade 4 toxicity. The 2-year overall survival, local relapse-free survival and colostomy-free survival was 89%, 77% and 85%, respectively.
No changes are made to the coverage statement.
2013 Update
A search of the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement.
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A prospective cohort study was conducted by Han and colleagues to evaluate toxicity, quality of life (QOL), and clinical outcomes in patients treated with intensity modulated radiation therapy (IMRT) and concurrent chemotherapy for anal and perianal cancer (Han, 2014). From June 2008 to November 2010, patients with anal or perianal cancer treated with IMRT were eligible. Radiation dose was 27 Gy in 15 fractions to 36 Gy in 20 fractions for elective targets and 45 Gy in 25 fractions to 63 Gy in 35 fractions for gross targets using standardized, institutional guidelines, with no planned treatment breaks. The chemotherapy regimen was 5-fluorouracil and mitomycin C. Toxicity was graded with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. QOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Correlations between dosimetric parameters and both physician-graded toxicities and patient-reported outcomes were evaluated by polyserial correlation. Fifty-eight patients were enrolled. The median follow-up time was 34 months; the median age was 56 years; 52% of patients were female; and 19% were human immunodeficiency virus-positive. Stage I, II, III, and IV disease was found in 9%, 57%, 26%, and 9% of patients, respectively. Twenty-six patients (45%) required a treatment break because of acute toxicity, mainly dermatitis (23/26). Acute grade 3 + toxicities included skin 46%, hematologic 38%, gastrointestinal 9%, and genitourinary 0. The 2-year overall survival (OS), disease-free survival (DFS), colostomy-free survival (CFS), and cumulative locoregional failure (LRF) rates were 90%, 77%, 84%, and 16%, respectively. The global QOL/health status, skin, defecation, and pain scores were significantly worse at the end of treatment than at baseline, but they returned to baseline 3 months after treatment. Social functioning and appetite scores were significantly better at 12 months than at baseline. Multiple dose-volume parameters correlated moderately with diarrhea, skin, and hematologic toxicity scores. IMRT reduces acute grade 3 + hematologic and gastrointestinal toxicities compared with reports from non-IMRT series, without compromising locoregional control. The reported QOL scores most relevant to acute toxicities returned to baseline by 3 months after treatment.
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Franco an d colleagues reported the 4-year outcomes of a consecutive series of anal cancer patients treated with concurrent chemo-radiation delivered with intensity-modulated radiotherapy (IMRT), employing a simultaneous integrated boost (SIB) approach (Franco, 2015). A consecutive series of 54 patients was enrolled between 2007 and 2013. Treatment schedule consisted of 50.4 Gy/28 fractions (1.8 Gy daily) to the gross tumor volume, while the elective nodal volumes were prescribed 42 Gy/28 fractions (1.5 Gy/daily) for patients having a cT2N0 disease. Patients with cT3-T4/N0-N3 tumors were prescribed 54 (T3) or 60 (T4) Gy/30 fractions (1.8-2 Gy daily) to the gross tumor volume; gross nodal volumes were prescribed 50.4 Gy/30 fr (1.68 Gy daily) if sized ≤ 3 cm or 54 Gy/30 fr (1.8 Gy daily) if > 3 cm; elective nodal regions were given 45 Gy/30 fractions (1.5 Gy daily). Chemotherapy was administered concurrently according to the Nigro's regimen. Primary endpoint was colostomy-free survival (CFS). Secondary endpoints were local control (LC), disease-free survival (DFS), cancer-specific survival (CSS), overall survival (OS), and toxicity profile. Median follow up was 32.6 months (range 12-84). The actuarial probability of being alive at 4 years without a colostomy (CFS) was 68.9% (95% CI: 50.3%-84.7%). Actuarial 4-year OS, CSS, DFS, and LC were 77.7% (95% CI: 60.7-88.1%), 81.5% (95% CI: 64%-91%), 65.5% (95% CI: 47.7%-78.5%), and 84.6% (95% CI: 71.6%-92%). Actuarial 4-year metastasis-free survival was 74.4% (95% CI: 55.5%-86.2%). Maximum detected acute toxicities were as follows: dermatologic -G3: 13%; GI-G3: 8%; GU-G3: 2%; anemia-G3: 2%; neutropenia-G3:11%; G4: 2%; thrombocytopenia- G3:2%. Four-year G2 chronic toxicity rates were 2.5% (95% CI: 3.6-16.4) for GU, 14.4% (95% CI: 7.1-28) for GI, 3.9% (95% CI: 1%-14.5%) for skin, and 4.2% (95% CI: 1.1-15.9) for genitalia.
2017 Update
A literature search conducted through February 2017 did not reveal any new information that would prompt a change in the coverage statement.
2018 Update
A literature search conducted using the MEDLINE database through January 2018 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
A literature search conducted using the MEDLINE database through February 2019 did not reveal any new information that would prompt a change in the coverage statement.
January 2020 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2020. No new literature was identified that would prompt a change in the coverage statement.
July 2020 Update
A literature search was conducted through June 2020. Following is a summary of the new literature to date.
July 2020 Update
A literature search was conducted through June 2020. Following is a summary of the new literature to date.
Bae et al (2017) published the results of retrospective study that evaluated the feasibility of simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) for preoperative concurrent chemoradiotherapy (PCRT) in locally advanced rectal cancer (LARC) versus 3-dimensional conformal radiotherapy (3D-CRT). 94 patients who were treated with PCRT for LARC from 2015 January to 2016 December were enrolled. SIB-IMRT was used in 53 patients, and 3D-CRT in 41 patients along with concomitant 5-fluorouracil plus leucovorin or capecitabine. Surgery was performed 8 weeks after PCRT. Between PCRT and surgery, one cycle of additional chemotherapy was administered. Pathologic tumor responses and acute gastrointestinal, genitourinary, hematologic, and skin toxicities were compared between the two groups. After PCRT, no significant differences were noted in tumor responses, pathologic complete response (9% vs. 7%; p = 1.000), pathologic tumor regression Grade 3 or higher (85% vs. 71%; p = 0.096), and R0 resection (87% vs. 85%; p = 0.843). The authors concluded that SIB-IMRT showed lower GU toxicity and similar tumor responses when compared with 3D-CRT in PCRT for LARC.
In 2017, Sun et al reported an analysis of the National Cancer Data Base to compare IMRT with 3D-CRT for the treatment of rectal adenocarcinoma. A total of 7386 patients with locally advanced rectal carcinoma were treated with neoadjuvant chemoradiotherapy (45-54 Gy) during the period from 2006 to 2013; 3330 (45%) received IMRT and 4065 (55%) received 3D-CRT. Use of IMRT increased from 24% in 2006 to 50% in 2013. Patient age, race, insurance status, Charlson-Deyo comorbidity score, hospital type, income and educations status, and clinical stage of disease were not predictive of which RT was used. The mean radiation dose was higher with IMRT (4735 centigray vs 4608 centigray, p<0.001) and the occurrence of sphincter loss surgery was higher. However, patients treated with IMRT had higher risk of positive margins. Multivariate analysis found no significant differences between the treatments for pathologic downstaging, unplanned readmission, 30-day mortality, or long-term survival. This study used unplanned readmission as a surrogate measure of adverse events but could not assess acute or late toxicity.
In 2017, Huang et al reported a retrospective comparison of outcomes and toxicity for preoperative image-guided IMRT versus 3D-CRT in locally advanced rectal cancer. A total of 144 consecutive patients who were treated between 2006 and 2015 were included in the analysis. The 3D-CRT group was treated with 45 Gy in 25 fractions while the IMRT group was treated with 45 Gy in 25 fractions with a simultaneous integrated boost of 0.2 Gy per day for the primary tumor up to a total dose of 50 Gy. Statistical analysis was performed for grade 0 or greater toxicity and was significant only for acute GI toxicity (p=0.039; see Table 5). Four-year OS and disease-free survival did not differ between the 2 groups. Multivariate analysis found IMRT to be an independent predictor of local failure-free survival (hazard ratio, 0.35; 95% CI, 0.11 to 0.95; p=0.042).
August 2020 Update
A literature search was conducted through July 2020. Following is a summary of the new literature to date.
Gynecologic Cancers
Systematic review
Lin et al (2018) completed a meta-analysis of 6 studies enrolling 1008 subjects in order to compare the efficacy and safety of IMRT with 3D-CRT or 2D-RT for definitive treatment of cervical cancer. Results revealed a nonsignificant difference in 3-year OS (OR, 2.41; 95% CI, 0.62 to 9.39; p=0.21) and disease-free survival rates (OR, 1.44; 95% CI, 0.69 to 3.01; p=0.33) between IMRT and 3D-CRT or 2D-RT. However, IMRT was associated with a significantly reduced rate of acute GI and genitourinary (GU) toxicity: Grade 2 GI: OR, 0.5; 95% CI, 0.28 to 0.89; p=0.02; Grade 3 or higher GI: OR, 0.55; 95% CI, 0.32 to 0.95; p=0.03; Grade 2 GU: OR, 0.41; 95% CI, 0.2 to 0.84; p=0.01; Grade 3 or higher GU: OR, 0.31; 95% CI, 0.14 to 0.67; p=0.003. Some chronic GU toxicity also occurred less frequently with IMRT (Grade 3: OR, 0.09; 95% CI, 0.01 to 0.67; p=0.02). This analysis had several limitations including the fact that most included studies had relatively small sample sizes and were retrospective and nonrandomized in nature. Additionally, some of the included studies did not compare clinical outcomes between the RT techniques.
Randomized Controlled Trials
A 2016 trial by Naik et al randomized 40 patients with cervical cancer to IMRT or to 3D-CRT. Both arms received concurrent radiation with cisplatin and 50 Gy at 25 fractions of RT. Dosimetric planning showed higher conformality and lower doses to organs at risk with IMRT. With follow-up through 90 days after treatment, vomiting and acute GI and genitourinary (GU) toxicity were significantly higher in the 3D-CRT group.
Klopp et al (2018) designed a randomized trial that measured the impact of pelvic IMRT versus standard 4-field RT on patient-reported toxicity and quality of life in 278 women with cervical and endometrial cancer. Results revealed that the mean Expanded Prostate Cancer Index Composite (EPIC) bowel score decreased significantly less in the IMRT as compared to the standard RT group from baseline to end of RT (18.6 versus 23.6 points; p=0.048). Additionally, both the mean EPIC urinary score (5.6 versus 10.4 points; p=0.03) and Trial Outcome Index score (8.8 versus 12.8 points; p=0.06) declined significantly less with IMRT as compared to standard RT. Frequent or almost constant diarrhea was also reported more frequently among women receiving standard RT versus IMRT at the end of RT (51.9% vs. 33.7%; p=0.01) and significantly more women administered standard RT were taking antidiarrheal medications 4 or more times daily (20.4% versus 7.8%; p=0.04).
Ghandi et al reported on a prospective randomized study that compared whole-pelvis IMRT with whole-pelvis CRT in 44 patients with locally advanced cervical cancer (Gandhi, 2013). Each treatment arm had 22 patients. OS at 27 months was 88% with IMRT versus 76% with CRT (p=0.645). However, fewer grade 2 or higher GI toxicities were experienced in the IMRT group than in the CRT group.
Nonrandomized Comparative Studies
In 2016, Shih et al reported a retrospective comparison of bowel obstruction following IMRT (n=120) or 3D-CRT (n=104) after hysterectomy for endometrial or cervical cancer. Groups were generally comparable, except more patients in the 3D-CRT group had open hysterectomy (81% vs 47%, p<0.001). Patients received regular examinations throughout a median follow-up of 67 months, and the 5-year rate of bowel obstruction was 0.9% in the IMRT group compared with 9.3% for 3D-CRT (p=0.006). A body mass index of 30 kg/m2 or more was also associated with less bowel obstruction. However, on multivariate analysis the only significant predictor of less bowel obstruction was IMRT (p=0.022).
In 2014, Chen et al reported on 101 patients with endometrial cancer treated with hysterectomy and adjuvant RT (Chen, 2014). No significant differences between IMRT patients (n=65) and CRT patients (n=36) were found in 5-year OS (82.9% vs 93.5%; p=0.26), local failure-free survival (93.7% vs 89.3%; p=0.68), and DFS (88.0% vs 82.8%; p=0.83). However, the IMRT patients experienced fewer acute and late toxicities. Shih et al reported the results on 46 patients who received IMRT after hysterectomy and bilateral salpingo-oophorectomy for endometrial cancer, 78% of whom had stage III disease (Shih, 2013). At a median 52-month follow-up, 5-year OS was 90% while toxicities were minimal.
Another study examined the use of posthysterectomy RT in women with high-risk cervical cancer. In the first study, 68 patients were treated with adjuvant pelvic RT, high dose-rate ICB, and concurrent chemotherapy (Chen, 2007). The initial 35 cases received CRT delivered to the whole pelvis; the next 33 patients underwent IMRT. All patients received 50.4 Gy of radiation in 28 fractions and 6 Gy of high dose rate vaginal cuff ICB in 3 insertions; cisplatin was administered concurrently to all patients. All patients completed the planned course of treatment. At median follow-up of 34.6 months (range, 12-52 months) in CRT recipients and 14 months (range, 6-25 months) in IMRT recipients, the 1-year locoregional control rate was 94% for CRT and 93% for IMRT. Grades 1 or 2 acute GI toxicities were noted in 36% and 80% of IMRT and CRT recipients, respectively (p<0.001), while acute grade 1 or 2 GU toxicities occurred in 30% and 60%, respectively (p=0.022). There was no significant difference between IMRT and CRT in the incidence of acute hematologic toxicities. Overall, the IMRT patients had lower rates of chronic GI toxicities (p=0.002) than the CRT patients.
Bladder Cancer
James et al (2012) reported on a multicenter, randomized control two armed phase 3 trial that enrolled 360 patients with muscle invasive bladder cancer to undergo radiotherapy with or without concurrent chemotherapy. The researchers concluded that chemotherapy with radiotherapy significantly improved locoregional control of bladder cancer, compared with radiotherapy alone, with no significant increase in adverse events.
Gastrointestinal Tract Cancers
Stomach
Ren et al (2019) completed a systematic review and meta-analysis evaluating the efficacy and safety of IMRT versus 3D-CRT that included 9 controlled clinical trials enrolling 516 patients with gastric cancer. Results revealed a slightly improved 3-year OS rate (risk ratio [RR], 1.16; 95% confidence interval [CI], 0.98 to 1.36) and a significantly better 2-year OS rate with IMRT (RR, 2.49; 95% CI, 1.18 to 5.25; p=0.02) as compared to 3D-CRT. Additionally, the 3-year rate of locoregional recurrence was improved with IMRT versus 3D-CRT (RR, 0.62; 95% CI, 0.39 to 0.98; p<0.05). Similar 3-year disease-free survival rates were noted between the techniques (RR, 1.16; 95% CI, 0.95 to 1.43; p>0.05). No significant differences in liver, GI, and kidney toxicity were observed among patients receiving IMRT compared with 3D-CRT. Limitations of this analysis included the small number of enrolled subjects (ie, the majority of studies had < 100 subjects), retrospective nature of includes studies, which increased the risk of selective reporting bias, and the heterogeneity of IMRT or 3D-CRT techniques in studies. Additionally, the detail and radiation fields of RT varied considerably among the studies, impacting efficacy and toxicity seen by investigators.
The efficacy and safety of 2 different adjuvant chemoradiotherapy regimens using 3D-CRT (n=27) or IMRT (n=33) were evaluated in 2 consecutive cohorts of patients who underwent primarily D2 resection for gastric cancer (Boda-Heggemann, 2009). The cohorts were generally well-matched, with American Joint Committee on Cancer (AJCC) advanced stage (II-IV) disease. Most (n=26 [96%]) who received 3D-CRT were treated with 5-fluorouracil (5-FU) plus folinic acid (FA). In the 3D-CRT cohort, 13 (50%) patients completed the 5-FU/FA regimen, 13 halted early because of acute toxicity or progression and received a median 60% of planned cycles. Patients in the IMRT cohort received capecitabine plus oxaliplatin (n=23 [70%]) or 5-FU/FA (n=10 [30%]). Five (50%) of 10 patients completed all planned 5-FU/FA cycles, the other 5 received a median 60% of cycles because of acute toxicity. Radiation was delivered to a total prescribed dose of 45 gray (Gy) at 1.8 Gy per fraction in 21 (81%) of the 3D-CRT cohort patients; 5 received less than 45 Gy because of treatment intolerance. Thirty (91%) patients in the IMRT cohort received the planned 45 Gy dosage; 2 (6%) were unable to tolerate the full course, and 1 case planned for 50.4 Gy was halted at 47 Gy. Median OS was 18 months in the 3D-CRT cohort, and more than 70 months in the IMRT cohort (p=0.049). Actuarial 2-year OS rates were 67% in the IMRT cohort and 37% in the 3D-CRT group (p not reported). Acute renal toxicity based on creatinine levels was generally lower in the IMRT cohort than in the 3D-CRT group, with a significant difference observed at 6 weeks (p=0.021). In the 3D-CRT group, LENT-SOMA scale grade 2 renal toxicity was observed in 2 (8%) patients whereas no grade 2 toxicity was reported in the IMRT group. In a subsequent report from this group, which included 27 3D-CRT patients and 38 IMRT patients, median OS times for 3D-CRT were 18 months versus 43 months for IMRT (p=0.060) (Boda-Heggemann , 2013). In the 3D-CRT group, actuarial 5-year OS rates were 26% versus 47% in the IMRT group (p not reported). Median disease-free survival (DFS) in the 3D-CRT group was 14 months versus 35 months in the IMRT group (p=0.069). The actuarial 5-year DFS rate was 22% for 3D-CRT and 44% for IMRT (p not reported). Interpretation of this study is limited by differences in the chemotherapy regimens for the 3D-CRT and IMRT groups.
Hepatobiliary
In a retrospective series with a historical control cohort, clinical results achieved with image-guided IMRT (n=24) were compared with results with CRT (n=24) in patients with primary adenocarcinoma of the biliary tract (Fuller, 2009). Most patients underwent postsurgical chemoradiotherapy with concurrent fluoropyrimidine-based regimens. IMRT treatment plans prescribed 46 to 56 Gy to the planning target volume (PTV) that included the tumor and involved lymph nodes, in daily fractions of 1.8 to 2 Gy. CRT involved 3D planning that delivered 46 to 50 Gy in 1.8- to 2-Gy daily fractions. Both groups received boost doses of 4 to 18 Gy as needed. Median estimated OS for all patients who completed treatment was 13.9 months (range, 9.0-17.6 months); the IMRT cohort had median OS of 17.6 months (range, 10.3-32.3 months), while the 3D-CRT cohort had a median OS of 9.0 months (range, 6.6-17.3 months). Acute gastrointestinal (GI) toxicities were mild to moderate, with no significant differences between patient cohorts. These results suggested that moderate dose escalation via CRT is technically and clinically feasible for treatment of biliary tract adenocarcinoma. However, while this series represents the largest group of patients with this disease treated using IMRT, generalization of its results is limited by the small numbers of patients, use of retrospective chart review data, nonrepresentative case spectrum (mostly advanced/metastatic disease), and comparison to a nonconcurrent control radiotherapy (RT) cohort.
Pancreatic
Literature searches identified 2 comparative studies and several case series on IMRT for pancreatic cancer.
Nonrandomized Comparative Studies
In 2016, Lee et al reported a prospective comparative study of GI toxicity in patients treated with concurrent chemoradiotherapy with IMRT (n=44) or 3D-CRT (n=40) for treatment of borderline resectable pancreatic cancer (Lee, 2016). Selection of treatment was by patient choice after explanation by a radiation oncologist. Symptoms of dyspepsia, nausea/vomiting, and diarrhea did not differ between the groups. Upper endoscopy revealed more patients with gastroduodenal ulcers in the 3D-CRT group (42.3%) than in patients treated with IMRT (9.1%; p=0.003). OS was longer in the IMRT group (22.6 months) than in the 3D-CRT group (15.8 months; p=0.006), but interpretation of this result is limited by risk of bias in this nonrandomized study.
Prasad et al (2016) retrospectively studied IMRT (n=134) and 3D-CRT (n=71) in patients with locally advanced pancreatic cancer. The institutional transition from 3D-CRT to IMRT for pancreatic cancer occurred in 2007. Propensity score analysis was performed to account for potential confounding variables, including age, gender, radiation dose, RT field size, and concurrent RT. Grade II GI toxicity occurred in 34% of patients treated with 3D-CRT compared to 16% of IMRT patients (propensity score odds ratio, 1.26; 95% confidence interval [CI], 1.08 to 1.45; p=0.001). Hematologic toxicity and median survival (15.3 months) were similar in the 2 groups.
National Comprehensive Cancer Network Guidelines
Gastrointestinal Tract Cancers
The NCCN guideline (v.2.2020) for gastric cancer indicates that IMRT "may be used in clinical settings where dose reduction to organs at risk is required, and cannot be achieved by 3D techniques." In addition, target volumes need to be carefully defined and encompassed while taking into account variations in stomach filling and respiratory motion.
The NCCN guideline (v.3.2020) for hepatobiliary cancers states that "All tumors irrespective of the location may be amenable to radiation therapy (3D conformal radiation therapy, intensity-modulated radiation therapy [IMRT], or stereotactic body radiation therapy [SBRT])."
IMRT is mentioned as an option in the NCCN guideline (v.1.2020) for pancreatic adenocarcinoma, stating that IMRT "is increasingly being applied for the therapy of locally advanced pancreatic adenocarcinoma and in the adjuvant setting with the aim of increasing radiation dose to the gross tumor while minimizing toxicity to surrounding tissues."24, In addition, the guideline states that "there is no clear consensus on the appropriate maximum dose of radiation when IMRT technique is used."
Gynecologic Cancers
For cervical cancer, the NCCN guideline (v.1.2020) indicates IMRT "is helpful in minimizing the dose to the bowel and other critical structures in the post-hysterectomy setting and in treating the para-aortic nodes when necessary." This technique can also be useful "when high doses are required to treat gross disease in regional lymph nodes." IMRT "should not be used as a routine alternative to brachytherapy for treatment of central disease in patients with an intact cervix." The guideline also mentions that "very careful attention to detail and reproducibility (including consideration of target and normal tissue definitions, patient and internal organ motion, soft tissue deformation, and rigorous dosimetric and physics quality assurance) is required for proper delivery of IMRT and related highly conformal technologies."
The NCCN guideline (v.1.2020) on uterine neoplasms states that radiotherapy for uterine neoplasms includes external-beam radiotherapy and/or brachytherapy but that IMRT may be considered "for normal tissue sparing."
The NCCN guideline (v.1.2020) on ovarian cancer does not mention IMRT.
Anorectal Cancers
NCCN guidelines for anal carcinoma (v.1.2020) state that IMRT “is preferred over 3D conformal RT [radiotherapy] in the treatment of anal carcinoma”; and that “Its use requires expertise and careful target design to avoid reduction in local control by so-called ‘marginal-miss’.”,
NCCN guidelines on rectal cancer (v.1.2020) indicate that “… IMRT … should only be used in the setting of a clinical trial or in unique clinical situations such as reirradiation of previously treated patients with recurrent disease or unique anatomical situations.”,
American College of Radiology
In 2020, the American Society for Radiation Oncology published a clinical practice guideline on RT for cervical cancer (Chino et al, 2020). One key question within the guideline asked when it was appropriate to deliver IMRT for women administered definitive or postoperative RT for cervical cancer? Recommendations regarding this clinical scenario included: "In women with cervical cancer treated with postoperative RT with or without chemotherapy, IMRT is recommended to decrease acute and chronic toxicity." This was a strong recommendation based on moderate quality evidence for acute toxicity and low quality evidence for chronic toxicity. "In women with cervical cancer treated with definitive RT with or without chemotherapy, IMRT is conditionally recommended to decrease acute and chronic toxicity." This was a conditional recommendation based on moderate quality evidence for acute and chronic toxicity. The guideline also notes that there are "no data that IMRT improves disease-specific survival or OS over 2D/3D techniques."
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2021, the American Society for Radiation Oncology published a clinical practice guideline on RT for rectal cancer (Wo, 2021). Within this guideline, IMRT-specific recommendations include:
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Chopra et al conducted the open-label, parallel-group, randomized, phase 3, Postoperative Adjuvant Radiation in Cervical Cancer (PARCER) trial in order to evaluate whether postoperative image-guided IMRT was associated with an improvement in late GI toxicity compared to 3D-CRT (Chopra, 2021). In PARCER, 300 patients with cervical cancer and an indication for adjuvant postoperative RT were randomly assigned to image-guided IMRT (n=151) or 3D-CRT (n=149), with a median follow-up of 46 months (interquartile range, 20 to 72 months). Results revealed significantly fewer primary endpoint events (i.e., grade ≥2 late GI toxicity) in the image-guided IMRT arm versus the 3D-CRT arm (29 vs. 54). The 3-year cumulative incidence of grade ≥2 late GI toxicity was significantly reduced in the IMRT arm (21.1% vs. 42.4%; hazard ratio [HR], 0.46; 95% CI, 0.29 to 0.73; p<.001) as was the cumulative incidence of 3-year grade ≥3 late GI toxicity (2.9% vs. 15.5%; HR, 0.22; 95% CI, 0.08 to 0.59; p<.003). The cumulative incidence of grade ≥2 any late toxicity was also significantly reduced with IMRT (28.1% vs. 48.9%; HR, 0.50; 95% CI, 0.33 to 0.76; p<.001). Patients administered IMRT reported less diarrhea (p=.04), improvement in appetite (p=.008), and fewer bowel symptoms (p=.002) compared to those administered 3D-CRT. No differences in disease outcomes were noted between the RT techniques including 3-year pelvic relapse-free survival (p=.55) and disease-free survival (p=.89).
In the international, randomized, PORTEC-3 trial, Wortman et al evaluated whether IMRT compared to 3D-CRT resulted in fewer adverse events and patient-reported symptoms among 658 patients with high-risk endometrial cancer (Wortman, 2022). Of these patients, 559 received 3D-CRT and 99 received IMRT; median follow-up at the time of analysis was 74.6 months. Results revealed no significant differences in frequency and grades of adverse events between the RT techniques. There was an increase in grade ≥3 adverse events (mainly GI and hematologic) with 3D-CRT (37.7% vs. 26.3%; p=.03). During follow-up, significantly more grade ≥2 diarrhea (15.4% vs. 4%; p<.01) and grade ≥2 hematologic adverse events (26.1% vs. 13.1%; p<.01) were observed in patients administered 3D-CRT as compared to IMRT. More patients reported diarrhea (37.5% vs. 28.6%; p=0.125), bowel urgency (22.1% vs. 10%; p=.0039), and abdominal cramps (18.2% vs. 8.6%; p=.058) following 3D-CRT as compared to IMRT.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Kapoor et al conducted a prospective, randomized, single-center, phase 3 trial that compared hematologic and GI toxicities in patients with cervical cancer (Stage IB to IVA) treated with IMRT and 3D-CRT (Kapoor, 2023). A total of 80 patients were randomized 1:1 to receive either IMRT (n=40) or 3D-CRT (n=40). The median patient age was 56.5 years (range, 36 to 67) and 59.5 years (range, 37 to 68) in the IMRT and 3D-CRT groups, respectively. The median dose of external radiation was 50 Gy in 25 fractions, and of brachytherapy was 24 Gy in 3 fractions in both groups. All patients received concurrent chemotherapy with cisplatin; the median number of cycles was 5 (range, 3 to 5) in both groups. All 5 cycles of concurrent chemotherapy could be completed in 25 (62.5%) patients and 24 (60%) patients in the IMRT and 3D-CRT groups, respectively. The median overall treatment time was 57 days (range, 56 to 85) and 57.5 days (range, 49 to 88) in patients receiving IMRT and 3D-CRT, respectively. The incidence of neutropenia (grade 2 or higher) was 15% and 42.5% in the IMRT and 3D-CRT groups, respectively (p<.001). Diarrhea (grade 2 or higher) was observed in 42.5% of patients in the IMRT group compared to 90% of patients in the 3D-CRT group. The study found that IMRT also had a better dosimetry profile compared to 3D-CRT.
The NCCN guideline (v.1.2023) for hepatocellular carcinoma states that "All tumors irrespective of the location may be amenable to RT [radiation therapy] (3D conformal radiation therapy, intensity-modulated radiation therapy [IMRT], or stereotactic body radiation therapy [SBRT])" (NCCN, 2023). The NCCN guideline (v.2.2023) on biliary tract cancers also states that "all tumors irrespective of the location may be amenable to RT (3D-CRT, IMRT, or SBRT)" (NCCN, 2023).
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