Demanes, DJ

Hayes, J

Rogers, L

Rogers, Leland

Hayes, John

Demanes, D Jeffrey

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UCLAUCLA Previously Published WorksTitleA critical ACR Appropriateness Criteria omissionPermalinkhttps://escholarship.org/uc/item/1q8876czJournalBRACHYTHERAPY, 13(5)ISSN1538-4721AuthorsRogers, LelandHayes, JohnDemanes, D JeffreyPublication Date2014DOI10.1016/j.brachy.2014.05.002 Peer reviewedeScholarship.org Powered by the California Digital LibraryUniversity of CaliforniaBrachytherapy 13 (2014) 522e528Letters to the EditorA critical ACR AppropriatenessCriteria omissionAn ACR panel (Hsu et al. (1)) recently published Appro-priateness Criteria for high-dose-rate (HDR) brachytherapyof prostate cancer. With all due respect to the committee,we believe that there has been a significant oversight thatrequires comment, especially with regard to HDR brachy-therapy as monotherapy. We acknowledge that there are avariety of acceptable ultrahypofractionated (one to threefractions) regimens, but there are yet no randomized com-parisons. As a matter of fact, the four to six or more fractionregimens have an excellent safety profile, have much longerfollow-up, and should be considered the standard againstwhich the new programs are measured. However, theAppropriateness Criteria document appears to have dis-counted this approach altogether. The authors statecorrectly that ‘‘further exploration of hypofractionation isneeded to determine a way to lower the number of frac-tions’’ and comment further that ‘‘future studies are likelyto continue to push toward fewer highly hypofractionatedtreatments.’’We agree that identifying the optimal dosing regimenshould be the objective of comparative studies and cooper-ative group efforts and that abbreviating hospital stay, thenumber of implant procedures, and the number of brachy-therapy fractions are meritorious, so long as they areaccomplished without compromising tumor control or lateeffects.The ACR panel omitted altogether the largest single-institution series of HDR monotherapy, published in theJournal of Urology in 2012 (2). This study described284 patients with intermediate-risk prostate cancer treatedwith HDR monotherapy using six fractions of 6.5 Gy. The5-year results with this approach have set a high standard.Cause-specific survival and clinical local control (LC)were 100%, and distant metastasis-free survival was98.8%. Five-year biochemical disease-free survival was94.4% for the entire cohort and 97.5% excluding the mi-nority of cases with clinical stage T2c tumors or O75%positive biopsy cores. The toxicity was also favorable. In-ternational Prostate Symptom Scores remained stable overthe entire follow-up range of 2e8 years. There were nourethral strictures, and potency preservation was 83%. Ra-diation Therapy Oncology Group (RTOG) Grade I rectaltoxicity was 4.2%, and there were 0% G2eG4 (2).Our intent with this editorial is to draw attention to thebody of evidence that supports six-fraction monotherapy.1538-4721/$ - see front matter  2014 American Brachytherapy Society. Publishttp://dx.doi.org/10.1016/j.brachy.2014.05.002The ACR panel referenced the large two-institution seriesby Demanes et al. but seemed to ignore more than halfof the patients’ data. There 298 patients treated withHDR monotherapy for either low-risk or low-intermediate-risk disease. Two HDR regimens were used:7 Gy  6 or 9.5 Gy  4. For this favorable disease cohort,8-year biochemical disease-free survival was 97% and 8-year LC, distant metastasis-free survival, and cause-specific survival each 99% (3). The authors did not directlycompare outcomes between the two regimens, but theirexcellent results validate a six-fraction regimen.The ACR guidelines also omitted several significantadditional studies reporting treatment results with six ormore fractions (Table 1). Yoshioka et al. (4) published a se-ries of 112 patients (68 high risk) treated with nine fractionsof HDR monotherapy in 2011. The 5-year prostate-specificantigen (PSA) control by risk group was 85% (low risk),93% (intermediate risk), and 79% (high risk). LC was97%, disease-free survival 87%, and overall survival96%. Toxicity rates were low. Komiya and colleagues (5)evaluated quality of life in 51 patients treated with45.5 Gy in seven fractions. Quality of life outcome scoresfor physical and well-being and sexual function recoveredto baseline status by 12 weeks and social/family well-being by 1 year. There were few severe complications.Mark et al. (6) reported 8-year results in 301 patientstreated with HDR monotherapy as 7 Gy  6 fractions intwo implants. PSA progression-free survival was 88%,and toxicity rates were low.Although the one- to three-fraction regimens are conve-nient and therefore appealing, long-term (O5 years) out-comes and toxicity are not yet available, and there isbasis for concern. Sullivan and coauthors evaluated 474 pa-tients for urethral stricture risk with varying HDR boostfraction schedules as low as 4 Gy  4 or 6.5 Gy  3 upto HDR monotherapy regimens of 11 Gy  3, with manyintervening fraction sizes. The strongest predictor of ure-thral stricture was HDR brachytherapy dose per fraction.In multivariate analysis, the hazard ratio for urethral stric-ture was 1.33 per Gy of HDR fraction size (7). Urethralstrictures are, needless to say, an important toxicity toavoid.The American Brachytherapy Society published aguideline for HDR prostate brachytherapy in 2012 andclearly acknowledged the validity of six fractions of6.5e7.25 Gy in the monotherapy setting, as well as recog-nizing the use of more rapid schedules, such as 9.5 Gy  4or 10.5 Gy  3 (8). For the American Brachytherapy Soci-ety review, the two reports with the largest number ofhed by Elsevier Inc. All rights reserved.Table 1HDR monotherapy outcome studies using six or more fractionsStudy N Risk Dose  Fx PSAePFS (%) LC (%) CSS (%) FUdyearsDemanes et al. (3) 157 Loweintermediate 7 Gy  6 97 99 99 5.2Komiya et al. (5) 51 All 6.5 Gy  7 96 n/a n/a 1.5Mark et al. (6) 317 All 7 Gy  6 88 n/a n/a 8Rogers et al. (2) 284 Intermediate 6.5 Gy  6 95 100 100 3Yoshioka et al. (4) 111 Intermediateehigh 6 Gy  9 79e93 97 87 5.46.5 Gy  7HDR 5 high-dose rate; LC 5 local control; CSS 5 cause-specific survival; PFS 5 progression-free survival; FU 5 follow-up.523Letters to the Editor / Brachytherapy 13 (2014) 522e528patients used six-fraction regimens with 6.5e7 Gy per frac-tion, whereas the next largest experience used four fractionsof 9.5 Gy (8).Although we support the concept of embracing themost convenient and cost-effective treatment, we do notbelieve that one- to three-fraction regimes have been es-tablished as the HDR treatment of choice at the exclusionof an established six-fraction option. By analogy, onemight assert that stereotactic body radiation therapyshould now be considered the external radiotherapy treat-ment of choice, at the exclusion of the lower dose perfraction and lengthier course intensity-modulated radia-tion therapy alternative. The proximity of the prostateto critical organs related to bowel, urinary, and sexualfunction and the excellent outcomes achieved in each ofthese respects with a six-fraction HDR regimen (2, 3)must give us pause to consider the potential for worsenedlong-term effects with more rapid fractionation. Opti-mally randomized trials should be done to compare pro-grams but, at a minimum, Appropriateness Criteriapublications should not ignore the data. We believe thatthe six-fraction regimens should have been listed in ta-ble 2 of the publication.With a combined experience exceeding 2 decades, hav-ing treated more than 6000 men with prostate cancer usingHDR brachytherapy and more than 1500 men with six-fraction HDR monotherapy, it is not unreasonable to expectit be included as a viable and standard treatment option insuch an important document. We respectfully request thatthe ACR publish a short note acknowledging the omissionand the validity of our request.Leland Rogers, MD, FACROJohn Hayes, MD, MSGammaWest Cancer ServicesSalt Lake City, UTD. Jeffrey Demanes, MD, FACRO, FACR, FASTROUCLA Health System, Department of Radiation OncologyLos Angeles, CAReferences[1] Hsu ICJ, Yamada Y, Assimos DG, et al. ACR AppropriatenessCriteria high-dose-rate brachytherapy for prostate cancer. Brachy-therapy 2014;13:27e31.[2] Rogers CL, Alder SC, Rogers RL, et al. High dose rate brachytherapyas monotherapy for intermediate risk prostate cancer. J Urol 2012;187:109e116.[3] Demanes JD, Martinez AA, Ghilezan M, et al. High-dose-rate mono-therapy: Safe and effective brachytherapy for patients with localizedprostate cancer. Int J Radiat Oncol Biol Phys 2011;81:1286e1292.[4] Yoshioka Y, Konishi K, Sumida I, et al. Monotherapeutic high-dose-rate brachytherapy for prostate cancer: Five-year results of anextreme hypofractionation regimen with 54 Gy in nine fractions.Int J Radiat Oncol Biol Phys 2011;80:469e475.[5] Komiya A, Fujiuchi Y, Ito T, et al. Early quality of life outcomes inpatients with prostate cancer managed by high-dose-rate brachyther-apy as monotherapy. Int J Urol 2013;20:185e192.[6] Mark RJ, Anderson PJ, Akins RS, et al. Interstitial high-dose-ratebrachytherapy as monotherapy for early stage prostate cancer:Median 8-year results in 301 patients. Brachytherapy 2010;9(suppl 1):S76.[7] Sullivan L, Williams SG, Tai KH, et al. Urethral stricture followinghigh dose rate brachytherapy for prostate cancer. Radiother Oncol2009;91:232e236.[8] Yomada Y, Rogers L, Demanes DJ, et al. American BrachytherapySociety consensus guidelines for HDR prostate brachytherapy.Brachytherapy 2012;11:20e32.Response to Drs Rogers, Hayes,and DemanesThe American College of Radiology AppropriatenessCriteria Panel would like to thank Drs Rogers, Hayes,and Demanes for their thoughtful and comprehensive com-ments and their interest in our work on high-dose-rate(HDR) brachytherapy.The American College of Radiology guidelines are basedon a comprehensive review of the published data available tothe panel. They included all the published data on HDRmonotherapy that used more than four fractions, includingYoshioka et al. (6 Gy  9) (1, 2). At the time of review,the largest published HDR monotherapy series was by De-manes et al.(3), published in 2011. This was a combinedreport from two institutions; one used 9.5 Gy  4 and theother used 7 Gy  6. This study was included in the review.However, the more recent articles by Rogers et al. (4) in2012 and Komiya et al. (5) in 2013 were not available atthe time of the review and therefore were not included.We designed the HDR monotherapy variant based on thelevel of evidence presented. Published full-length articles

A critical ACR Appropriateness Criteria omission

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