Interim report of toxicity from 3D conformal radiation therapy (3D-CRT) for prostate cancer on 3DOG/RTOG 9406, level III (79.2 gy)

Ryu, Janice; Winter, Kathryn; Michalski, Jeff M.; Purdy, James A.; Markoe, Arnold M.; Earle, John D.; Pérez, Carlos A.; Roach, Mack; Sandler, Howard M.; Pollack, Alan; Cox, James D.

doi:10.1016/s0360-3016(02)03006-7

Cited by 139 publications

(72 citation statements)

References 21 publications

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“…Our prior publications have demonstrated that treatment to doses as high as 79.2 Gy and 78 Gy in 1.8 Gy and 2.0 Gy fractions, respectively, resulted in lower than expected rates of ≥ grade 3 toxicities. [1][2][3][4] This is the first report of tumor control outcome in this series of patients. The overall survival, cause specific survival, and local failure rates are excellent and comparable to other modern series employing 3DCRT.…”

Section: Discussionmentioning

confidence: 62%

“…For quality assurance purposes, all participating institutions were required to register at least one patient to the first dose level of 68. 4 Gy minimum dose to the planning target volume in 1.8 Gy/day fractions. Once institution compliance to the protocol was established by the 3D QA Center (now Image Guided Therapy quality assurance Center, ITC), registration to higher dose levels was allowed.…”

Section: Methodsmentioning

confidence: 99%

“…We have previously reported and published results on treatment toxicity. [1][2][3][4] Three dose levels were initially planned, 68.4 Gy, 73.8 Gy, and 79.2 Gy. Because dose limiting toxicity was not identified in the first three dose levels, the study remained open to accrue patients to two additional dose levels, 74 Gy and 78 Gy.…”

Section: Introductionmentioning

confidence: 99%

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Clinical outcome of patients treated with 3D conformal radiation therapy 3D-CRT for prostate cancer on RTOG 9406

Michalski

Winter

Roach

et al. 2004

International Journal of Radiation OncologyBiologyPhysics

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Purpose-Report of clinical cancer control outcomes on RTOG 9406, a 3D conformal radiation therapy (3DCRT) dose escalation trial for localized adenocarcinoma of the prostate.Methods and Materials-RTOG 9406 is a Phase I/II multi-institutional dose escalation study of 3DCRT for men with localized prostate cancer. Patients were registered on five sequential dose levels: 68.4Gy, 73.8Gy, 79.2Gy, 74Gy and 78Gy with 1.8Gy/day (levels I through III) or 2.0Gy/ day (levels IV & V). Neoadjuvant hormone therapy (NHT) from 2 to 6 months was allowed. Protocol specific, ASTRO, and Phoenix biochemical failure definitions are reported. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Conflict of interest statement:Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute. No commercial products are described or endorsed by the authors. The authors have no relationship with organizations that would influence the results reported in this manuscript. NIH Public Access Author ManuscriptInt J Radiat Oncol Biol Phys. Author manuscript; available in PMC 2013 July 01. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author ManuscriptResults-Thirty-four institutions enrolled 1084 patients and 1051 patients are analyzable. Median follow-up for levels I, II, III, IV and V was 11.7, 10.4, 11.8, 10.4, and 9.2 years, respectively. Thirty-six percent of patients received NHT. The 5-year overall survival was 90%, 87%, 88%, 89%, and 88% for dose levels I-V. The 5-year clinical disease-free survival (excluding protocol PSA definition) for levels I-V is 84%, 78%, 81%, 82%, and 82%, respectively. By ASTRO definition, the 5-year disease-free survivals were 57%, 59%, 52%, 64% and 75% (low risk); 46%, 52%, 54%, 56%, and 63% (intermediate risk); and 50%, 34%, 46%, 34%, and 61% (high risk) for levels I-V, respectively. By the Phoenix definition, the 5-year disease-free survivals were 68%, 73%, 67%, 84%, and 80% (low risk); 70%, 62%, 70%, 74%, and 69% (intermediate risk); and 42%, 62%, 68%, 54%, and 67% (high risk) for levels I-V, respectively.Conclusion-Dose escalated 3DCRT yields favorable outcomes for localized prostate cancer. This multi-institutional experience allows comparison to other experiences with modern radiation therapy.

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Section: Discussionmentioning

confidence: 62%

Section: Methodsmentioning

confidence: 99%

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Clinical outcome of patients treated with 3D conformal radiation therapy 3D-CRT for prostate cancer on RTOG 9406

Michalski

Winter

Roach

et al. 2004

International Journal of Radiation OncologyBiologyPhysics

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“…Other HDR BT ( /100 Gy) papers report 2Á/8% grade 3 Á/4 late GU toxicity [10,15,21,36], while papers reporting toxicity after conformal EBRT dose escalation (74 Á/79 Gy) [16,18,32] indicate 1Á/9% grade 3Á/4 toxicity. The definition of the assessment point for late effects varies from 4 months to 24 months or more in these studies.…”

Section: Discussionmentioning

confidence: 99%

Combined curative radiotherapy including HDR brachytherapy and androgen deprivation in localized prostate cancer: A prospective assessment of acute and late treatment toxicity

et al. 2005

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Self-reported symptoms including urinary, bowel and sexual side effects were investigated prospectively at multiple assessment points before and after combined radiotherapy of prostate cancer including HDR brachytherapy and neoadjuvant androgen deprivation therapy. Between April 2000 and June 2003, patients with predominantly advanced localized prostate tumours subjected to this treatment were asked before treatment and on follow-up visits to complete a questionnaire covering urinary, bowel and sexual problems. The mainly descriptive analyses included 525 patients, responding to at least one questionnaire before or during the period 2 Á/34 months after radiotherapy. Adding androgen deprivation before radiotherapy significantly worsened sexual function. During radiotherapy, urinary, bowel and sexual problems increased and were reported at higher levels up to 34 months, although there seemed to be a general tendency to less pronounced irritative bowel and urinary tract symptoms over time. No side effects requiring surgery were reported. Classic late irradiation effects such as mucosal bleeding were demonstrated mainly during the second year after therapy, but appear less pronounced in comparison with dose escalated EBRT series. In conclusion, despite the high radiation dose given, the toxicity seemed comparable with that of other series but long term (5 Á/10 years) symptom outcome has to be determined.

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“…In fact, there is evidence that increased doses are associated with reduced risk of biochemical failure, distant metastasis and even overall survival. [14][15][16] Controversy exists if there is a benefit to irradiation of the pelvic lymph nodes with a total dose of about 45 Gy. A study conducted by the RTOG failed to show a benefit in treating lymph nodes and prostate compared to prostate alone in prostate cancer A2 and B tumors.…”

Section: Radiation or Surgery In Advanced Prostate Cancer R Kuefer Et Almentioning

confidence: 99%

Comparison of external radiation therapy vs radical prostatectomy in lymph node positive prostate cancer patients

Kuefer

Volkmer

Loeffler

et al. 2004

Prostate Cancer Prostatic Dis

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Introduction: Treatment options for lymph node positive prostate cancer are limited. We retrospectively compared patients who underwent external radiotherapy (ERT) to patients treated by radical prostatectomy (RPX). Materials and Methods: A total of 102 lymph node positive patients from the RPX series at Ulm University were evaluated. In all, 76 patients received adjuvant androgen withdrawal as part of their primary treatment. In the ERT group, 44 patients were treated at the University of Michigan using a fractionated regimen. Of these, 21 patients received early adjuvant hormonal therapy. Patients with neoadjuvant therapy before RPX or ERT were excluded. Results: In the RPX group, PSA nadir (nadirp0.2 vs 40.2 ng/ml) showed a strong association with outcome. In the ERT group, pretreatment PSA was an independent predictor of outcome (P ¼ 0.04) and patients with adjuvant hormonal therapy had a significant longer recurrence-free interval compared to patients without adjuvant therapy (P ¼ 0.004). Comparing only patients with adjuvant hormonal treatment after cancer-specific therapy, the ERT-treated patients had a borderline longer PSA recurrence-free survival time compared to the RPX-treated patients (P ¼ 0.05). Conclusions: In case of positive lymph nodes, RPX and ERT might be considered and need to be explained to the patient. For future treatment decisions, the presented findings and a potential survival benefit need to be evaluated in a larger prospective setting.

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Interim report of toxicity from 3D conformal radiation therapy (3D-CRT) for prostate cancer on 3DOG/RTOG 9406, level III (79.2 gy)

Cited by 139 publications

References 21 publications

Clinical outcome of patients treated with 3D conformal radiation therapy 3D-CRT for prostate cancer on RTOG 9406

Clinical outcome of patients treated with 3D conformal radiation therapy 3D-CRT for prostate cancer on RTOG 9406

Combined curative radiotherapy including HDR brachytherapy and androgen deprivation in localized prostate cancer: A prospective assessment of acute and late treatment toxicity

Comparison of external radiation therapy vs radical prostatectomy in lymph node positive prostate cancer patients

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