Phase III Trial Comparing Whole-Pelvic Versus Prostate-Only Radiotherapy and Neoadjuvant Versus Adjuvant Combined Androgen Suppression: Radiation Therapy Oncology Group 9413

Roach, Mack; DeSilvio, Michelle; Lawton, C.A.; Uhl, Valery; Machtay, Mitchell; Seider, Michael J.; Rotman, Marvin; Jones, Christopher U.; Asbell, Sucha O.; Valicenti, Richard K.; Han, Sangwon; Thomas, Charles R.; Shipley, W.

doi:10.1200/jco.2003.05.004

Cited by 600 publications

(282 citation statements)

References 30 publications

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“…[17][18][19][20] In brief, all patients received treatment with external beam radiation using megavoltage linear accelerators (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18). In all three institutions, the prostate gland was boosted using two interstitial brachytherapy procedures.…”

Section: Radiation Techniquementioning

confidence: 99%

“…[1][2][3][4][5][6][7] As several randomized trials have shown a benefit in the treatment of prostate cancer with high-dose RT, the need for AD with the use of a high-dose technique needs to be evaluated. [8][9][10] AD when combined with low-dose radiation has been shown to be an effective adjuvant treatment and to improve overall survival for prostate cancer patients with high-risk features.…”

Section: Introductionmentioning

confidence: 99%

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High-dose radiation employing external beam radiotherapy and high-dose rate brachytherapy with and without neoadjuvant androgen deprivation for prostate cancer patients with intermediate- and high-risk features

Vargas

Martı́nez

Galalae

et al. 2006

Prostate Cancer Prostatic Dis

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The role of neoadjuvant androgen deprivation (NAD) in high-risk prostate cancer patients receiving high-dose radiotherapy (RT) remains unstudied. To evaluate the effect of a course of NAD, we reviewed the experiences of three institutions treating these patients with combined RT and high-dose rate brachytherapy (HDR). Of 1260 prostate cancer patients with high-risk features (pretreatment prostate-specific antigen (PSA) X10, Gleason Score (GS) X7, or T stage XT2b), 560 received no NAD (n ¼ 308) or NAD for p6 months (n ¼ 252). Median dose to the prostate from RT and HDR was 42 and 23 Gy, respectively. Average total biologic equivalent prostate dose was 4100 Gy (a/b ¼ 1.2). Median follow-up was 4.3 years. Pretreatment characteristics were similar on v 2 tables for all 560 patients treated with or without NAD including pretreatment PSA (P ¼ 0.11), GS (P ¼ 0.4), and clinical T stage (P ¼ 0.2). Outcomes worsened for patients receiving NAD (5-year distant metastasis (DM) 10 vs 5% (P ¼ 0.04); cause-specific survival (CSS), 93 vs 98% (P ¼ 0.005)).Higher 5-year DM rates and lower CSS occurred in NAD patients with a GS between 8 and 10 (n ¼ 112 (P ¼ 0.03, P ¼ 0.02)), pretreatment PSAX15 (n ¼ 136 (P ¼ 0.03, P ¼ 0.008)), and palpable disease XT2a (n ¼ 434 (P ¼ 0.04, P ¼ 0.02)). The only two significant risk factors for DM on Cox multivariate analysis were GS (P ¼ 0.003, HR 2.8) and NAD (P ¼ 0.03, HR 2.7). AD given before definitive high-dose RT did not benefit prostate cancer patients with intermediate-and high-risk features. We favor the use of concurrent/adjuvant AD over prolonged NAD for prostate cancer patients for whom AD is clinically indicated.

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Section: Radiation Techniquementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

High-dose radiation employing external beam radiotherapy and high-dose rate brachytherapy with and without neoadjuvant androgen deprivation for prostate cancer patients with intermediate- and high-risk features

Vargas

Martı́nez

Galalae

et al. 2006

Prostate Cancer Prostatic Dis

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“…1, 2). It is noteworthy that randomized studies comparing long-term and short-term hormone use (e.g., RTOG 92-02 9 ) and those comparing different sequences of radiotherapy and hormone use (e.g., RTOG 94-13 50 ) were not included in the current study, because our model only allowed the use of studies that compared radiotherapy alone with radiotherapy plus hormone therapy. Although the model could be expanded to include individual arms of these other studies, errors and biases would be introduced by doing so.…”

Section: Discussionmentioning

confidence: 99%

Hormone therapy adjuvant to external beam radiotherapy for locally advanced prostate carcinoma

Jani

Kao

Hellman

2003

Cancer

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BACKGROUNDHormone therapy commonly is used to treat metastatic, locally advanced, and localized prostate carcinoma. The objective of the current investigation was to determine, using the number‐needed‐to‐treat (NNT) method, the effect of using hormone therapy to treat locally advanced disease, with consideration given to both the complications and the known advantages associated with hormone therapy.METHODSA literature review was performed to determine 1) the absolute benefit, based on available clinical endpoints, associated with the addition of hormone therapy to external beam radiotherapy for locally advanced prostate carcinoma; 2) the incidence of side effects of short‐term and long‐term hormone therapy; and 3) the stepwise progression from biochemical failure to death. A model was constructed to estimate the complication/utility‐adjusted survival detriment resulting from the side effects of short‐term (≤ 6 months) and long‐term (> 6 months) hormone therapy, and the absolute/unadjusted and complication‐adjusted NNTs for the addition of short‐term and long‐term hormone therapy were computed. In all cases, the magnitudes and signs of the NNTs obtained were used to gauge the effect of hormone therapy.RESULTSThe unadjusted NNTs were positive and in most cases had relatively small magnitudes (the greater the NNT, the smaller the benefit) for both short‐term and long‐term hormone therapy; these results were expected, and they suggested that there is a strong benefit associated with the use of hormones adjuvant to radiotherapy for locally advanced disease. Adjusted NNTs remained positive and had relatively small magnitudes even after the introduction into the analysis of complications of short‐term and long‐term hormone therapy. This finding, although weak with respect to the effect of short‐term hormone therapy on cause‐specific survival, remained robust over the range of values for utility impairment expected from short‐term and long‐term hormone therapy.CONCLUSIONSThe benefits of short‐term and long‐term hormone therapy for locally advanced prostate carcinoma appear to be significant and to outweigh the associated side effects. Long‐term therapy appears to be better than short‐term therapy in terms of virtually all endpoints studied, even when the increased incidence of side effects is considered. The current investigation was successful in the use of the complication‐adjusted NNT method for oncologic and radiotherapeutic scenarios in which the results of randomized trials could be summarized, adjusted for treatment toxicity, and individualized to a given patient. Cancer 2003. © 2003 American Cancer Society.

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“…The results of the 2 main randomised trials evaluating whole pelvis versus prostate only EBRT are conflicting. RTOG 9413 compared whole pelvis versus prostate only EBRT and neo-adjuvant versus adjuvant combined ADT 49 . Patients with a risk of LNI >15% were included (n=1.323).…”

Section: Whole Pelvis Irradiation For Lymph Node Metastasized Pcmentioning

confidence: 99%

Developments in External Beam Radiotherapy for Prostate Cancer

Lumen

Ost

Praet

et al. 2013

Urology

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Phase III Trial Comparing Whole-Pelvic Versus Prostate-Only Radiotherapy and Neoadjuvant Versus Adjuvant Combined Androgen Suppression: Radiation Therapy Oncology Group 9413

Abstract: WP RT + NCHT improves PFS compared with PO RT and NCHT or PO RT and AHT, and compared with WP RT + AHT in patients with a risk of LN involvement of 15%.

Cited by 600 publications

References 30 publications

High-dose radiation employing external beam radiotherapy and high-dose rate brachytherapy with and without neoadjuvant androgen deprivation for prostate cancer patients with intermediate- and high-risk features

High-dose radiation employing external beam radiotherapy and high-dose rate brachytherapy with and without neoadjuvant androgen deprivation for prostate cancer patients with intermediate- and high-risk features

Hormone therapy adjuvant to external beam radiotherapy for locally advanced prostate carcinoma

Developments in External Beam Radiotherapy for Prostate Cancer

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