An Update of the Phase III Trial Comparing Whole Pelvic to Prostate Only Radiotherapy and Neoadjuvant to Adjuvant Total Androgen Suppression: Updated Analysis of RTOG 94-13, With Emphasis on Unexpected Hormone/Radiation Interactions

Lawton, Colleen A.; DeSilvio, Michelle; Roach, Mack; Uhl, Valery; Kirsch, R.; Seider, Michael J.; Rotman, Marvin; Jones, C. Darryl; Asbell, Sucha O.; Valicenti, Richard K.; Hahn, S.; Thomas, Charles R.

doi:10.1016/j.ijrobp.2007.04.003

Cited by 445 publications

(264 citation statements)

References 23 publications

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“…It also has been demonstrated that whole-pelvic radiation, compared with prostate-only radiation, also improves outcomes in patients who have a risk >15% of lymph node involvement. 23 Before enrollment in the current study, 48 patients were deemed at risk of lymph node involvement and underwent pelvic lymph node dissection; all were diagnosed as negative. Therefore, providing prostate-only radiation should not have disadvantaged those patients.…”

Section: Gastrointestinalmentioning

confidence: 99%

A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer

Donnelly

Saliken

Brasher

et al. 2009

Cancer

139

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BACKGROUND: Localized prostate cancer can be treated several different ways, but head-to-head comparisons of treatments are infrequent. The authors of this report conducted a randomized, unblinded, noninferiority trial to compare cryoablation with external beam radiotherapy in these patients. METHODS: From December 1997 through February 2003, 244 men with newly diagnosed localized prostate cancer were assigned randomly to receive either cryoablation or radiotherapy (122 men in each arm). All received neoadjuvant antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a trifecta definition: 1) radiologic evidence of metastatic disease, or 2) initiation of further antineoplastic therapy, or 3) biochemical failure. Two definitions of biochemical failure were used: 1) 2 consecutive rises in prostate-specific antigen (PSA) with a final value >1.0 ng/mL, and 2) a rise above PSA nadir þ 2 ng/mL. Secondary endpoints included overall survival, disease-specific survival, and prostate biopsy at 36 months. RESULTS: The median follow-up was 100 months. Disease progression at 36 months was observed in 23.9% (PSA nadir þ 2 ng/mL, 17.1%) of men in the cryoablation arm and in 23.7% (PSA nadir þ 2 ng/mL, 13.2%) of men in the radiotherapy arm. No difference in overall or disease-specific survival were observed. At 36 months, more patients in the radiotherapy arm had a cancer-positive biopsy (28.9%) compared with patients in the cryoablation arm (7.7%). CONCLUSIONS: The observed difference in disease progression at 36 months was small, 0.2%; however, because of the wide confidence interval, from À10.8% to 11.2%, it was not possible to rule out inferiority (defined a priori as a 10% difference). With longer term follow-up, the trend favors cryoablation. Significantly fewer positive biopsies were documented after cryoablation than after radiotherapy. Cancer 2010;116:323-30.

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Section: Gastrointestinalmentioning

confidence: 99%

A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer

Donnelly

Saliken

Brasher

et al. 2009

Cancer

139

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“…This trial was updated in 2007 and surprisingly, whole pelvis EBRT no longer had a significant better PFS compared to prostate only EBRT, although a trend in favor for the group whole pelvis EBRT combined with neo-adjuvant ADT remained. 50 It is noteworthy that late GI toxicity grade ≥ 3 was highest for whole pelvis EBRT with neo-adjuvant ADT compared to other subgroups (5% vs 1-2%). The GETUG-01 trial included 444 patients with T1b-T3, N0pNx, M0 PC randomly assigned to whole pelvis or prostate only EBRT.…”

Section: Whole Pelvis Irradiation For Lymph Node Metastasized Pcmentioning

confidence: 87%

Developments in External Beam Radiotherapy for Prostate Cancer

Lumen

Ost

Praet

et al. 2013

Urology

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“…A recently published update of the same study demonstrated statistically significant differences in toxicity between the four arms with the neoadjuvant hormone therapy and whole pelvis RT group having the highest rate of late GI toxicity (11). On the other had, a pooled analysis of the RTOG studies 85-31, 86-10 and 92-02 suggested a protective role for AD in terms of GI and GU toxicity (10).…”

Section: Discussionmentioning

confidence: 97%

“…Some studies have suggested that the addition of AD increases the risk of GI and GU toxicity while others have not (7,(9)(10)(11). At Fox Chase Cancer Center, our experience is that the addition of long-term AD (LTAD) significantly increases grade 2 and higher GI and GU toxicity with in patients treated with 3DCRT for locally advanced prostate cancer (9).…”

Section: Introductionmentioning

confidence: 99%

Intensity Modulated Radiation Therapy Reduces Gastrointestinal Morbidity in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer

Sharma

Chen

et al. 2007

International Journal of Radiation Oncology*Biology*Physics

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Purpose-Androgen deprivation therapy (AD) has been shown to increase late ≥ grade 2 rectal toxicity when used concurrently with three-dimensional conformal radiotherapy (3DCRT). Intensity modulated radiotherapy (IMRT) has the potential to reduce toxicity by limiting the radiation dose received by the bowel and bladder. This study compares both genitourinary (GU) and gastrointestinal (GI) toxicity in men treated with 3DCRT+AD versus IMRT+AD.Methods and Materials-From July 1992 to July 2004, 293 men received 3DCRT (n=170) or IMRT (n=123) with concurrent AD (< 6 months, n=123; ≥ 6 months, n =170). Median RT doses were 76 Gy for 3DCRT (ICRU) and 76 Gy for IMRT (95% to the PTV). Toxicity was assessed by a patient symptom questionnaire assessing toxicity completed at each visit and recorded using a modified late effects normal tissue task force radiation morbidity scale (LENT).Results-Mean follow-up was 86 months (SD=29.3) for the 3DCRT group and 40 months (SD=9.7) for the IMRT group. Acute GI toxicity (OR=4, 95% CI: 1.6-11.7, p=0.005) was significantly higher with 3DCRT than with IMRT and was independent of AD duration (i.e. <6 vs. ≥6 months). Time to development of late GI toxicity was significantly longer in the IMRT group. The 5-year Kaplan-Meier estimates for ≥ grade 2 GI toxicity were 20% for 3DCRT versus 8% for IMRT (p=0.01). On MVA, ≥ grade 2 late GI toxicity (HR=2.1, 95% CI: 1.1-4.3, p=0.04) was more prevalent in 3DCRT patients. 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. Conclusions-Compared to 3DCRT, IMRT significantly decreased acute and late GI toxicity in patients treated with AD. NIH Public Access

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An Update of the Phase III Trial Comparing Whole Pelvic to Prostate Only Radiotherapy and Neoadjuvant to Adjuvant Total Androgen Suppression: Updated Analysis of RTOG 94-13, With Emphasis on Unexpected Hormone/Radiation Interactions

Cited by 445 publications

References 23 publications

A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer

A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer

Developments in External Beam Radiotherapy for Prostate Cancer

Intensity Modulated Radiation Therapy Reduces Gastrointestinal Morbidity in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer

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