Acute Toxicity and Quality of Life After Dose-Intensified Salvage Radiation Therapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: First Results of the Randomized Trial SAKK 09/10

Ghadjar, Pirus; Hayoz, Stefanie; Bernhard, Jürg; Zwahlen, Daniel R.; Hölscher, Tobias; Gut, Philipp; Gückenberger, Matthias; Hildebrandt, Guido; Müller, Arndt-Christian; Plaßwilm, Ludwig; Papachristofilou, Alexandros; Stalder, Lukas; Biaggi-Rudolf, Christine; Sumila, Marcin; Kranzbühler, Helmut; Najafi, Yousef; Ost, Piet; Azinwi, N.C.; Reuter, Christiane; Bodis, Stephan; Khanfir, Kaouthar; Wust, Peter; Thalmann, George N.; Aebersold, Daniel M.

doi:10.1200/jco.2015.63.3529

Cited by 98 publications

(57 citation statements)

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“…The results of acute toxicities and urinary continence recovery have been reported. 9,10 The incidence of acute grade 2 and 3 GU toxicity in the 64 Gy group was 13.0% and 0.6%, respectively, and those in the 70 Gy group were 16.6% and 1.7%. The acute grade 2 and 3 GI toxicity in the 64 Gy group was 16.0% and 0.6%, respectively, and those in the 70 Gy group were 15.4% and 2.3%.…”

Section: Discussionmentioning

confidence: 96%

“…A randomized controlled trial (RCT) on postoperative RT reported no difference in the incidence of acute toxicities between dose-intensified regimen (70 Gy) and the conventional dose regimen (64 Gy) using 3-dimensional conformal RT (3D-CRT) or intensity modulated radiation therapy (IMRT) (the Swiss SAKK 09/10 study). 9,10 However, to the best of our understanding, there is no report from a prospective study comparing survival outcomes or toxicities between standard doses (66 Gy in 33 fractions) and intensified doses (72 Gy in 36 fractions) using IGRT technology.…”

Section: Introductionmentioning

confidence: 99%

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Toxicity and Biochemical Outcomes of Dose-Intensified Postoperative Radiation Therapy for Prostate Cancer: Results of a Randomized Phase III Trial

Gao

et al. 2020

International Journal of Radiation Oncology*Biology*Physics

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Purpose: Our purpose was to compare toxicity and biochemical control in postprostatectomy patients treated with conventional (66 Gy) or dose-intensified (72 Gy) radiation therapy. Methods and Materials: Patients who had stage pT3-4, positive surgical margins, or rising prostate-specific antigen 0.2 ng/mL after radical prostatectomy were randomly assigned to receive either 66 Gy in 33 fractions or 72 Gy in 36 fractions. A primary endpoint was to assess the difference in biochemical progression-free survival (bPFS) between these 2 cohorts, and secondary endpoints were to assess differences in genitourinary (GU), gastrointestinal (GI), and hematologic toxicities between these 2 cohorts. bPFS was estimated by the KaplaneMeier method and toxicities were compared using the c 2 test.Results: Between September 2011 and November 2016, 144 patients were enrolled: 71 patients to the 66 Gy cohort and 73 patients to the 72 Gy cohort. The median follow-up time was 48.5 months (range, 14-79 months). There was no difference in 4-year bPFS between the 66 Gy and 72 Gy cohorts (75.9% vs 82.6%; P Z .299). However, in patients with a higher Gleason score (8-10), the 72 Gy cohort had statistically significant improvement in bPFS compared with the 66 Gy cohort (79.7% vs 55.7%; P Z .049). Toxicity analysis showed no difference in 2 acute or late GI or GU toxicities between these 2 cohorts. A total of 48 patients were scored as urinary incontinence before radiation therapy, of which 39 (81.3%) reported incontinence recovery or stable at 1-year follow-up, and only 9 (18.8%) patients reported worsening. There was no difference between the 2 cohorts in urinary incontinence either at baseline or at 1-year follow-up.Conclusions: Dose escalation (72 Gy) demonstrated no improvement in 4-year bPFS compared with the 66 Gy regimen. However, the dose escalation was not associated with greater acute or late GU or GI toxicities and did not increase urinary incontinence. Ó 2019 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Volume 106 Number 2 2020Postoperative RT for prostate cancer 283Abbreviations: ART Z adjuvant radiation therapy; ISUP Z International Society of Urologic Pathology; PSA Z prostate-specific antigen; PUFH Z Peking University First Hospital; RP Z radical prostatectomy; RT Z radiation therapy; SRT Z salvage radiation therapy; WPRT Z whole pelvic radiation therapy. Note: P values were calculated by Mann-Whitney U test or c 2 test where appropriate.

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Section: Discussionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

Toxicity and Biochemical Outcomes of Dose-Intensified Postoperative Radiation Therapy for Prostate Cancer: Results of a Randomized Phase III Trial

Gao

et al. 2020

International Journal of Radiation Oncology*Biology*Physics

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“…Thus, our finding was in line with the results of this population-based study in which higher doses were associated with GU toxicity. The long-term efficacy and toxicity of dose-escalated SRT should be evaluated in a randomized control trial (RCT) 36 .…”

Section: Discussionmentioning

confidence: 99%

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy

Tomita

Uchiyama

Mizuno

et al. 2020

Sci Rep

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The safety and efficacy of dose-escalated radiotherapy with intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) remain unclear in salvage radiotherapy (SRT) after radical prostatectomy. We examined the impact of these advanced radiotherapy techniques and dose intensification on the toxicity of SRT. This multi-institutional retrospective study included 421 patients who underwent SRT at the median dose of 66 Gy in 2-Gy fractions. IMRT and IGRT were used for 225 (53%) and 321 (76%) patients, respectively. At the median follow-up of 50 months, the cumulative incidence of late grade 2 or higher gastrointestinal (GI) and genitourinary (GU) toxicities was 4.8% and 24%, respectively. Multivariate analysis revealed that the non-use of either IMRT or IGRT, or both (hazard ratio [HR] 3.1, 95% confidence interval [CI] 1.8-5.4, p < 0.001) and use of whole-pelvic radiotherapy (HR 7.6, CI 1.0-56, p = 0.048) were associated with late GI toxicity, whereas a higher dose ≥68 Gy was the only factor associated with GU toxicities (HR 3.1, CI 1.3-7.4, p = 0.012). This study suggested that the incidence of GI toxicities can be reduced by IMRT and IGRT in SRT, whereas dose intensification may increase GU toxicity even with these advanced techniques.Prostate cancer patients with biochemical recurrence (BCR) after radical prostatectomy (RP) have a risk of metastasis and cancer death 1 . Approximately 30% of patients with an adverse feature, such as high Gleason score, develop BCR after RP 2 . Salvage radiotherapy (SRT) is the only curative option for these patients 3,4 . The target volume of SRT is the prostate bed with or without the seminal vesicle 5 , which is situated precisely between the bladder and rectum. In a dosimetric study using consensus guidelines for target volume delineations of SRT, intensity-modulated radiation therapy (IMRT) enabled dose increase within acceptable dose constraints of the organs at risk (OARs) such as the bladder and rectum 6 . Regarding definitive radiotherapy (RT) without RP, the ratio of IMRT markedly increased in the 2000s 7 due to benefits of high-dose prescription 8 . As systematic reviews and meta-analyses revealed that dose escalation improved biochemical control even in SRT 9,10 , dose escalation with IMRT has been employed for patients with BCR after RP [11][12][13] . However, dose-escalated RT, even with the IMRT technique, may increase toxicity. Image-guided radiation therapy (IGRT) enables more accurate setup by computed tomography (CT) immediately before treatment. IGRT is also one of the recent advanced RT techniques, as is IMRT, and is used more commonly with IMRT. However, the safety and efficacy of dose-escalated RT with IMRT and IGRT remain unclear. In addition, whether IMRT and IGRT reduce toxicity in SRT is still unknown. Thus, we examined the impact of advanced RT techniques and dose intensification on the toxicity of SRT after RP. Methods patient selection. We identified 421 patients who received SRT for BCR after RP between 2005 and 2017 at 15 institutions....

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“…Between February 2011 and April 2014, 350 patients were enrolled in an international phase III randomized controlled trial (Swiss Group for Clinical Cancer Research [SAKK] 09/10) on dose‐intensified (70 Gy over 7 weeks) vs standard‐dose (64 Gy over 6.4 weeks) salvage RT. These patients had biochemically relapsed prostate cancer without macroscopic disease, as previously described . The trial was conducted in 28 hospitals (14 in Switzerland, 11 in Germany and three in Belgium).…”

Section: Methodsmentioning

confidence: 99%

Importance and outcome relevance of central pathology review in prostatectomy specimens: data from the SAKK 09/10 randomized trial on prostate cancer

et al. 2017

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Acute Toxicity and Quality of Life After Dose-Intensified Salvage Radiation Therapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: First Results of the Randomized Trial SAKK 09/10

Abstract: Dose-intensified SRT was associated with low rates of acute grade 2 and 3 GU and GI toxicity. The impact of dose-intensified SRT on QoL was minor, except for a significantly greater worsening in urinary symptoms.

Cited by 98 publications

References 27 publications

Toxicity and Biochemical Outcomes of Dose-Intensified Postoperative Radiation Therapy for Prostate Cancer: Results of a Randomized Phase III Trial

Toxicity and Biochemical Outcomes of Dose-Intensified Postoperative Radiation Therapy for Prostate Cancer: Results of a Randomized Phase III Trial

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy

Importance and outcome relevance of central pathology review in prostatectomy specimens: data from the SAKK 09/10 randomized trial on prostate cancer

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