Hypofractionated Postoperative IMRT in Prostate Carcinoma: A Phase I/II Study

Macchia, G.; Siepe, G.; Capocaccia, Ilaria; Nguyen, Nam P.; Schiavina, Riccardo; Cammelli, S.; Guerri, Sara; Arcelli, A.; Buwenge, M.; Ntreta, M.; Cilla, Savino; Valentini, Vincenzo; Deodato, Francesco; Morganti, Alessio Giuseppe

doi:10.21873/anticanres.12025

Cited by 9 publications

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“…A higher rate of grade ≥2 genitourinary side effects was found in the adjuvant setting than in the salvage group (17.1% vs 9.8%). Macchia et al [35] reported the outcomes of using hypofractionated radiotherapy delivered with a simultaneous integrated boost after prostatectomy, with biochemical control and acute and late toxicity rates comparable with traditional treatment schemes.…”

Section: Evidence Synthesismentioning

confidence: 99%

Hypofractionated Postoperative Radiotherapy for Prostate Cancer: Is the Field Ready Yet?

Mahase

Nagar

2020

European Urology Open Science

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Context Radiotherapy (RT) is a valid adjuvant treatment for men with high-risk pathological features after radical prostatectomy and a salvage treatment for biochemical recurrence. A major inconvenience is that RT takes course over 7–8 wk in these settings, which has been shown to limit its use. Retrospective and pilot prospective investigations suggest that hypofractionation may provide noninferior outcomes but report variable results regarding toxicities. Additionally, our evolving understanding of prostate cancer radiobiology suggests that hypofractionated regimens may not increase toxicity. Objective We examine and review the rationale and clinical evidence of hypofractionated RT in the adjuvant and salvage settings for prostate cancer. Evidence acquisition We reviewed relevant literature, with a particular focus on recent studies employing hypofractionated RT. Evidence synthesis Hypofractionated RT in the adjuvant or salvage setting is not a standard option for prostate cancer RT outside of an investigational trial. While smaller studies show conflicting data regarding toxicity, initial evidence from larger clinical trials appears to demonstrate that hypofractionated postoperative RT is as effective and safe as conventionally fractionated courses. Conclusions With the growing acceptance of hypofractionation across other cancer sites and the rise of extreme hypofractionation for definitive prostate cancer treatment, hypofractionated postoperative therapy for prostate cancer is poised to become an option, as it may reduce the burden on men and treatment centers while maintaining clinical efficacy and safety. Prospective trials are currently ongoing to address efficacy and safety concerns. Patient summary Postoperative radiotherapy is a potentially curative treatment for patients with high-risk disease or recurrence after surgery. Shortening of the treatment regimen with the availability of modern treatment delivery techniques in conjunction with the integration of molecular imaging information to refine treatment volumes may improve therapeutic benefit without increasing toxicity.

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Section: Evidence Synthesismentioning

confidence: 99%

Hypofractionated Postoperative Radiotherapy for Prostate Cancer: Is the Field Ready Yet?

Mahase

Nagar

2020

European Urology Open Science

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“…Cuccia et al reported a 3-year bPFS of 73% in 75 patients treated with salvage or adjuvant aims, but the prescribed dose (63.8 Gy in 2.2-Gy fractions; EQD2, 67.45 Gy) was relatively low compared with those used in other HRT studies [ 32 ]. The phase I/II study by Macchia et al used RT with the 62.5 Gy in 2.5-Gy fractions scheme (EQD2 = 71.43 Gy) and reported a 5-year bPFS of 86.5% [ 28 ]. However, the study included a relatively small number of patients receiving RT with a salvage aim (18 of 124 patients).…”

Section: Discussionmentioning

confidence: 99%

“…Genitourinary (GU) and GI toxicities are considered to be key obstacles to the administration of HRT for prostate cancer in the postoperative setting. Although different toxicity scoring systems used in previous studies have made it difficult to assess the safety of HRT in the postoperative setting, most have demonstrated a tolerable toxicity profile [ 26 – 28 , 30 , 31 , 33 – 36 ]. Kruser et al (65 Gy in 2.5-Gy fractions) reported low rates of toxicity (one acute grade 3 GU toxicity, no acute grade 3 GI toxicities, and no late grade 3 toxicities) in 108 salvage RT patients [ 33 ].…”

Section: Discussionmentioning

confidence: 99%

“…Alongi et al reported no toxicities ≥ grade 3 in 39 patients who received RT with a median dose of 70 Gy in 2.5-Gy fractions [ 35 ]. A single acute grade 4 GU toxicity event was reported by Macchia et al (62.5 Gy in 2.5-Gy fractions) [ 28 ]. In the Lewis et al study, toxicity events > grade 3 were unusual in patients with a median dose of 65 Gy in 2.5-Gy fractions, although a relatively high rate of late GU toxicity was seen, noting a 4-year actuarial rate of late grade 3 GU toxicity of 28%, which was exclusively gross hematuria [ 31 ].…”

Section: Discussionmentioning

confidence: 99%

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Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial

Park

Kim

Ahn

et al. 2021

Trials

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Background While several phase III trials have investigated the role of hypofractionated radiotherapy in the definitive treatment of localized prostate cancer, prospective data reporting the outcomes of hypofractionated radiotherapy in the postoperative treatment setting are sparse. Therefore, this study is designed to assess the efficacy and treatment-related toxicity of hypofractionated salvage radiotherapy for the treatment of biochemical recurrence in men who underwent radical prostatectomy. The primary objective of this trial is to investigate whether hypofractionated radiotherapy improves biochemical control compared with conventionally fractionated radiotherapy. In addition, treatment-related toxicity, quality of life, and survival will be evaluated as secondary endpoints. Methods In this prospective, randomized, multi-institutional trial (the SHARE study), patients with intermediate- or high-risk prostate cancer will be randomized to receive either hypofractionated radiotherapy (65 Gy in 2.5-Gy fractions) or conventionally fractionated radiotherapy (66 Gy in 2-Gy fractions). Prostate bed irradiation or elective pelvic nodal irradiation including the prostate bed will be performed using intensity-modulated radiotherapy and daily image guidance. Treatment efficacy will be assessed using the serum tumor marker prostate-specific antigen, and toxicity will be evaluated through both physician- and patient-reported outcomes. Quality of life will also be investigated. Discussion This study is designed to demonstrate whether hypofractionated radiotherapy is beneficial in terms of biochemical control and toxicity compared with standard salvage radiotherapy. If hypofractionated radiotherapy is shown to be superior to conventionally fractionated radiotherapy, it will mean that improved biochemical control can be achieved, accompanied by greater patient convenience and more efficient use of medical resources. Trial registration ClinicalTrials.gov NCT03920033. Registered on 18 April 2019

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“…More recently, the same RT schedule was evaluated by Macchia et al 29 who published data about 124 patients using SIB-IMRT technique with concurrent hormonal therapy; with a median follow-up of 30 months, the authors observed one case of acute G4 urinary adverse event, and 5-year GI and GU toxicity rates of 1.1% and 7.3%, respectively; therefore, they also collected very promising results in terms of biochemical control, with 2- and 3-year bRFS rates of 96.5% and 91.1%, respectively, remarking the role of IMRT in improving the radiobiological effectiveness of treatment and assuring an excellent OARs sparing.…”

Section: Discussionmentioning

confidence: 99%

Hypofractionated postoperative helical tomotherapy in prostate cancer: a mono-institutional report of toxicity and clinical outcomes

Cuccia

Mortellaro²,

Serretta

et al. 2018

CMAR

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PurposeThis is a mono-institutional study of acute and late toxicities and early biochemical control of a retrospective series of 75 prostate cancer patients treated with moderate postoperative hypofractionation delivered by helical tomotherapy (HT).Patients and methodsFrom April 2013 to June 2017, 75 patients received adjuvant (n=37) or salvage (n=38) treatment, delivering to prostate bed a total dose of 63.8 Gy (equivalent dose in 2-Gy fractions=67.4 Gy) using 2.2 Gy fractions. Whole-pelvis irradiation was performed in 63% of cases (median dose, 49.3 Gy; range, 48–55.1 Gy). Concurrent hormonal therapy was administered in 46% of cases. Common Terminology Criteria for Adverse Events (version 4.0) was adopted for acute and late genitourinary (GU) and gastrointestinal (GI) toxicity evaluations. Biochemical progression was defined as PSA level increase of ≥0.2 or more above the postoperative radiotherapy (RT) nadir.ResultsAcute GU toxicities were as follows: G1 in 46% and G2 in 4%, detecting no G≥3 events. For GI toxicity, we recorded G1 in 36% and G2 in 18%. With a median follow-up of 30 months (range, 12–58 months), we found late toxicity G2 GI in 6.6% and G≥2 GU in 5.3%, including two patients who underwent surgical incontinence correction. Acute GI≥2 toxicity and diabetes were found to be predictive of late GI≥2 toxicity (P=0.04 and P=0.0019). Actuarial 2- and 3-year biochemical recurrence-free survivals were 88% and 73%, respectively, for the entire population.ConclusionIn our experience, moderate hypofractionated postoperative RT with HT was feasible and safe, with reports of low incidence of toxicity and promising biochemical control rates.

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Hypofractionated Postoperative IMRT in Prostate Carcinoma: A Phase I/II Study

Abstract: After RP, hypofractionated IMRT-SIB demonstrated a favorable toxicity profile and encouraging results in terms of relapse-free survival.

Cited by 9 publications

References 0 publications

Hypofractionated Postoperative Radiotherapy for Prostate Cancer: Is the Field Ready Yet?

Hypofractionated Postoperative Radiotherapy for Prostate Cancer: Is the Field Ready Yet?

Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial

Hypofractionated postoperative helical tomotherapy in prostate cancer: a mono-institutional report of toxicity and clinical outcomes

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