Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial

Tree, A.; Ostler, Peter; Voet, H. van der; Chu, William; Loblaw, Andrew; Ford, Daniel; Tolan, Shaun; Jain, Suneil; Martin, Alexander S.; Staffurth, John; Armstrong, John G.; Camilleri, Philip; Kancherla, Kiran; Frew, J.; Chan, Andrew; Dayes, Ian S.; Duffton, A.; Brand, D.; Henderson, Daniel R.; Morrison, Kirsty; Brown, Stephanie; Pugh, Julia; Burnett, Stephanie M.; Mahmud, Muneeb; Hinder, Victoria; Naismith, O.; Hall, Emma; As, Nicholas van; Lartigau, Éric; Patton, Suzanne E.; Thompson, Alan; Wells, Paula; Lymberiou, Timothy; Saunders, Deanna; Vilarino-Varela, Maria; Vavassis, Peter; Tsakiridis, Theodoros; Carlson, R; Rodrigues, George; Tanguay, Jean François; Iqbal, Shahid; Winkler, Mathias; Morgan, Scott C.; Mihai, Alina; Li, A; Din, Omar; Wade, Ros; Rimmer, Y.; Panades, Miguel; Oommen, Nikhil Babu

doi:10.1016/s1470-2045(22)00517-4

Cited by 151 publications

(94 citation statements)

References 24 publications

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“…Our results argue on a favorable role of SBRT on the immune response, and support SBRT as the treatment choice for both localized 7 , 39 and oligometastatic PCa. 40 In the framework of this treatment with logistic convenience, shorter treatment time and equivalent efficacy compared to conventional RT, 7 the identification of immunological advantages may be of great impact for both patients and physicians.…”

Section: Discussionsupporting

confidence: 70%

Stereotactic Ablative Radiation Therapy in 3 Fractions Induces a Favorable Systemic Immune Cell Profiling in Prostate Cancer Patients

Palermo¹,

Bottero

Panetta³

et al. 2023

OncoImmunology

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The impact of radiotherapy (RT) on immune cell status in prostate cancer (PCa) is only partially determined. The aim of this study was to assess the effect of different RT strategies on peripheral B, T, and Natural killer (NK) lymphocytes at precise longitudinal time-points in PCa. 18 patients treated with stereotactic body radiation therapy (SBRT) (40 Gy/3FRX), definitive moderate-hypofractionation (62 Gy/20FRX), or post-operative conventional-fractionation RT (66–69 Gy/30FRX) were prospectively evaluated for the immune cell profile in terms of immune cell composition, differentiation stage, cytokine production and inhibitory receptor (IR) expression. The immune-monitoring of the 18 patients revealed that RT affects the balance of systemic immune cells, with the main differences observed between SBRT and conventionally fractionated RT. SBRT favorably impacts immune response in term of increased B cells, central-memory and effector-memory CD8 + T cells, along with decreased Treg cells after treatment. On the contrary, conventional fractionated RT had a long-term negative effect on the systemic immune profile, including a decrease of total lymphocyte counts accompanied by an increase of neutrophils-to-lymphocytes ratio. Total B and T cells decreased and Treg-to-CD8 + ratio increased. Functionality of T lymphocytes were not affected by any of the 3-fractionation schedules. Interestingly, SBRT significantly up-regulates the expression of V-domain immunoglobulin suppressor of T-cell activation (VISTA) in CD8 + T cells in the absence of other IRs. Our results indicate the relevance of systematic immunomonitoring during RT to identify novel immune-related target to design trials of combined radio-immunotherapy as a promising strategy in the clinical management of PCa.

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Section: Discussionsupporting

confidence: 70%

Stereotactic Ablative Radiation Therapy in 3 Fractions Induces a Favorable Systemic Immune Cell Profiling in Prostate Cancer Patients

Palermo¹,

Bottero

Panetta³

et al. 2023

OncoImmunology

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“…Although the methods of analysis were different, the real-world data we have presented support this earlier report. Recently, an additional report of the PACE-B trial at 2 years was published [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

Stereotactic body radiation therapy for prostate cancer: a study comparing 3-year genitourinary toxicity between CyberKnife and volumetric-modulated arc therapy by propensity score analysis

et al. 2023

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Background To investigate whether the rate of stereotactic body radiation therapy-related (SBRT-related) genitourinary (GU) toxicity is lower in patients with prostate cancer treated with CyberKnife. Methods We retrospectively reviewed the medical records of patients with nonmetastatic prostate cancer at two institutions between 2017 and 2020. We analyzed 70 patients who were extracted by propensity score matching based on age, pre-treatment International Prostate Symptom Score (IPSS), and prostate volume. The patients were treated with SBRT, with a total dose of 36.25 Gy in five fractions over five consecutive weekdays, using CyberKnife or volumetric-modulated arc therapy (VMAT). Results The low-, medium-, and high-risk patients were 2, 19, and 14, respectively, in the CyberKnife group and 4, 17, and 14, respectively, in the VMAT group. The median follow-up time in both groups was 3 years. One patient with CyberKnife died of unrelated causes. No biochemical or clinical recurrence, distant metastases, or death from prostate cancer was observed. The peak values of IPSS in the acute phase (< 3 months) were significantly lower in the CyberKnife than in the VMAT group (CyberKnife:16.2 vs VMAT:20.2, p = 0.025). In multiple regression analyses, the treatment modality (p = 0.03), age (p = 0.01), bladder medication pre-irradiation (p = 0.03), and neoadjuvant androgen deprivation therapy (p = 0.04) contributed to the peak value of the acute-phase IPSS. The incidence of treatment-related grade 2 acute GU toxicity tended to be lower in the CyberKnife than the VMAT group (CyberKnife: 22.9% vs. VMAT: 45.7%, p = 0.077). No difference was noted between the groups with regard to late IPSS or GU toxicity and gastrointestinal toxicity in all phases. Toxicities of grade ≥ 3 have not been observed to date. Conclusions Regardless of treatment modality, SBRT is effective in treating prostate cancer without serious toxicity. However, CyberKnife has an advantage over VMAT in terms of acute prostate symptoms.

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“…Currently-available toxicity and efficacy outcomes of randomised studies indicate equivalence between profound and moderate hypofractionation, although the efficacy results of PACE-B are awaited. 36 , 37 , 38 , 39 Stereotactic body radiotherapy (SBRT) schedules of five to seven fractions is moving towards becoming a standard of care for radical radiotherapy to the prostate. Our findings provide reassurance that the “one size fits all” approach is valid across standard fractionation and moderate hypofractionation.…”

Section: Discussionmentioning

confidence: 99%

Multi-candidate immunohistochemical markers to assess radiation response and prognosis in prostate cancer: results from the CHHiP trial of radiotherapy fractionation

Wilkins¹,

Gusterson²,

Tovey³

et al. 2023

eBioMedicine

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Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial

Cited by 151 publications

References 24 publications

Stereotactic Ablative Radiation Therapy in 3 Fractions Induces a Favorable Systemic Immune Cell Profiling in Prostate Cancer Patients

Stereotactic Ablative Radiation Therapy in 3 Fractions Induces a Favorable Systemic Immune Cell Profiling in Prostate Cancer Patients

Stereotactic body radiation therapy for prostate cancer: a study comparing 3-year genitourinary toxicity between CyberKnife and volumetric-modulated arc therapy by propensity score analysis

Multi-candidate immunohistochemical markers to assess radiation response and prognosis in prostate cancer: results from the CHHiP trial of radiotherapy fractionation

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