Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials

Holch, Patricia; Henry, Ann; Davidson, Susan E; Gilbert, Alexandra; Routledge, Jacqueline A; Shearsmith, Leanne; Franks, K.; Ingleson, Emma; Albutt, Abigail; Velikova, Galina

doi:10.1016/j.ijrobp.2016.11.008

Cited by 27 publications

(27 citation statements)

References 80 publications

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“…The rates for the comparator CHHiP group were 8% to 9%, 10% to 11%, 16% to 18%, and 25% to 27%, respectively. Applicable results in the Holch et al systematic review (19) were similar to those in CHHiP. The increased acute and late GI toxicity seen in cohort 4 would be consistent with a consequential late side effect 20 , 21 .…”

Section: Discussionsupporting

confidence: 57%

“…To assess the impact of PLNRT, we compared these results with a large contemporaneous group of patients treated in the CHHiP phase 3 trial, which used IMRT to treat the prostate alone using similar CFRT/HFRT schedules and scored side effects with the same compendium of CRO and PRO (4) . We also used comparable data reported in a recent systematic review by Holch et al (19) , which included no studies with PLNRT. We found that acute grade 2+ GI toxicity occurred in 40% to 56% of CFRT patients in cohorts 1 to 3, compared with 25% in CHHiP and 21% to 60% in Holch et al, with a rate of 66% in cohort 4 (4-week HFRT), compared with 30% in the CHHiP HFRT group and 36% in Holch et al.…”

Section: Discussionmentioning

confidence: 99%

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Phase 1/2 Dose-Escalation Study of the Use of Intensity Modulated Radiation Therapy to Treat the Prostate and Pelvic Nodes in Patients With Prostate Cancer

Ferreira

Khan

Thomas

et al. 2017

International Journal of Radiation Oncology*Biology*Physics

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PurposeTo investigate the feasibility of dose escalation and hypofractionation of pelvic lymph node intensity modulated radiation therapy (PLN-IMRT) in prostate cancer (PCa).Methods and MaterialsIn a phase 1/2 study, patients with advanced localized PCa were sequentially treated with 70 to 74 Gy to the prostate and dose-escalating PLN-IMRT at doses of 50 Gy (cohort 1), 55 Gy (cohort 2), and 60 Gy (cohort 3) in 35 to 37 fractions. Two hypofractionated cohorts received 60 Gy to the prostate and 47 Gy to PLN in 20 fractions over 4 weeks (cohort 4) and 5 weeks (cohort 5). All patients received long-course androgen deprivation therapy. Primary outcome was late Radiation Therapy Oncology Group toxicity at 2 years after radiation therapy for all cohorts. Secondary outcomes were acute and late toxicity using other clinician/patient-reported instruments and treatment efficacy.ResultsBetween August 9, 2000, and June 9, 2010, 447 patients were enrolled. Median follow-up was 90 months. The 2-year rates of grade 2+ bowel/bladder toxicity were as follows: cohort 1, 8.3%/4.2% (95% confidence interval 2.2%-29.4%/0.6%-26.1%); cohort 2, 8.9%/5.9% (4.1%-18.7%/2.3%-15.0%); cohort 3, 13.2%/2.9% (8.6%-20.2%/1.1%-7.7%); cohort 4, 16.4%/4.8% (9.2%-28.4%/1.6%-14.3%); cohort 5, 12.2%/7.3% (7.6%-19.5%/3.9%-13.6%). Prevalence of bowel and bladder toxicity seemed to be stable over time. Other scales mirrored these results. The biochemical/clinical failure–free rate was 71% (66%-75%) at 5 years for the whole group, with pelvic lymph node control in 94% of patients.ConclusionsThis study shows the safety and tolerability of PLN-IMRT. Ongoing and planned phase 3 studies will need to demonstrate an increase in efficacy using PLN-IMRT to offset the small increase in bowel side effects compared with prostate-only IMRT.

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Section: Discussionsupporting

confidence: 57%

Section: Discussionmentioning

confidence: 99%

Phase 1/2 Dose-Escalation Study of the Use of Intensity Modulated Radiation Therapy to Treat the Prostate and Pelvic Nodes in Patients With Prostate Cancer

Ferreira

Khan

Thomas

et al. 2017

International Journal of Radiation Oncology*Biology*Physics

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“…An expanded validation of the EPIC bowel and urinary domains in this setting was a prespecified secondary endpoint of the randomized trial. Multiple instruments exist for measuring toxicity resulting from pelvic radiation and impact on quality of life [19,20]. The following were selected as they assessed clinically meaningful impact of differences in bowel irradiation on acute GI toxicity across treatment groups.…”

Section: Assessmentsmentioning

confidence: 99%

Expanded validation of the EPIC bowel and urinary domains for use in women with gynecologic cancer undergoing postoperative radiotherapy

Gil

Pugh

Klopp

et al. 2019

Gynecologic Oncology

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Objective: Women with endometrial or cervical cancer at risk for recurrence receive postoperative radiation therapy (RT). A patient reported outcomes (PRO) instrument to assess bowel and urinary toxicities is the Expanded Prostate Cancer Index Composite (EPIC), which has been validated in men with prostate cancer. As this instrument specifically measures bowel toxicity and the degree to which this is a problem, it was used in NRG Oncology/RTOG 1203 to compare intensity modulated RT (IMRT) to standard RT. This paper reports on the expanded validation of EPIC for use in women receiving pelvic RT. Methods: In addition to the EPIC bowel domain, urinary toxicity (EPIC urinary domain), patient reported bowel toxicities (PRO-CTCAE) and quality of life (Functional Assessment of Cancer Therapy (FACT)) were completed before, during and after treatment. Sensitivity, reliability and concurrent validity were assessed. Results: Mean bowel and urinary scores among 278 women enrolled were significantly worse during treatment and differed between groups. Acceptable to good reliability for bowel and urinary domain scores were obtained at all time points with the exception of one at baseline. Correlations between function and bother scores within the bowel and urinary domains were consistently stronger than those across domains. Correlations between bowel domain scores and PRO-CTCAE during treatment were stronger than those with the FACT. Conclusion: Correlations within and among the instruments indicate EPIC bowel and urinary domains are measuring conceptually discrete components of health. These EPIC domains are valid, reliable and sensitive instruments to measure PRO among women undergoing pelvic radiation.

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“…Rectal toxicity is one of the main side effects arising when treating prostate cancer with radiotherapy. Five-year grade ≥1 and ≥2 rectal bleeding (RB) rates have been reported to be around 30 and 10%, respectively, when combining intensity-modulated radiation therapy (IMRT) with image-guided radiotherapy (IGRT) (1,2). Several strategies may be implemented in order to spare the rectum and therefore decrease toxicity.…”

Section: Introductionmentioning

confidence: 99%

Planning With Patient-Specific Rectal Sub-Region Constraints Decreases Probability of Toxicity in Prostate Cancer Radiotherapy

et al. 2020

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Background: A rectal sub-region (SRR) has been previously identified by voxel-wise analysis in the inferior-anterior part of the rectum as highly predictive of rectal bleeding (RB) in prostate cancer radiotherapy. Translating the SRR to patient-specific radiotherapy planning is challenging as new constraints have to be defined. A recent geometry-based model proposed to optimize the planning by determining the achievable mean doses (AMDs) to the organs at risk (OARs), taking into account the overlap between the planning target volume (PTV) and OAR. The aim of this study was to quantify the SRR dose sparing by using the AMD model in the planning, while preserving the dose to the prostate. Material and Methods: Three-dimensional volumetric modulated arc therapy (VMAT) planning dose distributions for 60 patients were computed following four different strategies, delivering 78 Gy to the prostate, while meeting the genitourinary group dose constraints to the OAR: (i) a standard plan corresponding to the standard practice for rectum sparing (STD pl), (ii) a plan adding constraints to SRR (SRR pl), (iii) a plan using the AMD model applied to the rectum only (AMD_RECT pl), and (iv) a final plan using the AMD model applied to both the rectum and the SRR (AMD_RECT_SRR pl). After PTV dose normalization, plans were compared with regard to dose distributions, quality, and estimated risk of RB using a normal tissue complication probability model. Results: AMD_RECT_SRR pl showed the largest SRR dose sparing, with significant mean dose reductions of 7.7, 3, and 2.3 Gy, with respect to the STD pl , SRR pl , and AMD_RECT pl , respectively. AMD_RECT_SRR pl also decreased the mean rectal dose by 3.6 Gy relative to STD pl and by 3.3 Gy relative to SRR pl. The absolute risk of grade ≥1 RB decreased from 22.8% using STD pl planning to 17.6% using AMD_RECT_SRR pl considering SRR volume. AMD_RECT_SRR pl plans, however, showed slightly less dose homogeneity and significant increase of the number of monitor units, compared to the three other strategies. Conclusion: Compared to a standard prostate planning, applying dose constraints to a patient-specific SRR by using the achievable mean dose model decreased the mean dose by 7.7 Gy to the SRR and may decrease the relative risk of RB by 22%.

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Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials

Cited by 27 publications

References 80 publications

Phase 1/2 Dose-Escalation Study of the Use of Intensity Modulated Radiation Therapy to Treat the Prostate and Pelvic Nodes in Patients With Prostate Cancer

Phase 1/2 Dose-Escalation Study of the Use of Intensity Modulated Radiation Therapy to Treat the Prostate and Pelvic Nodes in Patients With Prostate Cancer

Expanded validation of the EPIC bowel and urinary domains for use in women with gynecologic cancer undergoing postoperative radiotherapy

Planning With Patient-Specific Rectal Sub-Region Constraints Decreases Probability of Toxicity in Prostate Cancer Radiotherapy

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