Dataset Information

Sexual organ-sparing with hydrogel spacer injections for rectal cancer radiotherapy: a feasibility pilot study.

ABSTRACT:

Objectives

The aim of this pilot study was to investigate in two rectal cancer patients undergoing neoadjuvant chemo-radiotherapy (nCRT) the implant feasibility and dosimetric benefit in sexual organ-sparing of an injectable, absorbable, radiopaque hydrogel spacer.

Methods

Two rectal cancer patients (one male and one female) underwent hydrogel implant between rectum and vagina/prostate before nCRT and curative surgery. A CT scan was performed before and after injection and a comparative dosimetric study was performed testing a standard (45/50 Gy) and a dose escalated (46/55.2 Gy) schedule.

Results

In both patients, the spacer implant in the recto-prostatic or recto-vaginal space was feasible and well tolerated. For the male, the dosimetric benefit with spacer was minimal for sexual organs. For the female however, doses delivered to the vagina were significantly reduced with spacer with a mean reduction of more than 5 Gy for both regimens.

Conclusions

For organ preservation protocols and selected sexually active female patients, use of hydrogel spacers can be considered to spare sexual organs from the high radiotherapy dose levels.

Advances in knowledge

For females with advanced rectal tumor, a spacer implant between the rectum and the vagina before nCRT is feasible and reduces doses delivered to the vagina.

SUBMITTER: Achard V

PROVIDER: S-EPMC8010550 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Sexual organ-sparing with hydrogel spacer injections for rectal cancer radiotherapy: a feasibility pilot study.

Achard Vérane V Ris Frederic F Rouzaud Michel M Puppa Giacomo G Buchs Nicolas C NC De Perrot Thomas T Koessler Thibaud T Picardi Cristina C Zilli Thomas T

The British journal of radiology 20210122 1120

<h4>Objectives</h4>The aim of this pilot study was to investigate in two rectal cancer patients undergoing neoadjuvant chemo-radiotherapy (nCRT) the implant feasibility and dosimetric benefit in sexual organ-sparing of an injectable, absorbable, radiopaque hydrogel spacer.<h4>Methods</h4>Two rectal cancer patients (one male and one female) underwent hydrogel implant between rectum and vagina/prostate before nCRT and curative surgery. A CT scan was performed before and after injection and a compa ...[more]

PMID: 33481641

Similar Datasets

Project description:PurposeThe purpose of this study was to analyze the impact of prostate rectal spacers on sexual quality of life (QOL) following external beam radiation therapy (RT).Methods and materialsPatient- reported QOL was evaluated using the Expanded Prostate Cancer Index Composite (EPIC). Patients were pooled from two sources: a randomized controlled trial and a non-randomized cohort of patients from a single institution. Both cohorts used the same spacing product and QOL instrument. Analysis was limited to those with good baseline pre-treatment sexual QOL (EPIC >/= 60). Differences in QOL summary score and individual items were assessed compared with baseline and between treatment arms.ResultsA total of 128 men had good baseline sexual function and were evaluated (64% with spacer and 36% without) with QOL data available for median 33 months (range: 2.5-69.4 months). Men without spacer were more likely to have declines in sexual function (p < 0.0001), bother (p = 0.0002), and sexual summary score (p < 0.0001). A minimally important difference of 10 points (1xMID) and 20 point (2xMID) was more likely without rectal spacer [10 points: odds ratio 3.53, (95% confidence interval 1.11-11.2), p = 0.032; 20 points: odds ratio 3.29, (95% confidence interval 1.16-9.33), p = 0.025]. Seven of 13 QOL items were statistically superior with hydrogel (six of nine functional and one of four bother), while no items were statistically superior for control. At baseline, more men treated with hydrogel had erections sufficient for intercourse; however, when analyzed only by the men with best baseline erectile potential and excluding those with worse function, the benefit of rectal spacing was maintained with a higher likelihood of preservation of erections sufficient for intercourse in those treated with hydrogel.ConclusionIn this pooled analysis of QOL after prostate RT, the utilization of a hydrogel spacer was associated with better sexual QOL, less men with measurable declines in sexual QOL, and higher rates of adequate erectile function.

Project description:Non-operative management of rectal cancer is increasingly being used in selected patients. Most reports include patients treated with chemoradiotherapy (CRT) before inclusion into a Watch & Wait (W&W) programme. The aim of this study was to report outcomes from a single-centre W&W programme involving a large cohort of patients. Patients treated with chemoradiotherapy (CRT) or short-course radiotherapy (SCRT) with or without chemotherapy, between 2008 and 2020, who showed signs of a clinical complete response (cCR) were reviewed. Patients were assessed using digital rectal examination, flexible endoscopy, carcinoembryonic antigen measurement, MRI, and CT imaging, discussed at the multidisciplinary tumour board meeting, and followed up in a dedicated W&W programme as from 2015. Outcomes including regrowth and 3-year survival (time to regrowth or death) were prospectively evaluated. Of 142 patients who were assessed, 88 fulfilled the criteria for cCR. Treatment before cCR included CRT, SCRT with chemotherapy, and SCRT alone in 16 (18 per cent), 28 (32 per cent), and 44 (50 per cent) patients, respectively. Patients treated with CRT and SCRT with chemotherapy had more advanced clinical T- and N-stage, compared with patients treated with SCRT alone (clinical T-stage > 2: 81 per cent and 89 per cent versus 47 per cent, respectively; clinical N-stage > 0: 75 per cent and 93 per cent versus 68 per cent, respectively). Overall rate of regrowth was 19 per cent, with 31 per cent, 21 per cent, and 14 per cent following CRT, SCRT with chemotherapy, and SCRT alone, respectively. Uni- and multivariable analyses evaluating the clinical parameters revealed no statistically significant associations with risk of local regrowth. All but one patient with regrowth underwent salvage surgery. The 3-year survival rate (death with regrowth as competing risk) was 93 per cent, with no significant difference between treatment groups. In this cohort of W&W patients, the vast majority received SCRT with or without chemotherapy and results consistent with previous W&W reports were obtained. No statistically significant differences in terms of regrowth rate were obtained when comparing CRT, SCRT with chemotherapy, and SCRT alone. SCRT can induce sustained cCR and may precede a W&W strategy.

Project description:PurposePancreatic cancer is the fourth leading cause of cancer-related death, with a very low 5-year overall survival rate (OS). Radiation therapy (RT) together with dose escalation significantly increases the OS at 2 and 3 years. However, dose escalation is very limited due to the proximity of the duodenum. Hydrogel spacers are an effective way to reduce duodenal toxicity, but the complexity of the anatomy and the procedure makes the success and effectiveness of the spacer procedure highly uncertain. To provide a preoperative simulation of hydrogel spacers, we presented a patient-specific spacer simulator algorithm and used it to create a decision support system (DSS) to provide a preoperative optimal spacer location to maximize the spacer benefits.Materials and methodsOur study was divided into three phases. In the validation phase, we evaluated the patient-specific spacer simulator algorithm (FEMOSSA) for the duodenal spacer using the dice similarity coefficient (DSC), overlap volume histogram (OVH), and radial nearest neighbor distance (RNND). For the simulation phase, we simulated four virtual spacer scenarios based on the location of the spacer in para-duodenal space. Next, stereotactic body radiation therapy (SBRT) plans were designed and dosimetrically analyzed. Finally, in the prediction phase, using the result of the simulation phase, we created a Bayesian DSS to predict the optimal spacer location and biological effective dose (BED).ResultsA realistic simulation of the spacer was achieved, reflected in a statistically significant increase in average target and duodenal DSC for the simulated spacer. Moreover, the small difference in average mean and 5th-percentile RNNDs (0.5 and 2.1 mm) and OVH thresholds (average of less than 0.75 mm) showed that the simulation attained similar separation as the real spacer. We found a spacer-location-independent decrease in duodenal V20Gy, a highly spacer-location-dependent change in V33Gy, and a strong correlation between L1cc and V33Gy. Finally, the Bayesian DSS predicted the change in BED with a root mean squared error of 3.6 Gys.ConclusionsA duodenal spacer simulator platform was developed and used to systematically study the dosimetric effect of spacer location. Further, L1cc is an informative anatomical feedback to guide the DSS to indicate the spacer efficacy, optimum location, and expected improvement.

Project description:PurposeRectal spacers have gained popularity as a dose-sparing material for prostate cancer radiation therapy (RT). However, the procedure can be associated with unintended rectal wall infiltration (RWI) of the spacer gel. We therefore classified RWI severity as a function of depth and explored its association with rectal toxicity using a data set from prostate cancer patients treated with RT on a prospective randomized clinical trial (RCT).Methods and materialsPostimplant T2-weighted magnetic resonance images of 149 subjects randomized to the hydrogel spacer arm of a published multicenter RCT were assessed for the presence and depth of RWI. All implants were assigned a score of 0 (no rectal wall signal changes), 1 (rectal wall edema/signal change), 2 (partial RWI), or 3 (full-thickness RWI); RWI was defined as a score of 2 or 3. Correlations were made between RWI score and physician-reported procedure, acute, and late rectal toxicity.ResultsAlthough 62.4% of implants had no rectal wall signal abnormalities, 24% [scores of 2 (20.1%) and 3 (4.0%)] of procedures exhibited radiographic evidence of RWI. Full-thickness RWI was associated with both a longer length (22.8 ± 7.0 mm, P = .008) and a larger circumferential percentage (35.8% ± 9.2%, P = .045) of rectal infiltration. Although 7 subjects (5%) experienced transient procedure-related rectal toxicities (most commonly perineal/rectal pain), only one had RWI (score of 2, National Cancer Institute's Common Terminology Criteria for Adverse Events grade 1). Consequently, no correlation was observed between procedural rectal toxicity and the presence/extent of RWI (P = .64). Similarly, no difference in acute (P = .64) or late (P = .85) rectal toxicity incidence or grade was detected between RWI categories; none of the 6 men with a RWI score of 3 developed late rectal toxicity by 15 months.ConclusionsBased on data from an RCT, RWI did not contribute to increased rectal toxicity prior and up to 15 months after conventional prostate cancer RT.

Project description:ImportanceThe polyethylene glycol-based hydrogel spacer (PHS) system temporarily separates the rectum from the prostate in patients undergoing radiotherapy (RT) for prostate cancer (PCa).ObjectiveTo compare incidence of bowel disorders and related procedures in patients receiving RT with and without PHS.Design, setting, and participantsThis retrospective cohort study used 4 datasets: Medicare 5% Standard Analytic Files, Medicare 100% Standard Analytic Files, Merative MarketScan Commercial Database, and Premier Healthcare Database. Participants included adult patients with PCa undergoing RT from 2015 to 2021.ExposurePlacement of PHS.Main outcomesAll-cause bowel disorders and related procedures, identified from diagnosis and procedure codes. Results were compared with age-matched male general population without PCa or RT.ResultsOf 261 906 patients with PCa included in the study, 25 167 (9.6%) received PHS (mean [SD] age, 70.7 [6.5] years) and 236 739 did not (mean [SD] age, 71.1 [7.5] years). One year prior to RT, patients who received PHS had a lower mean (SD) Charlson Comorbidity Index score than those who did not (2.48 [1.08] vs 3.14 [1.95]; P < .001). Stereotactic RT was more common in patients who received PHS (2743 [10.9%] vs 8810 [3.7%]; P < .001), while intensity-modulated RT was less common (12 755 [50.7%] vs 142 402 [60.2%]; P < .001). After 4 years post RT, patients who received PHS had a 25% lower hazard of bowel disorders (hazard ratio [HR], 0.75 [95% CI, 0.72-0.78]; P < .001) and a 46% lower hazard of related procedures (HR, 0.54 [95% CI, 0.47-0.62]; P < .001) than patients who did not receive PHS. Patients without PHS had higher hazard compared with an age-matched general population (disorders: 17.1% [95% CI, 17.3%-17.6%] vs 10.3% [95% CI, 10.1%-10.5%]; HR, 1.35 [95% CI, 1.32-1.37]; P < .001; procedures: 2.0% [95% CI, 1.9%-2.1%] vs 0.7% [95% CI, 0.7%-0.8%]; HR, 1.92 [95% CI, 1.79-2.06]; P < .001), while patients who received PHS did not (disorders: 12.4% vs 10.3%; HR, 1.00 [95% CI, 0.98-1.05]; P = .82; procedures: 1.1% [95% CI, 1.0%-1.3%] vs 0.7% [95% CI, 0.7%-0.8%]; HR, 1.11 [95% CI, 0.96-1.29]; P = .15). Common procedures included colonoscopy, sigmoidoscopy, and rectal resection.Conclusions and relevanceIn this cohort study of patients with PCa receiving RT, those receiving a PHS had a significantly lower incidence of all-cause bowel disorders and related procedures compared with patients who did not receive a PHS over the 4-year follow-up. The incidence among patients with PHS was similar to the general population. These findings are consistent with prior phase 3 trial results, where patients receiving PHS experienced no decline in bowel quality of life.

Dataset Information

Sexual organ-sparing with hydrogel spacer injections for rectal cancer radiotherapy: a feasibility pilot study.

Objectives

Methods

Results

Conclusions

Advances in knowledge

Publications

Sexual organ-sparing with hydrogel spacer injections for rectal cancer radiotherapy: a feasibility pilot study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets