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Background and purposeOn-site cone-beam computed tomography (CBCT) has gained in importance in adaptive brachytherapy during recent years. Besides treatment planning, there is increased need particularly for image-guidance during interventional procedures and for image-guided treatment quality assurance (QA). For this purpose, an innovative CBCT device was rolled out at our hospital as the first site worldwide. We present the first clinical images and experiences.Materials and methodsThe novel CBCT system is constructed of a 121 cm diameter ring gantry, and features a 43.2 × 43.2 cm2 flat-panel detector, wireless remote-control via tablet-PC, and battery-powered maneuverability. Within the first months of clinical operation, we performed CBCT-based treatment QA for a total of 26 patients (8 with breast, 16 with cervix, and 2 with vaginal cancer). CBCT scans were analyzed regarding potential movements of implanted applicators in-situ during the brachytherapy course.ResultsWith the presented device, treatment QA was feasible for the majority of patients. The CBCT scans of breast patients showed sufficient contrast between implanted catheters and tissue. For gynecologic patients, a distinct visualization of applicators was achieved in general. However, reasonable differentiations of organic soft tissues were not feasible.ConclusionThe CBCT system allowed basic treatment QA measures for breast and gynecologic patients. For image-guidance during interventional brachytherapy procedures, the current image quality is not adequate. Substantial performance enhancements are required for intraoperative image-guidance.

Purpose A novel, mobile cone‐beam computed tomography (CBCT) system for image‐guided adaptive brachytherapy was recently deployed at our hospital as worldwide first site. Prior to the device's clinical operation, a profound characterization of its imaging performance was conducted. This was essential to optimize both the imaging workflow and image quality for achieving the best possible clinical outcomes. We present the results of our investigations. Methods The novel CBCT‐system features a ring gantry with 121 cm clearance as well as a 43.2 × 43.2 cm2 flat‐panel detector, and is controlled via a tablet‐personal computer (PC). For evaluating its imaging performance, the geometric reproducibility as well as imaging fidelity, computed tomography (CT)‐number accuracy, uniformity, contrast‐noise‐ratio (CNR), noise characteristics, and spatial resolution as fundamental image quality parameters were assessed. As dose metric the weighted cone‐beam dose index (CBDIw) was measured. Image quality was evaluated using standard quality assurance (QA) as well as anthropomorphic upper torso and breast phantoms. Both in‐house and manufacturer protocols for abdomen, pelvis, and breast imaging were examined. Results Using the in‐house protocols, the QA phantom scans showed altogether a high image quality, with high CT‐number accuracy (R2 > 0.97) and uniformity (<12 Hounsfield Unit (HU) cupping), reasonable noise and imaging fidelity, and good CNR at bone–tissue transitions of up to 28:1. Spatial resolution was strongly limited by geometric instabilities of the device. The breast phantom scans fulfilled clinical requirements, whereas the abdomen and pelvis scans showed severe artifacts, particularly at air/bone–tissue transitions. Conclusion With the novel CBCT‐system, achieving a high image quality appears possible in principle. However, adaptations of the standard protocols, performance enhancements in image reconstruction referring to artifact reductions, as well as the extinction of geometric instabilities are imperative.

SummaryBackgroundSeveral randomised, phase 3 trials have investigated the value of different techniques of accelerated partial breast irradiation (APBI) for patients with early breast cancer after breast-conserving surgery compared with whole-breast irradiation. In a phase 3 randomised trial, we evaluated whether APBI using multicatheter brachytherapy is non-inferior compared with whole-breast irradiation. Here, we present the 10-year follow-up results. MethodsWe did a randomised, phase 3, non-inferiority trial at 16 hospitals and medical centres in Austria, Czech Republic, Germany, Hungary, Poland, Spain, and Switzerland. Patients aged 40 years or older with early invasive breast cancer or ductal carcinoma in situ treated with breast-conserving surgery were centrally randomly assigned (1:1) to receive either whole-breast irradiation or APBI using multicatheter brachytherapy. Whole-breast irradiation was delivered in 25 daily fractions of 50 Gy over 5 weeks, with a supplemental boost of 10 Gy to the tumour bed, and APBI was delivered as 30·1 Gy (seven fractions) and 32·0 Gy (eight fractions) of high-dose-rate brachytherapy in 5 days or as 50 Gy of pulsed-dose-rate brachytherapy over 5 treatment days. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was ipsilateral local recurrence, analysed in the as-treated population; the non-inferiority margin for the recurrence rate difference (defined for 5-year results) was 3 percentage points. The trial is registered with ClinicalTrials.gov, NCT00402519; the trial is complete. FindingsBetween April 20, 2004, and July 30, 2009, 1328 female patients were randomly assigned to whole breast irradiation (n=673) or APBI (n=655), of whom 551 in the whole-breast irradiation group and 633 in the APBI group were eligible for analysis. At a median follow-up of 10·36 years (IQR 9·12–11·28), the 10-year local recurrence rates were 1·58% (95% CI 0·37 to 2·8) in the whole-breast irradiation group and 3·51% (1·99 to 5·03) in the APBI group. The difference in 10-year rates between the groups was 1·93% (95% CI –0·018 to 3·87; p=0·074). Adverse events were mostly grade 1 and 2, in 234 (60%) of 393 participants in the whole-breast irradiation group and 314 (67%) of 470 participants in the APBI group, at 7·5-year or 10-year follow-up, or both. Patients in the APBI group had a significantly lower incidence of treatment-related grade 3 late side-effects than those in the whole-breast irradiation group (17 [4%] of 393 for whole-breast irradiation vs seven [1%] of 470 for APBI; p=0·021; at 7·5-year or 10-year follow-up, or both). At 10 years, the most common type of grade 3 adverse event in both treatment groups was fibrosis (six [2%] of 313 patients for whole-breast irradiation and three [1%] of 375 patients for APBI, p=0·56). No grade 4 adverse events or treatment-related deaths have been observed. InterpretationPostoperative APBI using multicatheter brachytherapy after breast-conserving surgery in patients with early breast cancer is a valuable alternative to whole-breast irradiation in terms of treatment efficacy and is associated with fewer late side-effects. FundingGerman Cancer Aid, Germany.

In a phase 3, randomised, non-inferiority trial, accelerated partial breast irradiation (APBI) for patients with stage 0, I, and IIA breast cancer who underwent breast-conserving treatment was compared with whole-breast irradiation. Here, we present 5-year follow-up results. We did a phase 3, randomised, non-inferiority trial at 16 hospitals and medical centres in seven European countries. 1184 patients with low-risk invasive and ductal carcinoma in situ treated with breast-conserving surgery were centrally randomised to either whole-breast irradiation or APBI using multicatheter brachytherapy. The primary endpoint was local recurrence. Analysis was done according to treatment received. This trial is registered with ClinicalTrials.gov, number NCT00402519. Between April 20, 2004, and July 30, 2009, 551 patients had whole-breast irradiation with tumour-bed boost and 633 patients received APBI using interstitial multicatheter brachytherapy. At 5-year follow-up, nine patients treated with APBI and five patients receiving whole-breast irradiation had a local recurrence; the cumulative incidence of local recurrence was 1·44% (95% CI 0·51–2·38) with APBI and 0·92% (0·12–1·73) with whole-breast irradiation (difference 0·52%, 95% CI −0·72 to 1·75; p=0·42). No grade 4 late side-effects were reported. The 5-year risk of grade 2–3 late side-effects to the skin was 3·2% with APBI versus 5·7% with whole-breast irradiation (p=0·08), and 5-year risk of grade 2–3 subcutaneous tissue late side-effects was 7·6% versus 6·3% (p=0·53). The risk of severe (grade 3) fibrosis at 5 years was 0·2% with whole-breast irradiation and 0% with APBI (p=0·46). The difference between treatments was below the relevance margin of 3 percentage points. Therefore, adjuvant APBI using multicatheter brachytherapy after breast-conserving surgery in patients with early breast cancer is not inferior to adjuvant whole-breast irradiation with respect to 5-year local control, disease-free survival, and overall survival. German Cancer Aid.

We previously confirmed the non-inferiority of accelerated partial breast irradiation (APBI) with interstitial brachytherapy in terms of local control and overall survival compared with whole-breast irradiation for patients with early-stage breast cancer who underwent breast-conserving surgery in a phase 3 randomised trial. Here, we present the 5-year late side-effects and cosmetic results of the trial. We did this randomised, controlled, phase 3 trial at 16 centres in seven European countries. Women aged 40 years or older with stage 0–IIA breast cancer who underwent breast-conserving surgery with microscopically clear resection margins of at least 2 mm were randomly assigned 1:1, via an online interface, to receive either whole-breast irradiation of 50 Gy with a tumour-bed boost of 10 Gy or APBI with interstitial brachytherapy. Randomisation was stratified by study centre, menopausal status, and tumour type (invasive carcinoma vs ductal carcinoma in situ), with a block size of ten, according to an automated dynamic algorithm. Patients and investigators were not masked to treatment allocation. The primary endpoint of our initial analysis was ipsilateral local recurrence; here, we report the secondary endpoints of late side-effects and cosmesis. We analysed physician-scored late toxicities and patient-scored and physician-scored cosmetic results from the date of breast-conserving surgery to the date of onset of event. Analysis was done according to treatment received (as-treated population). This trial is registered with ClinicalTrials.gov, number NCT00402519. Between April 20, 2004, and July 30, 2009, we randomly assigned 1328 women to receive either whole-breast irradiation (n=673) or APBI with interstitial brachytherapy (n=655); 1184 patients comprised the as-treated population (551 in the whole-breast irradiation group and 633 in the APBI group). At a median follow-up of 6·6 years (IQR 5·8–7·6), no patients had any grade 4 toxities, and three (<1%) of 484 patients in the APBI group and seven (2%) of 393 in the whole-breast irradiation group had grade 3 late skin toxicity (p=0·16). No patients in the APBI group and two (<1%) in the whole-breast irradiation group developed grade 3 late subcutaneous tissue toxicity (p=0·10). The cumulative incidence of any late side-effect of grade 2 or worse at 5 years was 27·0% (95% CI 23·0–30·9) in the whole-breast irradiation group versus 23·3% (19·9–26·8) in the APBI group (p=0·12). The cumulative incidence of grade 2–3 late skin toxicity at 5 years was 10·7% (95% CI 8·0–13·4) in the whole-breast irradiation group versus 6·9% (4·8–9·0) in the APBI group (difference −3·8%, 95% CI −7·2 to 0·4; p=0·020). The cumulative risk of grade 2–3 late subcutaneous tissue side-effects at 5 years was 9·7% (95% CI 7·1–12·3) in the whole-breast irradiation group versus 12·0% (9·4–14·7) in the APBI group (difference 2·4%; 95% CI −1·4 to 6·1; p=0·28). The cumulative incidence of grade 2–3 breast pain was 11·9% (95% CI 9·0–14·7) after whole-breast irradiation versus 8·4% (6·1–10·6) after APBI (difference −3·5%; 95% CI −7·1 to 0·1; p=0·074). At 5 years' follow-up, according to the patients' view, 413 (91%) of 454 patients had excellent to good cosmetic results in the whole-breast irradiation group versus 498 (92%) of 541 patients in the APBI group (p=0·62); when judged by the physicians, 408 (90%) of 454 patients and 503 (93%) of 542 patients, respectively, had excellent to good cosmetic results (p=0·12). No treatment-related deaths occurred, but six (15%) of 41 patients (three in each group) died from breast cancer, and 35 (85%) deaths (21 in the whole-breast irradiation group and 14 in the APBI group) were unrelated. 5-year toxicity profiles and cosmetic results were similar in patients treated with breast-conserving surgery followed by either APBI with interstitial brachytherapy or conventional whole-breast irradiation, with significantly fewer grade 2–3 late skin side-effects after APBI with interstitial brachytherapy. These findings provide further clinical evidence for the routine use of interstitial multicatheter brachytherapy-based APBI in the treatment of patients with low-risk breast cancer who opt for breast conservation. German Cancer Aid.

Moderate hypofractionation is the standard of care for adjuvant whole-breast radiotherapy after breast-conserving surgery for breast cancer. Recently, 10-year results from the FAST and 5‑year results from the FAST-Forward trial evaluating adjuvant whole-breast radiotherapy in 5 fractions over 5 weeks or 1 week have been published. This article summarizes recent data for moderate hypofractionation and results from the FAST and FAST-Forward trial on ultra-hypofractionation. While the FAST trial was not powered for comparison of local recurrence rates, FAST-Forward demonstrated non-inferiority for two ultra-hypofractionated regimens in terms of local control. In both trials, the higher-dose experimental arms resulted in elevated rates of late toxicity. For the lower dose experimental arms of 28.5 Gy over 5 weeks and 26 Gy over 1 week, moderate or marked late effects were similar in the majority of documented items compared to the respective standard arms, but significantly worse in some subdomains. The difference between the standard arm and the 26 Gy of the FAST-Forward trial concerning moderate or marked late effects increased with longer follow-up in disadvantage of the experimental arm for most items. For now, moderate hypofractionation with 40–42.5 Gy over 15–16 fractions remains the standard of care for the majority of patients with breast cancer who undergo whole-breast radiotherapy without regional nodal irradiation after breast-conserving surgery.

Purpose/Objective: The standard treatment for localized low-risk breast cancer is breast-conserving surgery, followed by adjuvant radiotherapy and appropriate systemic therapy. As the majority of local recurrences occur at the site of the primary tumor, numerous trials have investigated partial-breast irradiation (PBI) instead of whole-breast treatment (WBI) using a multitude of irradiation techniques and fractionation regimens. This meta-analysis addresses the impact on disease-specific endpoints, such as local and regional control, as well as disease-free survival of PBI compared to that of WBI in published randomized trials. Material and Methods: We conducted a systematic literature review and searched for randomized trials comparing WBI and PBI in early-stage breast cancer with publication dates after 2009. The meta-analysis was based on the published event rates and the effect sizes for available oncological endpoints of at least two trials reporting on them. We evaluated in-breast tumor recurrences (IBTR), local recurrences at the primary site and elsewhere in the ipsilateral breast, regional recurrences (RR), distant metastasis-free interval (DMFI), disease-free survival (DFS), contralateral breast cancer (CBC), and second primary cancer (SPC). Furthermore, we aimed to assess the impact of different PBI techniques and subgroups on IBTR. We performed all statistical analyses using the inverse variance heterogeneity model to pool effect sizes. Results: For the intended meta-analysis, we identified 13 trials (overall 15,561 patients) randomizing between PBI and WBI. IBTR was significantly higher after PBI (OR = 1.66; CI-95%: 1.07–2.58; p = 0.024) with an absolute difference of 1.35%. We detected significant heterogeneity in the analysis of the PBI technique with intraoperative radiotherapy resulting in higher local relapse rates (OR = 3.67; CI-95%: 2.28–5.90; p < 0.001). Other PBI techniques did not show differences to WBI in IBTR. Both strategies were equally effective at the primary tumor site, but PBI resulted in statistically more IBTRs elsewhere in the ipsilateral breast. IBTRs after WBI were more likely to be located at the primary tumor bed, whereas they appeared equally distributed within the breast after PBI. RR was also more frequent after PBI (OR = 1.75; CI-95%: 1.07–2.88; p < 0.001), yet we did not detect any differences in DMFI (OR = 1.08; CI-95%: 0.89–1.30; p = 0.475). DFS was significantly longer in patients treated with WBI (OR = 1.14; CI-95%: 1.02–1.27; p = 0.003). CBC and SPC were not different in the test groups (OR = 0.81; CI-95%: 0.65–1.01; p = 0.067 and OR = 1.09; CI-95%: 0.85–1.40; p = 0.481, respectively). Conclusion: Limiting the target volume to partial-breast radiotherapy appears to be appropriate when selecting patients with a low risk for local and regional recurrences and using a suitable technique.

To evaluate the efficacy and toxicity of interstitial temporary brachytherapy boost for prostate cancer patients using real-world data. Between 2008 and 2016, 115 patients treated with external beam radiotherapy (EBRT) followed by a brachytherapy boost (BT boost) were eligible for this retrospective analysis. Patients received either interstitial high-dose-rate brachytherapy (HDR-BT) with 2 x 9-9.5 Gray (Gy) schedule or pulsed-dose-rate brachytherapy (PDR-BT) with 35 Gy as boost after EBRT (50.4 Gy), up to a total dose of 86-98 Gy (EQD = 3). Primary endpoints of the present analysis were cumulative local recurrence rate (LRR), biochemical recurrence-free survival (bRFS), tumor-specific survival, and overall survival (OS). As secondary objective, treatment-related toxicity was evaluated. The median follow-up time was 87 (range, 9-159) months, and the median age was 72 (range, 48-83) years. The median prostate specific antigen value (PSA) was 12.2 (range, 2.4-288) ng/ml. 78/115 (68%) patients had high-risk prostate cancer according to the D'Amico classification. At 7 years, the cumulative LRR for the whole cohort was 1.8%. The 7-year bRFS, cancer-specific survival, and OS were 85.2%, 97.3%, and 88.9%. The 5-year prevalence of late toxicity grade 3 or higher according to the LENT-SOMA scale was 4%. There were no significant differences for treatment outcome or toxicity for HDR vs. PDR treatment. A prostate gland of 50 cm or more was not associated with worse treatment efficacy or increased side effects, apart from the prevalence of urethritis after 5 years ( = 0.035). BT boost in patients with prostate cancer is efficient and well-tolerated, with low rates of side effects also in elderly patients. HDR- and PDR-BT were equally efficient and well-tolerated. A large prostate gland is no contraindication for BT. Therefore, BT boost should be offered to all eligible patients.

Breast brachytherapy (BB) represents an important radiation therapy modality in modern breast cancer treatments. Currently, BB is mainly used for accelerated partial breast irradiation (APBI), local boost after whole breast radiation therapy (WBRT), and as salvage re-irradiation after second lumpectomy (APBrl). Two multi-catheter interstitial brachytherapy (MIB) techniques can be offered: intra-operative (IOB) and post-operative (POB) brachytherapy. The aim of this article was to summarize current available data on these two different brachytherapy approaches for breast cancer. A literature search was performed, and different experiences published by BB expert teams were analyzed and compared. These two different brachytherapy approaches for breast cancer have also been presented and discussed during meetings of the GEC-ESTRO BCWG. In addition, expert recommendations were defined. A comprehensive description and practical comparison of both the techniques, i.e., IOB and POB, considering the latest available published data were presented. Different technical, logistic, and clinical aspects of both the methods were thoroughly examined and analyzed. This detailed comparison of the two breast brachytherapy techniques was supported by scientific data from extensive experience of experts, facilitating an objective analysis that, to our knowledge, has not been previously published. Based on the comprehensive analysis of both the brachytherapy techniques available, this article serves as a valuable resource to guide breast teams in selecting the optimal BB technique (POB or IOB), considering hospital environment, multi-disciplinary collaboration, and patient logistics.