Unity Elekta is a unique magnetic resonance (MR)-linac that conjugates a 1.5 Tesla MR unit with a 7 MV flattening filter free accelerator.A prospective observational study for the clinical use of ...Elekta Unity is currently ongoing in our department. Herein, we present our preliminary report on the feasibility, quality of life, and patient-reported outcomes measures (PROMs) for localized prostate cancer (PC) treated with stereotactic body radiotherapy (SBRT).
The SBRT protocol consisted of a 35 Gy schedule delivered in 5 fractions within 2 weeks. Toxicity and quality of life (QoL) were assessed at baseline and after treatment using the Common Terminology Criteria for Adverse Events v5.0, International Prostatic Symptoms Score (IPSS), ICIQ-SF, IIEF-5, and EORTC-QLQ-C30 and PR-25 questionnaires.
Between October 2019 and January 2020, 25 patients with localized PC were recruited. The median age was 68 years (range, 54-82); 4 were low risk, 11 favorable intermediate risk (IR) and 10 unfavorable IR. Median iPSA was 6.8 ng/ml (range, 1-19), and 9 of these patients (36%) received concurrent androgen deprivation therapy. Median prostate volume was 36 cc (range, 20-61); median baseline IPSS was 5 (range, 0-10). Median time for fraction was 53 min (range, 34-86); adaptive strategy with daily critical structure and target re-contouring and daily replanning (adapt to shape) was performed in all cases. No grade ≥ 3 adverse event was observed, three patients (12%) reported grade 2 acute genitourinary toxicity (urinary frequency, urinary tract pain and urinary retention), while only one patient reported mild rectal pain. No relevant deteriorations were reported in PROMs.
To the best of our knowledge, this is the first experience reporting feasibility, clinician-reported outcome measurements, and PROMs for 1.5 T MR-guided adaptive SBRT for localized prostate cancer. The preliminary data collected here report optimal safety and excellent tolerability, as also confirmed by PROMs questionnaires. Moreover, the data on technical feasibility and timing of online daily adapted planning and delivery are promising. More mature data are warranted.
Date of approval April 2019 and numbered MRI/LINAC n°23,748.
We conducted a prospective phase II multicentric trial to determine if radical radiation therapy to all metastatic sites might improve the progression-free survival (PFS) in oligometastatic breast ...cancer patients. Secondary endpoints were local control (LC), overall survival (OS) and toxicity.
Inclusion criteria were the following: oligometastatic breast cancer with ≤5 metastatic sites, FDG-PET/CT staging, no brain metastases, primary tumor controlled. Radiotherapy could be delivered using stereotactic body radiotherapy (SBRT) technique or fractionated intensity modulated radiotherapy (IMRT). SBRT consisted of 30–45Gy in 3 fractions, while IMRT was delivered to a total dose of 60Gy in 25 fractions. We hypothesized that radical radiation therapy could increase the PFS from 30% (according to the published literature) to 50% at two years.
54 Patients with 92 metastatic lesions were enrolled. Forty-four were treated with SBRT, and 10 with IMRT. Forty-eight (89%) patients received a form of systemic therapy concomitantly to radiation therapy. Sites of metastatic disease were the following: bones 60 lesions, lymph nodes 23 lesions, lung 4 lesions, liver 5 lesions. After a median follow-up of 30months (range, 6–55months), 1- and 2-year PFS was 75% and 53%, respectively. Two-year LC and OS were 97% and 95%, respectively. Radiation therapy was well tolerated, and no Grade ≥3 toxicity was documented. Grade 2 toxicity were pain and fatigue in 2 cases.
Patients with oligometastatic breast cancer treated with radical radiotherapy to all metastatic sites may achieve long-term progression-free survival, without significant treatment-related toxicity. While waiting for data from randomized trials, the use of radical radiation therapy to all metastatic sites in patients with oligometastatic breast cancer should be considered a valuable option, and its recommendation should be individualized.
Improved outcome has been shown in patients with synchronous oligometastatic (sOM) NSCLC when treated with radical intent. As a uniform definition of sOM NSCLC is lacking, we developed a definition ...and diagnostic criteria by a consensus process.
A pan-European multidisciplinary consensus group was established. Consensus questions were built on the basis of current controversies, and definitions were extracted from a survey, cases and a systematic review. This statement was formulated during a consensus meeting.
It was determined that definition of sOM NSCLC is relevant when a radical treatment that may modify the disease course (leading to long-term disease control) is technically feasible for all tumor sites with acceptable toxicity. On the basis of the review, a maximum of five metastases and three organs was proposed. Mediastinal lymph node involvement was not counted as a metastatic site. Fludeoxyglucose F 18 positron emission tomography–computed tomography and brain imaging were considered mandatory. A dedicated liver magnetic resonance imaging scan was advised for a solitary liver metastasis, and thoracoscopy and biopsies of distant ipsilateral pleural sites were recommended for a solitary pleural metastasis. For mediastinal staging, fludeoxyglucose F 18 positron emission tomography–computed tomography was deemed the minimum requirement, with pathological confirmation recommended if this influences the treatment strategy. Biopsy of a solitary metastatic location was mandated unless the multidisciplinary team is of the opinion that the risks outweigh the benefits.
A multidisciplinary consensus statement on the definition and staging of sOM NSCLC has been formulated. This statement will help to standardize inclusion criteria in future clinical trials.
Synchronous oligometastatic (sOM) disease is an oncological concept characterized by a limited cancer burden. Patients with oligometastasis could potentially benefit from local radical treatments. ...Despite the fact that the sOM condition is well recognized, a universal definition, including a specific definition for NSCLC, is not yet available. The aim of this systematic review was to summarize the definitions of and staging requirements for use of the term synchronous oligometastatic in the context of NSCLC.
The key issue was formulated in one research question according to the population, intervention, comparator, and outcomes strategy. The question was introduced in MEDLINE (OvidSP). All articles dealing with sOM NSCLC and providing a definition of synchronous oligometastasis in NSCLC were selected and analyzed.
A total of 21 eligible articles focusing on sOM NSCLC were retrieved and analyzed. In 17 studies (81%), patients had to be staged with magnetic resonance imaging or computed tomography of the brain, thoracic and abdominal computed tomography, and positron emission tomography. The total number of metastases allowed in the definitions ranged from one to eight, but in 38.1% of studies the maximum number was 5. Most of the publications did not define the number of involved organs or the maximum number of metastases per organ. For mediastinal lymph node involvement, only five articles (27.8%) counted this as a metastatic site.
No uniform definition of sOM NSCLC could be retrieved by this systematic review. However, extended staging was mandated in most of the studies. An accepted oncological definition of synchronous oligometastasis is essential for patient selection to define prospective clinical trials.
Purpose
SBRT demonstrated to increase survival in oligometastatic patients. Nevertheless, little is known regarding the natural history of oligometastatic disease (OMD) and how SBRT may impact the ...transition to the polymetastatic disease (PMD).
Methods
97 liver metastases in 61 oligometastatic patients were treated with SBRT. Twenty patients (33%) had synchronous oligometastases, 41 (67%) presented with metachronous oligometastases. Median number of treated metastases was 2 (range 1–5).
Results
Median follow-up was 24 months. Median tPMC was 11 months (range 4–17 months). Median overall survival (OS) was 23 months (range 16–29 months). Cancer-specific survival predictive factors were having further OMD after SBRT (21 months versus 15 months;
p
= 0.00), and local control of treated metastases (27 months versus 18 months;
p
= 0.031). Median PFS was 7 months (range 4–12 months). Patients with 1 metastasis had longer median PFS as compared to those with 2–3 and 4–5 metastases (14.7 months versus 5.3 months versus 6.5 months;
p
= 0.041). At the last follow-up, 50/61 patients (82%) progressed, 16 of which (26.6%) again as oligometastatic and 34 (56%) as polymetastatic.
Conclusion
In the setting of oligometastatic disease, SBRT is able to delay the transition to the PMD. A proportion of patients relapse as oligometastatic and can be eventually evaluated for a further SBRT course. Interestingly, those patients retain a survival benefit as compared to those who had PMD. Further studies are needed to explore the role of SBRT in OMD and to identify treatment strategies able to maintain the oligometastatic state.
Abstract
Background
The assessment of organ motion is a crucial feature for prostate stereotactic body radiotherapy (SBRT). Rectal spacer may represent a helpful device in order to outdistance rectal ...wall from clinical target, but its impact on organ motion is still a matter of debate. MRI-Linac is a new frontier in radiation oncology as it allows a superior visualization of the real-time anatomy of the patient and the current highest level of adaptive radiotherapy.
Methods
We present data regarding a total of 100 fractions in 20 patients who underwent MRI-guided prostate SBRT for low-to-intermediate risk prostate cancer with or without spacer. Translational and rotational shifts were computed on the pre- and post-treatment MRI acquisitions referring to the delivery position for antero-posterior, latero-lateral and cranio-caudal direction, and assessed using the Mann-Whitney U-Test.
Results
All patients were treated with a five sessions schedule (35 Gy/5fx) using MRI-Linac for a median fraction treatment time of 50 min (range, 46–65). In the entire study sample, median rotational displacement was 0.1° in cranio-caudal, − 0.002° in latero-lateral and 0.01° in antero-posterior direction; median translational shift was 0.11 mm in cranio-caudal, − 0.24 mm in latero-lateral and − 0.22 mm in antero-posterior. A significant difference between spacer and no-spacer patients in terms of rotational shifts in the antero-posterior direction (
p
= 0.033) was observed; also for translational shifts a positive trend was detected in antero-posterior direction (
p
= 0.07), although with no statistical significance. We observed statistically significant differences in the pre-treatment planning phase in favor of the spacer cohort for several rectum dose constraints: rectum V32Gy < 5% (
p
= 0.001), V28 Gy < 10% (
p
= 0.001) and V18Gy < 35% (
p
= 0.039). Also for bladder V35 Gy < 1 cc, the use of spacer provided a dosimetric advantage compared to the no-spacer subpopulation (
p
= 0.04). Furthermore, PTV V33.2Gy > 95% was higher in the spacer cohort compared to the no-spacer one (
p
= 0.036).
Conclusion
In our experience, the application of rectal hydrogel spacer for prostate SBRT resulted in a significant impact on rotational antero-posterior shifts contributing to limit prostate intra-fraction motion. Further studies with larger sample size and longer follow-up are required to confirm this ideally favorable effect and to assess any potential impact on clinical outcomes.
The main aim of the current analysis was to explore the hypothetical advantages using rectal spacer during 1.5T MR-guided and daily adapted prostate cancer stereotactic body radiotherapy (SBRT) ...compared to a no-rectal spacer hydrogel cohort of patients.
The SBRT-protocol consisted of a 35 Gy schedule delivered in 5 fractions. Herein, we present a dosimetric analysis between spacer and no-spacer patients. Furthermore, treatment tolerability and feasibility were preliminarily assessed according to clinicians-reported outcomes at the end of treatment and patient-reported outcomes measures (PROMs) in both arms. Toxicity and quality of life were assessed at baseline and after treatment using the Common Terminology Criteria for Adverse Events v. 5.0, International Prostatic Symptoms Score, ICIQ-SF, IIEF-5, and EORTC-QLQ-C30 and PR-25 questionnaires.
120 plans (pre- and daily adaptive SBRT planning) were analyzed in 20 patients (10 patients in spacer group and 10 patients in no-spacer group) treated using 1.5T MR-guided adaptive SBRT. Statistically significant dosimetric advantages were observed in favor of the spacer insertion, improving the planning target volume coverage in terms of V33.2Gy >95% and planning target volume 37.5 Gy <2% mainly during daily-adapted SBRT. Also, rectum V32, V28 and V18Gy and bladder V35Gy <1 cc were significantly reduced in the spacer cohort. Concerning the PROMS, all questionnaires showed no difference between the pre- and post-SBRT evaluation in both arms, excepting the physical functioning item of EORTC QLQ-C30 questionnaire that was declined in the no-spacer group.
These preliminary results strongly suggest the adoption of perirectal spacer due to dosimetric advantages not only for rectal sparing but also for target coverage. Longer follow-up is required to validate the clinical impact in terms of clinicians-reported toxicity and PROMs.
This the first experience reporting preliminary data concerning the potential dosimetric impact of rectal hydrogel spacer on MR-guided SBRT for prostate cancer.
Background
We present preliminary data of the first older cancer patients treated with Hybrid Linac for stereotactic body radiotherapy (SBRT) consisting of 1.5 T MRI-guided and daily-adapted ...treatment. The aim was to assess feasibility, safety and the role of G8 and Charlson Comorbidity Index (CCI) questionnaires in predicting patients’ QoL, evaluated by patient-reported outcome measures (PROMs).
Methods
Two groups of patients with localized prostate cancer or abdominal-pelvic oligometastases were analyzed. SBRT schedule consisted of 35 Gy delivered in 5 fractions. The primary endpoint was to measure the impact of G8 and CCI on PROMs. Both G8 and the CCI were performed at baseline, while the EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) for PROMs assessment was prospectively performed at baseline and after SBRT.
Results
Forty older patients were analyzed. The median age was 73 years (range 65–85). For the entire population, the median G8 score was 15 (10–17) and the median CCI score was 6 (4–11). Concerning the PROMS, the EORTC-QLQ C30 questionnaire reported no difference between the pre- and post-SBRT evaluation in all patients, except for the fatigue item that declined after SBRT, especially in the group of patients with a G8 score < 15 and with age < 75 years (
p
= 0.049). No grade 3 or higher acute toxicity occurred.
Conclusion
This is the first report documenting for older cancer patients that 1.5 T MRI-guided daily-adapted SBRT is feasible, safe and does not impact on the QoL at the end of treatment. Longer follow-up is advocated to report long-term outcomes.
Trial registration
Date of approval April 2019 and numbered MRI/LINAC no. 23748.
Purpose
We report preliminary dosimetric data concerning the use of 1.5-T MR-guided daily-adaptive radiotherapy for abdomino-pelvic lymph-nodal oligometastases. We aimed to assess the impact of this ...technology on mitigating daily variations for both target coverage and organs-at-risk (OARs) sparing.
Methods
A total of 150 sessions for 30 oligometastases in 23 patients were analyzed. All patients were treated with MR-guided stereotactic body radiotherapy (SBRT) for a total dose of 35 Gy in five fractions. For each fraction, a quantitative analysis was performed for PTV volume, V35Gy and
D
mean
. Similarly, for OARs, we assessed daily variations of volume,
D
mean
,
D
max
. Any potential statistically significant change between baseline planning and daily-adaptive sessions was assessed using the Wilcoxon signed-rank test, assuming a
p
value < 0.05 as significant.
Results
Average baseline PTV, bowel, bladder, and single intestinal loop volumes were respectively 8.9 cc (range 0.7–41.2 cc), 1176 cc (119–3654 cc), 95 cc (39.7–202.9 cc), 18.3 cc (9.1–37.7 cc). No significant volume variations were detected for PTV (
p
= 0.21) bowel (
p
= 0.36), bladder (
p
= 0.47), except for single intestinal loops, which resulted smaller (
p
= 0.026). Average baseline V35Gy and
D
mean
for PTV were respectively 85.6% (72–98.8%) and 35.6 Gy (34.6–36.1 Gy). We recorded a slightly positive trend in favor of daily-adaptive strategy vs baseline planning for improved target coverage, although not reaching statistical significance (
p
= 0.11 and
p
= 0.18 for PTV-V35Gy and PTV-
D
mean
). Concerning OARs, a significant difference was observed in favor of daily-adapted treatments in terms of single intestinal loop
D
max
23.05 Gy (13.2–26.9 Gy) at baseline vs 20.5 Gy (12.1–24 Gy);
p
value = 0.0377 and
D
mean
14.4 Gy (6.5–18 Gy) at baseline vs 13.0 Gy (6.7–17.6 Gy);
p
value = 0.0003. Specifically for bladder, the average
D
max
was 18.6 Gy (0.4–34.3 Gy) at baseline vs 18.3 Gy (0.7–34.3 Gy) for a
p
value = 0.28; the average
D
mean
was 7.0 Gy (0.2–16.6 Gy) at baseline vs 6.98 Gy (0.2–16.4 Gy) for a
p
value = 0.66. Concerning the bowel, no differences in terms of
D
mean
4.78 Gy (1.3–10.9 Gy) vs 5.6 Gy (1.4–10.5 Gy);
p
value = 0.23 were observed between after daily-adapted sessions. A statistically significant difference was observed for bowel
D
max
26.4 Gy (7.7–34 Gy) vs 25.8 Gy (7.8–33.1 Gy);
p
value = 0.0086.
Conclusions
Daily-adaptive MR-guided SBRT reported a significantly improved single intestinal loop sparing for lymph-nodal oligometastases. Also, bowel
D
max
was significantly reduced with daily-adaptive strategy. A minor advantage was also reported in terms of PTV coverage, although not statistically significant.
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