Purpose. In modern breast cancer treatment, a growing role has been observed for breast reconstruction together with an increase in clinical indications for postmastectomy radiotherapy (PMRT). ...Choosing the optimum type of reconstructive technique is a clinical challenge. We therefore conducted a national multicenter study to analyze the impact of PMRT on breast reconstruction. Methods. We conducted a retrospective case-control multicenter study on women undergoing breast reconstruction. Data were collected from 18 Italian Breast Centres and stored in a cumulative database which included the following: autologous reconstruction, direct-to-implant (DTI), and tissue expander/immediate (TE/I). For all patients, we described complications and surgical endpoints to complications such as reconstruction failure, explant, change in type of reconstruction, and reintervention. Results. From 2001 to April 2020, 3116 patients were evaluated. The risk for any complication was significantly increased in patients receiving PMRT (aOR, 1.73; 95% CI, 1.33–2.24; p<0.001). PMRT was associated with a significant increase in the risk of capsular contracture in the DTI and TE/I groups (aOR, 2.24; 95% CI, 1.57–3.20; p<0.001). Comparing type of procedures, the risk of failure (aOR, 1.82; 95% CI, 1.06–3.12, p=0.030), explant (aOR, 3.34; 95% CI, 3.85–7.83, p<0.001), and severe complications (aOR, 2.54; 95% CI, 1.88–3.43, p<0.001) were significantly higher in the group undergoing DTI reconstruction as compared to TE/I reconstruction. Conclusion. Our study confirms that autologous reconstruction is the procedure least impacted by PMRT, while DTI appears to be the most impacted by PMRT, when compared with TE/I which shows a lower rate of explant and reconstruction failure. The trial is registered with NCT04783818, and the date of registration is 1 March, 2021, retrospectively registered.
Background
Adjuvant radiotherapy (aRT) has been shown to reduce the risk of local relapse in vulvar cancer (VC). In this multicentre study (OLDLADY-1.2), several Institutions have combined their ...retrospective data on VC patients to produce a real-world dataset aimed at collecting data on efficacy and safety of aRT.
Methods
The primary study end-point was the 2-year-local control, secondary end-points were the 2-year-metastasis free-survival, the 2-year-overall survival and the rate and severity of acute and late toxicities. Participating centres were required to fill data sets including age, stage, tumor diameter, type of surgery, margin status, depth of invasion, histology, grading as well technical/dosimetric details of radiotherapy. Data about response, local and regional recurrence, acute and late toxicities, follow-up and outcome measures were also collected.
Results
One hundred eighty-one patients with invasive VC from 9 Institutions were retrospectively identified. The majority of patients were stage III (63%), grade 2 (62.4%) squamous carcinoma (97.2%). Positive nodes were observed in 117 patients (64.6%), moreover tumor diameter > 4 cm, positive/close margins and depth of invasion deeper than 5 mm were found in 59.1%, 38.6%, 58% of patients, respectively. Sixty-one patients (33.7%) received adjuvant chemoradiation, and 120 (66.3%) received radiotherapy alone. aRT was started 3 months after surgery in 50.8% of patients. Prescribed volumes and doses heterogeneity was recorded according to margin status and nodal disease. Overall, 42.5% locoregional recurrences were recorded. With a median follow-up of 27 months (range 1–179), the 2-year actuarial local control rate, metastasis free and overall survival were 68.7%, 84.5%, and 67.5%, respectively. In term of safety, aRT leads to a prevalence of acute skin toxicity with a low incidence of severe toxicities.
Conclusions
In the context of aRT for VC the present study reports a broad spectrum of approaches which would deserve greater standardization in terms of doses, volumes and drugs used.
Background
Vulvar carcinoma is a rather uncommon gynecological malignancy affecting elderly women and the treatment of loco-regional advanced carcinoma of the vulva (LAVC) is a challenge for both ...gynecologic and radiation oncologists. Definitive chemoradiation (CRT) is the treatment of choice, but with disappointing results. In this multicenter study (OLDLADY-1.1), several institutions have combined their retrospective data on LAVC patients to produce a real-world dataset aimed at collecting data on efficacy and safety of CRT.
Methods
The primary study end-point was 2-year-local control (LC), secondary end-points were 2-year-metastasis free-survival (MFS), 2-year-overall survival (OS) and the rate and severity of acute and late toxicities. Participating centers were required to fill data sets including age, stage, histology, grading as well as technical/dosimetric details of CRT. Data about response, local and regional recurrence, acute and late toxicities, follow-up and outcome measures were also collected. The toxicity was a posteriori documented through the Common Terminology Criteria for Adverse Events version 5 scale.
Results
Retrospective analysis was performed on 65 patients with primary or recurrent LAVC treated at five different radiation oncology institutions covering 11-year time interval (February 2010–November 2021). Median age at diagnosis was 72 years (range 32–89). With a median follow-up of 19 months (range 1–114 months), 2-year actuarial LC, MFS and OS rate were 43.2%, 84.9% and 59.7%, respectively. In 29 patients (44%), CRT was temporarily stopped (median 5 days, range 1–53 days) due to toxicity. The treatment interruption was statistically significant at univariate analysis of factors predicting LC (
p
: 0.05) and OS rate (
p
: 0.011), and it was confirmed at the multivariate analysis for LC rate (
p
: 0.032). In terms of toxicity profile, no G4 event was recorded. Most adverse events were reported as grade 1 or 2. Only 14 acute G3 toxicities, all cutaneous, and 7 late G3 events (3 genitourinary, 3 cutaneous, and 1 vaginal stenosis) were recorded.
Conclusion
In the context of CRT for LAVC, the present study reports encouraging results even if there is clearly room for further improvements, in terms of both treatment outcomes, toxicity and treatment interruption management.
The main purpose of our psycho-educational groups was to help women with breast cancer, learn how to cope with the physical, emotional, and lifestyle changes associated with cancer as well as with ...medical treatments that can be painful and traumatic. With this study, we wanted to detect the effects that group action had on the women who participated in it.
We studied a total of 97 patients who participated in 13 psycho-education groups. The whole sample was female patients who had breast cancer with no recurrence or metastases.
All patients were evaluated with the Hospital Anxiety and Depression Scale (HADS) and the Body Image Scale (BIS). We found no significant effect on anxiety and body image for the brief psycho- educational group for women with breast cancer in this study. It is possible to highlight a statistical difference and hence an improvement between the results of the HADS depression test at T0 (first evaluation at the first meeting) and T1 (retest in the final meeting).
The tests did not show a significant effect on anxiety and body image perception, but the patients reported that the psycho-educational group was an important intervention for their life. Outcome measurement is more complex in psychosocial research because many variables come into play and each phase of treatment is characterized by different types of problems for the patient: physical, relational and psychological aspects are involved.
Nasopharyngeal carcinoma (NPC) is an epithelial malignancy, with a high metastatic potential. Epstein-Barr virus (EBV) infection plays a fundamental role, even if it is not well understood. The ...diagnosis of the disease in its early stage is infrequent. Imaging studies, positron emission tomography scans in addition to clinical examination, endoscopic examination, and biopsy provide information on the extent of the disease. The application of neoadjuvant chemotherapy followed by concomitant chemoradiation can improve the control of NPC. In March 2016, a 54-year-old male with NPC cT1 cN2 cM0, stage III (8th edition of American Joint Committee on Cancer (AJCC) staging system) underwent to a two-step treatment: induction chemotherapy by TPF regimen (docetaxel, cisplatin, 5-fluorouracil), followed by concomitant chemoradiotherapy (weekly cisplatin). The quantity of free plasma EBV-DNA can be related to the disease stage, and the detection of EBV-DNA during follow-up can be predictive of distant metastases. Especially, either plasma or serum EBV-DNA titer is estimated to reflect tumor volume. Biologically, such EBV-DNA reflects reproduced or released DNA from dead or dying tumor cells. On the other hand, EBV-specific DNA released as exosome may reflect the biological feature of the alive NPC tumor cell. The follow-up is ongoing after 21 months from a complete response.
Patients treated with postoperative radiotherapy for endometrial and cervical carcinomas from 1981 to 2000 were retrospectively analysed in order to assess the rate of late small bowel toxicity.
...Eight hundred and six patients had received pelvic irradiation, with total doses of 40-55 Gy. The mean age was 57 years. Three hundred and eighteen patients had been treated for cervical and 488 for endometrial cancer; 46 had diabetes and 22 vascular diseases; 141 had a history of smoking and 367 were previously submitted to surgery for benign diseases. A CT treatment plan had been applied in 285 patients; 256 had been treated by arc moving therapy, 232 with 2 opposed beams (AP-PA) and 318 with 3 or 4 coplanar beams. Three hundred and forty-six were treated with X photons of 10 MV or more, 202 with 4-5 MV and 258 with cobalt gamma rays. Personalized blocks had been used in 389. Thirty-four women had received chemotherapy. Five hundred and eighty-four had been treated with dose fractions of 180 cGy or more and 56 had received a boost with brachytherapy or external beams. Eighty-one had needed treatment discontinuation due to acute small bowel toxicity.
The median follow-up was 70 months. Thirty five patients had bowel obstructions, after a median time of 31 months. The 5- and 10-year toxicity rates were 4 and 7%. Uni- and multivariate comparisons identified age, acute toxicity and dose fraction as predictors for complications.
Postoperative pelvic irradiation with standard techniques for gynaecological carcinomas results in tolerable rates of clinically significant late bowel damage, while older patients suffering from significant acute toxicity seem to be at higher risk.
Background
Recent studies have reported improvement of outcomes (progression‐free survival, overall survival, and prolongation of androgen deprivation treatment‐free survival) with stereotactic body ...radiotherapy (SBRT) in non‐small cell lung cancer and prostate cancer. The aim of this retrospective, multicenter study (MITO RT‐01) was to define activity and safety of SBRT in a very large, real‐world data set of patients with metastatic, persistent, and recurrent ovarian cancer (MPR‐OC).
Materials and Methods
The endpoints of the study were the rate of complete response (CR) to SBRT and the 24‐month actuarial local control (LC) rate on “per‐lesion” basis. The secondary endpoints were acute and late toxicities and the 24‐month actuarial late toxicity‐free survival. Objective response rate (ORR) included CR and partial response (PR). Clinical benefit (CB) included ORR and stable disease (SD). Toxicity was evaluated by the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) and Common Terminology Criteria for Adverse Events (CTCAE) scales, according to center policy. Logistic and Cox regression were used for the uni‐ and multivariate analysis of factors predicting clinical CR and actuarial outcomes.
Results
CR, PR, and SD were observed in 291 (65.2%), 106 (23.8%), and 33 (7.4%) lesions, giving a rate of CB of 96.4%. Patient aged ≤60 years, planning target volume (PTV) ≤18 cm3, lymph node disease, and biologically effective dose α/β10 > 70 Gy were associated with higher chance of CR in the multivariate analysis. With a median follow‐up of 22 months (range, 3–120), the 24‐month actuarial LC rate was 81.9%. Achievement of CR and total dose >25 Gy were associated with better LC rate in the multivariate analysis. Mild toxicity was experienced in 54 (20.7%) patients; of 63 side effects, 48 were grade 1, and 15 were grade 2. The 24‐month late toxicity‐free survival rate was 95.1%.
Conclusions
This study confirms the activity and safety of SBRT in patients with MPR‐OC and identifies clinical and treatment parameters able to predict CR and LC rate.
Implications for Practice
This study aimed to define activity and safety of stereotactic body radiotherapy (SBRT) in a very large, real life data set of patients with metastatic, persistent, recurrent ovarian cancer (MPR‐OC). Patient age <60 years, PTV <18 cm3, lymph node disease, and biologically effective dose α/β10 >70 Gy were associated with higher chance of complete response (CR). Achievement of CR and total dose >25 Gy were associated with better local control (LC) rate. Mild toxicity was experienced in 20.7% of patients. In conclusion, this study confirms the activity and safety of SBRT in MPR‐OC patients and identifies clinical and treatment parameters able to predict CR and LC rate.
Traditional management of recurrent ovarian cancer is system chemotherapy. This article considers an alternative, focusing on the activity and safety of stereotactic body radiotherapy for patients with ovarian cancer.
We present a large real-world multicentric dataset of ovarian, uterine and cervical oligometastatic lesions treated with SBRT exploring efficacy and clinical outcomes. In addition, an exploratory ...machine learning analysis was performed.
A pooled analysis of gynecological oligometastases in terms of efficacy and clinical outcomes as well an exploratory machine learning model to predict the CR to SBRT were carried out. The CR rate following radiotherapy (RT) was the study main endpoint. The secondary endpoints included the 2-year actuarial LC, DMFS, PFS, and OS.
501 patients from 21 radiation oncology institutions with 846 gynecological metastases were analyzed, mainly ovarian (53.1%) and uterine metastases(32.1%).Multiple fraction radiotherapy was used in 762 metastases(90.1%).The most frequent schedule was 24 Gy in 3 fractions(13.4%). CR was observed in 538(63.7%) lesions. The Machine learning analysis showed a poor ability to find covariates strong enough to predict CR in the whole series. Analyzing them separately, in uterine cancer, if RT dose≥78.3Gy, the CR probability was 75.4%; if volume was <13.7 cc, the CR probability became 85.1%. In ovarian cancer, if the lesion was a lymph node, the CR probability was 71.4%; if volume was <17 cc, the CR probability rose to 78.4%. No covariate predicted the CR for cervical lesions. The overall 2-year actuarial LC was 79.2%, however it was 91.5% for CR and 52.5% for not CR lesions(p < 0.001). The overall 2-year DMFS, PFS and OS rate were 27.3%, 24.8% and 71.0%, with significant differences between CR and not CR.
CR was substantially associated to patient outcomes in our series of gynecological cancer oligometastatic lesions. The ability to predict a CR through artificial intelligence could also drive treatment choices in the context of personalized oncology.
•A large series of 846 oligometastatic gynecological cancers from 21 Institutions underwent Stereotactic Radiotherapy.•Excellent objective response and local control rates were reported in the whole series.•An Artificial Intelligence model (Machine learning analysis) was performed to find variables predicting complete response.•High dose, small target volume, and type of lesion were able to predict complete response in uterine and ovarian cancers.
The present study was designed to describe tumour features and treatments for patients with breast cancer. It also aimed at assessing the risk of distant metastases in relation to biological ...profiles, disease stages and treatment.
Data were analysed from 81,882 patients in the EUSOMA database (disease stages at diagnosis 0-IV; median age 61 years; range 20-100 years). All patients were treated between January 2016 and December 2021 in 53 Breast Centres within the EUSOMA certification process in 13 European countries. Cases were classified as HR+ /HER2-, HR+ /HER2 + , HR-/HER2 + or HR-/HER2- and data were analysed accordingly.
Univariable and multivariable analyses for distant metastases were conducted on a subset of 38,119 cases with information on whether or not they had developed them. Potential determinants included sub-group type, Ki67 value, disease stage, adjuvant systemic therapies and post-operative radiation therapy. In multivariable analysis, the HR-/HER2 + and HR-/HER2- sub-groups were associated with a higher risk of distant metastases than HR+ /HER2-. Ki67 > 20 % and advanced stage disease also carried a high risk. Radiation therapy emerged as a protective factor against distant metastases.
Present results show a large patient database offers an information stream that can be applied to reduce uncertainties in clinical practice. Database parameters need to be updated dynamically for outcome monitoring. Molecular prognostic factors, gene-expression signatures, tumour-infiltrating lymphocytes and circulating tumoral DNA should be added.
Aim of the study
The study aims to evaluate the performance of selected, high-volume, highly specialized, Italian Breast Centers at the time of COVID-19 pandemic (year 2020), compared to pre-pandemic ...time (year 2019), highlighting differences in terms of clinical presentation of breast cancer (BC) and therapeutic strategies.
Methods
Patients’ data were provided by the Senonetwork data warehouse Senonet. In order to examine changes in the surgical and oncological management of BC patients during different phases of COVID-19 pandemic, we took advantage of a selection quality indicators (QIs). We performed the analyses in two time-frames, from July to September (Jul-Sep) (2019 versus 2020) and from October to December (Oct-Dec) (2019 versus 2020).
Results
Our analysis did not show any statistically significant difference in terms of diagnosis, surgical, oncological and radiation therapy procedures between the two trimesters 2019 and 2020. Nevertheless, we observed statistically significant differences, favoring 2020, when analyzing time-to surgery and time-to radiotherapy. On the other hand, we observed a significant reduction of neoadjuvant chemotherapy and we did not recollect any data on a major use of neoadjuvant endocrine therapy.
Conclusions
In Italian Breast Centers, partners of Senonetwork, we could not observe any treatment delay or change in standard clinical practice for BC care during the 2020 pandemic year, compared to 2019 pre-pandemic year. This finding is in contrast with the globally reported decrease in the performance of the Italian Breast Centers due to the COVID-19 pandemic, and has to be linked to the sharp selection of Senonetwork Breast Centers.
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