Background: The purpose of this phase of the MUltimodal Targeted Axillary Surgery trial (ClinicalGov NCT04039893, July 31 2019) was to determine whether HLA-I expression and NK cell tumor infiltration in breast cancer are related to axillary tumor burden and other prognostic features.
CRT-related immunosuppression is associated with delayed durvalumab initiation and worse DCR. Larger PTV and higher lung and heart doses are associated with TRL. Median real-world OS and PFS are similar to those in the PACIFIC trial.
PET-PSMA is a powerful diagnostic tool that conditions significant changes in the therapeutic approach in those patients with occult biochemical recurrence with low PSA, changing the treatment in 75% of the cases when the study is positive.
PET-PSMA shows excellent diagnostic capability even in strictly selected patients with PSA values < 2ng/ml. Its indication with values < 0.5ng/mL should be assessed according to individual risk. In 56.9% of the patients in the study the positive result could influence changes in therapeutic strategy.
The limited current literature on the use of IORT in brain metastases appears to show efficacy and safety, but the most effective dose is unknown as well as whether it is as effective as other radiotherapy alternatives. Our study is ongoing and needs to be completed and evaluated with more follow-up in order to reach definitive conclusions.
Background: Some studies suggested that the patients included in the Z0011 trial may represent patients with ultrasound-negative axillary nodes and axillary invasion diagnosed by sentinel node (SN) biopsy. Nevertheless, the National Comprehensive Cancer Network (NCCN) guidelines recommend SN mapping if 1 or 2 suspicious lymph nodes are identified on axillary ultrasound (AU). The aim of this preliminary phase of the Multimodal Targeted Axillary Surgery (MUTAS) trial was to establish the accuracy of SN mapping in patients with axillary involvement undergoing upfront surgery.Methods: Between September 2019 and March 2022, we recruited patients with biopsy-proven metastatic axillary nodes and upfront surgery from a single center. We performed SN mapping in these patients before the surgical intervention, which included axillary lymph node dissection. The biopsy-proven metastatic node, SNs and the remaining axillary nodes were excised separately. SN status was considered representative of the status of the remaining axillary nodes. We calculated the sensitivity, specificity, negative predictive value and positive predictive value of the SN, overall and in patients with palpable nodes, in those with non-palpable nodes and an AU leading to diagnosis of axillary involvement, in those with 1 or 2 suspicious nodes on AU, and in patients with a single suspicious node on AU. We evaluated clinical, imaging and pathology features as predictors of the status of the remaining axillary nodes, false-negatives, and false-positives.Results: We included 25 patients in this phase. The false-negative rate of SN mapping was 28% overall, 21.42% for patients with palpable nodes, 36.36% for patients with non-palpable nodes and an AU diagnosis of axillary involvement, 28.75% for those with 1 or 2 suspicious nodes on AU, and 15.38% in patients with a single suspicious node on AU. The negative predictive value was highest in patients with a single suspicious node on AU (75%). The only significant predictive factor was that FN showed a higher Ki67 index score.Conclusions: In this study, SN mapping was not reliable in patients with biopsy-proven metastatic axillary nodes and upfront surgery for any of the subgroups studied. Further research should elucidate the best staging pathways in these patients to avoid premature de-escalation.
BACKGROUND:Radiotherapy (RT) combined with breast reconstruction can reduce the risk of cancer recurrence and increase the survival rate. However, this approach seems to worsen aesthetic outcomes and increase complication rates. The impact of breast reconstruction timing and techniques on clinical outcomes, however, remains unclear. For this reason, we aimed to perform a more comprehensive analysis of a series of patients undergoing RT and breast reconstruction.METHODS:Patients were divided into 4 groups according to the timing of reconstruction (before RT and after RT) and surgical technique (heterologous reconstruction and autologous reconstruction (AR)). The median time between RT and reconstruction, number of revision surgeries, incidence of complications, toxicity, aesthetics and associated clinical risk factors were used to assess the clinical outcomes. An objective system of skin toxicity evaluation was performed.RESULTS:Ninety-five patients were included in this study. No significant differences in the median time between RT and reconstruction, incidence of complications, toxicity or aesthetics were noted between different timings or techniques of reconstruction. Patients undergoing AR needed more revision surgeries to complete reconstruction. However, the total number of surgical procedures was similar between the groups. In a comparison between the treated and untreated breasts by an objective system, RT produced an increase in erythema and pigmentation and a decrease in elasticity in the treated breast (p<0.05 for all parameters). On multivariate analysis, smoking was a significant predictor associated with complications.CONCLUSIONS:Combined breast reconstruction and RT seem to be successful regardless of the order of treatment or the type of reconstruction.
Purpose To report long-term results of a randomized trial comparing accelerated partial breast irradiation (APBI) to whole-breast irradiation (WBI) in terms of efficacy, toxicity, and cosmesis. Methods and materials WBI group was treated with 3D conformal external irradiation, 2 Gy daily/fraction, 5 fractions/week, to a total dose of 50 Gy. APBI group was treated with 3D conformal external irradiation 3.75 Gy/fraction, twice a day, 5 fractions/week, to a total dose of 37.5 Gy in the APBI group. Patients were followed up every 6 months up to 5 years and yearly thereafter. During follow-up visits, the clinician evaluated chronic toxicity and scored cosmetic results with a four-scale system. Results After a median follow-up of 10.3 years, 43 patients in each group (84%) are alive without disease. One patient died after disease progression in the APBI arm, and there was no death in the WBI arm. The rest of the patients died from another disease different than breast cancer, similarly between groups. There was greater fibrosis in the APBI group (9 patients grade 1 and one grade 2) compared to WBI (3 patients grade 1 and one grade 2); p = 0.18. Regarding cosmesis, in APBI group, 19 and 21 (43.2 and 47%) patients had excellent or good results, similar to the WBI group with 18 patients (40.9%) in each cosmesis outcome. The WBI group did not have any patient with poor cosmesis but the APBI had 3 (6.8%; p = 0.24). Conclusion After a follow-up of 10 years, there were no differences in efficacy between the 2 treatment arms. Despite slight greater toxicity in the APBI group, the cosmesis was similar and satisfactory in both groups.
Purpose Radiation-induced toxicity (RIT) is usually assessed by inspection and palpation. Due to their subjective and unquantitative nature, objective methods are required. This study aimed to determine whether a quantitative tool is able to assess RIT and establish an underlying BED-response relationship in breast cancer. Methods Patients following seven different breast radiation protocols were recruited to this study for RIT assessment with qualitative and quantitative examination. The biologically equivalent dose (BED) was used to directly compare different radiation regimens. RIT was subjectively evaluated by physicians using the Radiation Therapy Oncology Group (RTOG) late toxicity scores. Simultaneously an objective multiprobe device was also used to quantitatively assess late RIT in terms of erythema, hyperpigmentation, elasticity and skin hydration. Results In 194 patients, in terms of the objective measurements, treated breasts showed higher erythema and hyperpigmentation and lower elasticity and hydration than untreated breasts ( p < 0.001, p < 0.001, p < 0.001, p = 0.019, respectively). As the BED increased, Δerythema and Δpigmentation gradually increased as well ( p = 0.006 and p = 0.002, respectively). Regarding the clinical assessment, the increase in BED resulted in a higher RTOG toxicity grade ( p < 0.001). Quantitative assessments were consistent with RTOG scores. As the RTOG toxicity grade increased, the erythema and pigmentation values increased, and the elasticity index decreased ( p < 0.001, p = 0.016, p = 0.005, respectively). Conclusions The multiprobe device can be a sensitive and simple tool for research purpose and quantitatively assessing RIT in patients undergoing radiotherapy for breast cancer. Physician-assessed toxicity scores and objective measurements revealed that the BED was positively associated with the severity of RIT.
Purpose Weekly irradiation in breast cancer in elderly patients is a treatment option, whose tolerance may be influenced by the fractionation used. The objective of this study is to compare the tolerance and long-term side effects of two different fractionations. Materials and methods 47 elderly patients were recruited after conservative or radical treatment that also received irradiation with a dose per fraction of 6.25 Gy or 5 Gy for one session per week, 6 sessions in total. The long-term tolerance results are compared by assessing toxicity using CTCAE version 5.0 scales for dermatitis, telangectasia, fibrosis and pain of the irradiated breast. In addition, objective parameters of skin status (erythema, hyperpigmentation, elasticity and hydration) by a multi-probe MultiSkin Test-Center system were obtained and compared between groups. Results After an average follow-up of 5 years, all patients were free of disease and with complete local control. A total of 20 patients with 6.25 Gy fractionation and 27 patients with 5 Gy fractionation have been included. Patients treated with lower fractionation had a lower incidence of dermatitis, telangectasia, fibrosis, or local pain. The decrease in elasticity measured by the multi-probe system was smaller with the fractionation of 5 Gy. No differences were observed in the other objective parameters. Conclusion Weekly irradiation with 5 Gy fractionation is better tolerated than with higher fractionation.
Dysphagia is a common toxicity of head and neck radiation therapy in patients undergoing chemoradiotherapy (CRT). There are discrepancies between the parameters by the instrumental methods and the perceptions of the patient. The objective of this study is to correlation the 10-item feeding assessment tool (EAT-10) for swallowing disorders, and the Penetration-Aspiration Scale (PAS) score obtained by videofluoroscopy, visual analogic scale (VAS) and functional oral intake scale (FOIS) within 3 months after treatment. We evaluated 46 patients included in "Redyor" study, measured at baseline (diagnosis), before and after initiating CRT, and at 3-month follow-up, were EAT-10, visual analogic scale (VAS) for self-impaired swallow, dysphagia assessed with PAS, functional oral intake scale (FOIS), maximal interincisor opening, and maximum isometric tongue pressure. Who had the EAT-10 test before, the end and 3 months after the treatment, to evaluate the relationship between PAS, VAS, and FOIS. A receiver operating characteristic (ROC) curve determined for the cut-off of the EAT-10. The Spearman correlation coefficients were calculated. A p <0.05 bilateral was considered statistically significant. Functional and self-perception values decreased in weeks 6 to 9 after CRT, coinciding with the worst EAT-10 score. A receiver operating characteristic (ROC) curve determined 3 cut-off points (with their respective sensitivity and specificity): baseline, 3 (86%, 77%); post-CRT, 15 (62.5%, 80%); and 3-month follow-up, 4 (83%, 75%). A strong correlation between VAS, FOIS, and EAT-10 observed at baseline subsequently disappeared. Table 1. New cut-off points for EAT-10 are suggested during the treatment. Our findings confirm the poor relationship between EAT-10 and the instrumental methods and highlight the need to optimize the use of tools to detect and monitor dysphagia in this cohort of patients with high risk of bronchoaspiration EAT-10, Eating Assessment Test; PAS, Penetration-Aspiration scale; VAS visual analogic scale for self-perception swallowing disturbances. Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy (ReDyOR) NCT02900911.Abstract 2838; Table 1Spearman correlation coefficients (r) between EAT-10 and PAS, FOIS and VAS in the study periodPASFOISVASBefore chemoradiotherapy (basal)0.314; p=0.0550.340; p=0.0370.451; p=0.005After chemoradiotherapy0.329; p=0.1450.127; p=0.5820.254; p=0.2673-months post-chemoradiotherapy0.275; p=0.3030.008; p=0.9760.005; p=0.987 Open table in a new tab
The weekly irradiation in breast cancer patients of advanced age is an option of treatment which tolerance can be influenced by the fractionation utilized. We analyze the long-term results of two weekly schedules. Between 1992 and 2016, we included 486 elderly patients presenting concomitant pathology or socio-familial problems in which it was not feasible to propose conventional treatment. They were treated with conservative surgery (or mastectomy in some cases) and then adjuvant hypofractionated irradiation, administering 5 Gy or 6.25 Gy in 6 fractions, once a week (total dose 30–37.5Gy) over 6 weeks. Both long-term fractionations have been compared in a cohort of 46 patients. Long term efficacy is evaluated as well as the chronic toxicity by means of scales of the CTCAE version 5.0 as for dermatitis, telangiectasia, fibrosis, and pain. Objective parameters of skin quality have been evaluated by means a multiprobe system, MultiSkin Test Center, measuring erythema, pigmentation, elasticity, and hydration. Median follow-up was 6 years. Overall survival according to the Kaplan-Meier method at 5 years was 74.2%±2.3%; breast cancer disease-free survival was 90%±1.6%; local relapse-free survival was 96.5%±1% showing that patients die more from other causes and not from their neoplasia. Acute dermatitis was mild (75.6% of the patients, grades I–III) and 30.6% had moderate chronic fibrosis. In the cohort of longer survivors, patients received doses of 6.25 Gy in 21 cases and 5 Gy in 25 cases. Patients treated with smaller dose presented lower incidence of dermatitis, telangiectasias fibrosis, or local pain. Diminish in elasticity measured by multiprobe system was also less marked in patients receiving doses of 5 Gy. There were no differences in the other parameters of skin quality at long term. Once-weekly hypofractionated radiotherapy is feasible and convenient option for elderly patients with breast cancer. It is a safe treatment modality with similar survival and local control results compared to standard fractionation, while the side effects are acceptable. Weekly irradiation at a 5 Gy per dose is equal in terms of efficacy but better tolerated compared to a superior dose schedule.
The diagnosis of unresectable locally advanced pancreatic adenocarcinoma (LAPC) requires confirmation, through imaging tests, of the unfeasibility of achieving a complete surgical resection, in the absence of metastatic spread. The increase in overall survival (OS), together with an appropriate symptom management is the therapeutic target in LAPC, maintaining an acceptable quality of life and, if possible, increasing the time until the appearance of metastasis. Chemoradiation (CRT) improves OS compared to best support treatment or radiotherapy (RT) but with greater toxicity. No significant increase in OS has been achieved with CRT when compared to chemotherapy (QT) alone in patients without disease progression after four months of treatment with QT. However, a significantly better local control, that is, a significant increase in the time to disease progression was associated with this approach. The greater effectiveness of the schemes FOLFIRINOX and gemcitabine (Gem) + Nab-paclitaxel compared to gemcitabine alone, has been extrapolated from metastatic disease to LAPC, representing a possible alternative for patients with good performance status (ECOG 0–1). In the absence of randomized clinical trials, Gem is the standard treatment in LAPC. If disease control is achieved after 4–6 cycles of QT, the use of CRT for consolidation can be considered an option vs QT treatment maintenance. Capecitabine has a better toxicity profile and effectiveness compared to gemcitabine as a radiosensitizer. After local progression, and without evidence of metastases, treatment with RT or CRT, in selected patients, can support to maintain the regional disease control.
The management of patients with pancreatic cancer has advanced over the last few years. We convey a multidisciplinary group of experts in an attempt to stablish practical guidelines for the diagnoses, staging and management of these patients. This paper summarizes the main conclusions of the working group. Patients with suspected pancreatic ductal adenocarcinoma should be rapidly evaluated and referred to high-volume centers. Multidisciplinary supervision is critical for proper diagnoses, staging and to frame a treatment plan. Surgical resection together with chemotherapy offers the highest chance for cure in early stage disease. Patients with advanced disease should be classified in treatment groups to guide systemic treatment. New chemotherapeutic regimens have resulted in improved survival. Symptomatic management is critical in this disease. Enrollment in a clinical trial is, in general, recommended.