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Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial.

ABSTRACT: Monocentric cohorts suggested that radiation-induced CD8 T-lymphocyte apoptosis (RILA) can predict late toxicity after curative intent radiotherapy (RT). We assessed the role of RILA as a predictor of breast fibrosis (bf +) after adjuvant breast RT in a prospective multicenter trial.A total of 502 breast-cancer patients (pts) treated by conservative surgery and adjuvant RT were recruited at ten centers. RILA was assessed before RT by flow cytometry. Impact of RILA on bf + (primary endpoint) or relapse was assessed using a competing risk method. Receiver-operator characteristic (ROC) curve analyses were also performed in intention to treat. This study is registered with ClinicalTrials.gov, number NCT00893035 and final analyses are presented here.Four hundred and fifty-six pts (90.8%) were included in the final analysis. One hundred and eight pts (23.7%) received whole breast and node irradiation. A boost dose of 10-16 Gy was delivered in 449 pts (98.5%). Adjuvant hormonotherapy was administered to 349 pts (76.5%). With a median follow-up of 38.6 months, grade ? 2 bf + was observed in 64 pts (14%). A decreased incidence of grade ? 2 bf + was observed for increasing values of RILA (p = 0.012). No grade 3 bf + was observed for patients with RILA ? 12%. The area under the ROC curve was 0.62. For cut-off values of RILA ? 20% and < 12%, sensitivity and specificity were 80% and 34%, 56% and 67%, respectively. Negative predictive value for grade ? 2 bf + was equal to 91% for RILA ? 20% and positive predictive value was equal to 22% for RILA < 12% where the overall prevalence of grade ? 2 bf + was estimated at 14%. A significant decrease in the risk of grade ? 2 bf + was found if patients had no adjuvant hormonotherapy (sHR = 0.31, p = 0.007) and presented a RILA ? 12% (sHR = 0.45, p = 0.002).RILA significantly predicts the risk of breast fibrosis. This study validates the use of RILA as a rapid screening test before RT delivery and will change definitely our daily clinical practice in radiation oncology.The French National Cancer Institute (INCa) through the "Program Hospitalier de Recherche Clinique (PHRC)".

SUBMITTER: Azria D

PROVIDER: S-EPMC4703704 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial.

Azria David D Riou Olivier O Castan Florence F Nguyen Tan Dat TD Peignaux Karine K Lemanski Claire C Lagrange Jean-Léon JL Kirova Youlia Y Lartigau Eric E Belkacemi Yazid Y Bourgier Céline C Rivera Sofia S Noël Georges G Clippe Sébastien S Mornex Françoise F Hennequin Christophe C Kramar Andrew A Gourgou Sophie S Pèlegrin André A Fenoglietto Pascal P Ozsahin Esat Mahmut EM

EBioMedicine 20151025 12

<h4>Background</h4>Monocentric cohorts suggested that radiation-induced CD8 T-lymphocyte apoptosis (RILA) can predict late toxicity after curative intent radiotherapy (RT). We assessed the role of RILA as a predictor of breast fibrosis (bf +) after adjuvant breast RT in a prospective multicenter trial.<h4>Methods</h4>A total of 502 breast-cancer patients (pts) treated by conservative surgery and adjuvant RT were recruited at ten centers. RILA was assessed before RT by flow cytometry. Impact of R ...[more]

PMID: 26844275

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Project description:BackgroundConsumer electronics and Web-enabled mobile devices are playing an increasing role in patient care, and their use in the oncologic sector opens up promising possibilities in the fields of supportive cancer care and systematic patient follow-up.ObjectiveThe objective of our study was to assess the acceptance and possible benefits of a mobile app-based concept for supportive care of cancer patients undergoing radiotherapy.MethodsIn total, 975 patients presenting for radiotherapy due to breast or prostate cancer were screened; of them, 200 owned a smartphone and consented to participate in the survey. Patients were requested to complete a questionnaire at 2 time points: prior to the initiation (T0) and after the completion (T1) of radiotherapy. The questionnaire included questions about the habits of smartphone usage, technical knowledge and abilities of the participants, readiness to use a mobile app within the context of radiotherapy, possible features of the mobile app, and general attitude toward the different aspects of oncologic treatments. For quantitative analysis, sum scores were calculated for all areas of interest, and results were correlated with patient characteristics. Additionally, answers were quantitatively compared between time points T0 and T1.ResultsMedian patient age was 57 (range 27-78) years. Of the 200 participants, 131 (66.2%) reported having the ability to use their smartphones with minimal to no help and 75.8% (150/200) had not used their smartphones in a medical context before. However, 73.3% (146/200) and 83.4% (166/200) of patients showed a strong interest in using a mobile app for supportive care during radiotherapy and as part of the clinical follow-up, respectively. Patients most commonly requested functionalities regarding appointment scheduling in the clinic (176/200, 88.0%) and the collection of patient-reported outcome data regarding their illness, therapy, and general well-being (130/200, 65.0%). Age was identified as the most influential factor regarding patient attitude, with patients aged <55 years being significantly more inclined toward and versed in smartphone use (P<.001). The acceptance of mobile apps was significantly higher in patients exhibiting a Karnofsky performance index <80% (P=.01). Support in the context of therapy-related side effects was judged most important by patients with poor clinical performance (P=.006). The overall acceptance of mobile apps in the context of radiotherapy surveillance was high at a median item sum score of 71.4/100 and was not significantly influenced by tumor stage, age, gender, treatment setting, or previous radiotherapies.ConclusionsThe acceptance of mobile apps for the surveillance and follow-up of cancer patients undergoing radiotherapy is high; this high acceptance level will serve as a basis for future clinical trials investigating the clinical benefits of mobile app-based treatment support. Introduction of mobile apps into the clinical routine should be considered as an opportunity to improve and intensify supportive treatment for cancer patients.

Dataset Information

Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial.

Publications

Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial.

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