BACKGROUND:The current study was performed to investigate the potential impact of tumor cell expression of estrogen receptor-a (ER-a), progesterone receptor (PR), and androgen receptor (AR) on the outcomes of patients who received radiotherapy (RT) for nonsmall cell lung cancer (NSCLC). METHODS: Tumor cell expression of ER-a, PR, and AR as well as 9 additional potential prognostic factors were retrospectively evaluated in 64 patients who underwent RT for AJCC stage II/III NSCLC. The endpoints investigated were locoregional control, metastases-free survival, and overall survival. The additional potential prognostic factors were age, gender, Karnofsky performance score, histology, T classification, N classification, surgery, smoking during RT, and hemoglobin levels during RT. Subgroup analyses were performed for women and men. RESULTS: On univariate analysis, locoregional control was not found to be associated with expression of PR or AR. ER-a expression demonstrated a strong trend toward worse locoregional control. On multivariate analysis, ER-a expression was found to be significantly associated with worse locoregional control (risk ratio [RR], 3.12; P ¼ .035). On univariate analysis, metastases-free survival was not associated with expression of ER-a, PR, or AR. On univariate analysis, survival was found to be negatively associated with expression of ER-a (P ¼ .003) but not with PR or AR expression. On multivariate analysis, ER-a expression maintained significance (RR, 2.73; P ¼ .022). CONCLUSIONS: Tumor cell expression of ER-a was found to be a negative prognostic factor for treatment outcomes in both women and men. Expression of PR and AR was not associated with outcomes.

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BackgroundThe aim of the present trial is to investigate a new option of skin protection in order to reduce the rate of grade ≥ 2 skin toxicity in patients receiving radiotherapy alone or radiochemotherapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).Methods / DesignThis is a randomized, active-controlled, parallel-group multi-center trial that compares the following treatments of radiation dermatitis in patients with head-and-neck cancer: Mepitel® Film (Arm A) vs. standard care (Arm B). The primary aim of this trial is to investigate the rate of patients experiencing grade ≥ 2 radiation dermatitis (according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03) until 50 Gy of radiotherapy. Evaluation until 50 Gy of radiotherapy has been selected as the primary endpoint, since up to 50 Gy, the irradiated volume includes the primary tumor and the bilateral cervical and supraclavicular lymph nodes, and, therefore, is similar in all patients. After 50 Gy, irradiated volumes are very individual, depending on location and size of the primary tumor, involvement of lymph nodes, and the treatment approach (definitive vs. adjuvant). In addition, the following endpoints will be evaluated: Time to grade 2 radiation dermatitis until 50 Gy of radiotherapy, rate of patients experiencing grade ≥ 2 radiation dermatitis during radio(chemo)therapy, rate of patients experiencing grade ≥ 3 skin toxicity during radio(chemo)therapy, adverse events, quality of life, and dermatitis-related pain. Administration of Mepitel® Film will be considered to be clinically relevant, if the rate of grade ≥ 2 radiation dermatitis can be reduced from 85% to 65%.DiscussionIf administration of Mepitel® Film instead of standard care will be able to significantly reduce the rate of grade ≥ 2 radiation dermatitis, it could become the new standard of skin care in patients irradiated for SCCHN.Trial registrationclinicaltrials.gov NCT03047174. Registered on 26th of January, 2017. First patient included on 9th of May, 2017.

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