Abstract

To compare acute skin toxicity in a prospective trial comparing concurrent or sequential anastrozole with radiation therapy in postmenopausal hormone receptor-positive breast cancer patients, and to analyze the impact of serum TGF-β 1 and IL-8 level on radiation-induced skin toxicity. From January 2, 2011 to June 20, 2012, 80 patients were enrolled in this prospective trial. Patients were randomized as concurrent group (n = 40) in which hormonal therapy with anastrozole 1mg per day combined concurrently with radiation therapy, and sequential group (n = 40) in which hormonal therapy with anastrozole were followed after completion of radiation therapy. Both groups were balanced in age, surgical types, and TN staging. Treatment outcomes, acute toxicity and serum TGF-β 1 and IL-8 levels (before and 4 weeks after the start of radiation therapy) were followed up and analyzed. The median age of the 80 patients was 58 yrs (49∼72 yrs). The percentage of stage I, II and III was 12.5%, 22.5% and 65% in the concurrent group and 12.5%, 37.5% and 50% in the sequential group, respectively. The median follow-up time was 24 months (12∼34 months). Five patients in the concurrent group and seven patients in the sequential group developed grade 2 or worse acute skin-related toxicity, the difference between two groups was not statistical significant (P > 0.05). The incidence of hematologic toxicity of two groups was no statistically significant difference (P > 0.05). There was no symptomatic radiation pneumonitis in two groups. The overall survival was 100% in both groups, the difference of metastasis-free survival between two groups was not statistically significant (P = 0.653). Both serum TGF-β 1 and IL-8 levels between two groups were not significantly different (P > 0.05). However, in the entire group, patients developing grade 2 or worse acute skin toxicity had higher serum levels of IL-8 at the 4th week after the start of radiation therapy compared to those with grade 1 skin toxicity only (P = 0.008). The sequence of adjuvant anastrozole with post-operative radiation therapy did not seem to impact the acute radiation-induced toxicity, nor did it appear to influence the therapeutic outcomes with early follow-up. Neither serum TGF-β 1 nor IL-8 level in the course of radiation therapy was influenced by the sequence of anastrozole with radiation therapy. Higher lever of serum IL-8 in the course of radiation therapy might be associated with more severe acute radiation-induced skin toxicity. Further follow-up is needed to identify the impact of serum IL-8 on late radiation toxicity.

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