Background and purpose Reported associations between risk of radiation-induced normal tissue injury and single nucleotide polymorphisms (SNPs) in TGFB1, encoding the pro-fibrotic cytokine transforming growth factor-beta 1 (TGF-β1), remain controversial. To overcome publication bias, the international Radiogenomics Consortium collected and analysed individual patient level data from both published and unpublished studies. Materials and methods TGFB1 SNP rs1800469 c.-1347T>C (previously known as C-509T) genotype, treatment- related data, and clinically-assessed fibrosis (measured at least 2 years after therapy) were available in 2782 participants from 11 cohorts. All received adjuvant breast radiotherapy. Associations between late fibrosis or overall toxicity, reported by STAT (Standardised Total Average Toxicity) score, and rs1800469 genotype were assessed. Results No statistically significant associations between either fibrosis or overall toxicity and rs1800469 genotype were observed with univariate or multivariate regression analysis. The multivariate odds ratio (OR), obtained from meta-analysis, for an increase in late fibrosis grade with each additional rare allele of rs1800469 was 0.98 (95% Confidence Interval (CI) 0.85–1.11). This CI is sufficiently narrow to rule out any clinically relevant effect on toxicity risk in carriers vs. non-carriers with a high probability. Conclusion This meta-analysis has not confirmed previous reports of association between fibrosis or overall toxicity and rs1800469 genotype in breast cancer patients. It has demonstrated successful collaboration within the Radiogenomics Consortium.

In a randomized trial, 105 postmenopausal women with advanced carcinoma of the breast received tamoxifen or aminoglutethimide or combined tamoxifen and aminoglutethimide. No differences were found in the rate of responses and duration of responses between the treatment groups. Toxicity was significantly greater (p < 0.01) in patients who received aminoglutethimide.

Seventy-two patients with advanced ovarian cancer received CAP chemotherapy followed by laparotomy and ‘second-effort’ surgery. The overall response to CAP therapy was 80%. A complete pathological response (CPR) was obtained in 16 patients and partial microscopic (PMiR) and macroscopic responses in 7 and 33 cases, respectively. The actuarial survival for the entire group was 36% at 50 months with a median survival of 34 months. No significant differences in survival between the CPR and PMiR groups were found. Radical second-effort surgery showed a somewhat beneficial effect. The tumor size before chemotherapy ( < 5 cm) and FIGO stage III had a significantly favorable effect on response rate and survival.