Selected breast cancer risk factors and early detection of the neoplasm in women from Lublin region attending screening program in St. John’s Cancer Center, years 2005–2006

[b]introduction and objective[/b]. In Poland, consulting is offered to women about risk factors of breast cancer, breast symptoms and early cancer detection. Study aims were to evaluate the correlation between some risk factors and women’s attendance to breast checkups, and to assess links between risk factors and detection of early breast cancer. [b]materials and methods. [/b]The study involved 8014 women aged 50–69 years, participating in breast cancer screening program. The frequency of breast checkups (mammography, CBE and BSE) and occurrence of breast cancer risk factors in studied women were evaluated as well as clinical stage of detected tumors. Odds ratios were used to compare relative odds of breast cancer with exposure to risk factors. [b]results. [/b]47.11% studied women had regularly undergone MMG, 30.82% had CBE within the previous year, 14.26% regularly performed BSE. The incidence of risk factors varied from 2.94% (menarche at ≤ 11 years) to 12.38% (current use of HRT). In 47.82% women, no evidence of studied risk factors was found. Women with history of breast biopsies and current users of HRT had MMG, CBE and BSE significantly more often ( p<0.0001). 29.27% early breast cancers (pTis, pT1abN0) were found among 82 detected tumors. Relative odds of breast cancer occurrence in women without the risk factors were significantly lower (OR = 0.55, 95% CI [0.35; 0.86]). Only nulliparous women had significantly higher odds of early breast cancer (OR = 7.37, 95% CI [1.32; 41.17]). [b]conclusions. [/b]Women using HRT and women after breast biopsy were significantly more likely to attend breast checkups. There were no significant links between most risk factors and odds of early stages of breast cancer. Women should have preventive checkups irrespective of their breast cancer risk factors

Randomised Phase Ii Study Evaluating, As First-Line Chemotherapy, Weekly Oral Vinorelbine As a Single-Agent Versus Weekly Paclitaxel As a Single-Agent in Estrogen Receptor Positive, Her2-Negative Patients with Advanced Breast Cancer (Norbreast-231 Trial)

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Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer

Purpose: Metastatic breast cancer (MBC) remains an incurable illness in the majority of cases, despite major therapeutic advances. This may be related to the ability of breast tumors to induce neoangiogenesis, even in the face of cytotoxic chemotherapy. Sunitinib, an inhibitor of key molecules involved in neoangiogenesis, has an established role in the treatment of metastatic renal cell and other cancers and demonstrated activity in a phase II trial in MBC. We performed a randomized phase III trial comparing sunitinib plus capecitabine (2,000 mg/m2) with single-agent capecitabine (2,500 mg/m2) in patients with heavily pretreated MBC. Patients and Methods: Eligibility criteria included MBC, prior therapy with anthracyclines and taxanes, one or two prior chemotherapy regimens for metastatic disease or early relapse after a taxane plus anthracycline adjuvant regimen, and adequate organ function and performance status. The primary end point was progression-free survival, for which the study had 90% power to detect a 50% improvement (from 4 to 6 months). Results: A total of 442 patients were randomly assigned. Progression-free survival was not significantly different between the treatment arms, with medians of 5.5 months (95% CI, 4.5 to 6.0) for the sunitinib plus capecitabine arm and 5.9 months (95% CI, 5.4 to 7.6) for the capecitabine monotherapy arm (hazard ratio, 1.22; 95% CI, 0.95 to 1.58; one-sided P = .941). There were no significant differences in response rate or overall survival. Toxicity, except for hand-foot syndrome, was more severe in the combination arm. Conclusion: The addition of sunitinib to capecitabine does not improve the clinical outcome of patients with MBC pretreated with anthracyclines and taxanes

A randomized, placebo-controlled phase 2 study of paclitaxel in combination with reparixin compared to paclitaxel alone as front-line therapy for metastatic triple-negative breast cancer (fRida)

Purpose: CXCR1, one of the receptors for CXCL8, has been identified as a druggable target on breast cancer cancer stem cells (CSC). Reparixin (R), an investigational oral inhibitor of CXCR1, was safely administered to metastatic breast cancer patients in combination with paclitaxel (P) and appeared to reduce CSC in a window-of-opportunity trial in operable breast cancer. The fRida trial (NCT02370238) evaluated the addition of R to weekly as first-line therapy for metastatic (m) TNBC. Subjects and Methods: Subjects with untreated mTNBC were randomized 1:1 to R or placebo days 1–21 in combination with weekly P 80 mg/m2 on days 1, 8, 15 of 28-day cycles. The primary endpoint was PFS by central review. Results: 123 subjects were randomized (62 to R + P and 61 to placebo + P). PFS was not different between the 2 groups (median 5.5 and 5.6 months for R + P and placebo + P, respectively; HR 1.13, p = 0.5996). ALDH+ and CD24−/CD44+ CSC centrally evaluated by IHC were found in 16 and 34 of the 54 subjects who provided a metastatic tissue biopsy at study entry. Serious adverse events (21.3 and 20% of subjects) and grade ≥ 3 adverse reactions (ADR) (9.1 and 6.3% of all ADRs) occurred at similar frequency in both groups. Conclusion: fRida is the first randomized, double-blind clinical trial of a CSC-targeting agent in combination with chemotherapy in breast cancer. The primary endpoint of prolonged PFS was not met. Clinical Trial Registration/Date of Registration: NCT01861054/February 24, 2015