The intraductal approach to the breast: raison d'être

Opportunities for the detection, prediction, and treatment of breast cancer exist at three biological levels: systemically via the blood, at the whole organ level, and within the individual ductal lobular structures of the breast. This review covers the evaluation of approaches targeted to the ductal lobular units, where breast cancer begins. Studies to date suggest the presence of 5 to 12 independent ductal lobular systems per breast, each harboring complex cellular fluids contributed by local and systemic processes. New techniques for accessing and interrogating these systems offer the potential to gauge the microenvironment of the breast and distill biological risk profiles

Preferences for oral versus intravenous adjuvant chemotherapy among early breast cancer patients

Makoto Ishitobi,1 Kazuyo Shibuya,2 Yoshifumi Komoike,1 Hiroki Koyama,1 Hideo Inaji1 1Department of Breast and Endocrine Surgery, 2Department of Nursing, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan Purpose: The purpose of this study was to evaluate preferences for oral versus intravenous adjuvant chemotherapy among early breast cancer patients (UMIN-CTR number UMIN000004696). Patients and methods: Eighty-two postmenopausal women with estrogen receptor-positive, human epidermal growth-factor receptor 2-negative breast cancer who had completed adjuvant chemotherapy were asked about their preferred route of administration of chemotherapy and the reason. Women also answered questions about their physical and psychological status and quality of life during chemotherapy. Results: Patients who had received oral chemotherapy preferred it more frequently than those who had received intravenous chemotherapy (100% versus 37%, respectively, chi-square =15.5; P<0.001). Patients who preferred the same route of administration of chemotherapy as they had previously received showed a significantly better psychological status during chemotherapy compared with those who preferred a different route. Conclusion: Our study showed that preferences for oral and intravenous chemotherapy strongly depended on the actual prior administration of chemotherapy and patients&#39; own experiences during chemotherapy. Keywords: breast cancer, adjuvant, chemotherapy, patient preference, oral, intravenou

A phase II, randomized, open-label, dose-finding study of TAS-108, a novel steroidal antiestrogen, administered orally in postmenopausal women with advanced or metastatic breast cancer.

Abstract Abstract #2132 Background: A phase II study was conducted to identify the recommended dose of TAS-108, a novel steroidal antiestrogen with full ERα antagonist, mainly metabolized by CYP3A4, in post menopausal Japanese women with advanced or metastatic breast cancer. This study was prepared referring to the multi-center phase II trial that performed in four countries (USA, Russia, Mexico and Chile), and performed in Japan. Both studies are not the same designs.&amp;#x2028; Patients and Methods: Patients with ER and/or PgR positive were eligible if they had one or two standard endocrine therapies, with or without one prior chemotherapy, for advanced disease. TAS-108 was administered orally at three different doses (40mg/80mg/120mg per day) for 24 weeks. The treatment was terminated if PD was observed. In this clinical study, clinical benefit (CB, CR+PR+SD for at least 24 weeks) rate as the primary end point was evaluated. The secondary endpoints were overall response rate and best overall response using RECIST; time to progression; adverse events (AEs) graded by CTC-AE (ver.3.0). Endometrial thickness (ET) and bone mineral density (BMD) as specific items of hormonal therapy were evaluated by transvaginal or transabdominal ultrasound, and dual-energy X-Ray absorptiometry method, respectively.&amp;#x2028; Results: Ninety eight patients were enrolled and randomized. One ineligible patient in the 120mg dose group dropped out without administration; therefore a total of ninety seven patients were administered and assessed for efficacy and safety. Thirty three patients received 40mg, 32 received 80mg and 120mg. The three treatment groups were well balanced. CB was observed in 10 patients (30.3%) in the 40mg group, and 8 patients (25.0%) in both the 80mg and 120mg groups. Retrospective analysis showed TAS-108 had effectiveness to patients who had failed on prior tamoxifen (TAM) or aromatase inhibitors (AI) treatment, including relapse during the adjuvant therapy or within 6 months from its completion. CB rate at the three doses respectively were 25.0/33.3/25.0% in 14 (4/6/4) patients failed on TAM, and 30.8/31.6/20.0% in 70 (26/19/25) patients failed on AI.&amp;#x2028; TAS-108 was well tolerated and most of the AEs were Grade1 or 2. The most frequent drug-related AEs were hot flush (22 patients, 22.7%, 7/8/7 patients in 40/80/120mg), perspiration (11 patients, 11.3%, 2/3/6), nausea (9 patients, 9.3%, 1/3/5), arthralgia (6 patients, 6.2%, 0/3/3). Neither remarkable change nor apparent dose-related trend among the three groups was observed in ET or BMD.&amp;#x2028; Conclusion: According to the protocol, 40mg was chosen as the recommended dose of TAS-108 for breast cancer. It was suggested that TAS-108 has clinical benefit for patients with breast cancer who have failed on prior TAM or AI treatments. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 2132.</jats:p