Growing cells of Saccharomyces cerevisiae immobilized in calcium alginate gel beads were employed in fluidizedbed reactors for continuous ethanol fermentation from cane molasses and other sugar sources. Some improvements were made in order to avoid microbial contamination and keep cell viability for stable long run operations. Notably, entrapment of sterol and unsaturated fatty acid into immobilized gel beads enhanced ethanol productivity more than 50 g ethanol/L gel h and prolonged life stability for more than one-half year. Cell concentration in the carrier was estimated over 250 g dry cell/L gel. A pilot plant with a total column volume of 4 kL was constructed and has been operated since 1982. As a result, it was confirmed that 8-10%(v/v)ethanol-containing broth was continuously produced from nonsterilized diluted cane molasses for over one-half year. The productivity of ethanol was calculated as 0.6 kL ethanol/kL reactor volume day with a 95% conversion yield versus the maximum theoretical yield for the case of 8.5% (v/v) ethanol broth.
Four cases of a deleterious mutation in BRCA1 or BRCA2 were detected among 20 cases. Their first degree relatives are now under consideration for visiting counseling divisions. The clinical system described in this study should play a role to protect BRCA1 or BRCA2 mutation carriers in Japan.
Background: Although superior antitumor activity of anastrozole over tamoxifen has been well established in postmenopausal breast cancer patients, it still remains to be examined whether or not anastrozole is superior to tamoxifen in premenopausal breast cancer patients whose ovarian function is suppressed by goserelin to postmenopausal levels. The aim of this study was to compare anastrozole plus goserelin versus tamoxifen plus goserelin as pre-operative treatment for premenopausal Japanese women with breast cancer.
Methods: Phase III, randomized, double-blind, parallel-group, multi-center study (D539BC00001). Premenopausal patients (pts) with ER-positive and HER2-negative breast cancer and with operable and measurable lesions (T [2-5 cm], N0, M0) were randomized 1:1 to receive a goserelin 3.6 mg depot injection once monthly plus either anastrozole 1 mg (A+G) or tamoxifen 20 mg (T+G) p.o. once daily. Treatment continued for 24 weeks prior to surgery or until any other criterion for discontinuation was met. Concomitant chemotherapy was not permitted during the pre-operative period. The primary objective was to assess the best overall tumor response (either a complete response [CR] or a partial response [PR]), according to modified RECIST criteria. Tumor size was measured by caliper and ultrasound every 4 weeks and by magnetic resonance imaging/computed tomography (MRI/CT) every 12 weeks. Tolerability (adverse events [AEs], laboratory tests, vital signs, WHO performance status) was assessed as a secondary objective. AEs were evaluated according to CTCAE v3.0.
Results: In total, 197 pts were randomized (A+G: 98, T+G: 99) and 185 pts completed the 24-week pre-operative treatment period and went on to receive breast surgery. The remaining 12 pts discontinued study treatment due to disease progression (A+G: 1; T+G: 5), voluntary discontinuation (A+G: 2; T+G: 3) and AE (T+G: 1). Pt demographics were generally well balanced. Median duration of exposure was similar for A+G (171 days) and T+G (170 days); treatment compliance was 99% for both. A+G led to a statistically significantly higher overall response rate compared with T+G, by caliper as well as by ultrasound and MRI/CT.
The safety profiles were consistent with the known safety profile of anastrozole, tamoxifen and goserelin. The incidence of AEs was similar
for A+G (88.8%) vs T+G (85.7%); most AEs were mild or moderate (CTC grade 1 or 2). The most common AEs were hot flash (A+G: 52.0%; T+G: 53.1%) and arthralgia (A+G: 35.7%; T+G: 20.4%). Conclusion: This study has demonstrated that the A+G combination has a superior benefit-risk profile compared with T+G as pre-operative treatment in Japanese premenopausal women with ER-positive breast cancer.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P1-12-03.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.