دورية أكاديمية
Cancer Research UK Phase I/II Committee. A Cancer Research (UK) randomised phase II study of idoxifene in patients with locally advanced / metastatic breast cancer resistant to tamoxifen
العنوان: | Cancer Research UK Phase I/II Committee. A Cancer Research (UK) randomised phase II study of idoxifene in patients with locally advanced / metastatic breast cancer resistant to tamoxifen |
---|---|
المؤلفون: | Johnston, S.R., Gumbrell, L.A., Evans, T.R., Coleman, R.E., Smith, I.E., Twelves, C.J., Soukop, M., Rea, D.W., Earl, H.M., Howell, A., Jones, A., Canney, P., Powels, T.J., Haynes, B.P., Nutley, B., Grimshaw, R., Jarman, Megan, Halbert, G.W., Brampton, M., Haviland, J.S., Dowsett, M., Coombes, R.C. |
سنة النشر: | 2004 |
المجموعة: | University of Southampton: e-Prints Soton |
الوصف: | Idoxifene is a novel selective oestrogen receptor modulator (SERM) which had greater binding affinity for the oestrogen receptor (ER) and reduced agonist activity compared with tamoxifen in preclinical studies. In a randomized phase II trial in 56 postmenopausal patients with progressive locally advanced/metastatic breast cancer we assessed whether idoxifene showed evidence of activity compared with an increased 40 mg/day dose of tamoxifen in patients who had previously demonstrated resistance to the standard 20 mg/day dose of tamoxifen. Of 47 patients eligible for response (25 idoxifene, 22 tamoxifen), two partial responses and two disease stabilizations (SD) for >6 months were seen with idoxifene (overall clinical benefit rate 16%, 95% CI 4.5–36.1%). The median duration of clinical benefit was 9.8 months. In contrast, no objective responses were seen with the increased 40 mg/day dose of tamoxifen, although two patients had SD for 7 and 14 months (clinical benefit rate 9%, 95% CI 1.1–29.2%). Idoxifene was well tolerated and the reported possible drug-related toxicities were similar in frequency to those with tamoxifen (hot flushes 13% vs 15%, mild nausea 20% vs 15%). Endocrine and lipid analysis in both groups showed a similar significant fall in serum follicle-stimulating hormone and luteinizing hormone after 4 weeks, together with a significant rise in sex hormone binding globulin levels and 11% reduction in serum cholesterol levels. In conclusion, while idoxifene was associated with only modest evidence of clinical activity in patients with tamoxifen-resistant breast cancer, its toxicity profile and effects on endocrine/lipid parameters were similar to those of tamoxifen |
نوع الوثيقة: | article in journal/newspaper |
اللغة: | English |
العلاقة: | Johnston, S.R., Gumbrell, L.A., Evans, T.R., Coleman, R.E., Smith, I.E., Twelves, C.J., Soukop, M., Rea, D.W., Earl, H.M., Howell, A., Jones, A., Canney, P., Powels, T.J., Haynes, B.P., Nutley, B., Grimshaw, R., Jarman, Megan, Halbert, G.W., Brampton, M., Haviland, J.S., Dowsett, M. and Coombes, R.C. (2004) Cancer Research UK Phase I/II Committee. A Cancer Research (UK) randomised phase II study of idoxifene in patients with locally advanced / metastatic breast cancer resistant to tamoxifen. Cancer Chemotherapy and Pharmacology, 53 (4), 341-348. (doi:10.1007/s00280-003-0733-6 ). |
الإتاحة: | https://doi.org/10.1007/s00280-003-0733-6Test https://eprints.soton.ac.uk/365430Test/ |
رقم الانضمام: | edsbas.D9111969 |
قاعدة البيانات: | BASE |
الوصف غير متاح. |