PURPOSE: To compare the effect of adjuvant endocrine therapies with and without chemotherapy on physical symptoms, anxiety, and depressive symptoms in premenopausal women with breast cancer in a randomized clinical trial (the Zoladex in Premenopausal Patients trial). PATIENTS AND METHODS: The patients were randomly assigned to goserelin, goserelin plus tamoxifen, tamoxifen alone, or no endocrine therapy. The duration of the endocrine treatment was 2 years. The groups were observed for 3 years after primary treatment (ie, during 2 years of active treatment as well as 1 year after cessation of the adjuvant endocrine therapy). All patients with node-positive disease receivedadjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (CMF), which was given concurrently with the endocrine treatment. RESULTS: Patients treated with CMF typically reported higher levels of physical symptoms than did patients who did not receive CMF. It was only among patients who did not receive chemotherapy that the endocrine treatment had differential effects. Goserelin was most burdensome and resulted in similar symptom levels as those of CMF, whereas the side effects of tamoxifen alone were milder. After cessation of the endocrine treatment, the side effects diminished in patients who had not received CMF, whereas patients treated with CMF reported ongoing problems at the 3-year follow-up. In contrast, anxiety and depressive symptoms were not significantly affected by endocrine treatment or chemotherapy during the 3 years of assessment. CONCLUSION:Goserelin and tamoxifen resulted in menopausal symptoms, but these symptoms were reversible. However, women treated with CMF experienced physical symptoms throughout the whole study period.
RCT Entities:
PURPOSE: To compare the effect of adjuvant endocrine therapies with and without chemotherapy on physical symptoms, anxiety, and depressive symptoms in premenopausal women with breast cancer in a randomized clinical trial (the Zoladex in Premenopausal Patients trial). PATIENTS AND METHODS: The patients were randomly assigned to goserelin, goserelin plus tamoxifen, tamoxifen alone, or no endocrine therapy. The duration of the endocrine treatment was 2 years. The groups were observed for 3 years after primary treatment (ie, during 2 years of active treatment as well as 1 year after cessation of the adjuvant endocrine therapy). All patients with node-positive disease received adjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (CMF), which was given concurrently with the endocrine treatment. RESULTS:Patients treated with CMF typically reported higher levels of physical symptoms than did patients who did not receive CMF. It was only among patients who did not receive chemotherapy that the endocrine treatment had differential effects. Goserelin was most burdensome and resulted in similar symptom levels as those of CMF, whereas the side effects of tamoxifen alone were milder. After cessation of the endocrine treatment, the side effects diminished in patients who had not received CMF, whereas patients treated with CMF reported ongoing problems at the 3-year follow-up. In contrast, anxiety and depressive symptoms were not significantly affected by endocrine treatment or chemotherapy during the 3 years of assessment. CONCLUSION: Goserelin and tamoxifen resulted in menopausal symptoms, but these symptoms were reversible. However, women treated with CMF experienced physical symptoms throughout the whole study period.
Authors: Catherine M Bender; John D Merriman; Amanda L Gentry; Gretchen M Ahrendt; Sarah L Berga; Adam M Brufsky; Frances E Casillo; Meredith M Dailey; Kirk I Erickson; Frances M Kratofil; Priscilla F McAuliffe; Margaret Q Rosenzweig; Christopher M Ryan; Susan M Sereika Journal: Cancer Date: 2015-04-23 Impact factor: 6.860
Authors: Jürg Bernhard; Weixiu Luo; Karin Ribi; Marco Colleoni; Harold J Burstein; Carlo Tondini; Graziella Pinotti; Simon Spazzapan; Thomas Ruhstaller; Fabio Puglisi; Lorenzo Pavesi; Vani Parmar; Meredith M Regan; Olivia Pagani; Gini F Fleming; Prudence A Francis; Karen N Price; Alan S Coates; Richard D Gelber; Aron Goldhirsch; Barbara A Walley Journal: Lancet Oncol Date: 2015-06-16 Impact factor: 41.316
Authors: Karin Ribi; Weixiu Luo; Jürg Bernhard; Prudence A Francis; Harold J Burstein; Eva Ciruelos; Meritxell Bellet; Lorenzo Pavesi; Ana Lluch; Marilena Visini; Vani Parmar; Carlo Tondini; Pierre Kerbrat; Antonia Perelló; Patrick Neven; Roberto Torres; Davide Lombardi; Fabio Puglisi; Per Karlsson; Thomas Ruhstaller; Marco Colleoni; Alan S Coates; Aron Goldhirsch; Karen N Price; Richard D Gelber; Meredith M Regan; Gini F Fleming Journal: J Clin Oncol Date: 2016-03-28 Impact factor: 44.544
Authors: K Ribi; J Bernhard; K Rufibach; B Thürlimann; R von Moos; T Ruhstaller; A Glaus; C Böhme Journal: Support Care Cancer Date: 2007-05-26 Impact factor: 3.603