BACKGROUND: Cancer subtype has recently become an increasingly important consideration when deciding the treatment strategy for breast cancer. For the estrogen receptor positive (ER+) subtype, the efficacy of adjuvant endocrine therapy is definitive, but that of adjuvant chemotherapy is controversial. METHODS: In order to evaluate the effect of adding doxorubicin (A) and cyclophosphamide (C) to tamoxifen (TAM) (ACT) on the overall survival (OS) of node-positive postmenopausal breast cancer (PMBC) patients, we conducted a randomized trial. Eligibility criteria included pathologically node-positive (n = 1-9) PMBC, stage I-IIIA disease. Patients were randomized to receive either TAM (20 mg daily) for 2 years or A (40 mg/m(2)) and C (500 mg/m(2)) plus TAM (ACT) as adjuvant therapy following surgery. RESULTS:One hundred twenty-nine patients were recruited (TAM 64, ACT 65) between October 1994 and July 1999. The hazard ratios for OS and relapse-free survival (RFS) were 0.58 (95 % CI 0.24-1.39; log-rank p = 0.22) and 0.45 (95 %CI 0.24-0.86; log-rank p = 0.013), respectively, in favor of ACT. The 5-year OS and RFS were 76.9 % (ER+ 87.1 %, ER- 53.3 %) and 54.9 % (ER+ 59.3 %, ER- 42.9 %) for TAM and 85.0 % (ER+ 90.0 %, ER- 77.1 %) and 76.7 % (ER+ 76.9 %, ER- 76.0 %) for ACT. A higher proportion of the patients receiving ACT than those receiving TAM experienced grade 3 decreased white blood cell count and grade 2-3 nausea. CONCLUSION: The efficacy of adding AC to TAM was not high for ER+, node-positive PMBC. However, adjuvant ACT therapy was considered to be effective for ER-, node-positive PMBC.
RCT Entities:
BACKGROUND: Cancer subtype has recently become an increasingly important consideration when deciding the treatment strategy for breast cancer. For the estrogen receptor positive (ER+) subtype, the efficacy of adjuvant endocrine therapy is definitive, but that of adjuvant chemotherapy is controversial. METHODS: In order to evaluate the effect of adding doxorubicin (A) and cyclophosphamide (C) to tamoxifen (TAM) (ACT) on the overall survival (OS) of node-positive postmenopausal breast cancer (PMBC) patients, we conducted a randomized trial. Eligibility criteria included pathologically node-positive (n = 1-9) PMBC, stage I-IIIA disease. Patients were randomized to receive either TAM (20 mg daily) for 2 years or A (40 mg/m(2)) and C (500 mg/m(2)) plus TAM (ACT) as adjuvant therapy following surgery. RESULTS: One hundred twenty-nine patients were recruited (TAM 64, ACT 65) between October 1994 and July 1999. The hazard ratios for OS and relapse-free survival (RFS) were 0.58 (95 % CI 0.24-1.39; log-rank p = 0.22) and 0.45 (95 %CI 0.24-0.86; log-rank p = 0.013), respectively, in favor of ACT. The 5-year OS and RFS were 76.9 % (ER+ 87.1 %, ER- 53.3 %) and 54.9 % (ER+ 59.3 %, ER- 42.9 %) for TAM and 85.0 % (ER+ 90.0 %, ER- 77.1 %) and 76.7 % (ER+ 76.9 %, ER- 76.0 %) for ACT. A higher proportion of the patients receiving ACT than those receiving TAM experienced grade 3 decreased white blood cell count and grade 2-3 nausea. CONCLUSION: The efficacy of adding AC to TAM was not high for ER+, node-positive PMBC. However, adjuvant ACT therapy was considered to be effective for ER-, node-positive PMBC.
Authors: Soonmyung Paik; Gong Tang; Steven Shak; Chungyeul Kim; Joffre Baker; Wanseop Kim; Maureen Cronin; Frederick L Baehner; Drew Watson; John Bryant; Joseph P Costantino; Charles E Geyer; D Lawrence Wickerham; Norman Wolmark Journal: J Clin Oncol Date: 2006-05-23 Impact factor: 44.544
Authors: K Tobinai; A Kohno; Y Shimada; T Watanabe; T Tamura; K Takeyama; M Narabayashi; T Fukutomi; H Kondo; M Shimoyama Journal: Jpn J Clin Oncol Date: 1993-08 Impact factor: 3.019
Authors: B Fisher; S Anderson; E Tan-Chiu; N Wolmark; D L Wickerham; E R Fisher; N V Dimitrov; J N Atkins; N Abramson; S Merajver; E H Romond; C G Kardinal; H R Shibata; R G Margolese; W B Farrar Journal: J Clin Oncol Date: 2001-02-15 Impact factor: 44.544
Authors: Judith Hugh; John Hanson; Maggie Chon U Cheang; Torsten O Nielsen; Charles M Perou; Charles Dumontet; John Reed; Maryla Krajewska; Isabelle Treilleux; Matthieu Rupin; Emmanuelle Magherini; John Mackey; Miguel Martin; Charles Vogel Journal: J Clin Oncol Date: 2009-02-09 Impact factor: 44.544
Authors: Mitch Dowsett; Torsten O Nielsen; Roger A'Hern; John Bartlett; R Charles Coombes; Jack Cuzick; Matthew Ellis; N Lynn Henry; Judith C Hugh; Tracy Lively; Lisa McShane; Soon Paik; Frederique Penault-Llorca; Ljudmila Prudkin; Meredith Regan; Janine Salter; Christos Sotiriou; Ian E Smith; Giuseppe Viale; Jo Anne Zujewski; Daniel F Hayes Journal: J Natl Cancer Inst Date: 2011-09-29 Impact factor: 13.506
Authors: Rainer Fagerholm; Sofia Khan; Marjanka K Schmidt; Montserrat García-Closas; Päivi Heikkilä; Jani Saarela; Jonathan Beesley; Maral Jamshidi; Kristiina Aittomäki; Jianjun Liu; H Raza Ali; Irene L Andrulis; Matthias W Beckmann; Sabine Behrens; Fiona M Blows; Hermann Brenner; Jenny Chang-Claude; Fergus J Couch; Kamila Czene; Peter A Fasching; Jonine Figueroa; Giuseppe Floris; Gord Glendon; Qi Guo; Per Hall; Emily Hallberg; Ute Hamann; Bernd Holleczek; Maartje J Hooning; John L Hopper; Agnes Jager; Maria Kabisch; Renske Keeman; Veli-Matti Kosma; Diether Lambrechts; Annika Lindblom; Arto Mannermaa; Sara Margolin; Elena Provenzano; Mitul Shah; Melissa C Southey; Joe Dennis; Michael Lush; Kyriaki Michailidou; Qin Wang; Manjeet K Bolla; Alison M Dunning; Douglas F Easton; Paul D P Pharoah; Georgia Chenevix-Trench; Carl Blomqvist; Heli Nevanlinna Journal: Oncotarget Date: 2017-03-14