BACKGROUND: We compared the efficacy of two different taxanes, docetaxel and paclitaxel, given either weekly or every 3 weeks, in the adjuvant treatment of breast cancer. METHODS: We enrolled 4950 women with axillary lymph node-positive or high-risk, lymph node-negative breast cancer. After randomization, all patients first received 4 cycles of intravenous doxorubicin and cyclophosphamide at 3-week intervals and were then assigned to intravenous paclitaxel or docetaxel given at 3-week intervals for 4 cycles or at 1-week intervals for 12 cycles. The primary end point was disease-free survival. RESULTS: As compared with patients receiving standard therapy (paclitaxel every 3 weeks), the odds ratio for disease-free survival was 1.27 among those receiving weekly paclitaxel (P=0.006), 1.23 among those receiving docetaxel every 3 weeks (P=0.02), and 1.09 among those receiving weekly docetaxel (P=0.29) (with an odds ratio >1 favoring the groups receiving experimental therapy). As compared with standard therapy, weekly paclitaxel was also associated with improved survival (odds ratio, 1.32; P=0.01). An exploratory analysis of a subgroup of patients whose tumors expressed no human epidermal growth factor receptor type 2 protein found similar improvements in disease-free and overall survival with weekly paclitaxel treatment, regardless of hormone-receptor expression. Grade 2, 3, or 4 neuropathy was more frequent with weekly paclitaxel than with paclitaxel every 3 weeks (27% vs. 20%). CONCLUSIONS:Weekly paclitaxel after standard adjuvant chemotherapy with doxorubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer. (ClinicalTrials.gov number, NCT00004125 [ClinicalTrials.gov].). Copyright 2008 Massachusetts Medical Society.
RCT Entities:
BACKGROUND: We compared the efficacy of two different taxanes, docetaxel and paclitaxel, given either weekly or every 3 weeks, in the adjuvant treatment of breast cancer. METHODS: We enrolled 4950 women with axillary lymph node-positive or high-risk, lymph node-negative breast cancer. After randomization, all patients first received 4 cycles of intravenous doxorubicin and cyclophosphamide at 3-week intervals and were then assigned to intravenous paclitaxel or docetaxel given at 3-week intervals for 4 cycles or at 1-week intervals for 12 cycles. The primary end point was disease-free survival. RESULTS: As compared with patients receiving standard therapy (paclitaxel every 3 weeks), the odds ratio for disease-free survival was 1.27 among those receiving weekly paclitaxel (P=0.006), 1.23 among those receiving docetaxel every 3 weeks (P=0.02), and 1.09 among those receiving weekly docetaxel (P=0.29) (with an odds ratio >1 favoring the groups receiving experimental therapy). As compared with standard therapy, weekly paclitaxel was also associated with improved survival (odds ratio, 1.32; P=0.01). An exploratory analysis of a subgroup of patients whose tumors expressed no human epidermal growth factor receptor type 2 protein found similar improvements in disease-free and overall survival with weekly paclitaxel treatment, regardless of hormone-receptor expression. Grade 2, 3, or 4 neuropathy was more frequent with weekly paclitaxel than with paclitaxel every 3 weeks (27% vs. 20%). CONCLUSIONS: Weekly paclitaxel after standard adjuvant chemotherapy with doxorubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer. (ClinicalTrials.gov number, NCT00004125 [ClinicalTrials.gov].). Copyright 2008 Massachusetts Medical Society.
Authors: S E Jones; J Erban; B Overmoyer; G T Budd; L Hutchins; E Lower; L Laufman; S Sundaram; W J Urba; K I Pritchard; R Mennel; D Richards; S Olsen; M L Meyers; P M Ravdin Journal: J Clin Oncol Date: 2005-08-20 Impact factor: 44.544
Authors: Miguel Martin; Tadeusz Pienkowski; John Mackey; Marek Pawlicki; Jean-Paul Guastalla; Charles Weaver; Eva Tomiak; Taher Al-Tweigeri; Linnea Chap; Eva Juhos; Raymond Guevin; Anthony Howell; Tommy Fornander; John Hainsworth; Robert Coleman; Jeferson Vinholes; Manuel Modiano; Tamas Pinter; Shou C Tang; Bruce Colwell; Catherine Prady; Louise Provencher; David Walde; Alvaro Rodriguez-Lescure; Judith Hugh; Camille Loret; Matthieu Rupin; Sandra Blitz; Philip Jacobs; Michael Murawsky; Alessandro Riva; Charles Vogel Journal: N Engl J Med Date: 2005-06-02 Impact factor: 91.245
Authors: Marc L Citron; Donald A Berry; Constance Cirrincione; Clifford Hudis; Eric P Winer; William J Gradishar; Nancy E Davidson; Silvana Martino; Robert Livingston; James N Ingle; Edith A Perez; John Carpenter; David Hurd; James F Holland; Barbara L Smith; Carolyn I Sartor; Eleanor H Leung; Jeffrey Abrams; Richard L Schilsky; Hyman B Muss; Larry Norton Journal: J Clin Oncol Date: 2003-02-13 Impact factor: 44.544
Authors: Donald A Berry; Constance Cirrincione; I Craig Henderson; Marc L Citron; Daniel R Budman; Lori J Goldstein; Silvana Martino; Edith A Perez; Hyman B Muss; Larry Norton; Clifford Hudis; Eric P Winer Journal: JAMA Date: 2006-04-12 Impact factor: 56.272
Authors: Daniel F Hayes; Ann D Thor; Lynn G Dressler; Donald Weaver; Susan Edgerton; David Cowan; Gloria Broadwater; Lori J Goldstein; Silvana Martino; James N Ingle; I Craig Henderson; Larry Norton; Eric P Winer; Clifford A Hudis; Matthew J Ellis; Donald A Berry Journal: N Engl J Med Date: 2007-10-11 Impact factor: 91.245
Authors: Clifford A Hudis; William E Barlow; Joseph P Costantino; Robert J Gray; Kathleen I Pritchard; Judith-Anne W Chapman; Joseph A Sparano; Sally Hunsberger; Rebecca A Enos; Richard D Gelber; Jo Anne Zujewski Journal: J Clin Oncol Date: 2007-05-20 Impact factor: 44.544
Authors: I Craig Henderson; Donald A Berry; George D Demetri; Constance T Cirrincione; Lori J Goldstein; Silvana Martino; James N Ingle; M Robert Cooper; Daniel F Hayes; Katherine H Tkaczuk; Gini Fleming; James F Holland; David B Duggan; John T Carpenter; Emil Frei; Richard L Schilsky; William C Wood; Hyman B Muss; Larry Norton Journal: J Clin Oncol Date: 2003-03-15 Impact factor: 44.544
Authors: Gabriel Ramirez; Ashley R Proctor; Ki Won Jung; Tong Tong Wu; Songfeng Han; Russell R Adams; Jingxuan Ren; Daniel K Byun; Kelley S Madden; Edward B Brown; Thomas H Foster; Parisa Farzam; Turgut Durduran; Regine Choe Journal: Biomed Opt Express Date: 2016-08-24 Impact factor: 3.732