Literature DB >> 16966367

Detailed analysis of a randomized phase III trial: can the tolerability of capecitabine plus docetaxel be improved without compromising its survival advantage?

R Leonard1, J O'Shaughnessy, S Vukelja, V Gorbounova, C A Chan-Navarro, D Maraninchi, N Barak-Wigler, J J McKendrick, W G Harker, A S Bexon, C Twelves.   

Abstract

BACKGROUND: In a phase III trial, 3-weekly capecitabine (1250 mg/m(2) twice daily days 1-14) plus docetaxel (75 mg/m(2) day 1) demonstrated significantly superior overall survival to 3-weekly docetaxel (100 mg/m(2) day 1). We report a retrospective analysis of the impact of capecitabine/docetaxel dose reduction on safety and efficacy. PATIENTS AND METHODS: Safety and efficacy data were analyzed retrospectively according to the actual doses of capecitabine and docetaxel administered.
RESULTS: More patients receiving capecitabine/docetaxel (65%) had dose reductions for adverse events than docetaxel alone (35%). In most patients requiring dose reduction with the combination (80%), capecitabine and docetaxel were simultaneously reduced to 950 mg/m(2) and 55 mg/m(2), respectively. Subsequently, there were fewer cycles (17%) with grade 3/4 adverse events than with the full doses (34%). Time to progression and overall survival appeared to be similar in patients starting the second cycle with reduced doses of capecitabine/docetaxel and those who continued to receive full doses of capecitabine/docetaxel for at least the first four cycles.
CONCLUSIONS: Capecitabine/docetaxel dosing flexibility allows management of side-effects without compromising efficacy. This retrospective analysis, as well as multiple phase II studies of taxanes with reduced-dose capecitabine, shows that reducing the starting dose of capecitabine with docetaxel is a reasonable strategy for the treatment of patients with metastatic breast cancer. In addition, reducing the dose of both agents may be appropriate.

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Year:  2006        PMID: 16966367     DOI: 10.1093/annonc/mdl134

Source DB:  PubMed          Journal:  Ann Oncol        ISSN: 0923-7534            Impact factor:   32.976


  10 in total

1.  Efficacy of Vitamin E Treatment for Hand-Foot Syndrome in Patients Receiving Capecitabine.

Authors:  Daigo Yamamoto; Chizuko Yamamoto; Satoru Iwase; Yujiro Kuroda; Hiroki Odagiri; Yoshinori Nagumo
Journal:  Breast Care (Basel)       Date:  2010-11-26       Impact factor: 2.860

2.  Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial.

Authors:  Lawrence G Lum; Archana Thakur; Zaid Al-Kadhimi; Gerald A Colvin; Francis J Cummings; Robert D Legare; Don S Dizon; Nicola Kouttab; Abby Maizel; William Colaiace; Qin Liu; Ritesh Rathore
Journal:  Clin Cancer Res       Date:  2015-02-16       Impact factor: 12.531

3.  Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American Society of Clinical Oncology Clinical Practice Guideline.

Authors:  Ann H Partridge; R Bryan Rumble; Lisa A Carey; Steven E Come; Nancy E Davidson; Angelo Di Leo; Julie Gralow; Gabriel N Hortobagyi; Beverly Moy; Douglas Yee; Shelley B Brundage; Michael A Danso; Maggie Wilcox; Ian E Smith
Journal:  J Clin Oncol       Date:  2014-09-02       Impact factor: 44.544

4.  North Central Cancer Treatment Group (NCCTG) N0432: phase II trial of docetaxel with capecitabine and bevacizumab as first-line chemotherapy for patients with metastatic breast cancer.

Authors:  E A Perez; D W Hillman; T Dentchev; N A Le-Lindqwister; L H Geeraerts; T R Fitch; H Liu; D L Graham; S P Kahanic; H M Gross; T A Patel; F M Palmieri; A C Dueck
Journal:  Ann Oncol       Date:  2009-11-09       Impact factor: 32.976

5.  Sequential administration of dose-dense epirubicin/cyclophosphamide followed by docetaxel/capecitabine for patients with HER2-negative and locally advanced or node-positive breast cancer.

Authors:  Yago Nieto; José Manuel Aramendía; Jaime Espinós; Susana De la Cruz; Oscar Fernández-Hidalgo; Marta Santisteban; Leyre Arbea; Javier Aristu; Rafael Martínez-Monge; Marta Moreno; Luis Pina; Josu Sola; Gerardo Zornoza; Fernando Martínez Regueira
Journal:  Cancer Chemother Pharmacol       Date:  2009-06-14       Impact factor: 3.333

6.  Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer.

Authors:  Siao-Nge Hoon; Peter Kh Lau; Alison M White; Max K Bulsara; Patricia D Banks; Andrew D Redfern
Journal:  Cochrane Database Syst Rev       Date:  2021-05-26

7.  Randomized trial of preoperative docetaxel with or without capecitabine after 4 cycles of 5-fluorouracil– epirubicin–cyclophosphamide (FEC) in early-stage breast cancer: exploratory analyses identify Ki67 as a predictive biomarker for response to neoadjuvant chemotherapy.

Authors:  S Ohno; L W C Chow; N Sato; N Masuda; H Sasano; F Takahashi; H Bando; H Iwata; T Morimoto; S Kamigaki; T Nakayama; S Nakamura; K Kuroi; K Aogi; M Kashiwaba; H Yamashita; K Hisamatsu; Y Ito; Y Yamamoto; T Ueno; E Fakhrejahani; N Yoshida; M Toi
Journal:  Breast Cancer Res Treat       Date:  2013-11       Impact factor: 4.872

8.  Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial.

Authors:  Junjie Li; Keda Yu; Da Pang; Changqin Wang; Jun Jiang; Suisheng Yang; Yunjiang Liu; Peifen Fu; Yuan Sheng; Guojun Zhang; Yali Cao; Qi He; Shude Cui; Xijing Wang; Guosheng Ren; Xinzheng Li; Shiyou Yu; Pengxi Liu; Xiang Qu; Jinhai Tang; Ouchen Wang; Zhimin Fan; Guoqin Jiang; Jin Zhang; Jiandong Wang; Hongwei Zhang; Shui Wang; Jianguo Zhang; Feng Jin; Nanyan Rao; Binlin Ma; Pingqing He; Binghe Xu; Zhigang Zhuang; Jianfeng Wang; Qiang Sun; Xiaofeng Guo; Miao Mo; Zhimin Shao
Journal:  J Clin Oncol       Date:  2020-04-10       Impact factor: 44.544

Review 9.  International guidelines for management of metastatic breast cancer: combination vs sequential single-agent chemotherapy.

Authors:  Fatima Cardoso; Philippe L Bedard; Eric P Winer; Olivia Pagani; Elzbieta Senkus-Konefka; Lesley J Fallowfield; Stella Kyriakides; Alberto Costa; Tanja Cufer; Kathy S Albain
Journal:  J Natl Cancer Inst       Date:  2009-08-05       Impact factor: 13.506

10.  XeNA: capecitabine plus docetaxel, with or without trastuzumab, as preoperative therapy for early breast cancer.

Authors:  Stefan Glück; Edward F McKenna; Melanie Royce
Journal:  Int J Med Sci       Date:  2008-11-04       Impact factor: 3.738

  10 in total

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