Phase III trial evaluating weekly paclitaxel versus docetaxel in combination with capecitabine in operable breast cancer

Journal of Clinical Oncology

Volumn 30, Issue 9, 2012, Pages 930-935

  Kelly, Catherine M ^a   Green, Marjorie C ^a   Broglio, Kristine ^a   Thomas, Eva S ^a   Brewster, Abenaa M ^a   Valero, Vicente ^a   Ibrahim, Nuhad K ^a   Gonzalez Angulo, Ana M ^a   Booser, Daniel J ^a   Walters, Ronald S ^a   Hunt, Kelly K ^a   Hortobagyi, Gabriel N ^a   Buzdar, Aman U ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CAPECITABINE; CYCLOPHOSPHAMIDE; DOCETAXEL; EPIRUBICIN; FLUOROURACIL; PACLITAXEL; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; TAXOID;

ADULT; ALLERGIC REACTION; ALOPECIA; ARTHRALGIA; ARTICLE; BAYES THEOREM; BLOOD TOXICITY; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER RELAPSE; CANCER STAGING; CANCER SURVIVAL; CLINICAL EVALUATION; CONFIDENCE INTERVAL; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLUID RETENTION; FOLLOW UP; GASTROINTESTINAL TOXICITY; HAND FOOT SYNDROME; HUMAN; HUMAN CELL; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PARTIAL MASTECTOMY; PATHOLOGY; PATIENT COMPLIANCE; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RECURRENCE FREE SURVIVAL; SIDE EFFECT; SKIN TOXICITY; STOMATITIS; VOMITING; BREAST TUMOR; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; INTRADUCTAL CARCINOMA; MIDDLE AGED; MORTALITY; MULTIMODALITY CANCER THERAPY; SURVIVAL RATE; TREATMENT OUTCOME;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CARCINOMA, INTRADUCTAL, NONINFILTRATING; COMBINED MODALITY THERAPY; CYCLOPHOSPHAMIDE; DEOXYCYTIDINE; EPIRUBICIN; FEMALE; FLUOROURACIL; FOLLOW-UP STUDIES; HUMANS; MIDDLE AGED; PACLITAXEL; SURVIVAL RATE; TAXOIDS; TREATMENT OUTCOME;

EID: 84860638574     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2011.36.2079     Document Type: Article

References (20)

1. Early Breast Cancer Trialists' Collaborative Group (EBCTCG): Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 365:1687-1717, 2005
2. Ferguson T, Wilcken N, Vagg R, et al: Taxanes for adjuvant treatment of early breast cancer. Cochrane Database Syst Rev 4:CD004421, 2007
3. De Laurentiis M, Cancello G, D'Agostino D, et al: Taxane-based combinations as adjuvant chemotherapy of early breast cancer: A meta-analysis of randomized trials. J Clin Oncol 26:44-53, 2008
4. Kelly CM, Hortobagyi GN: Adjuvant chemotherapy in early-stage breast cancer: What, when, and for whom? Surg Oncol Clin N Am 19:649-668, 2010
5. Sparano JA, Wang M, Martino S, et al: Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 358:1663-1671, 2008 (Pubitemid 351549913)
6. Green MC, Buzdar AU, Smith T, et al: Weekly paclitaxel improves pathologic complete remission in operable breast cancer when compared with paclitaxel once every 3 weeks. J Clin Oncol 23:5983-5992, 2005
7. Miwa M, Ura M, Nishida M, et al: Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 34:1274-1281, 1998 (Pubitemid 28342121)
8. Sawada N, Ishikawa T, Fukase Y, et al: Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by taxol/taxotere in human cancer xenografts. Clin Cancer Res 4:1013-1019, 1998 (Pubitemid 28183404)
9. O'Shaughnessy J, Miles D, Vukelja S, et al: Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results. J Clin Oncol 20:2812-2823, 2002 (Pubitemid 34651510)
10. Black MM, Speer FD: Nuclear structure in cancer tissues. Surg Gynecol Obstet 105:97-102, 1957
11. Hudis CA, Barlow WE, Costantino JP, et al: Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: The STEEP system. J Clin Oncol 25:2127-2132, 2007 (Pubitemid 46972801)
12. Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, et al: Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: An open-label, randomised controlled trial. Lancet Oncol 10:1145-1151, 2009
13. von Minckwitz G, Rezai M, Loibl S, et al: Capecitabine in addition to anthracycline- and taxane-based neoadjuvant treatment in patients with primary breast cancer: Phase III GeparQuattro study. J Clin Oncol 28:2015-2023, 2010
14. Steger GG, Greil R, Jakesz R, et al: Pathological complete response (pCR) in patient subgroups: An analysis of ABCSG-24, a phase III, randomized study of anthracycline- and taxane-based neoadjuvant therapy with or without capecitabine in early breast cancer (EBC). J Clin Oncol 28:74s, 2010 (suppl; abstr 530).
15. Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, et al: FinXX final 5-year analysis: Results of the randomised, open label, phase III trial in medium-tohigh risk early breast cancer. Presented at the 33rd Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 8-12, 2010 (abstr S4-1)
16. O'Shaughnessy J, Paul D, Stokoe C, et al: First efficacy results of a randomized, open-label, phase III study of adjuvant doxorubicin plus cyclophosphamide, followed by docetaxel with or without capecitabine, in high-risk early breast cancer. Presented at the 33rd Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 8-12, 2010 (abstr S4-2)
17. Dalivoust P, Debled M, Asselain B, et al: Capecitabine therapy for locally advanced or metastatic breast cancer: A difference between reported clinical trials and routine clinical practice? Results from the ELIXER Study in Routine Oncology Practice. Presented at the 33rd San Antonio Annual Breast Cancer Symposium, San Antonio, TX, December 8-12, 2010 (P6-11-04)
18. National Surgical Adjuvant Breast and Bowel Project (NSABP): A randomized phase III trial of neoadjuvant therapy in patients with palpable and operable breast cancer evaluating the effect on pathologic complete response (pCR) of adding capecitabine or gemcitabine to docetaxel when administered before AC with or without bevacizumab and correlative science studies attempting to identify predictors of high likelihood for pCR with each of the regimens. http://clinicaltrials.gov/ct2/show/NCT00408408?term=NSABP+B-40&rank=1
19. Spanish Breast Cancer Research Group: Multicenter, open-label, randomized phase III trial, to evaluate efficacy of maintenance treatment with capecitabine (X) following standard adjuvant chemotherapy, in operable breast cancer patients with negative hormone receptor, negative HER2 tumours. http://clinicaltrials.gov/ct2/show/NCT00130533?term=CIBOMA&rank=1
20. Poole C, Barrios C, O'Shaughnessy J, et al: Ongoing evaluation of capecitabine-based therapy in early breast cancer (EBC). Presented at the 33rd San Antonio Annual Breast Cancer Symposium, San Antonio, TX, December 8-12, 2010 (abstr P5-10-11)