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Article: Phase III randomized trial of dose intensive neoadjuvant chemotherapy with or without G-CSF in locally advanced breast cancer: Long-term results

TitlePhase III randomized trial of dose intensive neoadjuvant chemotherapy with or without G-CSF in locally advanced breast cancer: Long-term results
Authors
KeywordsBreast cancer
Disease-free survival
Dose intensity
G-CSF
Locally advanced
Overall survival
Issue Date2011
PublisherAlphaMed Press, Inc. The Journal's web site is located at http://www.theoncologist.org/
Citation
Oncologist, 2011, v. 16 n. 11, p. 1527-1534 How to Cite?
AbstractObjective. To compare the pathologic complete response (pCR) rate of patients treated with 5-fluorouracil (5-FU), doxorubicin, and cyclophosphamide (FAC) versus dose-intense FAC plus G-CSF in the neoadjuvant setting and to compare the delivered dose intensity, disease-free survival (DFS) and overall survival (OS) times, and toxicity between treatment arms in patients with breast cancer. Methods. Patients were randomized to receive preoperative FAC (5-FU, 500 mg/m 2 doxorubicin, 50 mg/m 2 cyclophosphamide, 500 mg/m 2) every 21 days for four cycles or dose-intense FAC (5-FU, 600 mg/m 2 doxorubicin, 60 mg/m 2 cyclophosphamide, 1,000 mg/m 2) plus G-CSF every 18 days for four cycles. Results. Two hundred two patients were randomly assigned. The median follow-up was 7.5 years. Patients randomized to FAC plus G-CSF had a higher pCR rate as well as clinical complete response rate; however, these differences were not statistically different from those with the FAC arm. Patients in the FAC G-CSF arm had a higher delivered dose intensity of doxorubicin in the neoadjuvant and adjuvant settings than those in the standard FAC arm. DFS and OS times were not significantly different between the two groups. However, the OS and DFS rates were significantly higher for patients who achieved a pCR than for those who did not. Thrombocytopenia, febrile neutropenia, and infection rates were higher in the FAC G-CSF arm. Conclusions. A higher delivered dose intensity of doxorubicin with the FAC G-CSF regimen did not result in a statistically significant higher pCR rate. However, patients who achieved a pCR experienced longer DFS and OS times. © Alpha Med Press.
Persistent Identifierhttp://hdl.handle.net/10722/146599
ISSN
2015 Impact Factor: 4.789
2015 SCImago Journal Rankings: 2.391
PubMed Central ID
ISI Accession Number ID
Funding AgencyGrant Number
NIH-NCI2P30 CA016672 28(PP-4)
Nellie B. Connally Breast Cancer Research Fund
Amgen
Novartis
Funding Information:

Supported, in part, by NIH-NCI: 2P30 CA016672 28(PP-4) and the Nellie B. Connally Breast Cancer Research Fund.

References

 

DC FieldValueLanguage
dc.contributor.authorArun, BKen_HK
dc.contributor.authorDhinghra, Ken_HK
dc.contributor.authorValero, Ven_HK
dc.contributor.authorKau, SWen_HK
dc.contributor.authorBroglio, Ken_HK
dc.contributor.authorBooser, Den_HK
dc.contributor.authorGuerra, Len_HK
dc.contributor.authorYin, Gen_HK
dc.contributor.authorWalters, Ren_HK
dc.contributor.authorSahin, Aen_HK
dc.contributor.authorIbrahim, Nen_HK
dc.contributor.authorBuzdar, AUen_HK
dc.contributor.authorFrye, Den_HK
dc.contributor.authorSneige, Nen_HK
dc.contributor.authorStrom, Een_HK
dc.contributor.authorRoss, Men_HK
dc.contributor.authorTheriault, RLen_HK
dc.contributor.authorVadhanRaj, Sen_HK
dc.contributor.authorHortobagyi, GNen_HK
dc.date.accessioned2012-05-02T08:37:20Z-
dc.date.available2012-05-02T08:37:20Z-
dc.date.issued2011en_HK
dc.identifier.citationOncologist, 2011, v. 16 n. 11, p. 1527-1534en_HK
dc.identifier.issn1083-7159en_HK
dc.identifier.urihttp://hdl.handle.net/10722/146599-
dc.description.abstractObjective. To compare the pathologic complete response (pCR) rate of patients treated with 5-fluorouracil (5-FU), doxorubicin, and cyclophosphamide (FAC) versus dose-intense FAC plus G-CSF in the neoadjuvant setting and to compare the delivered dose intensity, disease-free survival (DFS) and overall survival (OS) times, and toxicity between treatment arms in patients with breast cancer. Methods. Patients were randomized to receive preoperative FAC (5-FU, 500 mg/m 2 doxorubicin, 50 mg/m 2 cyclophosphamide, 500 mg/m 2) every 21 days for four cycles or dose-intense FAC (5-FU, 600 mg/m 2 doxorubicin, 60 mg/m 2 cyclophosphamide, 1,000 mg/m 2) plus G-CSF every 18 days for four cycles. Results. Two hundred two patients were randomly assigned. The median follow-up was 7.5 years. Patients randomized to FAC plus G-CSF had a higher pCR rate as well as clinical complete response rate; however, these differences were not statistically different from those with the FAC arm. Patients in the FAC G-CSF arm had a higher delivered dose intensity of doxorubicin in the neoadjuvant and adjuvant settings than those in the standard FAC arm. DFS and OS times were not significantly different between the two groups. However, the OS and DFS rates were significantly higher for patients who achieved a pCR than for those who did not. Thrombocytopenia, febrile neutropenia, and infection rates were higher in the FAC G-CSF arm. Conclusions. A higher delivered dose intensity of doxorubicin with the FAC G-CSF regimen did not result in a statistically significant higher pCR rate. However, patients who achieved a pCR experienced longer DFS and OS times. © Alpha Med Press.en_HK
dc.languageengen_US
dc.publisherAlphaMed Press, Inc. The Journal's web site is located at http://www.theoncologist.org/en_HK
dc.relation.ispartofOncologisten_HK
dc.subjectBreast canceren_HK
dc.subjectDisease-free survivalen_HK
dc.subjectDose intensityen_HK
dc.subjectG-CSFen_HK
dc.subjectLocally advanceden_HK
dc.subjectOverall survivalen_HK
dc.titlePhase III randomized trial of dose intensive neoadjuvant chemotherapy with or without G-CSF in locally advanced breast cancer: Long-term resultsen_HK
dc.typeArticleen_HK
dc.identifier.emailYin, G: gyin@hku.hken_HK
dc.identifier.authorityYin, G=rp00831en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1634/theoncologist.2011-0134en_HK
dc.identifier.pmid22042783-
dc.identifier.pmcidPMC3233286-
dc.identifier.scopuseid_2-s2.0-82355163145en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-82355163145&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume16en_HK
dc.identifier.issue11en_HK
dc.identifier.spage1527en_HK
dc.identifier.epage1534en_HK
dc.identifier.isiWOS:000297860900007-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridArun, BK=6603689664en_HK
dc.identifier.scopusauthoridDhinghra, K=54785860600en_HK
dc.identifier.scopusauthoridValero, V=7004692933en_HK
dc.identifier.scopusauthoridKau, SW=7005363979en_HK
dc.identifier.scopusauthoridBroglio, K=6602915196en_HK
dc.identifier.scopusauthoridBooser, D=7003498841en_HK
dc.identifier.scopusauthoridGuerra, L=7103192535en_HK
dc.identifier.scopusauthoridYin, G=8725807500en_HK
dc.identifier.scopusauthoridWalters, R=7201891325en_HK
dc.identifier.scopusauthoridSahin, A=7202605028en_HK
dc.identifier.scopusauthoridIbrahim, N=7102687915en_HK
dc.identifier.scopusauthoridBuzdar, AU=35379841900en_HK
dc.identifier.scopusauthoridFrye, D=16166214200en_HK
dc.identifier.scopusauthoridSneige, N=7007099187en_HK
dc.identifier.scopusauthoridStrom, E=7006061972en_HK
dc.identifier.scopusauthoridRoss, M=7403661921en_HK
dc.identifier.scopusauthoridTheriault, RL=7103232796en_HK
dc.identifier.scopusauthoridVadhanRaj, S=7005824818en_HK
dc.identifier.scopusauthoridHortobagyi, GN=7202399346en_HK

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