NSABP B-38: Definitive analysis of a randomized adjuvant trial comparing dose-dense (DD) AC->paclitaxel (P) plus gemcitabine (G) with DD AC->P and with docetaxel, doxorubicin, and cyclophosphamide (TAC) in women with operable, node-positive breast cancer. (Record no. 2598)

MARC details
000 -LEADER
fixed length control field 03806nam a22003497a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 170823s20122012 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 0732-183X
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 28140798
245 ## - TITLE STATEMENT
Title NSABP B-38: Definitive analysis of a randomized adjuvant trial comparing dose-dense (DD) AC->paclitaxel (P) plus gemcitabine (G) with DD AC->P and with docetaxel, doxorubicin, and cyclophosphamide (TAC) in women with operable, node-positive breast cancer.
251 ## - Source
Source Journal of Clinical Oncology. 30(18_suppl):LBA1000, 2012 Jun 20
252 ## - Abbreviated Source
Abbreviated source J Clin Oncol. 30(18_suppl):LBA1000, 2012 Jun 20
253 ## - Journal Name
Journal name Journal of clinical oncology : official journal of the American Society of Clinical Oncology
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2012
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2012
266 ## - Date added to catalog
Date added to catalog 2017-08-23
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1999 - present, Available in print through MWHC library: 1999 - 2008
520 ## - SUMMARY, ETC.
Abstract AML/MDS: N=5, 8, 11. All cycles completed in 91% for TAC and 88% for DD regimens.
520 ## - SUMMARY, ETC.
Abstract CONCLUSIONS: Addition of G to DD AC->P did not improve outcomes. No significant differences in efficacy endpoints were identified between DD AC->P and TAC, though toxicity profiles differed.
520 ## - SUMMARY, ETC.
Abstract FUNDING: NCI PHS U10-CA-37377, -69974, -12027, -69651 and NCCTG U10-CA25224, with additional funding from Eli Lilly & Company, and Amgen, Inc.
520 ## - SUMMARY, ETC.
Abstract LBA1000 Background: The primary aims were to determine whether adjuvant DD AC->PG will be superior to DD AC->P as well as to TAC in DFS and to compare the relative DFS of TAC and DD AC->P. Secondary endpoints include survival and toxicity.
520 ## - SUMMARY, ETC.
Abstract METHODS: From Nov 3, 2004 to May 3, 2007, 4894 women were randomized; 1630 to TAC (docetaxel [T] 75 mg/m<sup>2</sup>, doxorubicin [A] 50 mg/m<sup>2</sup>, cyclophosphamide [C] 500 mg/m<sup>2</sup> q3 wks x 6), 1634 to DD AC->P (A 60 mg/m<sup>2</sup> and C 600 mg/m<sup>2</sup> q2 wks x 4 followed by P 175 mg/m<sup>2</sup> q2 wks x 4), and 1630 to DD AC->PG (A 60 mg/m<sup>2</sup> and C 600 mg/m<sup>2</sup> q2 wks x 4 -> P 175 mg/m<sup>2</sup> + G 2000 mg/m<sup>2</sup>q2 wks x 4). Primary G-CSF support was required and erythropoiesis-stimulating agents (ESA) were used at investigator discretion. 52% were postmenopausal, 65% had 1 - 3 positive nodes, and 80% had HR+ breast cancer. Log-rank tests were used for pair-wise comparisons of the primary (DFS) and secondary (OS) endpoints among the three treatment arms.
520 ## - SUMMARY, ETC.
Abstract RESULTS: With 64 months median follow-up, 5-year DFS in DD AC->PG group was 80.6% compared with 82.2% in DD AC->P group (HR=1.1; p=0.27) and 80.1 % (HR=0.97; p=0.71) in TAC group. 5-year OS was 90.8% in DD AC->PG group as compared with 89.1% (HR=.89; p=0.25) in DD AC->P group and 89.6 % (HR=0.90; p=0.32) in TAC group. HR for DFS and OS of DD AC->P vs. TAC were 0.89 (p=0.14) and 1.01 (p=0.92) respectively. Toxicities for TAC, DD AC->P, DD AC->PG, respectively: febrile neutropenia (Gr 3/4: 9%, 4%, 4% [p<0.001]), sensory neuropathy (Gr 3/4: <1%, 7%, 6% [p<0.001]), diarrhea (Gr 3/4: 8 %, 2%, 2% [p<0.001]). Hgb was <10 in 12%, 26%, 33% with ESA use in 35.2%, 47%, 51.6% and transfusions in 3.7%, 6.3%, 9.4%. Deaths on treatment: N=13, 5, 7 (p=0.2).
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element IN PROCESS -- NOT YET INDEXED
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution Medstar Franklin Square Medical Center
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Zapas, John L
790 ## - Authors
All authors Atkins JN, Azar CA, Biggs DD, Brufsky A, Costantino JP, Donnellan PP, Fehrenbacher L, Geyer CE, Levine EA, Mamounas EP, Paik S, Perez EA, Polikoff J, Provencher L, Rastogi P, Robidoux A, Tang G, Wolmark N, Zapas JL
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1200/jco.2012.30.18_suppl.lba1000">https://dx.doi.org/10.1200/jco.2012.30.18_suppl.lba1000</a>
Public note https://dx.doi.org/10.1200/jco.2012.30.18_suppl.lba1000
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 08/23/2017   28140798 28140798 08/23/2017 08/23/2017 Journal Article

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