Gemcitabine plus Paclitaxel versus Paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Kathy AlbainJoyce O'Shaughnessy

Abstract

The objective of this phase III global study was to compare the efficacy of gemcitabine plus paclitaxel (GT) versus paclitaxel in patients with advanced breast cancer. It was designed as a pivotal study for the approval of G for a breast cancer treatment indication. Patients who relapsed after adjuvant anthracyclines were randomly assigned to gemcitabine,1,250 mg/m(2) days 1 and 8 plus paclitaxel, 175 mg/m(2) on day 1; or, to paclitaxel at same dose on day 1 (both arms administered every 21 days, unblinded). The primary end point was overall survival (OS) and secondary end points were time to progression (TTP), response rate (RR), progression-free survival, response duration, and toxicity. This final OS analysis was planned at 380 deaths. A total of 266 patients were randomly assigned to GT and 263 to paclitaxel. Median survival on GT was 18.6 months versus 15.8 months on paclitaxel (log-rank P = . 0489), with an adjusted Cox hazard ratio of 0.78 (95% CI, 0.64 to 0.96; P = .0187). The TTP was longer (6.14 v 3.98 months; log-rank P = .0002) and the RR was better (41.4% v 26.2%; P = .0002) on GT. There was more grade 3 to 4 neutropenia on GT and grade 2 to 4 fatigue and neuropathy were slightly more prevalent on GT. This phase II...Continue Reading

Associated Clinical Trials

References

Aug 1, 1995·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J S AbramsM A Friedman
Nov 1, 1995·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J CarmichaelA L Harris
Jun 1, 1996·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J M NabholtzB Winograd
Nov 24, 1999·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J F BishopR Canetta
Jun 18, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Joyce O'ShaughnessyRobert Leonard
Feb 15, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·George W SledgeWilliam C Wood
Dec 11, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Lynn M Schuchter
Feb 5, 2004·Annals of Oncology : Official Journal of the European Society for Medical Oncology·R ColomerV Guillem
Feb 18, 2004·The Breast : Official Journal of the European Society of Mastology·T BrodowiczC C Zielinski
Jun 1, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eric P WinerLarry Norton
Nov 17, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Lori J PierceKathy S Albain
Aug 20, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·S E JonesP M Ravdin
Dec 31, 2005·Clinical Breast Cancer·Gabriel N HortobagyiUNKNOWN ABREAST Investigators
Dec 31, 2005·Clinical Breast Cancer·Kathy S AlbainGabriel N Hortobagyi
May 10, 2006·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·C J PooleD Roychowdhury

❮ Previous
Next ❯

Citations

Mar 17, 2005·Breast Cancer Research and Treatment·Julie R Gralow
May 29, 2007·Breast Cancer Research and Treatment·Susan DentMaureen Trudeau
May 12, 2010·Breast Cancer Research and Treatment·C G MurphyA D Seidman
Aug 17, 2010·Breast Cancer Research and Treatment·Andrés García Palomo
Mar 21, 2013·Breast Cancer Research and Treatment·Iben KümlerDorte L Nielsen
Feb 22, 2012·Current Treatment Options in Oncology·Ana Elisa Lohmann, Stephen Chia
Jan 29, 2008·Breast Cancer : the Journal of the Japanese Breast Cancer Society·Stephen E Jones
Jul 14, 2011·Breast Cancer : the Journal of the Japanese Breast Cancer Society·Shintaro TakaoShigemitsu Takashima
Oct 25, 2011·Advances in Therapy·Philippe Aftimos, Ahmad Awada
Oct 2, 2013·Cellular Oncology (Dordrecht)·Anne-Laure PapaRania Harfouche
Jan 27, 2012·The New England Journal of Medicine·Harry D BearNorman Wolmark
Jul 10, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·F CardosoUNKNOWN ESMO Guidelines Working Group
Jul 18, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·S BeslijaUNKNOWN Central European Cooperative Oncology Group (CECOG)
Jul 25, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·W W TanE A Perez
Oct 13, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·H JoensuuP Kellokumpu-Lehtinen
Nov 27, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E M CiruelosJ Baselga
Dec 25, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M KozloffK Miller
Mar 26, 2010·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A ChanX Pivot
Jun 29, 2010·Annals of Oncology : Official Journal of the European Society for Medical Oncology·F CardosoUNKNOWN ESMO Guidelines Working Group
Oct 15, 2010·Annals of Oncology : Official Journal of the European Society for Medical Oncology·N BerradaF André
Oct 23, 2010·Annals of Oncology : Official Journal of the European Society for Medical Oncology·H Roché, L T Vahdat
Nov 19, 2010·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A D SeidmanD F Tai
Oct 20, 2011·Annals of Oncology : Official Journal of the European Society for Medical Oncology·F CardosoUNKNOWN ESMO Guidelines Working Group
Sep 8, 2011·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J M LöhrUNKNOWN CT4001 Study Group
Nov 20, 2012·Annals of Oncology : Official Journal of the European Society for Medical Oncology·F CardosoUNKNOWN ESMO Guidelines Working Group
Jan 5, 2011·Japanese Journal of Clinical Oncology·Kun-Ming RauYen-Yang Chen
Dec 11, 2008·Journal of the National Cancer Institute·Philippe L Bedard, Martine J Piccart-Gebhart
Aug 7, 2009·Journal of the National Cancer Institute·Fatima CardosoUNKNOWN ESO-MBC Task Force
Mar 31, 2012·International Journal of Breast Cancer·Keith D AmosCarey K Anders
May 24, 2012·Journal of Drug Delivery·Jun H Lee, Anjan Nan
Apr 17, 2013·BMC Cancer·David J Stewart, Razelle Kurzrock
Mar 21, 2012·Breast Cancer Research : BCR·Keerthi Gogineni, Angela DeMichele

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Joyce O'ShaughnessyRobert Leonard
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
William J GradisharJoyce O'Shaughnessy
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Eva ThomasHenri Roche
© 2022 Meta ULC. All rights reserved