2009
DOI: 10.1093/annonc/mdn661
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Phase II trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nab-paclitaxel) (Abraxane®) in combination with gemcitabine in patients with metastatic breast cancer (N0531)

Abstract: Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and practically eliminates the risk of hypersensitivity reactions associated with solvent-based paclitaxel. We studied weekly nab-paclitaxel and gemcitabine combination in an open-label one-stage, phase II trial in patients with previously untreated metastatic breast cancer (MBC). Nab-paclitaxel (125 mg/m(2)) and gemcitabine (1000 mg/m(2)) were administered on days 1 and 8 of a 21-day cycle until disease progression. Fifty patients were enrolled. … Show more

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Cited by 135 publications
(78 citation statements)
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“…22 Several trials adding other drugs to nab-paclitaxel have been conducted to further improve the efficacy, such as carboplatin, gemcitabine, bevacizumab, and herceptin. [23][24][25] On the basis of our knowledge, this is also the first trial showing that the already-strong antitumor activity of weekly nab-paclitaxel for MBC can be further increased by adding a chemotherapeutic agent.…”
Section: Discussionmentioning
confidence: 87%
“…22 Several trials adding other drugs to nab-paclitaxel have been conducted to further improve the efficacy, such as carboplatin, gemcitabine, bevacizumab, and herceptin. [23][24][25] On the basis of our knowledge, this is also the first trial showing that the already-strong antitumor activity of weekly nab-paclitaxel for MBC can be further increased by adding a chemotherapeutic agent.…”
Section: Discussionmentioning
confidence: 87%
“…Based on the intention-totreat population, the reported orr was significantly increased with nab-paclitaxel than with standard Various phase ii studies have examined combinations of nab-paclitaxel with targeted agents-namely, trastuzumab and bevacizumab-for early treatment of mbc (orrs ranged from 30% to 60%) [62][63][64] . Studied chemotherapy combinations have included nabpaclitaxel with gemcitabine and with capecitabine (orrs ranged from 50% to 61%) 61,64,65 . Currently, nab-paclitaxel is being investigated in combination with targeted agents such as bevacizumab (search for NCT00618657 at http://clinicaltrials.gov/ct2/search).…”
Section: 31mentioning
confidence: 99%
“…Recently, a new generation of taxane based drugs have been developed and are known as nanoparticle albumin bound taxane (nab-paclitaxel) [25,26]. This modification was reported to exhibit less side effects than that normally produced from the use of taxane, and shows enhanced drug delivery into the targeted cancerous cells [25,27,28]. Nab-paclitaxel has been subjected to several phases of clinical trials.…”
Section: Introductionmentioning
confidence: 99%