Abstract:
PURPOSE:This multicenter phase II trial evaluated the efficacy and safety of weekly nanoparticle albumin-bound paclitaxel with carboplatin and weekly trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer (MBC). PATIENTS AND METHODS:We treated 32 patients who had measurable MBC that was HER2-positive defined by an immunohistochemical staining score of 3+ or gene amplification by fluorescence in situ hybridization, required for those with an IHC of 2+. Patients were treated with albumin-bound paclitaxel 100 mg/m2 and carboplatin at area under the curve (AUC) = 2 on days 1, 8, and 15 of a 28-day cycle. Trastuzumab was administered at 2 mg/kg weekly after a loading dose of 4 mg/kg. Because of hypersensitivity reactions occurring during carboplatin infusion numbers 6-8 in 4 of the first 13 patients with this premedication-free regimen, the protocol was amended for carboplatin and dosed at AUC = 6 day 1 each 28-day cycle, in lieu of introducing steroid prophylaxis. Patients were treated with 6 cycles and allowed to continue with all 3 drugs or trastuzumab alone if free of progression and unacceptable toxicity after 6 cycles. RESULTS:The overall response rate (ORR) was 62.5% (95% CI, 45.7%-79.3%) with 3 confirmed complete responders (CRs; 9%) and 17 confirmed partial responses (PRs; 53%). An additional 6 patients (19%) had stable disease (SD) for greater than 16 weeks for a clinical benefit rate (ORR + SD > 16 weeks) of 81%. As of April 16, 2009, 20 patients (63%) had progressed with a median progression-free survival (PFS) of 16.6 months (95% CI, 7.5-26.5 months). Antitumor activity was similar for patients treated with weekly carboplatin and every-4-week carboplatin (ORR, 65% vs. 67%, respectively). Hematologic toxicities were the only grade 4 toxicities noted and were infrequent with grade 4 neutropenia in 3 patients (9%) and 1 febrile neutropenia. Grade 2/3 peripheral neuropathy was uncommon (13%/3%). CONCLUSION:Weekly albumin-bound paclitaxel with carboplatin and trastuzumab is highly active in HER2-overexpressing MBC. In the absence of corticosteroid premedication, which we avoided with albumin-bound paclitaxel, carboplatin seems best dosed every 4 weeks rather than weekly because of carboplatin-associated hypersensitivity reactions. The regimen was very well tolerated with few grade 3 and 4 nonhematologic toxicities experienced, and severe hematologic toxicity and peripheral neuropathy were infrequent.
journal_name
Clin Breast Cancerjournal_title
Clinical breast cancerauthors
Conlin AK,Seidman AD,Bach A,Lake D,Dickler M,D'Andrea G,Traina T,Danso M,Brufsky AM,Saleh M,Clawson A,Hudis CAdoi
10.3816/CBC.2010.n.036subject
Has Abstractpub_date
2010-08-01 00:00:00pages
281-7issue
4eissn
1526-8209issn
1938-0666pii
S1526-8209(11)70039-8journal_volume
10pub_type
杂志文章,多中心研究abstract::Neoadjuvant chemotherapy has been employed increasingly in operable breast cancer during recent years. Several randomized trials showed that the chances of breast conserving therapy are being enhanced, and that survival was not compromised by primary systemic therapy compared to adjuvant treatment. Apart from the surg...
journal_title:Clinical breast cancer
pub_type: 杂志文章,评审
doi:10.3816/cbc.2004.n.039
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journal_title:Clinical breast cancer
pub_type: 杂志文章
doi:10.1016/j.clbc.2010.11.001
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pub_type: 杂志文章
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journal_title:Clinical breast cancer
pub_type: 杂志文章
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journal_title:Clinical breast cancer
pub_type: 杂志文章,评审
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journal_title:Clinical breast cancer
pub_type: 杂志文章,随机对照试验
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journal_title:Clinical breast cancer
pub_type: 杂志文章,评审
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journal_title:Clinical breast cancer
pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Clinical breast cancer
pub_type: 杂志文章
doi:10.3816/cbc.2004.n.047
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journal_title:Clinical breast cancer
pub_type: 杂志文章
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journal_title:Clinical breast cancer
pub_type: 杂志文章,评审
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journal_title:Clinical breast cancer
pub_type: 杂志文章,meta分析
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更新日期:2018-10-01 00:00:00
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journal_title:Clinical breast cancer
pub_type: 杂志文章,评审
doi:10.3816/CBC.2001.n.008
更新日期:2001-04-01 00:00:00
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pub_type: 杂志文章
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更新日期:2018-08-01 00:00:00
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journal_title:Clinical breast cancer
pub_type: 杂志文章
doi:10.1016/j.clbc.2011.05.001
更新日期:2011-12-01 00:00:00
abstract::The sequential use of a doxorubicin combination followed by paclitaxel has been reported to improve disease-free and overall survival in patients with node-positive breast cancer beyond that obtained with doxorubicin/cyclophosphamide combinations. Epirubicin is associated with less cardiotoxicity than doxorubicin and ...
journal_title:Clinical breast cancer
pub_type: 杂志文章,评审
doi:10.3816/cbc.2000.s.010
更新日期:2000-09-01 00:00:00
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journal_title:Clinical breast cancer
pub_type: 杂志文章,多中心研究
doi:10.3816/cbc.2003.n.017
更新日期:2003-06-01 00:00:00
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journal_title:Clinical breast cancer
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Clinical breast cancer
pub_type: 杂志文章
doi:10.1016/j.clbc.2017.12.009
更新日期:2018-10-01 00:00:00
abstract::Tamoxifen reduced the risk of invasive breast cancer by 49% among women at increased risk for breast cancer in the Breast Cancer Prevention Trial P-1, and raloxifene reduced breast cancer incidence by more than 70% in the Multiple Outcomes of Raloxifene Evaluation osteoporosis trial. These findings led the National Su...
journal_title:Clinical breast cancer
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2002-06-01 00:00:00
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journal_title:Clinical breast cancer
pub_type: 杂志文章
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pub_type: 杂志文章
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journal_title:Clinical breast cancer
pub_type: 杂志文章,评审
doi:10.3816/cbc.2007.s.003
更新日期:2007-07-01 00:00:00
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journal_title:Clinical breast cancer
pub_type: 杂志文章
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更新日期:2018-04-01 00:00:00
abstract::Post-breast cancer treatment-related angiosarcomas were first observed in lymphedematous extremities after mastectomy and are now being reported with increasing frequency after lumpectomy and radiation. A case history is presented of a BRCA2 carrier who had a postmastectomy chest wall angiosarcoma but had neither ther...
journal_title:Clinical breast cancer
pub_type: 杂志文章
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journal_title:Clinical breast cancer
pub_type: 杂志文章,随机对照试验
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更新日期:2018-02-01 00:00:00
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journal_title:Clinical breast cancer
pub_type: 杂志文章,评审
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journal_title:Clinical breast cancer
pub_type: 杂志文章
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