title: A comparative analysis on the efficacy and safety of intaxel® and taxol® in advanced metastatic breast cancer.
abstract: BACKGROUND
  Among the presently available cytotoxic drugs, paclitaxel, in combination with doxorubicin and carboplatin, come under the highly active therapy for metastatic breast cancer. Between the two brands of paclitaxel (Intaxel, which is marketed by Fresenius Kabi and Taxol, the original paclitaxel which is manufactured by BMS) the similarity has not been evaluated in clinical trial settings till date. This prospective, controlled, randomized, multicentre, open-label phase IV study was planned to compare the safety and efficacy of Intaxel with Taxol, when they were used in combination with carboplatin or doxorubicin, as a second line treatment for metastatic breast cancer.
  
  
  METHODS
  Fourty nine eligible patients were randomized to receive Intaxel or Taxol with either doxorubicin or carboplatin. The patients who had received a prior anthracycline based chemotherapy were randomized to the paclitaxel/carboplatin arm. The patients were evaluated in three phases i.e. at baseline, during the treatment and at follow up for the tumour response, the time period till the disease progression and the toxicity. The time till the disease progression was assessed by the Kaplan-Meier method. The continuous and categorical variables were assessed by using the ANOVA test and Fisher's exact test, respectively.
  
  
  RESULTS
  After 3 cycles, an objective response rate of 55.56% (CR = 3, PR = 7) was noted in the Intaxel group and that of 59.09% (CR = 1, PR = 12) was noted in the Taxol group. After 6 cycles, an objective response rate of 50% was noted in both the groups. No significant difference was observed in the response rate of the two groups after 3 cycles (p > 0.05) and at the end of the treatment (p > 0.05). The patients who received Intaxel had a lower incidence of thrombocytopaenia (p = 0.0146) and neurosensory loss (p = 0.008) as compared to those who received Taxol.
  
  
  CONCLUSIONS
  The results of this study demonstrated that the safety and efficacy of Intaxel and Taxol are equivalent when they are used in combination with other cytotoxic agents as the second line of treatment for metastatic stage IV breast cancer.
authors.affiliation: National Institute of Oncology , Budapest .
authors.forename: Istvan
authors.initials: I
authors.lastname: Lang
authors.forename: Gabor
authors.initials: G
authors.lastname: Rubovszky
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Horvath
authors.forename: Erna
authors.initials: E
authors.lastname: Ganofszky
authors.forename: Eszter
authors.initials: E
authors.lastname: Szabo
authors.forename: Magdolna
authors.initials: M
authors.lastname: Dank
authors.forename: Katalin
authors.initials: K
authors.lastname: Boer
authors.forename: Erika
authors.initials: E
authors.lastname: Hitre
keywords: Intaxel; Metastatic breast cancer; Paclitaxel; Taxol
references.citation: Mayo Clin Proc. 2004 Jun;79(6):810-6
references.pmid: 15182098
references.citation: Cancer. 2000 Jan 1;88(1):124-31
references.pmid: 10618614
references.citation: J Coll Physicians Surg Pak. 2010 Nov;20(11):748-52
references.pmid: 21078249
references.citation: J Clin Oncol. 1996 Apr;14(4):1185-91
references.pmid: 8648373
references.citation: Lancet. 1994 Nov 5;344(8932):1267-72
references.pmid: 7967989
references.citation: Int J Clin Lab Res. 1994;24(1):6-14
references.pmid: 7910054
references.citation: Semin Oncol. 2011 Jun;38 Suppl 2:S11-6
references.pmid: 21600380
references.citation: Semin Oncol. 1995 Jun;22(3 Suppl 6):101-4
references.pmid: 7541151
references.citation: Oncology. 2003;64(3):207-12
references.pmid: 12697959
references.citation: J Natl Cancer Inst. 1995 Aug 2;87(15):1169-75
references.pmid: 7674322
references.citation: J Clin Oncol. 1998 Oct;16(10):3439-60
references.pmid: 9779724
references.citation: Cancer Treat Rev. 2004 Feb;30(1):53-81
references.pmid: 14766126
references.citation: J Clin Oncol. 1998 Oct;16(10):3353-61
references.pmid: 9779712
references.citation: Semin Oncol. 1996 Feb;23(1 Suppl 1):53-7
references.pmid: 8629039
references.citation: Drugs Today (Barc). 2001 Jan;37(1):57-65
references.pmid: 12783098
references.citation: Anticancer Res. 2003 Jan-Feb;23(1B):765-71
references.pmid: 12680181
references.citation: Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003366
references.pmid: 15846659
references.citation: J Clin Oncol. 1999 Oct;17(10):3038-47
references.pmid: 10506598
references.citation: Oncologist. 2001;6(2):133-46
references.pmid: 11306725
references.citation: Cancer. 2005 Feb 15;103(4):672-9
references.pmid: 15637696
references.citation: Oncologist. 2004;9(5):518-27
references.pmid: 15477636
references.citation: J Clin Oncol. 2000 May;18(10):2116-25
references.pmid: 10811677
references.citation: J Clin Oncol. 2001 Nov 15;19(22):4216-23
references.pmid: 11709565