A Comparative Analysis on the Efficacy and Safety of Intaxel® and Taxol® in Advanced Metastatic Breast Cancer
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 pa...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JCDR Research and Publications Private Limited
2013-06-01
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| Series: | Journal of Clinical and Diagnostic Research |
| Subjects: | |
| Online Access: | https://jcdr.net/articles/PDF/3027/35%20-%204742_PF1(M)_E(C)_F(T)_PF1(M)_PF1(T)_FA(T)_PF1(PUH)_PFA(H).pdf |
| Summary: | 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.
Conclusion: 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. |
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| ISSN: | 2249-782X 0973-709X |