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Breast metastatic PACLItaxel three weekly and trastuzumab weekly DISCONTINUED

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It is the consensus opinion of the medical oncology reference committee that this protocol is not considered best practice for this patient population as weekly paclitaxel is preferable in most circumstances.

Treatment Schedule Summary

Drug Dose Route Day
PACLItaxel 175 mg/m2 IV 1
Trastuzumab 4 mg/kg (loading dose only); 2 mg/kg (subsequent doses) IV 1, 8, 15

 Frequency: 21 days

Cycles: Continuous until disease progression or unacceptable toxicity (weekly trastuzumab to be continued after completion of paclitaxel chemotherapy)

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Bibliography

Slamon, D.,J., Leyland-Jones, B., Shak, S., et al. 2001. "Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. " N.Engl.J Med. 344(11):783-792

Background The HER2 gene, which encodes the growth factor receptorHER2, is amplified and HER2 is overexpressed in 25 to 30 percentof breast cancers, increasing the aggressiveness of the tumor. Methods We evaluated the efficacy and safety of trastuzumab,a recombinant monoclonal antibody against HER2, in women withmetastatic breast cancer that overexpressed HER2. We randomlyassigned 234 patients to receive standard chemotherapy aloneand 235 patients to receive standard chemotherapy plus trastuzumab.Patients who had not previously received adjuvant (postoperative)therapy with an anthracycline were treated with doxorubicin(or epirubicin in the case of 36 women) and cyclophosphamidewith (143 women) or without trastuzumab (138 women). Patientswho had previously received adjuvant anthracycline were treatedwith paclitaxel alone (96 women) or paclitaxel with trastuzumab(92 women). Results The addition of trastuzumab to chemotherapy was associatedwith a longer time to disease progression (median, 7.4 vs. 4.6months; P <0.001), a higher rate of objective response (50percent vs. 32 percent, P <0.001), a longer duration of response(median, 9.1 vs. 6.1 months; P <0.001), a lower rate of deathat 1 year (22 percent vs. 33 percent, P=0.008), longer survival(median survival, 25.1 vs. 20.3 months; P=0.046), and a 20 percentreduction in the risk of death. The most important adverse eventwas cardiac dysfunction, which occurred in 27 percent of thegroup given an anthracycline, cyclophosphamide, and trastuzumab;8 percent of the group given an anthracycline and cyclophosphamidealone; 13 percent of the group given paclitaxel and trastuzumab;and 1 percent of the group given paclitaxel alone. Althoughthe cardiotoxicity was potentially severe and, in some cases,life-threatening, the symptoms generally improved with standardmedical management. Conclusions Trastuzumab increases the clinical benefit of first-linechemotherapy in metastatic breast cancer that overexpressesHER2.

Version 3

Date Summary of changes
09/08/2009

Review and transfer to eviQ.
28/06/2010 Haematological dose modifications updated ( 20% changed to 25% dose reduction).
13/08/2010 Indications and PBS listing for paclitaxel updated.
26/10/2010 Dose modifications updated: "consider reducing" changed to " reduce".
10/01/2011

New format to allow for export of protocol information.
Protocol version number changed to V.2.
Antiemetics and premedications added to the treatment schedule.
Additional Clinical Information, Key Prescribing table and Key Administration table combined into new section titled Clinical Considerations.
Drug specific information placed behind the drug name link.
27/04/2012 Protocol reviewed at Medical Oncology Reference Committee meeting. Consensus to move protocol from "Superseded" to "Discontinued" folder as weekly paclitaxel is preferable in most circumstances, therefore next review in 2 years.
22/09/2015 Cardiac toxicity monitoring updated.
31/05/2017 Transferred to new eviQ website.

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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First approved:
Last reviewed:

The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/130

22 Mar 2019

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