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taxanes in metastatic breast cancer - Alberta Health Services

taxanes in metastatic breast cancer - Alberta Health Services

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CLINICAL PRACTICE GUIDELINE BR-001<br />

m. One phase III trial<br />

. 47 was 41.7 months for the triplet arm but had not yet been reached <strong>in</strong> the doublet ar<br />

compared paclitaxel/trastuzumab + carboplat<strong>in</strong> with paclitaxel/trastuzumab Median progression free<br />

survival was longer with the triplet arm (10.7 versus 7.1 months), and overall response rate higher (52<br />

versus 36%). No difference was found for median<br />

overall survival (35.7 versus 32.2 months).<br />

A Cochrane systematic<br />

review exam<strong>in</strong><strong>in</strong>g the efficacy of trastuzumab + other drug therapy, or trastuzumab<br />

alone <strong>in</strong> HER2 positive <strong>metastatic</strong> <strong>breast</strong> <strong>cancer</strong> is awaited.<br />

Summary statement<br />

The current panel largely considered the relevant trials of taxane regimens plus/m<strong>in</strong>us trastuzumab <strong>in</strong><br />

<strong>metastatic</strong> <strong>breast</strong> <strong>cancer</strong> where HER2 is over-expressed to create a de novo recommendation.<br />

Limitations<br />

The major limitation encountered <strong>in</strong> us<strong>in</strong>g the ADATPE process was that the two evidence-based<br />

guidel<strong>in</strong>es selected, NICE ly. A significant amount<br />

some <strong>in</strong>stances, this<br />

7 and CCO 6 were released <strong>in</strong> 2001 and 2003 respective<br />

of more current evidence was reviewed to ensure up-to-date recommendations. In<br />

required de novo recommendation development.<br />

Implications for <strong>Alberta</strong> <strong>Health</strong> <strong>Services</strong><br />

Most regimens recommended<br />

or listed as options <strong>in</strong> this guidel<strong>in</strong>e were available through the <strong>Alberta</strong><br />

<strong>Health</strong> <strong>Services</strong> – Cancer Care Drug Benefit Program as of July 2007 when the draft report was be<strong>in</strong>g<br />

sent for external review. Docetaxel and gemcitab<strong>in</strong>e would require<br />

a formulary addition request to the<br />

Prov<strong>in</strong>cial Pharmacy and Therapeutics Committee<br />

(which takes <strong>in</strong>to account cost implications). Nabpaclitaxel<br />

had recently been added to the Drug Benefit Program. In contrast to this guidel<strong>in</strong>e, criteria for<br />

use of nab-paclitaxel <strong>in</strong> the Drug Benefit Program <strong>in</strong>cludes: “demonstrated <strong>in</strong>tolerance to solvent-based<br />

<strong>taxanes</strong>.”<br />

IMPLEMENTATION STRATEGY<br />

• Present the guidel<strong>in</strong>e <strong>in</strong> the tumour team meet<strong>in</strong>gs and weekly rounds.<br />

• Post the<br />

guidel<strong>in</strong>e on the <strong>Alberta</strong> <strong>Health</strong> <strong>Services</strong> website.<br />

EVALUATION STRATEGY<br />

A formal review will be conducted <strong>in</strong> 2010, however if new evidence is brought forward before that time,<br />

the guidel<strong>in</strong>e will be changed accord<strong>in</strong>gly.<br />

DECLARATION OF CONFLICT OF INTEREST<br />

None of the authors of this guidel<strong>in</strong>e had any conflict of <strong>in</strong>terest related to evidence or recommendations <strong>in</strong><br />

this guidel<strong>in</strong>e.

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