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Docetaxel with prednisone or prednisolone for the treatment of ...

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128<br />

Appendix 6<br />

Study details and Participant details Intervention details Results Conclusion and<br />

design comments<br />

Outcome 6: Pain<br />

Pain relief: a two-point reduction in <strong>the</strong> PPI sc<strong>or</strong>e from<br />

baseline, <strong>with</strong>out an increase in <strong>the</strong> analgesic sc<strong>or</strong>e, <strong>or</strong> vice<br />

versa, maintained f<strong>or</strong> at least 3 weeks<br />

Number evaluated: (n = 464):<br />

I(1), 153; I(2), 154; C,157<br />

Response rate<br />

I(1): 35% (95% CI: 27 to 43, p = 0.01)<br />

I(2): 31% (95% CI: 24 to 39, p = 0.08)<br />

C: 22% (95% CI: 16 to 29)<br />

Duration (median months):<br />

I(1): 3.5 (95% CI: 2.4 to 8.1)<br />

I(2): 5.6 (95% CI: 2.8 to 6.8)<br />

C: 4.8 (95% CI: 4.4 to indeterminate)<br />

Outcome 7: HRQoL<br />

16-point improvement from baseline in <strong>the</strong> FACT-P sc<strong>or</strong>e on<br />

two measurements obtained at least 3 weeks apart<br />

Number evaluated (N = 815):<br />

I(1), 278; I(2), 270; C, 267<br />

Response rate:<br />

I(1): 22% (95% CI: 17 to 27, p = 0.009)<br />

I(2): 23% (95% CI: 18 to 28, p = 0.005)<br />

C: 13% (95% CI: 9 to 18)<br />

Withdrawals:<br />

I(1): 3 patients did not receive chemo<strong>the</strong>rapy<br />

I(2): 4 patients did not receive chemo<strong>the</strong>rapy<br />

C: 2 patients did not receive chemo<strong>the</strong>rapy<br />

Discontinuations:<br />

I(1), 38% patients stopped <strong>treatment</strong> due to progression <strong>of</strong><br />

disease, 11% due to adverse events<br />

I(2), 35% patients stopped <strong>treatment</strong> due to progression <strong>of</strong><br />

disease, 16% due to adverse events<br />

C, 56% patients stopped <strong>treatment</strong> due to progression <strong>of</strong><br />

disease, 10% due to adverse events<br />

continued

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