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The evidence supporting this treatment comes from a phase II trial of weekly paclitaxel administered in patients with platinum and paclitaxel-resistant ovarian and primary peritoneal cancer. 48 patients with platinum and paclitaxel-resistant ovarian cancer (defined as progression during, or recurrence within 6 months following prior treatment with both agents) received weekly paclitaxel until disease progression (assuming acceptable toxicity). Following the initial 12 weekly doses, treatment could be given for 3 weeks, with a 1 week break.r
The efficacy and toxicity of paclitaxel given weekly versus three weekly has also been reported in a randomised phase III trial by Rosenberg et al. Between February 1995 and June 1998, a total of 205 patients were randomised to receive weekly paclitaxel (n=104) and three weekly paclitaxel (n=101).r
Efficacy
Response r |
Number of cases |
(%) |
Complete response |
2 |
4 |
Partial response |
8 |
17 |
Stable disease |
22 |
46 |
Progressive disease |
15 |
31 |
Inevaluable |
1 |
2 |
In the study by Rosenberg et al, there was no statistically significant difference in the number of patients who responded to treatment or the median survival between groups (13.5 months for weekly group vs 14.7 months for 3 weekly group; p=0.98). Median time to progression was 6.1 months in the weekly group vs 8.1 months in the three weekly group (p=0.85). Some of these differences may be attributed to the lower median total dose given in the weekly arm.r
Toxicity
Serious adverse events were relatively uncommon.
Toxicity r |
Paclitaxel weekly |
Grade 2 (%) |
Grade 3/4 (%) |
Neutropenia |
0 |
3 |
Thrombocytopenia |
1 |
0 |
Anaemia |
35 |
5 |
Emesis |
8 |
1 |
Gastrointestinal |
19 |
7 |
Allergy |
5 |
0 |
Neurologic |
19 |
3 |
Fatigue |
15 |
7 |
Pain |
11 |
5 |
Myalgia/arthralgia |
0 |
0 |
Dyspnoea |
5 |
5 |
Infection |
3 |
1 |
Cardiovascular |
0 |
3 |
Pulmonary |
1 |
3 |
© Gynaecology Oncology 2006
The weekly paclitaxel regimen was found to have a better safety profile compared with the three weekly regimen. There was with a significantly lower incidence of neutropenia, arthralgia and grade 3 neuropathy and alopecia. Nail changes, however, was more frequently reported in the weekly paclitaxel group.r
Toxicity r |
Weekly paclitaxel (%) |
3 weekly paclitaxel (%) |
p-value |
Neutropenia (grade 3 to 4) |
18 |
45 |
<0.001 |
Neuropathy (grade 3) |
11 |
29 |
<0.001 |
Alopecia (grade 3) |
46 |
79 |
<0.001 |
Arthralgia/Myalgia (grade 1 to 3) |
59 |
84 |
<0.001 |
Nails (grade 1 to 3) |
36 |
2 |
<0.001 |