Table 2. Efficacy and safety of docetaxel (D) 60–75 mg m−2 plus carboplatin (C) AUC 5–6 every 3 weeks in women with recurrent or progressive ovarian cancer (OC): results from four Phase II studies (Meyer et al, 1999; Kolevska et al, 2001; Markman et al, 2001; Vorobiof et al, 2001).
|
No. of patients evaluable for |
Patient characteristics at presentation |
Response rate (% of evaluable patients) |
Length of follow-up, median [range] | Progression-free survival, median [range] | Toxicity (no. of patients) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Reference | Regimen | Safety | Efficacy | CR | PR | Overall | ||||
| Markman et al (2001) | D 60 mg m−2+C AUC 6 every 21 days for 6 cycles | 50 | 42 | Chemotherapy-naïve (94%) and platinum-pretreated (6%) patients with OC (12% stage I–II; 88% stage III–IV) | NS | NS | 81 | 21+ months [12+ to 41+] | >16 months | Grade IV neutropenia (32); neutropenic fever (8); grade III thrombocytopenia (2); hypersensitivity (17); peripheral neuropathy (3) |
| Kolevska et al (2001) | D 70 mg m−2+C AUC 6 every 21 days for 6 cycles | 19 | 15 | Chemotherapy-naïve patients with suboptimally debulked stage IIIc (63%) or IV (37%) OC | 27 | 53 | 87a | 8.9 months [0.6–26.4] | 13.1 months | Grade III/IV toxicities:b neutropenia (15); febrile neutropenia (2); nausea (2); vomiting (1); anaemia (2); thrombocytopenia (3) oedema (1); weight loss (1); dehydration (1); DVT (3); diarrhoea (2) |
| Meyer et al (1999) | D 75 mg m−2+C AUC 5every 21 days for 6 cycles | 27 | 27 | Chemotherapy-naïve (41%) and platinum-pretreated (59%) patients with stage III–IV OC | 52 | 29 | 81 | NS | NS | Neutropenia (grade II/III, 24); thrombocytopenia (grade II/III, 7); neuropathy (grade II, 2) |
| Vorobiof et al (2001) | D 75 mg m−2+C AUC 6every 21 days for 6 cycles | 20 | 11c | Chemotherapy-naïve patients with stage III–IV OC | 46 | 36 | 82 | NS | NS | Grade III–IV toxicities included anaemia, leucopenia, neutropenia, thrombocytopenia, nausea and vomiting |
Includes one minor response.
Data presented as number of episodes.
Includes patients with measurable disease and excludes those only evaluable for CA125 response.