Table 1 Main characteristics of included trials
From: Systematic Review of topotecan (Hycamtin) in relapsed small cell lung cancer
| Â | O'Brien 2006 | Von Pawel 1999 | Von Pawel 2001 | Eckardt 2007 |
|---|---|---|---|---|
Comparison | Oral topotecan (2.3 mg/m2/d on days 1-5 every 21 days) vs BSC | IV topotecan (1.5 to 2 mg/m2/d (as 30-minute infusion) on days 1-5 every 21 days) vs CAV (cyclophosphamide 1,000 mg/m2 (max 2,000 mg), doxorubicin 45 mg/m2 (max 100 mg), and vincristine 2 mg, administered on day 1 of each course) | Oral (2.3 mg/m2/d) vs IV topotecan (1.5 mg/m2/d (as 30-minute infusion) on days 1-5 every 21 days) | Oral (2.3 mg/m2/d) vs IV topotecan (1.5 mg/m2/d (as 30-minute infusion) on days 1-5 every 3 weeks) |
Design | Multinational, multicentre, open-label, phase III RCT | Multinational, multicentrel open-label RCT | Multinational, multicentre, open-label, phase II RCT | Multinational, multicentre, open-label, phase III RCT |
N | 141 | 211 | 106 | 304 |
Inclusion criteria | Documented relapse of limited or extensive SCLC at least 45 days after the cessation of first-line chemotherapy. Not considered suitable for further intravenous chemotherapy. Received one prior chemotherapy regimen only. Documented partial or complete response to first-line therapy. | Patients with documented progressive, limited or extensive SCLC that had recurred at least 60 days after the end of first-line chemotherapy | Patients with limited or extensive SCLC that had recurred at least 3 months after the end of first-line chemotherapy. Received one prior chemotherapy regimen only. | Patients with limited or extensive SCLC and documented complete or partial response to first-line therapy with disease recurrence after ≥90 days. Received one prior chemotherapy regimen only |
Mean age (range) | 59.2 (37-79) years | Not reported | 59.0 (35-79) years | 62.2 (35-82) years |
% extensive disease | 65% | 84% | 72% | 68% |
Performance status (% 0/1/2) | 10/60/29% | 18/61/21% | 26/52/22% | 27/60/13% |
Previous chemotherapy | Not reported | Platinum/etoposide: 48% CAV: 1% | Not reported | cisplatinum or carboplatinum + etoposide; |
| Â | Â | Both platinum/etoposide + CAV: 14% Cyclophosphamide/doxorubicin/etoposide : 17% | Â | vincristine + cisplatinum or carboplatinum + etoposide; |
| Â | Â | Vincristine/platinum/etoposide: 5% Other regimens: 15% | Â | cyclophosphamide +epirubicine + cisplatinum or carboplatinum + etoposide |
Previous surgery | 27% | 21% | Not reported | Not reported |
Previous radiotherapy | 51% | 59% | Not reported | Not reported |
Previous immunotherapy | 3% | 1% | Not reported | Not reported |
Liver metastases | 24% | 40% | 31% | 29% |