Table 2. Randomised trials for the treatment of relapsed SCLC.
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Results
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|---|---|---|---|---|---|---|---|---|---|---|
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Response rate (%)
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| Authors | Study type | Regimen | Schedule | Patients (n) | ORR | CR | PR | SD | Median TTP (weeks) | Median survival (weeks) |
| von Pawel et al (1999) | Randomised Phase II | CAV vs topotecan | Cyclophosphamide 1000 mg m–2 + doxorubicin 45 mg m–2 + vincristine 2 mg m–2, day 1, q3w | 104 | 18.3 | 1 | 18 | 12 | — | 24.7 |
| IV topotecan: 1.5 mg m–2, days 1–5, q3w | 107 | 24.3 | 0 | 26 | 21 | — | 25.0 | |||
| von Pawel et al (2001) | Randomised Phase II | Oral topotecan vs IV topotecan | Oral topotecan: 2.3 mg m–2, days 1–5, q3w | 52 | 23 | 2 | 21 | 19 | 14.9 | 32 |
| IV topotecan: 1.5 mg m–2, days 1–5, q3w | 54 | 15 | 4 | 11 | 30 | 13.1 | 25 | |||
| Eckardt (2007) | Randomised Phase III | Oral topotecan vs IV topotecan | Oral topotecan: 2.3 mg m–2, days 1–5, q3w | 153 | 18 | — | — | 18 | — | 33 |
| IV topotecan: 1.5 mg m–2, days 1–5, q3w | 151 | 22 | — | — | 23 | — | 35 | |||
| O’Brien et al (2006) | Randomised Phase III | Oral topotecan + BSC vs BSC alone | Oral topotecan: 2.3 mg m–2, days 1–5, q3w | 71 | 7 | 0 | 7 | 44 | 16.3 | 25.9 |
| BSC alone | 70 | — | — | — | — | — | 13.9 | |||
Abbreviations: ORR=overall response rate; CR=complete response; PR=partial response; SD=stable disease; TTP=time to progression; CAV=cyclophosphamide, doxorubicin and vincristine; BSC=best supportive care; SCLC=small cell ling cancer.