1st relapse treatment | 2nd relapse treatment | 3rd relapse treatment | |
No (%) | 233 (100.0) | 233 (100.0) | 144 (61.8) |
Overall survival* (months) | |||
Median±95% CI | 38.9±3.0 | 19.8±2.4 | 8.5±2.6 |
Range | 16.2–140.8 | 1.7–128.2 | 0.0–115.2 |
Progression free survival† (months) | |||
Median±95% CI | 12.0±1.4 | 7.3±1.2 | 4.4±1.8 |
Range | 6.0–70.0 | 0.7–53.8 | 0.0–115.2 |
Response rate (n (%)) | |||
Complete response | 92 (39) | 25 (11) | 2 (1) |
Partial response | 107 (46) | 208 (89) | 50 (35) |
Stable disease | 6 (3) | N/A‡ | 32 (22) |
Progressive disease | N/A | N/A‡ | 21 (15) |
Not recorded | 28 (12) | N/A‡ | 39 (27) |
*Sensitivity analysis of overall survival differed from the primary objective as response was not considered. Overall survival was calculated using; time from date of last cycle of secondline treatment until death or end of follow-up, time from date of last cycle of secondline platinum chemotherapy plus 4 weeks, until date of death due to any cause, and time from date of last cycle of secondline platinum chemotherapy plus 8 weeks until date of death due to any cause or the end of follow-up. Patients showing signs of progression within 4 and/or 8 weeks following the date of the last cycle of secondline platinum chemotherapy were excluded from the sensitivity analyses.
†Progression free survival calculation defined as time from the end date of the last cycle of the subsequent line of chemotherapy until the earliest documentation of disease progression, death, or end of follow-up.
‡Inclusion criteria for the study dictated all patients must have a complete or partial response to secondline chemotherapy.