TABLE 3.
Treatment outcomes
| Treatment outcome | Overall N = 63 | ECOG‐PS 2 N = 38 | ECOG‐PS ≥3 N = 25 | p value |
|---|---|---|---|---|
| Best response, n (%) | 0.558 | |||
| Complete response | 0 | 0 | 0 | |
| Partial response | 45 (71.4) | 27 (71.1) | 18 (72.0) | |
| Stable disease | 8 (12.7) | 6 (15.8) | 2 (8.0) | |
| Progressive disease | 10 (15.9) | 5 (13.2) | 5 (20.0) | |
| ORR (%) | 71.4% | 71.1% | 72.0% | |
| Median PFS, months (95% CI) | 4.4 (3.6–5.2) | 4.6 (3.8–5.6) | 3.1 (1.9–4.7) | 0.946 |
| Median OS, months (95% CI) | 6.5 (5.6–8.1) | 7.7 (5.8–9.7) | 5.1 (3.6–6.5) | 0.421 |
| Improvement to PS 1 or less after treatment of one cycle of CE, n (%) | 0.234 | |||
| Yes | 36 (57.1) | 24 (63.2) | 12 (48.0) | |
| No a | 27 (42.9) | 14 (36.8) | 13 (52.0) | |
| Toxicity during first cycle of CE, n (%) | ||||
| Neutropenia of grade 3 or higher | 40 (63.5) | 22 (57.9) | 18 (72.0) | 0.255 |
| FN | 13 (20.6) | 6 (15.8) | 7 (28.0) | 0.241 |
| Treatment‐related deaths associated with CE b , n (%) | 4 (6.3) | 2 (5.3) | 2 (8.0) | 0.663 |
| Modification of dosing plan due to side effects, n (%) | 24 (38.1) | 11 (28.9) | 13 (52.0) | 0.065 |
| Dose reduction | 14 (22.2) | 8 (21.1) | 6 (24.0) | |
| Discontinuation of administration c | 10 (15.9) | 3 (7.9) | 7 (28.0) |
Abbreviations: 95% CI, 95% confidence interval; CE, carboplatin plus etoposide; ECOG‐PS, Eastern Cooperative Oncology Groups Performance Status; FN, febrile neutropenia; ORR, objective response rate; OS, overall survival; PFS, progression‐free survival.
a
Including two deaths during one cycle of CE in the PS 2 group.
b
The causes of TRD were FN in two cases, aspiration in one case, and gastrointestinal bleeding in one case.
c
Including four treatment‐related death cases during CE therapy.