Table 1 Patient characteristics
CPT-11/GEM (Group A) | CPT-11 (Group B) | |||
---|---|---|---|---|
No. of patients | % | No. of patients | % | |
Patients randomised | 79 | 75 | ||
Evaluable for toxicity | 76 | 71 | ||
Evaluable for response | 76 | 71 | ||
Gender | ||||
Male | 71 | 93 | 63 | 89 |
Female | 5 | 7 | 8 | 11 |
Age (years) | ||||
Median (range) | 60.5 (42–72) | 64 (42–72) | ||
Performance status (WHO) | ||||
0–1 | 69 | 91 | 64 | 90 |
2 | 7 | 9 | 7 | 10 |
Histology | ||||
Adenocarcinomas | 25 | 33 | 24 | 34 |
Nonadenocarcinomas | 51 | 67 | 47 | 66 |
Stage | ||||
i.v. | 76 | 100 | 71 | 100 |
No. of organs involved | ||||
1 | 28 | 37 | 28 | 40 |
2 | 32 | 42 | 33 | 47 |
⩾3 | 16 | 21 | 10 | 13 |
Prior treatment | ||||
Radiotherapy | 12 | 15 | 17 | 23 |
Chemotherapy | 100 | 100 | 100 | 100 |
Platinum compound | ||||
CDDP | 59 | 78 | 58 | 82 |
Carboplatin | 17 | 22 | 13 | 18 |
Best response to first-line chemoTx | ||||
CR/PR | 27 | 36 | 19 | 27 |
SD/PD | 49 | 64 | 52 | 73 |