TABLE 1.
Characteristics of patients in each treatment arm
|
ARM A (n = 52) Standard gem – cis |
ARM B (n = 54) Low-dose gem - cis |
TOTAL | P | |
|---|---|---|---|---|
| Gender | 0.42 | |||
| Male | 39 | 44 | 83 | |
| Female | 13 | 10 | 23 | |
| Age | 0.41 | |||
| Median | 58 | 57 | 57 | |
| Range | 42–72 | 30–77 | 30–77 | |
| ECOG PS | 0.79 | |||
| 0 | 44 | 47 | 91 | |
| 1 | 8 | 7 | 15 | |
| Weight loss | 0.20 | |||
| ≤ 5 % | 41 | 47 | 88 | |
| > 5 % | 11 | 6 | 17 | |
| Histology | 0.18 | |||
| Squamous-cell carcinoma | 35 | 27 | 62 | |
| Adenocarcinoma | 7 | 16 | 23 | |
| Large cell carcinoma | 4 | 3 | 7 | |
| Other& Unspecified | 6 | 8 | 14 | |
| Stage | 0.15 | |||
| IA | 1 | 0 | 1 | |
| IB | 1 | 0 | 1 | |
| IIB | 1 | 2 | 3 | |
| IIIA | 19 | 31 | 50 | |
| IIIB | 30 | 21 | 51 | |
| Reason for inoperability | 0.36 | |||
| Extent of disease | 49 | 52 | 101 | |
| Functional | 3 | 1 | 4 | |
| Refuse | 0 | 1 | 1 | |
| Previous treatment | 0.09 | |||
| No | 48 | 44 | 92 | |
| Explorative thoracotomy | 3 | 10 | 13 | |
| Recurrent after lobectomy | 1 | 0 | 1 |
cis = ciplatin; ECOG PS = performance status based on the Eastern Cooperative Oncology Group; gem = gemcitabine; n = number of patients