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Abstract
Purpose
Since the combination of cisplatin plus gemcitabine (CG) had a significant survival advantage for the treatment of patients with chemotherapy-naïve advanced or metastatic non-small cell lung cancer (NSCLC), CG combination have been evaluated with different schedules. However, the best schedule is still unclear. We designed to compare the efficacy and toxicity of CG combination chemotherapy in two different doses of gemcitabine (1,000 or 1,250 mg/m2 3-weekly).
Materials and Methods
We randomized patients with stage III or IV NSCLC into either gemcitabine 1,250 mg/m2 or gemcitabine 1,000 mg/m2. Patients received cisplatin 60 mg/m2 intravenously on day1 of each 3-week cycle. Gemcitabine was administered intravenously on days 1 and 8 of each 3-week cycle.
Results
From April 2002 until July 2004, 125 patients were enrolled from four university hospitals (55 patients in the gemcitabine 1,000 mg/m2 arm and 70 patients in the gemcitabine 1,250 mg/m2 arm). Response rates were not significantly different in both arms (56.4% vs. 55.7%). However, grade 3 neutropenia was significantly lower in gemcitabine 1,000 mg/m2 arm compared to gemcitabine 1,250 mg/m2 arm (11.0% vs. 15.8%). No differences in non-haematologic toxicities in both arms except anorexia were observed. The median survival was 13.4 months for gemcitabine 1,000 mg group compared with 15.8 months for gemcitabine 1,250 mg group. There were no statistically significant differences in survival between the groups.
References
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Table 1.
Intracycle Dose Adjustments (Hematologic Toxicities)
| AGC*(×109/L) | Platelets (×109/L) | % of full-dose gemcitabine | |
|---|---|---|---|
| ≥1.0 | AND | ≥100 | 100 |
| 0.75 to 0.99 | OR | 75 to 99 | 75 |
| 0.5 to 0.74 | OR | 50 to74 | 50 |
| <0.5 | OR | <50 | HOLD |
Table 2.
Patients Characteristics
| Gemcitabine (1,000 mg/m2)(n=55) | Gemcitabine (1,250 mg/m2) (n=70) | |
|---|---|---|
| No. of patients (%) | No. of patients (%) | |
| Age (years) | ||
| Median | 64 | 65 |
| Range | 40∼76 | 30∼78 |
| Sex | ||
| Male | 47 (85.5) | 58 (82.9) |
| Female | 8 (14.5) | 12 (17.1) |
| ECOG | ||
| 0 | 8 (14.5) | 15 (21.4) |
| 1 | 38 (69.1) | 46 (65.7) |
| 2 | 9 (16.4) | 9 (12.9) |
| Stage* | ||
| IIIA | 17 (30.9) | 11 (15.8) |
| IIIB | 20 (36.4) | 31 (44.2) |
| IV | 18 (32.7) | 28 (40.0) |
| Histology | ||
| Adenocarcinoma | 20 (36.4) | 29 (41.4) |
| Squamous cell | 32 (58.2) | 34 (48.6) |
| Large cell | 2 (3.6) | 1 (1.4) |
| Others | 1 (2.8) | 6 (8.6) |
Table 3.
Comparision of Response between Two Groups
Table 4.
Comparison of Hematologic Toxicities between Two Groups
| Gemcitabine (1,000 mg/m2)(n*=480) | Gemcitabine (1,250 mg/m2) (n*=618) | p | |||
|---|---|---|---|---|---|
| No. | % | No. | % | ||
| Granulocytopenia | |||||
| Total | 53 | 11 | 98 | 15.8 | 0.016 |
| Grade 3 | 51 | 10.6 | 84 | 13.5 | |
| Grade 4 | 2 | 0.4 | 14 | 2.3 | |
| Thrombocytopenia | |||||
| Total | 22 | 4.6 | 23 | 3.7 | 0.113 |
| Grade 3 | 20 | 4.1 | 20 | 3.2 | |
| Grade 4 | 2 | 0.5 | 3 | 0.5 | |
| Anemia | |||||
| Total | 29 | 6.0 | 42 | 6.8 | 0.019 |
| Grade 3 | 29 | 6.0 | 42 | 6.8 | 0.119 |
| Grade 4 | 0 | 0.0 | 0 | 0.0 | |
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