We conducted a phase II trial of gemcitabine with S-1 to evaluate the activity and toxicity of such a combination in heavily pretreated patients (pts) with metastatic colorectal cancer (mCRC) who have progressed after treatment with 5-fluorouracil, oxaliplatin and irinotecan.Methods
Between December 2009 and November 2011, 23 pts (36 of planned) were enrolled, with the following characteristics: 12 males and 11 females, median age 57 years (28–72). S-1 was given orally (30 mg/m2) b.i.d. for 14 consecutive days and gemcitabine (1000 mg/m2) was given on days 8 and 15, every 21 days, until disease progression and for a maximum of nine cycles. The primary end point was the objective response rate (ORR).Results
The median number of cycles was 4 (range 1–9). OR was 8.7% (95% CI: 0–20.2) and THE disease control rate was 56.5% (95% CI: 36.4–76.9) with two partial responses and eleven stable diseases. The median duration of disease control was 8.5 months (95% CI: 3.8–13.2). The median progression-free survival was 3.2 months (95% CI: 1.9–4.5) and the median overall survival was 11.8 months (95% CI 4.0-19.5). Grade 3 and 4 toxicities were neutropenia (8%) and thrombocytopenia (4%).Conclusions
Combination chemotherapy with gemcitabine and S-1 was well tolerated and efficacious for refractory mCRC pts.