Journal
CANCER CHEMOTHERAPY AND PHARMACOLOGY
Volume 64, Issue 5, Pages 907-916Publisher
SPRINGER
DOI: 10.1007/s00280-009-0941-9
Keywords
Gemcitabine; Oxaliplatin; Rituximab; Non-Hodgkin lymphoma; Salvage treatment
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Funding
- Ricerca Finalizzata
- FSN
- Ministry of Health, Rome, Italy
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To determine the efficacy and safety of the combination of gemcitabine plus oxaliplatin, with and without rituximab, in patients with relapsed/refractory B-cell lymphoma unsuitable for high dose therapy. Patients were prospectively enrolled in two subsequent trials, GEMOX [gemcitabine (1200 mg/m(2), days 1 and 8) and oxaliplatin (120 mg/m(2), day 2), three-weekly] and R-GEMOX [rituximab (375 mg/m(2), day 1), gemcitabine (1200 mg/m(2), day 1) and oxaliplatin (120 mg/m(2), day 2), bi-weekly], up to six courses. Sixty-two patients were enrolled: GEMOX [n = 30; median age, 66 years (range, 46-85); previous chemotherapy a parts per thousand yen2, 70%; PS ECOG a parts per thousand yen 2, 57%]; R-GEMOX [n = 32; median age, 65 years (range 32-79); previous chemotherapy a parts per thousand yen2, 75%; PS ECOG a parts per thousand yen 2, 47%]. Overall and complete response rates were 57 and 30% (95% CI, 15-49) for GEMOX and 78 and 50% (95% CI, 32-68) in R-GEMOX, respectively. Grade 3/4 neutropenia occurred in 57 and 47% of cycles and grade 3/4 thrombocytopenia in 26 and 17% of courses for GEMOX and R-GEMOX, respectively. At 42 months, the failure-free survival (FFS) was 7% (95% CI, 0-16) for GEMOX and 28% (95% CI, 9-47) for R-GEMOX (P = 0.014), with overall survivals of 7 (95% CI, 0-16) and 37% (95% CI, 20-55), respectively (P = 0.016). Both regimes showed good tolerability and appealing response rates. FFS was more prolonged in R-GEMOX, but patients continuously relapsed without a clear plateau on survival curves.
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