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Erschienen in:
01.10.2009 | Original Article
Long-term results of gemcitabine plus oxaliplatin with and without rituximab as salvage treatment for transplant-ineligible patients with refractory/relapsing B-cell lymphoma
Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 5/2009
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Purpose
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.
Methods
Patients were prospectively enrolled in two subsequent trials, GEMOX [gemcitabine (1200 mg/m2, days 1 and 8) and oxaliplatin (120 mg/m2, day 2), three-weekly] and R-GEMOX [rituximab (375 mg/m2, day 1), gemcitabine (1200 mg/m2, day 1) and oxaliplatin (120 mg/m2, day 2), bi-weekly], up to six courses.
Results
Sixty-two patients were enrolled: GEMOX [n = 30; median age, 66 years (range, 46–85); previous chemotherapy ≥2, 70%; PS ECOG ≥ 2, 57%]; R-GEMOX [n = 32; median age, 65 years (range 32–79); previous chemotherapy ≥2, 75%; PS ECOG ≥ 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).
Conclusions
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.