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Long-term results of gemcitabine plus oxaliplatin with and without rituximab as salvage treatment for transplant-ineligible patients with refractory/relapsing B-cell lymphoma

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Abstract

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.

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Acknowledgments

Supported in part by Ricerca Finalizzata, FSN, Ministry of Health, Rome, Italy.

Conflicts of interest statement

All of the authors have no financial or other conflicts of interest to declare.

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Authors and Affiliations

  1. Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione ‘G.Pascale’, IRCCS, Via M. Semmola, 80131, Naples, Italy

    Gaetano Corazzelli, Gaetana Capobianco, Manuela Arcamone, Filippo Russo, Ferdinando Frigeri, Cristina Becchimanzi, Gianpaolo Marcacci & Antonio Pinto

  2. Internal Medicine Unit 2, Nucleo Ematologico Operativo, USL 7, Conegliano, Treviso, Italy

    Pier Ferruccio Ballerini

  3. Hematology Unit, AOUP ‘Paolo Giaccone’, Palermo, Italy

    Emilio Iannitto

  4. Pathology Unit, Istituto Nazionale Tumori, Fondazione ‘G.Pascale’, IRCCS, Naples, Italy

    Annarosaria De Chiara

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  1. Gaetano Corazzelli
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  2. Gaetana Capobianco
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Correspondence to Gaetano Corazzelli.

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Corazzelli, G., Capobianco, G., Arcamone, M. et al. Long-term results of gemcitabine plus oxaliplatin with and without rituximab as salvage treatment for transplant-ineligible patients with refractory/relapsing B-cell lymphoma. Cancer Chemother Pharmacol 64, 907–916 (2009). https://doi.org/10.1007/s00280-009-0941-9

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