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Prolonged Rituximab Shows Promise for Follicular Lymphoma and Mantle Cell Leukemia: Presented at NHL

By Chris Berrie

PRAGUE, CZECH REPUBLIC -- September 16, 2004 -- Prolonged treatment with rituximab significantly increases event-free survival following standard single-agent rituximab in patients with newly diagnosed or resistant/relapsed follicular lymphoma (FL) or mantle cell leukaemia (MCL).

The findings, from a study by the Swiss Group for Clinical Cancer Research (SAKK), were presented here September 11^th at The Role of Immunotherapy in NHL: Optimising Treatment Outcomes, sponsored by Roche.

Having noted from earlier trials not just the efficacy and safety of single-agent rituximab, but also the often relatively low proportion of complete responses (CR; 5%-10%) seen with this therapy, the SAKK group decided that the standard 375 mg/m² weekly for 4 weeks schedule might be enhanced to optimise the clinical efficacy. This was also supported by the significant correlation between the median antibody concentration in the blood and the response to treatment.

Michele Ghielmini, MD, vice-head, department of medical oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland, said that they designed this parallel FL/MCL trial to evaluate the efficacy and safety of prolonged rituximab therapy. In presenting an update of their recent publication with FL patients (Ghielmini et al. Blood. June 2004;103:4416-23), Dr. Ghielmini discussed the updated combined data on 202 patients in the FL trial and the 104 patients in the parallel MCL trial.

These 306 patients received the standard rituximab induction regimen of 375 mg/m² weekly for 4 weeks, which showed a response rate of 46% with a complete response of 6%. Those who responded to this treatment or who remained with stable disease after week 12 (FL, 151; MCL, 61) were randomised for observation or for further single infusions of rituximab 375 mg/m² every 2 months on months 3, 5, 7, and 9 (prolonged treatment).

The median EFS was significantly different between the prolonged treatment and observation (15 months vs 9 months, respectively; P =.005), but the median overall survival was not reached in either group (P =.37). They also carried out multivariate analyses to determine the prognostic factors for both the responses and the event-free survival, data which is under consideration at present for publication elsewhere.

Toxicity-related problems were distributed equally between the treatment arms, which demonstrates that the prolonged rituximab schedule was well tolerated and showed no additional toxicity, according to the researchers.

With an overall consideration of the full results from these 2 parallel trials, Dr. Ghielmini concluded, "What we can say here for these patients is that single-agent rituximab is a valid treatment for patients who have FL, low tumour burden, normal haemoglobin [levels], and also a VV152 Fc phenotype. Also, importantly, if the patients do respond to single agent rituximab, then prolonging the treatment is recommended."

As a final comment, Dr. Ghielmini indicated that there remains unanswered the question of the length and intensity of this prolonged rituximab treatment, and a new SAKK study (35/03) has just been started to attempt to provide further data towards the answering of this question.


[Presentation title: Rituximab Maintenance Therapy After Rituximab Induction. Abstract 489]

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