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DOI 10.1007/s10637-010-9523-2

Медицинская библиотека · Investigational new drugs · 2010

Dose modification of alemtuzumab in combination with dexamethasone, cytarabine, and cisplatin in patients with relapsed or refractory peripheral T-cell lymphoma: analysis of efficacy and toxicity.

Kim Seok Jin, Kim Kihyun, Park Yong, Kim Byung Soo, Huh Jooryung, Ko Young Hae, Park Keunchil, Suh Cheolwon, Kim Won Seog

Клиническое исследование II фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

BACKGROUND

There is still no consensus on the role of alemtuzumab as a salvage therapy for relapsed or refractory peripheral T-cell lymphoma (PTCL). We studied the efficacy and toxicity of combination treatment of alemtuzumab, dexamethasone, cytarabine, and cisplatin (A-DHAP) for treating PTCL.

METHODS

We enrolled 24 patients with relapsed or refractory PTCL. Each patient received DHAP plus alemtuzumab every 3 weeks for up to three cycles. Two alemtuzumab dosages of 70 mg or 40 mg were used per cycle. After A-DHAP treatment, the responders underwent autologous stem cell transplantation.

RESULTS

The overall response rate was 50.0% (12 of 24 patients), including five complete responders and seven partial responders. Analysis of the responses according to histological type showed a higher objective response rate for PTCL-unspecified (69.2%: four complete responders, five partial responders) than for extranodal NK/T cell lymphoma (12.5%, one partial responder). The median overall survival (OS) after enrollment was 6.0 months (95% confidence interval: 4.20-7.80 months), and the median response duration of responders was 2.93 months (95% confidence interval: 0.93-4.93 months). The overall response rate and OS did not differ significantly according to the dosage of alemtuzumab (70 mg vs. 40 mg, P > 0.05). The most frequent side effect was grade 3/4 leukopenia. Non-disease-related death occurred more frequently in patients who received 70 mg of alemtuzumab.

CONCLUSIONS

The combination of alemtuzumab plus DHAP might be effective salvage chemotherapy for PTCL, and 40 mg of alemtuzumab appears to be a more tolerable dosage when used in combination with DHAP.

Для цитирования: Kim Seok Jin, Kim Kihyun, Park Yong, Kim Byung Soo, Huh Jooryung, Ko Young Hae, Park Keunchil, Suh Cheolwon, Kim Won Seog. Dose modification of alemtuzumab in combination with dexamethasone, cytarabine, and cisplatin in patients with relapsed or refractory peripheral T-cell lymphoma: analysis of efficacy and toxicity.. Investigational new drugs. 2010. DOI: 10.1007/s10637-010-9523-2.

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