Rituximab plus infusional cyclophosphamide, doxorubicin, and etoposide in HIV-associated non-Hodgkin lymphoma: Pooled results from 3 phase 2 trials

Michele Spina, Ulrich Jaeger, Joseph A. Sparano, Renato Talamini, Cecilia Simonelli, Mariagrazia Michieli, Giuseppe Rossi, Ezio Nigra, Massimiliano Berretta, Chiara Cattaneo, Armin C. Rieger, Emanuela Vaccher, Umberto Tirelli

Research output: Contribution to journalArticle

150 Citations (Scopus)

Abstract

Evidence suggests that infusional therapy is a more effective means for administering cytotoxic therapy than intravenous bolus therapy for lymphoma and offers greater potential for therapeutic synergy with rituximab, which has a long half-life. We pooled the results of 3 prospective phase 2 trials evaluating rituximab in combination with 96-hour infusion of cyclophosphamide (187.5-200 mg/m2 per day), doxorubicin (12.5 mg/m2 per day), and etoposide (60 mg/m2 per day) (R-CDE) plus granulocyte-colony- stimulating factor (G-CSF) in 74 patients with HIV-associated, B-cell non-Hodgkin lym phoma, of whom 56 (76%) patients received concurrent highly active antiretroviral therapy (HAART). The complete remission (CR) rate was 70% (95% confidence interval [CI], 59%-81%), and the estimated 2-year failure-free survival and overall survival rates were 59% (95% CI, 47%-71%) and 64% (95% CI, 52%-76%), respectively. Ten (14%) patients had opportunistic infections during or within 3 months of the end of R-CDE, and 17 (23%) patients developed nonopportunistic infections after that time. Six (8%) patients died because of infection; 2 (3%) of those infections were bacterial sepsis during R-CDE, and 4 (5%) were opportunistic infections that occurred between 2 and 8 months after the completion of R-CDE. R-CDE produced a 70% CR rate and a 59% 2-year failure-free survival rate in patients with HIV-associated lymphoma. Consistent with other reports, adding rituximab to cytotoxic therapy in this population may increase the risk for life-threatening infection. Further studies evaluating rituximab in combination with infusional chemotherapy are warranted, but caution is advised.

Original languageEnglish (US)
Pages (from-to)1891-1897
Number of pages7
JournalBlood
Volume105
Issue number5
DOIs
StatePublished - Mar 1 2005
Externally publishedYes

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Etoposide
Non-Hodgkin's Lymphoma
Doxorubicin
Cyclophosphamide
HIV
Opportunistic Infections
Confidence Intervals
Chemotherapy
Lymphoma
Granulocyte Colony-Stimulating Factor
Survival Rate
Infection
Therapeutics
Highly Active Antiretroviral Therapy
Cells
Bacterial Infections
Half-Life
Rituximab
Sepsis
B-Lymphocytes

ASJC Scopus subject areas

  • Hematology

Cite this

Rituximab plus infusional cyclophosphamide, doxorubicin, and etoposide in HIV-associated non-Hodgkin lymphoma : Pooled results from 3 phase 2 trials. / Spina, Michele; Jaeger, Ulrich; Sparano, Joseph A.; Talamini, Renato; Simonelli, Cecilia; Michieli, Mariagrazia; Rossi, Giuseppe; Nigra, Ezio; Berretta, Massimiliano; Cattaneo, Chiara; Rieger, Armin C.; Vaccher, Emanuela; Tirelli, Umberto.

In: Blood, Vol. 105, No. 5, 01.03.2005, p. 1891-1897.

Research output: Contribution to journalArticle

Spina, M, Jaeger, U, Sparano, JA, Talamini, R, Simonelli, C, Michieli, M, Rossi, G, Nigra, E, Berretta, M, Cattaneo, C, Rieger, AC, Vaccher, E & Tirelli, U 2005, 'Rituximab plus infusional cyclophosphamide, doxorubicin, and etoposide in HIV-associated non-Hodgkin lymphoma: Pooled results from 3 phase 2 trials', Blood, vol. 105, no. 5, pp. 1891-1897. https://doi.org/10.1182/blood-2004-08-3300
Spina, Michele ; Jaeger, Ulrich ; Sparano, Joseph A. ; Talamini, Renato ; Simonelli, Cecilia ; Michieli, Mariagrazia ; Rossi, Giuseppe ; Nigra, Ezio ; Berretta, Massimiliano ; Cattaneo, Chiara ; Rieger, Armin C. ; Vaccher, Emanuela ; Tirelli, Umberto. / Rituximab plus infusional cyclophosphamide, doxorubicin, and etoposide in HIV-associated non-Hodgkin lymphoma : Pooled results from 3 phase 2 trials. In: Blood. 2005 ; Vol. 105, No. 5. pp. 1891-1897.
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abstract = "Evidence suggests that infusional therapy is a more effective means for administering cytotoxic therapy than intravenous bolus therapy for lymphoma and offers greater potential for therapeutic synergy with rituximab, which has a long half-life. We pooled the results of 3 prospective phase 2 trials evaluating rituximab in combination with 96-hour infusion of cyclophosphamide (187.5-200 mg/m2 per day), doxorubicin (12.5 mg/m2 per day), and etoposide (60 mg/m2 per day) (R-CDE) plus granulocyte-colony- stimulating factor (G-CSF) in 74 patients with HIV-associated, B-cell non-Hodgkin lym phoma, of whom 56 (76{\%}) patients received concurrent highly active antiretroviral therapy (HAART). The complete remission (CR) rate was 70{\%} (95{\%} confidence interval [CI], 59{\%}-81{\%}), and the estimated 2-year failure-free survival and overall survival rates were 59{\%} (95{\%} CI, 47{\%}-71{\%}) and 64{\%} (95{\%} CI, 52{\%}-76{\%}), respectively. Ten (14{\%}) patients had opportunistic infections during or within 3 months of the end of R-CDE, and 17 (23{\%}) patients developed nonopportunistic infections after that time. Six (8{\%}) patients died because of infection; 2 (3{\%}) of those infections were bacterial sepsis during R-CDE, and 4 (5{\%}) were opportunistic infections that occurred between 2 and 8 months after the completion of R-CDE. R-CDE produced a 70{\%} CR rate and a 59{\%} 2-year failure-free survival rate in patients with HIV-associated lymphoma. Consistent with other reports, adding rituximab to cytotoxic therapy in this population may increase the risk for life-threatening infection. Further studies evaluating rituximab in combination with infusional chemotherapy are warranted, but caution is advised.",
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AU - Sparano, Joseph A.

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AU - Simonelli, Cecilia

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N2 - Evidence suggests that infusional therapy is a more effective means for administering cytotoxic therapy than intravenous bolus therapy for lymphoma and offers greater potential for therapeutic synergy with rituximab, which has a long half-life. We pooled the results of 3 prospective phase 2 trials evaluating rituximab in combination with 96-hour infusion of cyclophosphamide (187.5-200 mg/m2 per day), doxorubicin (12.5 mg/m2 per day), and etoposide (60 mg/m2 per day) (R-CDE) plus granulocyte-colony- stimulating factor (G-CSF) in 74 patients with HIV-associated, B-cell non-Hodgkin lym phoma, of whom 56 (76%) patients received concurrent highly active antiretroviral therapy (HAART). The complete remission (CR) rate was 70% (95% confidence interval [CI], 59%-81%), and the estimated 2-year failure-free survival and overall survival rates were 59% (95% CI, 47%-71%) and 64% (95% CI, 52%-76%), respectively. Ten (14%) patients had opportunistic infections during or within 3 months of the end of R-CDE, and 17 (23%) patients developed nonopportunistic infections after that time. Six (8%) patients died because of infection; 2 (3%) of those infections were bacterial sepsis during R-CDE, and 4 (5%) were opportunistic infections that occurred between 2 and 8 months after the completion of R-CDE. R-CDE produced a 70% CR rate and a 59% 2-year failure-free survival rate in patients with HIV-associated lymphoma. Consistent with other reports, adding rituximab to cytotoxic therapy in this population may increase the risk for life-threatening infection. Further studies evaluating rituximab in combination with infusional chemotherapy are warranted, but caution is advised.

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