Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma

Myron S. Czuczman, A. Koryzna, A. Mohr, C. Stewart, K. Donohue, L. Blumenson, Z. P. Bernstein, P. McCarthy, A. Alam, F. Hernandez-Ilizaliturri, M. Skipper, K. Brown, Asher A Chanan Khan, D. Klippenstein, P. Loud, M. K. Rock, M. Benyunes, A. Grillo-Lopez, S. H. Bernstein

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Abstract

Purpose: To evaluate the safety and efficacy of fludarabine plus rituximab in treatment-naive or relapsed patients with low-grade and/or follicular non-Hodgkin's lymphoma. Patients and Methods: This was an open-label, single-arm, single-center phase II study enrolling 40 patients. During the first week of the study, patients received two infusions of rituximab 375 mg/m 2 administered 4 days apart. Seventy-two hours after the second infusion of rituximab, patients received the first of six cycles of fludarabine chemotherapy (25 mg/m2/d for 5 days on a 28-day cycle). Single infusions of rituximab were administered 72 hours before the second, fourth, and sixth cycles of fludarabine, and two infusions of rituximab were given 4 weeks after the last cycle of fludarabine. Treatment duration was 26 weeks. Results: An overall response rate of 90% (80% complete response rate) was achieved in the intent-to-treat population. Similar response rates were seen in treatment-naïve and previously treated patients. The median duration of response has not been reached at 40+ months. The median follow-up time in this study is 44 months (range, 15 to 66 months). In patients positive for the 14;18 translocation in blood and/or marrow at enrollment, molecular remission was achieved in 88% of cases, with patients remaining negative for up to 4 years to date. Hematologic toxicity was manageable, and except for a 15% incidence of herpes simplex/zoster infections, infectious complications were rare. Nonhematologic toxicities were minimal. Conclusion: Rituximab plus fludarabine was well tolerated and associated with an excellent complete response rate, including molecular remissions, in patients with low-grade or follicular lymphoma.

Original languageEnglish (US)
Pages (from-to)694-704
Number of pages11
JournalJournal of Clinical Oncology
Volume23
Issue number4
DOIs
StatePublished - 2005
Externally publishedYes

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Follicular Lymphoma
Non-Hodgkin's Lymphoma
Drug Therapy
fludarabine
Rituximab
Herpes Simplex
Herpes Zoster
Therapeutics
Bone Marrow
Safety
Incidence

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Czuczman, M. S., Koryzna, A., Mohr, A., Stewart, C., Donohue, K., Blumenson, L., ... Bernstein, S. H. (2005). Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma. Journal of Clinical Oncology, 23(4), 694-704. https://doi.org/10.1200/JCO.2005.02.172

Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma. / Czuczman, Myron S.; Koryzna, A.; Mohr, A.; Stewart, C.; Donohue, K.; Blumenson, L.; Bernstein, Z. P.; McCarthy, P.; Alam, A.; Hernandez-Ilizaliturri, F.; Skipper, M.; Brown, K.; Chanan Khan, Asher A; Klippenstein, D.; Loud, P.; Rock, M. K.; Benyunes, M.; Grillo-Lopez, A.; Bernstein, S. H.

In: Journal of Clinical Oncology, Vol. 23, No. 4, 2005, p. 694-704.

Research output: Contribution to journalArticle

Czuczman, MS, Koryzna, A, Mohr, A, Stewart, C, Donohue, K, Blumenson, L, Bernstein, ZP, McCarthy, P, Alam, A, Hernandez-Ilizaliturri, F, Skipper, M, Brown, K, Chanan Khan, AA, Klippenstein, D, Loud, P, Rock, MK, Benyunes, M, Grillo-Lopez, A & Bernstein, SH 2005, 'Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma', Journal of Clinical Oncology, vol. 23, no. 4, pp. 694-704. https://doi.org/10.1200/JCO.2005.02.172
Czuczman, Myron S. ; Koryzna, A. ; Mohr, A. ; Stewart, C. ; Donohue, K. ; Blumenson, L. ; Bernstein, Z. P. ; McCarthy, P. ; Alam, A. ; Hernandez-Ilizaliturri, F. ; Skipper, M. ; Brown, K. ; Chanan Khan, Asher A ; Klippenstein, D. ; Loud, P. ; Rock, M. K. ; Benyunes, M. ; Grillo-Lopez, A. ; Bernstein, S. H. / Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 4. pp. 694-704.
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abstract = "Purpose: To evaluate the safety and efficacy of fludarabine plus rituximab in treatment-naive or relapsed patients with low-grade and/or follicular non-Hodgkin's lymphoma. Patients and Methods: This was an open-label, single-arm, single-center phase II study enrolling 40 patients. During the first week of the study, patients received two infusions of rituximab 375 mg/m 2 administered 4 days apart. Seventy-two hours after the second infusion of rituximab, patients received the first of six cycles of fludarabine chemotherapy (25 mg/m2/d for 5 days on a 28-day cycle). Single infusions of rituximab were administered 72 hours before the second, fourth, and sixth cycles of fludarabine, and two infusions of rituximab were given 4 weeks after the last cycle of fludarabine. Treatment duration was 26 weeks. Results: An overall response rate of 90{\%} (80{\%} complete response rate) was achieved in the intent-to-treat population. Similar response rates were seen in treatment-na{\"i}ve and previously treated patients. The median duration of response has not been reached at 40+ months. The median follow-up time in this study is 44 months (range, 15 to 66 months). In patients positive for the 14;18 translocation in blood and/or marrow at enrollment, molecular remission was achieved in 88{\%} of cases, with patients remaining negative for up to 4 years to date. Hematologic toxicity was manageable, and except for a 15{\%} incidence of herpes simplex/zoster infections, infectious complications were rare. Nonhematologic toxicities were minimal. Conclusion: Rituximab plus fludarabine was well tolerated and associated with an excellent complete response rate, including molecular remissions, in patients with low-grade or follicular lymphoma.",
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T1 - Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma

AU - Czuczman, Myron S.

AU - Koryzna, A.

AU - Mohr, A.

AU - Stewart, C.

AU - Donohue, K.

AU - Blumenson, L.

AU - Bernstein, Z. P.

AU - McCarthy, P.

AU - Alam, A.

AU - Hernandez-Ilizaliturri, F.

AU - Skipper, M.

AU - Brown, K.

AU - Chanan Khan, Asher A

AU - Klippenstein, D.

AU - Loud, P.

AU - Rock, M. K.

AU - Benyunes, M.

AU - Grillo-Lopez, A.

AU - Bernstein, S. H.

PY - 2005

Y1 - 2005

N2 - Purpose: To evaluate the safety and efficacy of fludarabine plus rituximab in treatment-naive or relapsed patients with low-grade and/or follicular non-Hodgkin's lymphoma. Patients and Methods: This was an open-label, single-arm, single-center phase II study enrolling 40 patients. During the first week of the study, patients received two infusions of rituximab 375 mg/m 2 administered 4 days apart. Seventy-two hours after the second infusion of rituximab, patients received the first of six cycles of fludarabine chemotherapy (25 mg/m2/d for 5 days on a 28-day cycle). Single infusions of rituximab were administered 72 hours before the second, fourth, and sixth cycles of fludarabine, and two infusions of rituximab were given 4 weeks after the last cycle of fludarabine. Treatment duration was 26 weeks. Results: An overall response rate of 90% (80% complete response rate) was achieved in the intent-to-treat population. Similar response rates were seen in treatment-naïve and previously treated patients. The median duration of response has not been reached at 40+ months. The median follow-up time in this study is 44 months (range, 15 to 66 months). In patients positive for the 14;18 translocation in blood and/or marrow at enrollment, molecular remission was achieved in 88% of cases, with patients remaining negative for up to 4 years to date. Hematologic toxicity was manageable, and except for a 15% incidence of herpes simplex/zoster infections, infectious complications were rare. Nonhematologic toxicities were minimal. Conclusion: Rituximab plus fludarabine was well tolerated and associated with an excellent complete response rate, including molecular remissions, in patients with low-grade or follicular lymphoma.

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