Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis

Michael J. Glantz, Suzanne LaFollette, Kurt Jaeckle, William Shapiro, Lode Swinnen, Jack R. Rozental, Surasak Phuphanich, Lisa R. Rogers, John C. Gutheil, Tracy Batchelor, David Lyter, Marc Chamberlain, Bernard L. Maria, Charles Schiffer, Rifaat Bashir, David Thomas, Wayne Cowens, Stephen B. Howell

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Abstract

Purpose: To evaluate the efficacy and safety of a slow-release formulation of cytarabine (DepoCyt; Chiron Corp, Emeryville, CA, and Skye Pharma, Inc, San Diego, CA) that maintains cytotoxic concentrations of cytarabine (ara-C) in the CSF of most patients for more than 14 days. Patients and Methods: Twenty-eight patients with lymphoma and a positive CSF cytology were randomized to receive DepoCyt 50 mg once every 2 weeks or free ara-C 50 mg twice a week for 1 month. Patients whose CSF cytology converted to negative and who did not have neurologic progression received an additional 3 months of consolidation therapy and then 4 months of maintenance therapy. All patients received dexamethasone 4 mg orally bid on days 1 through 5 of each 2-week cycle. Results: The response rate was 71% for DepoCyt and 15% for ara-C on an intent-to-treat basis (P = .006). All of the patients on the DepoCyt arm but only 53% of those on the ara-C arm were able to complete the planned 1-month induction therapy regimen. Time to neurologic progression and survival trended in favor of DepoCyt (median, 78.5 v 42 days and 99.5 v 63 days, respectively; P > .05). DepoCyt treatment was associated with an improved mean change in Karnofsky performance score at the end of induction (P = .041). The major adverse events on both arms were headache and arachnoiditis, which were often caused by the underlying disease. Conclusion: DepoCyt injected once every 2 weeks produced a high response rate and a better quality of life as measured by Karnofsky score relative to that produced by free ara-C injected twice a week.

Original languageEnglish (US)
Pages (from-to)3110-3116
Number of pages7
JournalJournal of Clinical Oncology
Volume17
Issue number10
DOIs
StatePublished - Jan 1 1999

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Cytarabine
Meningitis
Nervous System
Therapeutics
Cell Biology
Arachnoiditis
Dexamethasone
Headache
Lymphoma
Quality of Life
Safety
Survival

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Glantz, Michael J. ; LaFollette, Suzanne ; Jaeckle, Kurt ; Shapiro, William ; Swinnen, Lode ; Rozental, Jack R. ; Phuphanich, Surasak ; Rogers, Lisa R. ; Gutheil, John C. ; Batchelor, Tracy ; Lyter, David ; Chamberlain, Marc ; Maria, Bernard L. ; Schiffer, Charles ; Bashir, Rifaat ; Thomas, David ; Cowens, Wayne ; Howell, Stephen B. / Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 10. pp. 3110-3116.
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abstract = "Purpose: To evaluate the efficacy and safety of a slow-release formulation of cytarabine (DepoCyt; Chiron Corp, Emeryville, CA, and Skye Pharma, Inc, San Diego, CA) that maintains cytotoxic concentrations of cytarabine (ara-C) in the CSF of most patients for more than 14 days. Patients and Methods: Twenty-eight patients with lymphoma and a positive CSF cytology were randomized to receive DepoCyt 50 mg once every 2 weeks or free ara-C 50 mg twice a week for 1 month. Patients whose CSF cytology converted to negative and who did not have neurologic progression received an additional 3 months of consolidation therapy and then 4 months of maintenance therapy. All patients received dexamethasone 4 mg orally bid on days 1 through 5 of each 2-week cycle. Results: The response rate was 71{\%} for DepoCyt and 15{\%} for ara-C on an intent-to-treat basis (P = .006). All of the patients on the DepoCyt arm but only 53{\%} of those on the ara-C arm were able to complete the planned 1-month induction therapy regimen. Time to neurologic progression and survival trended in favor of DepoCyt (median, 78.5 v 42 days and 99.5 v 63 days, respectively; P > .05). DepoCyt treatment was associated with an improved mean change in Karnofsky performance score at the end of induction (P = .041). The major adverse events on both arms were headache and arachnoiditis, which were often caused by the underlying disease. Conclusion: DepoCyt injected once every 2 weeks produced a high response rate and a better quality of life as measured by Karnofsky score relative to that produced by free ara-C injected twice a week.",
author = "Glantz, {Michael J.} and Suzanne LaFollette and Kurt Jaeckle and William Shapiro and Lode Swinnen and Rozental, {Jack R.} and Surasak Phuphanich and Rogers, {Lisa R.} and Gutheil, {John C.} and Tracy Batchelor and David Lyter and Marc Chamberlain and Maria, {Bernard L.} and Charles Schiffer and Rifaat Bashir and David Thomas and Wayne Cowens and Howell, {Stephen B.}",
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Glantz, MJ, LaFollette, S, Jaeckle, K, Shapiro, W, Swinnen, L, Rozental, JR, Phuphanich, S, Rogers, LR, Gutheil, JC, Batchelor, T, Lyter, D, Chamberlain, M, Maria, BL, Schiffer, C, Bashir, R, Thomas, D, Cowens, W & Howell, SB 1999, 'Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis', Journal of Clinical Oncology, vol. 17, no. 10, pp. 3110-3116. https://doi.org/10.1200/JCO.1999.17.10.3110

Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis. / Glantz, Michael J.; LaFollette, Suzanne; Jaeckle, Kurt; Shapiro, William; Swinnen, Lode; Rozental, Jack R.; Phuphanich, Surasak; Rogers, Lisa R.; Gutheil, John C.; Batchelor, Tracy; Lyter, David; Chamberlain, Marc; Maria, Bernard L.; Schiffer, Charles; Bashir, Rifaat; Thomas, David; Cowens, Wayne; Howell, Stephen B.

In: Journal of Clinical Oncology, Vol. 17, No. 10, 01.01.1999, p. 3110-3116.

Research output: Contribution to journalArticle

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T1 - Randomized trial of a slow-release versus a standard formulation of cytarabine for the intrathecal treatment of lymphomatous meningitis

AU - Glantz, Michael J.

AU - LaFollette, Suzanne

AU - Jaeckle, Kurt

AU - Shapiro, William

AU - Swinnen, Lode

AU - Rozental, Jack R.

AU - Phuphanich, Surasak

AU - Rogers, Lisa R.

AU - Gutheil, John C.

AU - Batchelor, Tracy

AU - Lyter, David

AU - Chamberlain, Marc

AU - Maria, Bernard L.

AU - Schiffer, Charles

AU - Bashir, Rifaat

AU - Thomas, David

AU - Cowens, Wayne

AU - Howell, Stephen B.

PY - 1999/1/1

Y1 - 1999/1/1

N2 - Purpose: To evaluate the efficacy and safety of a slow-release formulation of cytarabine (DepoCyt; Chiron Corp, Emeryville, CA, and Skye Pharma, Inc, San Diego, CA) that maintains cytotoxic concentrations of cytarabine (ara-C) in the CSF of most patients for more than 14 days. Patients and Methods: Twenty-eight patients with lymphoma and a positive CSF cytology were randomized to receive DepoCyt 50 mg once every 2 weeks or free ara-C 50 mg twice a week for 1 month. Patients whose CSF cytology converted to negative and who did not have neurologic progression received an additional 3 months of consolidation therapy and then 4 months of maintenance therapy. All patients received dexamethasone 4 mg orally bid on days 1 through 5 of each 2-week cycle. Results: The response rate was 71% for DepoCyt and 15% for ara-C on an intent-to-treat basis (P = .006). All of the patients on the DepoCyt arm but only 53% of those on the ara-C arm were able to complete the planned 1-month induction therapy regimen. Time to neurologic progression and survival trended in favor of DepoCyt (median, 78.5 v 42 days and 99.5 v 63 days, respectively; P > .05). DepoCyt treatment was associated with an improved mean change in Karnofsky performance score at the end of induction (P = .041). The major adverse events on both arms were headache and arachnoiditis, which were often caused by the underlying disease. Conclusion: DepoCyt injected once every 2 weeks produced a high response rate and a better quality of life as measured by Karnofsky score relative to that produced by free ara-C injected twice a week.

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