Treatment of cancer-associated hypercalcemia: Double-blind comparison of rapid and slow intravenous infusion regimens of pamidronate disodium and saline alone

Rasim A. Gucalp, Richard Theriault, Indrani Gill, Stefan Madajewicz, Robert Chapman, Rudolph Navari, Frederick Ahmann, Ken Zelenakas, Maika Heffernan, Robert D. Knight

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Abstract

Background: We assessed the effects of 60-mg single doses of pamidronate disodium compared with saline alone in the treatment of cancer-associated hypercalcemia. Methods: After pretreatment hydration, patients with corrected serum calcium concentrations of 3.0 mmol/L (12 mg/dL) or greater secondary to cancer were randomized to double-blind treatment with a single infusion of pamidronate disodium, 60 mg, over either 4 or 24 hours or continued infusions of 0.9% saline alone (n=23 per group). Corrected serum calcium levels were measured daily for 7 days of inpatient evaluation. Results: Response rates for both of the pamidronate regimens were significantly (P<.05) higher than that for saline alone. A complete response to treatment (corrected serum calcium concentration normalized) was observed for live (22%), 18 (78%), and 14 (61%) patients, respectively, who received saline alone, 4-hour infusion of pamidronate, and 24-hour infusion of pamidronate. There were no significant differences between the two pamidronate regimens. Median durations of complete response were 6, 6, and 11 days, respectively, and median times to relapse (includes complete plus partial responders and nonresponders) were 0, 7, and 7 days, respectively. Pamidronate was well tolerated as assessed by all clinical and laboratory measures, regardless of the time of infusion. Conclusions: A 4-hour infusion of pamidronate disodium, 60 mg, was as safe and effective as a 24-hour infusion, and both were superior to saline alone in lowering corrected serum calcium concentrations in patients with cancer associated hypercalcemia.

Original languageEnglish (US)
Pages (from-to)1935-1944
Number of pages10
JournalArchives of Internal Medicine
Volume154
Issue number17
DOIs
StatePublished - Sep 12 1994

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pamidronate
Second Primary Neoplasms
Hypercalcemia
Intravenous Infusions
Calcium
Serum

ASJC Scopus subject areas

  • Internal Medicine

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Treatment of cancer-associated hypercalcemia : Double-blind comparison of rapid and slow intravenous infusion regimens of pamidronate disodium and saline alone. / Gucalp, Rasim A.; Theriault, Richard; Gill, Indrani; Madajewicz, Stefan; Chapman, Robert; Navari, Rudolph; Ahmann, Frederick; Zelenakas, Ken; Heffernan, Maika; Knight, Robert D.

In: Archives of Internal Medicine, Vol. 154, No. 17, 12.09.1994, p. 1935-1944.

Research output: Contribution to journalArticle

Gucalp, Rasim A. ; Theriault, Richard ; Gill, Indrani ; Madajewicz, Stefan ; Chapman, Robert ; Navari, Rudolph ; Ahmann, Frederick ; Zelenakas, Ken ; Heffernan, Maika ; Knight, Robert D. / Treatment of cancer-associated hypercalcemia : Double-blind comparison of rapid and slow intravenous infusion regimens of pamidronate disodium and saline alone. In: Archives of Internal Medicine. 1994 ; Vol. 154, No. 17. pp. 1935-1944.
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abstract = "Background: We assessed the effects of 60-mg single doses of pamidronate disodium compared with saline alone in the treatment of cancer-associated hypercalcemia. Methods: After pretreatment hydration, patients with corrected serum calcium concentrations of 3.0 mmol/L (12 mg/dL) or greater secondary to cancer were randomized to double-blind treatment with a single infusion of pamidronate disodium, 60 mg, over either 4 or 24 hours or continued infusions of 0.9{\%} saline alone (n=23 per group). Corrected serum calcium levels were measured daily for 7 days of inpatient evaluation. Results: Response rates for both of the pamidronate regimens were significantly (P<.05) higher than that for saline alone. A complete response to treatment (corrected serum calcium concentration normalized) was observed for live (22{\%}), 18 (78{\%}), and 14 (61{\%}) patients, respectively, who received saline alone, 4-hour infusion of pamidronate, and 24-hour infusion of pamidronate. There were no significant differences between the two pamidronate regimens. Median durations of complete response were 6, 6, and 11 days, respectively, and median times to relapse (includes complete plus partial responders and nonresponders) were 0, 7, and 7 days, respectively. Pamidronate was well tolerated as assessed by all clinical and laboratory measures, regardless of the time of infusion. Conclusions: A 4-hour infusion of pamidronate disodium, 60 mg, was as safe and effective as a 24-hour infusion, and both were superior to saline alone in lowering corrected serum calcium concentrations in patients with cancer associated hypercalcemia.",
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T1 - Treatment of cancer-associated hypercalcemia

T2 - Double-blind comparison of rapid and slow intravenous infusion regimens of pamidronate disodium and saline alone

AU - Gucalp, Rasim A.

AU - Theriault, Richard

AU - Gill, Indrani

AU - Madajewicz, Stefan

AU - Chapman, Robert

AU - Navari, Rudolph

AU - Ahmann, Frederick

AU - Zelenakas, Ken

AU - Heffernan, Maika

AU - Knight, Robert D.

PY - 1994/9/12

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N2 - Background: We assessed the effects of 60-mg single doses of pamidronate disodium compared with saline alone in the treatment of cancer-associated hypercalcemia. Methods: After pretreatment hydration, patients with corrected serum calcium concentrations of 3.0 mmol/L (12 mg/dL) or greater secondary to cancer were randomized to double-blind treatment with a single infusion of pamidronate disodium, 60 mg, over either 4 or 24 hours or continued infusions of 0.9% saline alone (n=23 per group). Corrected serum calcium levels were measured daily for 7 days of inpatient evaluation. Results: Response rates for both of the pamidronate regimens were significantly (P<.05) higher than that for saline alone. A complete response to treatment (corrected serum calcium concentration normalized) was observed for live (22%), 18 (78%), and 14 (61%) patients, respectively, who received saline alone, 4-hour infusion of pamidronate, and 24-hour infusion of pamidronate. There were no significant differences between the two pamidronate regimens. Median durations of complete response were 6, 6, and 11 days, respectively, and median times to relapse (includes complete plus partial responders and nonresponders) were 0, 7, and 7 days, respectively. Pamidronate was well tolerated as assessed by all clinical and laboratory measures, regardless of the time of infusion. Conclusions: A 4-hour infusion of pamidronate disodium, 60 mg, was as safe and effective as a 24-hour infusion, and both were superior to saline alone in lowering corrected serum calcium concentrations in patients with cancer associated hypercalcemia.

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