PMID- 8558208
OWN - NLM
STAT- MEDLINE
DCOM- 19960223
LR  - 20181130
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 14
IP  - 1
DP  - 1996 Jan
TI  - Randomized phase II trial comparing different doses of the bisphosphonate 
      ibandronate in the treatment of hypercalcemia of malignancy.
PG  - 268-76
AB  - PURPOSE: To evaluate the hypocalcemic effect and safety of three different doses 
      of the bisphosphonate ibandronate in tumor-associated hypercalcemia, and to 
      identify factors predicting response. PATIENTS AND METHODS: One hundred 
      seventy-four cancer patients with a serum calcium level greater than 2.7 mmol/L 
      (10.8 mg/dL) were enrolled onto the trial. If hypercalcemia persisted after fluid 
      repletion, patients were randomly assigned to treatment with 0.6 mg, 1.1 mg, and 
      2.0 mg of ibandronate. Response, defined as restoration of normocalcemia, was 
      evaluated by an intent-to-treat analysis. RESULTS: One hundred seventy-three 
      (99%) patients were assessable for toxicity and 151 (87%) for efficacy. The 
      administration of 0.6 mg (group A), 1.1 mg (group B), or 2.0 mg (group C) of 
      ibandronate led to response rates of 44%, 52%, and 67%, respectively. 
      Significantly more patients in group C responded than in group A (P = .0276). Of 
      the various parameters examined, only the initial serum calcium level (P < .0001; 
      odds ratio, 0.083) and the dose of ibandronate (P = .0162; odds ratio, 2.094) 
      correlated with response. One hundred ninety-five adverse events (AEs) were 
      reported, 99 classified as serious and 96 as nonserious. Three serious and 
      sixteen nonserious AEs were considered related to ibandronate treatment. The 
      three serious AEs were one case with thrombocytopenia, one with nausea, and one 
      with fever. CONCLUSION: Ibandronate therapy led to a dose-dependent reduction in 
      serum calcium levels. The response to ibandronate treatment correlated negatively 
      with the initial serum calcium level and positively with the dose administered. A 
      dose of 2 mg was necessary to achieve a response rate comparable to that in 
      previous studies with the bisphosphonates pamidronate and clodronate. Because the 
      incidence of drug-associated AEs was low, a dose escalation of ibandronate can be 
      recommended for further clinical trials.
FAU - Pecherstorfer, M
AU  - Pecherstorfer M
AD  - I. Department of Medicine and Medical Oncology, Wilhelminenspital, Vienna, 
      Austria.
FAU - Herrmann, Z
AU  - Herrmann Z
FAU - Body, J J
AU  - Body JJ
FAU - Manegold, C
AU  - Manegold C
FAU - Degardin, M
AU  - Degardin M
FAU - Clemens, M R
AU  - Clemens MR
FAU - Thurlimann, B
AU  - Thurlimann B
FAU - Tubiana-Hulin, M
AU  - Tubiana-Hulin M
FAU - Steinhauer, E U
AU  - Steinhauer EU
FAU - van Eijkeren, M
AU  - van Eijkeren M
FAU - Huss, H J
AU  - Huss HJ
FAU - Thiebaud, D
AU  - Thiebaud D
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Diphosphonates)
RN  - SY7Q814VUP (Calcium)
RN  - UMD7G2653W (Ibandronic Acid)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Bone Resorption
MH  - Calcium/blood
MH  - Diphosphonates/adverse effects/pharmacology/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Fever/chemically induced
MH  - Humans
MH  - Hypercalcemia/blood/*drug therapy/etiology
MH  - Ibandronic Acid
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Neoplasms/*complications
MH  - Recurrence
MH  - Regression Analysis
MH  - Thrombocytopenia/chemically induced
MH  - Treatment Outcome
EDAT- 1996/01/01 00:00
MHDA- 1996/01/01 00:01
CRDT- 1996/01/01 00:00
PHST- 1996/01/01 00:00 [pubmed]
PHST- 1996/01/01 00:01 [medline]
PHST- 1996/01/01 00:00 [entrez]
AID - 10.1200/JCO.1996.14.1.268 [doi]
PST - ppublish
SO  - J Clin Oncol. 1996 Jan;14(1):268-76. doi: 10.1200/JCO.1996.14.1.268.