Samarium-153-EDTMP in bone metastases of hormone refractory prostate carcinoma: a phase I/II trial.
Samarium-153-ethylenediaminetetramethylene phosphoric acid (EDTMP), a bone-seeking radiopharmaceutical, was given to prostate cancer patients in a dose escalation protocol for pain palliation to determine the maximally tolerated dose. Fifty-two patients with hormone refractory prostate cancer with bony metastases were treated with doses beginning at 0.5 mCi/kg (18.5 MBq/kg), escalating in 0.5-mCi (18.5 MBq) increments to 3.0 mCi/kg (111 MBq/kg). Pain response after treatment was assessed as well as hematologic and serum chemistry parameters. Pain palliation with a mean duration of 2.6 mo was present in 74% of the patients. Toxicity was exclusively hematologic at the highest dose levels. No infectious or bleeding complications occurred, with 45 of the 52 (86%) patients demonstrating complete hematologic recovery. Patients receiving higher doses had significantly greater reductions in serum prostate specific antigen and serum prostatic acid phosphatase levels. The patients receiving greater doses also showed a trend toward improved survival.
Collins
C
C
Department of Medicine, University of Washington, Fred Hutchinson Cancer Research Center, Seattle.
Eary
J F
JF
Donaldson
G
G
Vernon
C
C
Bush
N E
NE
Petersdorf
S
S
Livingston
R B
RB
Gordon
E E
EE
Chapman
C R
CR
Appelbaum
F R
FR
D000368:Aged; D000369:Aged, 80 and over; D001859:Bone Neoplasms / Q000000981:diagnostic imaging / Q000532:radiotherapy* / Q000556:secondary*; D006728:Hormones / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D009943:Organophosphorus Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D010147:Pain Measurement; D011471:Prostatic Neoplasms / Q000188:drug therapy / Q000473:pathology*; D011868:Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*; D011877:Radionuclide Imaging; D011879:Radiotherapy Dosage; D012493:Samarium / Q000009:adverse effects / Q000627:therapeutic use
D006728:Hormones; D009942:Organometallic Compounds; D009943:Organophosphorus Compounds; D011868:Radioisotopes; D012493:Samarium; C061972:samarium Sm-153 lexidronam