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Paraplatin

Clinical Pharmacology
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Clinical Pharmacology

Paraplatin

Comparative Toxicity: The pattern of toxicity exerted by the carboplatin-containing regimen was significantly different from that of the cisplatin-containing combinations. Differences between the two studies may be explained by different cisplatin dosages and by different supportive care.

The carboplatin-containing regimen induced significantly more throm-bocytopenia and, in one study, significantly more leukopenia and more need for transfusional support. The cisplatin-containing regimen produced significantly more anemia in one study. However, no significant differences occurred in incidences of infections and hemorrhagic episodes.

Non-hematologic toxicities (emesis, neurotoxicity, ototoxicity, renal toxi-city, hypomagnesemia, and alopecia) were significantly more frequent in the cisplatin-containing arms.

ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER NCIC STUDY

    Carboplatin
Arm
Percent*		 Cisplatin
Arm
Percent*		 P-Values**
Bone Marrow
  Thrombocytopenia < 100,000/mm³ 70 29 < 0.001
  < 50,000/mm³ 41 6 < 0.001
  Neutropenia < 2000 cells/mm³ 97 96 n.s.
  < 1000 cells/mm³ 81 79 n.s.
  Leukopenia < 4000 cells/mm³ 98 97 n.s.
  < 2000 cells/mm³ 68 52 0.001
  Anemia < 11 g/dL 91 91 n.s.
  < 8 g/dL 18 12 n.s.
  Infections   14 12 n.s.
  Bleeding   10 4 n.s.
  Transfusions   42 31 0.018
Gastrointestinal
  Nausea and vomiting 93 98 0.010
  Vomiting 84 97 < 0.001
  Other GI side effects 50 62 0.013
Neurologic
  Peripheral neuropathies 16 42 < 0.001
  Ototoxicity 13 33 < 0.001
  Other sensory side effects 6 10 n.s.
  Central neurotoxicity 28 40 0.009
Renal
  Serum creatinine elevations 5 13 0.006
  Blood urea elevations 17 31 < 0.001
Hepatic
  Bilirubin elevations 5 3 n.s.
  SGOT elevations 17 13 n.s.
  Alkaline phosphatase elevations – – –
Electrolytes loss
  Sodium 10 20 0.005
  Potassium 16 22 n.s.
  Calcium 16 19 n.s.
  Magnesium 63 88 < 0.001
Other side effects
  Pain 36 37 n.s.
  Asthenia 40 33 n.s.
  Cardiovascular 15 19 n.s.
  Respiratory 8 9 n.s.
  Allergic 12 9 n.s.
  Genitourinary 10 10 n.s.
  Alopecia+ 50 62 0.017
  Mucositis 10 9 n.s.
*Values are in percent of evaluable patients.
** n. s. = not significant, p > 0. 05.
+May have been affected by cyclophosphamide dosage delivered.

ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER SWOG STUDY

    Carboplatin
Arm
Percent*		 Cisplatin
Arm
Percent*		 P-Values**
Bone Marrow
  Thrombocytopenia < 100,000/mm³ 59 35 < 0.001
  < 50,000/mm³ 22 11 0.006
  Neutropenia < 2000 cells/mm³ 95 97 n.s.
  < 1000 cells/mm³ 84 78 n.s.
  Leukopenia < 4000 cells/mm³ 97 97 n.s.
  < 2000 cells/mm³ 76 67 n.s.
  Anemia < 11 g/dL 88 87 n.s.
  < 8 g/dL 8 24 < 0.001
  Infections   18 21 n.s.
  Bleeding   6 4 n.s.
  Transfusions   25 33 n.s.
Gastrointestinal
  Nausea and vomiting 94 96 n.s.
  Vomiting 82 91 0.007
  Other GI side effects 40 48 n.s.
Neurologic
  Peripheral neuropathies 13 28 0.001
  Ototoxicity 12 30 < 0.001
  Other sensory side effects 4 6 n.s.
  Centra lneurotoxicity 23 29 n.s.
Renal
  Serum creatinine elevations 7 38 < 0.001
  Blood urea elevations – – –
Hepatic
  Bilirubin elevations 5 3 n.s.
  SGOT elevations 23 16 n.s.
  Alkaline phosphatase elevations 29 20 n.s.
Electrolytes loss
  Sodium – – –
  Potassium – – –
  Calcium – – –
  Magnesium 58 77 < 0.001
Other side effects
  Pain 54 52 n.s.
  Asthenia 43 46 n.s.
  Cardiovascular 23 30 n.s.
  Respiratory 12 11 n.s.
  Allergic 10 11 n.s.
  Genitourinary 11 13 n.s.
  Alopecia+ 43 57 0.009
  Mucositis 6 11 n.s.
*Values are in percent of evaluable patients.
** n. s. = not significant, p > 0. 05.
+May have been affected by cyclophosphamide dosage delivered.

Brand Name: Paraplatin
Generic Name: Carboplatin

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