carboplatin injection Clinical Studies

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CLINICAL STUDIES

Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer

In two prospectively randomized, controlled studies conducted by the National Cancer Institute of Canada, Clinical Trials Group (NCIC), and the Southwest Oncology Group (SWOG), 789 chemotherapy naive patients with advanced ovarian cancer were treated with carboplatin or cisplatin, both in combination with cyclophosphamide every 28 days for six courses before surgical reevaluation. The following results were obtained from both studies:

Comparative Efficacy

Overview of Pivotal Trials
NCICSWOG
Number of patients randomized447342
Median age (years)6062
Dose of cisplatin75 mg/m2100 mg/m2
Dose of carboplatin300 mg/m2300 mg/m2
Dose of cyclophosphamide600 mg/m2600 mg/m2
Residual tumor <2 cm (number of patients)39% (174/447)14% (49/342)
Clinical Response in Measurable Disease Patients
NCICSWOG
Carboplatin (number of patients)60% (48/80)58% (48/83)
Cisplatin (number of patients)58% (49/85)43% (33/76)
95% C.I. of difference (Carboplatin - Cisplatin)(-13.9%, 18.6%)(-2.3%, 31.1%)
Pathologic Complete Response*
NCICSWOG
*
114 Carboplatin and 109 Cisplatin patients did not undergo second look surgery in NCIC study. 90 Carboplatin and 106 Cisplatin patients did not undergo second look surgery in SWOG study.
Carboplatin (number of patients)11% (24/224)10% (17/171)
Cisplatin (number of patients)15% (33/223) 10% (17/171)
95% C.I. of difference (Carboplatin - Cisplatin)(-10.7%, 2.5%)(-6.9%, 6.9%)
Progression-Free Survival (PFS)
NCICSWOG
*
Kaplan-Meier Estimates
Unrelated deaths occurring in the absence of progression were counted as events (progression) in this analysis.
†
Analysis adjusted for factors found to be of prognostic significance were consistent with unadjusted analysis.
Median
Carboplatin59 weeks49 weeks
Cisplatin61 weeks47 weeks
2-year PFS*
Carboplatin31%21%
Cisplatin31%21%
95% C.I. of difference (Carboplatin - Cisplatin)(-9.3, 8.7)(-9.0, 9.4)
3-year PFS*
Carboplatin19%8%
Cisplatin23%14%
95% C.I. of difference (Carboplatin - Cisplatin)(-11.5, 4.5)(-14.1, 0.3)
Hazard Ratio†1.101.02
95% C.I. (Carboplatin - Cisplatin)(0.89, 1.35)(0.81, 1.29)
Survival
NCICSWOG
*
Kaplan-Meier Estimates
†
Analysis adjusted for factors found to be of prognostic significance were consistent with unadjusted analysis.
Median
Carboplatin 110 weeks86 weeks
Cisplatin99 weeks79 weeks
2-year Survival*
Carboplatin51.9%40.2%
Cisplatin 48.4%39.0%
95% C.I. of difference (Carboplatin - Cisplatin) (-6.2, 13.2)(-9.8, 12.2)
3-year Survival*
Carboplatin34.6%18.3%
Cisplatin33.1%24.9%
95% C.I. of difference (Carboplatin - Cisplatin)(-7.7, 10.7)(-15.9, 2.7)
Hazard Ratio†0.981.01
95% C.I. (Carboplatin - Cisplatin)(0.78, 1.23)(0.78, 1.30)

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 thrombocytopenia 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 toxicity, 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†
*
Values are in percent of evaluable patients
†
ns = not significant, p>0.05
‡
May have been affected by cyclophosphamide dosage delivered
Bone Marrow
  Thrombocytopenia<100,000/mm37029<0.001
<50,000/mm3416<0.001
  Neutropenia<2,000 cells/mm39796ns
<1,000 cells/mm38179ns
  Leukopenia<4,000 cells/mm39897ns
<2,000 cells/mm368520.001
  Anemia<11 g/dL9191ns
<8 g/dL1812ns
  Infections1412ns
  Bleeding104ns
  Transfusions42310.018
Gastrointestinal
  Nausea and vomiting93980.010
  Vomiting8497<0.001
  Other GI side effects50620.013
Neurologic
  Peripheral neuropathies1642<0.001
  Ototoxicity1333<0.001
  Other sensory side effects610ns
  Central neurotoxicity28400.009
Renal
  Serum creatinine elevations5130.006
  Blood urea elevations1731<0.001
Hepatic
  Bilirubin elevations53ns
  SGOT elevations1713ns
  Alkaline phosphatase elevations---
Electrolytes loss
  Sodium10200.005
  Potassium1622ns
  Calcium1619ns
  Magnesium6388<0.001
Other side effects
  Pain3637ns
  Asthenia4033ns
  Cardiovascular1519ns
  Respiratory89ns
  Allergic129ns
  Genitourinary1010ns
  Alopecia ‡50620.017
  Mucositis109ns
ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER SWOG STUDY
Carboplatin Arm Percent*Cisplatin Arm Percent*P-Values†
*
Values are in percent of evaluable patients
†
ns = not significant, p>0.05
‡
May have been affected by cyclophosphamide dosage delivered
Bone Marrow
  Thrombocytopenia<100,000/mm35935<0.001
<50,000/mm322110.006
  Neutropenia<2,000 cells/mm39597ns
<1,000 cells/mm38478ns
  Leukopenia<4,000 cells/mm39797ns
<2,000 cells/mm37667ns
  Anemia<11 g/dL8887ns
<8 g/dL824<0.001
  Infections1821ns
  Bleeding64ns
  Transfusions2533ns
Gastrointestinal
  Nausea and vomiting9496ns
  Vomiting82910.007
  Other GI side effects4048ns
Neurologic
  Peripheral neuropathies13280.001
  Ototoxicity1230<0.001
  Other sensory side effects46ns
  Central neurotoxicity2329ns
Renal
  Serum creatinine elevations738<0.001
  Blood urea elevations---
Hepatic
  Bilirubin elevations53ns
  SGOT elevations2316ns
  Alkaline phosphatase elevations2920ns
Electrolytes loss
  Sodium---
  Potassium---
  Calcium---
  Magnesium5877<0.001
Other side effects
  Pain5452ns
  Asthenia4346ns
  Cardiovascular2330ns
  Respiratory1211ns
  Allergic1011ns
  Genitourinary1113ns
  Alopecia ‡43570.009
  Mucositis611ns

Use as a Single Agent for Secondary Treatment of Advanced Ovarian Cancer

In two prospective, randomized controlled studies in patients with advanced ovarian cancer previously treated with chemotherapy, carboplatin achieved six clinical complete responses in 47 patients. The duration of these responses ranged from 45 to 71 + weeks.

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Clinical Studies

CLINICAL STUDIES

Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer

In two prospectively randomized, controlled studies conducted by the National Cancer Institute of Canada, Clinical Trials Group (NCIC), and the Southwest Oncology Group (SWOG), 789 chemotherapy naive patients with advanced ovarian cancer were treated with carboplatin or cisplatin, both in combination with cyclophosphamide every 28 days for six courses before surgical reevaluation. The following results were obtained from both studies:

Comparative Efficacy

Overview of Pivotal Trials
NCICSWOG
Number of patients randomized447342
Median age (years)6062
Dose of cisplatin75 mg/m2100 mg/m2
Dose of carboplatin300 mg/m2300 mg/m2
Dose of cyclophosphamide600 mg/m2600 mg/m2
Residual tumor <2 cm (number of patients)39% (174/447)14% (49/342)
Clinical Response in Measurable Disease Patients
NCICSWOG
Carboplatin (number of patients)60% (48/80)58% (48/83)
Cisplatin (number of patients)58% (49/85)43% (33/76)
95% C.I. of difference (Carboplatin - Cisplatin)(-13.9%, 18.6%)(-2.3%, 31.1%)
Pathologic Complete Response*
NCICSWOG
*
114 Carboplatin and 109 Cisplatin patients did not undergo second look surgery in NCIC study. 90 Carboplatin and 106 Cisplatin patients did not undergo second look surgery in SWOG study.
Carboplatin (number of patients)11% (24/224)10% (17/171)
Cisplatin (number of patients)15% (33/223) 10% (17/171)
95% C.I. of difference (Carboplatin - Cisplatin)(-10.7%, 2.5%)(-6.9%, 6.9%)
Progression-Free Survival (PFS)
NCICSWOG
*
Kaplan-Meier Estimates
Unrelated deaths occurring in the absence of progression were counted as events (progression) in this analysis.
†
Analysis adjusted for factors found to be of prognostic significance were consistent with unadjusted analysis.
Median
Carboplatin59 weeks49 weeks
Cisplatin61 weeks47 weeks
2-year PFS*
Carboplatin31%21%
Cisplatin31%21%
95% C.I. of difference (Carboplatin - Cisplatin)(-9.3, 8.7)(-9.0, 9.4)
3-year PFS*
Carboplatin19%8%
Cisplatin23%14%
95% C.I. of difference (Carboplatin - Cisplatin)(-11.5, 4.5)(-14.1, 0.3)
Hazard Ratio†1.101.02
95% C.I. (Carboplatin - Cisplatin)(0.89, 1.35)(0.81, 1.29)
Survival
NCICSWOG
*
Kaplan-Meier Estimates
†
Analysis adjusted for factors found to be of prognostic significance were consistent with unadjusted analysis.
Median
Carboplatin 110 weeks86 weeks
Cisplatin99 weeks79 weeks
2-year Survival*
Carboplatin51.9%40.2%
Cisplatin 48.4%39.0%
95% C.I. of difference (Carboplatin - Cisplatin) (-6.2, 13.2)(-9.8, 12.2)
3-year Survival*
Carboplatin34.6%18.3%
Cisplatin33.1%24.9%
95% C.I. of difference (Carboplatin - Cisplatin)(-7.7, 10.7)(-15.9, 2.7)
Hazard Ratio†0.981.01
95% C.I. (Carboplatin - Cisplatin)(0.78, 1.23)(0.78, 1.30)

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 thrombocytopenia 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 toxicity, 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†
*
Values are in percent of evaluable patients
†
ns = not significant, p>0.05
‡
May have been affected by cyclophosphamide dosage delivered
Bone Marrow
  Thrombocytopenia<100,000/mm37029<0.001
<50,000/mm3416<0.001
  Neutropenia<2,000 cells/mm39796ns
<1,000 cells/mm38179ns
  Leukopenia<4,000 cells/mm39897ns
<2,000 cells/mm368520.001
  Anemia<11 g/dL9191ns
<8 g/dL1812ns
  Infections1412ns
  Bleeding104ns
  Transfusions42310.018
Gastrointestinal
  Nausea and vomiting93980.010
  Vomiting8497<0.001
  Other GI side effects50620.013
Neurologic
  Peripheral neuropathies1642<0.001
  Ototoxicity1333<0.001
  Other sensory side effects610ns
  Central neurotoxicity28400.009
Renal
  Serum creatinine elevations5130.006
  Blood urea elevations1731<0.001
Hepatic
  Bilirubin elevations53ns
  SGOT elevations1713ns
  Alkaline phosphatase elevations---
Electrolytes loss
  Sodium10200.005
  Potassium1622ns
  Calcium1619ns
  Magnesium6388<0.001
Other side effects
  Pain3637ns
  Asthenia4033ns
  Cardiovascular1519ns
  Respiratory89ns
  Allergic129ns
  Genitourinary1010ns
  Alopecia ‡50620.017
  Mucositis109ns
ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER SWOG STUDY
Carboplatin Arm Percent*Cisplatin Arm Percent*P-Values†
*
Values are in percent of evaluable patients
†
ns = not significant, p>0.05
‡
May have been affected by cyclophosphamide dosage delivered
Bone Marrow
  Thrombocytopenia<100,000/mm35935<0.001
<50,000/mm322110.006
  Neutropenia<2,000 cells/mm39597ns
<1,000 cells/mm38478ns
  Leukopenia<4,000 cells/mm39797ns
<2,000 cells/mm37667ns
  Anemia<11 g/dL8887ns
<8 g/dL824<0.001
  Infections1821ns
  Bleeding64ns
  Transfusions2533ns
Gastrointestinal
  Nausea and vomiting9496ns
  Vomiting82910.007
  Other GI side effects4048ns
Neurologic
  Peripheral neuropathies13280.001
  Ototoxicity1230<0.001
  Other sensory side effects46ns
  Central neurotoxicity2329ns
Renal
  Serum creatinine elevations738<0.001
  Blood urea elevations---
Hepatic
  Bilirubin elevations53ns
  SGOT elevations2316ns
  Alkaline phosphatase elevations2920ns
Electrolytes loss
  Sodium---
  Potassium---
  Calcium---
  Magnesium5877<0.001
Other side effects
  Pain5452ns
  Asthenia4346ns
  Cardiovascular2330ns
  Respiratory1211ns
  Allergic1011ns
  Genitourinary1113ns
  Alopecia ‡43570.009
  Mucositis611ns

Use as a Single Agent for Secondary Treatment of Advanced Ovarian Cancer

In two prospective, randomized controlled studies in patients with advanced ovarian cancer previously treated with chemotherapy, carboplatin achieved six clinical complete responses in 47 patients. The duration of these responses ranged from 45 to 71 + weeks.
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