carboplatin injection 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 randomized

447

342

Median age (years)

60

62

Dose of cisplatin

75 mg/m2

100 mg/m2

Dose of carboplatin

300 mg/m2

300 mg/m2

Dose of cyclophosphamide

600 mg/m2

600 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

Carboplatin

59 weeks

49 weeks

Cisplatin

61 weeks

47 weeks

2-year PFS*

Carboplatin

31%

21%

Cisplatin

31%

21%

95% C.I. of difference (Carboplatin - Cisplatin)

(-9.3, 8.7)

(-9.0, 9.4)

3-year PFS*

Carboplatin

19%

8%

Cisplatin

23%

14%

95% C.I. of difference (Carboplatin - Cisplatin)

(-11.5, 4.5)

(-14.1, 0.3)

Hazard Ratio†

1.10

1.02

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 weeks

86 weeks

Cisplatin

99 weeks

79 weeks

2-year Survival*

Carboplatin

51.9%

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*

Carboplatin

34.6%

18.3%

Cisplatin

33.1%

24.9%

95% C.I. of difference (Carboplatin - Cisplatin)

(-7.7, 10.7)

(-15.9, 2.7)

Hazard Ratio†

0.98

1.01

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/mm3

70

29

<0.001

<50,000/mm3

41

6

<0.001

  Neutropenia

<2,000 cells/mm3

97

96

ns

<1,000 cells/mm3

81

79

ns

  Leukopenia

<4,000 cells/mm3

98

97

ns

<2,000 cells/mm3

68

52

0.001

  Anemia

<11 g/dL

91

91

ns

<8 g/dL

18

12

ns

  Infections

14

12

ns

  Bleeding

10

4

ns

  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

ns

  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

ns

  SGOT elevations

17

13

ns

  Alkaline phosphatase elevations

-

-

-

Electrolytes loss

  Sodium

10

20

0.005

  Potassium

16

22

ns

  Calcium

16

19

ns

  Magnesium

63

88

<0.001

Other side effects

  Pain

36

37

ns

  Asthenia

40

33

ns

  Cardiovascular

15

19

ns

  Respiratory

8

9

ns

  Allergic

12

9

ns

  Genitourinary

10

10

ns

  Alopecia ‡

50

62

0.017

  Mucositis

10

9

ns

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/mm3

59

35

<0.001

<50,000/mm3

22

11

0.006

  Neutropenia

<2,000 cells/mm3

95

97

ns

<1,000 cells/mm3

84

78

ns

  Leukopenia

<4,000 cells/mm3

97

97

ns

<2,000 cells/mm3

76

67

ns

  Anemia

<11 g/dL

88

87

ns

<8 g/dL

8

24

<0.001

  Infections

18

21

ns

  Bleeding

6

4

ns

  Transfusions

25

33

ns

Gastrointestinal

  Nausea and vomiting

94

96

ns

  Vomiting

82

91

0.007

  Other GI side effects

40

48

ns

Neurologic

  Peripheral neuropathies

13

28

0.001

  Ototoxicity

12

30

<0.001

  Other sensory side effects

4

6

ns

  Central neurotoxicity

23

29

ns

Renal

  Serum creatinine elevations

7

38

<0.001

  Blood urea elevations

-

-

-

Hepatic

  Bilirubin elevations

5

3

ns

  SGOT elevations

23

16

ns

  Alkaline phosphatase elevations

29

20

ns

Electrolytes loss

  Sodium

-

-

-

  Potassium

-

-

-

  Calcium

-

-

-

  Magnesium

58

77

<0.001

Other side effects

  Pain

54

52

ns

  Asthenia

43

46

ns

  Cardiovascular

23

30

ns

  Respiratory

12

11

ns

  Allergic

10

11

ns

  Genitourinary

11

13

ns

  Alopecia ‡

43

57

0.009

  Mucositis

6

11

ns

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 randomized

447

342

Median age (years)

60

62

Dose of cisplatin

75 mg/m2

100 mg/m2

Dose of carboplatin

300 mg/m2

300 mg/m2

Dose of cyclophosphamide

600 mg/m2

600 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

Carboplatin

59 weeks

49 weeks

Cisplatin

61 weeks

47 weeks

2-year PFS*

Carboplatin

31%

21%

Cisplatin

31%

21%

95% C.I. of difference (Carboplatin - Cisplatin)

(-9.3, 8.7)

(-9.0, 9.4)

3-year PFS*

Carboplatin

19%

8%

Cisplatin

23%

14%

95% C.I. of difference (Carboplatin - Cisplatin)

(-11.5, 4.5)

(-14.1, 0.3)

Hazard Ratio†

1.10

1.02

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 weeks

86 weeks

Cisplatin

99 weeks

79 weeks

2-year Survival*

Carboplatin

51.9%

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*

Carboplatin

34.6%

18.3%

Cisplatin

33.1%

24.9%

95% C.I. of difference (Carboplatin - Cisplatin)

(-7.7, 10.7)

(-15.9, 2.7)

Hazard Ratio†

0.98

1.01

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/mm3

70

29

<0.001

<50,000/mm3

41

6

<0.001

  Neutropenia

<2,000 cells/mm3

97

96

ns

<1,000 cells/mm3

81

79

ns

  Leukopenia

<4,000 cells/mm3

98

97

ns

<2,000 cells/mm3

68

52

0.001

  Anemia

<11 g/dL

91

91

ns

<8 g/dL

18

12

ns

  Infections

14

12

ns

  Bleeding

10

4

ns

  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

ns

  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

ns

  SGOT elevations

17

13

ns

  Alkaline phosphatase elevations

-

-

-

Electrolytes loss

  Sodium

10

20

0.005

  Potassium

16

22

ns

  Calcium

16

19

ns

  Magnesium

63

88

<0.001

Other side effects

  Pain

36

37

ns

  Asthenia

40

33

ns

  Cardiovascular

15

19

ns

  Respiratory

8

9

ns

  Allergic

12

9

ns

  Genitourinary

10

10

ns

  Alopecia ‡

50

62

0.017

  Mucositis

10

9

ns

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/mm3

59

35

<0.001

<50,000/mm3

22

11

0.006

  Neutropenia

<2,000 cells/mm3

95

97

ns

<1,000 cells/mm3

84

78

ns

  Leukopenia

<4,000 cells/mm3

97

97

ns

<2,000 cells/mm3

76

67

ns

  Anemia

<11 g/dL

88

87

ns

<8 g/dL

8

24

<0.001

  Infections

18

21

ns

  Bleeding

6

4

ns

  Transfusions

25

33

ns

Gastrointestinal

  Nausea and vomiting

94

96

ns

  Vomiting

82

91

0.007

  Other GI side effects

40

48

ns

Neurologic

  Peripheral neuropathies

13

28

0.001

  Ototoxicity

12

30

<0.001

  Other sensory side effects

4

6

ns

  Central neurotoxicity

23

29

ns

Renal

  Serum creatinine elevations

7

38

<0.001

  Blood urea elevations

-

-

-

Hepatic

  Bilirubin elevations

5

3

ns

  SGOT elevations

23

16

ns

  Alkaline phosphatase elevations

29

20

ns

Electrolytes loss

  Sodium

-

-

-

  Potassium

-

-

-

  Calcium

-

-

-

  Magnesium

58

77

<0.001

Other side effects

  Pain

54

52

ns

  Asthenia

43

46

ns

  Cardiovascular

23

30

ns

  Respiratory

12

11

ns

  Allergic

10

11

ns

  Genitourinary

11

13

ns

  Alopecia ‡

43

57

0.009

  Mucositis

6

11

ns

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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