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Bone Metastases In Renal Cell Carcinoma: What Can Be Done?. Fred Saad, MD, FRCS Director of Urologic Oncology Professor of Surgery/Urology U of M Chair in Prostate Cancer University of Montreal. Renal Cell Cancer: Background. More than 100,000 deaths per year worldwide

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Bone Metastases In Renal Cell Carcinoma: What Can Be Done?

Fred Saad, MD, FRCS

Director of Urologic Oncology

Professor of Surgery/Urology

U of M Chair in Prostate Cancer

University of Montreal


Renal Cell Cancer: Background

  • More than 100,000 deaths per year worldwide

  • Incidence steadily increasing over the past 3 decades

  • Many patients with renal cell cancer will develop bone metastases

Ries et al. SEER Cancer Statistics. At: http://seer.cancer.gov/csr/1973_1999/. Accessed 2002.

Zekri et al. Int J Oncol. 2001;19:379.


Bone Metastases in Renal Cell Cancer

  • The skeletal morbidity rate among patients with renal cell cancer during the first year was similar to that observed in patients with breast cancer and multiple myeloma (2.5 - 4.0 SREs/patient/year)

  • Bone metastases rarely respond to immune based therapy

  • Median survival of patients with bone mets: 12 months

Zekri et al. Int J Oncol. 2001;19:379.


Renal Cell Cancer: Radiologic Appearance of Bone Lesions

Among patients with bone lesions, the majority were osteolytic

Zekri et al. Int J Oncol. 2001;19:379.


Renal Cell Cancer: Distribution of Bone Metastases

No. of Patients (%)Site (n=31)

Pelvis15 (48)

Ribs15 (48)

Spine13 (42)

Femora 7 (23)

Humeri 3 (10)

Skull 3 (10)

Clavicle2 (6)

Ulna1 (3)

Tibia1 (3)

Zekri et al. Int J Oncol. 2001;19:379.


Renal Cell Cancer: Skeletal-Related Events

No. of patients (%) No. of

SRE (N=31) events

Radiotherapy 25 (81) 37

Long-bone fractures 13 (42) 15

Hypercalcemia 9 (29)* 16

Orthopedic surgery 9 (29) 12

Spinal cord compression 4 (13) 4

*An additional 32 patients developed hypercalcemia without evidence of metastatic bone disease on imaging tests. Criteria for hypercalcemia not defined.

Zekri et al. Int J Oncol. 2001;19:379.


Zoledronic Acid inPatients With Renal Cell Carcinoma and Bone Metastases

Long-Term Analysis (21 Months)


Zoledronic Acid in Solid Tumors: Trial Design*

R

A

N

DO

M

I

Z

E

D

n=257

Zoledronic acid 4 mg q3wk

n=250

Placebo q3wk

0

9 monthsCore analysis

21 months

Final analysis


Efficacy Analysis

  • Primaryefficacyendpoint

    • Proportionofpatientsexperiencing≥1SRE

      • Pathologicbonefracture

      • Radiationtherapytobone

      • Spinalcordcompression

      • Surgerytobone

  • Secondaryefficacyendpoints

    • TimetofirstSRE

    • Skeletalmorbidityrate

    • Timetoprogressionofbonemetastases

SRE = skeletal-related event; HCM = hypercalcemia of malignancy.


Tumor Types

Tumor Type No. of Patients (%)

NSCLC378(49)

Renalcellcarcinoma74*(10)

Smallcelllungcancer58(8)

Colon/rectal/intestinal55(7)

Cancerunknownprimary51(7)

Bladder32(4)

Esophagus/gastroesophageal17(2)

Headandneck17(2)

Melanoma16(2)

Thyroid11(1)

Othertumortypes(n=11)57(7)

*Zoledronic acid 4-mg group and placebo (n=46).

Rosen et al. J Clin Oncol. 2003;21:3150.


Proportion of Patients With Any SRE

Zoledronic acid significantly reduces the proportion of RCC patients with an SRE

P=0.011

100

79

80

60

RCC patients with any SRE (%)

41

40

20

0

Zol 4 mg

Placebo

(n=27) (n=19)


Time to First Skeletal-Related Event

Zoledronic acid significantly extends the time to first SRE

  • Median No. of DaysP Value

  • Zol 4 mg4240.006

  • Placebo72

  • Zol 4 mg27127421

    Placebo1941100

    *After start of study drug.


    Percent of Patients With Each SRE

    Zoledronic acid consistently reduces all types of SREs


    Time to Progression of Bone Lesions

    Zoledronic acid significantly extends the time to disease progression

    • Median No. of DaysP Value

  • Zol 4 mg5860.014

  • Placebo89

  • Zol 4 mg27137320

    Placebo1930000

    *After start of study drug.


    Time to First Pathologic Fracture

    Zoledronic acid significantly extends time to first pathologic fracture

    100

    • Median No. of DaysP Value

  • ZolNR0.003

  • Placebo168

  • 80

    60

    RCC patients without

    pathologic fracture (%)

    40

    20

    0

    0

    120

    240

    360

    480

    600

    *

    Days

    Zol 4 mg27179542

    Placebo1961111

    *After start of study drug.


    Survival

    • Median No. of daysP Value

  • Zol 4 mg3470.104

  • Placebo216

  • Zol 4 mg2723151182

    Placebo19148521

    *After start of study drug.


    Andersen-Gill Multiple Event Analysis

    58% reduction in the risk of developing an SRE for patients receiving zoledronic acid compared with placebo

    HazardRatio

    RiskReduction

    P Value

    0.69

    Lung and other solid tumors

    31%

    0.003

    0.42

    Renal cell cancer

    58%

    0.010

    0

    0.2

    0.4

    0.6

    0.8

    1

    1.2

    1.4

    1.6

    1.8

    2

    Relative risk

    In favor of placebo

    In favor of zoledronic acid


    Hematuria2 (11.1)1 (6.7)

    Blood creat increased0(0.0)0(0.0)

    Hyperuricemia1 (5.6)0 (0.0)

    Renal failure1 (5.6)0 (0.0)

    Difficulty in micturition0 (0.0)1 (6.7)

    Oliguria0 (0.0)1 (6.7)

    Total 4 (22.2) 3 (20.0)

    Most Frequent Renal-Related Adverse Events*

    No. of Patients (%)†

    Zol 4 mg Placebo

    (n=27)(n=19)

    *Post 15-minute infusion; †Safety-evaluable population; ‡>0.5 mg/dL if baseline <1.4 mg/dL; >1.0 mg/dL if baseline >1.4 mg/dL.


    Zoledronic Acid in Patients With Renal Cancer: Clinical Summary

    • Significantly reduced the proportion of patients with an SRE

    • Significantly decreased mean skeletal morbidity rate of all SREs

    • Extended time to first SRE and time to first fracture

    • Significantly increased median time to progression of bone lesions

    • Was safe and well tolerated


    Bone Metastatic Renal Cell Carcinoma: Conclusions

    • New treatment options now available for metastatic RCC increase survival and may increase the time patients are at risk for bone comlications

    • Zoledronic acid can be considered a treatment option for patients with bone metastases from renal cell carcinoma


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