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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

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
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
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
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
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
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 in patients with renal cell carcinoma and bone metastases

Zoledronic Acid inPatients With Renal Cell Carcinoma and Bone Metastases

Long-Term Analysis (21 Months)

zoledronic acid in solid tumors trial design
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
Efficacy Analysis
  • Primaryefficacyendpoint
    • Proportionofpatientsexperiencing≥1SRE
      • Pathologicbonefracture
      • Radiationtherapytobone
      • Spinalcordcompression
      • Surgerytobone
  • Secondaryefficacyendpoints
    • TimetofirstSRE
    • Skeletalmorbidityrate
    • Timetoprogressionofbonemetastases

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

tumor types
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
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
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
Percent of Patients With Each SRE

Zoledronic acid consistently reduces all types of SREs

time to progression of bone lesions
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
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
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
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

most frequent renal related adverse events
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
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
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