October 2009
Price: $2500
Deliverables: Survey Data Only
Please contact Howard.Brick@panelintelligence.com to purchase.
Project Objectives:
n Primary Objective: To gauge physician reactions to recent data regarding the effectiveness of denosumab in bone cancer and the potential for a market share shift from Zometa to denosumab
Study Scope and Participants:
n Specialties and quotas:
· 100 oncologists
n Screening Criteria:
· US-based oncologists
· Board-certified in specialty
· 2 to 30 years of experience post-training
· Minimum of 75% professional time spent in clinical practice
· Treats at least 20 cancer patients per month with bone metastases
<Page Break> Denosumab in Bone Cancer
· Text in red is for programming purposes only, and will not be seen by respondents.
· Quota: 100 oncologists
· Standard Intro Text:
¨ Thank you for your participation in this survey. Your opinions are very important to us.
¨
¨ First, you will be asked a few questions to ensure you qualify for the survey. If you qualify, you will be presented with the survey which should take approximately 15 minutes to complete.
¨
¨ If you qualify and complete the survey you will receive the promised honorarium in appreciation of your time.
¨
¨ First Name:
¨
¨ Last Name:
¨
¨ E-mail Address:
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Screening Questions
S1. Please select the setting which best describes where you spend most of your time in clinical practice.
ˇ Academic setting
ˇ Community setting
S2. Approximately how many patients with bone metastases resulting from each of the following cancer types do you manage in a typical month?
|
Cancer Type |
Number of Patients with Bone Metastases Managed per Month |
|
Metastatic breast cancer (mBC) |
_____ |
|
Metastatic hormone refractory prostate cancer |
_____ |
|
Other solid tumor types (not prostate or breast cancer) |
_____ |
· terminate if sum < 20
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· (Standard Qualify Text)
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SECTION ONE: Current treatment trends
1. What percentage of your patients with bone metastases resulting from each of the following tumor types receives systemic treatment for the reduction of skeletal related events (SRE)?
|
Cancer Type |
Percentage of Patients with Bone Metastases |
|
Metastatic breast cancer (mBC) (Hide row if S6_1 = 0) |
FORCE RESPONSE BETWEEN 0% AND 100% |
|
Metastatic hormone refractory prostate cancer (Hide row if S6_2 = 0) |
FORCE RESPONSE BETWEEN 0% AND 100% |
|
Other solid tumor types (not prostate or breast cancer) (Hide row if S6_3 = 0) |
FORCE RESPONSE BETWEEN 0% AND 100% |
· skip to q3 if q1_1 = 0 or was hidden but q1_2 > 0
· skip to q4 if q1_1 and q1_2 = 0 or were hidden BUT Q1_3 > 0
· SKIP TO Q5 IF Q1_1, Q1_2, anD Q1_3 = 0
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2. What percentage of your patients treated with systemic therapy for bone metastases resulting from metastatic breast cancer (mBC) receives each of the following?
Please note your answers must sum to 100%
|
Treatment |
Percentage of mBC Patients with Bone Metastases Treated with Systemic Therapy |
|
Aredia (pamidronate) |
|
|
Zometa (zoledronic acid) |
|
|
Other, please specify ________ |
|
|
Total |
MUST SUM TO 100% |
· SKIP TO Q4 IF Q1_2 = 0 and q1_3 > 0
· SKIP TO Q5 IF Q1_2 and q1_3 = 0
<Page Break>
3. What percentage of your patients treated with systemic therapy for bone metastases resulting from metastatic hormone refractory prostate cancer receives each of the following?
Please note your answers must sum to 100%
|
Treatment |
Percentage of Metastatic Hormone Refractory Prostate Cancer Patients with Bone Metastases Treated with Systemic Therapy |
|
Aredia (pamidronate) |
|
|
Zometa (zoledronic acid) |
|
|
Other, please specify ________ |
|
|
Total |
MUST SUM TO 100% |
<Page Break>
4. What percentage of your patients treated with systemic therapy for bone metastases resulting from other solid tumor types (not including prostate or breast cancer) receives each of the following?
Please note your answers must sum to 100%
|
Treatment |
Percentage of Other Solid Tumor Type Patients with Bone Metastases Treated with Systemic Therapy |
|
Aredia (pamidronate) |
|
|
Zometa (zoledronic acid) |
|
|
Other, please specify ________ |
|
|
Total |
MUST SUM TO 100% |
<Page Break>
5. What are the greatest strengths and weaknesses of Zometa in the treatment of bone metastases?
Strengths: OPEN-END TEXT BOX WITH 3 LINES
Weaknesses: OPEN-END TEXT BOX WITH 3 LINES
· Skip to q9 if s6_1 = 0
· Skip to q15 if s6_1 and s6_2 = 0
<Page Break>
SECTION two: denosumab evaluation
In this section you will be shown data regarding a novel agent, denosumab, in development for the treatment of bone metastases. Please review each piece of information carefully before answering the questions that follow.
Phase III trial evaluating (once monthly) subcutaneous denosumab versus Zometa (zoledronic acid) for the treatment of bone metastases in 2,046 patients with advanced breast cancer.
· Denosumab was superior in delaying the time to first on-study skeletal related events (SREs) (fracture, radiation to bone, surgery to bone, or spinal cord compression) (HR= 0.82, 95% CI: 0.71, 0.95), p<0.0001 for non-inferiority, p=0.01 for superiority. The median time to first on-study SRE was not reached for denosumab. The median time to first on-study SRE was 25.2 months for Zometa.
· Denosumab was superior in delaying the time to first-and-subsequent SREs (HR= 0.77, (95% CI: 0.66, 0.89), p=0.001
· Adverse events potentially associated with renal toxicity occurred in 4.9% of patients treated with denosumab compared to 8.5% in patients treated with Zometa. ONJ was infrequent and not significantly different between treatment arms.
· Overall survival (HR= 0.95, 95 percent CI: 0.81, 1.11; p=0.50) and time to cancer progression (hazard ratio 0.99, 95 percent CI: 0.89, 1.11; p=0.90) was balanced between treatment arms.
6. Based on the information presented above, what percentage of your patients treated with systemic therapy for bone metastases resulting from metastatic breast cancer (mBC) would receive each of the following one year following FDA approval of denosumab?
Please note, your answers regarding your current practice have been included for reference
|
Treatment |
Percentage of mBC Patients with Bone Metastases Treated with Systemic Therapy | |
|
|
Current Practice |
One Year Following Approval of Denosumab |
|
Denosumab |
N/A |
|
|
Aredia (pamidronate) |
<pipe response from Q2> |
|
|
Zometa (zoledronic acid) |
<pipe response from Q2> |
|
|
Other |
<pipe response from Q2> |
|
|
Total |
|
MUST SUM TO 100% |
· skip to q8 if q6_1 < 20%
<Page Break>
· link to breast cancer trial description
7. Which piece of data presented in the previous question is most compelling to your anticipated uptake of denosumab?
· rotate options
ˇ Denosumab’s superiority over Zometa in delaying time to first on-study skeletal related event (SRE)
ˇ Denosumab’s superiority over Zometa in delaying time to first-and-subsequent SREs
ˇ Denosumab’s lower rate of renal toxicity
ˇ Denosumab’s equivalent overall survival (in comparison to Zometa)
ˇ Denosumab’s equivalent progression free survival (in comparison to Zometa)
· skip to q15 if Q6_1= 100 AND S6_2 = 0 but s6_3 > 0
· skip to Q16 if Q6_1=100 AND S6_2 and S6_3 = 0
· else skip to Q9
<Page Break>
8. Previously you indicated you would use denosumab in [PIPE Q6_1] of your patients with bone metastases resulting from metastatic breast cancer. What data would you need to see in order to increase your uptake of denosumab? (OPEN-END)
· skip to q15 if S6_2 = 0 and s6_3 > 0
· skip to Q16 if S6_2=0 and S6_3 = 0
<Page Break>
Treatment of bone metastases in men with hormone refractory prostate cancer
This study is evaluating the delay in time to the development of the first skeletal related event. The purpose is to determine if denosumab is non-inferior to zoledronic acid. The primary endpoint is time to the first on-study SRE (non-inferiority). Secondary endpoints include among others time to first on-study SRE (superiority), time to the first-and-subsequent on-study SRE (superiority), incidence of treatment-emergent adverse events.
9. Assuming the trial above meets its primary endpoint of "non-inferiority" in delaying time to first SRE, what percentage of your metastatic hormone refractory prostate cancer patients with bone metastases would you treat with denosumab?
ˇ 0-20%
ˇ 21-40%
ˇ 41-60%
ˇ 61-80%
ˇ 81-100%
<Page Break>
· link to trial from q9
10. Assuming the trial above meets its secondary endpoint of "superiority" in delaying time to first SRE, what percentage of your metastatic hormone refractory prostate cancer patients with bone metastases would you treat with denosumab?
ˇ 0-20%
ˇ 21-40%
ˇ 41-60%
ˇ 61-80%
ˇ 81-100%
<Page Break>
11. Please think about a trial evaluating a drug for the prevention of bone metastases in your metastatic hormone refractory prostate cancer patients. What would be the minimum acceptable time to the first bone metastases in your high-risk patients to warrant use of a preventative agent? What would a desirable time of prevention to first bone metastases be?
Minimum time to first bone metastases: ___________ drop-down with months and years
Desirable time to first bone metastases: ___________ drop-down with months and years
<Page Break>
Prevention of bone metastases in men with hormone refractory prostate cancer
This study is evaluating the ability of denosumab to prolong bone metastases free survival in (n=1,780) men with hormone refractory prostate cancer. The primary endpoint is the time to first occurrence of bone metastasis or death from any cause and the secondary endpoint is the time to first occurrence of bone metastasis (excluding death) and overall survival. The trial is enrolling patients who are at “high risk” for developing bone metastasis, as defined by a PSA value >/= 8.0 ng/mL or PSA doubling time < /= 10.0 months.
12. Assuming that denosumab was able to show a 20% improvement over a placebo control with 2 years as the primary endpoint (time to first bone metastases): in what percentage your metastatic hormone refractory prostate cancer patients do you anticipate you would use denosumab for the prevention of bone metastases?
Please take into account that it’s likely not all of these prostate cancer patients are at high risk for bone metastases.
ˇ 0-20%
ˇ 21-40%
ˇ 41-60%
ˇ 61-80%
ˇ 81-100%
· skip to Q16 if S6_2 and S6_3 = 0
<Page Break>
13. What percentage of your metastatic hormone refractory prostate cancer patients meet the criteria for high risk as outlined in the study (PSA value >/= 8.0 ng/mL or PSA doubling time < /= 10.0 months)?
¨ _________ % high risk patients
<Page Break>
· link to trial from q12
14. Assuming that denosumab was able to show a 20% improvement over a placebo control with 2 years as the primary endpoint (time to first bone metastases) in the trial described above: in what percentage of these high risk metastatic hormone refractory prostate cancer patients do you anticipate you would use denosumab for the prevention of bone metastases?
ˇ 0-20%
ˇ 21-40%
ˇ 41-60%
ˇ 61-80%
ˇ 81-100%
<Page Break>
Phase III trial evaluating subcutaneous denosumab versus Zometa (zoledronic acid) for the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma.
· The primary endpoint, the median time to first on-study skeletal related event (SRE) was 20.6 months for those patients receiving denosumab and 16.3 months for those patients receiving Zometa (HR=0.84, 95% CI: 0.71-0.98), which is statistically significant for non-inferiority (p=0.0007). Although numerically greater, the delay in the time to first SRE associated with denosumab was not statistically “superior” compared to Zometa based upon the statistical testing strategy (adjusted p=0.06).
· The time to first-and-subsequent SRE was also numerically greater but not statistically superior compared to Zometa (HR=0.90, 95% CI: 0.77-1.04, p=0.14) (secondary endpoint).
· Osteonecrosis of the jaw (ONJ) was infrequent and not significantly different between treatment arms. Increased rates of renal adverse events and acute phase reactions occurred with zoledronic acid and hypocalcemia with denosumab.
15. Based on the information presented above, what percentage of your patients treated with systemic therapy for bone metastases resulting from other solid tumor types (not prostate cancer or breast cancer) would receive each of the following one year following FDA approval of denosumab?
Please note, your answers regarding your current practice have been included for reference
|
Treatment |
Percentage of Other Solid Tumor Patients with Bone Metastases Treated with Systemic Therapy | |
|
|
Current Practice |
One Year Following Approval of Denosumab |
|
Denosumab |
N/A |
|
|
Aredia (pamidronate) |
<pipe response from Q4> |
|
|
Zometa (zoledronic acid) |
<pipe response from Q4> |
|
|
Other |
<pipe response from Q4> |
|
|
Total |
|
MUST SUM TO 100% |
<Page Break>
16. Thinking of all your bone metastases patients, what are unmet needs of currently available treatments (Zometa, Aredia, etc.) that can be addressed by denosumab? (OPEN-END)
· end survey
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