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Other endpoints in screening studies for Soft Tissue Sarcomas. Jaap Verweij MD.PhD Dept of Medical Oncology Erasmus University Medical Center Rotterdam The Netherlands. Time. Surrogate Endpoint. Time. Disease. True Clinical Outcome. Intervention. Surrogate Endpoint. True Clinical

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other endpoints in screening studies for soft tissue sarcomas

Other endpoints in screening studies for Soft Tissue Sarcomas

Jaap Verweij MD.PhD

Dept of Medical Oncology

Erasmus University Medical Center

Rotterdam

The Netherlands

slide2
Time

Surrogate

Endpoint

Time

Disease

True Clinical

Outcome

slide3

Intervention

Surrogate

Endpoint

True Clinical

Outcome

Disease

slide4

Question:

If you know of all these ……… (Your Markers!)

Would you be able to cure

metastatic soft tissue sarcoma

(your ultimate aim)?

This is just a random selection of photographs. I apologize to anyone who is not listed

slide5

Intervention

Surrogate

Endpoint

True Clinical

Outcome

Disease

slide6

p = 0.02

We Should Desist Using RECIST

at Least in GIST

Robert S. Benjamin, M.D.

Department of Sarcoma Medical Oncology

The SARCOMA Center

slide8

?

  • How can we find the proof of concept:
  • early
  • when tumors do not shrink with treatment
slide9

Screening for new drugs in STS

  • Are we looking at the right spot?
which endpoint to use in screening for new agents
Which endpoint to use in screening for new agents?
  • Response rate
  • Progression Free Rate
  • Progression Arrest Rate
  • TTP ratio
response rate
Response Rate
  • Advantage:
    • Response relatively easily measurable
  • Disadvantage:
    • Does not take duration into account (DTIC 17%, duration 10 weeks)
    • Several cytotoxics discarded for response rate, but high SD rate
    • May not be appropriate for new cytostatic agents
slide14

Progression free rate(2nd line treatment)

100

90

80

70

60

50

40

30

20

10

0

(months)

0

3

6

9

12

15

O

N

Number of patients at risk :

221

234

47

16

5

1

Inactive agents

136

146

55

18

14

11

Active agents

Van Glabbeke et al, EJC 38:543-549,2002

progression free rates 2 nd line

Type of drug

N

3 months

6 months

Estim.

SE

Estim.

SE

Inactive

234

21 %

3 %

8 %

2 %

Active

146

39%

4 %

14%

3%

All patients

380

28 %

3 %

10 %

2 %

Progression free rates (2nd line)

Van Glabbeke et al, EJC 38:543-549,2002

slide16

Hypothetical tumor evolution during treatment

TTP1

TTP2

If TTP2/TTP1 > 1.33: potentially active agent*

* Mick et al, Contr.Clin.Trials 21:343-359. 2000

slide17

ET-743 as 3rd line treatment inj soft tissue sarcoma

Total population

Patients without tumor regression but long lasting stable disease

ASCO 2003, # 3293

slide18

The problem of duration

  • It could take long to assess
  • And in screening studies we would like to know early
using progression rate
Using progression rate

Set maximum PD rate above which agent will be rejected

PD rate of interest will depend on tumor type

Tumor RR PD rate

breast >30% <20%

NSCLC >20% <30%

Glioma >10% <40%

STS >10% <50% (??)

slide20

Progression Arrest* Rates

%

* Van Oosterom, In: Clinical Management of soft tissue sarcomas. Martinus Nijhoff Publishers, 131-138, 1986

response versus symptom benefit rate
Response versus Symptom benefit rate*

Gefitinib in NSCLC

Imatinib in GIST

slide23

Conclusions

Aim of screening studies

  • To estimate a.s.a.p.if a drug may be useful for patients

Endpoint for screening studies

  • Progression free rates
  • Progression arrest rates
  • TTP ratio
  • Symptom improvement?

All of these require proper validation