May, 31, 2008
AGENDA

7:00 PM Dr Love
Introduction and meeting overview

7:10 PM Dr Vogelzang
Topic: A tumor cell pathway schematic for the clinician

Agree, disagree or in between?
Participation in a Phase I/II clinical trial of biologic targeted therapy is an important alternative that should be available to patients with cancer, particularly those with advanced disease.

Discussion points:

  • Biologic rationale and mechanisms of action for new agents being tested in genitourinary malignancies
    - Anti-VEGF agents (ie, cediranib, pazopanib)
    - Endothelin receptor antagonists (ie, atrasentan, ZD4054)
    - Immunomodulatory agents (eg, lenalidomide, thalidomide)
    - Rapamycin derivatives (ie, everolimus)

7:15 PM Group discussion

7:30 PM Dr Lacouture
Topic: Management of the dermatologic complications of biologic agents, including EGFR inhibitors

Agree, disagree or in between?
Toxicity-driven management of dermatologic complications of biologic agents, including EGFR inhibitors can have a meaningful impact on quality of life and severity of events.

Discussion points:

  • Incidence, impact on quality of life and consistent therapy of dermatologic complications associated with EGFR and multikinase inhibitors
  • Potential treatment strategies and implications for use in the adjuvant setting

7:35 PM Group discussion

7:50 PM Dr Natale
Topic: Rationale for clinical studies of biologics targeting multiple pathways

Agree, disagree or in between?
Agents that target multiple pathways (eg, vandetanib) may prove to be more useful in clinical trials than combinations of agents targeting single pathways (eg, bevacizumab and erlotinib).

Discussion points:

  • Clinical development of vandetanib

7:55 PM Group discussion

8:10 PM Dr Riely
Topic: Integration of promising biologic agents into adjuvant therapy

Agree, disagree or in between?
Molecular therapies and agents with relatively favorable toxicity profiles may be considered for off-protocol use in the adjuvant setting if they have demonstrated clinical benefit in the metastatic setting: Eg, EGFR tyrosine kinase inhibitors as adjuvant therapy for Stage IB to III non-small cell lung cancer (NSCLC) in patients with EGFR FISH overexpression or EGFR mutations.

Discussion points:

  • Predictors of response in NSCLC
  • EGFR mutations and nonsmoking status as predictors of response
  • Current clinical trials addressing this question
  • IHC and FISH assays for EGFR

8:15 PM Group discussion

8:30 PM Dr Venook
Topic: Use of prospective tumor registries to gather important information on biologic agents — BRiTE tumor registry as a model

Agree, disagree or in between?
Data from the BRiTE registry justify the potential consideration of continuing bevacizumab on disease progression in a nonprotocol setting.

Discussion points:

  • BRiTE findings and iBET study of bevacizumab in advanced colorectal cancer
  • Utility of toxicity data from prospective tumor registries in community practice settings
  • Implications of mechanisms of anti-VEGF therapy and delivery of chemotherapy to tumor cells

8:35 PM Group discussion

8:50 PM Dr Sledge
Topic: Vascular complications of anti-VEGF treatment

Agree, disagree or in between?
The risk of vascular complications of anti-VEGF treatment, including hypertension, hemorrhage and thrombotic events, will not preclude evaluation in randomized adjuvant trials but should preclude use in off-protocol adjuvant therapy.

Discussion points:

  • Vascular complications with monoclonal antibodies and tyrosine kinase inhibitors acting on the VEGF pathway (eg, lung cancer data with bevacizumab, cediranib and sunitinib)
  • Target blood pressure for a patient receiving a VEGF inhibitor

8:55 PM Group discussion

9:10 PM Dr LoRusso
Topic: Clinical research development of biologic agents

Agree, disagree or in between?
Dose and schedule are critical factors in the clinical development of molecular agents, but to assess these effectively, the specific target of the therapy must be clearly identified.

Discussion points:

  • Trials of cediranib, vandetanib and vatalanib
    - How do you quantify optimal dose with a molecular targeted agent? MTD (maximal tolerated dose) versus OBD (optimal biologic dose)
  • Use of imaging (DCE-MRI) to confirm target activity, et cetera

9:15 PM Group discussion

9:30 PM Close