Deborah K. Armstrong, M.D., explains the newly-released patient guide for ovarian cancer patients, which was sponsored by the National Ovarian Cancer Coalition (NOCC).

1. NCCN Guidelines for Patients:
Ovarian Cancer
Deborah K. Armstrong, M.D.
NOCC Annual Conference
Baltimore, MD
February 2016

2. NCCN
• National Cooperative Cancer Network
– A not-for-profit alliance of 26 leading cancer centers
– Develops clinical practice guidelines for patients and
clinicians
• Continuously reassessed and updated
– Drug compendia based on guidelines
– Oncology research program
• Original research utilizing the NCCN database
• Sponsored research
• Young investigator awards
– NCCN Foundation (philanthropic arm)

3. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

4. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

5. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

6. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

7. Is the Ovary Really
the Organ of Origin
for “Ovarian” Cancer?

8. Fallopian Tube Origin of Ovarian Cancer
• No precancerous lesions have been identified in
the ovary
• Serous epithelium is seen in the FT, not in the
ovary
– most advanced ovarian cancers are serous
• There are several logs more epithelial cells in the
fallopian tube compared to the ovary
• Accumulation of pathologic changes in the FT
reflect findings in “ovarian cancer”

9. A. M. Karst and R. Drapkin J Oncol 2010

10. Slide 37
Presented By Usha Menon at 2015 ASCO Annual Meeting

11. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

12. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

13. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

14. Initial Chemotherapy for Ovarian Cancer
• 6 cycles taxane-platinum combination is standard
• IP admin benefits patients with low volume (optimal) disease but
has increased toxicity
– Surgical NED patients treated with IP have a median survival over 9 years
• Paclitaxel (taxol) and docetaxel (taxotere) equally effective in
combination with carboplatin
• Weekly (dose-dense) paclitaxel improves outcome in JGOG study
• GOG 262 confirms findings in suboptimal patients not receiving bevacizumab
• No current role for a third chemotherapeutic agent
• Bevacizumab during and after chemotherapy improves PFS but not
OS
• Pazopanib maintenance improves PFS, too early for OS.

15. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

16. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

17. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

18. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

19. What is a clinical trial?
• A clinical trial is any investigation of a new drug
or combination of drugs, clinical intervention, or
treatment
– New unapproved drugs
– FDA approved drugs in new situations
– New combinations
• All clinical trials involving human subjects are
required to have Institutional Review Board (IRB)
Approval
– Retrospective trial
– Prospective

20. Why do we do clinical trials?
• To improve disease outcome
• To decrease toxicity of treatment
• To identify new, active drugs or drug combinations
• To
• Despite being “new” trial
is at the tail end of a long
investigative process
– Paclitaxel:
• Discovered 1967
• Clinical trials late 80’s
• Standard care mid 90’s

21. Why Participate in a Clinical Trial?
• Benefit to society
– Clinical trials have got us to where we are now!
– Nationwide, only about 3% of patients with cancer
participate in clinical trials
• Benefit to individual
– Trials are usually done with significant oversight
and close clinical monitoring
– You may get a new, promising drugs years before
FDA approval
• many drugs are tested (and paid for) in clinical trials
– Most phase III trials are positive

22. Clinical Study: Pluses
• Access to new drugs & interventions
• Close monitoring
• Active role in health care
• Among the first to benefit
• Most Phase III trials are positive

23. Clinical Study: Minuses
• Logistics can be burdensome - less flexibility in
treatment and dose/schedule changes
• Unknown side effects
• New approach, may not work
• Only 3% of patients with cancer are in trials
(higher in pediatrics)

24. Considerations in the decision to
participate in a clinical trial
 How serious is your disease?
 What is the expected outcome with standard treatment?
 What are your other non-trial options?
 What is the standard of care?
 What toxicity does the standard of care have?
 What are the goals of the study?
 Decrease toxicity?
 Improve efficacy?

25. Considerations in the decision to
participate in a clinical trial
 What is being investigated?
 Is it a new agent
 A new way of using an approved agent?
 What are the risks?
 What are the costs?
 What are the added logistics?
 What is in it for you?
 What is in it for future generations?

26. Where are Clinical Trials Done?
• Large cancer center
• University hospital
• Local medical center or physician’s office
– NCI Community Clinical Oncology Program (CCOP)
– NCI Community Oncology Research Program
(NCORP)
• Internationally

27. Who Pays for Clinical Trials?
• Private Foundations
• Government
– Funding through grant mechanisms
• Individual grants (R01)
• Cooperative groups (NRG: NSABP, GOG, RTOG)
• SPORE grants
• Industry
– New drug approvals
– New indications of approved drugs

28. Types of Clinical Trials
• Preclinical
• Phase I – Goal: To define tolerable dose and schedule
– Primary endpoint is toxicity
– Pro – usually open entry criteria (good for rare diseases)
– Con - limited data and toxicity information on the treatment
• Phase II - Endpoint is response in a specific disease
– Pro – dose and schedule defined, some data to suggest efficacy,
may get access to new drugs or treatments before approved
– Con - barriers to entry are higher
• Phase III - Endpoint is comparison to current standard
– Pro - May get better treatment
– Con - may not get experimental arm, toxicity may be higher, may
not be as efficacious

29. Why are Clinical Trials Critically Important
for the Future of Cancer Care?
- The best treatment is often poorly understood.
- Access to novel, cutting-edge treatments.
- Advancing cancer care is a dual effort from
researchers and patients alike.
- Patient empowerment and involvement
- Care on a clinical trial is often more structured
for patients.
- The goal of improving patient results and
quality of life REQURES clinical trials

30. When is it appropriate to consider
a clinical trial?
• You must be eligible, no exceptions
• Treatment
– Something new or investigational, not otherwise available
to you
– A treatment that might expand your options
– A treatment that might result in less toxicity
– Treatment in a situation that might not ordinarily be
treated
• It needs to “feel right” to you
– You and your physician must be comfortable with all of
the options on the trial
• Don’t be scared off by consent forms, read them,
review them with your doctor and your family

31. Patient Misconceptions
About Clinical Trials
• Clinical trials are a last resort and are only offered to
patients who have no hope of responding to
“standard” therapy
• Clinical trials are for rare types of cancer
• I can go on a clinical trial any time
• If my doctor offers me a clinical trial, it is an indication
that (s)he doesn’t think I have long to live

32. What can YOU do?!
• Help raise awareness
– Join advocacy groups
• Be politically active!
– Lobby for increased research funding for ovarian
cancer
• Participate in clinical trials
• Support foundations that support women’s
cancer research

33. Motto & Take Home Message…
Basic Science Translational Medicine
Screening & Prevention Therapeutics

34. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.

35. © National Comprehensive Cancer Network, Inc. 2016, All rights reserved.
The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
For more information on the
NCCN Guidelines for Patients®
or the NCCN Foundation please contact
patientguidelines@nccn.org
or visit us at NCCN.org/Patients