NCCN Guidelines for Patients: Ovarian Cancer

Deborah K. Armstrong, M.D.NOCC Annual Conference

Baltimore, MDFebruary 2016

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)

© 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®.

© 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®.

© 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®.

© 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®.

Is the Ovary Really the Organ of Origin

for “Ovarian” Cancer?

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”

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

Slide 37

Presented By Usha Menon at 2015 ASCO Annual Meeting

© 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®.

© 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®.

© 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®.

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.

© 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®.

© 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®.

© 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®.

© 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®.

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

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

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

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

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)

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?

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?

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

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

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

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

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

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

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

Motto & Take Home Message…

Research

Cures

Cancer!National Coalitio

n for Cancer ResearchBasic Science Translational Medicine

Screening & Prevention Therapeutics

© 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®.

© 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