ASCO Sessions Feel Funding Impact

ASCO is a zoo. The animals in the zoo—often all crammed into the same overly air-conditioned enclosure—are not just oncologists but researchers, financial analysts, journalists, and vendors of every stripe and it depends on who’s opinion you ask for as to how the meeting went, however, most would agree that this year’s ASCO was not, by any measure, a stampede towards the latest uncanny clinical discovery.

There were no blockbuster revelations, no flashy new kid on the block, no miracle cures at this year’s ASCO. In fact, of the four studies selected for the plenary session (where presentations are often THE important findings of the conference) only one is predicted to have a major impact on patient care.

“The intent of the plenary choices was to showcase NCI supported funded studies,” explained Michael Morse, MD, professor of medicine at Duke University. “The point being that federal funding is still critically important, and that these investigations—these questions would not be asked, and these studies would not have been funded by a pharmaceutical company.”

Cifford Hudis, MD, president of ASCO elaborated. “Federally funded studies are often designed to answer questions that are critically important to patients, things like comparative effectiveness research, new indications for older generic drugs, and improvements in quality of life—studies that industry are not interested in performing.”

Yet, despite that critical need, federal funding for cancer research has diminished over the last ten years, and the negative impact on research is now apparent. “I can tell you at ASCO we are already seeing a real, and we think disturbing bit of evidence about the impact of reduction of federal support,” Dr, Hudis said. “The number of federally funded abstracts submitted to us has dropped sharply over the last 7 years, from 575 such studies in 2008, to 169 this year.”

“The question that we are facing now is, who is going to plan, and launch, and complete these kinds of trials in the future, and the answer, honestly, remains to be seen.”

The four federally funded studies of the plenary session, in brief:

Lapatinib vs. lapatinib plus traztuzumab (together or sequenced) vs. traztuzumab in the adjuvant setting in breast cancer—the ALTTO Trial

A perfect example of why federal funding is required: this trial took nearly five years to complete and involved more than 6,000 patients.

Motivation: Data from the combined use of these agents in the pre-operative (neoadjuvant) setting were positive. It was assumed, but had not been proven, that the same positive outcomes would be seen for adjuvant (post-operative) treatment.

Results: No benefit for the addition of lapatinib.

Take home: Results from neoadjuvant investigations may not translate into the adjuvant setting. “The question asked here is, in the larger sense, can we routinely use the preoperative setting and the improvement in pathologic complete response as a reliable surrogate for disease-free, and overall survival,” said Dr. Hudis. “According to the results in this trial is, maybe not. This is going to cause a tremendous amount of scientific discussion in terms of drug development.”

Bevacizumab/chemo vs. cetuximab/chemo in metastatic colorectal cancer

The chemo regimens used here (referred to as FOLFIRI, and FOLFOX) were of physician choice. Chemo was then combined with either cetuximab, or bevacizumab. N=1140.

Motivation: To determine which targeted agent is best in front-line treatment.

Results: No difference.

Take home: Chose the therapy that has the best side effect profile for a given patient.

Exemestane vs. tamoxifen as adjuvant treatment for hormone-positive, premenopausal women with early-stage breast cancer

Motivation: Exemestane (a generic drug), effective in post-menopausal women, requires low estrogen levels to work. Would it work in premenopausal women if ovarian suppression is used? N=4690.

Results: Short answer: Yes. A 34% relative risk reduction in the recurrence of breast cancer was observed for exemestane.

Take home: Concluded study author, Olivia Pagani, MD, “This provides strong evidence to adopt this treatment approach.”

Docetaxel plus hormone therapy vs. hormone alone in late-stage prostate cancer

Motivation: As put by study presenter, Christopher Sweeney, “The important question in hormone sensitive cancers is, do you throw everything at the patient in the beginning, or do you wait?” N=790.

Results: Throw everything. There was a survival advantage for docetaxel/hormone therapy of 57.6 months vs. 44.0 months for hormone therapy alone.

Take Home: Dr. Hudis: “Across all solid tumors this is an almost unprecedented improvement in median survival I know of. This could be transformative.”

Transformational indeed, yet, the study took nine years to complete and docetaxel is a generic drug. In the future, who but the federal government would support such research?

Only time will tell.