Editor's Note Touchdown

When I sojourned to the University of Miami to begin my internship in 1972, the football team wasn’t very good. In fact, lacking strong leadership and community support, the UM Hurricane team was literally on the verge of extinction. However, in 1979 a completely unexpected change in fortune occurred. A man named Howard Schnellenberger took the reins of the program and became head coach. The rest is history as Schnellenberger’s vision, leadership and savvy recruiting of talented players like quarterbacks Bernie Kosar and Vinny Testeverde helped elevate the program to the highest level — a national championship — within four years.

People with foresight and the ability to actualize their dreams are essential in every profession. Clinical cancer research is no exception. In this issue of our series, as in most of our programs, you will hear thoughtful, charismatic breast cancer research leaders chat about what’s new and exciting in the field. It is these dynamic people and others featured in our programs who are providing the much-needed leadership for breast cancer treatment and research.

Cliff Hudis and Hy Muss have been key members of the CALGB breast cancer committee for many years. Hy was chairman and Cliff is currently co-chair. Two recent trials from this group have permanently changed the face of adjuvant therapy, and dare we say it — the chemotherapy paradigm. CALGB-9344 survived some early criticism aimed primarily at the principal investigator, Craig Henderson, who was recently interviewed for our series. The bottom line is that this study was among the first to alert us to the substantial potential of taxanes in the adjuvant setting.

The follow-up trial, CALGB-9741, can legitimately be described as one of the most important randomized studies ever reported on the treatment of any cancer. With mathematical masterminding by Larry Norton, this trial posed a simple yet critical question: “Can the outcome of adjuvant chemotherapy for breast cancer be improved by simply changing the treatment schedule without altering the agents or doses utilized?” In this case, the question was whether dose-dense AC followed by T given every two weeks with growth factor support would result in fewer recurrences and deaths than an every three-week schedule.

The stunning answer — first delivered at the San Antonio Breast Cancer Symposium in December 2002 — is yes, and while we may not know whether it was the altered schedule of AC or T that was crucial in delivering the benefit, the results of this sentinel trial have everyone’s attention.

In this program, Cliff makes a critical related point, and for once I have actually been hearing the mentor (Larry) quoting the mentee (Cliff) during meetings. Specifically, Cliff addresses a recently published JCO paper by Gary Lyman (another recent interviewee) documenting frequent dose reductions and delays in the use of adjuvant chemotherapy in community treatment settings in the late 1990s. I personally believe that these types of dose delays are no longer common, but that is a story for another day. (See our recently published periodical Patterns of Care for more perspective on the subject.)

Cliff’s concept is simple yet easy to overlook, and relates to both CALGB-9741 and Gary’s work. If decreasing the treatment interval reduces the rates of recurrence and death, might dose reductions and delays increase the recurrence rate and mortality? What is important about the provocative patient care implications of this CALGB trial is that the leadership of Cliff, Hy and many others has now provided us with a pristine data set that has the potential to save lives.

Jeff Abrams — also interviewed in this issue — has made a similar impact by making the NCI’s Cancer Trials Support Unit (CTSU) a reality that is gaining momentum. By essentially linking the United States cooperative clinical trial groups into one “Intergroup,” the CTSU is significantly speeding up trial accrual. Jeff cites the example of the recently reported Canadian MA17 trial demonstrating an advantage to letrozole versus placebo in postmenopausal women completing five years of adjuvant tamoxifen. About 70 percent of the 5,000 women enrolled in this important randomized trial were from the United States and entered through the CTSU mechanism.

I remember hearing quiet grumbling when Jeff started the CTSU some years ago — new procedures, new paperwork, etc. No one is grumbling now, as randomized trials are able to provide us answers quicker than ever.

Melody Cobleigh is another research leader I interviewed for this program. You will always find Melody and her Windy City colleague, Janet Wolter, front and center at any NSABP meeting. I recall running into both of them at the hotel check-in line at the Orlando meeting last year. When I asked them what was new, Melody chirped, “I am trying to get the breast committee to do a trial incorporating trastuzumab plus radiation therapy for DCIS.” That got my attention, and we agreed to sit down and talk about this and other new research concepts in a future interview. As always, Melody tells it like it is, and perhaps like it may be in the future. Dynamic people like Cliff, Hy, Jeff and Melody have created and are creating a legacy for the future of breast cancer management.

Twenty-five years after Howard Schnellenberger began loading up the Hurricane football team roster with future NFL stars, the University of Miami continues to perfect its formula for success by constantly bringing in new leaders with new ideas. Twenty-five years from now I hope to write on these pages of the powerful legacy that was being created by today’s clinical research leaders who share their hopes and dreams with us in every issue of our series.

— Neil Love, MD
NLove@ResearchToPractice.net

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