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Milestones in Oncology |
As targeted cancer therapies replace the classical stathmokinetic drugs of the past and as oncology advances at a demanding and rapid pace, the editors of The Oncologist will, from time to time, invite us to pause and appreciate the lives of those who have brought about great innovations. Our Editor-in-Chief, Bruce Chabner, has aptly christened this new series, "Milestones in Oncology: Dialogues with the Innovators." In collaboration with the Society for Translational Oncology, the Journal will bring you peer-accepted papers accompanied by vibrant videotaped dialogues with those innovators whose works have marked true Milestones in Oncology.
Although we were not privileged before she died1 to capture a dialogue with Gertrude Elion, in this inaugural tribute we focus attention on her and her great gifts to patients.
On October 31, 2005, the Food and Drug Administration (FDA) approved nelarabine (Arranon®; GlaxoSmith-Kline, Research Triangle Park, NC) as a new drug to treat adults and children with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to, or has relapsed following, at least two chemotherapy regimens. Nelarabine is the first drug to treat this limited population of gravely ill patients. At the time of its approval, Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research (CDER) observed that these patients, for whom there are "no other proven effective alternatives," now have "a significant option...[since] Arranon has shown effectiveness in certain populations as a last-resort treatment, and we’re pleased to be able to approve it under our accelerated approval program."2
The numbers of patients are, by comparison with most cancers, quite small. About 1,600 patients are newly diagnosed with T-ALL/T-LBL each year in the United States. Of those, an estimated 500 patients per year have relapsed or refractory T-ALL/T-LBL, with approximately 200 of these patients being children. Acute lymphoblastic leukemia (ALL) is an aggressive disease that progresses rapidly without effective therapy. Each year an estimated 2,400 children and 1,200 adults are diagnosed with ALL in the U.S., of whom approximately 700 have T-ALL. Lymphoblastic lymphoma (LBL) represents approximately 30% of childhood and 3% of adult non-Hodgkin’s lymphoma (NHL). An estimated 50,000 patients are diagnosed with NHL each year, of whom approximately 900 have T-LBL.2
There are several elements that are remarkable. First, the drug is very significant for this rare subset of leukemic patients. Second, this drug was pursued by its sponsor, GlaxoSmithKline, even though it may never recover even the cost of its research and development. Finally, the chemical nucleus of this drug was developed decades ago in the powerfully productive laboratories of Gertrude Elion.
The story of nelarabine is interesting and important, to be sure. It marks a Milestone in Oncology. But the fact is that nelarabine is yet another life-lengthening molecule that percolated from Gertrude Elion’s productive intellectual reservoir and that fact caused us to pause and to ask about this great woman. The result is the following article by Rick Koenig. Then we are treated to her autobiography, commissioned by the Nobel Foundation when it conferred the Nobel Prize on her along with her lifelong collaborator, George Hitchings.
As we gaze to the future with cautious but warranted optimism, we are reminded of what Sir Isaac Newton, one of history’s greatest scientists, wrote to fellow scientist Robert Hooke: "If I have seen further it is by standing on the shoulders of Giants."3
We are blessed to have been hoisted upon the shoulders of a gentle and generous giant ... and the view that Gertrude Elion has given us proffers new hope for patients.
FOOTNOTES
1 Tributes to Gertrude Elion. Ingram RA, Kent RS, Barry DW et al. The Oncologist, Vol. 4, No. 2, 1999, http://theoncologist.alphamedpress.org/cgi/content/full/4/2/0-ii 
2 http://www.fda.gov/bbs/topics/NEWS/2005/NEW01251.html
3 "What Des-Cartes did was a good step. You have added much several ways, & especially in taking ye colours of thin plates into philosophical consideration. If I have seen further it is by standing on ye shoulders of Giants."— Newton to Hooke, 5 February 1676
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