A new standard of cancer care is emerging with all malignant lesions tested for genetic mutations prior to launching therapy. Drug therapy is then targeted to take advantage of these tumor mutations. This change was described in a recent article (see: Cancer Hospitals Make Gene Tests a New Standard for Care). Below is an excerpt from it:
Pinpointing the genetic changes that cause cancer has been a focus of researchers for more than a decade. Now, top cancer hospitals are making genetic testing a new standard of care in the field. When patients leave Memorial Sloan Kettering Cancer Center in New York after a biopsy, a sample of their tumor takes a different path. It travels across the street to a new laboratory, opened last month, where it will be tested for 341 genetic mutations, so-called biomarkers that will help doctors determine which drug may best help each patient, based more on their genetic profile than where the tumor appears....[C]linicians in hospitals including Sloan Kettering, the Dana-Farber Cancer Institute in Boston and others are moving quickly to translate study findings into everyday care based on the biomarkers....Once a tumor’s genes are analyzed, patients will be grouped with others who have the same mutations, with less regard for whether they have colon cancer, lung cancer or melanoma. The drugs they get will be based on that data. Sloan Kettering has 15 basket trials finished or ongoing, three of which will be presented at [an] oncology meeting this week....Pfizer Inc. and AstraZeneca Plc, are running a joint trial in the U.K. with 200 lung patients to sequence their tumors and try them on 14 different drugs. That’s a change in philosophy from even the very recent past, when researchers were often unable to say why some cancer drugs worked well in some patients but not others.
The excerpt makes mention of basket (clinical) trials. I found an article that defines this term in the context of making clinical trials more efficient, informative, and effective (see: Making Clinical Trials More Efficient, Informative, and Effective). Below is an excerpt from this second article:
The idea of aligning patients who carry a specific therapeutic target with a specific drug has resulted in higher response rates than have been previously seen, and now combination therapy is being considered to overcome the resistance that tumors often develop to anticancer drugs. New cancer drugs are initially tested in phase I trials, but we have become more nimble in confirming these responses early on rather than moving down the traditional paradigm. The development of the “basket” trial is one example. Instead of starting with multiple clinical trials in different diseases ..., we start with one trial — the basket — and one or more targets, and allow patients with multiple diseases to enroll in cohorts or groups. If one group shows good response, we expand this group to immediately assess whether others could benefit from the new therapy. If another group is unfortunately not showing evidence of effectiveness, this group may be closed and the patients can move on to consider other therapy. In this way, the exploration of the effectiveness of a treatment occurs early, quickly, and in one trial.
As I understand the term basket trial, it means that, in the case of malignant disease, a heterogeneous "basket" of patients are admitted to it. As noted in the first quote above, one such trial encompasses 200 lung cancer patients with presumably different histologic diagnoses generated by the pathologist. All of the tumors are sequenced. Various combinations of some 14 drugs are administered to the trial subjects. The groups that react positively to the treatment are expanded and the groups that do not are closed. I can also envision that, for some trials, patients with cancers of different organs but sharing similar genetic mutations would also be admitted to the same basket trial. The biostatistics underlying these basket trials must be incredibly complicated both in terms of managing the trial and reporting the trial results.