This is a report of a phase I clinical trial testing whether specific immune cells harvested from the bone marrow, grown in the lab and then re-infused into multiple myeloma patients can effectively change the immune environment in the patient and suggest a possibly improved disease outcome. It looks at using a different population of immune cells — marrow-infiltrating lymphocytes (MILs) — from those used in previous studies. These are both easier to retrieve and easier to grow in the lab, two factors that reduce the complexity of this treatment approach.
The release is in many ways a model for other organizations reporting on similar studies. The description of the study is clear, the language used appropriately conservative, and there is context regarding the novelty of the approach and current alternative treatments. Some discussion of possible costs — preliminary though it would have to be — would have completed the picture for readers. Rather than hyping such a study in a frenzied attempt to attract clicks and eyeballs, Hopkins presents the findings in a thoughtful way that reflects well on the institution’s reputation and will help build that reputation over the long haul.
Multiple myeloma is one of several cancers of the blood and the National Cancer Institute estimates that nearly 27,000 new cases of myeloma will be diagnosed this year. Less than half of patients live as much as five years after their diagnosis, and more than 11,000 patients are expected to die from the disease this year. Any new approach to treating this and other blood cancers stands to benefit the nearly 90,000 patients now living with this disease in the U.S.
The release, while loaded with information about the research, fails to mention costs related to this new approach at any point. This is in spite of the fact that the paper provides what’s necessary to fulfill this criterion. The study authors wrote: “The easy access to the tumor site, the absence of the need for surgical removal of the tissue containing the T cells, the numbers of cells obtained with the harvest, and the ability to expand products in all patients with a relatively short process at a reasonable cost contrast sharply with several limitations of TIL ACT” (a current therapeutic approach to the disease).
The release does a good job of spelling out the results of this phase 1 trial by providing data showing that MILs can target and kill cancer cells. It shows that in more than half of the study’s patients, their cancers had shrunk by at least half. In 15 of the 22 patients, their cancers did not progress for nearly a year after the MILs therapy. This wasn’t a controlled study, so it’s unclear how these patients would have fared without the MILs treatment, and the release could have attempted to provide some insight on that point. But we’re pleased that the release focuses appropriately on the apparent safety of the approach, rather than trying to make claims about survival benefits that aren’t supportable by this kind of small, uncontrolled study. The release also explains that the research provides information suggesting which patients might benefit best from this approach, and that other research at this cancer center is centered on testing this approach on different forms of cancer.
We’ll give this criterion a satisfactory rating since the release specifically spells out, “None of the participants had serious side effects from the MILs therapy.” However, the study is really too small, and the time span too short, to comment substantively on the possible harms that might be seen if and when the treatment is more widely used. The research paper actually makes the point that the new procedure doesn’t require the “surgical removal of tissue,” and the procedure can be done at bedside rather than an operating suite. But the removal of cells from the bone marrow is still an invasive procedure that carries its own risk of infection or other problems. The release would have benefited from at least mentioning this aspect.
The release makes a very good effort to objectively describe a technically complicated trial. It defines the trial at least twice as being “small” and calls it a “pilot,” suggesting that caution is appropriate when considering the results. It effectively explains the process involved in the treatments, including what was learned regarding the growth of cells in the lab after harvesting. It also points to the fact that while tumor-infiltrating lymphocytes (TILs) can only be retrieved from a quarter of the patient candidates for this technique, MILs were obtained from all of the patients in this study, suggesting that they may be a better tool for this therapy.
Describing multiple myeloma as “the second most common cancer originating in the blood” doesn’t add much to our understanding of this disease. However, other statistics provide context regarding the scope of the problem in the United States. We’ll give it a pass.
The funding sources for this research are listed in an end note in the release. No conflict of interest information is provided in the release, although the research paper discloses no conflicts.
The release does mention that other forms of this adoptive T cell therapy use different cells, suggesting that other approaches are possible. The release also notes, “Three days before the injections of expanded MILs, patients received high doses of chemotherapy and a stem cell transplant, standard treatments for multiple myeloma.”
The release points out that “several U.S. cancer centers have conducted similar experimental treatments” but adds that Johns Hopkins is the only one using the MIL cells. It also points to several other ongoing clinical trials at Hopkins that build on the findings of this small study. Using the terms “pilot” and “experimental,” the release signals that availability is very limited.
We like the fact that the headline itself defines this as a “pilot” clinical trial and that the lede says that it is “what is believed to be the first small clinical trial of its kind.” Those kinds of qualifiers both declare the specifics of the research and also provide informative caveats, allowing the reader to gauge how much credence to give to the findings. All too many other medical releases fail to provide this measured approach.
This release is conservative throughout in its choice of language in describing this research which, based on its findings, might be ripe for exaggeration.