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A randomized trial of rectal cancer treatment strategies is newsworthy, so why leave out numbers backing the claims?

New method reduces adverse effects of rectal cancer treatment

Our Review Summary

This brief news release describes a lengthy randomized trial at Sweden’s prestigious Karolinksa Institutet that compared various treatment regimens for patients with rectal cancer and concluded that delaying surgery after radiation therapy resulted in fewer postoperative complications. The study, published in The Lancet Oncology, also found no difference in outcomes between short-course and long-course radiation therapy prior to surgery. The news release refrains from disease mongering and is forthcoming about the fact that the study springs from a need to address adverse effects associated with radiation therapy. But it’s missing quantified benefits, cost data and a few other details that would help readers grasp the significance of the findings.

 

Why This Matters

The American Cancer Society estimates there will be 39,910 new cases of rectal cancer diagnosed in the U.S. this year. Colon and rectal cancer together constitute the second leading cause of cancer-related deaths in the U.S. and the third most common cancer in both men and women. Administering radiation to shrink a tumor before it is removed surgically was found to reduce recurrence and death versus surgery alone, but questions remained about how to pace radiation and how long to wait between radiation and surgery. According to these researchers, delaying surgery by several weeks not only results in fewer complications with no compromise in outcomes, but also gives patients time to adopt healthier lifestyles in preparation for surgery and undergo chemotherapy if there’s a high risk that the cancer will spread.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There’s no discussion of costs. Perhaps just changing the timing of the same treatments is cost neutral, but maybe not. It would be interesting to know if delaying surgery affects total treatment costs, particularly if it results in fewer complications. One 2009 study put the mean total colon cancer cost per U.S. Medicare patient at $29,196, noting that the cost for rectal cancer is substantially higher.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The news release itself does not quantify benefits. But according to the study, short-course radiation therapy with no delay in surgery resulted in postoperative complications 53 percent of the time, versus 41 percent of  cases in which surgery was delayed. The release would have been much stronger had it provided the outcomes of this randomized trial of 840 patients who were divided into different treatment arms.

We give the release credit for trying to convey what the study’s findings mean for patients through these statements:

The results of the study show that patients with delayed surgery develop fewer complications with equally good oncological outcomes. It also showed that there is no difference between long-course and short-course radiotherapy other than that the former considerably lengthens the time for treatment.

“The results of the study will give rise to improved therapeutic strategies, fewer complications with a sustained low incidence of local recurrence, and better survival rates for rectal cancer patients,” says Professor Martling. “The results can now be immediately put to clinical use to the considerable benefit of the patients.”

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

This was a close call. The news release refers to harms/adverse effects from radiotherapy at least four times but does not name even one potential harm, so we’re rating it unsatisfactory for the omission.

According to the study, the most common postoperative complication was infection, which occurred in 18 percent of patients. The study also mentions bowel obstruction and pelvic abscesses. About 7 percent of patients whose surgery was delayed were hospitalized for radiation toxicity.

The news release (and the abstract of the journal article) avoid a thornier question. Could delaying surgery after radiation treatment of rectal cancer increase the chance that rectal cancer will come back? The study found rectal cancer recurred in 2.8% of patients an average of 19 months after delayed surgery and in 2.2% of patients an average 33 months after surgery at the usual time. The small difference seems to favor the usual timing of surgery. The authors take a scientifically valid position that if the difference in rate between options could have happened up to 5 percent of the time by random chance, then the new option is “noninferior” to the standard treatment, as is the case here. It is quite possible that cancer outcomes are slightly worse for the new timing of treatments, but justified by a much bigger improvement in complication rate. The absolute difference in local cancer recurrence is only 0.6% (with a large margin of possible error) whereas surgical complications were reduced by an absolute 12% (41 vs. 53%).

The study notes that one potential drawback of delaying surgery is that it delays the start of chemotherapy in  regimens that include chemotherapy after a tumor has been removed. But it says chemotherapy could be more effective if administered before surgery, so a delay would present an opportunity to administer chemo. Whether that would help patients would need to be determined by another research study.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The news release does not give basic information to help readers grasp the significance of the study, such as the fact that it included 840 patients recruited over a span of more than 14 years. Because the study was adjusted to the changing treatment protocols over the course of the long study, the results are not as clean as the news release makes them seem. Changing protocols affected the study’s design and the representation of various treatment groups. Also, the study does not include long-term quality of life data, which it says will be published separately.

Does the news release commit disease-mongering?

Satisfactory

The news release does not engage in disease mongering. It says rectal cancer affects 2,000 men and women in Sweden per year.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The news release states that the study was financed by the Swedish Research Council and the Cancer Society in Stockholm, and through the regional ALF agreement between Stockholm County Council and Karolinska Institutet. According to the study, there are no conflicts of interest.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The purpose of this study was to compare the timing of existing standard treatment modalities. Complementary and alternative treatments are beyond the scope of the news release.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

Since these are existing treatments have already been in common use for many decades, availability is not an issue.

Does the news release establish the true novelty of the approach?

Satisfactory

The news release states that the trial tested the hypotheses that “the adverse effects of rectal cancer treatment can be reduced by administering more but lower doses of radiation for a longer time, or by increasing the interval between radiotherapy and surgery.”

Other trials such as this one have studied the timing of surgery for rectal cancer, but we couldn’t find any that examined the same variables as this study. That’s enough to earn a satisfactory rating for novelty.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release doesn’t rely on sensational language to describe the study results.

The headline calling this a “new therapy” might strike some readers as slightly misleading. However, the release explains that the researchers launched a 14-year study of the three protocols in the late 1990s, a few years after preoperative radiotherapy was first introduced for rectal cancer — partly owing to foundational research by the Swedish institute.

Since the Karolinska Institutet has been a world leader in rectal cancer research and treatment, its horn-tooting statement — “Thanks to our results, radiotherapy is recommended to many rectal cancer patients.” — appears justified.

Total Score: 6 of 10 Satisfactory

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