Nick Mulcahy

September 29, 2016

BOSTON — There is now an account of patients who die while receiving radiation therapy, thanks to a new study that is the first of its kind. The study is a reflection of the field's growing openness about patient safety issues.

"Our data show a low overall rate of mortality during radiation therapy," lead study author Brandon Dyer, MD, of the University of California, Davis, Comprehensive Cancer Center, Sacramento, told an audience here at a session on patient safety at the American Society for Radiation Oncology (ASTRO) 2016 Annual Meeting.

"We do a fairly good job at not treating patients who are not up for it," Dr Dyer told Medscape Medical News.

The team retrospectively reviewed morbidity and mortality (M&M) data for all 14,189 cancer patients treated with radiation at their institution from 2000 to 2016.

The investigators identified 78 patient deaths (0.55%) associated with radiation treatment. The deaths occurred either during actual treatment or during the treatment period. The range of annual mortality was two to 12 patients (median, four).

"Patients who died tended to be lung and breast cancer patients, being treated palliatively with 3D-CRT and with neoadjuvant or concurrent chemotherapy," he summarized. Notably, 30 deaths (of 78) were among lung cancer patients.

Death was most commonly due to "miscellaneous" causes, such as progressive disease (17 of the 78 total deaths) or multisystem organ failure (13/78). Most of the deaths were considered to be "not preventable" (67/78).

However, eight deaths were "possibly preventable," and three were deemed "preventable."

The analysis showed that the preventable deaths were strongly correlated with radiation therapy (P < .001), "suggesting that radiation therapy may have caused harm," said Dr Dyer.

Radiation therapy may have caused harm. Dr Brandon Dyer

The novel study should be viewed in the context of a new era in patient safety research in radiation oncology, said Gregory Russo, MD, of the Dartmouth Hitchcock Medical Center in Hanover, New Hampshire, who acted as study discussant.

Dr Russo believes that the increased "public discourse" on safety is an outgrowth of a 2010 New York Times article, "Radiation Offers New Cures, and Ways to Do Harm."

That article reviewed multiple high-profile radiation oncology debacles, including one among men treated for prostate cancer at the Veterans' Administration Hospital in Philadelphia in 2009, as reported by Medscape Medical News.

The news coverage "really scared everyone," said Dr Russo, who was inspired to publish his first academic article on safety in 2010. He revealed that he had a lawyer review the manuscript before publication.

"Safety science had a lot of problems in 2010," he summarized.

But ASTRO has since pumped up patient safety research at the annual meeting, he said. In 2016, there were six oral scientific presentations, nine e-posters, and 34 posters. Also, a Delta Air Lines executive delivered one of the meeting's keynote addresses, entitled, Safety Culture at a Global Air Carrier.

Nevertheless, "people have been afraid to publish studies about errors," Dr Russo also said.

Study Details

In the new study from the University of California, Davis, an analysis of independent variables revealed that of patients who died, the following were all strongly predictive of mortality: disease subsite (P = .002), completed dose (P = .001), radiotherapy intent (P = .001), radiation therapy modality (P < .001), timing of chemotherapy (P = .002), cause of mortality (P < .001), and factors related to radiation therapy (P < .001).

No other study in the literature has ever investigated mortality while undergoing radiation treatment, and no study has looked at the preventable causes, Dr Dyer said.

The new study was also important, suggested Dr Dyer, because "patient-centric" education in radiation oncology reviews the therapeutic ratio of risks and benefits, which should include death.

He said that the take-away message for clinicians and administrators is that at-risk metrics are needed.

"These findings reinforce the need for patient acuity of care stratification metrics to better identify and support those patients most likely to suffer from potentially preventable RT-induced morbidity or mortality," Dr Dyer said.

The study was enabled by the record-keeping at the University of California, Davis.

The assessments of M&M, preventable/possibly preventable outcome, and outcome related to radiation therapy were determined only from departmentally required M&M reporting to the institutional Clinical Quality Improvement and Patient Safety office using a hospital-wide standardized reporting form.

The collected patient characteristics included age, sex, date of event, disease site and subsite, tumor histology, TMN stage, and anatomic stage/prognostic group.

Treatment details collected included intent of radiotherapy (curative or palliative); timing of treatment (neoadjuvant/adjuvant); modality (3D or IMRT); use and timing of systemic therapy and surgery; prescribed and completed radiation dose; and use of brachytherapy. Notably, 49 deaths were among patients receiving palliative care. And 69 deaths were among patients receiving 3D-CRT.

The study authors and Dr Russo have disclosed no relevant financial relationships.

American Society for Radiation Oncology (ASTRO) 2016 Annual Meeting. Abstract 1170. Presented September 28, 2016.

Follow Medscape senior journalist Nick Mulcahy on Twitter: @MulcahyNick

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