Early Death After Chemo in Public Health England Dataset

Kristin Jenkins

September 06, 2016

The first-ever analysis of Public Health England's dataset of all patients with breast or lung cancer who received systemic anticancer therapy (SACT) in 2014 identifies many factors, including age and general well-being, as contributors to 30-day mortality.

The study report was published online August 30 in The Lancet Oncology.

"Our data suggest that treatment intent, patient age, performance status, whether patients had received previous systemic anticancer treatments, and sex all affect 30-day mortality risk in this context," Michael Wallington, PhD, from Cancer Research UK in London, and colleagues report. "To our knowledge, this is the first time these benchmarks in 30-day mortality after SACT have been established on a national basis."

These benchmarks could support clinical decision-making as well as discussions with patients "to allow better informed decisions" about treatment, the researchers say.

Study Details

The population-based, observational study included data from 28,364 women with breast cancer and 15,045 men and women with non-small cell lung cancer (NSCLC) who received SACT in England between January 1 and December 31, 2014. All were 24 years of age or older.

Analysis showed that 30-day mortality increased with age for patients with breast cancer and patients with NSCLC when SACT was given with the intent to cure.

Conversely, the risk for early death decreased with age for all patients receiving palliative SACT (breast curative: odds ratio [OR], 1.085, P < .0001; NSCLC curative: OR, 1.045, P = .00033; breast palliative: OR, 0.987, P = .00034; and NSCLC palliative: OR, 0.987; P = .0015).

Patients with breast cancer or NSCLC with worse general well-being and a performance score (PS) of 2 to 4 had a 5% rate of 30-day mortality compared with the 3% seen in those who were generally well, with a PS of 0 (breast curative: OR, 6.057, P = .0021; breast palliative: OR, 6.241, P < .0001; NSCLC palliative: OR, 3.384, P < .0001).

The 30-day mortality was also higher for treatment-naive patients than for those who had any previous SACT between 2012 and 2014 (breast palliative: OR, 2.326; P < .0001; NSCLC curative: OR, 3.371; P < .0001; NSCLC palliative: OR, 2.667, P < .0001), the study showed.

The high mortality rate we report here is a concern Dr Michael Wallington et al

These data suggest that the 30-day mortality rate after SACT with curative intent for NSCLC may be high when compared with published trial data, the study authors note. "The high mortality rate we report here is a concern because it could reduce any benefit from this intervention."

While the 30-day mortality rate in patients with breast cancer younger than age 60 years receiving curative SACT is similar to estimates of the treatment-related mortality in patients of the same age enrolled in the UK TACT trial, this similarity in early mortality ended as the age of patients in this national cohort increased.

In patients aged 60 to 69 years and those 70 years and older, 30-day mortality was higher than in patients in the UK TACT trial, the researchers point out. "This cohort represents a large proportion of patients with breast cancer with higher mortality than is typically reported in clinical trials."

"Simply reducing doses of or avoiding SACT altogether would reduce or eliminate instances of treatment-related early mortality, but at the cost of some patients being denied effective SACT and hence the survival and palliation benefits. In order to maximise the benefits of systemic treatment, it is important to gain a detailed understanding of how many different factors affecting patients are linked to the increased risk of early mortality," commented coauthor David Dodwell, MD, professor at the Institute of Oncology, St James Hospital, Leeds, UK.

"Patient choice is an important factor in decisions about treatment and the factors we have identified may provide a focus of discussions about treatment between patients and their clinicians to allow better informed decisions," Dr Dodwell said in a statement.

Hospitals With High Mortality Rates

The report also pinpoints National Health Service (NHS) hospital trusts in excess of the 95% control limits for 30-day mortality rates. This finding should "promote review of clinical decision making in these hospitals," researchers say.

In all, the researchers identified seven hospitals with higher-than-expected mortality rates for curative breast cancer, four hospitals with high rates for palliative breast cancer, five with high rates for curative NSCLC, and seven hospitals with high rates for palliative NSCLC.

The authors say many reasons may explain why trusts are identified as outliers, including poor data management and poor clinical care or decision making, and they have written to all trusts to inform them of their 30-day mortality status, encouraging them to review their practices.

While the study authors acknowledge that the dataset included only patients who received SACT, they also say their findings "suggest that efforts need to be made to further study the factors affecting 30-day mortality in England with the objective of developing a clinical decision support tool."  

In an accompanying editorial, David Cameron, MD, from the Edinburgh Cancer Centre, Western General Hospital, UK, calls the national report "a welcome analysis."

He also notes that the report supports the 2008 UK/England National Confidential Enquiry into Patient Outcome and Death (NCEPOD), which revealed variations in care received by chemotherapy patients who died within 30 days of treatment.

However, Dr Cameron also expressed several concerns. Chief among these are the "significant gaps and deficiencies in the national dataset" that the analysis uncovered.

The finding that 80% of patients from a total of 27 hospitals appeared to die within 30 days of their first cycle of chemotherapy, for instance, "presumably relates to an inadequacy in reporting the full treatment rather than a genuine practice of giving only one cycle of treatment to most patients," he says.

What's more, it is "disappointing" that almost 10 years after the NCEPOD report, some hospitals continue to report high mortality rates, Dr Cameron comments.

"Rightly, the identities of the trusts were not published, but these findings raise the question of when patients should be informed if their local hospital has a consistently higher 30-day mortality that cannot otherwise be explained."

In Scotland, the National Quality Performance Indicator program already includes 30-day chemotherapy mortality data as part of a push to improve the safe delivery of systemic anticancer therapy delivery, he points out.

"To someone who has worked in the UK National Health Service their whole clinical life, it remains a tragedy that we still cannot get complete national (anonymised) datasets to inform clinicians and patients and to drive real improvements in patient care," he says.

In a statement, Jem Rashbass, MD, a study coauthor and Cancer Lead at Public Health England, commented that, "Public Health England's National Cancer Registration and Analysis Service will work with all trusts to help them understand the findings and the implications for their data collection and care."

The study was funded by Public Health England. Dr Wallington and many coauthors have disclosed no relevant financial relationships. Coauthor Michael Peake, MD, reports relationships with Roche Pharmaceuticals Ltd, Pierre Fabre Oncology Ltd, Eli Lilly, AstraZeneca, and Merck Sharp & Dohme, and coauthor Dr Rashbass reports grants from NHS England. Editorialist Dr Cameron has disclosed no relevant financial relationships.

Lancet Oncol. Published online August 30, 2016. Abstract Editorial

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