Real-world data sets benchmark in ALCL as new therapies are adopted

Blood cancers

By Emma Wilkinson

4 Jun 2021

An analysis of real-world patient outcomes in treatment for anaplastic large cell lymphoma (sALCL) has shown the importance of assessing care outside clinical trials, say researchers.

The retrospective study of 214 patients treated at seven centres in Australia and the UK found inferior time to treatment failure with standard CHOP (cyclophosphamide, adriamycin, vincristine, prednisolone) regimens when compared to data from the 2019 practise-changing ECHELON-2 study.

It is one of the largest observational studies in sALCL and will “serve as a robust benchmark” as the new treatment standard of brentuximab-vedotin plus cyclophosphamide, doxorubicin, and prednisone BV-CHP is adopted in routine care, the team of researchers concluded.

The beneficial effect of the BV-CHP regimen over CHOP, as reported by ECHELON-2, is likely to be corroborated in patients in the routine setting but the real-world data suggests some degree of patient selection in the trials, they wrote in Advances in Therapy.

Data from patients treated before the approval of BV-CHP, showed that for CHOP-treated patients overall response rate was 65% and complete response 47%.

After 57 months of median follow-up, four-year time to treatment failure and overall survival were 41.2% and 58.9%, respectively.

The analysis confirmed that ALK-status is a strong and independent predictor of outcome with and ALK-positive disease independently associated with superior time to treatment failure.

They also reported results from 52 patients who received BV after relapse with three-year time to treatment failure and overall survival of 29.7% and 40.2%.

Comparing the real-world outcomes with the patients in the CHOP arm of the ECHELON- 2 trial, three-year time to treatment failure was 43.8% vs 49%, the researchers reported.

This was despite the ‘real-world’ CHOP-treated patients being younger (52 years vs 58 years), with a higher proportion of ALK-positive patients (45% vs 22%) and more early-stage I/II disease (38% vs 20%).

Only 9% of patients underwent autologous stem cell transplant after frontline therapy despite being frequently recommended in guidelines which probably reflects the uncertainty around the evidence of this approach, they said.

There was also a minority of patients who received best supportive care from the outset, suggesting there is a need for novel, low-toxicity and efficacious agents for this group.

“The present results highlight some degree of patient selection in the pivotal BV trials in the relapsed and front-line setting and serve as an appropriate benchmark for the comparison of patient outcomes treated with frontline BV-CHP,” the researchers concluded.

“Further research to gather real-world evidence of BV-CHP combination will be desirable.”

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