trialsTrialPositive

LMS-04

In leiomyosarcoma, adding trabectedin to doxorubicin roughly doubled the time the disease stayed controlled, the first randomised first-line gain in this sarcoma in decades.

LMS-04 randomised 150 patients with metastatic or unresectable uterine or soft tissue leiomyosarcoma to six cycles of doxorubicin plus trabectedin followed by trabectedin maintenance, or doxorubicin alone. Median progression-free survival was 12.2 months with the combination versus 6.2 months with doxorubicin (hazard ratio 0.41), with more haematological toxicity, and later follow-up also reported improved overall survival. Published in Lancet Oncology in 2022, it established doxorubicin plus trabectedin as a first-line standard for fit patients with leiomyosarcoma and as the model for histology-specific sarcoma trials.

Setting

Metastatic or unresectable leiomyosarcoma, first line: doxorubicin plus trabectedin (then trabectedin maintenance) versus doxorubicin

Phase

Phase 3

Sponsor

French Sarcoma Group / Centre Leon Berard

Registry

NCT02997358

Headline result

Median PFS 12.2 vs 6.2 months (HR 0.41); overall survival also favoured the combination at later follow-up.

Reported

2022

Enrolled

150

Outcomes

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In plain words

What these results mean for people, not percentages

150 people took part

Progression-free survival (median)primarysurrogate endpoint

Median 12.2 vs 6.2 months with Doxorubicin + trabectedin compared with Doxorubicin; about 6 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 59 percent lower chance of the event at any given time (hazard ratio 0.41, likely range 0.29 to 0.58).

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
These results apply to the people the trial enrolled: Metastatic or unresectable leiomyosarcoma, first line: doxorubicin plus trabectedin (then trabectedin maintenance) versus doxorubicin. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

150 participants enrolled.

Progression-free survival (median)primary

HR 0.41 (0.29 to 0.58) · p <0.0001

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Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Progression-free survival (median)primary	Doxorubicin + trabectedin	-	12.2 months	0.41 (0.29 to 0.58)	<0.0001	link
Progression-free survival (median)primary	Doxorubicin	-	6.2 months	0.41 (0.29 to 0.58)	<0.0001	link