trialsTrialCompleted

EORTC 62012

Adding ifosfamide to doxorubicin shrank more sarcomas and delayed progression but did not significantly lengthen life, so doxorubicin alone stayed the standard unless a tumour needs to shrink.

EORTC 62012 randomised 455 patients with previously untreated advanced soft tissue sarcoma to doxorubicin 75 mg/m2 alone or the same dose with ifosfamide 10 g/m2 and growth factor support. The combination improved objective response and progression-free survival at the cost of much greater haematological toxicity, but the primary endpoint of overall survival was not significantly improved. Published in Lancet Oncology in 2014, it is the reference for the first-line choice in advanced sarcoma: single-agent doxorubicin for palliation, the combination when response is needed, for example to make a tumour operable or relieve symptoms.

Setting

Advanced soft tissue sarcoma, first line: doxorubicin plus ifosfamide versus doxorubicin alone

Phase

Phase 3

Sponsor

EORTC

Registry

NCT00061984

Headline result

Median OS 14.3 vs 12.8 months (HR 0.83, not significant); median PFS 7.4 vs 4.6 months (HR 0.74).

Reported

2014

Enrolled

455

Outcomes

2top

In plain words

What these results mean for people, not percentages

455 people took part

Overall survival (median)primarysurvival endpoint

Median 14.3 vs 12.8 months with Doxorubicin + ifosfamide compared with Doxorubicin; about 1.5 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 17 percent lower chance of the event at any given time (hazard ratio 0.83, likely range 0.67 to 1.03).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Progression-free survival (median)surrogate endpoint

Median 7.4 vs 4.6 months with Doxorubicin + ifosfamide compared with Doxorubicin; about 2.8 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 26 percent lower chance of the event at any given time (hazard ratio 0.74, likely range 0.6 to 0.9).

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.

Caveats

These results apply to the people the trial enrolled: Advanced soft tissue sarcoma, first line: doxorubicin plus ifosfamide versus doxorubicin alone. 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.

455 participants enrolled.

Overall survival (median)primary

HR 0.83 (0.67 to 1.03) · p = 0.076

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Source

Progression-free survival (median)

HR 0.74 (0.6 to 0.9)

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Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Overall survival (median)primary	Doxorubicin + ifosfamide	-	14.3 months	0.83 (0.67 to 1.03)	0.076	link
Overall survival (median)primary	Doxorubicin	-	12.8 months	0.83 (0.67 to 1.03)	0.076	link
Progression-free survival (median)	Doxorubicin + ifosfamide	-	7.4 months	0.74 (0.6 to 0.9)	-	link
Progression-free survival (median)	Doxorubicin	-	4.6 months	0.74 (0.6 to 0.9)	-	link