Standard of Care for Soft Tissue Carcinoma

TON - November 2012, Vol 5, No 10 — November 15, 2012

Single-agent doxorubicin remains the standard of care as first-line treatment for unresectable or metastatic soft tissue sarcomas, according to results of a phase 3 trial conducted by EORTC and presented at the Presidential Symposium during the ESMO 2012 Congress (Abstract LBA7).2,3 This study is the latest in a string of trials attempting to improve outcomes with doxorubicin by adding other agents.

Soft-tissue sarcomas are a heterogeneous group of tumors that are relatively rare. Overall incidence is approximately 5 per 100,000, said Winette van der Graaf, MD, University of Nijmegen, the Netherlands. The complexity of the tumor types and the relative rarity of the tumors have made it challenging to conduct clinical trials, she added.

This study compared doxorubicin to doxorubicin/ifosfamide plus growth factor support in 455 patients aged 18 to 60 years with locally advanced or metastatic soft tissue sarcomas. This study used a higher dose of ifosfamide (10 g/m2 over 4 days with growth factor support) than previous studies that evaluated this combination.

Treatment was continued every 3 weeks for a maximum of 6 cycles or until the development of progressive disease. At a median follow-up of 56 months, there was no significant difference between the 2 treatment arms in overall survival (OS). Median OS was 14.3 months with the combination of doxorubicin/ifosfamide versus 12.8 months with doxorubicin alone; OS at 1 year was 60% and 51% for the 2 arms, respectively. Doxorubicin/ifosfamide achieved a longer progression-free survival: 7.4 months versus 4.6 months, respectively (P = .003), and higher overall response rates—26.5% versus 13.6%, re­spectively—but this came with a host of increased toxicity.

Based on these results, van der Graaf said that single-agent doxorubicin should remain the standard of care in the palliative setting. The combination might be useful for selected patients 60 years and younger with large tumors.

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