Phase II Trial of Doxorubicin Plus Escalated High-Dose Ifosfamide in Patients With Advanced Soft Tissue Sarcomas of the Adult: A Study of the Spanish Group for Research on Sarcomas (GEIS)
2006

High-Dose Ifosfamide and Doxorubicin for Advanced Soft Tissue Sarcomas

Sample size: 70 publication Evidence: moderate

Author Information

Author(s): A. López-Pousa, J. Martín, J. Montalar, R. de las Peñas, J. García del Muro, J. Cruz, J. Maurel, P. Escudero, A. Casado, J. M. Buesa

Primary Institution: Spanish Group for Research on Sarcomas (GEIS)

Hypothesis

To explore the tolerance and the activity of high-dose ifosfamide combined with doxorubicin in patients with soft tissue sarcomas.

Conclusion

The combination of doxorubicin and high-dose ifosfamide was tolerated by 71% of patients, but resulted in substantial toxicity.

Supporting Evidence

  • 71% of patients tolerated at least 4 cycles of treatment.
  • 54% of patients experienced febrile neutropenia.
  • The overall activity rate was 42% among assessable patients.

Takeaway

Doctors tested a new treatment for a type of cancer, and while many patients could handle it, a lot of them got very sick.

Methodology

Patients received doxorubicin and ifosfamide, with the ifosfamide dose adjusted based on toxicity, over a series of cycles.

Limitations

The study had a high rate of toxicity leading to treatment abandonment and three toxic deaths.

Participant Demographics

{"total":71,"male":29,"female":42,"median_age":55,"age_range":"22-65"}

Statistical Information

Confidence Interval

95% CI, 32 to 58%

Digital Object Identifier (DOI)

10.1155/SRCM/2006/26986

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