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Combined Chemotherapy and Radiation for Sarcomas Effective But Toxic: Presented at SSO

By Carole Bullock

CHICAGO -- March 19, 2008 -- Neoadjuvant chemotherapy plus radiation therapy for high-risk sarcomas, while effective, is a "highly toxic" regimen, researchers said here on March 15 at the Society of Surgical Oncology (SSO) 61st Annual Cancer Symposium. A dosing adjustment is recommended to ensure the effectiveness of this treatment's therapeutic role.

"This combined-modality treatment program can be delivered successfully," stated lead author William Kraybill, MD, Professor of Surgery and Vice-Chair of Surgery, University of Missouri, Kansas City, Missouri. "Survival outcomes in these high-risk sarcoma patients were quite impressive, but it is extraordinarily toxic, and a decreased dose and modification of treatment may be needed."

Dr. Kraybill reported on a 5-year follow-up of the 2006 Radiation Therapy Oncology Group (RTOG) study that tested 2 therapies: chemotherapy (CT) and radiation therapy (RT). Preoperative CT and all planned CT were completed for 78.1% and 56.3% of patients, respectively.

Estimated 5-year rates of disease-free survival were 56.1%, noted Dr. Kraybill. For distant disease-free survival and overall survival, the estimated 5-year rates were 64.1% and 71.2%, respectively.

The trial analysed 64 patients with high-grade soft-tissue sarcoma (8 cm in diameter) of the extremities and body wall. Patients were treated with 3 cycles of neoadjuvant CT (mesna, doxorubicin, ifosfamide, and dacarbazine) and preoperative RT (44 Gy administered in split courses), followed by 3 cycles of postoperative CT.

After approximately 8 years, 22 patients had died and 42 patients had survived (35 of whom had no recurrence post-treatment).

The 5-year rates of local-regional failure (including amputation) and distant metastasis were 22.2% (95% confidence interval [CI], 11.8, 32.6) and 28.1% (95% CI, 17, 39.2). The most common site of metastasis was the lung, and 6 patients experienced a second primary tumour in either the lung, neck, pancreas, or thigh, Dr. Kraybill noted

Three patients (4.7%) had grade 5 toxicities (2 myelodysplasia, 1 infection); 12 patients (18.8%) had grade 4 nonhaematologic toxicity.

Grade 3 and 2 delayed wound healing occurred in 3.3% and 9.8 % of patients, respectively.

Getting around the toxicity issue of this program may require newer radiation technology and less intensive CT for patients, Dr. Kraybill noted.

This study was funded by the RTOG.

[Presentation title: Updated Analysis of a Phase II Study of Neoadjuvant Chemotherapy and Radiation Therapy in the Management of High-Risk, High-Grade, Soft Tissue Sarcomas of the Extremities and Body Wall: Radiation Therapy Oncology Group Trial 9514. Abstract 50]

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