Abstract
10524 Background: Approximately 50% of pts with localized, >5 cm, high grade STS develop metastatic disease. Although controversial, adjuvant chemotherapy has demonstrated improved disease-free (DFS) and overall survival (OS). AI can cause significant toxicities that often lead to hospitalization. GT is active in metastatic STS pts and as compared to AI has a favorable schedule and toxicity profile. Methods: In a single-institution phase II study, pts with localized, resectable, high grade STS >5 cm were randomized to receive AI or GT. Pts were stratified by neo- or adjuvant treatment and extremity or non-extremity tumor. Pts received A (75 mg/m2 over 48 hrs) and I (2.5 g/m2/d on D1-3) or G (900 mg/m2 over 90 min on D1,8) and T (100 mg/m2 on D8), both arms with GCSF, for 4 cycles unless progression. Radiation was given after chemotherapy. The primary endpoint of the trial was hospitalization rate during chemotherapy and was compared using a chi square test and multiple logistic regression adjusting for other variables. The trial was powered to detect a reduction in hospitalization rate from 35% to 10% using GT. Survival functions were estimated using Kaplan-Meier method. Results: 84 pts were enrolled from 11/04-8/12 with 80 pts evaluable. The median age is 56 yrs (19-76) and tumor size is 7.8 cm (3.2-25). 55 pts received neoadjuvant therapy and 48 had extremity STS. In the AI arm, 13/37 (35%) pts were hospitalized vs. 11/43 (26%) in the GT arm (p=0.25). The most frequent reason for hospitalization in AI arm was febrile neutropenia (7 events) and in GT arm was hypersensitivity reaction (4 events). The median DFS of pts treated with AI vs GT is 24 months vs not reached, respectively; median follow up is 30 (1-87) months. The 2-year DFS rate is 53% (SD 9%) in the AI arm vs. 71% (SD 7%) in the GT arm and remains marginally significant after adjusting for age, gender, neoadjuvant therapy, tumor site and size (p=0.054). OS rates are not significantly different between arms. Conclusions: Hospitalization rate was not significantly lower with GT compared to AI, although toxicity profile was different. DFS but not OS is marginally improved with GT. Clinical trial information: NCT00189137.
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