Erschienen in:
24.01.2019 | Sarcoma
Window-of-Opportunity Trials: The Road Forward in Soft Tissue Sarcoma and Beyond
verfasst von:
Emily Z. Keung, MD, Christina L. Roland, MD, MS
Erschienen in:
Annals of Surgical Oncology
|
Ausgabe 5/2019
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Excerpt
In this issue of
Annals of Surgical Oncology, Ronellenfitsch et al.
1 report the results of a single-arm, phase II window-of-opportunity (WOO) study of preoperative pazopanib in patients with high-risk soft tissue sarcoma (STS). Treatment-naïve patients with localized, resectable, intermediate- or high-grade STS at least 5 cm in size were eligible to receive neoadjuvant pazopanib 800 mg for 21 days, followed by surgery 7–14 days after the last dose. The primary endpoint of the study was to evaluate the metabolic response rate (MRR), defined as a ≥ 50% reduction in mean standardized uptake value (SUV) of tumor areas between baseline and post-treatment [18F]-fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT). Twenty-one of the target 35 patients were enrolled prior to study termination based on the results of a planned futility analysis. Of 17 evaluable patients, one patient achieved a ≥ 50% reduction in mean SUV [MRR 5.9%, 95% confidence interval (CI) < 0.01–0.29]. It is also important to note that preoperative pazopanib did not appear to negatively impact tumor resectability, quality of resection, or perioperative outcomes. Most patients enrolled (19/21) underwent planned resection, all with negative margins, and with an acceptable profile of treatment-related toxicities (7/21 patients, 33.3% with grade 3 or 4) and postoperative complications (1 patient, grade 4). …
