title: Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide.
abstract: This multicenter, phase II trial evaluated the efficacy and safety of everolimus, an mTOR inhibitor, in patients with metastatic or recurrent bone and soft-tissue sarcoma after the failure of anthracycline- and ifosfamide-containing regimens. Everolimus was administered orally as 10 mg once daily. The primary endpoint was the progression-free rate (PFR) at 16 weeks, assessed by computed tomography scan according to RECIST v1.0. Between July 2010 and May 2011, 41 patients were enrolled in this study. Among them, 83% received two or more regimens of chemotherapy prior to study entry. In 38 patients who the primary endpoint was evaluable, 11 patients reached 16 weeks progression-free (one with partial response and 10 with stable disease), indicating a PFR at 16 weeks of 27% (95% confidence interval [CI], 16-42%). The PFR at 16 weeks was highest in patients with angiosarcoma (2 of 3, 67%). With a median follow-up of 10.9 months (range, 2.3-23.9 months) in living patients, the median progression-free survival was 1.9 months (95% CI, 1.3-2.4 months) and the median overall survival was 5.8 months (95% CI, 3.6-8.0 months). Most adverse events were generally mild and tolerable. Grade 3/4 toxicities included hyperglycemia (15%), stomatitis (7%), pain (5%), and asthenia (5%). Everolimus shows modest antitumor activity with manageable toxicities in heavily pretreated patients with bone and soft-tissue sarcoma.
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea, 138-736.
authors.forename: Changhoon
authors.initials: C
authors.lastname: Yoo
authors.forename: Jeeyun
authors.initials: J
authors.lastname: Lee
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Rha
authors.forename: Kyong Hwa
authors.initials: KH
authors.lastname: Park
authors.forename: Tae Min
authors.initials: TM
authors.lastname: Kim
authors.forename: Yu Jung
authors.initials: YJ
authors.lastname: Kim
authors.forename: Hyo Jin
authors.initials: HJ
authors.lastname: Lee
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Jin-Hee
authors.initials: JH
authors.lastname: Ahn
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy*; D000068338:Everolimus; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D012509:Sarcoma / Q000000981:diagnostic imaging / Q000188:drug therapy*; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012983:Soft Tissue Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D000068338:Everolimus; D007069:Ifosfamide; D020123:Sirolimus
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