| Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. | |
| | |
MedLine Citation:
|
PMID: 22025154 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
PURPOSE: Patients with Ewing sarcoma (ES) with metastases and those who relapse fare poorly and receive therapies that carry significant toxicity. This phase 1/2 study was conducted to evaluate the efficacy of figitumumab in advanced ES. PATIENTS AND METHODS: Patients with sarcoma 10 to 18 years old were enrolled in two dose escalation cohorts (20 and 30 mg/Kg intravenously every 4 weeks) in the phase 1 portion of the study. Patients with ES 10 years old or older were enrolled in the phase 2 portion of the study. The primary phase 2 objective was objective response rate (ORR). RESULTS: Thirty-one patients with ES (n = 16), osteosarcoma (n = 11), or other sarcomas (n = 4) were enrolled in the phase 1 portion of the study. Dose escalation proceeded to 30 mg/kg every 4 weeks with no dose-limiting toxicity identified. In the phase 2 portion of the study, 107 patients with ES received figitumumab at 30 mg/kg every 4 weeks for a median of 2 cycles (range, 1 to 16). Sixty three percent of phase 2 patients had received at least three prior treatment regimens. Of 106 evaluable patients, 15 had a partial response (ORR, 14.2%) and 25 had stable disease. Median overall survival was 8.9 months. Importantly, patients with a pretreatment circulating free insulin-like growth factor (IGF) -1 lower than 0.65 ng/mL (n = 14) had a median OS of 3.6 months, whereas those with a baseline free IGF-1 ≥ 0.65 ng/mL (n = 84) had a median OS of 10.4 months (P < .001). CONCLUSION: Figitumumab had modest activity as single agent in advanced ES. A strong association between pretreatment serum IGF-1 and survival benefit was identified. |
| | |
Authors:
|
Heribert Juergens; Najat C Daw; Birgit Geoerger; Stefano Ferrari; Milena Villarroel; Isabelle Aerts; Jeremy Whelan; Uta Dirksen; Mary L Hixon; Donghua Yin; Tao Wang; Stephanie Green; Luisa Paccagnella; Antonio Gualberto |
Related Documents
:
|
19263154 - Video-assisted breast surgery can sample the second and third sentinel nodes to omit ax... 9800974 - Identification and biopsy of the sentinel lymph node in breast cancer. 20119674 - Pilot study of sentinel-node-based adoptive immunotherapy in advanced colorectal cancer. 18417434 - Prognostic factors of cutaneous melanoma in relation to metastasis at the sentinel lymp... 21162064 - Experimental study of radioimmunotherapy versus chemotherapy for colorectal cancer. 23543294 - A phase ii study evaluating the feasibility of a 5-week cycle of s-1 plus irinotecan (i... |
Publication Detail:
|
Type: Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Date: 2011-10-24 |
Journal Detail:
|
Title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology Volume: 29 ISSN: 1527-7755 ISO Abbreviation: J. Clin. Oncol. Publication Date: 2011 Dec |
Date Detail:
|
Created Date: 2011-11-30 Completed Date: 2012-01-13 Revised Date: 2013-02-19 |
Medline Journal Info:
|
Nlm Unique ID: 8309333 Medline TA: J Clin Oncol Country: United States |
Other Details:
|
Languages: eng Pagination: 4534-40 Citation Subset: IM |
Affiliation:
|
University Children's Hospital, Muenster, Germany. |
| Data Bank Information | |
Bank Name/Acc. No.:
|
ClinicalTrials.gov/NCT00560235 |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Adolescent Adult Antibodies, Monoclonal / adverse effects, therapeutic use* Antineoplastic Agents / adverse effects, therapeutic use* Bone Neoplasms / drug therapy* Female Humans Immunoglobulins, Intravenous Male Middle Aged Receptor, IGF Type 1 / blood, immunology* Recurrence Retreatment Sarcoma, Ewing / drug therapy* |
| Grant Support | |
ID/Acronym/Agency:
|
ES015704/ES/NIEHS NIH HHS |
| Chemical | |
Reg. No./Substance:
|
0/Antibodies, Monoclonal; 0/Antineoplastic Agents; 0/Immunoglobulins, Intravenous; 0/figitumumab; EC 2.7.10.1/Receptor, IGF Type 1 |
| Comments/Corrections | |
Comment In:
|
J Clin Oncol. 2011 Dec 1;29(34):4581-3
[PMID:
22025158
]
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: S0356: a phase II clinical and prospective molecular trial with oxaliplatin, fluorouracil, and exter...
Next Document: Randomized Phase II Study of Erlotinib in Combination With Placebo or R1507, a Monoclonal Antibody t...