What question did this study set out to answer?

To evaluate the safety and efficacy of combining the IGF-1R monoclonal antibody cixutumumab and the mTOR inhibitor temsirolimus in chemotherapy-refractory bone and soft-tissue sarcomas stratified by IGF-1R expression.

March 8, 2013The Lancet OncologyOpen Access

Cixutumumab and temsirolimus for patients with bone and soft-tissue sarcoma: a multicentre, open-label, phase 2 trial

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Authors

GSGary K. SchwartzRutgers, The State University of New Jersey WTWilliam D. TapMemorial Sloan Kettering Cancer Center LQLi-Xuan QinMemorial Sloan Kettering Cancer Center

Discussion

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Implication

Randomized trial reveals modest progression-free survival with cixutumumab and temsirolimus in refractory sarcoma, indicating clinical activity independent of IGF-1R expression.

Key Points

To evaluate the safety and efficacy of combining the IGF-1R monoclonal antibody cixutumumab and the mTOR inhibitor temsirolimus in chemotherapy-refractory bone and soft-tissue sarcomas stratified by IGF-1R expression.
Multicentre, open-label, phase 2 trial conducted across 19 cancer centres in the USA using a Simon optimal two-stage design (NCT01016015).
A total of 388 patients were screened and allocated by immunohistochemistry into three groups: IGF-1R-positive soft-tissue sarcoma (n=57), IGF-1R-positive bone sarcoma (n=54), and IGF-1R-negative sarcoma (n=63).
Patients received weekly intravenous cixutumumab (6 mg/kg) and temsirolimus (25 mg flat dose) in 6-week cycles, with 12-week progression-free survival (PFS) evaluated in the first 54 patients per arm.
Progression-free survival at 12 weeks was 31% (17/54; 90% CI 21–43; one-sided 95% CI lower bound 21%) in IGF-1R-positive soft-tissue sarcoma, 35% (19/54; 90% CI 24–47; one-sided 95% CI lower bound 24%) in IGF-1R-positive bone sarcoma, and 39% (21/54; 90% CI 28–51; one-sided 95% CI lower bound 28%) in IGF-1R-negative sarcomas.
Out of 2546 reported adverse events across 174 treated patients, 214 (8%) were grade 3–4 toxicities, most commonly lymphopenia (14%, n=25), oral mucositis (11%, n=19), thrombocytopenia (11%, n=19), hyperglycemia (10%, n=18), anemia (9%, n=16), and hypophosphatemia (9%, n=16).

Cite This Study

Schwartz et al. (2013) studied this question.

synapsesocial.com/papers/6a0cc4559d761985b14a45fb https://doi.org/10.1016/s1470-2045(13)70049-4

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Implication

Randomized trial reveals modest progression-free survival with cixutumumab and temsirolimus in refractory sarcoma, indicating clinical activity independent of IGF-1R expression.

Cixutumumab and temsirolimus for patients with bone and soft-tissue sarcoma: a multicentre, open-label, phase 2 trial

Discussion

Member takes

Implication

Key Points

Cite This Study

Cixutumumab and temsirolimus for patients with bone and soft-tissue sarcoma: a multicentre, open-label, phase 2 trial

Discussion

Member takes

Implication

Key Points

Cite This Study

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