Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial
| Autor: | Shannon Stockton, Paul Catalano, Steven J Cohen, Barbara A Burtness, Edith P Mitchell, Efrat Dotan, Sam J Lubner, Pankaj Kumar, Mary F Mulcahy, George A Fisher, Theodore L Crandall, Al Benson |
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| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | The Oncologist. |
| ISSN: | 1549-490X 1083-7159 |
| Popis: | Background Patients with advanced esophageal cancer carry poor prognoses; limited data exist to guide second-line therapy in the metastatic setting. Paclitaxel has been used yet is associated with limited efficacy. There is preclinical evidence of synergy between paclitaxel and cixutumumab, a monoclonal antibody targeting insulin-like growth factor-1 receptor. We conducted a randomized phase II trial of paclitaxel (arm A) versus paclitaxel plus cixutumumab (arm B) in the second-line for patients with metastatic esophageal or gastroesophageal junction (GEJ) cancers. Methods The primary endpoint was progression-free survival (PFS); 87 patients (43 in arm A, 44 in arm B) were treated. Results Median PFS was 2.6 months in arm A [90% CL 1.8-3.5] and 2.3 months in arm B [90% 2.0-3.5], P = .86. Stable disease was observed in 29 (33%) patients. Objective response rates for Arms A and B were 12% [90% CI, 5-23%] and 14% [90% CI, 6-25%]. Median overall survival was 6.7 months [90% CL 4.9-9.5] in arm A and 7.2 months [90% CL 4.9-8.1] in arm B, P = 56. Conclusion The addition of cixutumumab to paclitaxel in second-line therapy of metastatic esophageal/GEJ cancer was well tolerated but did not improve clinical outcomes relative to standard of care (ClinicalTrials.gov Identifier: NCT01142388). |
| Databáze: | OpenAIRE |
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