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- Title
Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial.
- Authors
Stockton, Shannon; Catalano, Paul; Cohen, Steven J; Burtness, Barbara A; Mitchell, Edith P; Dotan, Efrat; Lubner, Sam J; Kumar, Pankaj; Mulcahy, Mary F; Fisher Jr., George A; Crandall, Theodore L; Benson, Al
- Abstract
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). Paclitaxel has been used for second-line treatment of esophageal cancer, with limited efficacy. Considering the preclinical evidence of synergy between paclitaxel and cixutumumab, this randomized phase II trial of paclitaxel (arm A) versus paclitaxel plus cixutumumab (arm B) was conducted.
- Subjects
THERAPEUTIC use of antineoplastic agents; DRUG efficacy; SOMATOMEDIN; COMBINATION drug therapy; CONFIDENCE intervals; DRUG tolerance; METASTASIS; RANDOMIZED controlled trials; TREATMENT effectiveness; DESCRIPTIVE statistics; PACLITAXEL; STATISTICAL sampling; PROGRESSION-free survival; ESOPHAGEAL tumors; OVERALL survival; EVALUATION
- Publication
Oncologist, 2023, Vol 28, Issue 9, p827
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1093/oncolo/oyad096