Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial

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

Research output: Contribution to journalArticlepeer-review

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).

Original languageEnglish
Pages (from-to)827-e822
JournalOncologist
Volume28
Issue number9
DOIs
StatePublished - Sep 2023

Keywords

  • esophageal
  • gastroesophageal junction
  • insulin-like growth factor-1 receptor
  • xixutumumab
  • Stomach Neoplasms/drug therapy
  • Humans
  • Esophageal Neoplasms/drug therapy
  • Antibodies, Monoclonal, Humanized/therapeutic use
  • Esophagogastric Junction/pathology
  • Paclitaxel/adverse effects
  • Antineoplastic Combined Chemotherapy Protocols/adverse effects

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