TY - JOUR
T1 - Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer
T2 - A Randomized Phase II ECOG-ACRIN Trial
AU - Stockton, Shannon
AU - Catalano, Paul
AU - Cohen, Steven J.
AU - Burtness, Barbara A.
AU - Mitchell, Edith P.
AU - Dotan, Efrat
AU - Lubner, Sam J.
AU - Kumar, Pankaj
AU - Mulcahy, Mary F.
AU - Fisher, George A.
AU - Crandall, Theodore L.
AU - Benson, Al
N1 - Publisher Copyright:
© 2023 The Author(s). Published by Oxford University Press.
PY - 2023/9
Y1 - 2023/9
N2 - 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).
AB - 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).
KW - esophageal
KW - gastroesophageal junction
KW - insulin-like growth factor-1 receptor
KW - xixutumumab
KW - Stomach Neoplasms/drug therapy
KW - Humans
KW - Esophageal Neoplasms/drug therapy
KW - Antibodies, Monoclonal, Humanized/therapeutic use
KW - Esophagogastric Junction/pathology
KW - Paclitaxel/adverse effects
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
UR - http://www.scopus.com/inward/record.url?scp=85172674343&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:000975658400001&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.1093/oncolo/oyad096
DO - 10.1093/oncolo/oyad096
M3 - Article
C2 - 37104870
SN - 1083-7159
VL - 28
SP - 827-e822
JO - Oncologist
JF - Oncologist
IS - 9
ER -