In metastatic esophageal/gastroesophageal junction (GEJ) cancer, the addition of cixutumumab to paclitaxel does not improve outcomes vs paclitaxel alone, according to results published in The Oncologist.

In a phase 2 trial, the median progression-free survival (PFS) and overall survival (OS) were similar in previously treated patients who received the combination and those who received paclitaxel monotherapy.

The trial ( Identifier: NCT01142388) enrolled 94 patients, 87 of whom were included in efficacy analyses. Patients had a median age of 62 years (range, 40-89), and most had an ECOG performance status of 0 or 1. Adenocarcinoma was the most common cancer type.

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Patients were randomly assigned to receive paclitaxel (80 mg/m2) alone or in combination with cixutumumab (10 mg/kg) in 28-day cycles, with CT scans every 2 cycles. The median duration of treatment in each study arm was 2 cycles.

In the intention-to-treat analysis, the median PFS was similar between the 2 arms, at 2.6 months in the paclitaxel-only arm and 2.3 months in the combination arm (P =.086).

There was also no significant difference in median OS, at 6.7 months for the paclitaxel-only arm and 7.2 months for the combination arm (P =.56).

Overall response rates were 11.6% with paclitaxel monotherapy and 13.7% for the combination. One complete response was reported, in a patient in the combination arm. There were 5 partial responses reported in each arm.

In a safety analysis of 84 patients, toxicities of grade 3 or higher were reported in 53% of patients in the paclitaxel-only arm and 52% of patients in the combination arm. Grade 5 adverse events deemed related to treatment were reported in 1 patient in each arm.

“Despite the study treatment being relatively well-tolerated, we did not find meaningful clinical benefit from adding cixutumumab to paclitaxel in this patient population,” the researchers concluded.

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


Stockton S, Catalano P, Cohen SJ, et al. Paclitaxel with or without cixutumumab as second-line treatment of metastatic esophageal or gastroesophageal junction cancer: A randomized phase II ECOG-ACRIN trial. Oncologist. Published online April 27, 2023. doi:10.1093/oncolo/oyad096