Frail Patients with Gastroesophageal Cancer May Benefit from Low-Dose Chemotherapy Combination

A GO2 randomized phase 2 trial evaluating patients with advanced gastroesophageal cancer in the United Kingdom found that the lowest test dose of oxaliplatin (Eloxatin) and capecitabine (Xeloda) was comparable to the highest dose in terms of delaying disease progression and minimizing adverse effects. The study findings were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in an oral abstract session.

Attendees at the meeting learned that the trial was designed to find the optimum dose of capecitabine and oxaliplatin for use in older or frail patients. Factors and other assessments were incorporated in the tool, known as overall treatment utility (OTU).

The trial ran from 2014 to 2017, wherein investigators randomly assigned patients aged 51 to 96 years old to the 3 following dosage levels:

• Level A: 130 milligrams per meter squared of body surface area (mg/m²) of oxaliplatin given once every 21 days and a 625 mg/m² dose of capecitabine twice per day given continuously.
• Level B: 80% of level A dosage.
• Level C: Level C was 60% of level A dosage.

Patients with decreased kidney function received 75% of the suggested doses of capecitabine, according to the study.

According to the data, investigators found that the combination of oxaliplatin, a therapy that inhibits DNA replication, and capecitabine, a therapy that inhibits tumor cell division, was found to be more effective than capecitabine alone. Overall survival was comparable across doses: patients lived a median of 7.5 months at Level A dosages, 6.7 months for Level B, and 7.6 months for Level C.

Adverse effects of grade 3 or more, which can often be serious, were seen in 56% of patients getting Level A and B doses but were seen in only 37% of those getting Level C doses. Patients receiving Level C doses also had a higher percentage of good OTU scores (43%) compared with Levels A and B (35% and 36% respectively).

“We conclude that the low-dose treatment may be offered to patients who are suitable for chemotherapy, but considered either too frail or too elderly for a full dose standard regime and the confidence that it can produce superior outcomes without compromising cancer control or survival,” lead study author Peter Hall, PhD, a medical oncologist at the University of Edinburgh, said in an ASCO presscast about the results.

This GO2 trial is the third study in the United Kington to use OTU as a study outcome in older and frail patients. The investigators are working on sub-analyses of their findings.

Reference

Hall PS, Swinson D, Waters JS, et al. Optimizing chemotherapy for frail and elderly patients (pts) with advanced gastroesophageal cancer (aGOAC): The GO2 phase III trial. J Clin Oncol 37, 2019 (suppl; abstr 4006). Presented at: 2019 ASCO Annual Meeting . May 31-June 4, Chicago, Illinois.