May 21, 2019
By Megan Brooks
NEW YORK (Reuters Health) - In frail older adults with advanced gastroesophageal cancer, lower doses of oxaliplatin and capecitabine work as well at delaying disease progression as higher doses with less toxicity, according to results of the phase 3 GO2 trial.
"Previous trials of palliative chemotherapy for gastric and esophageal cancer have not included frail or older patients, therefore the benefit of chemotherapy in these groups was unknown," lead study author Dr. Peter Hall of the University of Edinburgh said in a statement.
"We hope our finding helps patients make a more informed choice, between low-dose chemotherapy and no chemotherapy at all, with the knowledge that that low-dose chemotherapy can prove beneficial and still allow them to maintain some quality of life while slowing the progression of the disease," he added.
In the GO2 trial, 514 frail patients (median age, 76) were randomly allocated to three dosage levels of oxaliplatin and capecitabine. Level A was 130 mg/m2 of oxaliplatin given once every 21 days and 625 mg/m2 of capecitabine twice a day given continuously. Level B was 80% of Level A dosage and Level C was 60% of Level A dosage.
Patients with decreased kidney function received 75% of the suggested doses of capecitabine. After nine weeks, patients were assessed for "overall treatment utility" (OTU), a composite of cancer control, tolerability, quality of life and patient satisfaction.
The lowest dose level was as clinically beneficial in terms of progression-free survival as the highest dose, with less toxicity, Dr. Hall reported at a press briefing May 15. He will present the findings June 2 at the American Society of Clinical Oncology annual meeting in Chicago.
Patients who received Level C dosages had fewer toxic reactions to the drugs and better OTU outcomes than their peers who received Levels A or B dosages. Level C produced the best OTU even in younger, less frail people and no group benefited more from higher dosage levels.
Overall survival was comparable across dosage groups. 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. Median progression-free survival was 4.9, 4.1 and 4.3 months, respectively.
Side effects of grade 3 or higher occurred in 56% of patients on Level A and B doses compared with 37% of patients on Level C doses. Level C patients also had a higher percentage of good OTU scores (43%) compared to Levels A and B (35% and 36% respectively).
In a statement, ASCO president and briefing moderator Dr. Monica Bertagnolli, said, "'Less is more' is becoming a common refrain in some areas of cancer treatment, and one that is paying off for patients' quality of life. This trial seeks to balance quality of life and increased survival for older and frail people receiving palliative treatment for gastroesophageal cancer, providing data that we sorely need for this patient population. These data are important because they provide a potential new option for patients to slow the progression of the disease."
"This is the kind of data that oncologists get excited about - being able to give more-tolerable treatments with comparable outcomes," said Dr. Nicholas Rohs, assistant professor of medicine, hematology and medical oncology at The Tisch Cancer Institute at Mount Sinai in New York, who wasn't involved in the study.
"A combination of capecitabine and oxaliplatin is a commonly used regimen in my clinic and to know that we can reduce doses, without sacrificing benefit, will allow me to give this therapy to more patients than before," he told Reuters Health by email.
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