SIDEBAR: Trials’ Shortcomings Leave Role of Induction Chemotherapy Unclear

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Given certain shortcomings of the DeCIDE and PARADIGM trials, the true role of induction chemotherapy in head and neck cancer is still not clear, said George R. Blumenschein, Jr, MD, Associate Professor at The Unviersity of Texas MD Anderson Cancer Center, Houston, at the Best of ASCO San Diego meeting.

Studies Underpowered

Both trials suffered from “lower than anticipated accrual,” he said. “These studies were both underpowered for what they were trying to achieve. They didn’t meet complete accrual, so it’s very difficult to make definitive conclusions about the presented data. Since these studies did not meet their proposed enrollment, they were ultimately underpowered to answer their proposed primary endpoints.”

In addition, both were affected by better-than-expected outcomes in the control arms given chemoradiation alone. And DeCIDE used just two cycles of induction chemotherapy, when typical practice is to give three or even four.

If designed today, the trials would likely have greater standardization of chemoradiation to permit fair comparisons and would take tumor HPV status into account, as it is now recognized to be a major determinant of outcome in head and neck cancer, and approximately two-thirds of oropharynx tumors today are HPV-positive, according to Dr. Blumenschein.

Concurrent Chemoradiotherapy Still Standard of Care

“The role of induction chemotherapy has not been validated by these trials. When we look at these two head-to-head trials, we don’t see a clear-cut improvement in terms of induction chemotherapy followed by concurrent chemoradiotherapy, vs concurrent chemoradiotherapy. So concurrent chemoradiotherapy is still the standard of care,” he concluded.

However, he added, “I think induction chemotherapy may have a role, potentially in patients who have a higher risk for recurrence—N2c/N3 disease, patients who have level 4 lymph nodes.” ■

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