This article is more than 5 years old. Information may no longer be current.
Standard-dose radiation superior to high dose in stage III NSCLC
Click Here to Manage Email Alerts
Standard-dose radiotherapy extended survival and reduced treatment-associated deaths compared with high-dose radiotherapy among patients with stage III non–small cell lung cancer, according to results of a phase 3 study.
“Conventional thinking has been that if one can give higher-dose radiotherapy, that one can effectively kill the tumor better and, thus, prolong survival,” Jeffrey D. Bradley, MD, professor of radiation oncology at Washington University School of Medicine in St. Louis, said during a press conference held to highlight several studies that will be presented at the ASCO Annual Meeting. “This phase 3 trial was designed to test this hypothesis.”
The researchers randomly assigned 464 patients to standard-dose radiotherapy (60 Gy) or high-dose radiotherapy (74 Gy). Patients in both arms also underwent treatment with standard chemotherapy with paclitaxel and carboplatin. Patients in each arm then were randomly assigned to receive cetuximab (Erbitux, Eli Lilly) or no additional treatment.
Researchers halted treatment in the high-dose radiotherapy arm after results of an interim analysis showed standard-dose therapy yielded better outcomes.
Median survival among patients in the standard-dose arm was 28.7 months compared with 19.5 months among patients in the high-dose arm.
At 18 months, estimated OS was 67% in the standard-dose arm vs. 54% in the high-dose arm. Patients in the high-dose arm had higher rates of local recurrence (34% vs. 25%) and distant recurrence (44% vs. 35%). More treatment-associated deaths occurred in the higher-dose arm (10 vs. two).
Data related to cetuximab’s effect on survival will be reported at a later date, researchers said.
“Patients in the high-dose arm had a 56% greater risk for death than patients in the standard-dose arm, and there was a 37% increased risk for developing local progression in the high-dose arm,” Bradley said. “At this point, there is no clear reason for the poorer outcome we experienced in the high-dose arm. Possible explanations are increased heart dose, extended therapy duration, unreported toxicity or a combination of these factors.”
For more information:
Bradley JD. Abstract #7501. Scheduled for presentation at: ASCO Annual Meeting; May 31-June 4, 2013; Chicago.
Disclosure: The research was supported by NCI and Eli Lilly.