Adding temozolomide to radiation therapy improves survival in adult patients with slow-growing brain tumor, trial finds

Each radiation and temozolomide, a generic chemotherapy remedy in capsule kind, have significant single-modality anti-tumor exercise towards slow-growing, low-grade gliomas. The randomized part 3 trial E3F05 by the ECOG-ACRIN Most cancers Analysis Group (ECOG-ACRIN) examined whether or not mixed remedy utilizing temozolomide alongside radiation remedy is more practical than radiation remedy alone in these sufferers.

The trial adopted 172 sufferers for greater than 10 years, and its outcomes have a direct scientific influence by offering the primary proof from a randomized part 3 trial that temozolomide improves long-term survival for these sufferers.

“We discovered that the 10-year survival price was 70% with the mixed remedy with temozolomide chemotherapy and radiation, in comparison with 47% with radiation alone because the preliminary method. This discovery is vital as a result of till now, now we have not had compelling proof that temozolomide improves total survival in grade 2 gliomas,” stated lead investigator David Schiff, MD, the Harrison Distinguished Professor of Neurology, Neurological Surgical procedure and Drugs and co-director of the UVA Neuro-Oncology Middle on the College of Virginia.

Dr. Schiff introduced the placing outcomes as a late-breaking summary on the Society of Neuro-Oncology’s 2024 SNO Annual Assembly.

The E3F05 trial began in September 2009 and enrolled sufferers with low-grade gliomas who had not acquired prior radiation or chemotherapy remedy. Trial members had been randomized 1:1 to obtain both radiation alone (50.4 Gy in 28 fractions) or radiation (50.4 Gy) with temozolomide adopted by 12 four-week cycles of post-radiation temozolomide).

Accrual stopped 5 years later, in 2014, after one other cooperative group trial, RTOG 9802 reported profit from the addition of PCV chemotherapy to radiation in grade 2 gliomas. PCV is procarbazine (P), CCNU (C), which generically is named lomustine, and vincristine (V). By the point accrual stopped, 172 sufferers had enrolled in E3F05. The median age of the 172 members was 44 (vary 19–78), and 54% had been male.

“As a result of the RTOG 9802 trial was constructive for a profit from PCV chemotherapy, it was not moral to have a radiation-alone arm in E3F05, which is why our trial was closed to accrual. Although we couldn’t enroll the complete group as deliberate, after following all sufferers on the trial, outcomes reached statistical significance exhibiting the good thing about combined-modality temozolomide versus radiation alone,” stated Dr. Schiff.

The outcomes of this trial may have a direct scientific influence.

“Because the outcomes of RTOG 9802 got here out in 2014, sufferers with grade 2 glioma are routinely receiving radiation plus chemotherapy. Some are getting PCV as a result of that’s what RTOG confirmed was useful.

“Others are getting radiation plus temozolomide as a result of temozolomide is loads simpler for the oncologist to present and loads much less poisonous for sufferers to take, and it does not contain an intravenous infusion of vincristine. However till now, there actually was no supporting proof in grade 2 gliomas that temozolomide was useful,” stated Dr. Schiff.

Whereas grade 3 or greater toxicity was extra frequent in E3F05 trial members handled with temozolomide in comparison with radiation, toxicity was in step with prior research of temozolomide.

“There have been no sudden toxicities from the addition of temozolomide,” stated Dr. Schiff. “We noticed extra fatigue, gastrointestinal misery (nausea), and myelosuppression (thrombocytopenia, neutropenia, and so on.) however similar to what has been reported many, many instances.”

He added, “Importantly, the magnitude of survival profit from the addition of temozolomide was related in oligodendrogliomas and astrocytomas. This discovering stands in distinction to some uncontrolled and retrospective research suggesting that temozolomide could also be considerably much less efficient towards oligodendrogliomas than PCV.”

There may be extra to come back from E3F05. Pending correlative research are investigating the standard of life and neurocognitive knowledge collected from sufferers on each arms of the research, in addition to extra molecular analyses.

Offered by
ECOG-ACRIN Most cancers Analysis Group