Updated December 20th, 2023

Lung Cancer Drug Tagrisso Shows Real Benefit For Early Stage Lung Cancer Patients With EGFR Mutation

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TAGRISSO For Early Stage Lung Cancer Patients

TAGRISSO is an FDA approved drug for the treatment of advanced lung cancer patients with specific gene mutations.
A blind clinical trial found that an impressive 80% of early stage lung cancer patients who took TAGRISSO three years after surgery and chemotherapy did not relapse.
There is no concrete evidence yet whether early stage lung cancer patients’ overall survival rate improves when taking TAGRISSO, which has sparked debates among lung cancer experts.

A historic new treatment option for early stage lung cancer patients with epidermal growth factor receptor (EGFR mutations) may be underway, as clinical trials testing Osimertinib (brand name TAGRISSO) have made promising new discoveries. However, an expert tells SurvivorNet that questions surrounding overall survival rates have sparked a heated debate among oncologists.

TAGRISSO was initially approved by the Food and Drug Administration (FDA) in 2018 for the treatment of stage 4 lung cancer patients with EGFR mutations. EGFR is a protein that is present on the surface of lung cancer cells, and if mutated, cannot properly regulate cell growth. TAGRISSO specifically targets and blocks EGFR mutations found on the cancer cells. The gene mutation is present in around 15% of white and African-American patients and up to 50% in patients of East-Asian descent.

In a blind clinical trial with over 600 participants, researchers found that early stage lung cancer patients with EGFR mutations, who take the drug for three years after surgery and adjuvent chemotherapy (chemo given after surgery), are at significant less risk of the disease returning.

“Eighty percent of the patients who received [TAGRISSO] had not relapsed, and had not died of recurrent cancer after three years,” says Dr. Ronald Natale, the Director of the Lung Cancer Clinical Research Program at Cedars-Sinai Medical Center, and one of the researchers on the TAGRISSO clinical trial. “Where as, the percentage of the patients who received chemotherapy alone was 28%. That’s a huge difference. One of the biggest differences we’ve ever seen.”

Side effects of TAGRISSO are relatively mild, and Dr. Natale says that there were no significant difference in side effects for early stage lung cancer patients compared to advanced stage patients during the study. Side effects of the drug typically include mild skin rashes and mild fatigue.

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Controversy Over Survival Rate

While the preliminary findings are promising, Dr. Natale points out there’s been a strong debate among oncologists in regards to TAGRISSO affecting patients’ overall survival rate. For advanced stage lung cancer patients, the drug has proven to have good response rates and improved overall survivor. However, in these clinical trials, there’s has been little evidence to suggest that survival rate for early stage lung cancer patients will improve significantly.

“In the end, the overall survival may not be much different,” Dr. Natale says. “Or it may only slightly favor the early use of [TAGRISSO]. That remains to be seen. It’s probably going to take a couple of more years of following the patients to get the final answer regarding overall survival rate. That’s where there’s some controversy among lung cancer experts regarding the value of this data. Everyone admits that the differences in the outcomes at this first endpoint is really very impressive, but they also recognize that the impact of overall survival is a more important endpoint so for a couple of years we’re either going to be treading water or left with the quandary of ‘what do we do with our patients?'”

In addition to the question of overall survival rate, researchers also have to factor in costs associated with TAGRISSO, which Dr. Natale says can total up to $250,000 a year. Taking that into account, along with the fact that patients involved in the study took TAGRISSO for three years, the medication might be extremely costly to both healthcare professionals and patients, especially if some patients are forced to pay out of pocket.

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“There’s no question that the overall survival rate outcome is going to be important to help us sort out whether or not we should use this, and for a couple of years there’s going to be a lot of discussion among people who are going to fall on both sides of this issue,” Dr. Natale says. “Some are going to feel strongly that we should wait, and not spend the enormous amount of money [and] expose patients to the side effects until we know for sure that it improves overall survival. Others are going to say ‘why wait? This drug is better than the previous drugs we’ve used so why not use it now while we’re treading water waiting on overall survival?'”

Note: Dr. Natale discloses that wife works for TAGRISSO manufacturer, AstraZeneca, but this clinical trial was conducted separately and was not impacted by his wife’s work.

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