- Although chemotherapy has been the standard first line of treatment for advanced non-small cell lung cancer, immunotherapy has recently emerged as a potentially more effective alternative.
- Clinical trial data suggest that cemiplimab, a type of immunotherapy, in combination with chemotherapy, can produce greater improvements in overall survival than chemotherapy alone.
- A phase 3 randomized clinical trial showed that the cemiplimab and chemotherapy combination also produced a greater reduction in pain symptoms and delayed the deterioration of symptoms and functions associated with quality of life than chemotherapy alone in non-small cell lung cancer patients.
The phase 3 EMPOWER-Lung 3 clinical trial had previously shown that cemiplimab in combination with chemotherapy is more effective than chemotherapy alone in enhancing survival outcomes in individuals with advanced non-small cell lung cancer.
Now, an analysis of patient-reported outcome data from the clinical trial demonstrates that the cemiplimab and chemotherapy combination can also reduce pain, shortness of breath, constipation, insomnia, and nausea compared to chemotherapy alone as well as delay the time to deterioration of symptoms.
The results were published in the journal Cancer.
“This study provides valuable evidence supporting the use of cemiplimab in combination with chemotherapy for the first-line treatment of advanced non-small cell lung cancer,” said Dr. Wael Harb, a hematologist and medical oncologist at MemorialCare Cancer Institute at Orange Coast Medical Center in California who was not involved in the study.
“The key takeaway is that this combination not only improves patients’ overall survival but also significantly enhances their quality of life,” he told Medical News Today. “This means that patients experienced fewer or less severe symptoms like pain, shortness of breath, and nausea. These results are important as they show that we can tackle cancer aggressively while still ensuring that patients maintain a good quality of life during treatment.”
Immunotherapy in non-small cell lung cancer
Lung cancer is the leading cause of death due to cancer in the United States. Non-small cell lung cancer is the most common type of lung cancer, accounting for 80 to 85 % of all lung cancer cases.
Advanced-stage cancer refers to tumors that have spread and thus cannot be surgically removed. Advanced-stage cancers generally have a poor prognosis and are unlikely to respond to treatments.
Conventionally, chemotherapy has been the standard initial or first line of treatment for advanced non-small cell lung cancer. However, chemotherapy has limited efficacy against advanced non-small cell lung cancers and is associated with severe adverse effects and development of resistance to chemotherapy.
More recently, immunotherapy has emerged as an effective treatment as a first-line treatment for advanced non-small cell lung cancer. Immunotherapy stimulates the body’s immune system to recognize cancer cells and eliminate them.
T cells in the immune system help to recognize cancer cells. Immune cells such as dendritic cells and macrophages present proteins from cancer cells to T cells and activate the T cell response.
T cells express the programmed cell death (PD-1) receptor, an immune checkpoint protein, on their surface. The PD-1 ligand (PD-L1), expressed by macrophages and dendritic cells, binds to the PD-1 receptor and prevents the activation of a T-cell response. However, tumor cells can also express PD-L1, thus avoiding their elimination by T cells.
Studies have shown that antibodies against PD1 or PD-L1 can improve T-cell response and clinical outcomes in people with cancer. Such immunotherapies are also effective as the first line of treatment against non-small cell lung cancer.
Quality of life
The randomized phase 3 clinical trial EMPOWER-Lung 3 previously demonstrated that a combination of cemiplimab, an antibody against PD-1, with chemotherapy produced greater improvements in overall survival and increased the period of time in the absence of disease progression compared with chemotherapy in the absence of immunotherapy.
The goal of treatment for individuals with advanced-stage disease is not only to prolong survival but also to improve the quality of life.
Symptoms of non-small cell lung cancer include pain, cough, and dyspnea that adversely impact a person’s quality of life.
Moreover, the use of a combination of multiple treatments can increase the potential for adverse effects, thus having a detrimental effect on the quality of life.
In the recent study, researchers used data from the EMPOWER-Lung 3 trial to compare the impact of cemiplimab in combination with chemotherapy on the quality of life of advanced non-small cell lung cancer patients with chemotherapy alone.
Details from the cancer immunotherapy study
The analysis consisted of 312 people assigned to the cemiplimab and chemotherapy combination and another 154 participants receiving placebo and chemotherapy aa a control group as first-line treatment for advanced non-small cell lung cancer.
The individuals in each group were administered either cemiplimab or a placebo every three weeks for up to 108 weeks each in combination with four cycles of chemotherapy.
The researchers used patient-reported outcomes to assess the impact of these treatments on quality of life.
These health outcomes are obtained directly from patients without being interpreted by a clinician. These patient-reported results are used by clinicians to facilitate individualized care and management of the patient’s condition.
The researchers administered questionnaires to the patients to assess patient-related outcomes. These questionnaires included the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), designed to assess the health-related quality of life of cancer patients as well as the QLQ-LC13 for evaluating the quality of life in lung cancer patients.
These questionnaires were administered at baseline, before each of the initial six treatments, and subsequently after every three cycles of treatment.
Based on responses to QLQ-C30 assessing health-related quality of life, the researchers found that patients receiving the cemiplimab and chemotherapy combination reported a greater reduction in pain during the trial than those in the control group.
The cemiplimab/ chemotherapy combination also increased the time to deterioration for symptoms such as pain, dyspnea, nausea, vomiting, and constipation, as well as physical and emotional functioning.
The researchers found no differences in improvements in lung cancer-specific symptoms in people treated with the cemiplimab/chemotherapy or placebo/chemotherapy combination.
However, the cemiplimab/chemotherapy combination delayed the time to deterioration for these symptoms, including coughing, sore mouth, hair loss, coughing up blood, and difficulty swallowing.
Strengths and limitations
Being a randomized controlled trial, the study’s results are significant. Harb said.
“A major strength of this study is that it used a large, diverse patient population, making the results more reliable and applicable to a broad range of patients. It also used internationally recognized measurement scales to assess patients’ quality of life, which makes the results easier to compare with other studies,” he said.
“However, there are a few limitations to consider. For example, the study compared patients’ quality of life scores to a pre-existing set of reference values. But these reference values might not perfectly match the experiences of all real-world lung cancer patients. So, while the results are promising, we have to be a bit cautious about applying them to every patient.” Harb added.
Given that cemiplimab activates the immune system, it can also lead to excessive activation of the immune system.
“The immune response is also an inflammatory response, and that correlates with the downside, which are the side effects that may happen with this type of medication, the inflammatory response could be strong and can affect other organs,” said Dr. Federico Albrecht, an oncologist/hematologist at Miami Cancer Institute, a part of Baptist Health in Florida.
“If that happens, that means we’re going to have to discontinue, but depending on the strength of that immune response, we can stop the immunotherapy transiently and then treat it with steroids,” he told Medical News Today. “However, most of the patients will be able to receive immunotherapy, cemiplimab again, to continue this therapy as long as the disease is controlled and stabilized.”
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