Influence of Acetaminophen on Treatment Outcomes in Advanced Non-Small Cell Lung Cancer Pooled Data Analyses from Five Randomized Control Trials of First-Line Atezolizumab

Lead Investigator: Kazuki Takada, Saiseikai Fukuoka General Hospital, Fukuoka, Japan
Title of Proposal Research: Influence of Acetaminophen on Treatment Outcomes in Advanced Non-Small Cell Lung Cancer Pooled Data Analyses from Five Randomized Control Trials of First-Line Atezolizumab
Vivli Data Request: 9275
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

The probability of a person developing lung cancer in their lifetime is around 1 in 15 to 17, establishing lung cancer as a principal cause of deaths related to cancer. Non-small cell lung cancer (NSCLC) is the most common form, comprising 85% of all diagnosed lung cancer cases. Within NSCLC, the most frequent histological subtypes are adenocarcinoma (which develops in the glands) and squamous cell carcinoma (which develops as growth cells on the skin), constituting 50% and 30% of cases, respectively. The evolution of immunotherapy (a type of cancer treatment using the patient’s own immune system to fight cancer cells) specifically immune checkpoint inhibitors (ICIs) like atezolizumab, that stop tumors from evading white blood cells and stimulate an immune response against the tumor cells, has introduced promising treatment avenues for these patients.

In recent years, it has been frequently reported that the drugs being used in combination with immunotherapy for malignant tumors are affecting the efficacy of ICI treatments. Acetaminophen is a medication that is commonly used in clinical settings, a type of fever reducer and pain reliever, is often used for pain control in cancer treatment and it has been previously reported to weaken vaccine effects. Furthermore, recent reports have suggested the possibility that the use of acetaminophen may reduce the effectiveness of ICI treatments, and that the effects of combined chemotherapy and immunotherapy prior to surgery may be diminished. However, the impact of acetaminophen use on the efficacy of ICI treatments in patients with advanced NSCLC is not clear.

Patients receiving ICI treatment sometimes take acetaminophen concurrently for symptom management. Understanding the interaction between acetaminophen and ICI treatment outcomes is thus crucial.
The purpose of this study is to examine the impact of acetaminophen use on the therapeutic outcomes in patients with advanced NSCLC treated with first-line atezolizumab.

Requested Studies:

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367794
Sponsor ID: GO29437

A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367781
Sponsor ID: GO29537

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02366143
Sponsor ID: GO29436

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02657434
Sponsor ID: GO29438

A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02409342
Sponsor ID: GO29431