HealthDay News — Artificial intelligence (AI)-based computer-aided detection (CAD) software improves the detection of actionable lung nodules on chest radiographs, without increased false-referral rates, according to a study published online February 7 in Radiology.

Ju Gang Nam, MD, PhD, from the Artificial Intelligence Collaborative Network at the Seoul National University Hospital and College of Medicine in South Korea, and colleagues examined whether commercial AI-based CAD software can improve the detection rate of actionable lung nodules on chest radiographs in a single-center study. Participants who underwent chest radiography between July 2020 and December 2021 were enrolled and randomly assigned into an AI group and non-AI (control) group (5238 to each group). Each radiograph was interpreted by one of three radiologists with 13 to 36 years of experience.

The researchers found that the trial met the predefined primary outcome, with an improved detection rate of actionable nodules in the AI vs non-AI group (0.59 vs 0.25%; odds ratio, 2.4). For malignant lung nodules, the detection rate was higher in the AI than non-AI group (0.15 vs 0.0%). Similar false-referral rates were seen for the AI and non-AI groups (45.9 vs 56.0%); positive-report rates were also similar between the groups (2.3 vs 1.9%).

“The improved detection rate of actionable lung nodules with a similar false-referral rate suggests that using AI-based CAD may improve lung cancer diagnosis without imposing an additional radiation hazard,” the authors write.

Several authors disclosed financial ties to the medical device industry.

Abstract/Full Text

Editorial

The approval was based on data from the randomized, active-controlled, open-label, phase 3 ALINA study (ClinicalTrials.gov Identifier: NCT03456076), which evaluated the efficacy and safety of alectinib in 257 adults with ALK-positive NSCLC (tumors ≥4cm or node positive) following complete tumor resection. Study participants were randomly assigned 1:1 to receive either alectinib 600mg orally twice daily or platinum-based chemotherapy.

The major efficacy outcome measures were disease-free survival (DFS) in patients with stage II-IIIA NSCLC and in patients with stage IB-IIIA NSCLC (intent-to-treat [ITT] population). DFS was defined as the time from date of randomization to the date of occurrence of any of the following: first documented recurrence of disease, new primary NSCLC, or death due to any cause, whichever occurred first. 

Results showed treatment with alectinib reduced the risk of disease recurrence or death by 76% in the ITT population compared with chemotherapy (hazard ratio [HR], 0.24; 95% CI, 0.13-0.43; P <.0001). Median DFS was not reached (95% CI, not estimable [NE], NE) in the alectinib arm and was 41.3 months (95% CI, 28.5, NE) in the chemotherapy arm.

In the stage II-IIIA population, median DFS was not reached (95% CI, NE, NE) in the alectinib arm and was 44.4 months (95% CI, 27.8, NE) in the chemotherapy arm (HR 0.24 [95% CI, 0.13-0.45]; P <.0001).

In an exploratory analysis of site(s) of relapse, 3.1% of patients (n=4) in the alectinib arm and 11% of patients (n=14) in the chemotherapy arm had brain involvement at the time of disease recurrence. Overall survival data were not mature at the time of DFS analysis.

The most common adverse reactions reported in patients taking alectinib were hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, and cough.

Alecensa, a kinase inhibitor, is also indicated for the treatment of adults with ALK-positive metastatic NSCLC as detected by an FDA-approved test.

(HealthDay News) — For patients with advanced anaplastic lymphoma kinase-positive non-small cell lung cancer, alectinib exposure is lower when taken with low-fat yogurt, according to a study published in the June issue of the Journal of the National Comprehensive Cancer Network.

Daan A.C. Lanser, from Erasmus MC Cancer Institute in Rotterdam, Netherlands, and colleagues conducted a randomized 3-period crossover clinical study comparing alectinib exposure among patients with different diets. The first alectinib dose was taken with a continental breakfast, 250g low-fat yogurt, or a self-chosen lunch every 7 days, and the second dose was taken with a self-chosen dinner. On day 8, sampling for alectinib exposure (C_trough) was performed, just prior to alectinib intake.

The researchers found that the mean C_trough was 14% and 20% lower when taken with low-fat yogurt compared with continental breakfast and self-chosen lunch, respectively, in 20 evaluable patients. Exposure did not change for administration with a self-chosen lunch compared with a continental breakfast.

“This is important information for patients, since we know that higher alectinib concentrations in blood could result in more efficacy of the drug, a longer treatment duration and therefore, hopefully, a better survival,” Lanser said in a statement. “We believe that taking it with a substantial meal containing enough fat is far more important for the absorption and efficacy of the treatment than to wait 12 hours between doses.”

Several authors disclosed ties to the pharmaceutical industry.

Abstract/Full Text

Updated trial results show a sustained clinical benefit with amivantamab in patients with non-small cell lung cancer (NSCLC) and EGFR exon 20 insertions whose disease progressed on platinum-based chemotherapy. 

These results, from the phase 1 CHRYSALIS trial, were presented at the European Lung Cancer Congress 2023.

The CHRYSALIS trial (ClinicalTrials.gov Identifier: NCT02609776) included 114 heavily pretreated patients with NSCLC and EGFR exon 20 insertions. The patients’ median age was 62 (range, 36-84) years, 61% were women, and 25% had brain metastases. 

The median number of prior treatments was 2 (range, 1-7). All patients had received platinum chemotherapy, 44% had received immunotherapy, and 20% had received EGFR tyrosine kinase inhibitors.

On study, patients received amivantamab monotherapy. At the data cutoff, the median follow-up was 19.2 months, the median treatment duration was 7.5 months, and 48 patients (42%) were still alive. 

The median progression-free survival (PFS) was 6.9 months. The 1-year PFS rate was 35.4%, and the 2-year PFS rate was 13.7%. The median overall survival (OS) was 23 months. The 1-year OS rate was 73.3%, and the 2-year OS rate was 47.2%.

Amivantamab demonstrated consistent efficacy regardless of prior therapy, said study presenter Pilar Garrido, MD, PhD, of Hospital Universitario Ramon y Cajal in Madrid.

Dr Garrido noted that 48 patients (42%) had a sustained clinical benefit, which was defined as being on amivantamab for 12 or more cycles. Clinical benefit was more likely among patients who achieved a partial response or better, patients with good performance status, and those who did not have baseline alterations in the RAS/RAF/MEK pathway. 

At the data cutoff, treatment was ongoing in 15 patients (13%) who had received amivantamab for a median of 2.6 years. Seven of these patients were still progression-free, and 8 were receiving treatment beyond disease progression. 

Dr Garrido noted that no new safety signals were detected with longer follow-up. Treatment-related dose interruptions occurred in 29% of patients, dose reductions occurred in 18%, and discontinuations occurred in 7%. 

The most frequent adverse events of any grade were rash (89%) and infusion-related reactions (67%). The most common grade 3 or higher adverse events were venous thromboembolism (6%) and dyspnea (5%).

Amivantamab is currently under investigation in the frontline setting in the phase 3 PAPILLON study (ClinicalTrials.gov Identifier: NCT04538664). Researchers are comparing amivantamab plus chemotherapy with chemotherapy alone in patients with NSCLC and EGFR exon 20 insertions.

Disclosures: This research was supported by Janssen Research & Development, LLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Garrido Lopez P, Girard N, Cho BC, et al. Long-term efficacy, safety and predictors of response to amivantamab among patients with post-platinum EGFR Ex20ins-mutated advanced NSCLC. ELCC 2023. March 29 – April 1, 2023. Abstract 3O.

The table below is a review of notable updates that occurred in April 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

Phase 3 trial results support atezolizumab as a potential first-line treatment option for patients with advanced non-small cell lung cancer (NSCLC) who are ineligible for platinum-based chemotherapy, according to researchers.

The trial showed that patients had significantly better survival outcomes with first-line atezolizumab than with single-agent chemotherapy. Researchers reported these results in The Lancet.

The trial (IPSOS; ClinicalTrials.gov Identifier: NCT03191786) included 453 patients with stage IIIB or IV NSCLC who were deemed unsuitable for platinum-based chemotherapy. The patients’ median age at baseline was 75 years, and about one-third of patients were 80 years of age or older.

The patients were randomly assigned to receive atezolizumab (n=302) or chemotherapy (n=151). Atezolizumab was given at 1200mg every 3 weeks. Chemotherapy (vinorelbine or gemcitabine) was given on 3-weekly or 4-weekly cycles.

At a median follow-up of 41 months, the median overall survival (OS) was 10.3 months in the atezolizumab arm and 9.2 months in the chemotherapy arm (stratified hazard ratio [sHR], 0.78; 95% CI, 0.63-0.97; P =.028).

At 12 months, the OS rate was 44% in the atezolizumab arm and 39% in the chemotherapy arm. At 24 months, the OS rate was 24% and 12%, respectively. The median progression-free survival (PFS) was 4.2 months in the atezolizumab arm and 4.0 months in the chemotherapy arm (sHR, 0.87; 95% CI, 0.70-1.07). At 12 months, the PFS rate was 20% in the atezolizumab arm and 14% in the chemotherapy arm. At 24 months, the PFS rate was 9% and 2%, respectively.

The objective response rate was 17% with atezolizumab and 8% with chemotherapy. The median duration of response was 14.0 months and 7.8 months, respectively.

A total of 447 patients were evaluable for safety (300 in the atezolizumab arm and 147 in the chemotherapy arm). The rate of adverse events (AEs) was 92% in the atezolizumab arm and 97% in the chemotherapy arm.

The most common AEs in the atezolizumab arm were dyspnea (20%), cough (20%), and anemia (16%). The most common AEs in the chemotherapy arm were anemia (33%), nausea (24%), and vomiting (16%). The rate of treatment-related AEs was 57% in the atezolizumab arm and 80% in the chemotherapy arm. The rate of treatment-related grade 3-4 AEs was 16% in the atezolizumab arm and 33% in the chemotherapy arm. The rate of treatment-related deaths was 1% and 3%, respectively.

“First-line treatment with atezolizumab monotherapy was associated with improved overall survival, a doubling of the 2-year survival rate, maintenance of quality of life, and a favorable safety profile compared with single-agent chemotherapy,” the researchers wrote. “These data support atezolizumab monotherapy as a potential first-line treatment option for patients with advanced NSCLC who are ineligible for platinum-based chemotherapy.”

Disclosures: This research was supported by F Hoffmann-La Roche and Genentech Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

The Food and Drug Administration (FDA) has approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

Augtyro is an oral tyrosine kinase inhibitor (TKI) that targets ROS1– or NTRK-positive locally advanced or metastatic solid tumors. The approval was based on data from the open-label, multi-cohort, phase 1/2 TRIDENT-1 trial (ClinicalTrials.gov Identifier: NCT03093116), which evaluated the anti-tumor activity and safety of repotrectinib in patients with advanced solid tumors, including NSCLC. 

Study participants received repotrectinib 160mg orally once daily for 14 days, and then were increased to 160mg twice daily until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR). 

Among 71 ROS1 TKI-naïve patients, results showed an ORR of 79% (95% CI, 68-88) with 6% of patients achieving complete response and 73% achieving partial response. Median duration of response was 34.1 months (95% CI, 25.6-not evaluable), with 70% of patients having a response lasting at least 12 months.

Among 56 patients pretreated with 1 prior ROS1 TKI, the ORR was 38% (95% CI, 25-52) with 5% of patients achieving complete response and 32% achieving partial response. Median duration of response was 14.8 months (95% CI, 7.6-not evaluable), with 48% of patients having a response lasting at least 12 months.

Among patients who had measurable central nervous system (CNS) metastases at baseline, responses in intracranial lesions were observed in 7 of 8 TKI-naïve patients and 5 of 12 of those who were TKI-pretreated.

The most common adverse reactions reported with Augtyro were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, ataxia, fatigue, cognitive disorders, and muscular weakness. The prescribing information also includes warnings and precautions associated with CNS effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevations, hyperuricemia, skeletal fractures, and embryo-fetal toxicity.  

Augtyro is supplied as a 40mg capsule. Patients should be selected for treatment based on the presence of ROS1 rearrangement(s) in tumor specimens detected using an FDA-approved test. Prior to initiating treatment, liver function tests, including bilirubin, and uric acid levels should be evaluated.

The product is expected to be available in mid-December 2023.

Biomarkers should be used when selecting cancer patients for immune checkpoint inhibitor (ICI) therapy, according to researchers. 

They found that cancer patients who have biomarker-positive tumors have better objective response rates (ORR), progression-free survival (PFS), and overall survival (OS) on ICI treatment.

These findings, from a meta-analysis, were published in the European Journal of Cancer.

The meta-analysis included 174 phase 1 and 2 trials that encompassed 19,178 cancer patients. The most common cancer types were melanoma (27 studies), non-small cell lung cancer (n=26), esophageal or gastric cancer (n=17), and breast cancer (n=14). 

Correlative predictive biomarkers were investigated in 132 studies. Biomarkers included PD-L1 expression (n=111), tumor mutational burden (n=20), mutations (n=17), tumor-infiltrating lymphocytes (n=15), microsatellite instability/mismatch repair deficiency (n=10), gene expression/RNA-based signatures (n=10), and other biomarkers.

Patients with biomarkers had a significantly higher ORR than patients without biomarkers; 30% and 16%, respectively (odds ratio [OR}, 2.15; 95% CI, 1.79-2.58, P <.0001).

Patients with biomarkers also had significantly better PFS (hazard ratio [HR], 0.55; 95% CI, 0.45-0.67; P <.0001) and OS (HR, 0.65; 95% CI, 0.53-0.80; P <.0001).

In a multivariate analysis, patients with biomarkers had significantly better ORRs (OR, 2.11; 95% CI, 1.77-2.51, P <.001) and PFS (HR, 0.56; 95% C.I, 0.43-0.72; P <.001). Due to a small number of studies, OS was not included in the multivariate analysis.

“This meta-analysis demonstrated that the use of immune-related biomarkers is important for selection of patients who will benefit from ICIs,” the researchers concluded. 

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Fountzilas E, Vo HH, Mueller P, et al. Correlation between biomarkers and treatment outcomes in diverse cancers: A systematic review and meta-analysis of phase I and II immunotherapy clinical trials. Eur J Cancer. Published online May 22, 2023. doi:10.1016/j.ejca.2023.05.015

The Food and Drug Administration (FDA) has approved Braftovi^® (encorafenib) in combination with Mektovi^® (binimetinib) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

The approval was based on data from the open-label, single-arm, phase 2 PHAROS study (ClinicalTrials.gov Identifier: NCT03915951), which evaluated the efficacy and safety of encorafenib plus binimetinib in 98 adults with BRAF V600E mutation-positive metastatic NSCLC who were treatment-naïve or had been previously treated with 1 prior line of systemic therapy in the metastatic setting (platinum-based chemotherapy and/or anti-PD-1/PD-L1 therapies). Study participants received encorafenib 450mg orally once daily plus binimetinib 45mg orally twice daily until disease progression or unacceptable toxicity. 

Among the 59 treatment-naïve patients, the objective response rate (ORR; primary endpoint) was 75% (95% CI, 62-85), with 15% of patients having complete response and 59% having partial response. The median duration of response (DOR; secondary endpoint) was not estimable (95% CI, 23.1 months, not estimable [NE]); 75% of responders had responses lasting at least 6 months, while 59% had responses lasting at least 12 months.

Among the 39 previously-treated patients, ORR was 46% (95% CI, 30-63), with 10% of patients having complete response and 36% having partial response. Median DOR was 16.7 months (95% CI, 7.4, NE); 67% of responders had responses lasting at least 6 months, while 33% had responses lasting at least 12 months.

The most common adverse reactions reported in the NSCLC trial were fatigue, nausea, diarrhea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough.

“BRAF V600E mutations identify a unique subtype of metastatic non-small cell lung cancer that presents an actionable biomarker that precision medicines like Braftovi + Mektovi combination therapy can help address,” said Gregory Riely, MD, PhD, Vice Chair, Clinical Research in the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK) and PHAROS investigator. “The PHAROS trial demonstrated that these patients could benefit from Braftovi + Mektovi targeted therapy regardless of their prior treatment history. Given the specific efficacy and safety profile, patients and providers now have another option to help personalize treatment plans based on individual risk factors and preferences.”

The FDA has also approved the FoundationOne^®CDx (tissue) and FoundationOne^® Liquid CDx (plasma) as companion diagnostics for Braftovi and Mektovi. The tumor tissue should be tested if there is no mutation detected in a plasma specimen.

Breakthroughs in targeted therapy and immunotherapy are partly responsible for the recent decline in cancer deaths seen in the United States, according to the AACR Cancer Progress Report 2023.¹

The overall rate of cancer death in the US fell by 33% between 1991 and 2020, which translates to 3.8 million lives saved, according to the report. Death rates have decreased for lung cancer, colorectal cancer, prostate cancer, female breast cancer, and melanoma.

“These gains have really reflected a whole variety of different advances, but mostly this has been about efforts in basic science,” AACR President Philip D. Greenberg, MD, of Fred Hutchinson Cancer Research Center in Seattle, said during a presentation about the AACR report.

Dr Greenberg noted that initiatives such as the Human Genome Project and The Cancer Genome Atlas have enabled the creation of targeted therapies, which are “increasingly precise and decreasingly toxic.”

Immunotherapy breakthroughs have also reduced the toxicity of treatments, leading to improved quality of life for patients. “Precision oncology, personalized medicine; it’s about creating drugs and using them to very selectively target the disease and not injure the person,” Dr Greenberg summarized.

The AACR report highlighted several targeted therapies with unique mechanisms of action that have been approved by the US Food and Drug Administration (FDA) since the early 2000s, including gefitinib in 2003, crizotinib in 2011, and sotorasib in 2021.

All of these therapies were approved to treat lung cancer, and these approvals coincided with declining lung cancer deaths. The decrease in lung cancer deaths per year grew from 0.9% between 1995 and 2005 to nearly 5% between 2014 and 2020.

The report also highlighted more recent FDA approvals. Between August 1, 2022, and July 31, 2023, the FDA approved 14 new cancer therapies and expanded the approved use of 12 therapies to encompass new cancers. The therapies include a range of cell-signaling inhibitors, antibody-drug conjugates, bispecific antibodies, and immune checkpoint inhibitors.

“A decade ago, there was 1 single immune checkpoint inhibitor,” Dr Greenberg pointed out. “Now . . . 11 checkpoint inhibitors have now been approved by the FDA up through 2023. And rather than using it to treat the single disease that it was approved for a decade ago, we now use it to treat 20 diseases.”

Two new imaging agents — pafolacianine and flotufolastat fluorine-18 —were also approved by the FDA between August 1, 2022, and July 31, 2023.

Ongoing Challenges

“Of course, despite all this progress, there’s a whole lot of work that needs to be done,” Dr Greenberg said. “There are still, even now, structural barriers for lots of people. There’s clearly disproportionate medical care being delivered to medically underserved populations. This includes, of course, racial and ethnic minorities, but it also includes the rural populations, which is not commonly appreciated, but rural populations participate very minimally in cancer trials.”

“Similarly, although precision medicine has really improved outcomes, we need ways of expanding that so that it includes more diseases,” Dr Greenberg added. “Pancreatic cancer, for example, and glioblastoma still have horrible 5-year relative survival rates, and so we need new advances.”

To address some of these challenges, the AACR has launched a new initiative known as the AACR Cancer Centers Alliance.²  The initiative aims to encourage collaboration among US cancer centers and “accelerate the pace of discovery by providing an ongoing mechanism for transferring new knowledge, sharing resources . . ., and driving innovation that impacts cancer science, cancer care delivery, and science and health policy.”²

Dr Greenberg suggested that the future of cancer research is bright. “I really enthusiastically look forward to what can happen,” he said. “I think there’s no reason not to be optimistic. . . . We’re in this time of unparalleled opportunities.”

Disclosures: Dr Greenberg has relationships with Affini-T, Rapt Therapeutics, Elpiscience, Fibrogen, Immunoscape, Metagenomi, Earli, Catalio, and Nextech. No disclosures were provided in relation to the AACR Cancer Progress Report 2023. Some authors of the Cancer Discovery article declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the article for a full list of disclosures.

Cancer patients were more likely to die from the BA.1 and BA.2 omicron variants of SARS-CoV-2 than from wild-type SARS-CoV-2, according to research published in JAMA Oncology.^1,2

The study showed that, among US cancer patients, COVID-19 deaths were more likely during the initial omicron wave when the BA.1 and BA.2 variants were in circulation (December 2021 to February 2022) than when wild-type SARS-CoV-2 was circulating (December 2020 to February 2021).

According to data from the US Centers for Disease Control and Prevention, there were 54,692 COVID-19 deaths among patients with cancer and 1,008,510 COVID-19 deaths in the general population from March 1, 2020, through May 31, 2022.

This study included 34,350 patients with cancer and 628,156 individuals from the general population who died from COVID-19 when wild-type SARS-CoV-2 was in circulation (December 2020-February 2021), the delta variant was in circulation (July 2021-November 2021), or the BA.1 and BA.2 omicron variants were in circulation (December 2021-February 2022).

The highest number of COVID-19-related deaths among patients with cancer occurred during the 2021-2022 omicron wave. At the peak of this wave, in January 2022, there were 18% more deaths than during the peak of the wild-type period, which occurred during January 2021.

This trend was maintained when patients were stratified by age group. The number of deaths per month among patients with cancer younger than 50 years of age was 64% higher during the 2021 to 2022 omicron wave than during the wild-type wave. The number was 62% higher among patients aged 50 to 59 years, 31% higher for those aged 60 to 69 years, and 16% higher for those aged 70 to 79 years.

When the researchers looked at individual cancer types, they found that COVID-19 deaths were more likely during the 2021-2022 omicron wave for most cancer types. The exceptions were brain cancer (mortality ratio [MR], 0.77; 95% CI, 0.65-0.90), thyroid cancer (MR, 0.76; 95% CI, 0.54-0.99), and bladder cancer (MR, 0.58; 95% CI, 0.52-0.65).

Patients with lymphoma had the greatest increase in deaths from the wild-type wave to the 2021 to 2022 omicron wave, at 38% (mortality ratio [MR], 1.38; 95% CI, 1.31-1.45).

In the general population, the highest number of COVID-19 deaths per month occurred when wild-type SARS-CoV-2 was prevalent. At the peak of the initial omicron wave in January 2022, there were 21% fewer deaths in the general US population than at the peak of the wild-type period in January 2021 (MR, 0.69; 95% CI, 0.69-0.70).

“[W]hile the general US population experienced a large reduction in COVID-19 mortality during the winter Omicron period, patients with cancer experienced the highest COVID-19 mortality during the winter Omicron period, likely due to increased SARS-CoV-2 exposure during this period combined with the reduced effectiveness of COVID-19 vaccines and increased risk of COVID-19 mortality in this population,” the researchers wrote. “With future COVID-19 waves imminent, strategies to protect those at highest risk should remain a high priority, even during future pandemic waves with less virulent SARS-CoV-2 variants.”

Disclosures: One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

1. Potter AL, Vaddaraju V, Venkateswaran S, et al. Deaths due to COVID-19 in patients with cancer during different waves of the pandemic in the US. JAMA Oncol. Published online August 31, 2023. doi: 10.1001/jamaoncol.2023.3066

2. SARS-CoV-2 sequences by variant, United States, Jan 3, 2022. Our World in Data. Updated August 22, 2023. Accessed September 1, 2023.

HealthDay News — Cemiplimab plus chemotherapy results in significant overall improvement in pain symptoms and delayed deterioration in cancer-related and lung cancer-specific symptoms and functions, according to a study published online May 8 in Cancer.

Tamta Makharadze, MD, from LTD High Technology Hospital Med Center in Batumi, Georgia, and colleagues evaluated patient-reported outcomes from the EMPOWER-Lung 3 phase 3 trial. The analysis included 312 patients assigned to cemiplimab plus platinum-doublet chemotherapy and 154 receiving placebo plus chemotherapy as first-line treatment for advanced non-small cell lung cancer.

The researchers found that for pain symptoms, there was a statistically significant overall improvement from baseline and significant delay in time to definitive clinically meaningful deterioration (TTD; hazard ratio, 0.39; 95% CI, 0.26 to 0.60; P <.0001) favoring cemiplimab plus chemotherapy. For functioning and symptom scales, there were also statistically significant delays seen in TTD, all favoring cemiplimab plus chemotherapy. From baseline, there was a significant overall improvement observed in global health status/quality of life with cemiplimab plus chemotherapy vs a nonsignificant overall change from baseline for placebo plus chemotherapy (hazard ratios [95% CI], 1.69 [0.20 to 3.19] vs 1.08 [−1.34 to 3.51]; between arms, P =.673).

“We show that the favorable efficacy achieved with cemiplimab plus chemotherapy over placebo plus chemotherapy is accompanied by significant overall improvement in pain and significant delay in TTD in multiple patient-reported cancer-related and lung cancer-specific functions and symptoms,” the authors write.

Several authors disclosed financial ties to Regeneron, which manufactures cemiplimab and funded the study.

Abstract/Full Text

HealthDay News — Artificial intelligence (AI) chatbots generally produce accurate information for the top cancer-related web searches, according to a report published online August 24 in JAMA Oncology.

Alexander Pan, from State University of New York Downstate Health Sciences University in Brooklyn, and colleagues assessed the quality of information and presence of misinformation about cancers generated by 4 AI chatbots. The analysis included 100 text responses to the five most commonly searched queries (Google Trends) related to the five most common cancers (skin, lung, breast, colorectal, and prostate).

The researchers found that the quality of text responses generated by the 4 AI chatbots was good (median DISCERN score of 5), and no misinformation was identified. Understandability was rated as moderate using the Patient Education Materials Assessment Tool (median understandability score, 66.7%), while actionability was poor (median actionability score, 20.0%). Based on the Flesch-Kincaid Grade Level score, the responses were written at the college level.

“These limitations suggest that AI chatbots should be used supplementarily and not as a primary source for medical information,” the authors write.

Abstract/Full Text (subscription or payment may be required)

Chemotherapy-Induced Nausea and Vomiting Prophylaxis