In patients with esophageal cancer, chemotherapy with or without pembrolizumab (Keytruda) yielded health-related quality of life (HRQoL) results over 18 weeks, according to results from a phase 3 study of KEYNOTE-590 (NCT03189719).1
Data previously reported at the European Society for Medical Oncology Virtual Congress 2020 showed improved survival, improved survival, and overall response rates and therapeutic safety profile with the pembrolizumab combination plus placebo versus chemotherapy plus chemotherapy for the treatment of patients with advanced. esophageal cancer.2 The update to this trial presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium 2021 aimed to determine whether the experimental treatment had any adverse effects on HRQoL.
“Adding pembrolizumab to chemotherapy maintained HRQoL measures relative to baseline and did not degrade HRQoL compared to chemotherapy alone,” explained lead researcher Wasat Mansoor, MBChB, MRCP, PhD , at an oral presentation. “These results support the use of pembrolizumab in addition to chemotherapy as a first-line treatment for advanced and local metastatic esophageal cancer or Siewert type 1 adenocarcinoma (esophagogastric junction).”
For the global health status / quality of life per EORTC QLQ-C30 questionnaire, the mean square change (LSM) from baseline to week 18 did not find a significant difference between arms (–0.10; 95% CI, –3.40 to –3.20 ; P. = .9530). Further, the median time to decline for global health status / quality of life was similar between arms (HR, 0.86; 95% CI, 0.66–1.13; P. = .2864).
Researchers found that, with QLQ-OES18 pain subscription, LSM adjustment from baseline to week 18 was superior for the pembrolizumab combination and chemotherapy versus chemotherapy alone (–4.78 vs –1.85; [-2.94; 95% CI, –5.86 to –0.02]; P. = .0487).
Even more, no significant difference was found from baseline to week 18 in LSM adjustment for both reflux (1.1.19; 95% CI, –4.49 to –2.10; P. = 0.4781) no dysphagia (-2.35; 95% CI, –7.78 to –3.07; P. = .3945).
When asked about concerns about the lack of a better quality of life with the combination of pembrolizumab supplementation with chemotherapy, Mansoor explained, “We need to remember that these were high end points and some of them investigative in nature. Surprisingly, these tests often show a decline in quality of life rather than excellence. ”
The research team administered EORTC QLQ-C30, EORTC QLQ-OES18, and EQ-5D-5L questionnaires electronically at baseline every 3 weeks up to week 24 and then every 9 weeks up to 1 year or so. treatment. HRQoL was studied for all patients with treatment who completed the HRQoL assessments (n = 711).
The EORTC QLQ-C30 questionnaire was developed to assess the quality of life of patients with cancer, while the EORTC QLQ-OES18 questionnaire is specific for disease and has been tested to address measures associated with esophageal cancers. Finally, the EQ-5D-5L model includes assessments of mobility, self-care, normal activity, pain / discomfort, and anxiety / depression as well as a visual analog scale to general health status. to measure.
Time to decline in EORTC QLQ-C30 and EORTC QLQ-OES18 questionnaires was calculated as a decline from baseline greater than or equal to 10. For all assessments, baseline compliance and at week 18 greater than or equal to 90%.
The main points of completion of the research were overall survival and non-survival. Secondary endpoints included overall response rate and patient-reported outcomes.
Comparative safety profiles were observed with both treatment groups, and no new safety markers were found. The average duration of patients on each individual treatment was 7.7 months for the pembrolizumab plus chemotherapy combination and 5.8 months for placebo plus chemotherapy.
References:
Mansoor W, Kulkarni AS, Kato K, et al. Health-related quality of life (HRQoL) of pembrolizumab in addition to chemotherapy versus chemotherapy as a first-line treatment in patients with advanced esophageal cancer: A phase III study of KEYNOTE-590. J Clin Oncol. 2021; 39 (solair): 168.
Kato K, Sun J, Shah MA, et al. Pembrolizumab in addition to chemotherapy versus chemotherapy as a first-line treatment in patients with advanced esophageal cancer: a phase 3 study of KEYNOTE-590. Ann Oncol. 2020; 31 (supplies 4): LBA8_PR. doi: 10.1016 / annonc / annonc325