Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): a multicentre, international, randomised, open-label phase 3 trial

Brahmer, Julie R.; Rodríguez-Abreu, Delvys; Robinson, Andrew; Hui, Rina; Csőszi, Tibor; Fülöp, András; Gottfried, Maya; Peled, Nir; Tafreshi, Ali; Cuffe, Sinéad; O’Brien, Mary; Rao, Suman; Hotta, Katsuyuki; Zhang, Jin; Lubiniecki, Gregory M.; Deitz, Anne C.; Rangwala, Reshma; Reck, Martin

doi:10.1016/s1470-2045(17)30690-3

Cited by 277 publications

(232 citation statements)

References 28 publications

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“…As expected, a decrease in GHS and FS scores went along with more symptoms (higher SS) during therapy. Although changes of 10 points or greater have been accepted as clinically meaningful, differences as low as 4 points have been reported to be relevant in NSCLC trials [14, 16]. Pronounced drops were found for certain domains, e.g., role function scores (mean change –40 at the end of therapy), essentially documenting the constraint in daily function.…”

Section: Resultsmentioning

confidence: 99%

“…When patients had progressive disease or were too weak to continue or if the therapy plan changed (e.g., to surgery or clinical trial), PRO recording was discontinued. Compliance was defined as the proportion of patients who completed the questionnaire at each visit against those who were scheduled for concurrent chemoradiation and adjuvant chemotherapy as denominator [14]. …”

Section: Methodsmentioning

confidence: 99%

“…The higher the calculated SS (range 0–100), the more complaints the patient has. We chose, in line with others, a decrease of a minimum of 10 points for GHS and FS and an increase of a minimum of 10 points for SS as clinically meaningful deterioration [14, 16]. …”

Section: Methodsmentioning

confidence: 99%

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Health Outcomes for Definite Concurrent Chemoradiation in Locally Advanced Non-Small Cell Lung Cancer: A Prospective Study

et al. 2018

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Background: In patients with locally advanced lung cancer treated with concurrent chemoradiation, outcome measurements have been mostly limited to survival. Objectives: We aimed to measure outcomes that matter to these patients beyond survival in a general clinical practice. Methods: In a prospective single-centre study, consecutive patients with locally advanced non-small cell lung cancer reported their own outcomes using the EORTC Quality of Life Questionnaire Core 30 at baseline, during therapy, at therapy stop and till 1 year after therapy end every 3 months. Survival, complications, quality of death and case-mix variables were measured. Results: There were 32 consecutive patients included prospectively from June 2013 until September 2016. Median overall survival was 24.3 months (95% CI 12.7–35.9). Severe toxicity (grade III–IV) was frequent (haematologic toxicity III–IV in 59%). Patient-reported outcomes (PROs) documented the burden on global health status and on functional domains (physical, role, social, emotional and cognitive functioning). Deterioration was pronounced during and after treatment with drops over 20 up to 40% points from baseline for physical, role and social functioning. Clinically meaningful negative effects did persist up to 6 and 9 months for physical and role functioning. Fifty-six percent of the deceased patients died in hospital. Conclusions: The assault on health-related quality of life during concurrent chemoradiation for locally advanced lung cancer is considerable. Loss of physical and role functioning persists up to 6 and 9 months after therapy end, respectively. Measuring PROs can help to identify issues for improvement of the value of care delivered.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Health Outcomes for Definite Concurrent Chemoradiation in Locally Advanced Non-Small Cell Lung Cancer: A Prospective Study

et al. 2018

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“…Consequently, clinical trials of blocking monoclonal antibodies (mAbs) against PD‐1 and PD‐L1 in a variety of solid tumors have shown promising results and have validated this pathway as a therapeutic target. The KEYNOTE‐024 clinical trial demonstrated that pembrolizumab, an anti‐PD‐1 immune checkpoint inhibitor, is associated with longer progression‐free and overall survival (OS) than platinum‐based chemotherapy in advanced non‐small cell lung cancer (NSCLC) patients with a PD‐L1 tumor proportion score (TPS) of ≥ 50% . Therefore, evaluation of the relationship between clinicopathological characteristics and a PD‐L1 TPS ≥ 50% might provide valuable information to predict benefit for patients receiving first‐line immunotherapy.…”

Section: Introductionmentioning

confidence: 99%

Clinical significance of ≥ 50% PD‐L1 expression with the SP263 monoclonal antibody in non‐small cell lung cancer patients

Song

Guo

et al. 2018

Thoracic Cancer

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Background PD‐L1 expression in tumor cells has been associated with the efficacy of immune checkpoint inhibitors in non‐small cell lung cancer (NSCLC). The aim of this study was to explore correlations between smoking, genetic profiles, patient outcomes, and PD‐L1 expression in NSCLC. Methods PD‐L1 expression was evaluated in 241 surgically resected specimens by immunostaining and 50% was set as the cutoff value. Results Of the 241 tumors analyzed, a PD‐L1 tumor proportion score (TPS) of ≥ 50% was detected in 35 cases (14.5%) and a TPS of < 50% in 206 cases (85.5%). A PD‐L1 TPS ≥ 50% was significantly associated with smoking and EGFR wild‐type status ( P < 0.001 and P = 0.039, respectively). Detailed assessment of smoking variables showed that total smoking duration was a predictor of a PD‐L1 TPS ≥ 50% ( P = 0.001). Univariate and multivariate survival analyses revealed that patients with a PD‐L1 TPS ≥ 50% had poorer disease‐free and overall survival than those with a PD‐L1 TPS < 50% ( P = 0.001 and P < 0.001, respectively). Conclusion The incidence of a PD‐L1 TPS ≥ 50% was significantly higher in smoking and EGFR wild‐type NSCLC patients, particularly in long‐term smokers. A PD‐L1 TPS of ≥ 50% was an independent adverse prognostic factor for survival in patients with NSCLC.

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“…Pembrolizumab has proven safe and efficacious in the treatment of a host of diseases, including NSCLC [26][27][28][29], melanoma [26,30], malignant mesothelioma [31], Hodgkin lymphoma [32][33][34], urothelial cancer [35,36], breast cancer [37], and progressive primary brain tumors [38]. Pembrolizumab has rarely been utilized in the gynecologic setting; however, it has been reported to have a favorable safety profile and durable antitumor activity in cervical and endometrial cancer [39][40][41] as well as gestational trophoblastic neoplasia [42].…”

Section: Discussionmentioning

confidence: 99%

Pembrolizumab in Recurrent Squamous Cell Carcinoma of the Vulva: Case Report and Review of the Literature

Shields

Gordinier

2018

Gynecol Obstet Invest

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Advanced vulvar cancer is associated with a very poor prognosis. Surgical resection is the mainstay of treatment, with radiation indicated for areas at high risk for recurrence. When surgical and radiation options have been exhausted, the effectiveness of systemic chemotherapy is poor. No biologic or targeted agents have been approved for the management of advanced or recurrent vulvar cancer. Pembrolizumab, a humanized monoclonal antibody against programmed death 1 (PD-1), has been successfully used as a target of tumor immune therapy in small cell lung cancer and melanoma. We present the first case in the literature of a patient with recurrent vulvar cancer who was treated successfully with pembrolizumab. Caris next-generation testing revealed a PD-L1 and PD-1 mutation (PD-L1 positive, 2+, 100%). She attained a complete clinical remission after 2 cycles, and a CT scan after 6 cycles revealed a significant response by RECIST criteria. After completing 10 cycles, treatment was stopped due to complications of severe malnutrition related to narcotic abuse. A CT scan 10 weeks after the final treatment revealed no adenopathy. Pembrolizumab is a safe and effective chemotherapeutic agent to treat recurrent vulvar carcinoma.

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Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): a multicentre, international, randomised, open-label phase 3 trial

Cited by 277 publications

References 28 publications

Health Outcomes for Definite Concurrent Chemoradiation in Locally Advanced Non-Small Cell Lung Cancer: A Prospective Study

Health Outcomes for Definite Concurrent Chemoradiation in Locally Advanced Non-Small Cell Lung Cancer: A Prospective Study

Clinical significance of ≥ 50% PD‐L1 expression with the SP263 monoclonal antibody in non‐small cell lung cancer patients

Pembrolizumab in Recurrent Squamous Cell Carcinoma of the Vulva: Case Report and Review of the Literature

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