دورية أكاديمية
Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab.
| العنوان: | Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab. |
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| المؤلفون: | Milowsky MI; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC., O'Donnell PH; University of Chicago, Chicago, IL., Hoimes CJ; Duke Cancer Institute, Duke University, Durham, NC., Petrylak DP; Yale Cancer Center, New Haven, CT., Flaig TW; University of Colorado Comprehensive Cancer Center, Aurora, CO., Moon HH; Kaiser Permanente Southern California, Riverside, CA., Friedlander TW; University of California San Francisco Medical Center, San Francisco, CA., Mar N; University of California Irvine, Irvine, CA., McKay RR; University of California San Diego, San Diego, CA., Srinivas S; Stanford University Medical Center, Stanford, CA., Gravis G; Institut Paoli-Calmettes, Marseille, France., Ramamurthy C; MD Anderson Cancer Center, University of Texas Health, San Antonio, TX., Bupathi M; Rocky Mountain Cancer Centers, Littleton, CO., Bracarda S; Azienda Ospedaliera Santa Maria Terni, Terni, Italy., Wright P; Seagen Inc, Bothell, WA., Hepp Z; Seagen Inc, Bothell, WA., Carret AS; Seagen Inc, Bothell, WA., Yu Y; Seagen Inc, Bothell, WA., Dillon R; Astellas Pharma Inc, Northbrook, IL., Kataria R; Merck & Co, Inc, Rahway, NJ., Beaumont JL; Clinical Outcomes Solutions Ltd, Tucson, AZ., Purnajo I; Clinical Outcomes Solutions Ltd, Tucson, AZ., Rosenberg JE; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY. |
| المصدر: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Apr 20; Vol. 42 (12), pp. 1403-1414. Date of Electronic Publication: 2024 Jan 12. |
| نوع المنشور: | Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology Original Publication: New York, N.Y. : Grune & Stratton, c1983- |
| مواضيع طبية MeSH: | Antibodies, Monoclonal* , Antibodies, Monoclonal, Humanized* , Carcinoma, Transitional Cell* , Sleep Initiation and Maintenance Disorders*, Humans ; Cisplatin ; Pain ; Patient Reported Outcome Measures ; Quality of Life/psychology |
| مستخلص: | Purpose: Locally advanced/metastatic urothelial cancer (la/mUC) affects patients' quality of life (QOL) and functioning. We describe the impact of first-line (1L) enfortumab vedotin (EV) alone or with pembrolizumab (P) on QOL/functioning/symptoms in patients with la/mUC who were cisplatin-ineligible from EV-103 Cohort K. Methods: In this phase Ib/II trial, patients were randomly assigned 1:1 to EV + P or EV monotherapy (mono). Exploratory patient-reported outcomes (PROs) were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire (EORTC QLQ-C30) and Brief Pain Inventory Short Form (BPI-SF) at baseline, once per week for cycles 1-3, and then in every cycle through the end of treatment. Changes in scores from baseline to week 24, reported as least squares mean (standard error), were assessed by mixed models for repeated measures. There were no formal statistical comparisons between treatment arms. Results: Of 149 patients treated, 65 (EV + P) and 63 (EV mono) comprised the PRO analysis set. For EV + P, EORTC QLQ-C30 QOL was maintained through week 24 with improvements in emotional functioning, pain, and insomnia. Clinically meaningful improvements were seen in EORTC QLQ-C30 pain after EV + P at weeks 12 (-14.41 [3.14]) and 24 (-14.99 [3.56]) and BPI-SF worst pain at week 24 (-2.07 [0.37]). For EV mono, EORTC QLQ-C30 QOL remained stable with clinically meaningful improvements in EORTC QLQ-C30 pain (-12.55 [4.27]), insomnia (-14.46 [4.69]), and constipation (-10.09 [4.35]) at week 24. There were small-to-moderate improvements in BPI-SF worst pain at week 24. Conclusion: EV + P in patients with la/mUC who were cisplatin-ineligible was associated with preservation or improvement of QOL/functioning/symptoms. Improvement in pain was seen in both PRO instruments and treatment arms. These data complement clinical outcomes of 1L EV + P. |
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| سلسلة جزيئية: | ClinicalTrials.gov NCT03288545 |
| المشرفين على المادة: | 0 (Antibodies, Monoclonal) 0 (Antibodies, Monoclonal, Humanized) Q20Q21Q62J (Cisplatin) DLE8519RWM (enfortumab vedotin) DPT0O3T46P (pembrolizumab) |
| تواريخ الأحداث: | Date Created: 20240112 Date Completed: 20240419 Latest Revision: 20240517 |
| رمز التحديث: | 20240517 |
| مُعرف محوري في PubMed: | PMC11095879 |
| DOI: | 10.1200/JCO.23.01547 |
| PMID: | 38215355 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1527-7755 |
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| DOI: | 10.1200/JCO.23.01547 |