Samer Salah1, Jae-Lyun Lee2, Antonio Rozzi3, Hiroshi Kitamura4, Kazumasa Matsumoto5, Daniel J Vis6, Sandy Srinivas7, Rafael Morales-Barrera8, Joan Carles8, Dalia Al-Rimawi9, Soonil Lee10, Ki Hong Kim11, Kouji Izumi12, Jeremy Lewin13. 1. Department of Medical Oncology and Hematology, Princess Margaret Cancer Center, Toronto, Canada. Electronic address: samer.salah@uhn.on.ca. 2. Department of Oncology and Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 3. Medical Oncology Unit, Istituto Neurotraumatologico Italiano (INI), Grottaferrata, Rome, Italy. 4. Department of Urology, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama, Japan. 5. Department of Urology, Kitasato University School of Medicine, Kanagawa, Japan. 6. Department of Molecular Carcinogenesis, Netherlands Cancer Institute, Amsterdam, Netherlands. 7. Medical Oncology Department, Stanford University Medical Center, Stanford, CA. 8. Genitourinary, CNS, and Sarcoma Tumor Unit, Vall d' Hebron University Hospital, Vall d' Hebron Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain. 9. Office of Scientific Affairs and Research, King Hussein Cancer Centre, Amman, Jordan. 10. Division of Hematology-Oncology, Department of Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, Korea. 11. Department of Urology, Soonchunhyang University College of Medicine, Cheonan, Chungcheongnam-do, Korea. 12. Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Ishikawa, Japan. 13. Department of Medical Oncology and Hematology, Princess Margaret Cancer Center, Toronto, Canada.
Abstract
BACKGROUND: Older patients with metastatic urothelial carcinoma (UC) are under-represented in clinical trials, and data regarding outcomes for second-line therapy is limited. MATERIALS AND METHODS: Individual data for patients with metastatic UC, aged ≥ 70 years, were pooled from 10 second-line studies. The influence of potential prognostic factors on overall survival (OS) was assessed via univariate and multivariate Cox regression analysis. RESULTS: In total, 102 patients were included; the median age was 74.0 years (range, 70-88 years). Second-line chemotherapy was single-agent in 42 (41%) patients and combination regimens in 60 (59%) patients. Median progression-free and OS were 4.3 and 9.7 months, respectively. In multivariate analysis, age > 75 years, Eastern Cooperative Oncology Group performance status ≥ 1, serum hemoglobin < 10 g/dL, and non-lymph node only metastasis predicted inferior OS. Median OS for patients with 0, 1, 2, and ≥ 3 adverse factors was unreached, 15.5, 9.8, and 4.8 months, respectively (P < .001). There was no difference in OS between patients treated with single-agent or combination chemotherapy. Combination regimens were associated with higher occurrences of any ≥ grade 2 toxicity (80% vs. 38%; P < .001), ≥ grade 2 hematologic (78% vs. 12%; P < .001), and ≥ grade 2 gastrointestinal toxicity (36% vs. 7%; P < .001). CONCLUSION: In this pooled analysis of older patients with metastatic UC, combination chemotherapy for second-line treatment was associated with greater toxicity without improvement in OS. Eastern Cooperative Oncology Group performance status ≥1, serum hemoglobin < 10 g/dL, and age > 75 years predicted worse survival, whereas isolated lymph node metastasis predicted a favorable outcome.
BACKGROUND: Older patients with metastatic urothelial carcinoma (UC) are under-represented in clinical trials, and data regarding outcomes for second-line therapy is limited. MATERIALS AND METHODS: Individual data for patients with metastatic UC, aged ≥ 70 years, were pooled from 10 second-line studies. The influence of potential prognostic factors on overall survival (OS) was assessed via univariate and multivariate Cox regression analysis. RESULTS: In total, 102 patients were included; the median age was 74.0 years (range, 70-88 years). Second-line chemotherapy was single-agent in 42 (41%) patients and combination regimens in 60 (59%) patients. Median progression-free and OS were 4.3 and 9.7 months, respectively. In multivariate analysis, age > 75 years, Eastern Cooperative Oncology Group performance status ≥ 1, serum hemoglobin < 10 g/dL, and non-lymph node only metastasis predicted inferior OS. Median OS for patients with 0, 1, 2, and ≥ 3 adverse factors was unreached, 15.5, 9.8, and 4.8 months, respectively (P < .001). There was no difference in OS between patients treated with single-agent or combination chemotherapy. Combination regimens were associated with higher occurrences of any ≥ grade 2 toxicity (80% vs. 38%; P < .001), ≥ grade 2 hematologic (78% vs. 12%; P < .001), and ≥ grade 2 gastrointestinal toxicity (36% vs. 7%; P < .001). CONCLUSION: In this pooled analysis of older patients with metastatic UC, combination chemotherapy for second-line treatment was associated with greater toxicity without improvement in OS. Eastern Cooperative Oncology Group performance status ≥1, serum hemoglobin < 10 g/dL, and age > 75 years predicted worse survival, whereas isolated lymph node metastasis predicted a favorable outcome.
Authors: Andrea B Apolo; John A Ellerton; Jeffrey R Infante; Manish Agrawal; Michael S Gordon; Raid Aljumaily; Theodore Gourdin; Luc Dirix; Keun-Wook Lee; Matthew H Taylor; Patrick Schöffski; Ding Wang; Alain Ravaud; Juliane Manitz; Gregory Pennock; Mary Ruisi; James L Gulley; Manish R Patel Journal: J Immunother Cancer Date: 2020-10 Impact factor: 13.751