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Randomized Comparison of Pazopanib and Doxorubicin as First-Line Treatment in Patients With Metastatic Soft Tissue Sarcoma Age 60 Years or Older: Results of a German Intergroup Study.
Grünwald, Viktor; Karch, Annika; Schuler, Markus; Schöffski, Patrick; Kopp, Hans-Georg; Bauer, Sebastian; Kasper, Bernd; Lindner, Lars H; Chemnitz, Jens-Marcus; Crysandt, Martina; Stein, Alexander; Steffen, Björn; Richter, Stephan; Egerer, Gerlinde; Ivanyi, Philipp; Zimmermann, Silke; Liu, Xiaofei; Kunitz, Annegret.
Afiliação
  • Grünwald V; Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Medical School Hannover, Hannover, Germany.
  • Karch A; Interdisciplinary Genitourinary Oncology at the West-German Cancer Center, Clinic for Internal Medicine (Tumor Research) and Clinic for Urology, University Hospital Essen, Essen, Germany.
  • Schuler M; Institute for Biostatistics, Medical School Hannover, Hannover, Germany.
  • Schöffski P; Helios Clinic, Berlin, Germany.
  • Kopp HG; Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, Katholieke Universiteit Leuven, Leuven, Belgium.
  • Bauer S; Robert Bosch Centrum für Tumorerkrankungen Stuttgart, Stuttgart, Germany.
  • Kasper B; Clinic for Internal Medicine (Tumor Research), University Hospital Essen, Essen, Germany.
  • Lindner LH; Sarcoma Unit, Mannheim University Medical Center, Mannheim, Germany.
  • Chemnitz JM; Department of Medicine III, University Hospital, Ludwig Maximilian University Munich, Munich, Germany.
  • Crysandt M; Community Hospital Middle Rine, Middle Rine, Germany.
  • Stein A; Department of Hematology, Oncology, Clinical Infectious Diseases, Clinical Immunology, Hemostaseology and Medical Intensive Care, University Hospital Cologne, Cologne, Germany.
  • Steffen B; University Hospital Aachen, Aachen, Germany.
  • Richter S; University Hospital Hamburg-Eppendorf, Hamburg-Eppendorf, Germany.
  • Egerer G; University Hospital Frankfurt, Frankfurt, Germany.
  • Ivanyi P; University Hospital Carl Gustav Carus, University Cancer Center/Medical Department I, Dresden, Germany.
  • Zimmermann S; University Hospital Heidelberg, Heidelberg, Germany.
  • Liu X; Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Medical School Hannover, Hannover, Germany.
  • Kunitz A; Hannover Clinical Trial Center, Hannover, Germany.
J Clin Oncol ; 38(30): 3555-3564, 2020 10 20.
Article em En | MEDLINE | ID: mdl-32840417
ABSTRACT

PURPOSE:

Doxorubicin is a standard of care in patients with advanced, inoperable soft tissue sarcoma (STS). We tested whether pazopanib has efficacy comparable to that of doxorubicin in elderly patients with STS and offers superior tolerability for hematologic toxicity. PATIENTS AND

METHODS:

Patients age 60 years or older without previous systemic treatment for progressive advanced or metastatic STS who had Eastern Cooperative Oncology Group performance status of 0 to 2 and adequate organ function were included. Treatment consisted of pazopanib 800 mg once per day or doxorubicin 75 mg/m2 once every 3 weeks (≤ 6 cycles) after being randomly assigned in a 21 ratio. Noninferiority was assumed for progression-free survival (PFS), if the upper limit of the 95% CI for the hazard ratio (HR) was less than 1.8. Neutropenia and febrile neutropenia were key secondary end points. The European Organisation for Research and Treatment of Cancer (30-item) Quality of Life Questionnaire and geriatric assessment were used to measure patient-reported outcomes. Cox regression analysis and Kaplan-Meier curves were used for analysis.

RESULTS:

Pazopanib and doxorubicin were given to 81 and 39 patients, respectively. The median age was 71 years (range, 60-88 years). PFS was noninferior (HR, 1.00; 95% CI, 0.65 to 1.53) and the incidence of grade 4 neutropenia and febrile neutropenia favored pazopanib. Objective response rates for pazopanib and doxorubicin were 12.3% and 15.4%, respectively. Overall survival did not differ significantly between arms (HR, 1.08; 95% CI, 0.68 to 1.72; P = .735). Geriatric assessment revealed 2 or more comorbidities in 15.8% of the patients and impairment of activities of daily living in 28.3% of patients.

CONCLUSION:

Pazopanib was noninferior to doxorubicin, rendering pazopanib a putative therapeutic option in the first-line treatment of STS in patients age 60 years or older. The distinct adverse event profile may be used to counsel patients and tailor therapy to individual needs.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirimidinas / Sarcoma / Sulfonamidas / Doxorrubicina Tipo de estudo: Clinical_trials / Etiology_studies Limite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Alemanha

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirimidinas / Sarcoma / Sulfonamidas / Doxorrubicina Tipo de estudo: Clinical_trials / Etiology_studies Limite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Oncol Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Alemanha