Survival outcomes and risk group validation from SWOG S0925, a randomized phase II study of cixutumumab in new metastatic hormone-sensitive prostate cancer
| Autor: | Risa L. Wong, David I. Quinn, Mai T. Duong, Nicholas J. Vogelzang, Evan Y. Yu, Ian M. Thompson, Heather H. Cheng, Maha Hussain, Neeraj Agarwal, Catherine M. Tangen |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Oncology
Male Cancer Research medicine.medical_specialty medicine.drug_class Urology Population 030232 urology & nephrology Phases of clinical research Disease Kaplan-Meier Estimate Antibodies Monoclonal Humanized Risk Assessment Article 03 medical and health sciences chemistry.chemical_compound Prostate cancer 0302 clinical medicine Risk Factors Internal medicine Antineoplastic Combined Chemotherapy Protocols Medicine Humans education Aged education.field_of_study business.industry Proportional hazards model Prostate Cixutumumab Prostatic Neoplasms Androgen Antagonists Middle Aged Prostate-Specific Antigen Androgen medicine.disease Prognosis Progression-Free Survival Castration chemistry 030220 oncology & carcinogenesis Kallikreins business |
| Zdroj: | Prostate cancer and prostatic diseases |
| ISSN: | 1476-5608 1365-7852 |
| Popis: | Background: Cixutumumab, a monoclonal antibody targeting insulin-like growth factor I receptor, did not improve undetectable PSA rate at 28 weeks when combined with androgen deprivation in the randomized phase II SWOG S0925 trial for patients with new metastatic hormone-sensitive prostate cancer. We now present mature survival analyses, along with pre-specified secondary and exploratory endpoints. Methods: We randomized 210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm. We used Kaplan-Meier curves to analyze overall survival, radiographic progression-free survival, and castration resistance-free survival by treatment arm, disease volume, and risk group. We explored differences in survival by treatment arm via covariate-adjusted Cox proportional hazards models adjusted for disease volume and risk. Results: No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p=0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p=0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p=0.88). At baseline, 105/198 (53.0%) patients had high risk features and 119/210 (56.7%) had high volume disease; 16.7% of patients had discordant classifications of high or low category for risk and volume. Adjusting for risk or volume yielded no differences in overall survival between arms. Inferior survival was observed in high risk (HR 1.89 [1.29-2.80]; p=0.001) and high volume (HR 2.75 [1.84-4.10]; p0.2 to ≤4.0 ng/mL (HR 3.72 [1.99-6.95]; p4.0 ng/mL (HR 7.13 [4.24-11.9]; p |
| Databáze: | OpenAIRE |
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