Sarcoma

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

In the October 20, 2020 edition of Journal of Clinical Oncology, Viktor Grünwald and colleagues report on the results of a phase 2 trial in advanced untreated STS in elderly patients randomized to either pazopanib or doxorubicin.

The investigators tested whether pazopanib has efficacy comparable to that of doxorubicin, which is standard of care in the first-line for advanced soft tissue sarcoma, in elderly patients with STS and offers superior tolerability for hematologic toxicity.

PATIENTS AND METHODS

Patients over the age of 60, without previous systemic treatment for progressive advanced or metastatic STS with an ECOG of 0 – 2 and acceptable organ function were included in the trial. Treatment involved pazopanib 800 mg once daily or doxorubicin dosed at 75 mg/m2 q3 weeks (up to 6 cycles) after randomization in a 2:1 ratio. Noninferiority was assumed for PFS, if the upper limit of the 95% CI for HR was less than 1.8.  Rates of neutropenia and febrile neutropenia were 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. Kaplan-Meier and Cox regression analysis curves were utilized.

RESULTS

81 and 39 patients, received pazopanib and doxorubicin, respectively. The median age was 71 years (range, 60-88 years).  Progression free survival was noninferior (HR, 1.00; 95% CI, 0.65 to 1.53) and the incidence of grade 4 neutropenia and febrile neutropenia was in favor of pazopanib. ORR for pazopanib was 12.3% and doxorubicin was 15.4%, respectively.  There was no difference in overall survival in both 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.

The authors concluded “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.”

Reference:

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

https://ascopubs.org/doi/full/10.1200/JCO.20.00714

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