Study Type – Therapy (case series)
Level of Evidence 4
What’s known on the subject? and What does the study add?
At this point there is very little known about the benefit of combining antiangiogenic therapy and chemotherapy in the treatment of advanced renal cell carcinoma. This retrospective study provides important preliminary data on combination therapy, and forms the basis of an ongoing clinical trial testing the combination of gemcitabine, capecitabine and bevacizumab in patients with sarcomatoid renal cell carcinoma.
• To investigate the effect of combining gemcitabine plus capecitabine (GX) with bevacizumab (A) in patients with metastatic RCC previously treated with cytokines and targeted agents.
• The combination of GX + A was evaluated in patients with metastatic RCC using institutional databases.
• Data included demographics, previous therapies, number of metastatic sites, Memorial Sloan-Kettering Cancer Center risk stratification variables, and previous nephrectomy status.
• Descriptive statistics and survival analysis were employed for data analysis.
• Between January 2005 and October 2008, 28 patients were identified. Mean age was 55.7 years. Fifteen (53.57%) patients had been given tyrosine kinase inhibitor (TKI) previously. Nine (32.14%) patients had clear cell histology, 10 (35.71%) patients had sarcomatoid features on histopathology, and 19 patients (67.86%) had a prior nephrectomy.
• Initial treatment consisted of G (mean dose 786.07 mg/m2) every 2 weeks, X (mean dose 2.73 g/day), and A (mean dose 10 mg/kg) every 2 weeks. Median progression-free survival (PFS) was 5.9 months and the median overall survival (OS) was 10.4 months.
• In patients with previous TKI therapy, median PFS was 6.2 months and median OS was 11.7 months.
• In patients with sarcomatoid features, median PFS was 3.9 months and OS was 9.0 months.
• Three patients discontinued one or more of the drugs because of adverse reactions.
• The combination of GX + A shows potential efficacy and acceptable tolerability in patients with intermediate and poor prognosis metastatic RCC.
• Based on these observations, a phase II trial is now underway assessing this combination in patients with sarcomatoid RCC.