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- PATIENTS AND METHODS
- CONFLICT OF INTEREST
Study Type – Therapy (case series)
Level of Evidence 4
What’s known on the subject? and What does the study add?
Second line therapy in metastatic RCC is often mTOR directed therapies. There are no approved drugs to overcome VEGFR tyrosine-kinase inhibitor (TKI) resistance. The combination of gemcitabine and sunitinib has been a safe and active combination in untreated mRCC based on Phase I data. However, the benefit of adding gemcitabine to sunitinib in sunitinib refractory cases was unknown until our case series.
This case series provides clinical rationale for combining sunitinib and gemcitabine in sunitinib refractory cases. This novel combination could be formally tested in a prospective randomized trial to determine its activity and impact on progression free survival. Additionally, further testing could provide insight into the mechanisms involved in overcoming sunitinib resistance.
• To investigate the role of adding gemcitabine at the time of sunitinib failure in patients with metastatic renal cell cancer (mRCC).
PATIENTS AND METHODS
• A retrospective chart review of 13 patients with mRCC who experienced disease progression on sunitinib and received gemcitabine 750 mg/m2 i.v. on days 1 and 8 and sunitinib 37.5 mg/day on days 2–15 every 21 days from September 2006–2009 was carried out.
• Responses were assessed using the Response Evaluation Criteria in Solid Tumors.
• The median age was 59, male to female ratio 10:3, Eastern Cooperative Oncology Group performance status 1–3; the number of prior regimens ranged from one to five, and duration on sunitinib alone ranged from 3 months to >1 year.
• Twelve out of 13 patients received more than two cycles with one documented partial response, five stable disease and seven progressive disease.
• The median time to progression was 21 weeks.
• We documented grade 4 pulmonary emboli (n= 1), grade 3 neutropenia (n= 2), anaemia (n= 2) and thrombocytopenia (n= 1).
• The combination of sunitinib and gemcitabine in patients with mRCC may delay disease progression in some patients exhibiting resistance to sunitinib. This regimen merits further prospective investigation in this patient population.