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A phase I trial of sunitinib and rapamycin in patients with advanced non-small cell lung cancer

Saiama N Waqar1, Priya K Gopalan, Kristina Williams

  • 1Division of Medical Oncology, Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO 63110, USA.

Chemotherapy
|May 3, 2013
PubMed
Abstract

Insights

The combination of sunitinib and rapamycin showed acceptable tolerability in advanced non-small cell lung cancer (NSCLC) patients. Further phase II studies are warranted to explore this combination therapy for NSCLC.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Sunitinib, an oral multitargeted tyrosine kinase inhibitor, demonstrates activity in non-small cell lung cancer (NSCLC).
  • Resistance to tyrosine kinase inhibitors (TKIs) involves the mammalian target of rapamycin (mTOR) pathway, suggesting mTOR inhibitors could reverse resistance.

Purpose of the Study:

  • To evaluate the safety and tolerability of combining sunitinib and rapamycin in advanced NSCLC patients.
  • To determine the maximum tolerated dose (MTD) for this combination therapy.

Main Methods:

  • A phase I clinical study was conducted.
  • Nineteen patients with advanced NSCLC were enrolled.
  • Dose-limiting toxicities were identified to establish the MTD.

Main Results:

  • The maximum tolerated dose was determined as sunitinib 25 mg daily and rapamycin 2 mg daily, with a 4-weeks-on/2-weeks-off schedule.
  • The most frequent dose-limiting toxicities included infection, pneumonia, diarrhea/dehydration, and treatment delay due to thrombocytopenia.
  • No objective responses were observed; however, 6 patients achieved stable disease as their best response.

Conclusions:

  • The combination of sunitinib and rapamycin is well-tolerated in patients with advanced NSCLC.
  • This combination warrants further investigation in phase II clinical trials for NSCLC treatment.

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