Abstract | PURPOSE: PATIENTS AND METHODS: This was an open-label, single-arm, multicenter, phase II study with a Simon two-stage minimax design. Patients received a starting dose of axitinib 5 mg orally BID. The primary end point was Response Evaluation Criteria in Solid Tumors (RECIST) -defined objective response rate. Secondary end points included safety and tolerability, overall survival (OS), and progression-free survival (PFS). RESULTS: Thirty-two patients were enrolled, with a median age of 66.5 years. The majority of patients (75%) had adenocarcinoma. Nine patients (28%) had received no prior chemotherapy for metastatic disease, and 23 (72%) had received > or = one regimen. Three patients (9%) had a RECIST investigator-assessed, confirmed partial response (PR); disease control rate (PR + stable disease) was 41%. Median PFS was 4.9 months overall (95% CI, 3.6 to 7.0 months). Median OS was 14.8 months (95% CI, 10.7 months to not estimable) overall and 14.8 months (95% CI, 12.5 months to not estimable) in patients receiving first-line axitinib. One-year survival rates for patients with or without prior therapy for metastatic disease were 57% and 78%, respectively. Grade 3 treatment-related adverse events in > or = 5% of patients comprised fatigue (22%), hypertension (9%), and hyponatremia (9%). CONCLUSION:
Axitinib demonstrated single-agent activity in patients with advanced NSCLC. Therapy was well tolerated with manageable toxicities. Further investigation of this VEGFR inhibitor in NSCLC is of interest.
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Authors | Joan H Schiller, Timothy Larson, S-H Ignatius Ou, Steven Limentani, Alan Sandler, Everett Vokes, Sinil Kim, Katherine Liau, Paul Bycott, Anthony J Olszanski, Joachim von Pawel |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 27
Issue 23
Pg. 3836-41
(Aug 10 2009)
ISSN: 1527-7755 [Electronic] United States |
PMID | 19597027
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents
- Imidazoles
- Indazoles
- Axitinib
- Receptors, Vascular Endothelial Growth Factor
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Topics |
- Administration, Oral
- Adult
- Aged
- Antineoplastic Agents
(administration & dosage, adverse effects, therapeutic use)
- Axitinib
- Carcinoma, Non-Small-Cell Lung
(drug therapy, pathology)
- Disease-Free Survival
- Drug Administration Schedule
- Female
- Humans
- Imidazoles
(administration & dosage, adverse effects, therapeutic use)
- Indazoles
(administration & dosage, adverse effects, therapeutic use)
- Kaplan-Meier Estimate
- Lung Neoplasms
(drug therapy, pathology)
- Male
- Middle Aged
- Receptors, Vascular Endothelial Growth Factor
(antagonists & inhibitors)
- Treatment Outcome
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