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Published on: February 12, 2017
Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung
Chandra P Belani1, Nobuyuki Yamamoto, Igor M Bondarenko
1Penn State Milton S, Hershey Medical Center, Penn State Hershey Cancer Institute, Hershey, PA, USA. cbelani@hmc.psu.edu.
Background:
The efficacy and safety of axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 in combination with pemetrexed and cisplatin was evaluated in patients with advanced non-squamous non-small-cell lung cancer (NSCLC).
Methods:
Overall, 170 patients were randomly assigned to receive axitinib at a starting dose of 5-mg twice daily continuously plus pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) on day 1 of up to six 21-day cycles (arm I); axitinib on days 2 through 19 of each cycle plus pemetrexed/cisplatin (arm II); or pemetrexed/cisplatin alone (arm III). The primary endpoint was progression-free survival (PFS).
Results:
Median PFS was 8.0, 7.9, and 7.1 months in arms I, II, and III, respectively (hazard ratio: arms I vs. III, 0.89 [P = 0.36] and arms II vs. III, 1.02 [P = 0.54]). Median overall survival was 17.0 months (arm I), 14.7 months (arm II), and 15.9 months (arm III). Objective response rates (ORRs) for axitinib-containing arms were 45.5% (arm I) and 39.7% (arm II) compared with 26.3% for pemetrexed/cisplatin alone (arm III). Gastrointestinal disorders and fatigue were frequently reported across all treatment arms. The most common all-causality grade ≥3 adverse events were hypertension in axitinib-containing arms (20% and 17%, arms I and II, respectively) and fatigue with pemetrexed/cisplatin alone (16%).
Conclusion:
Axitinib in combination with pemetrexed/cisplatin was generally well tolerated. Axitinib combinations resulted in non-significant differences in PFS and numerically higher ORR compared with chemotherapy alone in advanced NSCLC.
Trial Registration:
ClinicalTrials.gov: NCT00768755 (October 7, 2008).
Insights
Axitinib combined with chemotherapy showed a higher objective response rate but no significant improvement in progression-free survival for advanced non-small-cell lung cancer patients. The combination was generally well-tolerated, with hypertension as a common side effect.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- Investigated the efficacy and safety of axitinib, a VEGFR inhibitor, combined with chemotherapy for advanced non-squamous non-small-cell lung cancer (NSCLC).
- Evaluated axitinib in combination with pemetrexed and cisplatin against standard chemotherapy.
- Trial registered under NCT00768755.
Purpose of the Study:
- To assess the efficacy and safety of axitinib plus pemetrexed/cisplatin in advanced NSCLC.
- To compare progression-free survival (PFS) and objective response rates (ORR) between treatment arms.
- To identify adverse events associated with the combination therapy.
Main Methods:
- 170 patients with advanced NSCLC were randomized into three arms.
- Arm I: Axitinib continuous + Pemetrexed/Cisplatin.
- Arm II: Axitinib intermittent + Pemetrexed/Cisplatin.
- Arm III: Pemetrexed/Cisplatin alone. Primary endpoint was PFS.
Main Results:
- Median PFS was 8.0 months (Arm I), 7.9 months (Arm II), and 7.1 months (Arm III), with no significant difference (PFS HRs vs. Arm III: 0.89 and 1.02).
- Objective response rates (ORRs) were higher in axitinib arms (45.5% and 39.7%) compared to chemotherapy alone (26.3%).
- Hypertension was a common grade ≥3 adverse event in axitinib arms (20% and 17%).
Conclusions:
- Axitinib in combination with pemetrexed/cisplatin demonstrated generally good tolerability in advanced NSCLC.
- The combination therapy resulted in numerically higher ORRs but did not significantly improve PFS compared to chemotherapy alone.
- Further research may explore optimized combination strategies for NSCLC treatment.
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