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Motesanib plus carboplatin/paclitaxel in patients with advanced squamous non-small-cell lung cancer: results from the
Silvia Novello1, Giorgio V Scagliotti, Oleksandr Sydorenko
1*Department of Oncology, University of Turin, San Luigi Hospital, Turin, Italy; †Thoracic Surgery Department, Zaporizhzhya State Medical University, Zaporizhzhya, Ukraine; ‡Sumy Regional Oncology Centre, Sumy State University, Sumy, Ukraine; §Centrul de Oncologie Medicala, Iasi, Romania; ‖Central Hospital Bad Berka, Bad Berka, Germany; ¶Department of Medical Oncology, The Christie National Health Services Foundation Trust, Manchester, United Kingdom; #Department of Biostatistics & Epidemiology, Amgen Inc., South San Francisco; **Department of Oncology, Amgen Inc., Thousand Oaks, CA; and ††Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, TN.
Introduction:
The phase 3 MONET1 study evaluated motesanib (a small-molecule inhibitor of vascular endothelial growth factor receptors) plus carboplatin/paclitaxel versus placebo plus carboplatin/paclitaxel as first-line therapy for advanced non-small-cell lung cancer (NSCLC). Treatment and enrollment of patients with squamous histology were permanently discontinued following higher early mortality and gross hemoptysis in those with squamous NSCLC who received motesanib. Enrollment of patients with nonsquamous histology was temporarily halted, but resumed following a protocol amendment (Scagliotti et al. J Clin Oncol. 2012;30:2829-2836). Herein, we report data from the squamous cohort.
Methods:
Patients with stage IIIB/IV or recurrent squamous NSCLC (without prior systemic therapy for advanced disease) received up to six 3-week cycles of chemotherapy (carboplatin, area under the curve 6 mg/mL•min/paclitaxel, 200 mg/m) and were randomized 1:1 to receive motesanib 125 mg (Arm A) or placebo (Arm B) once daily. The primary end point was overall survival.
Results:
Three-hundred and sixty patients with squamous NSCLC were randomized (Arm A, n = 182; Arm B, n = 178) between July 2007 and November 2008. Twenty-three patients (13%) in Arm A and 10 (6%) in Arm B had fatal adverse events within the first 60 days of treatment. Among these, six patients in Arm A, but none in Arm B, had fatal bleeding events. At final analysis, serious adverse events had occurred in 47% of patients in Arm A and 29% of patients in Arm B. Median overall survival was similar in Arms A and B (11.1 versus 10.7 months).
Conclusions:
Motesanib plus carboplatin/paclitaxel had unacceptable toxicity compared with carboplatin/paclitaxel alone in patients with advanced squamous NSCLC.
Insights
Motesanib combined with chemotherapy showed unacceptable toxicity in advanced squamous non-small-cell lung cancer (NSCLC). The addition of motesanib led to higher early mortality and fatal bleeding events compared to chemotherapy alone.
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- The MONET1 phase 3 study investigated motesanib, a VEGFR inhibitor, combined with carboplatin/paclitaxel for advanced non-small-cell lung cancer (NSCLC).
- Early findings indicated higher mortality and hemoptysis in squamous NSCLC patients receiving motesanib, leading to treatment discontinuation for this subgroup.
Purpose of the Study:
- To report the safety and efficacy data from the squamous NSCLC cohort of the MONET1 study.
- To compare overall survival and adverse events between motesanib plus chemotherapy and placebo plus chemotherapy in advanced squamous NSCLC.
Main Methods:
- 360 patients with advanced squamous NSCLC received carboplatin/paclitaxel plus either motesanib (Arm A) or placebo (Arm B).
- Patients received up to six cycles of chemotherapy, with motesanib or placebo administered daily.
- The primary endpoint was overall survival.
Main Results:
- Fatal adverse events occurred in 13% of patients in the motesanib arm versus 6% in the placebo arm within 60 days.
- Six fatal bleeding events were observed in the motesanib arm, compared to none in the placebo arm.
- Median overall survival was similar between arms (11.1 months vs. 10.7 months), but serious adverse events were higher with motesanib (47% vs. 29%).
Conclusions:
- Motesanib plus carboplatin/paclitaxel demonstrated unacceptable toxicity in advanced squamous NSCLC.
- The combination therapy showed no significant improvement in overall survival despite increased risks.
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