A phase II, open-label study of ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patients with stage IIIB/IV non-small-cell lung cancer

D. Ross Camidge, Eamon M. Berge, Robert C. Doebele, Marc S. Ballas, Thierry Jahan, Missak Haigentz, David Hoffman, James Spicer, Howard West, Pablo Lee, Ling Yang, Adarsh Joshi, Ling Gao, Sergey Yurasov, Alain Mita

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

Introduction: The objective of this study was to determine whether the addition of ramucirumab to first-line paclitaxel-carboplatin chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) resulted in a 6-month progression-free survival (PFS) rate that compares favorably with the historic rate for bevacizumab combined with paclitaxel-carboplatin in this patient population. Methods: In this phase II, single-arm, open-label, multicenter study, 40 patients with advanced NSCLC received ramucirumab (10 mg/kg intravenous [IV]) followed by paclitaxel (200 mg/m 2 IV) and carboplatin area under the curve = 6 on day 1 every 21 days as first-line therapy. Therapy continued for up to six cycles. Patients not experiencing withdrawal criteria may have continued ramucirumab monotherapy every 3 weeks. The primary endpoint was PFS at 6 months, with 80% power to detect a 6-month PFS rate of at least 55%. Results: The 6-month PFS rate was 59.0% and the objective response rate was 55.0%. The most common treatment-related adverse events were fatigue, peripheral neuropathy, nausea, epistaxis, and myalgia. Single-nucleotide polymorphism (SNP) rs2981582 on the FGFR-2 gene had significant associations with improved overall survival, PFS, and best overall response (p values without multiplicity adjustment were 0.0059, 0.0429, and 0.0392, respectively). Conclusion: Ramucirumab in combination with paclitaxel-carboplatin resulted in a 6-month PFS rate and safety profile that compared favorably with the historical control. In addition, no deaths were associated with this treatment. Furthermore, we describe an association of SNP on FGFR-2 gene with survival and response. These findings warrant further clinical investigation in patients with NSCLC.

Original languageEnglish (US)
Pages (from-to)1532-1539
Number of pages8
JournalJournal of Thoracic Oncology
Volume9
Issue number10
DOIs
StatePublished - Oct 1 2014
Externally publishedYes

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Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Disease-Free Survival
Survival Rate
Single Nucleotide Polymorphism
Therapeutics
Social Adjustment
Epistaxis
Survival
Myalgia
Peripheral Nervous System Diseases
Nausea
Genes
Multicenter Studies
Area Under Curve
Fatigue
ramucirumab
Safety
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Camidge, D. Ross ; Berge, Eamon M. ; Doebele, Robert C. ; Ballas, Marc S. ; Jahan, Thierry ; Haigentz, Missak ; Hoffman, David ; Spicer, James ; West, Howard ; Lee, Pablo ; Yang, Ling ; Joshi, Adarsh ; Gao, Ling ; Yurasov, Sergey ; Mita, Alain. / A phase II, open-label study of ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patients with stage IIIB/IV non-small-cell lung cancer. In: Journal of Thoracic Oncology. 2014 ; Vol. 9, No. 10. pp. 1532-1539.
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title = "A phase II, open-label study of ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patients with stage IIIB/IV non-small-cell lung cancer",
abstract = "Introduction: The objective of this study was to determine whether the addition of ramucirumab to first-line paclitaxel-carboplatin chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) resulted in a 6-month progression-free survival (PFS) rate that compares favorably with the historic rate for bevacizumab combined with paclitaxel-carboplatin in this patient population. Methods: In this phase II, single-arm, open-label, multicenter study, 40 patients with advanced NSCLC received ramucirumab (10 mg/kg intravenous [IV]) followed by paclitaxel (200 mg/m 2 IV) and carboplatin area under the curve = 6 on day 1 every 21 days as first-line therapy. Therapy continued for up to six cycles. Patients not experiencing withdrawal criteria may have continued ramucirumab monotherapy every 3 weeks. The primary endpoint was PFS at 6 months, with 80{\%} power to detect a 6-month PFS rate of at least 55{\%}. Results: The 6-month PFS rate was 59.0{\%} and the objective response rate was 55.0{\%}. The most common treatment-related adverse events were fatigue, peripheral neuropathy, nausea, epistaxis, and myalgia. Single-nucleotide polymorphism (SNP) rs2981582 on the FGFR-2 gene had significant associations with improved overall survival, PFS, and best overall response (p values without multiplicity adjustment were 0.0059, 0.0429, and 0.0392, respectively). Conclusion: Ramucirumab in combination with paclitaxel-carboplatin resulted in a 6-month PFS rate and safety profile that compared favorably with the historical control. In addition, no deaths were associated with this treatment. Furthermore, we describe an association of SNP on FGFR-2 gene with survival and response. These findings warrant further clinical investigation in patients with NSCLC.",
author = "Camidge, {D. Ross} and Berge, {Eamon M.} and Doebele, {Robert C.} and Ballas, {Marc S.} and Thierry Jahan and Missak Haigentz and David Hoffman and James Spicer and Howard West and Pablo Lee and Ling Yang and Adarsh Joshi and Ling Gao and Sergey Yurasov and Alain Mita",
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Camidge, DR, Berge, EM, Doebele, RC, Ballas, MS, Jahan, T, Haigentz, M, Hoffman, D, Spicer, J, West, H, Lee, P, Yang, L, Joshi, A, Gao, L, Yurasov, S & Mita, A 2014, 'A phase II, open-label study of ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patients with stage IIIB/IV non-small-cell lung cancer', Journal of Thoracic Oncology, vol. 9, no. 10, pp. 1532-1539. https://doi.org/10.1097/JTO.0000000000000273

A phase II, open-label study of ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patients with stage IIIB/IV non-small-cell lung cancer. / Camidge, D. Ross; Berge, Eamon M.; Doebele, Robert C.; Ballas, Marc S.; Jahan, Thierry; Haigentz, Missak; Hoffman, David; Spicer, James; West, Howard; Lee, Pablo; Yang, Ling; Joshi, Adarsh; Gao, Ling; Yurasov, Sergey; Mita, Alain.

In: Journal of Thoracic Oncology, Vol. 9, No. 10, 01.10.2014, p. 1532-1539.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A phase II, open-label study of ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patients with stage IIIB/IV non-small-cell lung cancer

AU - Camidge, D. Ross

AU - Berge, Eamon M.

AU - Doebele, Robert C.

AU - Ballas, Marc S.

AU - Jahan, Thierry

AU - Haigentz, Missak

AU - Hoffman, David

AU - Spicer, James

AU - West, Howard

AU - Lee, Pablo

AU - Yang, Ling

AU - Joshi, Adarsh

AU - Gao, Ling

AU - Yurasov, Sergey

AU - Mita, Alain

PY - 2014/10/1

Y1 - 2014/10/1

N2 - Introduction: The objective of this study was to determine whether the addition of ramucirumab to first-line paclitaxel-carboplatin chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) resulted in a 6-month progression-free survival (PFS) rate that compares favorably with the historic rate for bevacizumab combined with paclitaxel-carboplatin in this patient population. Methods: In this phase II, single-arm, open-label, multicenter study, 40 patients with advanced NSCLC received ramucirumab (10 mg/kg intravenous [IV]) followed by paclitaxel (200 mg/m 2 IV) and carboplatin area under the curve = 6 on day 1 every 21 days as first-line therapy. Therapy continued for up to six cycles. Patients not experiencing withdrawal criteria may have continued ramucirumab monotherapy every 3 weeks. The primary endpoint was PFS at 6 months, with 80% power to detect a 6-month PFS rate of at least 55%. Results: The 6-month PFS rate was 59.0% and the objective response rate was 55.0%. The most common treatment-related adverse events were fatigue, peripheral neuropathy, nausea, epistaxis, and myalgia. Single-nucleotide polymorphism (SNP) rs2981582 on the FGFR-2 gene had significant associations with improved overall survival, PFS, and best overall response (p values without multiplicity adjustment were 0.0059, 0.0429, and 0.0392, respectively). Conclusion: Ramucirumab in combination with paclitaxel-carboplatin resulted in a 6-month PFS rate and safety profile that compared favorably with the historical control. In addition, no deaths were associated with this treatment. Furthermore, we describe an association of SNP on FGFR-2 gene with survival and response. These findings warrant further clinical investigation in patients with NSCLC.

AB - Introduction: The objective of this study was to determine whether the addition of ramucirumab to first-line paclitaxel-carboplatin chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) resulted in a 6-month progression-free survival (PFS) rate that compares favorably with the historic rate for bevacizumab combined with paclitaxel-carboplatin in this patient population. Methods: In this phase II, single-arm, open-label, multicenter study, 40 patients with advanced NSCLC received ramucirumab (10 mg/kg intravenous [IV]) followed by paclitaxel (200 mg/m 2 IV) and carboplatin area under the curve = 6 on day 1 every 21 days as first-line therapy. Therapy continued for up to six cycles. Patients not experiencing withdrawal criteria may have continued ramucirumab monotherapy every 3 weeks. The primary endpoint was PFS at 6 months, with 80% power to detect a 6-month PFS rate of at least 55%. Results: The 6-month PFS rate was 59.0% and the objective response rate was 55.0%. The most common treatment-related adverse events were fatigue, peripheral neuropathy, nausea, epistaxis, and myalgia. Single-nucleotide polymorphism (SNP) rs2981582 on the FGFR-2 gene had significant associations with improved overall survival, PFS, and best overall response (p values without multiplicity adjustment were 0.0059, 0.0429, and 0.0392, respectively). Conclusion: Ramucirumab in combination with paclitaxel-carboplatin resulted in a 6-month PFS rate and safety profile that compared favorably with the historical control. In addition, no deaths were associated with this treatment. Furthermore, we describe an association of SNP on FGFR-2 gene with survival and response. These findings warrant further clinical investigation in patients with NSCLC.

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