Southwest Oncology Group S0802: a randomized, phase II trial of weekly topotecan with and without ziv-aflibercept in patients with platinum-treated small-cell lung cancer

Jeffrey W Allen; James Moon; Mary Redman; Shirish M Gadgeel; Karen Kelly; Philip C Mack; Hanna M Saba; Mohamed K Mohamed; Mohammad Jahanzeb; David R Gandara

doi:10.1200/JCO.2013.51.4109

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Southwest Oncology Group S0802: a randomized, phase II trial of weekly topotecan with and without ziv-aflibercept in patients with platinum-treated small-cell lung cancer

Journal article

Open access

Peer reviewed

Southwest Oncology Group S0802: a randomized, phase II trial of weekly topotecan with and without ziv-aflibercept in patients with platinum-treated small-cell lung cancer

Jeffrey W Allen, James Moon, Mary Redman, Shirish M Gadgeel, Karen Kelly, Philip C Mack, Hanna M Saba, Mohamed K Mohamed, Mohammad Jahanzeb and David R Gandara

Journal of clinical oncology, Vol.32(23), pp.2463-2470

2014-08-10

DOI: https://doi.org/10.1200/JCO.2013.51.4109

PMCID: PMC4121504

PMID: 25002722

Abstract

Antineoplastic Combined Chemotherapy Protocols - therapeutic use

Female

Humans

Lung Neoplasms - drug therapy

Lung Neoplasms - pathology

Male

Middle Aged

Receptors, Vascular Endothelial Growth Factor - administration & dosage

Recombinant Fusion Proteins - administration & dosage

Small Cell Lung Carcinoma - drug therapy

Small Cell Lung Carcinoma - pathology

Survival Analysis

Topoisomerase I Inhibitors - administration & dosage

Topotecan - administration & dosage

Topotecan - therapeutic use

Development of new therapies for previously treated small-cell lung cancer (SCLC) is a major unmet need. Here, we describe a randomized, phase II trial of weekly topotecan with or without ziv-aflibercept (VEGF-trap) in this clinical setting. Patients with previously treated SCLC (one line of platinum-based chemotherapy), performance status of 0 to 1, adequate organ function, treated brain metastases, and no recent vascular events or bleeding diatheses were eligible. Eligible patients were stratified as platinum-sensitive or platinum-refractory and randomly assigned to receive weekly topotecan 4 mg/m(2) intravenously (IV) with or without ziv-aflibercept 6 mg/kg IV every 21 days. Progression-free survival (PFS) at 3 months was the primary end point. In 189 randomly assigned patients, treatment arms were well balanced with regard to clinical characteristics. The 3-month PFS was significantly improved with the addition of ziv-aflibercept in patients who had platinum-refractory disease (27% v 10%; P = .02) but not in patients with platinum-sensitive disease (24% v 15%; P = .22). Although response rate was low, disease control rate was higher with combination therapy than with topotecan alone in patients who had platinum-sensitive disease (37% v 18%; P = .05) and in those who had platinum-refractory disease (25% v 15%; P = .14). Overall survival (OS) was not significantly improved in either strata. Grades 3 to 5 toxicities were more common with the addition of ziv-aflibercept. Ziv-aflibercept improved the 3-month PFS in patients who had platinum-refractory SCLC, but its addition increased toxicity. OS was similar with combined ziv-aflibercept and topotecan compared with topotecan in both strata.

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Collaboration types: Domestic collaboration
Citation topics: 1 Clinical & Life Sciences; 1.199 Lung Cancer; 1.199.1885 Small Cell Lung Cancer
Web Of Science research areas: Oncology
ESI research areas: Clinical Medicine

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Title: Southwest Oncology Group S0802: a randomized, phase II trial of weekly topotecan with and without ziv-aflibercept in patients with platinum-treated small-cell lung cancer
Creators: Jeffrey W Allen - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL. Jeffrey.allen@stjoe.org
James Moon - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL
Mary Redman - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL
Shirish M Gadgeel - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL
Karen Kelly - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL
Philip C Mack - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL
Hanna M Saba - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL
Mohamed K Mohamed - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL
Mohammad Jahanzeb - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL
David R Gandara - Jeffrey W. Allen, University of Tennessee Health Science Center, Memphis, TN; James Moon, Mary Redman, Southwest Oncology Group Statistical Center, Seattle, WA; Shirish M. Gadgeel, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Karen Kelly, Phillip C. Mack, David R. Gandara, University of California Davis Cancer Center, Sacramento, CA; Hanna M. Saba, Central Illinois CCOP/Cancer Care Specialists of Central Illinois, Effingham, IL; Mohamed K. Mohamed, Moses Cone Health System, Greensboro, NC; and Mohammad Jahanzeb, University of Miami, Miami, FL
Publication Details: Journal of clinical oncology, Vol.32(23), pp.2463-2470
Grant note: CA63848 / NCI NIH HHS CA46113 / NCI NIH HHS U10 CA052654 / NCI NIH HHS CA45377 / NCI NIH HHS CA74647 / NCI NIH HHS N01 CA045560 / NCI NIH HHS U10 CA014028 / NCI NIH HHS N01 CA067575 / NCI NIH HHS U10 CA035431 / NCI NIH HHS U10 CA045807 / NCI NIH HHS N01 CA038926 / NCI NIH HHS U10 CA180819 / NCI NIH HHS U10 CA180888 / NCI NIH HHS N01 CA032102 / NCI NIH HHS N01 CA013612 / NCI NIH HHS CA11083 / NCI NIH HHS CA46368 / NCI NIH HHS U10 CA046282 / NCI NIH HHS U10 CA045808 / NCI NIH HHS U10 CA035119 / NCI NIH HHS CA52654 / NCI NIH HHS N01 CA046441 / NCI NIH HHS CA58861 / NCI NIH HHS N01 CA027057 / NCI NIH HHS U10 CA035128 / NCI NIH HHS N01 CA004919 / NCI NIH HHS CA37981 / NCI NIH HHS CA16385 / NCI NIH HHS CA35128 / NCI NIH HHS U10 CA058861 / NCI NIH HHS U10 CA035178 / NCI NIH HHS U10 CA004919 / NCI NIH HHS CA45808 / NCI NIH HHS U10 CA063845 / NCI NIH HHS CA35421 / NCI NIH HHS U10 CA020319 / NCI NIH HHS U10 CA180846 / NCI NIH HHS CA14028 / NCI NIH HHS U10 CA045560 / NCI NIH HHS U10 CA046368 / NCI NIH HHS CA46282 / NCI NIH HHS CA42777 / NCI NIH HHS U10 CA074647 / NCI NIH HHS N01 CA035431 / NCI NIH HHS U10 CA032102 / NCI NIH HHS U10 CA045377 / NCI NIH HHS CA68183 / NCI NIH HHS U10 CA035261 / NCI NIH HHS U10 CA035090 / NCI NIH HHS N01 CA045807 / NCI NIH HHS U10 CA067575 / NCI NIH HHS U10 CA011083 / NCI NIH HHS CA35261 / NCI NIH HHS U10 CA038926 / NCI NIH HHS CA35090 / NCI NIH HHS U10 CA042777 / NCI NIH HHS CA76447 / NCI NIH HHS U10 CA013612 / NCI NIH HHS U10 CA063848 / NCI NIH HHS U10 CA035421 / NCI NIH HHS U10 CA046441 / NCI NIH HHS U10 CA027057 / NCI NIH HHS CA22433 / NCI NIH HHS CA45450 / NCI NIH HHS N01 CA035119 / NCI NIH HHS CA20319 / NCI NIH HHS CA12644 / NCI NIH HHS CA63845 / NCI NIH HHS U10 CA045450 / NCI NIH HHS P30 CA093373 / NCI NIH HHS N01 CA035178 / NCI NIH HHS CA76429 / NCI NIH HHS
Language: English
Resource Type: Journal article
PMID: 25002722
PMCID: PMC4121504
Record Identifier: 991031615033002976