Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014
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.
Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 6 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 6 pooled it
4.9field-weighted citation impact, top 3% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
46 citing papers in PubMed, 6 syntheses or guidelines pooled it, 73 citations in OpenAlex.
- Comparison of the second-line treatments for patients with small cell lung cancer sensitive to previous platinum-based chemotherapy: A systematic review and Bayesian network analysis.Frontiers in oncology · 2023Pooled it
- The impact of angiogenesis inhibitors on survival of patients with small cell lung cancer.Cancer medicine · 2019Pooled it
- Angiogenesis inhibitors for the treatment of small cell lung cancer (SCLC): A meta-analysis of 7 randomized controlled trials.Medicine · 2017Pooled it
- Pooled it
- Incidence and risk of severe infections associated with aflibercept in cancer patients: a systematic review and meta-analysis.British journal of clinical pharmacology · 2016Pooled it
- Topotecan for Relapsed Small-cell Lung Cancer: Systematic Review and Meta-Analysis of 1347 Patients.Scientific reports · 2015Pooled it
- Efficacy and biomarker exploration of anlotinib plus penpulimab in second-line ES-SCLC: Results from the phase 2 ALTER-L041 trial.Cell reports. Medicine · 2026Trial
- A phase II study of anlotinib combined with etoposide and platinum-based regimens in the first-line treatment of extensive-stage small cell lung cancer.Thoracic cancer · 2022Trial
- Peripheral blood indices to predict PFS/OS with anlotinib as a subsequent treatment in advanced small-cell lung cancer.Cancer biology & medicine · 2021Trial
- Apatinib in patients with extensive-stage small-cell lung cancer after second-line or third-line chemotherapy: a phase II, single-arm, multicentre, prospective study.British journal of cancer · 2019Trial
- Trial
- Disease Control Rate at 8 Weeks Predicts Subsequent Survival in Platinum-Treated Extensive Stage Small-Cell Lung Cancer: Results From the Southwest Oncology Group (SWOG) Database.Clinical lung cancer · 2016Trial
- Relevance of platinum-sensitivity status in relapsed/refractory extensive-stage small-cell lung cancer in the modern era: a patient-level analysis of southwest oncology group trials.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2015Trial
- The Five-Decade Journey of Small Cell Lung Cancer.Cancer communications (London, England) · 2026Review
- Unmasking biomarkers in small cell lung cancer: implication for precision oncology.Frontiers in oncology · 2026Review
- Clinical efficacy and safety of immune checkpoint inhibitors plus anlotinib as secondline or subsequent therapy in extensive stage small cell lung cancer: a retrospective study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Article
- Advancements in the Understanding of Small-Cell Neuroendocrine Cervical Cancer: Where We Stand and What Lies Ahead.Journal of personalized medicine · 2024Review
- Sintilimab plus anlotinib as second or further-line therapy for extensive disease small cell lung cancer: a phase 2 investigator-initiated non-randomized controlled trial.EClinicalMedicine · 2024Article
- Review
- State of affairs regarding targeted pharmacological therapy of cancers metastasized to the brain.Neurosurgical review · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Jeffrey W AllenJeffrey 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 MoonJeffrey 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 RedmanJeffrey 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 GadgeelJeffrey 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 KellyJeffrey 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 MackJeffrey 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 SabaJeffrey 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 MohamedJeffrey 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 JahanzebJeffrey 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 GandaraJeffrey 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.
The Barbara Ann Karmanos Cancer Institute · US
Funding
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1MSWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3MSWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2MStaff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9MSOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8MSOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6MCOMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0MUPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5MMICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2MGRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2MCOMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0MDAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0MNCI NIH HHS CA11083NCI NIH HHS CA12644NCI NIH HHS CA14028NCI NIH HHS CA16385NCI NIH HHS CA20319NCI NIH HHS CA22433NCI NIH HHS CA35090NCI NIH HHS CA35128NCI NIH HHS CA35261NCI NIH HHS CA35421NCI NIH HHS CA37981NCI NIH HHS CA42777NCI NIH HHS CA45377NCI NIH HHS CA45450NCI NIH HHS CA45808NCI NIH HHS CA46113NCI NIH HHS CA46282NCI NIH HHS CA46368NCI NIH HHS CA52654NCI NIH HHS CA58861NCI NIH HHS CA63845NCI NIH HHS CA63848NCI NIH HHS CA68183NCI NIH HHS CA74647NCI NIH HHS CA76429NCI NIH HHS CA76447NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA013612NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA067575NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA016385NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA022433NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035128NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035261NCI NIH HHS U10 CA035421NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037981NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA042777NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045450NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046113NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046368NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA052654NCI NIH HHS U10 CA058861NCI NIH HHS U10 CA063845NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA068183NCI NIH HHS U10 CA074647NCI NIH HHS U10 CA076447NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233340
Abstract
purposeDevelopment 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 AND
methodsPatients 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.
resultsIn 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.
conclusionZiv-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.
Indexed as
Antineoplastic Combined Chemotherapy ProtocolsFemaleHumansLung NeoplasmsMaleMiddle AgedReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsSmall Cell Lung CarcinomaSurvival AnalysisTopoisomerase I InhibitorsTopotecanafliberceptReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTopoisomerase I InhibitorsTopotecan
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