Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015
Chemotherapy With or Without Maintenance Sunitinib for Untreated Extensive-Stage Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase II Study-CALGB 30504 (Alliance).
Abstract 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, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 4 of them syntheses that pooled it.
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77citing papers in PubMed, 4 pooled it
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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.
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Who cites it
77 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Prophylactic cranial irradiation for extensive stage small cell lung cancer: a meta-analysis of randomized controlled trials.Frontiers in oncology · 2023Pooled it
- The impact of angiogenesis inhibitors on survival of patients with small cell lung cancer.Cancer medicine · 2019Pooled it
- Initial management of small-cell lung cancer (limited- and extensive-stage) and the role of thoracic radiotherapy and first-line chemotherapy: a systematic review.Current oncology (Toronto, Ont.) · 2019Pooled it
- Angiogenesis inhibitors for the treatment of small cell lung cancer (SCLC): A meta-analysis of 7 randomized controlled trials.Medicine · 2017Pooled it
- Durvalumab plus anlotinib versus durvalumab alone as maintenance treatment in extensive-stage small-cell lung cancer (DURABLE): a multicenter, randomized, phase II trial and biomarker analysis.Nature communications · 2026Trial
- Pamiparib as consolidation treatment after concurrent chemoradiotherapy of limited-stage small cell lung cancer: a single-arm, open-label phase 2 trial.Radiation oncology (London, England) · 2024Trial
- 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
- Apatinib as maintenance therapy following standard first-line chemotherapy in extensive disease small cell lung cancer: A phase II single-arm trial.Thoracic cancer · 2022Trial
- Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Trial
- Prospective Single-Arm Phase 1 and 2 Study: Ipilimumab and Nivolumab With Thoracic Radiation Therapy After Platinum Chemotherapy in Extensive-Stage Small Cell Lung Cancer.International journal of radiation oncology, biology, physics · 2021Trial
- A randomized phase 2 trial of apatinib vs observation as maintenance treatment following first-line induction chemotherapy in extensive- stage small cell lung cancer.Investigational new drugs · 2020Trial
- 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
- Immunotherapeutic maintenance treatment with toll-like receptor 9 agonist lefitolimod in patients with extensive-stage small-cell lung cancer: results from the exploratory, controlled, randomized, international phase II IMPULSE study.Annals of oncology : official journal of the European Society for Medical Oncology · 2018Trial
- Phase II Study of Maintenance Pembrolizumab in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC).Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2018Trial
- Pazopanib maintenance after first-line etoposide and platinum chemotherapy in patients with extensive disease small-cell lung cancer: a multicentre, randomised, placebo-controlled Phase II study (KCSG-LU12-07).British journal of cancer · 2018Trial
- Second-line pazopanib in patients with relapsed and refractory small-cell lung cancer: a multicentre phase II study of the Hellenic Oncology Research Group.British journal of cancer · 2017Trial
- Sunitinib maintenance therapy after response to docetaxel in metastatic castration resistant prostate cancer (mCRPC).Investigational new drugs · 2016Trial
- Outcome and Biomarker Analysis from a Multicenter Phase 2 Study of Ipilimumab in Combination with Carboplatin and Etoposide as First-Line Therapy for Extensive-Stage SCLC.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2016Trial
- Positive Interaction between Prophylactic Cranial Irradiation and Maintenance Sunitinib for Untreated Extensive-Stage Small Cell Lung Cancer Patients After Standard Chemotherapy: A Secondary Analysis of CALGB 30504 (ALLIANCE).Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2016Trial
- PAX5 modulates vascularization and contributes to neuroendocrine lineage transition during carcinoma progression.The Journal of clinical investigation · 2026Article
17 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
12 authors.
Neal E ReadyNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY. ready001@mc.duke.edu.
Herbert H PangNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Lin GuNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Gregory A OttersonNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Sachdev P ThomasNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Antonius A MillerNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Maria BaggstromNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Gregory A MastersNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Stephen L GrazianoNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Jeffrey CrawfordNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Jeffrey BogartNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Everett E VokesNeal E. Ready and Jeffrey Crawford, Duke University Medical Center; Herbert H. Pang and Lin Gu, Alliance Statistics and Data Center, Duke University Medical Center, Durham; Antonius A. Miller, Wake Forest University Medical Center, Winston Salem, NC; Gregory A. Otterson, Ohio State University Medical Center, Columbus, OH; Sachdev P. Thomas, Illinois Oncology Research Association Community Clinical Oncology Program, Illinois Cancer Care, Peoria; Everett E. Vokes, University of Chicago, Chicago, IL; Maria Baggstrom, Washington University School of Medicine, St Louis, MO; Gregory A. Masters, Christiana Healthcare Services, Christiana Hospital, Newark, DE; Stephen L. Graziano and Jeffrey Bogart, State University of New York Upstate Medical University, Syracuse, NY.
Funding
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3MCANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4MStatistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0MCANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4MRe-Engineering Translational Research at the University of ChicagoUL1TR000430 · NCATS · UNIVERSITY OF CHICAGO · PI SOLWAY, JULIAN · 2012 to 2016
$20.2MWashington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6MOSU as Network Lead Academic Participating Site for the NCI NCTNU10CA180850 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A, CHAKRAVARTI, ARNAB · 2014 to 2018
$6.8MNCATS NIH HHS UL1 TR000430NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180850NCI NIH HHS U10 CA180882
Abstract
purposeTo evaluate the efficacy of maintenance sunitinib after chemotherapy for small-cell lung cancer (SCLC). PATIENTS AND
methodsThe Cancer and Leukemia Group B 30504 trial was a randomized, placebo-controlled, phase II study that enrolled patients before chemotherapy (cisplatin 80 mg/m(2) or carboplatin area under the curve of 5 on day 1 plus etoposide 100 mg/m(2) per day on days 1 to 3 every 21 days for four to six cycles). Patients without progression were randomly assigned 1:1 to placebo or sunitinib 37.5 mg per day until progression. Cross-over after progression was allowed. The primary end point was progression-free survival (PFS) from random assignment for maintenance placebo versus sunitinib using a one-sided log-rank test with α = .15; 80 randomly assigned patients provided 89% power to detect a hazard ratio (HR) of 1.67.
resultsOne hundred forty-four patients were enrolled; 138 patients received chemotherapy. Ninety-five patients were randomly assigned; 10 patients did not receive maintenance therapy (five on each arm). Eighty-five patients received maintenance therapy (placebo, n = 41; sunitinib, n = 44). Grade 3 adverse events with more than 5% incidence were fatigue (19%), decreased neutrophils (14%), decreased leukocytes (7%), and decreased platelets (7%) for sunitinib and fatigue (10%) for placebo; grade 4 adverse events were GI hemorrhage (n = 1) and pancreatitis, hypocalcemia, and elevated lipase (n = 1; all in same patient) for sunitinib and thrombocytopenia (n = 1) and hypernatremia (n = 1) for placebo. Median PFS on maintenance was 2.1 months for placebo and 3.7 months for sunitinib (HR, 1.62; 70% CI, 1.27 to 2.08; 95% CI, 1.02 to 2.60; one-sided P = .02). Median overall survival from random assignment was 6.9 months for placebo and 9.0 months for sunitinib (HR, 1.28; 95% CI, 0.79 to 2.10; one-sided P = .16). Three sunitinib and no placebo patients achieved complete response during maintenance. Ten (77%) of 13 patients evaluable after cross-over had stable disease on sunitinib (6 to 27 weeks).
conclusionMaintenance sunitinib was safe and improved PFS in extensive-stage SCLC.
Indexed as
AdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCisplatinDisease-Free SurvivalDisease ProgressionDouble-Blind MethodEtoposideFemaleHumansIndolesKaplan-Meier EstimateLung NeoplasmsMaleAntineoplastic AgentsCarboplatinCisplatinEtoposideIndolesPyrrolesSunitinib
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