Evidence map›Paper›PMID 24858462›Full record

Trial reportCancer chemotherapy and pharmacology2014

Interferon alpha plus 13-cis-retinoic acid modulation of BCL-2 plus paclitaxel for recurrent small-cell lung cancer (SCLC): an Eastern Cooperative Oncology Group study (E6501).

Rathi N Pillai, Joseph Aisner, Suzanne E Dahlberg, John S Rogers, Robert S DiPaola, Seena Aisner, Suresh S Ramalingam, Joan H Schiller

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 23 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. [Research Progress of Immunotherapy and Prognostic Markers in Small Cell Lung Cancer].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2020
    Review
  5. Advances and challenges in immunotherapy of small cell lung cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2020
    Article
  6. Review
  7. Review
  8. Review
  9. The role of immunotherapy in small cell lung cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2019
    Review
  10. Progress and challenges in the treatment of small cell lung cancer.Medical oncology (Northwood, London, England) · 2017
    Review
  11. Targeting Myeloid-Derived Suppressor Cells in Cancer.Advances in experimental medicine and biology · 2017
    Review
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Rathi N PillaiWinship Cancer Institute, Emory University, Atlanta, GA, USA.
Joseph Aisner
Suzanne E Dahlberg
John S Rogers
Robert S DiPaola
Seena Aisner
Suresh S Ramalingam
Joan H Schiller
Emory University · USRutgers Cancer Institute of New JerseyDana-Farber Cancer Institute · USSouthwestern Medical CenterUniversity Hospital, Newark · USWest Virginia University · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO · 2014 to 2026
$111.2M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
Foreign Accrual - ECOGU10CA037403 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2014
$34.6M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
EASTERN COOPERATIVE ONCOLOGY GROUP CHAIR'S OFFICEU10CA086802 · NCI · MCP HAHNEMANN UNIVERSITY · PI COMIS, ROBERT L · 1999 to 2013
$13.3M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
EASTERN COOPERATIVE ONCOLOGY GROUP--WISCONSIN STUDIESU10CA021076 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI KAHL, BRAD · 1985 to 2013
$8.2M
UT Southwestern NCI National Clinical Trials Network Lead Academic Site - U10U10CA180870 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI GERBER, DAVID ERIC · 2014 to 2018
$3.4M
Participation in the Eastern Cooperative Oncology GroupU10CA107868 · NCI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI AISNER, JOSEPH · 2004 to 2013
$2.3M
NCI NIH HHS CA21076NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA66636NCI NIH HHS U10 CA021076NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA037403NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA086802NCI NIH HHS U10 CA107868NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180870NCI NIH HHS U24 CA114737
6 · The paper itself

Abstract

backgroundPatients with recurrent small-cell lung cancer (SCLC) have dismal outcomes. The failure of salvage therapy is due to the possible development of resistance mechanisms, such as the upregulation of the anti-apoptosis protein, Bcl-2. We conducted a phase II study to evaluate if modulation of Bcl-2 with 13-cis-retinoic acid (13-CRA) and interferon alpha could improve response rates when combined with paclitaxel in patients with recurrent SCLC.

methodsPatients with recurrent SCLC and measurable disease were treated with interferon alpha at 6 million units/m² subcutaneously and 13-CRA 1 mg/kg orally on days 1 and 2 and paclitaxel 75 mg/m² intravenously on day 2 of each week for 6 weeks of an 8-week treatment cycle. Treatment was continued until disease progression, development of unacceptable toxicity, or withdrawal of consent. The primary endpoint was response rate with secondary endpoints of progression-free survival (PFS) and overall survival (OS). Bcl-2 levels were assessed in peripheral blood mononuclear cells (PBMCs).

resultsThirty-seven patients were enrolled; 34 were included in the intention-to-treat analysis as 3 patients were ineligible for the study. There were 3 partial responses (9 %), and 5 patients had stable disease (15 %) as best response. The median PFS was 2 months, and median OS was 6.2 months. Although mean Bcl-2 protein levels decreased with therapy in PBMCs, there was no association between Bcl-2 levels and response rate or survival.

conclusionDespite sound pre-clinical evidence, the addition of 13-CRA and interferon alpha to paclitaxel did not improve outcomes for recurrent SCLC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkersCarcinoma, Small CellChemotherapy-Induced Febrile NeutropeniaCohort StudiesEarly Termination of Clinical TrialsFemaleFollow-Up StudiesHumansInterferon-alphaIsotretinoinLeukocytes, MononuclearLeukopeniaLung NeoplasmsMaleMiddle AgedBiomarkersIFNA1 protein, humanInterferon-alphaIsotretinoinPaclitaxelProto-Oncogene Proteins c-bcl-2

Identifiers

PMID24858462
PMCPMC4296897
OpenAlexW2084117853

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.