Evidence map›Paper›PMID 30591959›Full record

Trial reportCancer immunology, immunotherapy : CII2019

Randomized-controlled phase II trial of salvage chemotherapy after immunization with a TP53-transfected dendritic cell-based vaccine (Ad.p53-DC) in patients with recurrent small cell lung cancer.

Alberto A Chiappori, Charles C Williams, Jhanelle E Gray, Tawee Tanvetyanon, Eric B Haura, Ben C Creelan, Ram Thapa, Dung-Tsa Chen, George R Simon, Gerold Bepler and 2 more

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
1.5field-weighted citation impact, top 14% 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

40 citing papers in PubMed, 61 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. The next generation of immunotherapies for lung cancers.Nature reviews. Clinical oncology · 2025
    Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Cancer biotherapy: review and prospect.Clinical and experimental medicine · 2024
    Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. [Research Progress of Lung Cancer Vaccines].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2023
    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

12 authors at 4 institutions in 1 country.

Alberto A ChiapporiDepartment of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902, Magnolia Drive, FOB1, Tampa, FL, 33612, USA. alberto.chiappori@moffitt.org.
Charles C WilliamsDepartment of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902, Magnolia Drive, FOB1, Tampa, FL, 33612, USA.
Jhanelle E GrayDepartment of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902, Magnolia Drive, FOB1, Tampa, FL, 33612, USA.
Tawee TanvetyanonDepartment of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902, Magnolia Drive, FOB1, Tampa, FL, 33612, USA.
Eric B HauraDepartment of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902, Magnolia Drive, FOB1, Tampa, FL, 33612, USA.
Ben C CreelanDepartment of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902, Magnolia Drive, FOB1, Tampa, FL, 33612, USA.
Ram ThapaDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.
Dung-Tsa ChenDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, 33612, USA.
George R SimonMD Anderson Cancer Center, Houston, TX, 77030, USA.
Gerold BeplerKarmanos Cancer Institute, Detroit, MI, 48201, USA.
Dmitry I GabrilovichWistar Institute, Philadelphia, PA, 19104, USA.
Scott J AntoniaDepartment of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902, Magnolia Drive, FOB1, Tampa, FL, 33612, USA.
Moffitt Cancer Center · USThe Barbara Ann Karmanos Cancer Institute · USThe University of Texas MD Anderson Cancer Center · USThe Wistar Institute · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
Tumor Microenvironment and MetastasisP30CA010815 · NCI · WISTAR INSTITUTE · PI Luis J Montaner · 1985 to 2026
$75.9M
SPORE in Lung CancerP50CA119997 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI GABRILOVICH, DMITRY I · 2008 to 2012
$11.0M
NCI NIH HHS P30 CA010815NCI NIH HHS P30 CA076292NCI NIH HHS P30-CA076292NCI NIH HHS P50 CA119997NIH HHS 5 P50 CA119997
6 · The paper itself

Abstract

Small cell lung cancer TP53 mutations lead to expression of tumor antigens that elicits specific cytotoxic T-cell immune responses. In this phase II study, dendritic cells transfected with wild-type TP53 (vaccine) were administered to patients with extensive-stage small cell lung cancer after chemotherapy. Patients were randomized 1:1:1 to arm A (observation), arm B (vaccine alone), or arm C (vaccine plus all-trans-retinoic acid). Vaccine was administered every 2 weeks (3 times), and all patients were to receive paclitaxel at progression. Our primary endpoint was overall response rate (ORR) to paclitaxel. The study was not designed to detect overall response rate differences between arms. Of 69 patients enrolled (performance status 0/1, median age 62 years), 55 were treated in stage 1 (18 in arm A, 20 in arm B, and 17 in arm C) and 14 in stage 2 (arm C only), per 2-stage Simon Minimax design. The vaccine was safe, with mostly grade 1/2 toxicities, although 1 arm-B patient experienced grade 3 fatigue and 8 arm-C patients experienced grade 3 toxicities. Positive immune responses were obtained in 20% of arm B (95% confidence interval [CI], 5.3-48.6) and 43.3% of arm C (95% CI 23.9-65.1). The ORRs to the second-line chemotherapy (including paclitaxel) were 15.4% (95% CI 2.7-46.3), 16.7% (95% CI 2.9-49.1), and 23.8% (95% CI 9.1-47.5) for arms A, B, and C, with no survival differences between arms. Although our vaccine failed to improve ORRs to the second-line chemotherapy, its safety profile and therapeutic immune potential remain. Combinations with the other immunotherapeutic agents are reasonable options.

Indexed as

VaccinationAdultAgedCancer VaccinesDendritic CellsFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalPaclitaxelSalvage TherapySmall Cell Lung CarcinomaTransfectionTumor Suppressor Protein p53Cancer VaccinesPaclitaxelTumor Suppressor Protein p53Dendritic cell vaccineImmunotherapySmall cell lung cancerTP53/p53Tumor antigens

Identifiers

PMID30591959
PMCPMC6426813
OpenAlexW2907240414

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.