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
Open accessAbstract
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.
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The phase II randomized trial in 2019 of salvage chemotherapy after immunization with DC-p53 in recurrent SCLC failed to meet expectations.
“Although objective clinical responses were observed in some patients, the phase II randomized trial in 2019 of salvage chemotherapy after immunization with DC-p53 in recurrent SCLC failed to meet expectations.597”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [597]
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- Authors
- Chiappori, A. A., Williams, C. C., Gray, J. E., Tanvetyanon, T., Haura, E. B., Creelan, B. C., Thapa, R., Chen, D.-T., Simon, G. R., Bepler, G., Gabrilovich, D. I., & Antonia, S. J.
- Affiliations
- Moffitt Cancer Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- The Barbara Ann Karmanos Cancer Institute (US)
- The Wistar Institute (US)
- Corresponding author
- Chiappori, Alberto A.
- ORCID
- Venue
- Cancer Immunology, Immunotherapy
- Published
- 2018-12-27
- Volume
- 68
- Issue
- 3
- Pages
- 517-527
- ISSN
- 0340-7004 (ISSN-L)
- 1432-0851
- PMC
- PMC6426813
- OpenAlex
- W2907240414
- Cited by
- 64
- References
- 47
- Citations by year
- 2026: 8 · 2025: 9 · 2024: 9 · 2023: 12 · 2022: 10 · 2021: 8 · 2020: 6 · 2019: 2
- FWCI
- 1.72
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Cancer Immunology Immunotherapy (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5 P50 CA119997)
- National Cancer Institute (P30-CA076292)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- small cell lung cancer, recurrent cancer, dendritic cell vaccine, all-trans retinoic acid, paclitaxel, salvage chemotherapy, second-line chemotherapy, tumor antigens, immune response, vaccine safety, overall response rate
- MeSH terms
- Adult, Aged, Dendritic Cells, Female, Humans, Lung Neoplasms, Male, Middle Aged, Neoplasm Recurrence, Local, Transfection, Vaccination, Tumor Suppressor Protein p53, Salvage Therapy, Paclitaxel, Cancer Vaccines, Small Cell Lung Carcinoma
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