Abstract |
In patients with metastatic cancer, therapeutic anticancer vaccines are rarely associated with objective antitumor responses; so, many investigators have focused on progression-free survival (PFS) as a key endpoint for clinical trials. However, it is not clear that PFS is a surrogate for overall survival (OS), and OS may be a more appropriate endpoint because of the effects on long-term memory in the adaptive immune system. Recently, reported vaccine trials were reviewed to determine their primary and secondary endpoints and results. Randomized trials testing sipuleucel-T and prostvac-vf in prostate cancer and ipilimumab and eltrapuldencel-T in melanoma were associated with low objective response rates, no improvement in PFS, but statistically significant improvement in OS. Although compared with PFS, it takes longer to get a final result when OS is the primary endpoint; there is increasing evidence that if long-term memory recognition of tumor-associated antigens is the mechanism of action of an investigational product, then OS may be the only valid clinical endpoint for efficacy.
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Authors | Robert O Dillman |
Journal | Cancer biotherapy & radiopharmaceuticals
(Cancer Biother Radiopharm)
Vol. 30
Issue 4
Pg. 147-51
(May 2015)
ISSN: 1557-8852 [Electronic] United States |
PMID | 25747158
(Publication Type: Journal Article)
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Chemical References |
- Antibodies, Monoclonal
- Antigens, Neoplasm
- Cancer Vaccines
- Ipilimumab
- PROSTVAC
- Tissue Extracts
- sipuleucel-T
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Topics |
- Antibodies, Monoclonal
(immunology, therapeutic use)
- Antigens, Neoplasm
(immunology)
- Cancer Vaccines
(immunology, therapeutic use)
- Clinical Trials, Phase II as Topic
- Clinical Trials, Phase III as Topic
- Disease-Free Survival
- Humans
- Ipilimumab
- Male
- Melanoma
(drug therapy, immunology)
- Prostatic Neoplasms
(drug therapy, immunology)
- Randomized Controlled Trials as Topic
- Tissue Extracts
(immunology, therapeutic use)
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