In studies investigating the combination of two or more anticancer drugs that are already approved for independent use, or 'maintenance' regimens, the use of progression-free survival as the end point for approval is inadequate; sequential treatment with the same agents or existing salvage therapies, respectively, might provide an equivalent survival benefit, with lower toxicity, cost, and treatment burden, therefore, the use of an overall survival end point is essential to justify such interventions.
This is a preview of subscription content, access via your institution
Access options
Access Nature and 54 other Nature Portfolio journals
Get Nature+, our best-value online-access subscription
$29.99 / 30 days
cancel any time
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Prasad, V., Kim, C., Burotto, M. & Vandross, A. The strength of association between surrogate end points and survival in oncology: a systematic review of trial-level meta-analyses. JAMA Intern. Med. 175, 1389–1398 (2015).
Booth, C. M. & Eisenhauer, E. A. Progression-free survival: meaningful or simply measurable? J. Clin. Oncol. 30, 1030–1033 (2012).
Mailankody, S. & Prasad, V. Five years of cancer drug approvals: innovation, efficacy, and costs. JAMA Oncol. 1, 539–540 (2015).
Larkin, J. et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N. Engl. J. Med. 373, 23–34 (2015).
Hanna, N. H. et al. Maintenance daily oral etoposide versus no further therapy following induction chemotherapy with etoposide plus ifosfamide plus cisplatin in extensive small-cell lung cancer: a Hoosier Oncology Group randomized study. Ann. Oncol. 13, 95–102 (2002).
Goodwin, J. S. Routine cancer antigen 125 surveillance — the fatal attraction of testing. JAMA Oncol. 2, 1412–1413 (2016).
Moskowitz, C. H. et al. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 385, 1853–1862 (2015).
Sweetenhan, J. W. et al. Updated efficacy and safety data from the AETHERA trial of consolidation with brentuximab vedotin after autologous stem cell transplant (ASCT) in Hodgkin lymphoma patients at high risk of relapse [abstract]. Biol. Blood Marrow Transplant. 22, S36 (2016).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no competing financial interests.
Supplementary information
Supplementary information S1 (table)
Selected studies of combination and maintenance therapies in oncology (DOC 56 kb)
Rights and permissions
About this article
Cite this article
Gyawali, B., Prasad, V. Combining drugs and extending treatment — a PFS end point is not sufficient. Nat Rev Clin Oncol 14, 521–522 (2017). https://doi.org/10.1038/nrclinonc.2017.72
Published:
Issue Date:
DOI: https://doi.org/10.1038/nrclinonc.2017.72
This article is cited by
-
Overall survival as a primary end point in multiple myeloma trials
Nature Reviews Clinical Oncology (2022)
-
Combination therapy patents: a new front in evergreening
Nature Biotechnology (2021)
-
PARP inhibition — opportunities in pancreatic cancer
Nature Reviews Clinical Oncology (2019)
