Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Jun 1;4(6):874-876.
doi: 10.1001/jamaoncol.2018.0275.

Evaluating Treatment Effect Based on Duration of Response for a Comparative Oncology Study

Affiliations

Evaluating Treatment Effect Based on Duration of Response for a Comparative Oncology Study

Bo Huang et al. JAMA Oncol. .

Abstract

This study evaluates the duration of response for crizotinib vs chemotherapy for patients with ALK-positive lung cancer using data from the PROFILE-1014 randomized clinical trial.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Drs Huang, Talukder, and Rothenberg are employees and stock holders of Pfizer Inc. No other conflicts are reported.

Figures

Figure 1.
Figure 1.. Kaplan-Meier Curves for Progression/Death (P/D) and Progression/Death/Response (P/D/R) With Data From PROFILE-1014
A, Kaplan-Meier curves of progression-free survival (PFS) for chemotherapy and crizotinib. B, Restricted mean P/D event-free time up to month 30: the shaded area under the Kaplan-Meier curve of PFS for crizotinib. C, Restricted mean P/D/R event-free time up to month 30: the shaded area under the Kaplan-Meier curve of time to P/D/R for crizotinib. D: Restricted mean DOR for crizotinib up to month 30: the shaded area between the 2 Kaplan-Meier curves in panels B and C.
Figure 2.
Figure 2.. Possible Case Patterns
Possible patterns (without censoring) of times to response (R) and progression/death (P/D) up to month 30.

References

    1. US Food and Drug Administration Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. Washington, DC, US Food and Drug Administration. 2007. May:1-9. https://www.fda.gov/downloads/Drugs/Guidances/ucm071590.pdf. Accessed January 8, 2018.
    1. Committee for Medicinal Products for Human Use Guideline on the evaluation of anticancer medicinal products in man. London: EMA. 2005. Dec 14. https://pdfs.semanticscholar.org/7aea/821e889c4d76d1a11581ecf22899707013.... Accessed January 8, 2018.
    1. Ellis S, Carroll KJ, Pemberton K. Analysis of duration of response in oncology trials. Contemp Clin Trials. 2008;29(4):456-465. - PubMed
    1. Solomon BJ, Mok T, Kim DW, et al. ; PROFILE 1014 Investigators . First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371(23):2167-2177. - PubMed
    1. Uno H, Claggett B, Tian L, et al. . Moving beyond the hazard ratio in quantifying the between-group difference in survival analysis. J Clin Oncol. 2014;32(22):2380-2385. - PMC - PubMed

MeSH terms