Treatment

Investigate lung cancer staging, systemic therapeutic options for
advanced NSCLC, meaningful clinical end points, and treatment patterns within the VA and in the general population.

STAGING

Clinical staging defines prognosis and resectability

 

Treatment options vary as a function of stage of disease

  • Mortality rates change with each stage of NSCLC2
    – 5-year survival of patients with Stage IA NSCLC is 73% compared with 9% of patients with Stage IIIB NSCLC

RT = radiation therapy

References: 1. American Lung Association. Staging. www.lung.org/lung-disease/lung-cancer/learning-more-about-lung-cancer/diagnosing-lung-
cancer/staging.html?print=t. Accessed May 7, 2015.  2 . Travis WD, Brambilla E, Noguchi M, et al. International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society international multidisciplinary classification of lung adenocarcinoma. J Thorac Oncol. 2011;6(2):244-285. 3 . Referenced With permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer, v4.2016. © National Comprehensive Cancer Network, Inc 2016. All rights reserved. Accessed June 14, 2016. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.

THERAPY

* Adapted from NCCN® Guidelines

Reference: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer, v4. 2016. © National Comprehensive Cancer Network, Inc 2016. Al l rights reserved. Accessed June, 14, 2016. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network. Inc.

CLINICAL END POINTS

Overall survival (OS)

  • OS is universally accepted direct measure of benefit that can be easily and precisely measured1
  • OS may be affected by crossover therapy and sequential therapy1
  • Clinical studies with an OS end point include noncancer deaths1
  • In rare subsets of patients, even in common malignancies such as NSCLC,  it may be difficult to screen patients and power a study for an OS end point2

Progression-free survival (PFS)

  • PFS is not statistically validated as a surrogate for survival in all settings1
  • Regular FDA approval can be granted based on large, clinically meaningful improvement in PFS2
  • PFS relies on a smaller sample size and shorter follow-up compared with survival studies1
  • Because PFS  is not precisely measured it is subject to assessment bias, particularly in open-label studies; however, PFS is generally based on objective and quantitative assessment1
  • PFS includes measurement of stable disease and is not affected by crossover or subsequent therapies1
  • PFS requires frequent and balanced timing of assessments among treatment arms1

Objective response rate (ORR)

  • Although ORR is not a direct measure of benefit, it is a clinically meaningful end point in NSCLC  trials that can help physicians choose an appropriate treatment1,3
  • ORR can be assessed in single-arm studies, and assessed earlier and in smaller studies compared with survival studies1
  • ORR is not a comprehensive measure of drug activity; however, studies using ORR as an end point are able to attribute tumor response to the drug, and rule out natural history of disease1
  • Spatial measurement of tumor shrinkage is a form of direct, real-time clinical assessment 3

The measure of target lesions is the aggregate of dimensions identified at baseline.

Adapted with permission from Wolters Kluwer: The Cancer Journal,  Xavier Pivot, MD, PhD, Antoine Thierry-Vuillemin, MD, et al., Response Rates, A Valuable Signal of Promising Activity? Cancer J 2009; 15: 361 -365) 2009.

References: 1. Food and Drug Administration. Guidance for industry: Clinical trial endpoints for the approval of cancer drugs and biologics. http://www.fda.gov/downloads/Drugs/…/Guidances/ucm071590.pdf. Published May 2007. Accessed March 11,2016. 2. Blumenthal GM, Karuri SW, Zhang H, et al. Overall response rate, progression-free-survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: a US Food and Drug Administration trial-level and patient-level analyses. J Clin Oncol. 2015;33(9):1008-1014. 3.Pivot X, Thierry-Vuillemin A, Villanueva C, Bazan F. Response rates: a valuable signal of promising activity? Cancer J. 2009;15(5)361-365.

TREATMENT PATTERNS

Approximately 105,000 patients with advanceda NSCLC received first-line therapy in 2014, including1:

  • ~49,000  patients with advanced adenocarcinoma
  • ~25,000  patients with advanced squamous cell carcinoma

 

*Other includes large cell carcinoma, non-small cell carcinoma, other specified carcinomas.
aStage IIIB and IV.
bEstimates based on Kantar Health CancerMPact® Patient Metrics, 2014.

 

Treatment patterns in the VA

Records of 20,172 patients diagnosed with metastatic NSCLC were analyzed using the Veterans Affairs Central Cancer Registry during 2001-20082

  • 5,888 received chemotherapy within 4 months
  • Of which 4,352 received a platinum doublet

References: 1. Kantar Health CancerMPact® Patient Metrics, 2014. 2. Santant-Davila R, Szabo A, Arce-Lara C, Williams CD, Kelley MJ, Whittle J. Cisplatin versus carboplatin-based regimens for the treatment of patients with metastatic lung cancer. An analysis of Veterans Health Administration data. J Thorac Oncol. 2014;9(5):702-709.

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