PATIENTS WITH ADVANCED SQUAMOUS NSCLC ARE IN URGENT NEED OF OPTIONS THAT MAY DELIVER TUMOR RESPONSE

NSCLC histology2
Squamous cell carcinoma in Advanced Non-Small Cell Lung Cancer (NSCLC) patient histology - chart
~30% of lung cancers are squamous cell carcinoma
Squamous cell carcinoma
Squamous cell carcinoma in Advanced Non-Small Cell Lung Cancer (NSCLC) lung tumor
  • Associated with a poorer prognosis than nonsquamous3
  • Tumors are often centrally located4,5
  • Have been shown to grow twice as fast as adenocarcinoma6,7
  • Often seen extrinsically pushing into airway structures as they grow8
  • Associated with a history of smoking4
  • Importance of Tumor Response Rates

    RESPONSE RATES
    ARE HELPFUL IN ASSESSING CLINICAL BENEFIT

    ORR is a clinically meaningful endpoint in NSCLC trials that can help physicians choose an appropriate treatment9
    Using ORR as an endpoint in oncology drug approval has a long history
    There has been more than 30 years of experience with response criteria10

    ORR= overall response rate.

    TUMOR RESPONSE
    IS A RIGOROUS MEASUREMENT9

    Spatial measurement of tumor shrinkage is a form of direct, real-­time clinical assessment9

    Measure of the greater unidimensional diameters

    RECIST Criteria8

    CR=complete response

    PR=partial response

    SD=stable disease

    PD=progressive disease

    CR

    Disappearance of all clinical and radiological evidence of target lesions

    PR

    ≥30% decrease of the greater unidimensional diameters

    SD

    Failure to observe CR or PR, but not PD

    PD

    ≥20% increase of the greater unidimensional diameters or presence of new lesion

    Measure of the greater
    unidimensional
    diameters

    Complete Response (CR)

    Disappearance of all clinical and radiological evidence of target lesions

    Partial Response (PR)

    ≥30% decrease of the greater unidimensional diameters

    Stable Disease (SD)

    Failure to observe CR or PR, but not PD

    Progressive Disease (PD)

    ≥20% increase of the greater unidimensional diameters or presence of new lesion

    Response assessment under RECIST guidelines is based on measurement of the longest single-dimension diameters of target lesions, which are identified at baseline.

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The clinical trial described in this article served as the
basis for the approval for ABRXANE for Injectable Suspension.
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