Randomized clinical trial eligibility rates for chemotherapy (CT) and antiangiogenic therapy (AAT) in a population-based cohort of newly diagnosed non-small cell lung cancer (NSCLC) patients

Abstract

6538 Background: NSCLC leads the US in cancer deaths, but randomized clinical trials (RCT) of CT with/without antiangiogenic therapy (AAT) are relatively slow to accrue. Treatment guidelines for NSCLC are based on RCTs that enroll patients with a mean age of 62–64 without serious comorbidities. SEER mean age of NSCLC diagnosis in the US is 70. Methods: 326 consecutively diagnosed (from January 1, 2006) NSCLC patients from a large prepaid health care delivery system (Kaiser Permanente Northern California-KPNC), were retrospectively evaluated by manual chart and electronic medical record review for eligibility criteria (EC) to enter treatment defining RCTs, i.e. E4599, S0023. The KPNC members are representative of the regional population. Ineligibility, the main endpoint, was determined on imaging and laboratory tests and history in the medical record. This may overestimate eligibility. Results: Age at diagnosis:<60years-18%, <65–28%, <70–50%, >75–34%, >80–18%; mean (SD)age- 69.3 (10.6). Male:Female 51:49%. Adeno-49%; Squamous-22%; LargeCell-2.5%; NSC NOS-27%. Current/former smokers-90%. Staging: IA-14%; IB-13%; IIA+B-4%; IIIA-17%; IIIB+IV-52%. Surgical resection-26%. When standard RCT eligibility criteria were applied to the entire cohort, 34% (CI 29%-39%) were eligible. Only 23% (CI 19%-28%) were both eligible and <75yo. stage IIIB+IV patients were 29% (CI 24%-36%) eligible at all ages, 20% (15%-26%) were both eligible and <75yo. When AAT EC were added, 21% (17%-26%) were eligible for all ages, 14% (CI 10%-18%) eligible and <75yo., and 9%(CI 6%-13%) eligible and <70yo. Conclusions: Treatment guidelines for NSCLC are based on RCTs enrolling the healthiest quartile of the youngest half of patients. The majority of NSCLC patients are excluded by trial eligibility criteria or subjective age criteria from entering CT and/or AAT RCTs. Toxicities in these older and more comorbid NSCLC patients likely alter the risk:benefit ratio. RCTs specific for the 70+yo and comorbid NSCLC patients are needed to help define the best therapy for this understudied majority of lung cancer patients. No significant financial relationships to disclose.