NGR‐hTNF and Doxorubicin as Second‐Line Treatment of Patients with Small Cell Lung Cancer

AbstractBackground.Relapsed small cell lung cancer (SCLC) patients have limited treatment options and poor outcomes. NGR‐hTNF is a vascular‐targeting agent, which increases intratumoral chemotherapy penetration and T‐lymphocyte infiltration.Methods.Twenty‐eight patients relapsing after at least one platinum‐based regimen with a treatment‐free interval shorter (n = 16; platinum‐resistant) or longer (n = 12; platinum‐sensitive) than 3 months received NGR‐hTNF 0.8 μg/m2 plus doxorubicin 75 mg/m2 every 3 weeks. The primary endpoint of this single‐arm phase II trial was progression‐free survival (PFS), and safety, response rate, and survival were secondary endpoints.Results.The most common grade 3–4 toxicities were neutropenia (53%) and anemia (21%). Median PFS was 3.2 months for all patients, 2.7 months for platinum‐resistant patients, and 4.1 months for platinum‐sensitive patients. Seven patients had partial responses (25%), including four (25%) with platinum‐resistant and three (25%) with platinum‐sensitive relapse. Mean changes from baseline in tumor burden (after two, four, and six cycles) did not differ between platinum‐resistant (−9%, −29%, and −32%) and platinum‐sensitive (−11%, −20%, and −43%) cohorts. Overall survival was associated only with baseline lymphocyte counts, with median survival times of 13.1 and 5.2 months for lymphocyte counts above or below the median, respectively.Conclusion.NGR‐hTNF plus doxorubicin showed manageable toxicity and promising activity in patients with relapsed SCLC.

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