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Mi-Ryung Jin

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-31 - Weekly Regimen of PAXUS-PM, a Novel Cremophor-Free, with Carboplatin in Patients with Advanced Non-Small-Cell Lung Cancer in Vietnam (ID 11869)

      16:45 - 18:00  |  Presenting Author(s): Mi-Ryung Jin

      • Abstract


      The rationale for developing an alternative paclitaxel formulation concerns Cremophor EL-related side effects, and a novel paclitaxel delivery system might augment its therapeutic efficacy. PAXUS PM (or also known as GENEXOL-PM) is a novel polymeric micelle formulated paclitaxel free of Cremophor. The polymeric micelle formulation is composed of hundreds of low molecular weight, non-toxic, and biodegradable amphiphilic diblock copolymers which include monomethoxy poly (ethylene glycol)-block-poly(D,L-lactide). PAXUS-PM is used to breast cancer, non-small cell lung cancer, and ovarian cancer as 3 week regimen. In other words the data of weekly therapy in NSCLC is not published.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This prospective, single-arm, clinical study was designed to evaluate the efficacy and safety of the combination of Genexol-PM and carboplatin for the treatment of advanced non-small-cell lung cancer (NSCLC).

      Subjects with non‑small cell lung cancer who met the inclusion/exclusion criteria underwent the tests required per treatment plans and then received Genexol-PM 100mg/m2 and carboplatin 5 AUC(or 6AUC) on day 1, 8, 15 of every 3-week cycle for a maximum of six cycles as first-line therapy.

      The study evaluated the objective response rate as primary objective, and other variables including overall survival (OS), progression free survival (PFS), time to tumor progression (TTP), duration of overall response and adverse events.

      4c3880bb027f159e801041b1021e88e8 Result

      Thirty patients were enrolled and analyzed intermittently in this study. The median number of administered cycles was 6. Overall response rate was 76.67% with 2 complete responses (CR) and 21 partial responses (PR). There weren’t any patients with progressive disease.

      The Hematological toxicities were manageable and the major hematological toxic effects were grade 1/2 neutropenia(n=12, 40.0%), grade1 thrombocytopenia(n=1, 3.3%) and grade 1/2 anemia(n=8, 26.7%). There were no grade3/4 adverse events, such as neutropenia and hypersensitivity reactions. The major non-hematologic toxic effects included grade 2 nausea, vomiting and alopecia in all 30 patients.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Genexol-PM plus carboplatin combination chemotherapy showed excellent antitumor activity. In this study, there was no significant risk of hematologic and non-hematologic adverse events of grade 3/4. Among the paclitaxel formulations developed to allow high doses, there were limitations as an intermediate result, but good efficacy and safety results were obtained in lung cancer. Therefore, the use of CrEL-free, polymeric micelle formulation of paclitaxel allowed administration of higher doses of paclitaxel and showed safe and efficacious results.