Virtual Library

Start Your Search

Daniel Breadner

Author of

  • +

    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
    • +

      P1.01-91 - A Phase I Study of Fixed Dose Vinorelbine and Escalating Doses of Ifosfamide in First-Line Advanced Non-Small Cell Lung Cancer (ID 14266)

      16:45 - 18:00  |  Author(s): Daniel Breadner

      • Abstract


      Platinum doublet chemotherapy is generally the backbone treatment of advanced NSCLC (aNSCLC), although toxicity and limited benefit necessitated the need for investigation of alternatives. We examined vinorelbine and ifosfamide combination chemotherapy as a possible alternative in first-line aNSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      31 patients were enrolled and treated between January 2004 and July 2006. Vinorelbine (25 mg/m2) and escalating doses of ifosfamide were given on days 1 and 8 q21 days. The starting dose of ifosfamide was 2.0 g/m2. If 1/6 patients experienced dose-limiting toxicities (DLT) in cycle 1, the next cohort was recruited and given an additional 0.25 g/m2 of ifosfamide. If ³ 2/6 patients within a cohort experienced DLT, recruitment was halted, and previous cohort’s dose was determined to be ideal for phase II study. DLT were defined as grade 4 hematologic or grades 3 or 4 non-hematologic toxicities.

      4c3880bb027f159e801041b1021e88e8 Result

      The ideal phase II ifosfamide dose was determined to be 2.0 g/m2. Median PFS and OS were 5.5 and 9.2 months, respectively. The ORR was 12.9% and the 1-year OS was 21%, both lower than historical reports of platinum doublet efficacy and even vinorelbine monotherapy at 30 mg/m2. Six “excellent responders” were identified who survived between 20 and 45 months. DLT were experienced by 58% of patients. DLT were largely hematologic, but higher doses of ifosfamide produced non-hematologic toxicities.

      8eea62084ca7e541d918e823422bd82e Conclusion

      There was no significant evidence that vinorelbine and ifosfamide combination could provide an alternative to platinum doublet chemotherapy based on inferior efficacy and the high rate of DLT. The 6 “excellent responders” may be explained by chance or secondary to subsequent treatment with erlotinib while harbouring occult EGFR mutations. Further study may be relevant to examine synergy between vinorelbine or ifosfamide with modern targeted therapies.