Author of

• 10743

  +

  P1.10 - Poster Session 1 - Chemotherapy (ID 204)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10768

    +

    P1.10-025 - Randomized phase II trial of Safety of Biweekly Docetaxel/Cisplatin vs Gemcitabine/Cisplatin as first-line therapy for advanced non-small cell lung cancer patients who are elderly or poor performance status (ID 1484)

    09:30 - 09:30  |  Author(s): H.J. Yun
    • Abstract

    Background
    Cisplatin with docetaxel (DP) or gemcitabine (GP) is one of standard regimen for advanced non-small cell lung cancer(NSCLC). DP is regarded more toxic compared with GP. There is an increasing interest in a biweekly split administration of DP to reduce its toxicity. Hypothesis here was 1st-line biweekly DP is as safe as GP in elderly or poor performance status (PS) patients (pts).

    Methods
    Chemotherapy naïve pts with NSCLC (IIIB/IV) who were elderly(>65) or poor PS (ECOG 2) were randomized to biweekly DP or GP by balancing for ECOG (0-1 vs 2), stage (IIIB vs IV) and age (<65 vs >65). DP with docetaxel (35mg/m2)/cisplatin(30mg/m2) iv or GP with gemcitabine (1000mg/m2) /cisplatin(30mg/m2) iv was given on days 1,8 every 3 weeks . Chemotherapy lasted upto 6 cycles or until progression. Primary endpoint was safety (proportion of grade 3/4 toxicities). Planned sample size was 49 pts in each.

    Results
    From Nov 2009 to Jan 2013, a total of 97 pts were randomized (DP 50/GP 47). Adenoca was 58% in DP and 51% in GP while that of squamous cell ca 34% in DP and 40% in GP. Stage IIIB/IV was 33%/66% in DP and 42%/59% in GP. In DP a total 228 adverse events (AEs) were reported and 27 were grade 3/4 toxicities while 211 AEs and 21 grade 3/4 toxicities in GP. Neutropenia was the most frequent grade 3/4 toxicity in both (DP 8.9%; GP 15.9%). In DP grade 3/4 leukopenia (8.9%), hyponatremia(6.7%), anemia(4.4%) and anorexia (4.4%) were observed while anemia (9.1%) and hyponatremia (6.8%) in GP. In total AEs, anemia was the most common in both (DP 66.7% ; GP 63.6%). Then, in the following order, hyponatremia (53.3%), anorexia (53.3%) and fatigue(40%) were common in DP while anorexia, (56.8%), fatigue(36.4%) and neutropenia(45.5%) were common in GP. Death during treatment was occurred in 1 pt in each. Both regimen showed similar grade 3/4 toxicities with similar profiles. Survivals seemed to be favorable in GP compared with DP with no statistical significance. Progression-free survivals were 3.72 (DP) and 5.56 (GP) months (p=0.341). Overall survivals were 14.93 (DP) and 20.82 (GP) months (p=0.209).

    Conclusion
    This study showed DP is similar with GP in terms of toxicity and efficacy in treatment of elderly or poor performance patients.