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J. Yang



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    P1.05 - Poster Session with Presenters Present (ID 457)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Early Stage NSCLC
    • Presentations: 1
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      P1.05-046 - Randomized Study of Adjuvant Docetaxel vs. Observation for Completely Resected StageⅠB-Ⅲa NSCLC with 11 Years' Median Follow-Up (ID 5722)

      14:30 - 14:30  |  Author(s): J. Yang

      • Abstract

      Background:
      Although previous meta-analyses have verified the significance of adjuvant chemotherapy, the role of adjuvant carbopatin plus docetaxel(DC) among patients with completely resected NSCLC with long periods of follow-up remains unclear.

      Methods:
      Eligible patients were randomly assigned to 4 cycles of DC or observation after complete resection. The primary end point was DFS; secondary ones were OS, the toxicity and safety of drugs. An increase of 15% in 1-year survival rate (observation arm 70%) with a sample size of 270 patients was considered significant.

      Results:
      This trial was suspended prematurely in June 2005 due to the negative survival benefits from chemotherapy in stage IB patients in the JBR10 trial. 82 patients were enrolled between 2002 to 2005(43 and 39 in each arm).Two arms were well-balanced on age, gender, histology, smoking history and staging. Median follow-up was 11 years(10.5-13y). DFS was marginally significantly longer in DC arm than observation (10.4 vs. 3.7y; HR=0.58; 95% CI, 0.33-1.03; P=0.06), as was 5-year DFS rates(63% vs. 41%, P=0.057). No statistical significance existed in OS (NR vs. 7.1y; P=0.103) or 5-year survival rates(76% vs. 61%; P=0.148). Multivariable analysis revealed patients receiving adjuvant DC(HR=0.54，95%CI 0.30-0.96，P=0.036) and with stage IB disease(HR=0.34，95%CI, 0.19-0.61，P<0.001) bore lower recurrence risk. In DC arm, 84% of patients received at least one cycle of DC, and 53% of patients finished four. Grades 3 adverse events occurred in 5%(2/43) in chemotherapy group. The time-varying endpoints showed adjuvant DC could delay the recurrence and mortality in the first postoperative 5ys, while two arms tended to be equivalent after 5ys. Figure 1



      Conclusion:
      This is the first randomized trial used DC as adjuvant chemotherapy suggesting a potentially significant role for completely resected early stage NSCLC with safety and compliance. Additionally, at least 10ys’ follow-up for each patient was vital to investigate the long-term time-varying recurrence and mortality pattern.