Author of

• 11673

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  P2.09 - Poster Session 2 - Combined Modality (ID 213)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Combined Modality
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11690

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    P2.09-017 - Phase III study of concurrent cisplatin with pemtrexed versus vinorelbine and LCAHRT for unresectable stage III NSCLC (ID 3031)

    09:30 - 09:30  |  Author(s): Z. Wu
    • Abstract

    Background
    To evaluate pemetrexed in combination with cisplatin in these patients, a randomized phase III study of concurrent cisplatin with pemtrexed or vinorelbine and late course accelerated hyperfractionated radiotherapy (LCAHRT) was performed.

    Methods
    Patients with unresectable stage III non–small cell lung cancer （NSCLC） were randomly assigned to two concurrent regimens. Arm1 included cisplatin at 25 mg/m2 on days 1-3, 22-24 and vinorelbine at 25 mg/m2 on days 1,8 and 22,29 with concurrent LCAHRT. Arm 2 used cisplatin at 25 mg/m2 on days 1-3, 22-24 and pemtrexed at 500 mg/m2 on days 1 and 22 with the same radiotherapy protocol. The primary endpoint was progression free survival (PFS), and secondary endpoints included overall survival (OS ) and toxicities. Kaplan–Meier analyses were used to assess survival, and toxic effects were examined using the Pearson Chi-Square test. All statistical tests were two-sided.

    Results
    A total of 104 patients were enrolled with 100 ones analyzed for 3 in arm 1 and 1 in arm 2 were not finished treatment according to the protocol. The characteristics of study population between the two arms were well balanced. The median PFS were 15 and 23 months , respectively （p=0.014）, while median OS were 25 and 25.5 months for arms 1–2, respectively （p= 0.270）. In arms 1 and 2, the median OS of squamous cell carcinoma was 22.5m and 23m, while non-squamous cell carcinoma 27m and not reached, respectively (p=0.216). The median PFS of squamous cell carcinoma was 17m and 20m, while non-squamous cell carcinoma 15m and not reached, respectively (p=0.020). Compared with lower radiation doses, patients treated with more than or equal to 70 Gy had a better OS and PFS (p=0.002) for both arms. Concerning toxicities, for arms 1 and 2, grade 3-4 depression of white blood cell was 20/48 and 11/52 (p=0.027), grade 2-3 hemotoblatin 8/48 and 5/52 (p=0.047), grade 1-3 radiation induced pneumonitis 40/48 and 31/52 (p=0.032). The differences of other adverse events including esophagitis, nausea, vomiting, platelet were not statistical difference.

    Conclusion
    Comparing with NP, concurrent pem/DDP at full systemic doses and LCAHRT was well tolerated, with promising activity and milder side effects in a Chinese population with inoperable stage III NSCLC in spite of histology types.