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X. Song



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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-050 - A Interim Analysis of Randomized Phase III Trial of Nedaplatin or Cisplatin Combined with Docetaxel as First-Line Treatment for Advanced ASQC (ID 1225)

      09:30 - 09:30  |  Author(s): X. Song

      • Abstract
      • Slides

      Background:
      Cisplatin combined with docetaxel is one of the stand treatment in advanced squamous cell carcinoma(ASQC) of the lung. Nedaplatin combined with docetaxel has demonstrated potent activity in ASQC in phase II study. But until now there is no randomized phase III study comparing these 2 chemotherapy regimens. The aim of this study was to evaluate and compare the efficacy and safety between the combination chemotherapy of nedaplatin or cisplatin plus docetaxel in patients with ASQC.

      Methods:
      This is a multicentre, open-label, randomized, phase III study in China (NCT02088515). Chemo-naive stage IIIB/IV squamous NSCLC with Eastern Cooperative Oncology Group performance status 0/1 were randomized (1:1) to four cycles of nedaplatin (80 mg/m[2]) plus docetaxel(75 mg/m[2]) or cisplatin(75 mg/m[2]) plus docetaxel (75 mg/m[2]) . The primary endpoint was progression-free survival (PFS). Secondary end points were overall survival (OS), overall response rate (ORR), disease control rate (DCR) and quality of life.

      Results:
      From December 2013 to January 2015, 117 patients were accrued: nedaplatin plus docetaxel (n = 57) and cisplatin plus docetaxel (n = 60). The objective response rates were 27% and 31% and the disease control rate were 78.92 % and 82.67% in nedaplatin and cisplatin groups, respectively. There is no significance difference in nausea / vomiting(21% vs 30%) , diarrhea(3% vs 5%), liver dysfunction(12% vs 15%), neutropenia(60% vs 65%), thrombocytopenia(10% vs 12%), anemia(8% vs 7%) between the 2 arms. The renal dysfunction incidence is higher in the cisplatin group(3% vs 0%). Although there is no 3/4 grade toxicities difference between 2 arms including nausea / vomiting(0% vs 0%) , diarrhea(0% vs 1%), liver dysfunction(0% vs 0%), renal dysfunction(0% vs 0%) , neutropenia(4% vs 3%), thrombocytopenia(0% vs 0%), anemia(0% vs 0%) . This is an interim analysis and we haven't got the data of survival and quality of life.

      Conclusion:
      There is no ORR difference between the group of nedaplatin plus docetaxel and cisplatin plus docetaxel. But the toxicity of nedaplatin regiment is less toxicities, especially in renal toxicity,as first-line treatment for patients with advanced squamous NSCLC

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