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F. Jian
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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: 2
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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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): F. Jian
- Abstract
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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P3.01-053 - Efficacy and Safety of Extended Therapy with Endostar Combined with Chemotherapy in Patients with Advanced NSCLC: A Retrospective Study (ID 1393)
09:30 - 09:30 | Author(s): F. Jian
- Abstract
Background:
It is known that the addition of endostar (recombinant human endostatin, a novel broad-spectrum inhibitor of tumor angiogenesis) to chemotherapy resulted in a significant effective benefit in the treatment of patients with advanced non–small cell lung cancer (NSCLC). Previous research showed that multicycle application of angiogenetic drug combined with chemotherapy might prolong overall survival of NSCLC. However, the optimal treatment duration of endostar and chemotherapy remains uncertain.
Methods:
A retrospective analysis of ≥ 4 cycles versus < 4 cycles of endostar combined with platinum-based doublet chemotherapy(PBDC) was performed in patients with advanced NSCLC. For efficacy assessments, patients received ≥ 4 cycles of therapy (extended group) were compared with those who received less than 4 cycles but not because of tumor progression (control group). Toxicity analyses were performed for all patients.
Results:
A total of 232 patients were enrolled, of whom 128 patients completed at least four cycles of the therapy (extended group), 64 patients ceased their therapy before 4 cycles not because of progression(control group). The median progress free survival(PFS) was 8.2 months versus 5.4 months in extended group and control group (p=0.027), and the median overall survival(OS) was 22.5 months versus 13.6 months (p=0.000), respectively. Subgroup analysis showed that, among the EGFR mutation-positive patients, the control group seemed to result in a trend toward survival benefit according to the Kaplan-Meier curves, although the differences are not statistically significant. Hematological toxicity and fatigue occurred more frequently in patients received 4 or more cycles (p﹤0.05), but no statistically significant difference was detected in all grade ≥3 adverse events. Figure 1Figure 2
Conclusion:
Extended treatment of endostar combined with chemotherapy exhibited increased survival and acceptable toxicity in previously untreated patients with NSCLC, supporting further evaluation in larger prospective studies.
