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Y. Chen
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P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.07-004 - The Relationship between UGT1A1 Gene Polymorphism and Irinotecan Effect on ED-SCLC (ID 301)
09:30 - 09:30 | Author(s): Y. Chen
- Abstract
Background:
NCCN recommends IP program as a first-line chemotherapy of ED-SCLC.Several clinical study conducted in colorectal cancer showed that the polymorphism of UGT1A1*28 gene can evaluate the risk of severe neutropenia and diarrhea occurred in patients receiving irinotecan chemotherapy. The purpose of this research is to analyze the distribution of UGT1A1 gene polymorphisms in Chinese Han patients with ED-SCLC,and to evaluate correlations between UGT1A1 gene polymorphisms and toxicity and efficacy of irinotecan in patients with ED-SCLC.
Methods:
Analysis of UGT1A1*28 and UGT1A1*6 gene polymorphisms were performed by peripheral blood gene sequencing. From June 2011 to Nov 2013, 67 cases admitted to hospital with ED-SCLC treated by irinotecan(CPT-11) based regimen were enrolled in this study. We observe the relationship of PFS , OS and AEs between different genotypes.
Results:
Figure 1 figure 1 the PFS and different gene type Figure 2 figure 2 the OS and different gene type The median PFS of wild type UGT1A1*28 (TA6/6) and mutant (TA6/7) was 9.9 months and 10 months respectively; the median PFS of wild type UGT1A1*6 (G/G) and UGT1A1*6 mutant (G/A) was 9.7 months and 9.9 months respectively. The median OS of wild type UGT1A1*28 (TA6/6) and mutant (TA6/7) was 13.9 months and 14.5 months respectively; the median OS of wild type UGT1A1*6 (G/G) and UGT1A1*6 mutant (G/A) was 13.8 months and 14.1 months respectively. No significant difference of PFS and OS was observed between different genotypes(p>0.05). The incidence of grade 3 and 4 delayed diarrhea and neutropenia in patients carrying UGT1A1*6 G/A was higher than that in the WT genotype(36.4% vs. 6.6% p<0.05; 27.2% vs. 4.4% p<0.05 respectively); The patients simultaneously carrying UGT1A1*28 TA6/7 and UGT1A1*6 G/A were prone to suffering 3 and 4 delayed diarrhea and neutropenia.
Conclusion:
Although UGT1A1 polymorphisms failed to predict the efficacy of CPT-11 in ED-SCLC, the prediction of adverse effect may worth attention.
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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
- 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): Y. Chen
- 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