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X. Chen
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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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P3.01-052 - Randomized Phase II Individualized Chemotherapy Study Based on BRCA1 and RRM1 Message RNA Level for Advanced NSCLC (BRAVO Study) (ID 2306)
09:30 - 09:30 | Author(s): X. Chen
- Abstract
Background:
We assessed whether BRCA1 and RRM1 message RNA(mRNA) levels could help to select chemotherapy regimen to improve objective response rate in patients with advanced NSCLC.
Methods:
Eligible patients were randomly assigned 2:1 according to stratification factors of smoking, gender and histological type. In experimental arm, gemcitabine/cisplatin(GP) were selected if both RRM1 and ERCC1 mRNA levels were low, irinotecan/cisplatin(IP) if RRM1 high and BRCA1 low, gemcitabine/vinorelbine(GN) if RRM1 low and BRCA1 high, and docetaxel(T) if both high. GP was chose in the control arm. The primary end point was objective response rate (ORR). (Registered No. NCT01424709).
Results:
121 patients were enrolled and 120 received at least one dose of therapy. The median number of cycles given was four in both arms. In experimental arm, 36 patients treated with GP, 14 with IP, 13 with GN and 17 with T. The ORR and DCR were 33.3% and 79.5% in the experimental arm, which were not significant different from 32.5% (p=0.12) and 87.5%(p=0.18) in the control arm. When patients with both low mRNA levels of RRM1 and ERCC1 were removed, the sub-analysis showed the ORR in the experimental arm was marginally significantly higher than in the control arm (42% vs. 36.3%, p=0.06)). Survival analysis showed similar PFS in the two arms (5.1 vs. 5.3m, p=0.11), while sub-analysis revealed that PFS was marginally significantly longer in the experimental arm (5.7 vs. 5.3m p=0.09). No unexpected side effect happened in both arms.
Conclusion:
BRCA1 and RRM1 mRNA levels were potentially used for therapeutic decision making in newly diagnosed patients with advanced NSCLC.
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P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.04-010 - EML4-ALK Fusion Detected by qRT-PCR Confers Similar Response to Crizotinib as Detected by FISH in Patients with Advanced NSCLC (ID 2338)
09:30 - 09:30 | Author(s): X. Chen
- Abstract
Background:
Quantitative reverse transcriptase polymerase chain reaction assay (qRT-PCR) has been proved to have high sensitivity and specificity to detect anaplastic lymphoma kinase (ALK) rearrangements. The aim of this study was to investigate the response to crizotinib in patients of advanced non-small-cell lung cancer (NSCLC) with ALK rearrangements detected by qRT-PCR.
Methods:
Patients with advanced NSCLC who had their ALK rearrangement status detected by qRT-PCR were included in this analysis. The utility of qRT-PCR and fluorescence in situ hybridization assay (FISH) were compared in patients who were treated with crizotinib based on their positive ALK rearrangements.
Results:
1010 patients were included in this study. Among them, 104 patients were ALK qRT-PCR positive and 53 of them received crizotinib treatment. Among 255 tumors simultaneously analyzed by FISH and RT-PCR, the latter successfully detected all the 25 tumors with arrangements, including two cases which were missed by FISH. The overall response rate (ORR) and median progression free survival (mPFS) of the 53 patients with ALK rearrangements who received crizotinib treatment were 60.4% (95%CI, 47.2-73.6) and 8.4 months (95% CI 6.75-10.05) respectively, which were similar to the 21 patients detected by FISH with ORR of 57.1% (95% CI 33.3-76.2) (p=0.799) and mPFS of 7.4 months (95% CI 4.43-10.38) (p=0.833) after crizotinib treatment. Interestingly, there were 2 patients responded to crizotinib had their ALK rearrangement detected by qRT-PCR but not FISH.
Conclusion:
qRT-PCR should be considered as an alternative assay to detect ALK fusion oncogene in NSCLC patients who might be benefit from crizotinib treatment.
