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K. Goto
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MA07 - ALK-ROS1 in Advanced NSCLC (ID 385)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
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MA07.03 - Alectinib (ALC) versus Crizotinib (CRZ) in ALK-Positive Non-Small Cell Lung Cancer (ALK+ NSCLC): Primary Results from Phase III Study (J-ALEX) (ID 5597)
11:12 - 11:18 | Author(s): K. Goto
- Abstract
- Presentation
Background:
ALK inhibitors are the standard treatment for ALK+ NSCLC and the comparison between 2 ALK inhibitors will be valuable in determining therapeutic strategy for ALK+ NSCLC patients (pts). We conducted the randomized open-label Phase III trial designed to prove the superior PFS of ALC to CRZ in ALK-inhibitor naïve ALK+ NSCLC.
Methods:
ALK+ NSCLC pts were randomized 1:1 either to receive ALC (300 mg b.i.d.) or CRZ (250 mg b.i.d.) and stratified by ECOG PS (0/1 vs 2), treatment line (1[st] vs 2[nd]), and clinical stage (IIIB/IV vs recurrence). Primary endpoint was PFS according to the blinded independent review board. Secondary endpoints included overall survival, objective response rate, and safety. Under an assumption of expected hazard ratio (HR) of 0.643, 164 events were required to have 80% power with 2-sided alpha of 0.05. Three interim analyses (IA) for early stopping due to efficacy were planned after 33%, 50%, and 75% of required PFS events occurred.
Results:
207 pts were enrolled at 41 centers in Japan between November 2013 and August 2015. Independent data monitoring committee recommended the release of study data because the superiority in PFS had been demonstrated for ALC based on second IA. The PFS HR of ALC arm to CRZ arm was 0.34 (99.6826% CI: 0.17-0.70, stratified log-rank p<0.0001). Median PFS was not reached (95% CI: 20.3-Not Reached (NR)) in ALC arm while it was 10.2 months (95%CI: 8.2-12.0) in CRZ arm. ALC demonstrated favorable result of PFS in each sub-group for instance, treatment line (1[st] line: HR = 0.30, ALC: NR vs CRZ: 10.2 months, 2[nd] line: HR = 0.39, ALC: 20.3 months vs CRZ: 8.2 months), brain metastases at baseline (yes: HR = 0.08, ALC: NR vs CRZ: 10.2 months, no: HR = 0.39, ALC: 20.3 moths vs CRZ: 10.0 months) and clinical stage (stage IIIb/IV: HR = 0.31 ALC: 20.3 months vs CRZ: 8.3 months, recurrence: HR = 0.49, ALC: NR vs CRZ: 11.6 months). Grade 3-4 AEs (ALC: 26% vs CRZ: 52%), discontinuation of study drug due to AEs (ALC: 9% vs CRZ: 20%) and dose interruptions due to AEs (ALC: 29% vs CRZ: 74%) occurred with lower rate in the ALC arm. There were no treatment-related deaths in either arm.
Conclusion:
ALC demonstrated prolonged PFS compared with CRZ in all sub-groups with a favorable AE profile representing a potential new standard treatment for 1[st] line ALK+ NSCLC pts.
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P3.01 - Poster Session with Presenters Present (ID 469)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Biology/Pathology
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.01-033 - Changes in the Tumor Microenvironment during Lymphatic Metastasis of Lung Squamous Cell Carcinoma (ID 6341)
14:30 - 14:30 | Author(s): K. Goto
- Abstract
Background:
Metastasis and growth in neoplastic lesions requires the multi-step regulation of microenvironmental factors. We aimed to elucidate the microenvironmental changes in the process of lymphatic metastasis of lung squamous cell carcinoma.
Methods:
We examined the morphological characteristics of 102 cases of Primary Tumor (PT), 50 of intralymphatic tumor (ILT), 51 of lymph node (LN) micrometastasis (LN-Mic; less than 2 mm in size) and 82 of LN Macrometastasis (LN-Mac; greater than 10 mm in size). Afterwards we evaluated the expression of nine molecules (EGFR, FGFR2, CD44, ALDH1, Podoplanin, E-cadherin, S100A4, geminin and ezrin) in matched PT, ILT, LN-Mic and LN-Mac from 23 of these cases.
Results:
The number of smooth muscle actin α-positive fibroblasts, CD34-positive microvessels and CD204-positive macrophages were also examined. As a result, the mitotic index of cancer cells was significantly lower in ILT and LN-Mic than PT and LN-Mac (p<0.001). Moreover stromal reaction in ILT and LN-Mic was less prominent than in PT and LN-Mac (p<0.001). Immunohistochemical study revealed that EGFR expression level and frequency of geminin positive cells in ILT and LN-Mic were significantly lower than in PT and LN-Mac (p<0.05). The number of stromal cells indicated by staining of CD34, CD204 and smooth muscle actin α in ILT and LN-Mic also was significantly lower than in PT and LN-Mac (p<0.05).
Conclusion:
In lung squamous cell carcinoma, drastic microenvironmental changes (e.g., growth factor receptor expression and proliferative capacity of cancer cells and structural changes in stromal cells) occur during both the process of lymphatic permeation and the progression into macrometastases.
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P3.05 - Poster Session with Presenters Present (ID 475)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Palliative Care/Ethics
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.05-007 - Prospective Evaluation for Combination Antiemetic Therapy on CINV in NSCLC Receiving Carboplatin-Based Chemotherapy of MEC (ID 3737)
14:30 - 14:30 | Author(s): K. Goto
- Abstract
Background:
The incidence of delayed chemotherapy-induced nausea and vomiting (CINV) for non-small cell lung cancer (NSCLC) patients receiving carboplatin (CBDCA) -based chemotherapy (CBDCA+pemetrexed (PEM) / CBDCA+ paclitaxel (PTX)) has not been clearly controlled.
Methods:
We used the combined data from the two prospective observational studies; A nationwide survey of CINV study group and the other prospective observational study in Japan. We assessed whether delayed CINV were controlled with combination antiemetic treatment. We also evaluate risk factors by logistic regression analysis.
Results:
A total of 240 patients were evaluable in this study. The median age was 66 (range:34-82) with 173 males and 67 females. Three antiemetics were used in 54 (22.5%) patients. Delayed nausea and vomiting were experienced more commonly in women than in men. Delayed nausea was well controlled with 3 antiemetics than with 2 antiemetics for women (45.0% vs. 72.3%; P=0.0506). Delayed vomiting was well controlled with 3 antiemetics than with 2 antiemetics for overall (11.1% vs. 23.1%; P=0.0571) and for women (20.0% vs. 44.7%; P=0.0962). We identified several risk factors; women (OR=2.903 ;95% confidence interval [CI], 1.607-5.242 ;P=0.0004) and age (OR=0.968 ;95%CI, 0.938-0.999 ;P=0.0442) for delayed nausea, and women (OR=4.252 ;95%CI, 2.154-8.394 ;P<0.0001) and 2 antiemetics (OR=3.140 ;95%CI, 1.205-8.179 ;P=0.0192) for delayed vomiting.
Conclusion:
Three antiemetics combination are encouraged for NSCLC patients treated with CBDCA-based chemotherapy to alleviate delayed vomiting.
