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N. Nogami
Author of
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MA 07 - ALK, ROS and HER2 (ID 673)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:Robert C. Doebele, J.C. Ho
- Coordinates: 10/17/2017, 15:45 - 17:30, Room 316
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MA 07.11 - A Phase II Study of Trastuzumab Emtansine in HER2-positive Non-Small-Cell-Lung Cancer (ID 8453)
16:55 - 17:00 | Author(s): N. Nogami
- Abstract
- Presentation
Background:
Trastuzumab emtansine (T-DM1), an anti-HER2 antibody conjugated with vinca-alkaloid, has been approved for clinical use in HER2-positive breast cancer. HER2-alterations are detected even in non-small-cell lung cancer (NSCLC). We have launched a phase II trial of T-DM1 monotherapy for patients with HER2-positive lung cancer.
Method:
Eligible patients had pathologically diagnosed NSCLC with documented HER2-positivity (immunohistochemistry [IHC] 3+, both IHC 2+ and fluorescence in situ hybridization [FISH] +, or exon 20 insertion mutation) and were previously treated with standard chemotherapy. Thirty patients would receive T-DM1 3.6 mg/kg every 3 weeks. The primary endpoint is the overall response rate (ORR) per RECIST v1.1.
Result:
This study was early terminated due to the limited efficacy, leading that only 16 patients were registered. The demographics of the 15 evaluable patients were as follows: age (median; 67, range: 45-77), sex (male; 47%), performance status (0-1; 80%), histology (non-squamous; 100%), HER2 status (IHC3+; 33%, IHC2+/FISH; 20%, and mutation; 47%) and number of prior chemotherapeutic regimens (median; 4, range: 1-7). Of 15 patients, one, who possessed HER2 mutation achieved a partial response, resulting in ORR of 6.7%. None of the 15 patients experienced treatment-related deaths. Survival data would be presented at the meeting.
Conclusion:
T-DM1 has a limited efficacy for HER2-positive NSCLCs in our cohort. Additional molecular approaches are warranted for the precision medicine in HER2-positive tumors. UMIN registration number 000019446.
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OA 05 - Next Generation TKI (ID 657)
- Event: WCLC 2017
- Type: Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:James Chih-Hsin Yang, Fiona Blackhall
- Coordinates: 10/16/2017, 15:45 - 17:30, Room 301 + 302
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OA 05.08 - Final Result of Phase I/II Study (AF-001JP) of Alectinib, a Selective CNS-Active ALK Inhibitor, in ALK+ NSCLC Patients (Pts) (ID 9732)
17:00 - 17:10 | Author(s): N. Nogami
- Abstract
- Presentation
Background:
Alectinib (ALC) is a selective, CNS-active ALK tyrosine kinase inhibitor. In two Phase 3 studies (J-ALEX and ALEX), ALC proved superior efficacy and tolerability compared to crizotinib (CRZ). Here we report the final efficacy and safety results of the 46 pts enrolled in the phase II part of study AF-001JP with a longer follow-up period than that observed in J-ALEX and ALEX studies.
Method:
ALC 300 mg b.i.d was given to ALK+ NSCLC pts who were ALK inhibitor-naive and had disease progression after at least one line of chemotherapy to investigate the efficacy and safety until the investigator confirmed no further clinical benefits.
Result:
This study was completed in December 2016. The median treatment duration was 46.1 months (range: 1-62). 20 of 46 pts were on treatment with alectinib at the study termination. Progressive disease (PD) was confirmed in 20 pts (43%). Median PFS was not reached and 4-year PFS rate was 52% (95% CI: 36-66). 14 of 46 pts had CNS metastasis at baseline. Median PFS was 38 months (95% CI: 9-NE) in pts with CNS metastases and was not reached in pts without CNS metastases. Four pts had CNS progression and the 4-year cumulative incidence rate of CNS progression was 9.5%. Median OS was not reached and the 4-year OS rate was 70% (95% CI: 54-81). Safety profile was similar to that reported previously and there were no treatment-related Grade 4 or 5 adverse events for this long administration period.
Conclusion:
Regardless of CNS metastases at baseline, ALC have demonstrated excellent efficacy in ALK+ NSCLC pts without prior ALK inhibitor treatment. ALC was well tolerated over a prolonged administration period.
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P2.05 - Early Stage NSCLC (ID 706)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.05-009 - Outcome of Stereotactic Body Radiotherapy for Clinical Stage I Non Small Cell Lung Cancer and CT Findings: Comparison with Surgical Resection (ID 9964)
09:30 - 09:30 | Author(s): N. Nogami
- Abstract
Background:
The standard care for Stage I non small cell lung cancer (NSCLC) is surgical resection, but stereotactic body radiotherapy (SBRT) can be an alternative treatment option, especially for patients with comorbidities. However, it is difficult to compare the outcomes of SBRT with surgical resection because their characteristics are so different, and the risk factors for recurrence after SBRT are not fully understood. In this study, we report pretreatment clinical characteristics and CT findings in patients treated with SBRT, and reviewed patients underwent surgery with similar tumors.
Method:
Between January 2012 and December 2015, patients treated with SBRT for cT1-2N0M0 NSCLC and 218 patients who underwent surgery for cT1b-2N0M0 NSCLC in our institution were analyzed.
Result:
During the study period, 88 patients were treated with SBRT. The 3-year disease free survival (3-year DFS) for all patients was 81.2%. There were 15 cases of recurrences (9 cases of lymph node recurrences, 8 cases of distant metastases and 2 cases of local recurrence. 4 cases were both lymph node and distant metastases). There was no recurrence among the patients with no more than 1cm of consolidation (cT1a or less according to the 8th edition of the Union for International Cancer Control TNM classification) and all recurrent cases were with solid pattern predominant tumors (maximum consolidation diameters were more than 50% of tumor diameters) based on CT findings. Then we evaluated outcomes and clinical characteristics of patients who were treated with SBRT or underwent surgery for cStage I, cT1b or more and solid predominant NSCLC during the same period. 61 patients were treated with SBRT and 218 underwent surgery (190 cases of lobectomy, 21 secmentectomy and 7 wedge resection). Among clinical characteristics, smaller tumor sizes tend to be treated with SBRT (average sizes were 2.25 and 2.57 cm respectively, p=0.055). The mean age was significantly higher in SBRT group (78.5 vs 68.0, p<0.001). Surgical resection was associated with improved DFS (3-year DFS 84.4% vs 73.4%, p=0.004) and lymph node metastasis was found in 34 cases (15.6%) pathologically in patients underwent surgery, suggesting they are incurable with SBRT.
Conclusion:
The main limitations of this study are the small number of cases and different patient characteristics. Taken together, our data suggesting SBRT is acceptable for patients with cT1a or less, cStage I NSCLC, and surgical resection is recommended for patients with more advanced NSCLC.
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-072 - Dacomitinib Versus Gefitinib for First-Line Treatment of Advanced EGFR+ NSCLC in Japanese Patients (ARCHER 1050) (ID 8476)
09:30 - 09:30 | Author(s): N. Nogami
- Abstract
Background:
Second-generation EGFR tyrosine-kinase inhibitor dacomitinib has shown encouraging activity as first-line therapy in patients with EGFR-activating mutation-positive (EGFR[+]) advanced NSCLC. We performed the first randomized, open-label phase 3 trial comparing dacomitinib with gefitinib as first-line therapy (NCT01774721) which demonstrated a clinically meaningful and statistically significant benefit of dacomitinib versus gefitinib (PFS per IRC: HR, 0.59 [95%CI, 0.47–0.74]; 1-sided P<0.0001; median PFS, 14.7 vs 9.2 months). We present results from Japanese patients enrolled in this ongoing study.
Method:
Patients with newly diagnosed stage IIIB/IV recurrent NSCLC harboring an EGFR-activating mutation (exon 19 deletion or exon 21 L858R ± exon 20 T790M) were randomized 1:1 to once-daily oral dacomitinib 45 mg or gefitinib 250 mg until disease progression or discontinuation. Patients with CNS mets excluded. Stratification was by race and EGFR mutation subtype. The primary endpoint was progression-free survival (PFS) per blinded independent review committee (IRC).
Result:
Among 452 patients enrolled in ARCHER 1050, 81 were Japanese. Slight imbalances in baseline characteristics were observed (Table). PFS and duration of response improvement in Japanese patients was consistent with global results.
Objective response rates per IRC were similar (dacomitinib, 75.0% [95%CI, 58.8–87.3]; gefitinib, 75.6% [95%CI, 59.7–87.6]; 2-sided P=0.9579). Overall survival data are not mature. All 81 patients received study treatment. No grade 4/5 adverse events (AEs were observed with dacomitinib, while 3 grade 4 AEs and 1 grade 5 AE (disease progression) occurred with gefitinib. The most common grade 3 AEs were dermatitis acneiform (27.5%) and paronychia (22.5%) with dacomitinib and alanine aminotransferase increased (12.2%) and abnormal hepatic function (7.3%) with gefitinib. No new safety signals were identified.Japanese Intention-to-Treat Population Dacomitinib (n = 40) n (%) Gefitinib (n = 41) n (%) Unstratified HR [95% CI] 1-sided p-value Male 15 (37.5) 20 (48.8) Age, years <65 ≥65 19 (47.5) 21 (52.5) 15 (36.6) 26 (63.4) Smoking status Never smoked Ex-smoker Smoker 19 (47.5) 20 (50.0) 1 (2.5) 24 (58.5) 16 (39.0) 1 (2.4) ECOG PS 0 1 28 (70.0) 12 (30.0) 21 (51.2) 20 (48.8) Median, months Median, months PFS per IRC 18.2 (95% CI, 11.0–31.3) 9.3 (95% CI, 7.4–14.7) 0.54 (95% CI, 0.31–0.95) P=0.0141 PFS per INV 18.3 (95% CI, 14.6–22.1) 10.2 (95% CI, 7.3–16.9) 0.61 (95% CI, 0.36–1.04) P=0.0334 DoR per IRC in responders # of responders=30 17.5 (95% CI, 10.2–34.3) # of responders=31 8.3 (95% CI, 5.6–12.9) 0.44 (95% CI, 0.22–0.84) P=0.0056 CI, confidence interval; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; INV, investigator assessment.
Conclusion:
Dacomitinib significantly improved PFS and duration of response over gefitinib in first-line treatment of Japanese patients with advanced EGFR[+] NSCLC, with a manageable safety profile.
