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H. Isobe
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P2.01 - Advanced NSCLC (ID 618)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)
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P2.01-005 - A Randomized Phase II Trial of Erlotinib vs S-1 in Patients with NSCLC as Third- or Fourth-Line Therapy (HOT1002) (ID 7579)
09:00 - 09:00 | Author(s): H. Isobe
- Abstract
Background:
Because of the improved efficacy of first and second-line therapy in patients (pts) with non-small cell lung cancer (NSCLC) with wild type EGFR, a high proportion of patients receive third-line therapy and beyond. When this study was planned, erlotinib, an EGFR tyrosine kinase inhibitor, was recommended as standard second-line therapy, irrespective of EGFR status, based on the results of BR 21 study. We conducted the Hokkaido Lung Cancer Clinical Study Group (HOT) 1002 trial, to compare erlotinib (E) with S-1 (S) for NSCLC as third or fourth-line therapy.
Method:
This study was a multicenter, randomized phase II study in Japan. All eligible pts had a recurrent or advanced NSCLC with wild type or unknown EGFR and had progressed after two or three previous chemotherapies. Pts were randomly assigned and treated with E or S until either disease progression or unacceptable toxicity. The primary endpoint was the disease control rate (DCR). The secondary endpoints included the overall survival (OS), progression-free survival (PFS), response rate (RR), toxicity and quality of life (QOL).
Result:
From May 2011 to March 2016, 37 pts were randomly assigned to receive erlotinib (n=19) or S-1 (n=18). This study was terminated immaturely because of the poor pts accrual. The median number of treatment cycles was 3 (range 1-10) in E and 4 (range 1-11) in S. DCR/RR was 42.1%/15.8% in E and 66.7%/16.7% in S. Median PFS/OS (months) was 1.6 (95% CI; 0.8-3.7)/ 8.0 (95% CI; 4.2-13.3) in E and 3.3 (95% CI; 1.5-5.8)/12.2 (95% CI; 5.5-16.3) in S (p=0.094/0.42). Although the patient number was too small for statistical comparison, S group showed better PFS than E group both as third-line (1.5 vs 2.7 months) and fourth-line (3.3 vs.5.9 months). In both treatment groups, the most commonly reported Gr 3-4 non-hematological toxicities were fatigue, anorexia and nausea. There was one Gr 5 event pneumonitis in S. No significant difference was seen in QOL.
Conclusion:
Although this trial had no statistical power to draw any conclusions, treatment with S-1 as a third-/fourth-line showed numerically better clinical outcomes compared with erlotinib.
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P2.03 - Chemotherapy/Targeted Therapy (ID 704)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.03-010 - Updated Survival Outcomes of NEJ005/TCOG0902, a Randomized PII of Gefitinib and Chemotherapy in EGFR-Mutant NSCLC (ID 7948)
09:30 - 09:30 | Author(s): H. Isobe
- Abstract
Background:
North East Japan Study Group (NEJ) 005/ Tokyo Cooperative Oncology Group (TCOG) 0902 study has demonstrated that first-line concurrent (C) and sequential alternating (S) combination therapies of EGFR tyrosine kinase inhibitor (gefitinib) plus platinum-based doublet chemotherapy (carboplatin/pemetrexed) offer promising efficacy with predictable toxicities for patients with EGFR-mutant NSCLC (ASCO2014, Ann Oncol 2015). However, overall survival (OS) data were insufficient because of the lack of death events in the primary report.
Method:
Progression-free survival (PFS) and OS were re-evaluated at the final data cutoff point (March 2017) for the entire population (N = 80).
Result:
At the median follow-up time of 35.6 months, 88.8% of patients had progressive disease and 77.5% of patients had died. Median PFS was 17.5 months for the C regimen and 15.3 months for the S regimen (p = 0.13). Median OS time was 41.9 with the C regimen and 30.7 months with the S regimen (p = 0.036). Updated response rates were similar in both groups (90.2% and 82.1%, respectively; p = 0.34). Patients who had common mutations showed no significant differences in PFS according to type of mutation. Patients with Del19 displayed relatively better OS (median: 45.3 and 33.3 months for C and S regimens) than those with L858R (31.4 and 28.9 months). No severe adverse events including interstitial lung disease have occurred during the follow-up period since the primary report. In an exploratory analysis, there was no significant difference in post progression survival and overall survival between patients with progression of target or non-target lesions and those progressed with new lesions.
Conclusion:
This updated analysis has confirmed that PFS is improved with first-line combination therapies compared to that with gefitinib monotherapy, and the C regimen in particular offers an overall survival benefit of 42 months in the EGFR-mutated setting. Our on-going NEJ009 study will clarify whether this combinational strategy can be incorporated into routine clinical practice.
