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T. Kozuki
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-010 - Development of Skin Rash within the First Week Is a Potential Surrogate Marker of Effect in Afatinib for EGFR Mutant NSCLC (ID 1184)
09:30 - 17:00 | Author(s): T. Kozuki
- Abstract
Background:
Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are now key agents in EGFR-mutant non-small-cell lung cancer (NSCLC). In gefitinib or erlotinib monotherapy, its efficacy could be predicted by development of skin rash, however, it has not been fully evaluated if this is similarly the case with afatinib monotherapy.
Methods:
We retrospectively studied consecutive 49 patients with EGFR-mutant NSCLC who received afatinib therapy between 2009 and 2015. Relationship with several toxicities and tumor response was examined.
Results:
Figure 1Figure 2The Grade 2 or worse common adverse events (AEs) included skin rash in 17 patients (35%), diarrhea in 19 (39%) and mucositis in 15 (31%). Of these, number of patients who developed ≥ Grade 2 AEs within the first week was 5 (10%; skin rash), 12 (25%; diarrhea) and 4 (8%; mucositis). As for objective response, 21 (43%) of the 49 had partial response. In association with AEs and antitumor effect, those who had Grade 2 or worse skin rash within the first week tended to have better tumor response as compared with those who did not have (80% vs. 39%; p = 0.077).
Conclusion:
Our small study demonstrated that early development of skin rash might predict the response to afatinib monotherapy.
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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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P3.01-085 - Randomized Phase II Study of Docetaxel plus Bevacizumab or Pemetrexed plus Bevacizumab for Elderly Non-Squamous NSCLC (TORG1323) (ID 1742)
09:30 - 17:00 | Author(s): T. Kozuki
- Abstract
Background:
A randomized study comparing carboplatin plus weekly paclitaxel versus single-agent chemotherapy in elderly patients with non-small cell lung cancer (NSCLC) demonstrated a survival advantage for combination therapy, however, increased toxicity and treatment-related deaths were also observed. Thus, single agent approaches remain the standard of care and the improvement of treatment remains a challenge in elderly patients. The combination of bevacizumab and other platinum-based chemotherapies is the standard of care in non-elderly patients with non-squamous NSCLC. Additionally, a randomized phase II study suggested the improvement of efficacy for the combination of B plus single-agent pemetrexed or docetaxel compared with single-agent alone. Even in elderly patients, two prospective studies which we conducted demonstrated the feasibility of the combination of bevacizumab and single agent pemetrexed or docetaxel. Thus we plan this randomized phase II study (TORG1323) to select the optimal regimen for experimental arm of the future phase III study in elderly patients.
Methods:
TORG1323 is an open label multicenter randomized phase II study to compare docetaxel plus bevacizumab (DB) with pemetrexed plus bevacizumab (PB). The primary endpoint is progression free survival (PFS, assessed by independent review committee). The secondary endpoints are safety, PFS (assessed by investigators), objective response rate, overall survival, time to treatment failure and quality of life. Eligible patients are 75 years or older, have histologically or cytologically documented stage IIIb, IV or recurrent non-squamous NSCLC for which they had no received chemotherapy, ECOG performance status 0 or 1, and adequate organ function. Patients are randomly assigned to PB and DB arm (1:1). Bevacizumab is administered 15 mg/kg, pemetrexed is 500 mg/m[2] and docetaxel is 50 mg/m[2] every 3 weeks until disease progression or unacceptable toxicity. Selection design is adopted for this study. The planned sample size is 120 patients to yield 80 % power to select an optimal regimen correctly. Enrollment time is 2 years 8 months and follow-up time is 1 year. The first patient on this clinical trial was enrolled in April 2014. Further details can be found on UMIN Clinical Trials Registry (UMIN000012786). Figure 1
Results:
not applicable
Conclusion:
not applicable
