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D. Keefe
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-073 - Impact of Prophylactic Doxycycline (Doxy) on Maintaining Planned Dosing of Dacomitinib (D) an Irreversible panHER Inhibitor (ID 2631)
09:30 - 09:30 | Author(s): D. Keefe
- Abstract
Background:
ARCHER 1042 (NCT01465802) was a randomized patient (pt) blinded trial that explored prophylactic interventions to minimize select dermatologic adverse events of interest (SDAEI) and diarrhea associated with D, an irreversible small molecule PanHER inhibitor.
Methods:
In Cohorts I (CI) and II (CII) pts with advanced NSCLC, ≥1 prior chemo, ECOG 0–2, were randomized (pt blinded) in CI to (a) D 45 mg daily (QD) plus placebo (pbo) (D+pbo) or (b) D 45 mg QD plus doxy 100 mg twice daily x 4 wks (D+doxy) and in CII assigned to D 45 mg QD plus probiotic (prob) and topical alclometasone (alclo) (D+prob+alclo). Primary endpoints in first 8 wks included: all grade (G) and G≥2 SDAEI and PRO (Skindex-16) (CI, CII) and CII G and G≥2 diarrhea and PRO (modified Mucositis Daily Questionnaire). Plasma samples were collected to confirm that exposure of D is not altered with doxy treatment.
Results:
As of August 25, 2014, 112 pts randomized to Cohort I D+pbo vs. D+doxy (median age 66 years, 53% male) and 59 pts to CII D+prob+alclo (median age 66 years, 66% male) were evaluable (>6 wks treatment). Median relative dose intensity (RDI) of D in the first 8 wks was 82.74% for D+doxy compared with 79.76% for D+pbo and 75.00% for D+prob+alclo. Figure 1 PRO Skindex scores improved with prophylactic doxy, but not alclo; prophylactic probiotic was not associated with improved CTCAE or PRO. Plasma exposure of D was similar when administered either with pbo or doxy.
Conclusion:
These preliminary data suggest prophylactic doxy improves ≥G2 Select Dermatologic AEs with improved D RDI and less need for dose discontinuations. The prophylactic effect observed with doxy cannot be attributed to altered exposure of D. In contrast, prophylactic topical corticosteroids had no effect on rash or diarrhea.
