Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
26527790
DOI
10.1200/jco.2015.61.4370
PII: JCO.2015.61.4370
Knihovny.cz E-zdroje
- MeSH
- adjuvantní chemoterapie MeSH
- cetuximab aplikace a dávkování MeSH
- chemoradioterapie * MeSH
- chinazoliny terapeutické užití MeSH
- cílená molekulární terapie MeSH
- cisplatina aplikace a dávkování MeSH
- dlaždicobuněčné karcinomy hlavy a krku MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- erbB receptory účinky léků genetika MeSH
- frakcionace dávky záření MeSH
- Kaplanův-Meierův odhad MeSH
- lapatinib MeSH
- lidé středního věku MeSH
- lidé MeSH
- mezinárodní spolupráce MeSH
- nádory hlavy a krku metabolismus terapie MeSH
- odds ratio MeSH
- přežití bez známek nemoci MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití MeSH
- senioři MeSH
- spinocelulární karcinom metabolismus terapie MeSH
- udržovací chemoterapie * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- cetuximab MeSH
- chinazoliny MeSH
- cisplatina MeSH
- EGFR protein, human MeSH Prohlížeč
- erbB receptory MeSH
- lapatinib MeSH
PURPOSE: This multicenter phase III study evaluated the efficacy and safety of lapatinib, an epidermal growth factor receptor/ErbB2 inhibitor, administered concomitantly with chemoradiotherapy and as maintenance monotherapy in patients with high-risk surgically treated squamous cell carcinoma of the head and neck (SCCHN). PATIENTS AND METHODS: Patients with resected stage II to IVA SCCHN, with a surgical margin ≤ 5 mm and/or extracapsular extension, were randomly assigned to chemoradiotherapy (66 Gy total radiation dose and cisplatin 100 mg/m(2) per day administered on days 1, 22, and 43) plus placebo or lapatinib (1,500 mg per day) before and during chemoradiotherapy, followed by 12 months of maintenance monotherapy. RESULTS: Six hundred eighty-eight patients were enrolled (lapatinib, n = 346; placebo, n = 342). With a median follow-up time of 35.3 months, the study ended early because of the apparent plateauing of disease-free survival (DFS) events. Median DFS assessed by an independent review committee was 53.6 months and not reached for lapatinib and placebo, respectively (hazard ratio, 1.10; 95% CI, 0.85 to 1.43). Investigator-assessed results confirmed the independent review committee assessment. No significant differences in DFS by human papillomavirus status or overall survival were observed between treatment arms. Similar numbers of patients in both treatment arms experienced adverse events (AEs), with more patients in the lapatinib arm than the placebo arm experiencing serious AEs (48% v 40%, respectively). The most commonly observed treatment-related AEs were diarrhea and rash, both predominantly in the lapatinib arm. CONCLUSION: Addition of lapatinib to chemoradiotherapy and its use as long-term maintenance therapy does not offer any efficacy benefits and had additional toxicity compared with placebo in patients with surgically treated high-risk SCCHN.
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT00424255
