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
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
26527790
DOI
10.1200/jco.2015.61.4370
PII: JCO.2015.61.4370
Knihovny.cz E-resources
- MeSH
- Chemotherapy, Adjuvant MeSH
- Cetuximab administration & dosage MeSH
- Chemoradiotherapy * MeSH
- Quinazolines therapeutic use MeSH
- Molecular Targeted Therapy MeSH
- Cisplatin administration & dosage MeSH
- Squamous Cell Carcinoma of Head and Neck MeSH
- Adult MeSH
- Double-Blind Method MeSH
- ErbB Receptors drug effects genetics MeSH
- Dose Fractionation, Radiation MeSH
- Kaplan-Meier Estimate MeSH
- Lapatinib MeSH
- Middle Aged MeSH
- Humans MeSH
- International Cooperation MeSH
- Head and Neck Neoplasms metabolism therapy MeSH
- Odds Ratio MeSH
- Disease-Free Survival MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Aged MeSH
- Carcinoma, Squamous Cell metabolism therapy MeSH
- Maintenance Chemotherapy * MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Cetuximab MeSH
- Quinazolines MeSH
- Cisplatin MeSH
- EGFR protein, human MeSH Browser
- ErbB Receptors 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.
References provided by Crossref.org
ClinicalTrials.gov
NCT00424255
