ABSTRACT
Cancer clinical trials are instrumental in driving forward medical advancements and enhancing patient outcomes. However, despite their significance, only a small fraction of adult cancer patients, less than one in 20, participate in these trials, indicating significant obstacles in recruitment and engagement. These trials not only assess treatment effectiveness but also serve as vibrant platforms where scientific ingenuity converges with human resilience, fostering a culture of exploration and empowerment. Furthermore, they spur innovation in treatment methods, supportive care, and survivorship strategies, addressing the diverse needs of patients. Moreover, clinical trials prioritize diversity and inclusivity, ensuring that treatments are relevant across various demographic groups and promoting equity in healthcare access. Despite challenges, cancer clinical trials have showcased remarkable resilience and adaptability, particularly in navigating the complexities of the COVID-19 pandemic, underscoring their flexibility and ingenuity. By acknowledging the invaluable contributions of patients and researchers, we recommit to propelling cancer science forward and reshaping the landscape of cancer care for future generations.
ABSTRACT
This case report outlines the diagnostic and treatment experience of a 50-year-old male diagnosed with moderately differentiated squamous cell carcinoma (SCC) in the right lower alveolus. It underscores the challenges of oral squamous cell carcinoma (OSCC) diagnosis and management, emphasizing the need for comprehensive multidisciplinary approaches. The patient's initial presentation with persistent mandibular pain highlighted the complexities of diagnosing oral and maxillofacial pathologies. A detailed clinical examination revealed unique ulceroproliferative growth, showcasing the importance of meticulous clinical assessment. Histopathological confirmation solidified the diagnosis. Treatment involved surgery, adjuvant radiotherapy, and concurrent chemotherapy. Post-chemotherapy, the patient responded positively, underlining treatment efficacy. Transitioning to oral chemotherapy demonstrated adaptability. Vigilant follow-up, exemplified by detecting non-healing ulcers and erosions, is crucial for early intervention. This case informs oral squamous cell carcinoma management. Integrated therapy's success underscores the value of combining surgery, chemotherapy, and radiotherapy. The patient's response to gefitinib, cyclophosphamide, and methotrexate suggests promise for targeted therapies. Patient-centered care, interdisciplinary collaboration, and adaptability are vital. This case report illustrates oral squamous cell carcinoma eradication through multidimensional treatment. The patient's journey highlights accurate diagnosis, adaptable therapy, and vigilant follow-up. It informs the field and fosters further research and innovation.
ABSTRACT
IMPORTANCE: Locoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC. OBJECTIVE: To assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population. INTERVENTIONS: Patients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal. MAIN OUTCOMES AND MEASURES: The primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life. RESULTS: A total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group). CONCLUSIONS AND RELEVANCE: This study's findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01345669.
