Impact of PET/CT on Staging and Treatment of Advanced Head and Neck Squamous Cell Carcinoma.

OBJECTIVE: To understand the effects of positron emission tomography/computed tomography (PET/CT) evaluation on patients with previously untreated head and neck squamous cell carcinoma (HNSCC) with clinical evidence of regional lymph node involvement. STUDY DESIGN: Prospective blinded study. SETTING: Tertiary care cancer center. SUBJECTS AND METHODS: Informed consent was obtained and data collected from 52 consecutive previously untreated patients with HNSCC and clinical evidence of cervical metastasis. All patients underwent conventional evaluation for HNSCC and whole body PET/CT. Data were evaluated by 5 independent reviewers, who performed TNM staging per the American Joint Committee on Cancer (seventh edition) manual and proposed a treatment plan prior to viewing, and after reviewing, PET/CT. Cases where at least 3 of 5 reviewers agreed were considered significant. RESULTS: There were 0 patients for whom review of the PET/CT altered the T-class assessment (95% CI, 0-6.8), 12 (23.1%) for whom PET/CT altered N classification (95% CI, 12.5-34.5), and 2 (3.8%) for whom PET/CT altered the M classification (95% CI, 0.5-13.2). For 5 patients (9.6%), overall stage was altered per PET/CT review (95% CI, 3.2-21). For 3 patients (5.8%), PET/CT findings prompted reviewers to alter treatment recommendations (95% CI, 1.2-15.9). CONCLUSION: When added to more conventional patient evaluation, PET/CT results in changes to the TNM categories, but overall staging and treatment were less frequently affected. Whether PET/CT should be used routinely for patients with stage III and IV HNSCC is still subjective and merits further study.

Vosaroxin in combination with decitabine in newly diagnosed older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome.

Vosaroxin is an anti-cancer quinolone-derived DNA topoisomerase II inhibitor. We investigated vosaroxin with decitabine in patients ≥60 years of age with newly diagnosed acute myeloid leukemia (n=58) or myelodysplastic syndrome (≥10% blasts) (n=7) in a phase II non-randomized trial. The initial 22 patients received vosaroxin 90 mg/m2 on days 1 and 4 with decitabine 20 mg/m2 on days 1-5 every 4-6 weeks for up to seven cycles. Due to a high incidence of mucositis the subsequent 43 patients were given vosaroxin 70 mg/m2 on days 1 and 4. These 65 patients, with a median age of 69 years (range, 60-78), some of whom with secondary leukemia (22%), adverse karyotype (35%), or TP53 mutation (20%), are evaluable. The overall response rate was 74% including complete remission in 31 (48%), complete remission with incomplete platelet recovery in 11 (17%), and complete remission with incomplete count recovery in six (9%). The median number of cycles to response was one (range, 1-4). Grade 3/4 mucositis was noted in 17% of all patients. The 70 mg/m2 induction dose of vosaroxin was associated with similar rates of overall response (74% versus 73%) and complete remission (51% versus 41%, P=0.44), reduced incidence of mucositis (30% versus 59%, P=0.02), reduced 8-week mortality (9% versus 23%; P=0.14), and improved median overall survival (14.6 months versus 5.5 months, P=0.007). Minimal residual disease-negative status by multiparametric flow-cytometry at response (± 3 months) was achieved in 21 of 39 (54%) evaluable responders and was associated with better median overall survival (34.0 months versus 8.3 months, P=0.023). In conclusion, the combination of vosaroxin with decitabine is effective and well tolerated at a dose of 70 mg/m2 and warrants randomized prospective evaluation. ClinicalTrials.gov: NCT01893320.

Repeat PEG placement is safe for head and neck cancer patients.

PURPOSE: Percutaneous endoscopic gastrostomy (PEG) provides durable nutritional access for head and neck (HNC) patients as they undergo treatment. Continuing treatment of HNC may necessitate repeat PEG placement. We report our outcomes with repeat PEG compared to first-time PEG in HNC patients. MATERIALS AND METHODS: A retrospective chart review identified morbidity, mortality, and possible risk factors for complications. RESULTS: Repeat PEG tubes constituted 17% of PEG procedures. Morbidity was rare and similar complication rates were found between the initial PEG and repeat PEG groups (2% vs. 11%, p=0.131). There were no mortalities. CONCLUSIONS: Repeat PEG plays an important role in the care of HNC patients and can be considered a safe means to establish durable enteric feeding access for patients with recurrent cancer or treatment complications.

Acellular dermis compared to skin grafts in oral cavity reconstruction.

OBJECTIVES/HYPOTHESIS: To compare the efficacy of acellular dermal matrix (ADM) and split thickness skin grafts (STSG) in oral cavity reconstruction. STUDY DESIGN: Prospective cohort study. METHODS: Thirty-four patients were included in this study (ADM, n = 22; STSG, n = 12). Evaluation for patient demographics, graft site, graft contracture, and functional status as defined by the EORTC QLQ-C30 and the H&N35 questionnaires. A subgroup of patients underwent graft site biopsy for histological analysis. A cost estimate of both procedures was also performed. RESULTS: Patient groups were similar in age, sex, race, smoking exposure, and site grafted. More patients were treated with radiation therapy (pre- or postoperative) in the ADM group (45%) compared to the STSG group (17%). Graft failure rate was higher in the ADM group (14% vs. 0%), and both groups had similar estimated graft contraction. The quality of life survey results favored the ADM group, but only the category of trouble with social eating was statistically significant (P = .03). Radiation therapy had a significantly negative impact for both ADM and STSG. Histology demonstrated increased inflammation, fibrosis, and elastic fibers in the STSG group. The cost of the STSG was 3.5 times higher than the ADM group. CONCLUSIONS: Acellular dermis grafting for reconstruction of the oral cavity offers several advantages over STSG, including the lack of donor site morbidity, lower cost, a natural appearing mucosal surface, and comparable if not superior functional status. Lower graft survival rates for ADM in the setting of prior radiation and with thicker graft material was encountered.