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e21663Background: Medication-related osteonecrosis of the jaw (MRONJ) is defined as exposed jawbone or bone that can be probed through a fistula, persisting for 8 or more weeks. MRONJ occurs in the...

TPS661 Background: Stomatitis is a frequent adverse event associated with the oral mTOR inhibitor everolimus that can impact treatment adherence. Steroid mouthwashes, gels, or pastes used to treat ...

6040 Background: Local and systemic symptoms during radiation therapy (RT) may be exacerbated by dysregulated inflammation and its downstream toxic effects. Minocycline (mino) can suppress pro-infl...

e19520 Background: Mucositis is a common complication in cancer pts receiving CT. We have shown that palifermin (recombinant Keratinocyte Growth Factor), administered as single dose prior to CT, alleviated severe mucositis in pts receiving doxorubicin-based CT (Ann Int Med 2010). Caphosol is a supersaturated electrolyte solution of calcium phosphate that has been indicated as oral rinse for xerostomia and as an adjunct to treat OM induced by radiation or high-dose CT. Purpose of the study was to evaluate the preliminary efficacy of Caphosol in pts receiving CT. Methods: Pts were randomized 1:1 to Caphosol vs. baking soda (control) as an oral rinse five times daily from initiation of CT. All pts received doxorubicin (75 or 90 mg/m2 by continuous infusion over 3 days) with ifosfamide (10 gm/m2) or cisplatin (120 mg/m2). Pts that experienced Grade (Gr) > 3 mucositis received palifermin (180 mcg/kg) iv 3 days before CT in subsequent cycles. Results: 28 of 30 pts received treatment and were evaluble; 15 men and 13 women, with median age 51 (range, 20-65 yrs). Incidence of Gr > 2 OM was 57% (8 of 14 pts) for Caphosol vs. 86% (12 of 14) for control (P=0.21). Incidence of Gr > 3 OM was 29% (4/14) for Caphosol vs. 43% (6/14) for control (P=0.43). However, the benefit was limited to oral but not other GI mucosal sites. Of 10 pts (Caphosol: 4, BS: 6,) with Gr > 3 OM, 6 crossed over to palifermin (Caphosol: 3, BS: 3); the other 4 pts (Caphosol: 1, BS: 3) came off the study. All 6 pts, that received palifermin, avoided severe OM in the next cycle. The median duration of Gr > 2 OM in the cycle before cross-over was 8 days (range: 5-12) vs. 0 days (0-3) in palifermin cycle (p=0.0032) and Gr > 3 OM was 5 days (2-7) vs. 0 days (p=0.0015). Oral assessment and the pts-reported outcome were in substantial agreement for the OM grading (weighted kappa, 0.78, 95% CI: 0.44-0.87, p

5600 Background: Previous studies have shown that patient-reported outcomes with QOL instruments are predictive of survival. We investigate the relationship between HNC patient-reported symptoms and survival in addition to clinician ratings of ECOG performance status (PS). Methods: 129 patients with HNC participated in the study. Patients completed the M. D. Anderson Symptom Inventory - Head and Neck module (MDASI-HN) prior to radiotherapy or chemoradiotherapy. Cluster analysis was used to identify those who were symptomatic due to their disease prior to treatment. Cox regression was used to examine differences in survival between symptom burden groups with PS as covariate. Logistic regression was used to determine the relationship of overall survival status with symptom burden and performance status. Results: 46% (60/129) of HNC patients were identified to have symptoms prior to therapy. The top symptoms at presentation were fatigue, emotional distress, pain, disturbed sleep, drowsiness and sadness. Unde...

8097 Background: The aims of this study are to validate a symptom inventory in patients with HNC for reliability in identifying the occurrence and severity of symptoms, and overall symptom burden. ...

5503 Background: Xerostomia is a frequent debilitating complication of head and neck cancer radiotherapy. Morbidities include dental caries, oral infections, and impaired quality of life. Methods: Two multicenter double-blind trials were conducted to assess the efficacy and safety of cevimeline in the treatment of radiation-induced xerostomia. Each trial enrolled subjects ≥18 years of age with head and neck cancer who had received >4000 cGy of radiation ≥4 months before entry and had clinically significant salivary gland dysfunction. Subjects were randomized to cevimeline 30 mg TID or placebo for 12 weeks, with escalation to 45 mg TID or placebo equivalent at 6 weeks if no improvement was reported. Subjects experiencing side effects after dose escalation could de-escalate to 30 mg TID. The primary efficacy endpoint was global evaluation of oral dryness, with a secondary endpoint being change in unstimulated salivary flow. Results: A total of 570 subjects (284 in the 003 and 286 in the 004 study) were rand...