Aurora Mirabile

Aprepitant versus metoclopramide, both combined with dexamethasone, for the prevention of cisplatin-induced delayed emesis: a randomized, double-blind study

BACKGROUND A combination of aprepitant, a 5-HT3 receptor antagonist (r.a.), and dexamethasone is recommended for the prophylaxis of cisplatin-induced nausea and vomiting in the acute phase, and aprepitant + dexamethasone (A + D) in the delayed phase. The aim of this study was to verify if A + D is superior to metoclopramide plus dexamethasone (M + D) in preventing delayed emesis in cancer patients receiving the same prophylaxis for acute emesis. PATIENTS AND METHODS A randomized double-blind study comparing A + D versus M + D was completed in previously untreated cancer patients. Before chemotherapy, all patients were treated with intravenous palonosetron 0.25 mg and dexamethasone 12 mg, and oral aprepitant 125 mg. On day 2-4, patients randomly received oral dexamethasone 8 mg plus aprepitant 80 mg once daily (days 2-3) or metoclopramide 20 mg four times daily plus dexamethasone 8 mg bid. Primary endpoint was rate of complete response (no vomiting, no rescue treatment) in day 2-5 after chemotherapy. RESULTS Due to difficulty in the accrual of patients, 303 of the 480 planned patients were enrolled, 284 were fully evaluable, 147 receiving A + D, 137 M + D. Day 1 results were similar in both arms. On day 2-5, complete response rate was not significantly different (80.3% with A + D versus 82.5% with M + D, P < 0.38, respectively), and all secondary endpoints were also similar (complete protection, total control, no vomiting, no nausea, and score of Functional Living Index-Emesis; P < 0.24). Adverse events incidence was not significantly different between the two treatments. CONCLUSIONS In cancer patients submitted to cisplatin-based chemotherapy, receiving the same antiemetic prophylaxis for acute emesis, A + D is not superior to M + D in preventing delayed emesis, and both treatments present similar toxicity. CLINICALTRIALSGOV NUMBER NCT00869310.BACKGROUND A combination of aprepitant, a 5-HT3 receptor antagonist (r.a.), and dexamethasone is recommended for the prophylaxis of cisplatin-induced nausea and vomiting in the acute phase, and aprepitant + dexamethasone (A + D) in the delayed phase. The aim of this study was to verify if A + D is superior to metoclopramide plus dexamethasone (M + D) in preventing delayed emesis in cancer patients receiving the same prophylaxis for acute emesis. PATIENTS AND METHODS A randomized double-blind study comparing A + D versus M + D was completed in previously untreated cancer patients. Before chemotherapy, all patients were treated with intravenous palonosetron 0.25 mg and dexamethasone 12 mg, and oral aprepitant 125 mg. On day 2-4, patients randomly received oral dexamethasone 8 mg plus aprepitant 80 mg once daily (days 2-3) or metoclopramide 20 mg four times daily plus dexamethasone 8 mg bid. Primary endpoint was rate of complete response (no vomiting, no rescue treatment) in day 2-5 after chemotherapy. RESULTS Due to difficulty in the accrual of patients, 303 of the 480 planned patients were enrolled, 284 were fully evaluable, 147 receiving A + D, 137M + D. Day 1 results were similar in both arms. On day 2-5, complete response rate was not significantly different (80.3% with A + D versus 82.5% with M + D, P < 0.38, respectively), and all secondary endpoints were also similar (complete protection, total control, no vomiting, no nausea, and score of Functional Living Index-Emesis; P < 0.24). Adverse events incidence was not significantly different between the two treatments. CONCLUSIONS In cancer patients submitted to cisplatin-based chemotherapy, receiving the same antiemetic prophylaxis for acute emesis, A + D is not superior to M + D in preventing delayed emesis, and both treatments present similar toxicity. CLINICALTRIALS. GOV NUMBER NCT00869310.

Targeted therapy in head and neck cancer

Purpose of reviewResults of clinical studies on targeted cancer therapies are rapidly accumulating. This is also true in the field of head and neck cancer (HNC). Due to the unique multidisciplinary needs of the disease, it is of paramount importance that physicians who treat HNC are aware of the evolving changes that research is offering. Recent findingsMany targeted agents directed at inhibiting epithelial growth factor receptors (EGFRs) are under investigation in both curable loco-regional advanced disease in combination with standard treatments and in the recurrent metastatic setting. Human papilloma virus (HPV)-positive tumors present a distinct biological profile. Consequently, the role of targeted agents in this specific setting still needs to be refined. Herein we will briefly review the results of the most recent studies on targeted agents. Cetuximab and other monoclonal antibodies (panitumumab, zalotumumab and nimotumumab) have been already investigated in phase III studies; and some results are now available. Small molecules inhibiting EGFR have still to prove their efficacy. Other agents such as vascular endothelial cell growth factor receptor, vascular endoinsulin-like growth factor 1 receptor, MET, PI3KA and mammalian target of rapamycin inhibitor are in development. SummaryAt present treatment options in HNC are changing and include targeted agents with demonstrated efficacy. A better selection based on biological factors of patients who are potentially responsive to such targeted agents is being actively pursued.

Sepsis in head and neck cancer patients treated with chemotherapy and radiation: Literature review and consensus.

The reporting of infection/sepsis in chemo/radiation-treated head and neck cancer patients is sparse and the problem is underestimated. A multidisciplinary group of head and neck cancer specialists from Italy met with the aim of reaching a consensus on a clinical definition and management of infections and sepsis. The Delphi appropriateness method was used for this consensus. External expert reviewers then evaluated the conclusions carefully according to their area of expertise. The paper contains seven clusters of statements about the clinical definition and management of infections and sepsis in head and neck cancer patients, which had a consensus. Furthermore, it offers a review of recent literature in these topics.

Fentanyl pectin nasal spray as treatment for incident predictable breakthrough pain (BTP) in oral mucositis induced by chemoradiotherapy in head and neck cancer

BACKGROUND Painful mucositis is one of the most distressing toxicities of chemoradiotherapy (CRT) for head and neck cancer (HNC), with the characteristics of incidental predictable breakthrough pain (BTP) during swallowing. Fentanyl pectin nasal spray (FPNS) could be a good therapeutic option. METHODS Patients were prospectively considered if receiving basal analgesic therapy with opiates for painful mucositis of grade ⩾4 on a numerical rating scale from 0 to 10. They were offered FPNS 100mcg before oral intake. When patients reached the effective dose, they evaluated the basal pain intensity before FPNS use and after 10, 20, 30 and 40min. RESULTS Seventeen HNC patients were offered FPNS before oral intake, with 15 patients completing treatment. Mean reduction of incidental BTP intensity after FPNS was 3.1 points (range 1.2-5.8). Mean time elapsed since FPNS use and highest pain reduction was 26min. CONCLUSIONS FPNS demonstrated activity against BTP when swallowing in HNC patients. These data should be considered as hypothesis-generating.

Pain management in head and neck cancer patients undergoing chemo-radiotherapy: Clinical practical recommendations

Pain in head and neck cancer represents a major issue, before, during and after the oncological treatments. The most frequent cause of pain is chemo/radiation related oral mucositis, which involves 80% of the patients and worsens their quality of life inhibiting speaking, eating, drinking or swallowing and sometimes reducing the treatment compliance, the maximum dose intensity and thus the potential efficacy of treatment. Nevertheless pain is still often under estimated and undertreated. An Italian multidisciplinary group of head and neck cancer specialists met with the aim of reaching a consensus on pain management in this setting. The Delphi Appropriateness method was used for the consensus. External expert reviewers evaluated the final statements. The paper contains 30 consensus-reached statements about pain management in HNC patients and offers a review of recent literature in these topics.

Temporal course and predictive factors of analgesic opioid requirement for chemoradiation-induced oral mucositis in oropharyngeal cancer

Oral mucositis (OM)‐related pain affects most patients with head and neck cancer during treatments, but its management is not standardized.

Role of nutrition in incidence and management of cancer therapy-induced diarrhea (CTID): HEAT (Health Eat and Toxicity) prospective interventional study and preliminary data.

e18251Background: Metastatic colorectal cancer (mCRC) patients (pts) are at high risk of CTID influencing treatment outcome. The primary end-point of our study was the decrease of grade 3-4 (G3-4 f...

Health care-associated infections in patients with head and neck cancer treated with chemotherapy and/or radiotherapy

The incidence of health care–associated infections in patients with head and neck cancer receiving chemotherapy and/or radiotherapy (RT) is unknown. This retrospective study investigated the most common pathogens and their antibiotic sensitivity/resistance patterns in patients with head and neck cancer.