Phase III study of nivolumab alone or combined with ipilimumab as immunotherapy versus standard of care in resectable head and neck squamous cell carcinoma.

Locally advanced head and neck squamous cell carcinoma (LA-HNSCC) often requires postoperative chemoradiation with high risk of toxicity. Disease-free survival (DFS) after 2 years is approximately 70%. Combining nivolumab (N), a PD-1-inhibitor and ipilimumab (I), a CTLA4- inhibitor, may improve DFS due to antitumor effects of immunotherapy. The IMSTAR-HN study compares neoadjuvant N and N ± I 6 months after adjuvant therapy versus standard therapy as first-line treatment for LA-HNSCC. Eligible patients have treatment-naive LA-HNSCC, Eastern cooperative oncology group performance score (PS) ≤1 and no distant metastasis. 276 patients will be randomized into two arms. Primary endpoint is DFS and secondary endpoint includes locoregional control (LRC) and overall survival (OS). This study is one of the first in HNSCCs implementing immunotherapy in first-line treatment in a curative setting. Clinical Trial Registration: NCT03700905 (ClinicalTrials.gov).

Simultaneous Integrated Boost (SIB): RapidArc and Tomotherapy Plan Comparison for Unilateral and Bilateral Neck Irradiation.

AIM: The aim of the present study was to compare simultaneous integrated boost (SIB) plans using volumetric modulated arc therapy (RapidArc®; RA) or tomotherapy (TT) for bilateral (BL) and unilateral (UL) treatment in head-and-neck cancer (HNC) patients. MATERIAL AND METHODS: Seventeen computed tomography scans (CTs) of 16 patients with SIB were replanned using TT and RA. We defined three groups: All, UL and BL, compared the dose distributions, homogeneity, conformity to planning target volume (PTV), organs at risk (OAR) and healthy tissue (HT) sparing. We evaluated a therapeutic-width index (TWI) based on PTV coverage and parotid gland (PG) sparing. RESULTS: PTV coverage for RA and TT was equivalent for all groups. UL irradiation resulted in similar doses to the HT for both techniques but TT achieved better sparing of spinal cord, larynx and contralateral PGs. TT provided better homogeneity. RA gave better conformity. CONCLUSION: Both methods achieved clinically acceptable results for UL and BL treatment, RA with better dose conformity to elective PTV, TT with better OAR sparing and homogeneity.

Anesthesia with Propofol versus Sevoflurane: Does the Longer Neuromuscular Block under Sevoflurane Anesthesia Reduce Laryngeal Injuries?

Anesthesia can be maintained with propofol or sevoflurane. Volatile anesthetics increase neuromuscular block of muscle relaxants. We tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anesthesia with propofol. In this prospective trial, 65 patients were randomized in 2 groups: SEVO group, anesthesia with sevoflurane, and TIVA group, total intravenous anesthesia with propofol. Intubating and extubating conditions were evaluated. Vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness and sore throat were assessed up to 72 h after surgery. Hoarseness and sore throat were comparable between both groups (not significant). Similar findings were observed for vocal cord injuries: 9 (SEVO) versus 5 (TIVA) patients; P = 0.36; the overall incidence was 24%. Type of vocal cord injuries: 9 erythema and 5 edema of the vocal folds. Neuromuscular block was significantly longer in the SEVO group compared with the TIVA group: 71 (range: 38-148) min versus 52 (range: 21-74) min; P < 0.001. Five patients (TIVA group) versus 11 patients (SEVO group) needed neostigmine to achieve a TOF ratio of 1.0 (P = 0.14). Under anesthesia with propofol laryngeal injuries were not increased; the risk for residual curarization, however, was lower compared with sevoflurane.