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Background: Surgery is a cornerstone of breast cancer management. Prior to surgery, a wire marker is placed at the site of the tumor, to enable the surgeon to accurately localize the lesion during later surgery. This procedure can generate considerable anxiety for many patients. We investigated the value of conversational hypnosis (CH) in reducing anxiety in patients undergoing preoperative wire placement under radiographic control. Methods: Randomized, multicentre study in 7 centers in France. Inclusion criteria were patients aged >18 years with an Eastern Cooperative Oncology Group performance status ≤2, scheduled to undergo preoperative wire placement in one or several breast lesions. Patients were randomized in a 1:1 ratio, stratified by center to undergo preoperative wire placement with or without the use of CH by a radiological technician trained in the CH technique. The primary endpoint was the percentage of patients with an anxiety score ≥ 6 on a visual analog scale ranging from 0 (absence of anxiety) to 10 (maximal anxiety). Secondary endpoints were pain score, perceived duration reported by the patient, technician satisfaction with their relationship with the patient, and ease of marker insertion reported by the radiologist. Semi-structured interviews were performed with patients to assess their perception of the marker placement procedure. Results: The trial was prematurely interrupted for futility after a planned interim analysis after accrual of 167 patients, i.e., half the planned sample size. Prior to marker placement, 29.3% (n = 24) of patients in the control group had an anxiety score ≥ 6, versus 42.3% (n = 33) in the CH group (p = 0.08). After marker placement, the change of anxiety score was not significantly different between groups (11.0% (n = 9) versus 14.3% (n = 11), p = 0.615). There was no significant difference in any of the secondary endpoints. In the interviews, patients from both groups frequently spoke of a feeling of trust. Conclusion: This study failed to show a benefit of conversational hypnosis on anxiety in patients undergoing marker placement prior to surgery for breast cancer. The fact that some caregivers had learned this personalized therapeutic communication technique may have had a positive impact on the whole caregiving team. Trial registration: The study was registered with ClinicalTrials.gov (NCT02867644).
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OBJECTIVE: For most patients suffering from recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC), chemotherapy is the main option after considering surgery and reirradiation. Cetuximab combined with a platinum-fluorouracil regimen (EXTREME) has been the standard of care for over a decade. Nevertheless, a significant number of patients remain unfit for this regimen because of age, severe comorbidities, or poor performance status. The aim of this study is to investigate an alternative regimen with sufficient efficacy and safety. METHODS: We reviewed retrospectively the medical charts of all patients treated with paclitaxel, carboplatin, and cetuximab (PCC) at our institution. Eligibility criteria were as follows: first-line R/M-HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx not suitable for local therapy, cisplatin, and/or 5-FU ineligibility, ECOG-PS: 0-2. PCC consisted of paclitaxel 80 mg/m2, carboplatin AUC 2, and cetuximab at an initial dose of 400 mg/m2 then 250 mg/m2, for 16 weekly administrations followed by cetuximab maintenance for patients for whom a disease control was obtained. The primary endpoint was overall survival (OS), and secondary endpoints were overall response rate (ORR), progression free survival (PFS), and safety. RESULTS: We identified 60 consecutive patients treated with PCC between 2010 and 2016 at our institution. Thirty-one patients (52%) were ECOG-PS 2. Fifty-five patients (92%) were cisplatin ineligible. ORR was 43.3% (95% CI, 30.8-55.8), and disease control rate was 65% (95% CI, 52.9-77.1). With a median follow-up of 35.7 months (IQR 28.6-48.8), median PFS was 5.8 months (95% CI, 4.5-7.2), and median OS was 11.7 months (95% CI, 7.5-14.8). For ECOG-PS 0-1 patients, median OS was 14.8 months (95% CI, 12.2-21.7) while it was only 7.5 months (95%CI: 5.5-12.7) for ECOG-PS 2 patients (p < 0.04). Grades III-IV toxicities occurred in 30 patients (50%). Most toxicities were hematologic. Six patients (10%) had febrile neutropenia. Nonhematologic toxicities were reported such as cutaneous toxicities, neuropathy, infusion-related reactions, or electrolyte disorders. CONCLUSION: The weekly PCC regimen seems to be an interesting option in cisplatin-unfit patients. This study shows favorable PFS and OS when compared with what is achieved with the EXTREME regimen and a high controlled disease rate with predictable and manageable toxicities even in the more fragile population.
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PURPOSE: The purpose of this study was to evaluate the efficacy and tolerance of normofractionated stereotactic radiation therapy (RT) and intensity modulated RT with helical tomotherapy for skull base meningioma. METHODS AND MATERIALS: Between January 2009 and 2014, 46 patients with skull base meningioma were treated with normofractionated intensity modulated RT in stereotactic conditions (50%) or with helical tomotherapy (50%). Most of the lesions were localized in the cavernous sinus (59%). The mean planning target volume was 47.2 mL (range, 1.1-223 mL). RESULTS: After treatment, 5 lesions exhibited a partial response radiologically and 39 lesions were stable. At the time of treatment, 35 patients were symptomatic with a mean of 2 symptoms per patient. The most frequent symptoms were visual impairment (41%), cranial nerve dysfunction (20%), and headache (16%). The median follow-up time was 42 months (range, 10-76 months). After RT, 71% of patients exhibited an improvement of at least 1 symptom with a median interval of 15.6 months (range, 5.3-30.5 months). The most frequent improved symptoms were cranial nerve deficits (47%), visual impairment (45%), and headache (42%).The clinical response was correlated with the clinical target volume (CTV) margin (P = .06), extended clinical follow-up time (P = .004), and larger planning target volume (P = .05) by univariate analysis. Taking in account correlation factors, in the multivariate analysis, only CTV was a favorable significant factor of clinical improvement (P = .049; hazard ratio: 5 95%; confidence interval, 1.1-28). We observed 3 cases of trigeminal nerve dysfunction at 4.2, 5.7, and 24.6 months; 2 cases of visual disturbance at 10.1 and 24 months; 2 cases of neurocognitive disorders at 12.9 and 35.2 months; and 1 case of stroke at 20.3 months. CONCLUSIONS: RT for skull base meningiomas is an effective and safe treatment, leading in most cases to clinical improvement. The addition of a CTV margin to meningioma volume improved the symptoms of patients.
