Pain in desmoid-type fibromatosis: Prevalence, determinants and prognosis value.

The aim of this study is to evaluate the prevalence, determinants and prognostic value of pain at diagnosis in patients with desmoid-type fibromatosis (DF). We selected patients from the ALTITUDES cohort (NCT02867033), managed by surgery, active surveillance or systemic treatments, with pain assessment at diagnosis. Patients were invited to fill QLQ-C30 questionnaire and Hospital Anxiety Depression Scale. Determinants were identified using logistic models. Prognostic value on event-free survival (EFS) was evaluated using the Cox model. Overall, 382 patients were included in the current study (median age: 40.2 years; 117 men). The prevalence of pain was 36%, without significant difference according to first-line treatment (P = .18). In the multivariate analysis, pain was significantly associated with tumor size >50 mm (P = .013) and tumor site (P < .001); pain was more frequent in the neck and shoulder locations (odds ratio: 3.05 [1.27-7.29]). Pain at baseline was significantly associated with poor quality of life (P < .001), depression (P = .02), lower performance status (P = .03) and functional impairment (P = .001); we also observed a nonsignificant association with anxiety (P = .10). In the univariate analysis, baseline pain was associated with poor EFS; the 3-year EFS was 54% in patients with pain compared to 72% in those without pain. After adjustment for sex, age, size and line of treatment, pain was still associated with poor EFS (hazard ratio: 1.82 [1.23-2.68], P = .003). One third of recently diagnosed patients with DF experienced pain, especially those with larger tumors and neck/shoulder locations. Pain was associated with unfavorable EFS after adjustment for the confounders.

Evaluation of long-term living conditions in patients treated for localised prostate cancer.

PURPOSE: To evaluate the evolution of living conditions (LC) in long-term survivors of localised prostate cancer 10 years after treatment compared with those of a same-age control group from the general population. METHODS: Two hundred and eighty-seven patients diagnosed with prostate cancer in 2001 were selected in 11 French cancer registries. They were matched with controls randomly selected for age and residency. Both patients and controls completed a self-administered LC questionnaire concerning their familial, social and professional life, and general and specific quality of life (QoL) and anxiety and depression questionnaires. RESULTS: Compared with controls, patients reported more sexual modifications (p < .0001), but without any difference in marital status. Patients' circle of friends was more stable than that of the controls (91% vs. 63%; p < .0001) and patients reported fewer friendship modifications than controls (p < .0006). Their professional and physical activities were also preserved. They reported more anxiolytic intake (p = .002) but did not consult their general practitioner more often. Type of specialist consulted differed in the two groups. CONCLUSION: Patients treated for localised prostate cancer had the same living conditions as men of the same age. Their social life was satisfying on the whole, albeit they reported more sexual difficulties than their counterparts.

A double-blind placebo-controlled randomized phase II trial assessing the activity and safety of regorafenib in non-adipocytic sarcoma patients previously treated with both chemotherapy and pazopanib.

BACKGROUND: Metastatic soft tissue sarcomas (STSs) management remains an unmet medical need. We assessed the activity and safety of regorafenib in patients with metastatic non-adipocytic STS who were previously treated with both chemotherapy and pazopanib. PATIENTS AND METHODS: This double-blind, placebo-controlled, multicenter comparative randomized phase II trial included patients with histologically proven advanced and inoperable STS. Patients receiving placebo were offered optional cross-over for centrally confirmed disease progression. Primary end-point was centrally reviewed Response Evaluation Criteria in Solid Tumours-based progression-free survival (PFS), analysed on the intent-to-treat data set. In total, 24 events were required for 90% power, hazard ratio (HR) = 0.33 (median PFS, 3.6 versus 1.2 months), and 1-sided α = 0.1 (ClinicalTrials.gov, NCT01900743). RESULTS: From December 2015 to October 2017, 37 patients were randomized; 18 to regorafenib and 19 to placebo. Thirteen patients assigned to placebo switched to regorafenib after progression. Median follow-up was 27.2 months (95% confidence interval [CI]: 24.4-not reached). We observed a significant PFS benefit of regorafenib compared with placebo (adjusted HR = 0.33; 95% CI: 0.15-0.74; p = 0.0007 median PFS = 2.1 versus 1.1 months, respectively), and a large and nearly significant overall survival (OS) benefit despite the cross-over (adjusted HR = 0.49; 95% CI: 0.23-1.06; p = 0.007; median OS = 17.8 versus 8.2 months). Before cross-over, the most common grade III or higher adverse events were lymphopenia (5 versus 1, respectively), diarrhoea (4 versus 0), dyspnoea (3 versus 1), skin toxicity (3 versus 0), arterial hypertension (2 versus 0), and increased transaminases (2 versus 0). CONCLUSION: The present study demonstrated a meaningful clinical anti-tumour activity with regorafenib in heavily pre-treated patients with non-adipocytic STS.

Optimisation of chemotherapy prescription and preparation in an ambulatory unit: Validation of the OPTIMA program.

OBJECTIVE: We implemented the two-step OPTIMA program to anticipate chemotherapy prescription which aims to assess the discrepancy rate between anticipated and real prescription and its impact on waiting time and quality of care. METHODS: This prospective study included cancer patients receiving any intravenous chemotherapy. The OPTIMA program consists in a nurse phone call and a blood sample two days before the planned treatment. Collected information and biological results were used by a physician to issue a non-effective (step 1) or effective (step 2) anticipated prescription the day before the consultation. The real prescription was given as usual by another physician on the day of the consultation. Waiting time was collected, and patients' satisfaction with care was assessed with the OUT-PATSAT35 questionnaire. RESULTS: Respectively, 540 and 979 consultations (283 and 294 patients) were analysed in both steps. The discrepancy rate was 8.7% (step 1). In routine practice, the OPTIMA program (step 2) reduced patients' waiting time (median time 55 vs. 95 min, p < 0.001). A high general care satisfaction score was observed in both steps (80.7% and 80.2%). CONCLUSIONS: This anticipation program demonstrated the accuracy of chemotherapy prescription, whatever the regimen and cancer site, and its impact on waiting time optimisation.

Technical report: optimal quantity of saline for epidural pressure waveform analysis.

PURPOSE: Epidural waveform analysis (EPWA) is a simple test to confirm the optimal placement of an epidural catheter. It relies on the transmission of the thecal pressure waveform through the epidural catheter. Little is known about the optimal volume of catheter injectate needed to optimize the EPWA test. METHODS: In a randomized controlled trial we compared three different catheters: stimulating, open-ended hole [S1]; stimulating, three-hole [S3]; non-stimulating three-hole [NS3]) in 60 patients in an unblinded pilot study. After catheter insertion using a loss of resistance to air technique, we recorded the dose response curve of EPWA and the presence of epidural pressure wave transmitted through the catheter to repeated injections of 2.5 mL saline boluses in the catheter to a total volume of 10 mL. All patients were followed by the acute pain service to confirm adequacy of postoperative epidural analgesia. RESULTS: The S3 catheters were significantly more responsive (able to transmit a pulsatile waveform) compared to the S1 [P = 0.003 (S3) and P = 0.012 (NS3)] at low injectate volume, while there was no differences between the S3 catheters in their ability to transmit a waveform for EPWA (P = 0.25). There was no increase in responsiveness after 2.5 mL injected for S3 catheters and 5 mL for the S1 catheter. Three patients had soft catheters that did not transmit an epidural pulsative waveform. CONCLUSIONS: For EPWAs, S3 epidural catheters are superior to S1 catheters for determining pulsative waveform transmission at low injectate volume. The optimal initial quantity of saline for EPWA is 5 mL regardless of the catheter type used.

A prospective comparative study of two indirect methods for confirming the localization of an epidural catheter for postoperative analgesia.

We prospectively evaluated, in randomized order, 2 indirect methods of confirming the localization of an epidural catheter for postoperative analgesia in 218 surgical patients: epidural stimulation test (EST) and epidural pressure waveform analysis (EPWA). The epidural space was localized by using a loss of resistance technique. All catheters were inserted 5 cm into the epidural space and primed with 5 mL of 0.9% normal saline. There were no differences between the methods: the positive predictive value and specificity were high (100% in both groups), but the sensitivity was moderate (80% for EST and 81% for EPWA) and the negative predictive value was low (16% for EST and 17% for EPWA). Combining both methods yielded better sensitivity (97%) and negative predictive value (57%) (P < 0.001). The sensitivity of EST was increased to 87% (P < 0.05) if sensory response was included as well as motor response for stimulation less than 10 mA. We suggest the inclusion of sensory response in the appropriate dermatome at a current <10 mA as a criterion for adequate epidural catheter localization for EST testing. EPWA sensitivity was significantly better with older patients: 94% for patients older than 80 yr compared with 63% for patients younger than 40, 73% for patients 40 to 60, and 85% for patients aged 60 to 80 yr (P = 0.03). We conclude that the two tests are comparable for confirming catheter placement.