Final results of a prospective study of scalp cooling in preventing chemotherapy-induced alopecia.

Aim: Alopecia is a distressing effect of cancer treatments. Our study examined efficacy and safety of scalp cooling to prevent chemotherapy-induced alopecia. Materials & methods: Early breast cancer patients candidate to anthracycline and/or taxane were eligible. Dean's alopecia scale was used to classify alopecia. Results: From February 2016 to November 2018, 127 women were enrolled; 55 (43.3%) received epirubicin/cyclophosphamide (4 EC 3 weeks) followed by paclitaxel (12 P weeks); 50 (39.4%) received 4 EC 3 weeks; 20 (15.7%) received 12 P weeks/trastuzumab and 2 docetaxel/cyclophosphamide (4 TC 3 weeks). The success rate was 71.7% (G0 21.3%, G1 31.5%, G2 18.9%). Frequent side effects were: coldness, headache, scalp pain and head heaviness. Conclusion: In our study, scalp cooling can prevent alopecia thus supporting the wider use in early breast cancer.

3D sonohysterography vs hysteroscopy: a cross-sectional study for the evaluation of endouterine diseases.

PURPOSE: To assess the concordance between the presumed diagnosis obtained with the 3D sonohysterography (SHG) and with the diagnostic hysteroscopy (HYS); to determine whether the 3D SHG has the accuracy needed to be considered as a diagnostic screening standard in cases of suspected endouterine pathology. METHODS: We selected 224 patients who voluntarily decided to undergo 3D SHG from a population with suspected presence of endouterine disease at TVS. The patients underwent first 3D SHG and then diagnostic HYS. We recorded each patient's discomfort/pain during the two techniques. We used the "Bayes Theorem" to calculate the sensitivity and specificity of the 3D SHG as compared to HYS. RESULTS: Overall the 3D SHG diagnosis was confirmed in 156/224 cases (69.64 %). Concordance for endometrial thickening was 0 %; for Asherman's syndrome was 50.00 %; for polyp was 77.78 %; and for myoma, mucus accumulation and Müllerian anomalies (arcuate uterus, septate and subseptate uterus) was 100.00 %. Furthermore, 3D SHG was better tolerated than HYS. CONCLUSION: Despite the diagnostic accuracy and mini-invasiveness of 3D SHG, we suggest that it cannot be a substitute of HYS in endouterine disease diagnosis, but it could be considered as a good method of screening to address patients to hysteroscopic confirmation.

The Effectiveness of Hypnoanalgesia Using Conventional and Placebo Hypnosis Induction.

The effectiveness of hypnosis-based pain management is well-established. However, mechanisms of action and specific effective components are not well understood. The sociocognitive theory of hypnosis proposes that the effectiveness of hypnosis for pain management is determined by the nonspecific features of response expectancy and context. We tested this claim by contrasting the effectiveness of 2 hypnoanalgesia procedures in a within subjects design using the cold pressor task. The 2 procedures were identical, including analgesic suggestions, except for the hypnosis induction used. One condition involved a well-established hypnosis induction, including suggestions for focused attention, relaxation, and deepening. The other condition included a sham induction procedure using only white noise. In our confirmatory analysis (N = 46), we found that pain tolerance increased compared to baseline equivalently in the conventional and sham induction conditions (mean increase 13.7 and 12.4 seconds respectively, average within subject difference -1.27 seconds, 90% confidence interval [CI] = -8.46, 5.90). This finding supports the claim of the sociocognitive theory considering that response expectancy for pain reduction was also equivalent between the conditions (average difference 2.30, 90% CI = -2.23, 6.84). However, self-reported hypnosis depth was greater in the conventional induction condition (average difference -.78, 90% CI: -1.36, -.07), which contradicts sociocognitive predictions. Our findings indicate that conventional procedural elements of hypnosis inductions, such as suggestions for focused attention, relaxation, and deepening, may not be necessary to achieve acute pain reduction in an experimental setting when the hypnosis intervention includes analgesic suggestions. PERSPECTIVE: This study assessed the necessary effective components of hypnosis-based analgesia interventions. Our findings suggest that procedural features such as suggestions for focused attention, relaxation, and deepening may not be necessary for hypnoanalgesia as long as pain relief suggestions are present, and the hypnosis context and response expectancy are established. TRIAL REGISTRATION: This trial was registered on Open Science Framework with the registry number e96xk, available at https://osf.io/e96xk.

How do turbidite systems behave from the hydrogeological point of view? New insights and open questions coming from an interdisciplinary work in southern Italy.

Turbidite successions can behave either as aquitards or aquifers depending on their lithological and hydraulic features. In particular, post-depositional processes can increase rock permeability due to fracture development in the competent layers. Thus, at a local scale, turbidite systems warrant further detailed investigations, aimed at reconstructing reliable hydrogeological models. The objective of this work was to investigate from the hydrogeological perspective a turbiditic aquifer located in southern Italy, where several perennial and seasonal springs were detected. Considering the complex hydrodynamics of these systems at the catchment scale, to reach an optimal characterization, a multidisciplinary approach was adopted. The conceptual framework employed microbial communities as groundwater tracers, together with the physicochemical features and isotopic signature of springs and streams from water samples. Meanwhile, geophysical investigations coupled with the geological survey provided the contextualization of the hydrogeological data into the detailed geological reconstruction of the study area. This modus operandi allowed us to typify several differences among the samples, allowing identification of sources and paths of surface water and groundwater, along with diffuse groundwater outflow along streams. As a final result, a hydrogeological conceptual model was reconstructed, underlining how at a very local scale the lithologic, hydraulic, and geomorphological heterogeneity of the studied relief can lead to an improved hydrogeological conceptual model compared to that of other turbidite systems. These results open new questions about the hydrogeological behavior of turbiditic aquifers, which could be pivotal in future research. In fact, these systems could support relevant ecosystems and anthropic activities, especially where climate change will force the research of new (and probably less hydrogeologically efficient) water sources.

Test-Retest Reliability of the Stanford Hypnotic Susceptibility Scale, Form C and the Elkins Hypnotizability Scale.

This project aimed to assess the consistency of hypnotizability over repeated assessments when measured by the Stanford Hypnotic Susceptibility Scale: Form C (SHSS:C), and the Elkins Hypnotizability Scale (EHS) and to contrast score distribution and pleasantness of these scales. University students were administered either the SHSS:C or the EHS twice with a one-week delay by separate experimenters. Test-retest reliability of the EHS and the SHSS:C was r s =.82 (.71-.92) and r s =.66, 95% (.47-.86), respectively (Spearman's correlation). Hypnotizability was comparable at test and retest in the EHS group, SHSS:C scores decreased by the retest. We found that the SHSS:C produced higher scores than the EHS, and the pleasantness of the 2 scales was comparable. Overall, our results supported the reliability of the EHS, while SHSS:C scores were more inconsistent between the 2 assessments. More research is warranted.

Insulin sensitiser agents alone and in co-treatment with r-FSH for ovulation induction in PCOS women.

OBJECTIVE: The aim of this study was to compare the effectiveness of myo-inositol (MYO) and metformin, in monotherapy or in association with recombinant follicle stimulating hormone (r-FSH), in the treatment of menstrual irregularities, chronic anovulation, and female infertility in patients with polycystic ovary syndrome (PCOS). MATERIALS AND METHODS: One hundred twenty patients were randomly treated with metformin 1500 mg/day orally (n = 60), or 4 g MYO plus 400 microg folic acid daily (n = 60), continuously. If no pregnancy occurred, r-FSH (37.5 units/day) was added to the treatment for a maximum of three attempts. RESULTS: Fifty percent of the patients who assumed metformin restored spontaneous ovulation, 18.3% of these obtained pregnancy. The remaining 42 patients were treated with metformin plus r-FSH. Pregnancy occurred in a total of 11 women (26.1%). The total pregnancy rate was 36.6%. Sixty-five percent of the patients treated with MYO plus folic acid restored spontaneous ovulation activity, 30% of these obtained pregnancy. The remaining 38 patients were treated with MYO, folic acid plus r-FSH. Pregnancy occurred in a total of 11 women (28.9%). The total pregnancy rate was 48.4%. CONCLUSIONS: Both metformin and MYO, can be considered as first line treatment for restoring normal menstrual cycles in most patients with PCOS, even if MYO treatment seems to be more effective than metformin.

Cisplatin/Pemetrexed Followed by Maintenance Pemetrexed Versus Carboplatin/Paclitaxel/Bevacizumab Followed by Maintenance Bevacizumab in Advanced Nonsquamous Lung Cancer: The GOIM (Gruppo Oncologico Italia Meridionale) ERACLE Phase III Randomized Trial.

INTRODUCTION: Cisplatin with pemetrexed (CP) and carboplatin with paclitaxel and bevacizumab (CbTB) are standard first-line treatments for patients with advanced nonsquamous (NS) non-small-cell lung cancer (NSCLC). Quality of life (QoL) is a key objective in the management of advanced NSCLC. Thus, effect on QoL could be an additional factor in the choice of treatment. PATIENTS AND METHODS: Patients with untreated stage IIIB/IV NS-NSCLC and Eastern Cooperative Oncology Group performance status of 0 or 1 were randomized to receive first-line chemotherapy with cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2), every 3 weeks, for 6 cycles followed by maintenance pemetrexed; or carboplatin area under the curve 6, paclitaxel 200 mg/m(2), and bevacizumab 15 mg/kg, every 3 weeks, for 6 cycles followed by maintenance bevacizumab. The primary end point was the difference in QoL between the 2 treatment arms after 12 weeks of maintenance, measured using the EuroQoL 5 Dimensions-Index (EQ5D-I) and EQ5D-visual analogue scale (EQ5D-VAS). RESULTS: One hundred eighteen patients were randomized to CP (n = 60) or CbTB (n = 58). Baseline characteristics were well balanced. The proportion of patients evaluable for the primary end point was lower than planned. After 12 weeks of maintenance, the difference between mean changes in EQ5D-I was 0.137, favoring CP (95% confidence interval [CI], -0.02 to 0.29, Wilcoxon P = .078), although not statistically significant; and the difference between mean changes in EQ5D-VAS was 0.97 (95% CI, -9.37 to 11.31, Wilcoxon P = .41). CONCLUSION: Although the study was underpowered because of a small number of patients evaluable for the primary end point, QoL did not differ between treatment arms. Other factors such as comorbidities and schedule should be used when deciding on first-line treatment.

Panitumumab after progression on cetuximab in KRAS wild-type metastatic colorectal cancer patients: a single institution experience.

AIMS AND BACKGROUND: Few data describe the activity of panitumumab after cetuximab-irinotecan-based regimen failure in patients with KRAS wild-type metastatic colorectal cancer (WT MCRC). METHODS: The aim of this study is to assess if panitumumab has some activity in this setting. RESULTS: We retrospectively analyzed 25 patients with KRAS WT MCRC who received panitumumab from July 2009 to January 2013 after progression on cetuximab. All patients had previously received cetuximab and irinotecan (20 patients) or oxaliplatin (5 patients). We withdrew cetuximab for intolerance in 4 patients (16%). Twenty-one patients (84%) who had previously responded to cetuximab (overall response rate [ORR] plus stable disease ≥5 months) received panitumumab off-label after progression on cetuximab because they were strongly motivated to continue treatment without chemotherapy. The median number of cycles of panitumumab was 7 (range 1-54). Only 20 patients were evaluable for ORR (5 patients received 1-2 cycles and then died). We observed 1 (5%) partial response, 5 (25%) stable disease, median duration 9 months. Median progression-free survival (PFS) and overall survival (OS) were 5 (3-28) and 8 (5-41) months, respectively. All patients were evaluable for toxicity. No patients developed anemia or neutropenia. One patient (4%) developed grade 2 thrombocytopenia, 8 patients (32%) grade 2-3 dry skin or rash, and 2 patients (8%) grade 2 nausea-vomiting (Common Terminology Criteria for Adverse Events version 4.03). CONCLUSIONS: Our data, with all the limits of a retrospective analysis, show longer PFS and OS as compared to other series in the same setting, demonstrating that panitumumab has treatment effectiveness in patients with KRAS WT MCRC who progressed on prior cetuximab. Further confirmatory prospective studies with a larger series of patients are necessary.

Interleukin-2, interferon-alpha and medroxyprogesterone acetate in metastatic renal cell carcinoma.

BACKGROUND: Interleukin-2 (IL-2) and interferon-alpha (IFN-alpha) are the main immuno-biological agents used in the therapy of metastatic renal cell carcinoma (RCC). Unfortunately the promising results obtained in biological studies have not yet been confirmed in clinical studies. One reason is linked to the immunosuppression of metastatic patients which is caused by macrophage products. IL-6 in particular is considered a growth factor for RCC. Medroxyprogesterone acetate (MPA) may interfere with IL-6 macrophage production, possibly causing a synergistic effect in association with IL-2 and IFN-alpha. Therefore the purpose of our study was to evaluate the toxicity and the efficacy of the association between IL-2, IFN-alpha and MPA. PATIENTS AND METHODS: Forty-two consecutive patients with metastatic RCC were enrolled. IL-2 was administered subcutaneously at doses of 4.5 million UI on days 1-5, 8-12, 15-19 and 22-26; IFN-alpha was administered s.c. at a dose of 3 million t.t.w; MPA was administered orally at a dose of 1000 mg daily. This schedule was repeated after a rest of 2 weeks. RESULTS: Toxicity was mild: the main symptoms observed were fatigue and fever. Six CR (14%), five PR (12%), thirteen SD (31%) and seventeen PD (41%) were observed for an overall response rate of 26%. Patients with good PS and low levels of CRP had a better prognosis. CONCLUSION: Considering both the good activity and the low toxicity of this scheme, we think that it could be carried out in normal clinical practice.

Clinical outcomes and cardiac safety of continuous antiHer2 therapy in c-erbB2-positive metastatic breast cancer patients.

BACKGROUND: To explore clinical outcomes and cardiac safety of continuous antiHer2 therapy. PATIENTS AND METHODS: This retrospective study evaluates overall survival (OS), time to treatment failure (TTF), and cardiac safety of 80 consecutive Her2-positive metastatic breast cancer (MBC) patients that received ≥ 12 months of therapy with trastuzumab, followed by lapatinib-based or trastuzumab-based therapy. RESULTS: All patients received trastuzumab as first antiHer2 therapy; 54% received lapatinib in the second or subsequent line. Median OS was 34 months (12-120 months). Median OS was 48 months in the subgroup of 43 patients who received lapatinib and 26 months in the 37 patients who did not. Median TTF was shorter for lapatinib. There were three cardiac events and trastuzumab-based chemotherapy (CT) was interrupted in one patient because left ventricular ejection fraction (LVEF) decreased to ≤ 40%. CONCLUSION: Continuous antiHer2 therapy provides good clinical outcomes, especially in those patients who received lapatinib. Cardiac dysfunction was a rare event, reversible, associated to trastuzumab and not related to treatment duration.

Induction pemetrexed and cisplatin followed by maintenance pemetrexed versus carboplatin plus paclitaxel plus bevacizumab followed by maintenance bevacizumab: a quality of life-oriented randomized phase III study in patients with advanced non-squamous non-small-cell lung cancer (ERACLE).

In advanced non-small-cell lung cancer (NSCLC), substantial similarities in terms of treatment efficacy and survival have emerged over the years between the different systemic chemotherapy regimens used. More recently, other topics such as histotype, maintenance therapy and quality of life have been explored to ameliorate this plateau. We present the treatment rationale and study design of the ERACLE (induction pEmetrexed and cisplatin followed by maintenance pemetRexed versus cArboplatin-paCLitaxel and bEvacizumab followed by maintenance bevacizumab) trial. Patients enrolled in the ERACLE trial are randomized between combination treatment arms: (A) cisplatin 75 mg/m(2) day 1 and pemetrexed 500 mg/m(2) day 1, every 3 weeks for six cycles followed (in responders or with stable disease) by pemetrexed 500 mg/m(2) day 1, every 3 weeks until progression; and (B) carboplatin AUC 6 day 1, plus paclitaxel 200 mg/m(2) day 1 and plus bevacizumab 15 mg/kg, every 3 weeks for six cycles followed (in responders or patients with stable disease) by bevacizumab 15 mg/kg every 3 weeks until progression. The primary objective of the study is to evaluate the difference in terms of quality of life between treatment arms. together with co-primary endpoints represented by the EuroQoL group (EQ-5D) questionnaire total score and the EQ-5D visual analog scale. Secondary endpoints are the evaluation of treatment activity and exploratory evaluation of treatment efficacy.