Adjuvant PEFG (Cisplatin, Epirubicin, 5-Fluorouracil, Gemcitabine) or Gemcitabine Followed by Chemoradiation in Pancreatic Cancer: A Randomized Phase II Trial

Background

Information from randomized trials on the role of combination chemotherapy in the adjuvant treatment of pancreatic adenocarcinoma is limited. This randomized phase II trial aimed to identify the most promising regimen warranting phase III evaluation.

Methods

Therapy-naive patients, age 18?C75?years, Karnofsky Performance Status (KPS) >60, gross total resection of stage IB?CIII pancreatic adenocarcinoma, stratified for center and surgical margins, were randomly assigned to receive either gemcitabine 1?g/m² weekly on days 1, 8, and 15 (arm A) or the PEFG regimen (cisplatin and epirubicin 40?mg/m², day 1; gemcitabine 600?mg/m², days 1, 8; 5-fluorouracil 200?mg/m² daily, days 1?C28) (arm B). Chemotherapy was administered every 4?weeks for 3?months and followed by irradiation concurrent to continuous infusion of 5-fluorouracil 250?mg/m² daily. Primary endpoint was the probability of being disease-free at 1?year from surgery. Assuming P0?=?35% and P1?=?55%, ???=?.05 and ???=?.10, the study was to enroll 51 patients per arm.

Results

A total of 102 patients were randomized; 100 were eligible (arm A: 51; arm B: 49). Baseline characteristic (A/B) were: Median age was 61/60?years; 75% had KPS >80 75/76%; 36% grade 3 tumor 29/43%, 79% stage IIB/III 75/84%, 31% R1 resection 35/29%. Survival figures (A/B) were: Median disease-free survival was 11.7 and 15.2?months; 1-year disease-free survival 49.0% (95% confidence interval [95% CI] 35?C63%) and 69.4% (95% CI 56?C83%); median survival 24.8 and 28.9?months. Combination chemotherapy produced more hematological toxicity without relevant differences in nonhematological toxicities.

Conclusions

The 4-drug regimen deserves further assessment in resectable pancreatic cancer.     

Early outcomes of colon laparoscopic resection in the elderly patients compared with the younger

Background

The aim of this study was to define any benefits in terms of early outcome for laparoscopic colectomy in patients over 75 years old (OP) compared with the outcomes of a younger populations (YP).

Methods

Forty elderly patients undergoing laparoscopic colectomy for colorectal cancer between 2007-2011 were studied, the patients are divided for gender, age, year of surgery, site of cancer, and comorbidity on admission and compared with 40 younger patients.

Results and discussion

Mean (standard deviation) age was 81.3 in OP and 68.3 YP Conversion rate was the same between the two groups. There was no difference in operative mean time . The overall mortality rate was 0% percent. The surgical morbidity rate was the same but there was an increased in cardiologic e bronchopneumonia complications in older population. Patients treated with laparoscopic approach had a faster recovery of bowel function and a significant reduction of the mean length of hospital stay not age related. Laparoscopy allowed a better preservation of postoperative independence status.

Conclusions

Laparoscopic colectomy for cancer in elderly patients is safe and beneficial including preservation of postoperative independence and a reduction of length of hospital stay.

     

Does Primary or Secondary Chondrocalcinosis Influence Long-term Survivorship of Unicompartmental Arthroplasty?

Background  

Coexistence of degenerative arthritis and calcium pyrophosphate dihydrate (CPPD) crystals (or radiological chondrocalcinosis) with osteoarthritis (OA) of the knees is frequent at the time of arthroplasty. Several studies suggest more rapid clinical and radiographic progression with CPPD than with OA alone. However, it is unclear whether chondrocalcinosis predisposes to higher risks of progression of arthritis in other compartments.     

Acute surgical removal of low-grade (Spetzler-Martin I-II) bleeding arteriovenous malformations

Background

Early surgical removal of cerebral AVMs is a relatively infrequent therapeutic option when dealing with a cerebral hemorrhage caused by AVM rupture: even in the case of low-grade AVMs, delayed treatment is, if possible, preferred because it is considered safer for patients and more comfortable for surgeons. To assess whether acute surgery may be a safe and effective management, we conducted a retrospective analysis of our early surgery strategy for ruptured low-grade AVMs.

Methods

We reviewed 27 patients with SM grade I-II AVM treated during 2004 to 2008 in the acute stage of bleeding (within the first 6 days after bleed). All patients showed a cerebral AVM on DSA at admission, and surgical removal was controlled by postoperative angiography. Neurological outcomes were assessed with GOS. The average length of follow-up was 22 months (48-3 months).

Results

Before surgery, 16 (59%) patients showed a GCS of 8 or less, 2 of them presenting an acute rebleeding after first hemorrhage. All patients underwent radical AVM surgical removal and hematoma evacuation in a single-stage procedure. Most patients (78%) were operated within the first day of hemorrhage. A favorable functional outcome (GOS: good recovery or moderate disability) was observed in 23 patients (85%). Mortality was 7.4%. Outcome was not significantly correlated with GCS at presentation and with presence of preoperative anisocoria.

Conclusions

Early surgery for grade I-II AVMs is a safe and definitive treatment, achieving both immediate cerebral decompression and patient protection against rebleeding, reducing time of hospital stay and allowing a more rapid rehabilitative course whenever necessary.     

Treatment of inferior turbinate hypertrophy: a randomized clinical trial

In the past 130 years, many surgical procedures for turbinate reduction have been developed. We analyzed the long-term efficacy of 6 of these surgical techniques (turbinectomy, laser cautery, electrocautery, cryotherapy, submucosal resection, and submucosal resection with lateral displacement) over a 6-year follow-up period. We randomly divided 382 patients into 6 therapeutic groups and surgically treated them at the Department of Otorhinolaryngology of the University of Siena. After 6 years, only submucosal resection resulted in optimal long-term normalization of nasal patency and in restoration of mucociliary clearance and local secretory IgA production to a physiological level with few postoperative complications (p < .001). The addition of lateral displacement of the inferior turbinate improved the long-term results. We recommend, in spite of the greater surgical skill required, submucosal resection combined with lateral displacement as the first-choice technique for the treatment of nasal obstruction due to hypertrophy of the inferior turbinates.     

Factors affecting long-term changes of liver stiffness in direct-acting anti-hepatitis C virus therapy: A multicentre prospective study

The long-term changes of liver stiffness (LS) in patients who achieve viral clearance after direct-acting anti-HCV therapy remain undefined. We conducted a multicentre prospective study to investigate this aspect. Patients with HCV infection treated with DAAs were enrolled from six Italian centres; they underwent clinical, biochemical, ultrasound and transient elastography evaluations before treatment (T0), 12 weeks (SVR12) and 24 months (T24) after the end of therapy. Among the 516 consecutive patients enrolled, 301 had cirrhosis. LS significantly decreased from T0 to SVR (14.3 vs 11.1 kPa, p = .002), with a progressive reduction until T24 (8.7 kPa, p < .001). However, only patients with steatosis and those who developed HCC did not experience a late improvement in LS. Multivariate analysis of baseline and follow-up variables identified steatosis as the only independent predictor of failure of LS improvement (OR 1.802, p = .013). ROC curve analysis of the association of LS with the risk of developing HCC showed that SVR12 ≥14.0 kPa had the highest accuracy (sensitivity 82%, specificity 99%; AUC: 0.774). Multivariate analysis revealed that LS was the only variable independently associated with an increased risk of developing HCC (OR 6.470, p = .035). Achieving an SVR was associated with a progressive, long-term decline of LS, suggesting a late improvement in liver fibrosis, besides the resolution of inflammation. Fatty liver and the development of HCC interfered with late reduction of LS. Patients with an LS ≥14 kPa at 12 weeks after the end of treatment were at higher risk for developing HCC.     

Two hugging balloons at high pressures successfully dilate a lesion refractory to routine coronary angioplasty.

A small portion of lesions are refractory to coronary angioplasty even when very high pressures are used. This leads to a failed angioplasty and emergent bypass surgery. We successfully attempted the technique of hugging balloons or two polyethelene terephthalate (PET) balloons inflated simultaneously side by side which successfully dilated a lesion which would not dilate using standard techniques. This technique successfully dilated the lesion as the geometry of two balloons inflated side by side is different from one balloon. Two balloons inflated side by side consists of two outer semi-circles and a central trapezoidal square area. This altered geometric configuration may be important in successfully dilating a lesion refractory to standard dilating techniques. Higher pressures can be attained with smaller balloons as the burst pressure is higher in smaller balloons compared to larger balloons.     

Prevalence and correlates of multiple organ damage in referred treated hypertensives: data from the ETODH study

This study, carried out in a large cohort of treated essential hypertensives attending an out-patient hospital hypertension clinic, extends previous observations by showing that a clustering of two or three markers of organ damage (OD) has a higher prevalence than a single organ involvement. These findings call for a systematic evaluation of cardiac and extracardiac OD in treated hypertensive patients referred to a specialist setting.