Efficacy of adjuvant chemotherapy schedules for breast cancer according to body mass index: results from the phase III GIM2 trial.

BACKGROUND: The phase III GIM2 trial showed improved disease-free survival (DFS) and overall survival (OS) with adjuvant dose-dense (DD) as compared with standard-interval (SI) chemotherapy in women with node-positive early-stage breast cancer (BC). This exploratory analysis aimed to investigate the benefit of different schedules according to body mass index (BMI) in this trial. PATIENTS AND METHODS: This analysis explored the efficacy, in terms of DFS and OS, of different chemotherapy schedules according to BMI. Univariate and multivariable Cox proportional hazard models, adjusted for relevant prognostic factors, were used. RESULTS: Out of 2091 patients enrolled, 1925 with known baseline BMI were randomized in the DD versus SI comparison and therefore included in this analysis: 31.6% were overweight and 19.3% obese. Overweight and obesity were significantly associated with postmenopausal status, pT >2, and pN >2 tumors. After a median follow-up of 15.0 years (interquartile range 8.4-16.3 years), multivariable Cox survival models demonstrated no association of different BMI categories on DFS [adjusted hazard ratio (adjHR) 0.96, 95% confidence interval (CI) 0.80-1.15 and adjHR 1.11, 95% CI 0.91-1.35 for overweight and obese patients, respectively, compared to patients with normal BMI] or OS (adjHR 0.90, 95% CI 0.71-1.14 and adjHR 1.18, 95% CI 0.92-1.52 for overweight and obese patients, respectively). No significant interaction was found between BMI and treatment schedule in terms of DFS (Pfor interaction = 0.56) or OS (Pfor interaction = 0.19). The survival benefit of DD chemotherapy was observed irrespective of different BMI categories, with a more pronounced benefit for overweight and obese patients. CONCLUSION: In node-positive BC patients, DD schedule should be considered the preferred schedule irrespective of BMI.

MRI with DWI for the Detection of Posttreatment Head and Neck Squamous Cell Carcinoma: Why Morphologic MRI Criteria Matter.

BACKGROUND AND PURPOSE: Although diffusion-weighted imaging combined with morphologic MRI (DWIMRI) is used to detect posttreatment recurrent and second primary head and neck squamous cell carcinoma, the diagnostic criteria used so far have not been clarified. We hypothesized that precise MRI criteria based on signal intensity patterns on T2 and contrast-enhanced T1 complement DWI and therefore improve the diagnostic performance of DWIMRI. MATERIALS AND METHODS: We analyzed 1.5T MRI examinations of 100 consecutive patients treated with radiation therapy with or without additional surgery for head and neck squamous cell carcinoma. MRI examinations included morphologic sequences and DWI (b=0 and b=1000 s/mm2). Histology and follow-up served as the standard of reference. Two experienced readers, blinded to clinical/histologic/follow-up data, evaluated images according to clearly defined criteria for the diagnosis of recurrent head and neck squamous cell carcinoma/second primary head and neck squamous cell carcinoma occurring after treatment, post-radiation therapy inflammatory edema, and late fibrosis. DWI analysis included qualitative (visual) and quantitative evaluation with an ADC threshold. RESULTS: Recurrent head and neck squamous cell carcinoma/second primary head and neck squamous cell carcinoma occurring after treatment was present in 36 patients, whereas 64 patients had post-radiation therapy lesions only. The Cohen κ for differentiating tumor from post-radiation therapy lesions with MRI and qualitative DWIMRI was 0.822 and 0.881, respectively. Mean ADCmean in recurrent head and neck squamous cell carcinoma/second primary head and neck squamous cell carcinoma occurring after treatment (1.097 ± 0.295 × 10-3 mm2/s) was significantly lower (P < .05) than in post-radiation therapy inflammatory edema (1.754 ± 0.343 × 10-3 mm2/s); however, it was similar to that in late fibrosis (0.987 ± 0.264 × 10-3 mm2/s, P > .05). Although ADCs were similar in tumors and late fibrosis, morphologic MRI criteria facilitated distinction between the 2 conditions. The sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios (95% CI) of DWIMRI with ADCmean < 1.22 × 10-3 mm2/s and precise MRI criteria were 92.1% (83.5-100.0), 95.4% (90.3-100.0), 92.1% (83.5-100.0), 95.4% (90.2-100.0), 19.9 (6.58-60.5), and 0.08 (0.03-0.24), respectively, indicating a good diagnostic performance to rule in and rule out disease. CONCLUSIONS: Adding precise morphologic MRI criteria to quantitative DWI enables reproducible and accurate detection of recurrent head and neck squamous cell carcinoma/second primary head and neck squamous cell carcinoma occurring after treatment.

CT scan-based modelling of anastomotic leak risk after colorectal surgery.

AIM: Prolonged ileus, low-grade fever and abdominal discomfort are common during the first week after colonic resection. Undiagnosed anastomotic leak carries a poor outcome and computed tomography (CT) scan is the best imaging tool for assessing postoperative abdominal complications. We used a CT scan-based model to quantify the risk of anastomotic leak after colorectal surgery. METHOD: A case-control analysis of 74 patients who underwent clinico-radiological evaluation after colorectal surgery for suspicion of anastomotic leak was undertaken and a multivariable analysis of risk factors for leak was performed. A logistic regression model was used to identify determinant variables and construct a predictive score. RESULTS: Out of 74 patients with a clinical suspicion of anastomotic leak, 17 (23%) had this complication confirmed following repeat laparotomy. In multivariate analysis, three variables were associated with anastomotic leak: (1) white blood cells count > 9 × 10(9) /l (OR = 14.8); (2) presence of ≥ 500 cm(3) of intra- abdominal fluid (OR = 13.4); and (3) pneumoperitoneum at the site of anastomosis (OR = 9.9). Each of these three parameters contributed one point to the risk score. The observed risk of leak was 0, 6, 31 and 100%, respectively, for patients with scores of 0, 1, 2 and 3. The area under the receiver operating characteristic curve for the score was 0.83 (0.72-0.94). CONCLUSION: This CT scan-based model seems clinically promising for objective quantification of the risk of a leak after colorectal surgery.

Assessment of recurrence and complications following uncomplicated diverticulitis.

BACKGROUND: The natural history of sigmoid diverticulitis has been inferred from population-based or retrospective studies. This study assessed the risk of a recurrent attack following the first episode of uncomplicated diverticulitis. METHODS: Patients admitted between January 2007 and December 2011 with a first episode of uncomplicated sigmoid diverticulitis confirmed on computed tomography were enrolled in this prospective study. After successful medical management of the first episode, follow-up was conducted through yearly telephone interviews. Cox proportional hazards regression was performed to model the impact of various parameters on eventual recurrences and complications. RESULTS: During a median follow-up of 24 (range 3-63) months, 46 (16·4 per cent) of 280 patients experienced a second episode of diverticulitis. Six patients (2·1 per cent) subsequently developed complicated diverticulitis and four (1·4 per cent) underwent emergency surgery for peritonitis. In multivariable analysis, a raised serum level of C-reactive protein (over 240 mg/l) during the first attack was associated with early recurrence (hazard ratio 1·75, 95 per cent confidence interval 1·04 to 2·94; P = 0·035). CONCLUSION: Uncomplicated sigmoid diverticulitis follows a benign course with few recurrences and little need for emergency surgery. REGISTRATION NUMBER: NCT01015378 (http://www.clinicaltrials.gov).

Response to chemotherapy of solitary fibrous tumour: a retrospective study.

BACKGROUND: To report on anthracycline-based chemotherapy in a retrospective case-series analysis of solitary fibrous tumour (SFT) patients treated within the Italian Rare Cancer Network. PATIENTS AND METHODS: We reviewed a set of SFT treated with chemotherapy since 2002, focusing on anthracycline, administered alone or in combination with ifosfamide. Responses to ifosfamide as a single agent were also evaluated. Pathologic diagnosis was centrally reviewed, distinguishing typical, malignant (MSFT) and dedifferentiated (DSFT) subtypes. RESULTS: Among 42 SFT patients treated with chemotherapy, we selected 31 cases (mean age: 62 years; locally advanced/metastatic: 13/18; front-line/further line: 25/6; typical/MSFT/DSFT/not assessable: 1/17/12/1) who received anthracycline-based chemotherapy (anthracycline monotherapy: eight; anthracycline+ifosfamide: 23). 30 patients are evaluable for response. Best response by Response Evaluation Criteria in Solid Tumours (RECIST) was: partial response (PR): 6 (20%), stable disease (SD): eight (27%), progressive disease (PD): 16 (53%) cases. Responses were confirmed after 3 months. Median progression-free survival (PFS) was 4 (range 2-15) months, with 20% of patients being progression-free at 6 months. PR was found in 2/18 (11%) MSFT and 4/12 (30%) DSFT, with a median PFS of 3.5 and 5 months in MSFT and DSFT, respectively. 19 patients received high-dose prolonged-infusion ifosfamide (front-line/further line: 11/8; typical/MSFT/DSFT: 0/15/4) with two (10%) PR, five (26%) SD, 12 (63%) PD. CONCLUSIONS: This retrospective series suggests that in SFT anthracyclines have a degree of antitumour activity in the range of soft tissue sarcoma chemotherapy. Ifosfamide monotherapy seemed to have lower activity. A higher response rate was observed in DSFT in comparison to MSFT. Studies on targeted therapies are ongoing.

Clinicoradiological score for predicting the risk of strangulated small bowel obstruction.

BACKGROUND: Intestinal ischaemia as a result of small bowel obstruction (SBO) requires prompt recognition and early intervention. A clinicoradiological score was sought to predict the risk of ischaemia in patients with SBO. METHODS: A clinico-radiological protocol for the assessment of patients presenting with SBO was used. A logistic regression model was applied to identify determinant variables and construct a clinical score that would predict ischaemia requiring resection. RESULTS: Of 233 consecutive patients with SBO, 138 required laparotomy of whom 45 underwent intestinal resection. In multivariable analysis, six variables correlated with small bowel resection and were given one point each towards the clinical score: history of pain lasting 4 days or more, guarding, C-reactive protein level at least 75 mg/l, leucocyte count 10 x 10(9)/l or greater, free intraperitoneal fluid volume at least 500 ml on computed tomography (CT) and reduction of CT small bowel wall contrast enhancement. The risk of intestinal ischaemia was 6 per cent in patients with a score of 1 or less, whereas 21 of 29 patients with a score of 3 or more underwent small bowel resection. A positive score of 3 or more had a sensitivity of 67.7 per cent and specificity 90.8 per cent; the area under the receiver operating characteristic curve was 0.87 (95 per cent confidence interval 0.79 to 0.95). CONCLUSION: By combining clinical, laboratory and radiological parameters, the clinical score allowed early identification of strangulated SBO.

Clinical and histopathological risk factors to predict sentinel lymph node positivity, disease-free and overall survival in clinical stages I-II AJCC skin melanoma: outcome analysis from a single-institution prospectively collected database.

BACKGROUND: To investigate if the tumour infiltrating lymphocytes (TILs) are able to predict the sentinel lymph node (SLN) positivity, the disease-free survival (DFS) and overall survival (OS) in clinical stages I-II AJCC primary cutaneous melanoma (PCM). METHODS: The study included consecutive patients with PCM, all diagnosed, treated and followed up prospectively. Logistic regression was used to investigate the association between DFS, OS, SLN positivity and Breslow thickness, Clark level, TIL, ulceration, lesion site, gender, regression and age. RESULTS: From November 1998 to October 2008, 1251 consecutive patients with PCM were evaluated. Median age was 51 (range 15-96) with 32.2% (N=393) of them older than 60; 44.8% of them were males. Of the whole series, a total of 404 patients with primary vertical growth phase (VGP) melanoma and no clinical evidence of metastatic disease underwent SLN biopsy. Of these, 74 (18.8%) had a positive SLN. In a multivariate analysis, primary melanoma on the extremities versus that on the axial locations (truncal and head/neck) (OR 0.49, 95% CI 0.25-0.98, p 0.04) and TILs (TILs versus no TILs) (OR 0.47, 95%CI 0.25-0.90, p 0.02) were predictive for lower probability of SLN involvement, while thickness (>4mm versus 0-1mm) (OR 24, 19, 95% CI 4.91-119.13, p<.001) was predictive for higher risk of SLN positivity. A multivariate stepwise analysis confirmed these results. The histological status of the SLN was the most significant predictor of DFS and OS. Patients with a negative SLN had a 5-year DFS of 75.9%, compared with 35.2% in patients with a positive SLN (p<.0001) and a 5-year OS of 88.7% versus 42.9%, respectively (p<.0001). CONCLUSIONS: Our study demonstrates that the absence of TILs predicts SLN metastasis, in multivariate analysis the SLN positivity predicts DFS and OS.

Axillary recurrence in sentinel lymph node-negative breast cancer patients.

BACKGROUND: Sentinel lymph node biopsy (SLNB) was developed to axillary lymph node dissection (ALND) in the treatment of breast cancer. SLNB is predictive of axillary node status. Major concern is the occurrence of a false-negative SLN. Purpose of this study is to determine the rate of axillary recurrence in our series of unselected patients. PATIENTS AND METHODS: All patients with a negative SLNB from November 1999 to December 2006 have been treated and followed at our unit. Information on patients' characteristics, treatment and follow-up has been collected. RESULTS: Eight-hundred and four patients with negative SLNB did not receive ALND. After a median follow-up of 38.8 months, 21 patients had distant metastases, four had axillary relapse, nine had an in-breast recurrence and two had both. All patients with axillary recurrence received axillary dissection and systemic adjuvant therapy. They are all presently alive and free from disease. CONCLUSION: Data from this series, the largest from a general hospital, showed that isolated axillary node recurrence after negative SLNB is rare (<1%) and comparable with those reported from referral cancer institutions. We confirm that SLNB for the treatment of early breast cancer patients of a community-based hospital is safe and reliable.

Vascular invasion in pancreatic cancer: evaluation of endoscopic ultrasonography, computed tomography, ultrasonography, and angiography.

PRINCIPLES: Current methods for detecting vascular invasion in pancreatic cancer can be inaccurate, invasive, and expensive. The aim of this study is to assess the value of current imaging modalities in determining vascular invasion by pancreatic cancer. METHODS: The results of Endoscopic Ultrasonography (EUS), Computed Tomography (CT), Ultrasonography (US), and Angiography performed in 170 patients, suffering from pancreatic cancer, were retrospectively studied and correlated with intra-operative findings and surgical anatomopathological diagnosis after resection. We assessed sensitivity, specificity, positive and negative predictive values, and accuracy for detecting vascular invasion. RESULTS: EUS turned out to be the most reliable imaging technique for detecting vascular invasion in pancreatic cancer, with a sensitivity of 55%, specificity of 90%, positive predictive value of 61.1%, negative predictive value of 87.5%, and accuracy of 82.2%. CT results were 39.4%, 90%, 52%, 84.4%, and 79.1% for the respective categories, with however, better results with multislice CT. The US results were 3.7% for the sensitivity, 96.3% for the specificity, 25% for the positive predictive value, 75.2% for the negative predictive value, and 73.4% for the accuracy. For angiography, the sensitivity, the specificity, the positive predictive value, the negative predictive value, and the accuracy were 52.6%, 72.3%, 43.5%, 79.1%, and 66.7% respectively. CONCLUSION: In this study, EUS was the most valuable imaging modality in assessing vascular invasion (especially for venous invasion) for pancreatic cancer, with an accuracy of more than 80%. A further prospective study should be carried out to evaluate the combination of imaging modalities for the detection of vascular involvement, especially with multi-slice CT which almost reached the performances obtained by EUS.

Percutaneous CT scan-guided drainage vs. antibiotherapy alone for Hinchey II diverticulitis: a case-control study.

PURPOSE: CT-scan-guided percutaneous abscess drainage of Hinchey Stage II diverticulitis is considered the best initial approach to treat conservatively the abscess and to subsequently perform an elective sigmoidectomy. However, drainage is not always technically feasible, may expose the patient to additional morbidity, and has not been critically evaluated in this indication. This study was undertaken to compare the results of percutaneous drainage vs. antibiotic therapy alone in patients with Hinchey II diverticulitis. METHODS: This was a case-control study of all patients who presented in our institution with Hinchey Stage II diverticulitis between 1993 and 2005. Thirty-four patients underwent abscess drainage under CT-scan guidance (Group 1), and 32 patients were treated with antibiotic therapy alone (Group 2), in most cases because CT-scan-guided abscess drainage was considered technically unfeasible by the interventional radiology team. Initial conservative treatment was considered a failure when: 1) emergency surgery had to be performed, 2) signs of worsening sepsis developed, and 3) abscess recurred within four weeks of drainage. RESULTS: The median size of abscess was 6 (range, 3-18) cm in Group 1 and 4 (range, 3-10) cm in Group 2 (P = 0.002). Median duration of drainage was 8 (range, 1-18) days. Conservative treatment failed in 11 patients (33 percent) of Group 1, and in 6 patients (19 percent) of Group 2 (P = 0.26). Ten patients (29 percent) in Group 1 and five patients (16 percent) in Group 2 underwent emergency surgery (P = 0.24); there were four postoperative deaths (26.6 percent) in this subgroup. Twelve patients (35 percent) in Group 1 and 16 patients (50 percent) in Group 2 subsequently underwent an elective sigmoid resection (P = 0.31). In this subgroup of patients, there was neither anastomotic leakage nor postoperative death. CONCLUSIONS: Emergency surgery for Hinchey Stage II diverticulitis carries a high mortality rate and should be avoided. To achieve this, antibiotic therapy alone seems to be a safe alternative, whenever percutaneous drainage is technically difficult or hazardous. Actually, our data did not demonstrate any benefit of CT scan-guided percutaneous abscess drainage, suggesting that the role of interventional radiology techniques in this indication deserves further critical evaluation.

Results from percutaneous drainage of Hinchey stage II diverticulitis guided by computed tomography scan.

BACKGROUND: Percutaneous abscess drainage guided by computed tomography scan is considered the initial step in the management of patients presenting with Hinchey II diverticulitis. The rationale behind this approach is to manage the septic complication conservatively and to follow this later using elective sigmoidectomy with primary anastomosis. METHODS: The clinical outcomes for Hinchey II patients who underwent percutaneous abscess drainage in our institution were reviewed. Drainage was considered a failure when signs of continuing sepsis developed, abscess or fistula recurred within 4 weeks of drainage, and emergency surgical resection with or without a colostomy had to be performed. RESULTS: A total of 34 patients (17 men and 17 women; median age, 71 years; range, 34-90 years) were considered for analysis. The median abscess size was 6 cm (range, 3-18 cm), and the median duration of drainage was 8 days (range, 1-18 days). Drainage was considered successful for 23 patients (67%). The causes of failure for the remaining 11 patients included continuing sepsis (n = 5), abscess recurrence (n = 5), and fistula formation (n = 1). Ten patients who failed percutaneous abscess drainage underwent an emergency Hartmann procedure, with a median delay of 14 days (range, 1-65 days) between drainage and surgery. Three patients in this group (33%) died in the immediate postoperative period. Among the 23 patients successfully drained, 12 underwent elective sigmoid resection with a primary anastomosis. The median delay between drainage and surgery was 101 days (range, 40-420 days). In this group, there were no anastomotic leaks and no mortality. CONCLUSION: Drainage of Hinchey II diverticulitis guided by computed scan was successful in two-thirds of the cases, and 35% of the patients eventually underwent a safe elective sigmoid resection with primary anastomosis. By contrast, failure of percutaneous abscess drainage to control sepsis is associated with a high mortality rate when an emergency resection is performed. The current results demonstrate that percutaneous abscess drainage is an effective initial therapeutic approach for patients with Hinchey II diverticulitis, and that emergency surgery should be avoided whenever possible.

Population-based sentinel lymph node biopsy in early invasive breast cancer.

INTRODUCTION: Sentinel lymph node biopsy (SLNB) has been proposed as a reliable method for staging of early invasive breast cancer (EIBC). In the present study we analyse the impact of this procedure when systematically applied to all unselected women of a community-based Breast Cancer Unit (BCU). METHODS: All consecutive women with unifocal cT1-2 (

New drugs and combinations in the palliative treatment of colon and rectal cancer.

Colorectal cancer (CRC) is a common disease. The overall survival has improved only marginally in recent decades despite advances in surgery and early detection. Potentially curative resection at disease presentation can be performed only in 70-80% of the patients, and overall survival at 5 years is less than 60%. Advanced disease is associated with a poor prognosis. Treatment for advanced colorectal cancer has nevertheless made progress in the last few years. Systemic chemotherapy doubles the survival of these patients compared to untreated controls. Chemotherapy has demonstrated effective palliation, improvement of quality of life (QoL) and symptom improvement in such patients. For nearly four decades, fluorouracil (5FU) has been the mainstay of treatment. New compounds active against colorectal cancer are now available. Several studies on this topic are ongoing.

Gemcitabine plus vinorelbine in elderly or unfit patients with non-small cell lung cancer.

Cisplatin-based combinations are efficacious in increasing the overall survival of patients with non-small cell lung cancer (NSCLC), but their toxicity makes them unsuitable for elderly and unfit patients. The primary objective of this non-randomized phase II study was to evaluate the feasibility and activity of the gemcitabine plus vinorelbine combination in previously untreated elderly and/or unfit patients with measurable stage III or IV NSCLC. Forty-three patients aged >/= 65 years or with contraindications against cisplatin treatment (36 males and seven females: median age 66 years; range 48-75: PS 0 = 11, PS 1 = 19, PS 2 = 13) received intravenous (i.v.) gemcitabine 1000 mg m(-2), followed by vinorelbine 25 mg m(-2)i.v. on day 1 and 8 every 21 days. Fifteen patients (34.9%) achieved partial remission (confidence interval: 27. 6-42.2%) for a median duration of 6 months; the median survival of these patients has not yet been reached. A further 15 had stable disease for a median of 4 months and a median survival of 7 months. The 10 patients (23.2%) who experienced disease progression had a median survival of 4 months. Three patients are not evaluable. The 1-year actuarial survival rate is 31.1%. The treatment was well tolerated: only 35% of the patients had grade 3 or 4 granulocytopenia on day 14, none experienced episodes of neutropenic fever, and there was no evidence of severe haematological toxicity upon recycling. Only 9% of the patients suffered from gastrointestinal toxicity (grade 3); increased but reversible transaminase levels were observed in 11.6%. In conclusion, the results of this phase II study show that the combination of gemcitabine and vinorelbine is active and well tolerated in NSCLC, and thus encourage its use in elderly or unfit patients.

CT criteria for management of blunt liver trauma: correlation with angiographic and surgical findings.

PURPOSE: To determine the contrast material-enhanced computed tomographic (CT) criteria for selection of hemodynamically stable patients with blunt hepatic injury for angiographic evaluation. MATERIALS AND METHODS: Seventy-two patients with blunt liver injury underwent CT and hepatic angiography. Hepatic injuries were graded with CT-based classification. Scans were assessed for evidence of contrast extravasation and laceration or contusion extending into the hepatic vein(s), inferior vena cava, porta hepatis, or gallbladder fossa. Medical, angiographic, and surgical records were reviewed to determine angiographic findings, surgical indications and findings, and outcomes. RESULTS: Compared with hepatic angiography, CT was 65% (11 of 17 patients) sensitive and 85% (41 of 48 patients) specific for detection of arterial vascular injury. When CT severity grades 2 and 3 were analyzed, the sensitivity and specificity of CT were 100% (three of three patients) and 94% (34 of 36 patients), respectively (P <.001). Injury involving at least one major hepatic vein was found in 15 (88%) of 17 patients who required liver-related surgery and in 23 (42%) of 55 of the other patients (P <.01). CONCLUSION: CT-based criteria, including hepatic injury grade, signs of arterial vascular injury, and presence or absence of major hepatic venous involvement assists in selecting patients for hepatic angiography and those at increased risk of ongoing or delayed hepatic bleeding or other posttraumatic complications.

The value of oxaliplatin in combination with continuous infusion +/- bolus 5-fluorouracil and levo-folinic acid in metastatic colorectal cancer progressing after 5FU-based chemotherapy: a GISCAD (Italian Group for the Study of Digestive Tract) cancer phase II trial.

AIMS AND BACKGROUND: The phase II trial was designed to evaluate the activity of combined oxaliplatin (L-OHP), continuous infusion (CI) +/- bolus 5-fluorouracil (5FU) and levo-folinic acid (I-FA) in patients with metastatic colorectal cancer progressing after one or more lines of 5FU-based chemotherapy. PATIENTS AND METHODS: We designed two contemporary studies: in the former we enrolled patients previously treated with 1 line of chemotherapy, and in the latter, patients previously treated with 2, 3 and 4 lines. Seventy-six consecutive patients were enrolled: 45 received L-OHP (85 mg/m2 i.v. 2 h on day 1) + I-FA (100 mg/m2 i.v. 2 h on days 1 and 2) + 5FU i.v. bolus (400 mg/m2 days 1 and 2) + 5FU (600 mg/m2 CI 22 h days 1 and 2 (FOLFOX 4); 31 received L-OHP (100 mg/m2 i.v. 2 h on day 1) + I-FA (250 mg/m2 i.v. 2 h on days 1 and 2), followed by 5FU (1500 mg/m2 Cl 24 h days 1 and 2 (FOLFOX 2). The treatment was recycled every 2 weeks and continued until progression and/or unacceptable toxicity or patient preference. The primary end point was activity (tumor growth control [TGC]: partial response [PR] + stable disease [SD]); the secondary end points were time to progression (TTP), overall survival (OS) and toxicity. RESULTS: Forty-five patients in 2nd line (22 FOLFOX 4, 23 FOLFOX 2), 23 (17 FOLFOX 4, 6 FOLFOX 2) in 3rd, 4 in 4th and 1 in 5th line were assessable; 3 were lost to follow-up. In 15 patients (11 FOLFOX 4, 4 FOLFOX 2), disease involved the liver only. A total of 533 courses were administered with a range of 1-14 in FOLFOX4 and 1-12 in FOLFOX2; dose intensity was 92.85%, and the total dose of the administered L-OHP was 98.29%. As a 2nd line treatment, FOLFOX 4 achieved TGC in 72.8% of the patients (PR, 18.2%; SD, 54.6%), with a median TTP of 6 months and a median OS of 7 months, whereas in the FOLFOX 2 group these figures were 78.3% (PR 21.8%, SD 56.5%), and 5 and 9 months. As a 3rd line treatment, FOLFOX 4 produced TGC in 41.1% of patients (PR 23.5%, SD 17.6%), with a median TTP of 5 months and median OS of 7+ months, whereas FOLFOX 2 obtained respective values of 50% (PR 16.7%, SD 33.3%), 7 and 9 months. As a 4th line of treatment, TGC was achieved in 2 patients (1 PR, 1 SD); the patient in 5th line therapy obtained a SD. With "de Gramont" as the first-line regimen, patients assessable were 24 in FOLFOX 4 and 18 in FOLFOX 2. In the former population, TGC was 70.8% (PR 37.5%, SD 33.3%), with a TTP of 6 months and OS of 10 months, whereas with FOLFOX2 these values were 61.1% (PR 5.6%, SD 55.5), 5 and 7 months. In patients with liver involvement only, FOLFOX 4 obtained TGC in 63.6% of cases (with a TTP of 7 months and OS of 6+ months), FOLFOX 2 in 100% (with a TTP of 9.5 months and OS of 13.5+ months). Both schedules exhibited an acceptable toxicity: neurologic, hematologic and hepatic grade 3 side effects occurred in a limited number of patients, with a higher frequency in the FOLFOX 2 group. CONCLUSIONS: Treatment with L-OHP, CI +/- bolus 5FU and I-FA was well tolerated. The activity in terms of TGC was interesting and comparable with results reported in the literature for the standard treatment for 2nd line, i.e. irinotecan alone. Treatment was effective in 2nd line and in patients previously treated with more than two chemotherapy lines; in particular, treatment was active in patients with hepatic disease only. Although the two schedules seemed to achieve the same benefit with the same tolerance, we could not define from the study the better regime.

[Endoscopic gastrostomy in patients with complicated heart diseases]. / Gastrostomia endoscópica em pacientes com cardiopatia complicada.

Complicated cardiologic patients with brain ischemia and heart failure need long term enteral nutrition. Long term nasoenteral tube feeding may cause complications that could be avoided with percutaneous endoscopic gastrostomy. The aim of this study was to evaluate the indications for percutaneous endoscopic gastrostomy and its main complications. Twelve patients were submitted to percutaneous endoscopic gastrostomy (eight male) with main age of 62.42 +/- 22.10 years old. Brain ischemia was the main indication of percutaneous endoscopic gastrostomy and occurred after 35.58 +/- 26.79 days, after initiated enteral nutrition. There were no complications during procedure. On late post operatory period there were local infection in one cases, treated with local care. In conclusion, percutaneous endoscopic gastrostomy is a secure technique with low incidence of complications and its indication should be earlier.