Is It Possible a Conservative Approach After Radiochemotherapy in Locally Advanced Rectal Cancer (LARC)? A Systematic Review of the Literature and Meta-analysis.

BACKGROUND: Locally advanced rectal cancer is usually treated with a preoperative approach with radiochemotherapy followed by surgery. Patients obtaining a pathologic complete response have a very favorable long-term prognosis. This study was intended to assess whether major surgery can reduce tumor recurrences and prolong survival of patients with a complete response after radiochemotherapy. METHODS: Computerized literature search was performed to identify relevant articles. Comparative studies reporting the outcomes of non-operative and operative management in patients after neoadjuvant treatment were reviewed. Data synthesis was performed using Review Manager 5.0 software. RESULTS: Twelve non-randomized comparative studies with a total of 1812 patients were suitable for analysis. There was no significant difference in overall survival at 3 and 5 years (odds ratio [OR] 1.31; 95% CI 0.64-2.69; p = 0.46 and 1.48; 95% CI 1.00-2.20; p = 0.50) and in disease-free survival at 3 and 5 years (odds ratio [OR] 1.20; 95% CI 0.68-2.14; p = 0.53 and 1.22; 95% CI 0.86-1.74; p = 0.26, respectively) between locally advanced rectal cancer patients treated with and without operative approach. CONCLUSIONS: Major surgery does not seem to improve prognosis in patients obtaining a complete response after radiochemotherapy. Clinical trials, using clear criteria to identify complete response patients, are needed to recommend non-operative approach.

Can the addition of radiotherapy postoperatively increase clinical outcome of patients with gastric cancer? A systematic review of the literature and meta-analysis.

BACKGROUND: Although several studies have been carried out to determine the best treatment for gastric carcinoma, the data on survival rate still remain inconclusive. OBJECTIVE: To evaluate the effects of postoperative radio-chemotherapy on overall and disease-free survival. DATA SOURCES: MEDLINE and CANCERLIT searches of reference lists (for the period 1970 to 2016) were supplemented with hand search of reference lists. STUDY SELECTION: The present work includes randomized controlled trials comparing postoperative radio-chemotherapy to postoperative chemotherapy or to surgery alone in patients with resected gastric carcinoma without evidence of metastatic disease. Ten randomized controlled trials were analyzed in total: four compared postoperative radiochemotherapy to surgery alone (708 patients), and six compared postoperative radiochemotherapy to postoperative chemotherapy (1020 patients). DATA EXTRACTION: According to "intention to treat" method, three independent observers have extracted from each trial, the data on patients, intervention, and outcomes. These data were subsequently combined using DerSimonian and Laird methods. RESULTS: Postoperative radiochemotherapy significantly increases 3-year and 5-year overall survival and 3-year and 5-year disease free survival rate compared to postoperative chemotherapy (RR 0.89; 95%CI 0.81-0.97 and RR 0.82; 95%CI 0.71-0.95) or surgery alone (RR 0.83; 95% CI 0.77-0.91 and RR 0.80; 95% CI 0.65-0.98). CONCLUSIONS: In patients with resected gastric cancer, postoperative radiochemotherapy obtains: 1) an increase in overall survival, 2) an increase in disease free survival, and 3) a gain in 5 year disease free survival independent of surgical procedure.

A path for diagnosis and therapy of colon cancer: a continuous quality improvement.

OBJECTIVE: Prognosis of colorectal cancer strongly depends on stage at diagnosis, which can be cured in most cases at an early stage. The results were supported by different screening programmes. Few data concerning analysis of different phases of Colorectal Cancer Program were reported in literature. The aim of this study is to analyze "step by step", from a longitudinal type, the Colorectal Cancer Program, active at our Institution, verifying compliance with standards of care. METHODS: We compared two different populations during the same period: patients referring to our Clinical Oncology Unit coming from Regional Colorectal Cancer Screening Program and the other population that was not in any Colorectal Cancer Program. RESULTS: Considering patients from the Regional Colorectal Cancer Screening Program (19 patients, corresponding to 24.0% of the general case study), 3 (15.8%) were deceased and 16 (84.2%) were alive without evidence of the disease (NED). Concerning patients that are not coming from Regional Colorectal Cancer Screening Program (61 patients, corresponding to 76.0% of the general case study), 9 (14.8%) were deceased, 43 (70.5%) were NED, 8 (13.1%) were alive with metastases and 1 (1.6%) was lost during follow-up (PFU). CONCLUSIONS: On the basis of this experience, we concluded for high-quality care for both populations. Any critical point should be carefully analyzed in order to implement quality of care.

Skin rash during cetuximab treatment in advanced colorectal cancer: is age a clinical predictor?

PURPOSE: The aim of this study is to evaluate the intensity and the duration of skin rash in young and elderly patients treated with cetuximab for advanced colorectal cancer, in order to define a possible relationship between age and skin toxicity. METHODS: We retrospectively analyzed all consecutive patients with advanced colorectal cancer who developed skin rash during cetuximab treatment at the Clinical Oncology Unit from June 2006 to May 2011. We divided the general case study into two subgroups: young and elderly patients (≥ 65 years old), and we compared clinical, pathological, and therapeutical characteristics of both subgroups. RESULTS: Among the 31 patients affected by advanced colorectal cancer (64.5 % with colon cancer and 35.5 % with rectal cancer) treated with cetuximab, 19 patients (61.3 %) developed skin toxicities: seven patients (36.8 %) had grade 1 skin rash, nine patients (47.4 %) had grade 2, three patients (15.8 %) had grade 3, and no grade 4 was found. Ten (52.6 %) out of 19 patients were elderly (>65 years). Concerning skin rash, grading was substantially comparable between the two subgroups, but median duration of skin rash was higher in the first subgroup for all grades. The univariate analysis showed no statistical significant difference in overall survival between young and elderly patients (p = 0.171), such as age that does not seem to statistically influence the appearance (p = 0.386), duration (p = 0.455), and grade of skin rash (p = 0.765). CONCLUSIONS: Age is an insufficient predictor of skin toxicity during cetuximab treatment in advanced colorectal cancer and does not seem to statistically influence the appearance, duration, and grade of skin rash.

Skin rash during erlotinib for advanced non-small cell lung cancer: is age a clinical predictor?

The aim of this study was to evaluate the intensity and the duration of acneiform skin rash in young and elderly patients, to define a possible relationship between age and skin rash. We retrospectively analyzed all consecutive patients with advanced NSCLC who developed acneiform skin rash during erlotinib treatment at our Clinical Oncology Unit from June 2006 to May 2011. We divided the general case study into two subgroups: young and elderly patients (≥ 65 years) and we compared clinical, pathological and therapeutical characteristics of both subgroups. Among 25 patients affected by advanced NSCLC treated with erlotinib during the reference period, 19 patients (76.0 %) developed acneiform skin rash. Fourteen (73.7 %) of 19 patients were elderly. The majority of elderly patients has developed acneiform skin rash (82.4 vs 62.5 %). In addition, in elderly patients, acneiform skin rash has a higher intensity (for mild rash 7.1 vs 20.0 %, for moderate rash 57.1 vs 60.0 %, for severe rash 35.7 vs 20.0 %) and longer duration, especially for mild and moderate rash (for mild rash 154 vs 40 days, for moderate rash 120 vs 76 days, for severe rash 31 vs 85 days). The univariate analysis showed no statistical significant difference in OS between young and elderly patients (p = 0.191), such as age, does not seem to influence the appearance (p = 0.386), duration (p = 0.455) and grade of acneiform skin rash (p = 0.765). In conclusion, we can affirm that age is an insufficient predictor of acneiform skin rash during erlotinib treatment in advanced NSCLC and does not seem to statistically influence the appearance, duration and grade of skin rash.

The management of skin toxicity during erlotinib in advanced non-small cell lung cancer: how much does it cost?

INTRODUCTION: The aim of this study is to estimate the costs for the foreseeable management of skin toxicity (papulo-pustular reactions) in patients treated with erlotinib for non-small cell lung cancer (NSCLC) in order to value the direct medical economical impact. No studies like the above have been published until now. MATERIALS AND METHODS: We retrospectively analyzed all consecutive patients with NSCLC treated with erlotinib at Clinical Oncology Unit of University Hospital of Ferrara, Italy from June 2007 to May 2011. We evaluated severity and median duration of papulo-pustular reactions for each grade and we identified costs for the different therapeutic interventions. RESULTS: We evaluated 25 patients. Median time follow-up was 18.65 months (range 5.69-88.36). Finally, follow-up 7 patients (28.0%) were alive with metastases and 18 patients (72.0%) were deceased. Nineteen patients (76.0%) developed papulo-pustular reactions: 2 patients (10.5%) mild rash, 11 patients (57.9%) moderate rash and 6 patients (31.6%) severe rash; no case of hospitalization was observed. Median duration of mild rash was 97 days (costs-range: 157.7-452.2 €), median duration of moderate rash was 89 days (costs-range: 438.7-1035.6 €) and median duration of severe rash was 34 days (costs-range: 460.3-1057.2 €). CONCLUSIONS: Our experience, though the analysis of not selected case study, showed that management of skin toxicities related to erlotinib is not so expensive, especially for low grade; therefore, we also recommended to give particular attention to low grade of toxicities for reducing progression to high grade and consequent risk of hospitalization, which really impact on costs.

The management of skin toxicity during cetuximab treatment in advanced colorectal cancer: how much does it cost? A retrospecive economic assessment from a single-center experience.

AIMS AND BACKGROUND: Skin rash is a predictable and manageable side effect of anti-EGFR therapy such as cetuximab. The aim of this study is to estimate the costs for the foreseeable management of skin toxicity in patients treated with cetuximab in our institute in order to assess the direct medical economic impact. METHODS AND STUDY DESIGN: We retrospectively analyzed all consecutive patients with advanced colorectal cancer treated with cetuximab at our institute from June 2006 to May 2011. We evaluated the severity and mean duration of skin rash for each grade and we identified the costs for the different therapeutic interventions. Patients were treated according to the general consensus management of skin toxicity associated with cetuximab treatment. RESULTS: We evaluated 31 patients. The median follow-up was 28.95 months (range, 1.84-75.49). At last follow-up 10 patients (32.3%) were alive with metastases, 18 patients (58.1%) had died, 1 patient (3.2%) was alive without evidence of disease, and 2 patients (6.5%) were lost to follow-up. The median progression-free survival was 8.26 months and the median overall survival 32.89 months. Nineteen patients (61.3%) developed skin toxicities: 7 patients (22.6%) grade 1, 9 patients (29.0%) grade 2, 3 patients (9.7%) grade 3; no grade 4 skin toxicity was observed. The median duration of grade 1 toxicity was 79 days (no specific treatments were started), of grade 2 toxicity 95 days (cost range, € 199.50-294.50) and of grade 3 toxicity 64 days (cost range, € 159.42-233.90). CONCLUSIONS: Our experience, through the analysis of nonselected cases, showed that the management of skin toxicities related to cetuximab is not so expensive. We recommend proper care of low-grade toxicities in order to reduce progression to high-grade toxicities and the resulting risk of hospitalization, which really impacts on costs.

[Oncological quality indicators and Colorectal Cancer Program: data from 2009-2010 of University Hospital in Ferrara, Italy]. / Gli standard oncologici nel Percorso Diagnostico Terapeutico Assistenziale del paziente con carcinoma del colon: dati del biennio 2009-2010 presso l'UO di Oncologia Clinica dell'AOU di Ferrara.

The aim of this study is to analyse the oncological quality indicators on our Colorectal Cancer Program, that are reflective of the scope of care, feasible to implement and supported by evidence. We compared two different populations during the same period: patients referring to our Clinical Oncology Unit coming from Regional Colorectal Cancer Screening Program and the other population that was not in any Colorectal Cancer Program. On the basis of our experience, we concluded for high-quality care for both population. Any critical point should be carefully analysed in order to implement quality of care.

Gastrointestinal stromal tumors and other malignancies: a case series.

PURPOSE: This paper aims to review the clinical and pathological features of gastrointestinal stromal tumors (GISTs) occurring with other malignancies. METHODS: A retrospective analysis has been worked out considering all consecutive patients with GISTs referred to our institution between February 2002 and June 2010. We analyzed the relationship among clinical and biological characteristics of the disease and the occurrence of second cancer. RESULTS: Twenty-four patients with GIST have been recorded: in eight cases (33.3%), a second cancer was diagnosed and was synchronous in six patients. In the subgroup of synchronous malignancy, GISTs (four of stomach and one of ileum) were discovered during surgery for other gastrointestinal cancers, whereas one case (arising in the duodenum) was diagnosed during the staging procedure for another primary cancer. In the subgroup of GISTs associated with a second cancer, median age at diagnosis was higher (69 vs. 65 years), patients were more frequently male (62.5% vs. 43.8%), GISTs were smaller (median size 3 vs. 8 cm), and spindle cell histology was less frequent (25% vs. 69.2%); all cases were CD117-positive. Other characteristics were similar in the two subgroups, with the exception of risk category, with low or very low cases higher (75% vs. 20%), even if not statistically, in the subgroup of cases associated with other cancers. CONCLUSIONS: Because of the limited number of cases, we cannot exclude an incidental relationship, but this association should be considered, especially during disease staging or surgery for other gastrointestinal cancer, when lesions in other intestinal tracts are detected. Larger studies are needed.

The first 2 years of colorectal cancer screening in Ferrara, Italy.

We report on the first screening round in the District of Ferrara, a region of Emilia-Romagna, carried out between March 2005 and March 2007 to illustrate the effort of colorectal cancer (CRC) screening from administration and information to therapy and follow-up. After invitation of 38 344 persons aged 50-69 years (28.5%), 19 480 (50.8%) accepted the immunological faecal occult blood test, with 1 149 (6%) resulting positive. One thousand and one individuals (88.2%) who tested positive for immunological faecal occult blood test accepted examination by either colonoscopy (99.5%) or barium enema (0.5%). Out of 996 screenees having a colonoscopy, 231 had low-risk adenomas (23.2%) and 239 had high-risk adenomas (24%), and were treated endoscopically (96%) or surgically (4%). Ninety-one cancers were diagnosed in 9.1% of colonoscopies (Dukes stadia: A, 58.2%; B, 19.8%; C, 18.7%; D, 3.3%). Fourteen cancers (all in polyps) were treated endoscopically, and the remaining 77 were treated by surgery. One Dukes B patient and 13 of 17 Dukes C patients received adjuvant chemotherapy. Three Dukes D patients had chemotherapy only. During the 2-year study period, 87 screenees had a follow-up colonoscopy: no neoplasia was found in 35 patients initially diagnosed with cancer; low-risk adenomas were found in 31 of 52 patients with initial high-risk adenomas. In conclusion, the first CRC screening round in Ferrara was easy to organize, had a high acceptance, and detected 91 cancers (78% of which were in Dukes stages A and B, compared with only 40% in sporadic CRC in the same background population). Chemotherapy was necessary in 17 cases. This report may motivate other health authorities to initiate CRC screening campaigns.