Neurotoxicity of FOLFOX-4 as adjuvant treatment for patients with colon and gastric cancer: a randomized study of two different schedules of oxaliplatin.

PURPOSE: The dose limiting toxicity of oxaliplatin (l-HOP) is neurotoxicity, which is characterized by an acute neuropathy and a clinically distinct chronic neuropathy. This randomized study evaluated if prolonged l-HOP infusion over the conventional l-HOP schedule was useful in reducing acute and possibly chronic l-HOP induced neurotoxicity in colon and gastric cancer patients receiving l-HOP-based regimen as adjuvant chemotherapy. METHODS: Sixty-four patients were randomly assigned to group A (26 colon and 6 gastric cancer) and to group B (23 colon and 9 gastric cancer). Chemotherapy in both groups consisted of l-HOP 85 mg/m(2) i.v. only on day 1, with leucovorin 100 mg/m(2) i.v. as a 2-h infusion followed by bolus 5-fluorouracil (5-FU) 400 mg/m(2)/day and a 22-h infusion of 5-FU 600 mg/m(2)/day, repeated for two consecutive days every 2 weeks for a maximum of 12 cycles. Patients in group A received l-HOP as a continuous 6-h i.v. infusion, and patients in group B received l-HOP as the conventional 2-h i.v. infusion. RESULTS: The percentage of patients presenting with grade >/=2 neurotoxicity was statistically lower in group A than in group B (28.1% vs. 59.3%: P = 0.02). There was a statistically lower percentage of cycles with grade >/=2 neurotoxicity in group A (6.1%) than in group B (18.5%) (P < 0.001). CONCLUSIONS: This study suggests that l-HOP as a continuous 6-h infusion is useful in preventing and reducing acute l-HOP induced neurotoxicity in patients with colon and gastric cancer receiving FOLFOX-4 regimen as adjuvant treatment.

Folinic acid, 5-fluorouracil and etoposide after curative resection for gastric cancer.

BACKGROUND/AIMS: The aim of this study was to evaluate the survival benefit of adjuvant chemotherapy with etoposide, leucovorin and 5-fluorouracil (ELF) in gastric cancer patients undergoing previous surgery with a curative intent. METHODOLOGY: The clinical outcome of 49 patients with resected gastric cancer treated with adjuvant chemotherapy was compared with that of 85 surgically treated historical controls who did not receive any adjuvant treatment. The chemotherapy regimen consisted of six cycles of daily 1-hour intravenous infusions of folinic acid 100 mg/m2 and 5-FU 400 mg/ m2, and a 2-hour infusion of etoposide 100 mg/m2, for three days every 28 days. RESULTS: The 5-year relapse-free survival was 32% in the adjuvant arm and 27% in the control arm (p = 0.6). At the last follow-up, there were 32 deaths in the adjuvant arm and 60 in the control arm. The median duration of survival was respectively 23 and 19 months, and the 5-year survival rates were 34% and 29% (p = 0.4). The chemotherapy was well tolerated. CONCLUSIONS: Our data suggest that ELF adjuvant treatment is a safe and well tolerable combination chemotherapy in patients with resected gastric cancer, but it does not seem to improve prognosis in comparison with historical controls.

Adjuvant epirubicin with or without Ifosfamide for adult soft-tissue sarcoma.

This randomized study compared the efficacy of epirubicin-based adjuvant chemotherapy on the disease-free interval (DFI) and overall survival of patients with high-risk soft-tissue sarcomas. After curative surgery, 43 of the 88 enrolled patients were assigned to surgery with or without radiotherapy and 45 to surgery plus chemotherapy (26 epirubicin, 19 epirubicin + ifosfamide) with or without radiotherapy. The trial closed prematurely because of poor patient accrual. There was a statistical significant difference in the 5-year disease-free survival of the patients receiving adjuvant chemotherapy with or without radiotherapy (69%) and that of those treated with surgery with or without radiotherapy (44%) ( p= 0.01). The 5-year survival of the patients treated with adjuvant chemotherapy with or without radiotherapy was 72% as against 47% of those treated with surgery with or without radiotherapy ( p= 0.06). The power of the study was 0.65 for both the DFI and overall survival. The results of the study suggest a possible advantage of epirubicin-based adjuvant chemotherapy in patients with soft-tissue sarcoma at high risk of relapse.

Transanal resection of rectal lipoma mimicking rectal prolapse: description of a case and review of the literature.

Submucosal lipomas of the large bowel are uncommon. Occasionally, they occur in the rectum and may cause aspecific symptoms; presentation with rectal prolapse is very unusual and may lead to a misdiagnosis of simple mucosal prolapse. The paper describes an additional case of a prolapsing rectal mass that led to diagnosis and surgical treatment of a rectal lipoma under local anesthesia.

Outcome of surgical treatment of colorectal cancer in the elderly.

The aim of this study is to compare the clinical features and the perioperative and long-term outcomes after primary surgery for colorectal cancer (CRC) in the elderly population with those observed in younger patients. All the patients over the age of 55 who underwent primary surgery for CRC in our clinic from 1988 to 2008 were included in this study and divided into two age groups: 55-75 and >75 years considering the age of diagnosis. 914 consecutive patients were enrolled in the study (352 > 75 years). In the elderly group, tumors were predominantly right sided, and the overall number of comorbidities was statistical more frequent. Elderly patients underwent emergency surgery more than the control group (p = 0.0008). There were no significant differences between the two groups in terms of curative and palliative resections. The overall operative mortality rate was 5.9% in the study group compared with 2.1% in the control study (p = 0.0033). The overall 3-year, 5-year and 10-year survival rates were, respectively, 37, 16.2 and 5.1% in the study group, when compared with 52.3, 35.1 and 24.7% in the control group (p = 0.022, p = 0.0001 and p = 0.0001, respectively). More patients were lost during the follow-up in the elderly group (p = 0.0003) and more deaths unrelated to cancer were found in the study group compared with the control group (p = 0.0005). The cancer specific mortality was similar between the two groups. In conclusion, elderly patients that underwent major colorectal resection have an acceptable perioperative morbidity, mortality and survival rate when compared with younger patients. Age alone should not be considered a reason to deny surgery to these patients.

Diffuse cutaneous metastases as the only sign of extranodal tumor spread in a patient with adenocarcinoma of the colon.

Cutaneous metastases from large bowel cancer are uncommon and are usually associated with organ involvement. Localization of lesions to the skin is mainly attributed to vascular and anatomical relationship, since most of them are seen in the abdominal wall or in a surgical scar. We report a 73-year-old woman in whom metastatic nodules from a poorly differentiated adenocarcinoma of the right colon developed throughout the skin (buttock, trunk, chest wall, arms, and neck) and remained the only sign of extranodal tumor spread until patient's death, seven months later. This unusual behaviour suggests that localization of neoplastic cells to the skin may be a site-specific process, determined by adhesion molecules and/or by growth factors found at that site.

Care with regard to details improves the outcome of Longo mucoprolapsectomy: long term follow up.

In this study we evaluated the results of stapled hemorrhoidopexy considering the histological features of the resected tissue obtained after the intervention, the staple line height and the improvement of the quality of life after the treatment. From January 2003 to December 2006, 72 patients with symptomatic grade 3 and 4 hemorrhoid that underwent stapled hemorrhoidopexy in our clinic were enroled in the study. Preoperative, intraoperative and postoperative characteristics of the patients were evaluated, including demographics, staple line height, specimen histology, complications, recurrence, day to return to work, quality of life (QoL) score and use of analgesics. Staple line height was always above 2.5 cm from the dentate line. Smooth muscle fibers were observed in 97.2%. The complication rate was 18%. Bleeding was observed in 5.5%. Fecal urgency was referred in 6.9%. Recurrence rate was 6.9%. Mean follow-up was 68 months. Hemorrhoidopexy is safe and effective but extreme attention must be paid to some critical details. We consider the placement of the purse string suture as a critical factor in the outcome of the patients. We find that some amount of the muscle fibers would invariably be involved in the resected specimen, without any significant impact in the clinical outcome or in the quality of life improvement.

Continuous oral capecitabine at fixed dose in patients older than 75 years with metastatic colorectal and gastric cancer: a study of the Multidisciplinary Oncology Group on Gastrointestinal Tumors.

The aim of this study was to investigate the safety profile of continuous oral capecitabine at fixed dose in patients older than 75 years, having metastatic colorectal and gastric cancer. Capecitabine was administered at a fixed dose of 2000 mg daily without interruptions. Thirty-four patients were considered evaluable for toxicity and efficacy. The median age was 81 years (range 76-85). The median duration of treatment was 113 days (range 24-238 days). No grade 4 toxicity was observed. One patient had grade 3 nausea and vomiting, and one had grade 3 diarrhea. Partial responses were observed in six patients with colorectal cancer, and in one patient with gastric cancer. This study suggests that continuous oral capecitabine at a fixed daily dose of 2000 mg is well tolerated, and that it allows for the simplification and ease of dosing in elderly patients with metastatic colorectal and gastric cancer.

FOLFOX-4 stop and go and capecitabine maintenance chemotherapy in the treatment of metastatic colorectal cancer.

OBJECTIVE: Patients with metastatic colorectal cancer (MCC) usually receive FOLFOX-4, or other oxaliplatin (L-HOP)-based regimens, until the occurrence of progressive disease, with an increase in the incidence of neurotoxicity which is correlated to the cumulative dose of L-HOP. The aim of this study was to evaluate if FOLFOX-4 stop and go and capecitabine maintenance chemotherapy is associated with a low incidence of severe neurotoxicity in the treatment of MCC patients. METHODS: Thirty-three patients were treated with FOLFOX-4 (L-HOP 85 mg/m(2) day 1, leucovorin 200 mg/m(2), 5-fluorouracil bolus 400 mg/m(2) and 22 h 600 mg/m(2) days 1 and 2, every 2 weeks). Patients who achieved objective response (OR) or stable disease (SD) then received oral capecitabine 2,500 mg/m(2) days 1-14 every 3 weeks; L-HOP was reintroduced as soon as progression occurred. RESULTS: Twenty-eight of the 29 patients who achieved OR or SD then received capecitabine. FOLFOX-4 was reintroduced in 18 patients (56.2%). The median response duration (RD) was 9.2 months and median progression-free survival (PFS) was 8.6 months. Twenty-eight patients (87.5%) had peripheral neuropathy during treatment, but grade 3 neurotoxicity was observed in only 1 patient (3.1%). CONCLUSIONS: FOLFOX-4 stop and go and capecitabine maintenance chemotherapy was associated with a very low incidence of grade 3 neurotoxicity. Although the number of patients enrolled was far too low for a definite conclusion, RD and PFS were comparable to those usually reported in the treatment of MCC patients.