Does the addition of oxaliplatin to preoperative chemoradiation benefit cT4 or fixed cT3 rectal cancer treatment? A subgroup analysis from a prospective study.

BACKGROUND: Whether there is any benefit derived from adding oxaliplatin to fluoropyrimidine-based preoperative chemoradiation is currently unknown in cases of advanced cT3 or cT4 tumours. Our aim was to evaluate this issue by analysing a randomized trial, which compared two schedules of preoperative treatment (chemoradiation vs. 5 × 5 Gy with 3 cycles of consolidation chemotherapy) for cT4 or fixed cT3 rectal cancer. PATIENTS AND METHODS: Delivery of oxaliplatin was mandatory to the first part of the study. For the second part, its delivery in both treatment-assigned groups was left to the discretion of the local investigator. We analysed a subgroup of 272 patients (136 in the oxaliplatin group and 136 in the fluorouracil-only group) from institutions that had omitted oxaliplatin in the second part of the study. RESULTS: Circumferential resection margin negative (CRM-) status rate was 68% in the oxaliplatin group and 70% in the fluorouracil-only group, p = 0.72. The pathological complete response rate (pCR) was correspondingly 14% vs. 7%, p = 0.10. Following multivariable analysis, when comparing the CRM- status in the oxaliplatin group to the fluorouracil-only group, the odds ratio was 0.79 (95 CI 0.35-1.74), p = 0.54; there being no interaction between concomitant chemoradiation and 5 × 5 Gy with consolidation chemotherapy; pinteraction = 0.073. For pCR, the corresponding results were 0.47 (95 CI 0.19-1.16), p = 0.10, pinteraction = 0.84. CONCLUSION: No benefit was found of adding oxaliplatin in terms of CRM nor pCR rates for either concomitant or sequential settings in preoperative radiochemotherapy for very advanced rectal cancer.

Long-course oxaliplatin-based preoperative chemoradiation versus 5 × 5 Gy and consolidation chemotherapy for cT4 or fixed cT3 rectal cancer: results of a randomized phase III study.

BACKGROUND: Improvements in local control are required when using preoperative chemoradiation for cT4 or advanced cT3 rectal cancer. There is therefore a need to explore more effective schedules. PATIENTS AND METHODS: Patients with fixed cT3 or cT4 cancer were randomized either to 5 × 5 Gy and three cycles of FOLFOX4 (group A) or to 50.4 Gy in 28 fractions combined with two 5-day cycles of bolus 5-Fu 325 mg/m(2)/day and leucovorin 20 mg/m(2)/day during the first and fifth week of irradiation along with five infusions of oxaliplatin 50 mg/m(2) once weekly (group B). The protocol was amended in 2012 to allow oxaliplatin to be then foregone in both groups. RESULTS: Of 541 entered patients, 515 were eligible for analysis; 261 in group A and 254 in group B. Preoperative treatment acute toxicity was lower in group A than group B, P = 0.006; any toxicity being, respectively, 75% versus 83%, grade III-IV 23% versus 21% and toxic deaths 1% versus 3%. R0 resection rates (primary end point) and pathological complete response rates in groups A and B were, respectively, 77% versus 71%, P = 0.07, and 16% versus 12%, P = 0.17. The median follow-up was 35 months. At 3 years, the rates of overall survival and disease-free survival in groups A and B were, respectively, 73% versus 65%, P = 0.046, and 53% versus 52%, P = 0.85, together with the cumulative incidence of local failure and distant metastases being, respectively, 22% versus 21%, P = 0.82, and 30% versus 27%, P = 0.26. Postoperative and late complications rates in group A and group B were, respectively, 29% versus 25%, P = 0.18, and 20% versus 22%, P = 0.54. CONCLUSIONS: No differences were observed in local efficacy between 5 × 5 Gy with consolidation chemotherapy and long-course chemoradiation. Nevertheless, an improved overall survival and lower acute toxicity favours the 5 × 5 Gy schedule with consolidation chemotherapy. CLINICAL TRIAL NUMBER: The trial is registered as ClinicalTrials.gov number NCT00833131.

[Verification of indications for kidney biopsy in children with steroid-dependent nephrotic syndrome]. / Weryfikacja wskazan do biopsji nerki u dzieci ze sterydozaleznym zespolem nerczycowym.

The aim of this study was to assess if cytostatic treatment of steroidodependent nephrotic syndrome in children should be preceded by renal biopsy. The result of treatment of 75 children with steroidodependent nephrotic syndrome were analysed. They were randomized for treatment with chlorambucil and cyclophosphamide and divided into two groups. Group I includes 32 children without preceding biopsy, group II, 43 children with established histopatologic diagnosis. Remission was achieved by 25 (78%) children in group I (15 (79%) of 19 treated with chlorambucil and 10(77%) of 13 treated with cyclophosphamide) and 38 (88.4%) in group II (25 (96%) of 26 treated with chlorambucil and 13 (76%) of 17 treated with cyclophosphamide). The results of therapy in children of two groups are comparable. This would indicate that a trial of cytostatic treatment can be started without previous renal biopsy.

[Evaluation of the efficacy of levamisole in corticosteroid-dependent nephrotic syndrome in children]. / Ocena skutecznosci lewamizolu u dzieci ze sterydozaleznym zespolem nerczycowym.

The efficacy of levamisole was evaluated in 22 steroid-dependent nephrotic children. All of them were treated before with glucocorticoids. In 45.5% of children, prednisone was with-drawn after levamisole treatment and the remissions obtained lasted more than six months, 18.2% of the children relapsed after prednisone withdrawal and 36.4% children did not respond to levamisole treatment. Levamisole could be recommended for steroid-dependent patients with recurrent infections, in which alkylating agents are contraindicated.

Preliminary results of examination of the large bowel with the colonoscope.

In 20 patients the colon was inspected with a CF-LB "Olympus" coloscope. The most frequent indication for colonoscopy were doubtful radiological changes in the colon requiring differential diagnosis. Thirteen patients were examined trying to inspect the whole colon and in 9 cases the cecum was reached after 10 to 60 min. In 3 cases colonoscopy demonstrated presence of colonic carcinoma (two tumors located in the cecum), and in 4 other cases this possibility was ruled out and it was possible, thus, to avoid exploratory laparotomy.