Purpose: To compare the outcome among patients with invasive bladder cancer treated with cystectomy alone with outcome among those treated with combined-modality treatment in a randomised phase III trial.Patients and methods: Patients with histologically confirmed invasive non-metastatic bladder cancer T2-3, N0 and M0 were randomly assigned to two arms: Arm 1: of which all patients underwent radical cystectomy (RC) alone; and Arm 2, of which all patients were subjected to maximal transurethral resection of bladder tumour, followed 2 weeks later by combined chemoradiotherapy. The whole pelvis received 46 Gy in 23 fractions over 4?5 weeks. Chemotherapy was administered concomitantly with radiotherapy with: cisplatin 70 mg/m 2 q. 3 weeks and Gemcitabine 300 mg/m 2 D 1, 8 and 15 q. 3 weeks for two cycles. Patients who had complete response were shifted to phase II treatment: 20 Gy/10 fractions/2 weeks to the bladder. Patients with residual tumour underwent RC.Results: Of the 80 patients assigned Arm 2, a visibly completed transurethral resection of the bladder tumour was possible in 48 patients (60%). Phase I of combined chemoradiotherapy (CCRT) was accomplished in 74 patients. Post-induction urologic evaluation revealed no evidence of disease in 62 patients (83?8%) and residual disease in 12 patients (16?2%). Phase II of CCRT was completed in 58 of the 62 patients. The median follow-up for all patients is 27 months (range: 4-49). The 3-year overall survival (OS) for the combined-modality group and for the surgery group were 61 and 63%, respectively (p 5 0?425), whereas the disease-specific survival (DSS) for each group was 69 and 73%, respectively (p 5 0?714). The 3-year OS with bladder preservation for Arm 2 patients was 50%. Multivariate analysis for the whole series showed that tumour stage and performance status (PS) were the only factors independently associated with DSS, although PS was the only factor independently associated with OS. In addition, residual disease after transurethral resection of the bladder tumour in Arm 2 patients was independently associated with both DSS and OS. Acute toxicity was moderate and most of the late toxicities were grade 2 with no grade 4 toxicity and no treatment-related deaths, none required cystectomy for bladder contraction. 428Conclusion: This study demonstrates that trimodality bladder-preserving approach represents a valid alternative for suitable patients. The OS and DSS rates of patients treated with trimodality bladder-preserving protocol are comparable to the results reported on patients treated with immediate radical cystectomy.
Purpose. The purpose of this prospective pilot study was to determine the efficacy of preoperative chemotherapy with six cycles of FOLFOX 6 (without radiation therapy) followed by radical surgery followed by six additional cycles of FOLFOX 6 for patients with stage II/III rectal cancer. Patients and Methods. From January 2010 to January 2014, patients with locally advanced rectal cancer who met the eligibility criteria were enrolled in this study. Patients received FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium i.v. over 2 hours on day 1, then bolus, and then continuous fluorouracil i.v. over 46 hours on days 1 and 2. Treatment was repeated every 14 days for 6 courses followed by radical surgery followed by additional 6 cycles of FOLFOX 6. Results. In total, 45 patients were enrolled in this study. In the preoperative re-evaluation, the overall response rate was 68.8% (clinical complete response was 4.4%, and the partial response was 64.4%). There were 14 cases (31.2%) of stable disease. No patients had progressive disease. Postoperatively, the pathologic complete response rate was 8 of 45 (17.8%; 95% confidence interval [CI]: 8.9%-28.9%). The median follow-up was 29 months (range 9-54 months). The actuarial 3-year overall survival and disease-free survival rates for all patients were 80.8% (standard error, 1.877; 95% CI: 69.3%-92.3%) and 67.9% (standard error, 2.319; 95% CI: 54.3%-81.5%), respectively. Conclusion. Neoadjuvant chemotherapy (FOLFOX) without radiotherapy is active and safe but cannot be considered a standard of care until the results of prospective randomized phase III trials are available. The Oncologist 2015; 20:752-757 Implications for Practice: Neoadjuvant radiotherapy of rectal cancer represents the current standard of care. However, its use is also associated with short-term toxicity and long-term morbidity.With the increasing use of total mesorectal resection resulting in better local control and advances in systemic therapy for colorectal cancer, this study highlights the question of whether radiation is a necessary component of neoadjuvant therapy for all patients with rectal cancer or whether select patients could be spared the additional toxicities and inconvenience of radiotherapy. This study suggests that neoadjuvant FOLFOX without radiotherapy is active and safe, but it could not be considered a standard of care till now.
Purpose: To assess the safety and efficacy of the use of concurrent radiation therapy and docetaxel in adjuvant treatment oflocally advanced breast cancer (LABC). Patients and methods: Between February 2009 and January 2013, 62 patients with LABC who underwent primary mastectomy or neoadjuvant chemotherapy (FEC) followed by mastectomy at Assiut University Hospitals were entered into this trial. Three to five weeks after mastectomy or after the last dose of adjuvant FEC, patients were given concurrent chemoradiotherapy. Weekly intravenously docetaxel (30 mg/m 2) was given over 9 weeks. Results: The median follow-up for all patients is 32 months (range 12-63). Forty-eight patients (77.4%) remain alive, 12 patients (19.4%) died due to breast cancer, and 2 (3.2%) from other nonrelated causes. The 3-year rate of local recurrence free survival (LRFS) and disease free survival (DFS)were 93.8% (95% CI, 87.8-99.8%) and 70.2% (95% CI, 58.8-81.6%, Figure 1) respectively. The 3-year overall survival rate was 89.4% (95% confidence interval [95% CI], 81.7-97.1%; Figure 2). Four (6.4%) patients experienced locoregional recurrence as the first site of recurrence and 22 (35.5%) patients developed distant metastases. Acute toxicities were moderate during concomitant chemoradiotherapy. Five patients (8.1%) had grade 3-4 radiation dermatitis. Grade 3-4 radiation pneumonitis developed in 2 patients. Long-term toxicity was rare. Conclusion: Concurrent docetaxel and radiotherapyis an acceptable adjuvant regimen for patients withLABC. Although it does not apparently improve local control and/or survival, it shortened total treatment time, and was well tolerated.
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