A prospective randomized trial for postoperative vs. preoperative adjuvant radiotherapy for muscle-invasive bladder cancer.

PURPOSE: Although radical cystectomy is considered to be the primary treatment for muscle-invasive bladder cancer, it is associated with unfavorable outcome. Local recurrence is still a major problem. Survival rates as well as quality of live are far from being satisfactory. Postoperative radiotherapy is considered the standard adjuvant treatment in the NCI-Egypt. This is a prospective randomized study conducted to compare preoperative with postoperative radiotherapy as regard the survival and complication rates. PATIENTS AND METHODS: In the period from May, 2004 to June 2007, 100 eligible patients were included into the study, 50 patients in each treatment arm. Pelvic irradiation was identical in both groups aiming at 50 Gy/25 Fs/5 wk. Radical cystectomy was the standard surgery. Locoregional control, survival rates, and complications rates were compared in both arms. RESULTS: Patients had a median follow-up period of 32 months (range 0-69 months). Patients had an average age of 54.8 ± 9.5 years with a male/female ratio 3:1. In the present study, transitional cell carcinoma constitutes (51%), while squamous cell carcinoma was reported in 46% of cases. Grades II and III pathology were 81% and 17%, respectively. Pathological stage P2b was encountered in 39.5% of the patients followed by P3b (33.3%) and P3a (14.6%). For the preoperative group, the 3-year overall survival, disease-free survival, locoregional control, and metastases-free survival rates were 53.4%, 47.4%, 89.3%, and 61.5%, respectively. The corresponding figures for the postoperative group were 51.8%, 34.1%, 80.6%, and 55.7% for the postoperative group. None of the patients had serious radiation reactions. CONCLUSION: In our study, preoperative radiotherapy was almost equivalent to postoperative radiation therapy as regard OS, DFS, as well as complication rates. Given the recent physical developments in radiation therapy techniques and the biological rationale for treating the pelvis after cystectomy, adjuvant radiotherapy should be re-evaluated world wide. Preoperative radiotherapy may re-emerge as a useful tool for adjuvant treatment.

Locally advanced rectal carcinoma: preoperative radiotherapy versus postoperative chemoradiation, 10-year follow-up results of a randomized clinical study.

PURPOSE: A prospective study was designed to randomize locally advanced rectal carcinoma patients between either preoperative radiotherapy (+/- postoperative chemotherapy) or postoperative adjuvant chemoradiation. Two end points were evaluated, local recurrence and survival, aiming at defining prognostic parameters that can help in the choice of the optimum treatment modality. PATIENTS AND METHODS: This is a prospective randomized clinical study including patients with locally advanced low rectal cancer treated at the National Cancer Institute (NCI), Cairo University, during the period from December 1994 to January 1999. Fifty patients with previously untreated rectal cancer were randomized into two groups, Group I: Subjected to surgery followed by radiation therapy (50Gy/5 weeks, 2Gy/fraction, 5 days/week) plus chemotherapy and Group II, subjected to preoperative radiotherapy (46Gy/4.5 weeks, 2Gy/ fraction, 5 days/week) followed by surgery +/- postoperative chemotherapy. Chemotherapy in the concomitant setting was given in the form of Leucovorin in a dose of 300mg/m2 as a short i.v. infusion followed by 5-FU in a dose of 350mg/m2 as a 6 hour i.v. infusion, whereas adjuvant chemotherapy consisted of 5- FU as 600mg/m2 short i.v. infusion weekly for 48 weeks, in addition to levamisole tablets. RESULTS: The long-term treatment end results obtained showed that group I patients had a slightly higher 10-year overall survival (OS) rate when compared to group II patients (63% versus 60%, p=0.698). The corresponding figures for the 10-year disease-free survival (DFS) were 65% and 66%, respectively, p=0.816. Although the 10- year local failure rate (persistent/relapsed disease) was higher for the preoperative group, it was not of statistical significance, (30% Vs. 8%, p=0.057). On the other hand, the 10-year distant metastasis free survival was higher in the preoperative group (88% Vs. 72%), yet this difference did not reach statistical significance (p=0.16). The rate of acute radiation reactions was higher in the postoperative group, with no increase in the operative complications in the preoperative group. Moreover, none of the 50 patients had grade 3 or more late radiation/surgical squealae. There were no grade 3 or 4 chemotherapy related toxicities. CONCLUSIONS: This work showed equal results for DFS and OS rates between preoperative and postoperative radiation therapy with the same acceptable acute and late radiation toxicity. High dose preoperative irradiation did not cause any significant increase in acute or late radiation induced reactions, delay in wound healing or increased postoperative morbidity when compared to postoperative adjuvant radiochemotherapy. Duke' s stage and response to preoperative irradiation proved to be of significance regarding DFS, while compliance to systemic therapy was of significance regarding both OS and DFS.

Hypofractionation versus conventional fractionation radiotherapy after conservative treatment of breast cancer: early skin reactions and cosmetic results.

PURPOSE: To compare in a prospective trial the acute skin reaction and late cosmetic effects of normal fractionation versus hypofractionation radiotherapy after breast conserving surgery. PATIENTS AND METHODS: Thirty patients with T 1-2N0M0 breast cancer who underwent breast conserving surgery (BCS) were included in the study. Half of the patients received whole breast irradiation, consisting of 50 Gy/25f/5w+boost 10Gy/5f/1w to tumor bed (group A). The other half received 42.5Gy/16f/22 days (group B). The two groups were comparable otherwise. Early skin reaction and late cosmetic results were graded according to RTOG guidelines. RESULTS: The study showed no statistical significant difference between the two treatment groups as regards acute skin reactions and cosmetic appearance. However, the maximum skin reaction occurred 2 weeks earlier for patients within group B (3rd week) compared to group A (5th week). Apart from breast volume, there was no significant correlation between any of the patients or tumor factors and the incidence of acute skin reactions in either group of patients. Patients with large breast volume >1100cc had a higher rate and a longer duration of maximum skin reaction in group A (4 weeks versus 2 weeks in patients with small breast volume