Purpose Fluorouracil plus cisplatin and radiation twice a day (FCT) is an established chemoradiation (CRT) regimen for selective bladder-sparing treatment of muscle-invasive bladder cancer. Gemcitabine and once daily radiation (GD) is a well-supported alternative. The current trial evaluates these regimens. Methods Patients with cT2-4a muscle-invasive bladder cancer were randomly assigned to FCT or GD. Patients underwent transurethral resection and induction CRT to 40 Gy. Patients who achieved a complete response (CR) received consolidation CRT to 64 Gy and others underwent cystectomy. We administered adjuvant gemcitabine/cisplatin chemotherapy. The primary end point was the rate of freedom from distant metastasis at 3 years (DMF3). The trial was not statistically powered to compare regimens, but to assess whether either regimen exceeded a DMF3 benchmark of 75%. Toxicity and efficacy end points, including CR and bladder-intact distant metastasis free survival at 3 years (BI-DMFS3), were assessed. Results From December 2008 to April 2014, 70 patients were enrolled, of which 66 were eligible for analysis, 33 per arm. Median follow-up was 5.1 years (range, 0.4 to 7.8 years) for eligible living patients. DMF3 was 78% and 84% for FCT and GD, respectively. BI-DMFS3 was 67% and 72%, respectively. Postinduction CR rates were 88% and 78%, respectively. Of 33 patients in the FCT arm, 21 (64%) experienced treatment-related grade 3 and 4 toxicities during protocol treatment, with 18 (55%), two (6%), and two patients (6%) experiencing grade 3 and 4 hematologic, GI, and genitourinary toxicity, respectively. For the 33 patients in the GD arm, these figures were 18 (55%) overall and 14 (42%), three (9%) and two patients (6%), respectively. Conclusion Both regimens demonstrated DMF3 greater than 75%. There were fewer toxicities observed in the GD arm. Either gemcitabine and once daily radiation or a cisplatin-based regimen could serve as a base for future trials of systemic therapy.

This secondary analysis of a randomized clinical trial examines the effect of androgen deprivation therapy (ADT) during radiotherapy in patients who were classified as having either favorable intermediate-risk or unfavorable intermediate-risk prostate cancer.

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The sole benefit of internal mammary area irradiation (IMNI) on treatment outcome is unknown. We examined whether the inclusion of IMNI in regional nodal irradiation improved outcomes in women with node-positive breast cancer. Materials/Methods: KROG 08-06 is a multicenter, prospective, randomized phase 3 trial done at 13 hospitals in South Korea. Patients with pathologically confirmed node-positive breast cancer after breast conservation surgery (BCS) or mastectomy with axillary lymph node dissection were eligible. Patients with distant metastasis or those who had neoadjuvant treatment were excluded. All patients underwent regional nodal irradiation along with breast or chest wall irradiation using 3-dimensional conformal radiotherapy with a total dose of 45−54 Gy and fractional dose of 1.8−2.0 Gy. Patients were stratified according to the type of surgery (BCS or mastectomy) and N stage (N1 or N2, N3) and randomly allocated to either IMNI or no IMNI. The primary endpoint was 7-year disease-free survival (DFS). Secondary endpoints were rates of overall survival, breast cancer-specific survival, and toxicity. Results: Between 2008 and 2013, 747 patients were enrolled, of whom 362 patients in IMNI arm and 373 patients in non-IMNI arm were analyzed. Nearly all patients underwent taxane-based adjuvant systemic treatment. At a median follow-up of 8.4 years, 127 patients had breast cancerrelated events and 89 patients died. At 7 years, the DFS rates were 81.9% in non-IMNI arm and 85.3% in IMNI arm (HR, 0.80; 95% CI, 0.57−1.14; P = .220). Subgroup analyses showed significantly improved DFS and breast cancer mortality in IMNI arm among the patients with medio-centrally located tumors. In this subgroup, the 7-year DFS rates were 81.6% without IMNI versus 91.8% with IMNI (HR, 0.42; 95% CI, 0.22−0.82; P = .010) and the 7-year breast cancer mortality rates were 10.2% versus 4.9% (HR, 0.40; 95% CI, 0.17−0.99; P = .048). There were no differences in adverse effects including cardiac toxicity and radiation pneumonitis between treatment arms. Conclusion: Including IMNI in regional nodal irradiation did not significantly improve DFS for unselected women with node-positive breast cancer. Women with medially or centrally located tumors can be considered for applying IMNI when performing regional nodal irradiation.

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