Increasing Diversity of Patients in Radiation Oncology Clinical Trials.

Radiation oncology clinical trials lack full representation of the ethnic and racial diversity present in the general United States and in the cancer patient population. There are low rates of both recruitment and enrollment of individuals from underrepresented ethnic and racial backgrounds, especially Black and Hispanic patients, people with disabilities, and patients from underrepresented sexual and gender groups. Even if approached for enrollment, barriers such as mistrust in medical research stemming from historical abuse and contemporary biased systems, low socioeconomic status, and lack of awareness prohibit historically marginalized populations from participating in clinical trials. In this review, we reflect on these specific barriers and detail approaches to increase diversity of the patient population in radiation oncology clinical trials to better reflect the communities we serve. We hope that implementation of these approaches will increase the diversity of clinical trials patient populations in not only radiation oncology but also other medical specialties.

Post Mastectomy Radiation for Stage II Breast Cancer Patients with T1/T2 Lesions.

OBJECTIVE: Post mastectomy radiation (PMR) is usually recommended for T3 or N2 breast cancer (BC). The role of PMR for stage II BC with T1/T2 lesions remains controversial. The aim of this study was to assess the role of PMR in this subgroup of patients. MATERIALS AND METHODS: A retrospective analysis of a prospectively collected database of all stage II BC patients treated with mastectomy at our institution between the years 2005-2008 was performed. Demographics, disease-free survival rates were compared between the patients receiving radiation vs. those who were not irradiated. RESULTS: Eighty-two patients underwent mastectomies for stage II disease with a T1/T2 lesion. Twenty-two of those (27%) received PMR. Loco regional recurrence (LRR) occurred only in the non -irradiated (NR) group. A Kaplan Meier analysis of time to LRR in the NR group was performed. Mean time to local failure was 78.9 months, 6% at 3 years and 13% at 5 years. The time to LRR was significantly lower in the estrogen receptor (ER) negative group compared to the ER positive group (64 vs. 82 months, p=0.029). LRR free rate at 5 years was 100% in low grade tumors vs. 53% in high grade tumors, (p=0.001). In a Cox regression multivariate analysis none of those factors maintained significance. CONCLUSION: ER negative status, high grade and node negativity were associated with LRR. A prospective trial randomizing stage II BC patients with T1/T2 lesions, negative hormone receptors and high-grade tumors to PMR following mastectomy arm vs. no radiation arm is recommended.

Efficacy and toxicity of chemoradiotherapy with carboplatin and irinotecan followed by consolidation docetaxel for unresectable stage III non-small cell lung cancer.

INTRODUCTION: In 2003, consolidation docetaxel was a promising concept for unresectable stage IIIA/B nonsmall cell lung cancer (NSCLC). To test the hypothesis that chemoradiotherapy with carboplatin and irinotecan followed by consolidation docetaxel would be feasible and clinically active, we conducted a phase II study. METHODS: Thirty-two patients with unresectable stage IIIA/B NSCLC received irinotecan (30 mg/m) and carboplatin dosed to a target area under the concentration curve of 2, each administered weekly for 7 weeks. Concurrent radiotherapy was administered more than 7 weeks to a total dose of 63 Gy in 35 fractions. Consolidation docetaxel (75 mg/m) was administered every 3 weeks for 3 doses 4 weeks after chemoradiotherapy. The primary end point was objective response rate by RECIST. RESULTS: Complete responses occurred in 4 patients and partial responses occurred in 14, for an objective response rate of 56.3% (95% confidence interval [CI], 37.7-73.6%). Median progression-free survival was 6.5 months (95% CI, 4.6-13.5); median duration of survival was 14.8 months (95% CI, 6.9-27.3). The most common hematologic toxicity was leukopenia, which were grade 3 or 4 in 16 patients (50%). Radiation pneumonitis (grade >or=2) occurred in 13 of 31 treated patients (42%). CONCLUSIONS: These findings suggested that concurrent chemoradiotherapy with carboplatin and irinotecan followed by consolidation docetaxel is clinically active based on median survival in patients with unresectable stage III NSCLC; however, the 42% incidence of clinical radiation pneumonitis was unexpected and warrants further investigation to determine the mechanism and preventive strategies.