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BACKGROUND To determine the safety and maximum-tolerated dose of concurrent sunitinib and image-guided radiotherapy (IGRT) followed by maintenance sunitinib in oligometastastic patients. METHODS: Eligible patients had 1 to 5 sites of metastatic cancer measuring ≤6 cm. The most common treatment sites were bone, liver, and lung. Patients were treated with concurrent sunitinib (Day 1 through Day 28) and IGRT (40-50 Gy in 10 fractions starting on Day 8) followed by maintenance sunitinib (50 mg daily, 4 weeks on/2 weeks off starting on Day 43). The starting dose was sunitinib 25 mg and IGRT 40 Gy. Doses were escalated in a ping-pong design with incremental increases in either sunitinib or IGRT. RESULTS: Twenty-one patients with 36 metastatic lesions were enrolled, with a median follow-up of 10 months. No dose limiting toxicities (DLT) were noted at dose levels 1 or 2 (SU 37.5 mg/RT 40 Gy). One of 10 patients at dose level 3 (SU 37.5 mg/RT 50 Gy) and 2 of 5 patients at dose level 4 (SU 50 mg/RT 50 Gy) experienced DLTs comprising grade 4 myelosuppression and grade 3 nausea. At last follow-up, 8 patients are alive without evidence of progression. The 1-year local, progression-free, and overall survival were 85%, 44%, and 75%, respectively. CONCLUSIONS: Addition of SU (25 to 37.5 mg) to IGRT is tolerable in patients with oligome-tastases, without potentiation of RT toxicity. On the basis of promising antitumor responses observed with this novel combination, a multi-institutional phase 2 trial using SU 37.5 mg/RT 50 Gy is ongoing.

BackgroundProstate cancer is the most common cancer affecting men in the United States. Management options for localized disease exist, yet an evidence-based criterion standard for treatment still has to emerge. Although 5-year survival rates approach 98%, all treatment options carry the possibility for significant side effects, such as erectile dysfunction and urinary incontinence. It is therefore recommended that patients be actively involved in the treatment decision process. We have developed an Internet/CD-ROM-based multimedia Prostate Interactive Educational System (PIES) to enhance patients’ treatment decision making. PIES virtually mirrors a health center to provide patients with information about prostate cancer and its treatment through an intuitive interface, using videos, animations, graphics, and texts.Objectives(1) To examine the acceptability and feasibility of the PIES intervention and to report preliminary outcomes of the program in a pilot trial among patients with a new prostate cancer diagnosis, and (2) to explore the potential impact of tailoring PIES treatment information to participants’ information-seeking styles on study outcomes.MethodsParticipants (n = 72) were patients with newly diagnosed localized prostate cancer who had not made a treatment decision. Patients were randomly assigned to 3 experimental conditions: (1) control condition (providing information through standard National Cancer Institute brochures; 26%), and PIES (2) with tailoring (43%) and (3) without tailoring to a patient’s information-seeking style (31%). Questionnaires were administrated before (t1) and immediately after the intervention (t2). Measurements include evaluation and acceptability of the PIES intervention, monitoring/blunting information-seeking style, psychological distress, and decision-related variables (eg, decisional confidence, feeling informed about prostate cancer and treatment, and treatment preference).ResultsThe PIES program was well accepted by patients and did not interfere with the clinical routine. About 79% of eligible patients (72/91) completed the pre- and post-PIES intervention assessments. Patients in the PIES groups compared with those in the control condition were significantly more likely to report higher levels of confidence in their treatment choices, higher levels of helpfulness of the information they received in making a treatment decision, and that the information they received was emotionally reassuring. Patients in the PIES groups compared with those in the control condition were significantly less likely to need more information about treatment options, were less anxious about their treatment choices, and thought the information they received was clear (P < .05). Tailoring PIES information to information-seeking style was not related to decision-making variables.ConclusionsThis pilot study confirms that the implementation of PIES within a clinical practice is feasible and acceptable to patients with a recent diagnosis of prostate cancer. PIES improved key decision-making pr...

Purpose Several small studies have indicated that the ATM rs1801516 SNP is associated with risk of normal tissue toxicity after radiotherapy. However, the findings have not been consistent. In order to test this SNP in a well-powered study, an individual patient data meta-analysis was carried out by the International Radiogenomics Consortium. Materials and methods The analysis included 5456 patients from 17 different cohorts. 2759 patients were given radiotherapy for breast cancer and 2697 for prostate cancer. Eight toxicity scores (overall toxicity, acute toxicity, late toxicity, acute skin toxicity, acute rectal toxicity, telangiectasia, fibrosis and late rectal toxicity) were analyzed. Adjustments were made for treatment and patient related factors with potential impact on the risk of toxicity. Results For all endpoints except late rectal toxicity, a significantly increased risk of toxicity was found for carriers of the minor (Asn) allele with odds ratios of approximately 1.5 for acute toxicity and 1.2 for late toxicity. The results were consistent with a co-dominant pattern of inheritance. Conclusion This study convincingly showed a significant association between the ATM rs1801516 Asn allele and increased risk of radiation-induced normal tissue toxicity.

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BACKGROUND. Although adjuvant radiotherapy (RT) is often recommended for locally advanced squamous cell carcinoma of the head and neck (HNSCC), its effect on overall or cancer‐specific survival has not been clearly demonstrated. In the current study, the frequency and effect of adjuvant RT on overall survival was investigated in patients with resected lymph node‐positive head and neck cancer. METHODS. Within the Surveillance, Epidemiology, and End Results (SEER) database, patients were selected with lymph node‐positive HNSCC (American Joint Committee on Cancer and SEER stage 3/4) who were treated either with surgery alone or surgery and RT and were diagnosed between 1988 and 2001. A total of 8795 patients who met the inclusion criteria for analysis comprised the study population, with a median follow‐up of 4.3 years for patients still alive at the time of last follow‒up. RESULTS. Adjuvant RT was utilized in 84% of patients. Adjuvant RT improved the 5‐year overall survival (43.2% [95% confidence interval (95% CI), 41.9–44.4%] for surgery + RT vs 33.4% [95% CI, 30.7–36.0%] for surgery alone; P < .001) and cancer‐specific survival (50.9% for surgery + RT vs 42.1% for surgery) on univariate analysis. On multivariate analysis, adjuvant RT (hazards ratio [HR] of 0.78; 95% CI, 0.71–0.86 [P < .001]) remained a significant predictor of improved survival. The significant benefit of radiation on overall survival was noted for lymph node‐positive patients with both primary tumors localized to the involved organ (HR of 0.81; 95% CI, 0.71–0.94 [P = .007]) and more locally invasive primary tumors (HR of 0.77; 95% CI, 0.68–0.87 [P < .001]). CONCLUSIONS. In what to the authors' knowledge is the largest reported analysis of adjuvant RT in patients with locally advanced HNSCC published to date, adjuvant RT resulted in an approximately 10% absolute increase in 5‐year cancer‐specific survival and overall survival for patients with lymph node‐positive HNSCC compared with surgery alone. Despite combined surgery and adjuvant RT, outcomes in this high‐risk population remain suboptimal, emphasizing the need for continued investigation of innovative treatment approaches. Cancer 2008. © 2007 American Cancer Society.

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