Heidi Penttinen

Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments

Objective: The study aimed at investigating the quality of life (QoL) and physical performance and activity, and their interrelations, in Finnish female breast cancer patients shortly after adjuvant treatments.

Recruitment of breast cancer survivors into a 12-month supervised exercise intervention is feasible

BACKGROUND The BREX study is one of the largest randomised prospective exercise interventions of breast cancer survivors which aims at investigate whether regular exercise could reduce the long-term side effects of the adjuvant treatments and improve quality of life. MATERIAL AND METHODS The study was limited to consider patients aged 35-68 years, who had recently completed adjuvant chemotherapy or started endocrine therapy. In this paper, we describe the recruitment process of the 413 randomised patients from the Helsinki University Hospital between September 2005 and September 2007. RESULTS 768 potentially eligible patients out of the 1321 screened (via medical records) were contacted by phone. After the phone call 240 patients were excluded due to health problems that contraindicated exercise training. The most common health problems were musculoskeletal disorders. A total of 528 patients were considered as eligible for the intervention. Ultimately 413 of them agreed to participate resulting in a 53.8% recruitment rate of the potentially eligible patients. The most important reasons for declining were social, not health related. Eligible patients who did not want to participate did not differ significantly from those who participated according to age, health status, breast cancer treatment and tumour type. DISCUSSION The high recruitment rate demonstrates breast cancer patients willingness to participate even in long-lasting supervised exercise programs shortly after adjuvant treatments. After taking into account the selection of the population by age and musculoskeletal health, the results of the present intervention can be generalized to represent urban breast cancer patient population in Finland.

Pharmacokinetics, Antitumor Activity, and Safety of ODM-201 in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: An Open-label Phase 1 Study

BACKGROUND ODM-201 is a novel second-generation androgen receptor inhibitor for the treatment of metastatic castration-resistant prostate cancer (mCRPC). OBJECTIVE To evaluate the pharmacokinetics of ODM-201 tablet products and preliminary long-term safety, tolerability, and antitumor activity of ODM-201 in chemotherapy-naive men with mCRPC. DESIGN, SETTING, AND PARTICIPANTS Thirty patients were enrolled in this open-label phase 1 trial. Patients received a single 600-mg dose of ODM-201 in capsules with food and one 600-mg dose of ODM-201 tablet product (TabA or TabB) with food and in the fasted state in a random order. In the extension, patients received 600mg twice daily ODM-201 taken with food in capsules. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS We analyzed the pharmacokinetics of ODM-201 tablet formulations. Safety and tolerability were assessed until disease progression or an intolerable adverse event (AE). Antitumor activity was assessed by prostate-specific antigen (PSA) levels and imaging. RESULTS AND LIMITATIONS The capsule:TabA ratio of area under the concentration-time curve from time zero to the last sample at 48h was 1.06 (90% confidence interval [CI], 0.91-1.24); the capsule:TabB ratio was 0.97 (90% CI, 0.82-1.14). At week 12, 25 of 30 patients (83%) had a PSA response (≥50% reduction from baseline). Median time to radiographic progression was 66 wk (95% CI, 41-79). Most common AEs were fatigue (n=4 [13%]) and nausea (n=4 [13%]). CONCLUSIONS The study showed that the tablet formulation of ODM-201 had similar pharmacokinetics compared with the capsule. Treatment with a 600-mg twice daily dose of ODM-201 provided anticancer activity and was well tolerated in men with chemotherapy-naive mCRPC. PATIENT SUMMARY The findings of this study showed that ODM-201 is well tolerated and provided antitumor activity in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (mCRPC) and that the 300-mg tablet formulation can be used in further clinical studies. A phase 3 trial with ODM-201 600mg twice daily in patients with non-mCRPC is ongoing.