Joseph D. Ruether

A population-based study examining the impact of a multidisciplinary rapid access clinic on utilization of initial treatment options for patients with localized prostate cancer.

15 Background: Treatment decisions in localized prostate cancer (LPCa) are complicated by the variety of available options. A rapid access cancer clinic (RAC) has been unique to Calgary, Alberta (AB) since 2007. RAC offers multidisciplinary prostate cancer care by a urologist, medical oncologist, and radiation oncologist. It is hypothesized that treatment utilization data from decisions taken at RAC may serve to benchmark the appropriateness of treatment decisions on a population level. OBJECTIVES To compare utilization rates for initial treatment of LPCa between AB and RAC. METHODS Records of patients with clinically LPCa in AB between 2007-9 were reviewed with ethics approval. Records were linked to the AB cancer registry database. Clinical, treatment and health services characteristics pertaining to patients attending RAC were compared to those managed elsewhere in AB. The primary endpoints were utilization rates by initial treatment; prostatectomy (P), radiotherapy (RT), hormone therapy (H), active surveillance (A). A logistics regression model was constructed to examine the influence of RAC on initial treatment decisions, while controlling for interactions and factors of interest. RESULTS 2,660 patients were diagnosed with LPCa. 375 presented to RAC. Utilization rates among RAC patients: P-60.3% (95%CI: 55.3-65.2), A-16%(12.3-19.7), RT-11.7%(8.5-15.0) and H-8.0%(CI:5.2-10.8). This compares to AB rates of P-47.2%(45.9-48.3), A-6.1%(15.2-17.0), RT-18.8%(17.9-19.7), and H-14.5%(13.6-15.4). On multivariate analysis, RAC was associated with a trend towards receiving RT (OR 1.6, p=0.097). CONCLUSIONS A specialized clinic for LPCa may be associated with a higher likelihood of receiving radiotherapy as initial treatment compared to the prostate cancer population in Alberta.

Results of a phase II study of sunitinib (SU) maintenance after response to docetaxel in metastatic castration-resistant prostate cancer (mCRPC).

153 Background: Docetaxel (D) remains the standard first cytotoxic therapy in mCRPC. Given its mechanism of action, acceptable toxicity profile and simple administration, SU had potential as maintenance therapy for mCRPC. In this multicenter study, we evaluated the tolerability and efficacy of SU monotherapy in patients (pts) with mCRPC who have responded to D. METHODS Pts withmCRPC and responding/stable disease at the time of D completion were enrolled in this multicentre trial. Pts received 50mg of SU daily on 4/2 week on/off cycles. The primary endpoint was progression-free survival (PFS), defined on the basis of RECIST criteria and worsening disease-related symptoms requiring further therapy. Because the effect of SU on PSA is not well known, PSA progression alone was not considered disease progression. PFS of 180 days was considered to be a clinically meaningful threshold for recommending further study of SU. PSA response was a secondary endpoint. The threshold for PSA-progression (PSA-P) was defined as a 25% increase in PSA over baseline. RESULTS Twenty-three pts were enrolled and treated. Mean age was 66.5 years (48-78). ECOG scores of 0, 1, and 2 were reported for 9, 13 and 1 pts respectively. Mean number of prior cycles of D was 8.6 (4-12). A total of 92 cycles of SU were administered; a mean of 4 per pt (1-11). Mean follow-up was 5.4 months (0.6-15). A total of 479 adverse events (AE) were recorded, of which 88% were Grade 1-2 and 12% were Grade 3-4. The AE were of a type and severity expected for SU. Three Grade 4s occurred, consisting of hepatitis, myelosuppression, and pneumonia. Median PFS was 133 days (95% CI: 48-154). Most pts had immediate PSA increases without evidence of disease progression, with the mean increases in PSA over baseline being 197%, 342%, and 1437% in Cycles 1, 2, and 3, respectively (p<0.05). CONCLUSIONS Although SU was well tolerated as maintenance therapy with predictable side-effects, median PFS was lower than the predefined threshold of 180 days. PSA values were not informative as significant increases were observed as early as Cycle 2. This agent is not considered worthy of further investigation in this setting of maintenance therapy. CLINICAL TRIAL INFORMATION NCT00550810.

A randomized phase II study of pelareorep and docetaxel or docetaxel alone in men with metastatic castration resistant prostate cancer: CCTG study IND 209

Background Pelareorep is an oncolytic virus with activity in many cancers including prostate. It has in vitro synergism with microtubule-targeted agents. We undertook a clinical trial evaluating pelareorep in mCRPC patients receiving docetaxel. Patients and Methods In this randomized, open-label phase II study, patients received docetaxel 75mg/m2 on day 1 of a 21-day cycle and prednisone 5mg twice daily, in combination with pelareorep (arm A) or alone (arm B). The primary endpoint was 12 weeks lack of disease progression rate (LPD). Results Eighty-five pts were randomized. Median age was 69, ECOG performance status was 0/1/2 in 31%/66%/3% of patients. Bone/regional lymph node/liver metastases were present in 98%/24%/6%. The median prognostic score was slightly higher in Arm A (144 vs. 129 p= 0.005). Adverse events were as expected but more prevalent in arm A. The 12-week LPD rate was 61% and 52.4% in arms A/B (p=0.51). Median survival was 19.1 on Arm A and 21.1 months on Arm B (HR 1.83; 95% CI 0.96 to 3.52; p=0.06). No survival benefit of pelareorep was found. Conclusion Pelareorep with docetaxel was tolerable with comparable LPD in both arms but response and survival were inferior and so this combination does not merit further study.

Exploring correlates of quality of life in older family caregivers to cancer patients.

186 Background: Family caregivers (FCs) have negative impacts to their physical and emotional health, and poorer quality of life (QoL) compared to non-caregivers. Most research on FCs has included heterogeneous samples, therefore little is known about specific groups such as older (age 60+) FCs. Older persons are at increased risk for health problems, may have co-morbidities, and be socially isolated. Understanding factors related to QoL may lead to interventions targeted to older FCs. The purpose of this study was to examine factors associated with QoL in older FCs to cancer patients. METHODS The data for this study are from a larger survey of FCs aged 60+, recruited from a hospital-based cancer facility. FCs were included if their care recipient had breast, prostate or colorectal cancer. QoL was measured using the MOSF-36. Analyses using descriptive statistics and Pearsons correlations were conducted. RESULTS n = 168 participants consented, with n = 129 surveys returned. The majority of participants were female (60.5 %), 70 yrs old (sd 7.4), had at least a college diploma (65.2 %), were spouses of the patient 92.2%, and retired (60.5%). Mean caregiving hours per week was 24.2 (sd 26.3). Mean time as a caregiver was 31 months (45.9). The majority of patients were on treatment (75.2%) and were 71.3 yrs old (sd 7.5). The Physical Component Summary (PCS) of the MOSF-36 was significantly correlated with gender r = -.24, social support r = .25, sleep quality r = -.47, depression r = -.51, state anxiety r = -.40, and trait anxiety r = -.45 (all ps < .01). There were significant correlations between the Mental Component Summary (MCS) and social support r = .40, sleep quality r = -.40, depression r = -.77, gender r = -.25, state anxiety r = -.72, and trait anxiety r = -.71 (all ps < .01). The MCS was correlated with caregiving hours, r = -.197 (p < .05), however, not with patient treatment status. The PCS was not correlated with caregiving hours or patient treatment status. CONCLUSIONS Consistent with previous FC research across different diseases, QoL was associated with gender, caregiving hours per week, social support, sleep quality, depression, and anxiety. Interventions for older FCs of cancer patients could be targeted to specific factors of overall QoL.

Promoting consultation recording practice in oncology: Identification of critical implementation factors and determination of patient benefit.

155 Background: The objectives of this implementation study were to 1) identify and address the evidentiary, contextual, and facilitative mechanisms that serve to retard or promote the transfer and uptake of consultation recording use in oncology practice, and 2) follow patients during the first few days following receipt of the consultation recording to document, from the patients perspective, the benefits realized from listening to the recording. METHODS Nine medical and 9 radiation oncologists from cancer centers in three Canadian cities (Calgary, Vancouver, Winnipeg) recorded their primary treatment consultations for 228 patients newly diagnosed with prostate or breast cancer. The Digital Recording Use Semi-Structured Interview (DRUSSI) was conducted at two days post-consultation and at 1-week post-consultation. Each oncologist was given a feedback letter summarizing the consultation recording benefits reported by their patients. RESULTS Sixty-nine percent of patients listened to at least a portion of the recording within the first week following the consultation. Consultation recording favourableness ratings were high: 93.6% rated the intervention between 75-100 on a 100-point scale. Four main areas of benefit were reported: 1) Anxiety reduction; 2) Enhanced retention of information; 3) Better informed decision making; and 4) Improved communication with family members. Eight fundamental components of successful transfer and uptake of consultation recording practice were identified. CONCLUSIONS Implementation research and additional randomized trials are needed to facilitate the transfer and uptake of consultation recording use so that far more patients and significant others may realize the associated benefits.