Real-world benefit of nivolumab in a Canadian non-small-cell lung cancer cohort.

Background: Nivolumab was the first immuno-oncology agent available for the treatment of lung cancer in Canada. In the present study, we evaluated the real-world benefit of nivolumab in Canadian patients with lung cancer. Methods: Patients included in the cohort were identified from a registry of patients treated through expanded access to nivolumab before and after Health Canada approval. Demographics were collected from the application forms. Outcome data for the duration of treatment and survival were collected retrospectively. Results: In contrast to the randomized clinical trial populations, our study cohort included patients who were older (median age: 66 years; range: 36-92 years) and who had an Eastern Cooperative Oncology Group performance status of 2 (8.9%). Despite the poorer-prognosis cohort, median overall survival was 12.0 months, which is comparable to the survival demonstrated in the randomized phase iii trials of nivolumab in lung cancer. Median time to treatment discontinuation was 3.45 months and was similar for all patient subgroups, including poorer-prognosis groups such as those with a performance status of 2, those 75 years of age and older, and those with brain metastases. Conclusions: Nivolumab given in a real-world clinical setting was associated with results similar to those reported in the phase iii clinical trial setting.

Continuity clinics in oncology training programs in Canada.

PURPOSE: Continuity clinics (ccs) give trainees an opportunity for longitudinal follow-up of a patient cohort. Trainees can function in a semi-autonomous manner and prepare for independent practice. Data about such clinics in Canada are limited. Our objective was to assess the utility of ccs in Canadian oncology training programs. METHODS: Surveys were developed by the authors for medical and radiation oncology program directors (pds) and trainees, to assess the utility of ccs in Canadian oncology training programs.oncology patients, to assess their attitudes toward ccs. The pds were contacted by e-mail, using the Web site of the Canadian Resident Matching Service; the trainees were contacted by e-mail through the pds and their administrative assistants. Surveys were distributed electronically using SurveyMonkey. Patients were approached by staff oncologists during follow-up visits at The Ottawa Hospital Cancer Centre. RESULTS: Completed surveys were received from 33% of trainees and 63% of pds contacted; patient surveys were completed by 95 patients. Participation in a cc was reported by 47% of responding pds and 37% of responding trainees. Among respondents, 80% rated the ccs as "important" or "very important" to training. The biggest challenge identified by trainees and pds was lack of clinic space. Most pds (57%) and trainees (59%) felt that the staff oncologist should review the patient only if the trainee has concerns, but only 37% of patients shared that view (p = 0.0002). However, many patients expressed the desire to participate in trainee education. CONCLUSIONS: Continuity clinics are considered beneficial by pds and trainees. Patients desire more trainee supervision than the trainees themselves and the pds do, a factor that should be considered when implementing a cc.

Progression-free survival as a clinical trial endpoint in advanced renal cell carcinoma.

Traditionally, overall survival (os) has been considered the "gold standard" for evaluating new systemic oncologic therapies, because death is easy to define, is easily compared across disease sites, and is not subject to investigator bias. However, as the available options for continuing therapy increase, the use of os as a clinical trial endpoint has become problematic because of the increasing crossover and contamination of trials. As a result, the approval of promising new therapies may be delayed.Many clinicians believe that progression-free survival (pfs) is a more viable option for evaluating new therapies in metastatic and advanced renal cell carcinoma. As with all endpoints, pfs has inherent biases, and those biases must be addressed to ensure that trial results are not compromised and that they will be accepted by regulatory authorities. In this paper, we examine the issues surrounding the use of pfs as a clinical trial endpoint, and we suggest solutions to ensure that data integrity is maintained.