Patterns of response with talimogene laherparepvec in combination with ipilimumab or ipilimumab alone in metastatic unresectable melanoma.

Talimogene laherparepvec (T-VEC) has demonstrated efficacy for unresectable melanoma. We explored response patterns from a phase 2 study evaluating patients with unresectable stage IIIB-IVM1c malignant melanoma who received T-VEC plus ipilimumab or ipilimumab alone. Patients with objective response per modified irRC were evaluated for pseudo-progression (single ≥25% increase in tumour burden before response). Patients without pseudo-progression were classified by whether they responded within or after 6 months of treatment start; those with pseudo-progression were classified by whether pseudo-progression was due to increase in existing lesions or development of new lesions. Overall, 39% (n = 38/98) in the combination arm and 18% (n = 18/100) in the ipilimumab arm had an objective response. Eight responders (combination, n = 7 [18.4%]; ipilimumab, n = 1 [5.6%]) had pseudo-progression; most occurred by week 12 and were caused by an increase in existing lesions. These data reinforce use of T-VEC through initial progression when combined with checkpoint inhibitors.Trial Registration NCT01740297 (ClinicalTrials.gov; date of registration, December 4, 2012); 2012-000307-32 (ClinicalTrialsRegister.eu; date of registration, May 13, 2014).

Medical Knowledge Assessment by Hematology and Medical Oncology In-Training Examinations Are Better Than Program Director Assessments at Predicting Subspecialty Certification Examination Performance.

The Accreditation Council for Graduate Medical Education's Next Accreditation System requires training programs to demonstrate that fellows are achieving competence in medical knowledge (MK), as part of a global assessment of clinical competency. Passing American Board of Internal Medicine (ABIM) certification examinations is recognized as a metric of MK competency. This study examines several in-training MK assessment approaches and their ability to predict performance on the ABIM Hematology or Medical Oncology Certification Examinations. Results of a Hematology In-Service Examination (ISE) and an Oncology In-Training Examination (ITE), program director (PD) ratings, demographic variables, United States Medical Licensing Examination (USMLE), and ABIM Internal Medicine (IM) Certification Examination were compared. Stepwise multiple regression and logistic regression analyses evaluated these assessment approaches as predictors of performance on the Hematology or Medical Oncology Certification Examinations. Hematology ISE scores were the strongest predictor of Hematology Certification Examination scores (ß = 0.41) (passing odds ratio [OR], 1.012; 95 % confidence interval [CI], 1.008-1.015), and the Oncology ITE scores were the strongest predictor of Medical Oncology Certification Examination scores (ß = 0.45) (passing OR, 1.013; 95 % CI, 1.011-1.016). PD rating of MK was the weakest predictor of Medical Oncology Certification Examination scores (ß = 0.07) and was not significantly predictive of Hematology Certification Examination scores. Hematology and Oncology ITEs are better predictors of certification examination performance than PD ratings of MK, reinforcing the effectiveness of ITEs for competency-based assessment of MK.

Pre-Post Evaluation of Collaborative Oncology Palliative Care for Patients With Stage IV Cancer.

CONTEXT: The Collaborative Care Model improves care processes and outcomes but has never been tested for palliative care. OBJECTIVES: To develop and evaluate a model of collaborative oncology palliative care for Stage IV cancer. METHODS: We conducted a pre-post evaluation of Collaborative Oncology Palliative Care (CO-Pal), enrolling patients with Stage IV lung, breast or genitourinary cancers and acute illness hospitalization. CO-Pal has 4 components: 1) oncologist communication skills training; 2) patient tracking; 3) palliative care needs assessment; and 4) care coordination stratified by high vs. low palliative care need. Health record reviews from hospital admission through 60 days provided data on outcomes - goals-of-care discussions (primary outcome), advance care planning, symptom treatment, specialty palliative care and hospice use, and hospital transfers. RESULTS: We enrolled 256 patients (n = 114 pre and n = 142 post-intervention); 60-day mortality was 32%. Comparing patients pre vs post-intervention, CO-Pal did not increase overall goals-of-care discussions, but did increase advance care planning (48% vs 63%, P = 0.021) and hospice use (19% vs 31%, P = 0.034). CO-Pal did not impact symptom treatment, overall treatment plans, or 60-day hospital transfers. During the intervention phase, high-need vs low-need patients had more goals-of-care discussions (60% vs. 15%, P < 0.001) and more use of specialty palliative care (64% vs 22%, P < 0.001) and hospice (44% vs 16%, P < 0.001). CONCLUSION: Collaborative oncology palliative care is efficient and feasible. While it did not increase overall goals-of-care discussions, it was effective to increase overall advance care planning and hospice use for patients with Stage IV cancer.

Development of an Art of Oncology Curriculum to Mitigate Burnout and Foster Solidarity Among Hematology/Oncology Fellows.

PURPOSE: Oncologists and fellows in hematology/oncology (HO) training programs report high levels of burnout. The Accreditation Council for Graduate Medical Education requires accredited programs to have a mechanism to foster well-being among fellows. METHODS: Through an iterative process involving a multidisciplinary committee, we created a 3-year longitudinal Art of Oncology (AOO) curriculum intended to address burnout and foster solidary among HO fellows. Sessions used narratives to promote the formation of a shared mental model through discussion of the mutual experience of caring for patients with cancer. We tested the feasibility, acceptability, and initial effectiveness of implementing the curriculum into traditional didactic lectures as a pilot intervention from 2018 to 2019. Eight sessions were completed. RESULTS: Sixteen fellows participated. Most were married (63%) and planned on pursuing careers in academic medicine (75%). The sample was racially and ethnically diverse (31% minority representation). Thirty-eight percent of fellows reported burnout symptoms. AOO sessions had higher attendance than didactic lectures (P = .04). Of 14 fellows who completed all follow-up assessments (87.5% response rate), 93% (13 of 14 fellows) felt the sessions were very or somewhat helpful and that sessions improved solidarity. Preparedness in managing work-life balance significantly improved (paired t test, mean difference, 0.53; P = .04). Measured levels of burnout did not significantly improve from baseline (mean difference, -0.133; P = .67). Work-life balance was associated with burnout on multivariable analysis (coefficient, 0.40; P = .03). CONCLUSION: The implementation of a dedicated AOO curriculum is feasible and viewed as helpful by HO fellows. Larger studies are needed to assess the efficacy of this curricular intervention.