Scholars@Duke
Michael Roger Harrison

Michael Roger Harrison

Associate Professor of Medicine
Medicine, Medical Oncology

Scholarly Works - Conferences

Real-world early quality of life (QOL) changes on IO-based regimens in the prospective observational ODYSSEY metastatic renal cell carcinoma (mRCC) study.

Conference Journal of Clinical Oncology · March 1, 2026 Lack of standardized reporting and collection of patient-reported outcomes (PROs) limits cross-trial comparisons of first-line IO-based regimens for mRCC. Prospectively collected real world data may fill this important knowledge gap. Pts with stable/improv ... Full text Cite

A randomized phase 2 trial of nivolumab, relatlimab plus ipilimumab vs. nivolumab plus ipilimumab in first-line advanced renal cell carcinoma.

Conference Journal of Clinical Oncology · March 1, 2026 Ipilimumab plus nivolumab (ipi/nivo) is a standard of care for treatment-naïve, metastatic clear cell renal cell carcinoma (ccRCC). While durability of response may be superior to combination therapy with PD-1 inhibitors and agent tyrosine kinase inhibitor ... Full text Cite

Clinical and genomic predictors of sipuleucel-T (sip-T) outcomes in men with metastatic castration-resistant prostate cancer (mCRPC).

Conference Journal of Clinical Oncology · March 1, 2026 228Background: Survival outcomes with sip-T in mCRPC are variable, and mechanisms dri ... Full text Cite

Physician perspectives on the implementability of a cardiovascular risk score for prostate cancer: A PRISM-guided evaluation.

Conference Journal of Clinical Oncology · March 1, 2026 57Background: Cardiovascular disease (CVD) is the leading non-cancer cause of death a ... Full text Cite

Profiling of exceptional responders (ER) and non-responders (NR) to androgen receptor pathway inhibitors (ARPI) in men with metastatic hormone sensitive and castration resistant prostate cancer.

Conference Journal of Clinical Oncology · June 2025 e17107Background: In clinical practicea subset of patients treated with androgen deprivation therapy (ADT) plus an ARPI achie ... Full text Cite

Real-world quality of life (QOL) in patients (pts) with metastatic renal cell carcinoma (mRCC) on active surveillance (AS) in the ODYSSEY prospective observational study.

Conference Journal of Clinical Oncology · June 2025 4553Background: AS is a recognized strategy in select pts with mRCC to maximize QOL and delay potential toxicity of systemic ... Full text Cite

Real-world quality of life (QOL) for patients (pts) with metastatic renal cell carcinoma (mRCC) treated with systemic therapy (ST) in the prospective observational ODYSSEY study.

Conference Journal of Clinical Oncology · June 2025 4558Background: In the past 7 years, 4 immuno-oncology (IO) based combinations have been approved for mRCC. However, QOL data ... Full text Cite

Overall survival outcomes with sipuleucel-T (Sip-T) among Black men with metastatic castrate-resistant prostate cancer (mCRPC) also treated with androgen receptor pathway inhibitors (ARPI).

Conference Journal of Clinical Oncology · June 2025 e17064Background: Analyses of clinical trials data suggest thatBlack men have equal or even improved overall survival (OS) wi ... Full text Cite

Preliminary analysis of baseline characteristics, patient reported outcomes (PROs), and treatment selection in ODYSSEY

Conference Journal of Clinical Oncology · January 1, 2024 Background: Tyrosine kinase inhibitors (TKI) and immuno-oncology (IO) agents alone or in combination have revolutionized the landscape of management for untreated metastatic renal cell carcinoma (mRCC). Baseline quality of life (QOL) outside of interventio ... Full text Cite

Primary analysis of STARTAR: A phase 2 salvage trial of androgen receptor (AR) inhibition with androgen deprivation therapy (ADT) and apalutamide with radiation therapy (RT) followed by docetaxel in men with PSA recurrent prostate cancer (PC) after radical prostatectomy (RP).

Conference Journal of Clinical Oncology · June 1, 2023 5016 Background: ADT with salvage RT improves survival for men with PSA recurrence after RP. For high risk PSA recurrence, current standard ADT duration is up to 2 years with RT; shortening but intensifying systemic therapy may i ... Full text Cite

A prospective trial of apalutamide and abiraterone acetate plus prednisone in Black and White men with metastatic castrate-resistant prostate cancer.

Conference Journal of Clinical Oncology · June 1, 2023 5015 Background: Abi Race was the first prospective parallel cohort study of abiraterone acetate plus prednisone (AAP) in Black and White men with metastatic castrate-resistant prostate cancer (mCRPC) and demonstrated greater pro ... Full text Cite

Effect of neoadjuvant chemotherapy (NAC) on patient preferences for adjuvant treatment in muscle-invasive urothelial carcinoma (MIUC): A multi-country discrete choice experiment (DCE).

Conference Journal of Clinical Oncology · February 20, 2022 454 Background: Patient preference is an important factor in selecting appropriate treatment choices. Although underutilized, the standard of care for MIUC is with NAC, whereas evidence for adjuvant therapy is less clear. With th ... Full text Cite

Five Year Results of Short Course Complete Androgen Blockade With Abiraterone Acetate and LHRH Agonist for Unfavorable Intermediate and Favorable High Risk Prostate Cancer.

Conference International journal of radiation oncology, biology, physics · November 2021 Purpose/objective(s)Androgen deprivation therapy (ADT) and radiotherapy (RT) are synergistic, and the combination results in improved survival outcomes for aggressive prostate cancers. However, long-term ADT carries substantial burden of toxicity ... Full text Cite

Association of baseline neutrophil-to-eosinophil ratio (NER) and neutrophil-to-lymphocyte ratio (NLR) with response to combination immunotherapy (IO) with ipilimumab plus nivolumab (ipi/nivo) in patients with metastatic renal cell carcinoma (mRCC).

Conference Journal of Clinical Oncology · May 20, 2021 4563 Background: Previous reports have shown that the baseline neutrophil-to-lymphocyte ratio (NLR) is associated with prognosis in patients with mRCC. However, NLR has not been shown to reliably predict for response to IO. Retro ... Full text Cite

Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors: An updated analysis of EV-201 Cohort 2.

Conference Journal of Clinical Oncology · May 20, 2021 4524 Background: Cisplatin (cis)-ineligible, platinum-naive patients (pts) with locally advanced or metastatic urothelial carcinoma (la/mUC) who progress on/after anti-PD-1/L1 treatment (tx) have a poor prognosis and few tx optio ... Full text Cite

Interim analysis of STARTAR: A phase II salvage trial of androgen receptor (AR) inhibition with androgen deprivation therapy (ADT) and apalutamide with radiation therapy (RT) followed by docetaxel in men with PSA recurrent prostate cancer (PC) after radical prostatectomy (RP).

Conference Journal of Clinical Oncology · February 20, 2021 90 Background: ADT with salvage RT improves survival for men with PSA recurrence after RP. Current standard duration of ADT for high risk PSA recurrence is up to 2 years with RT; therefore shortening but intensifying systemic the ... Full text Cite

Nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma (nccRCC): Safety and efficacy from CheckMate 920.

Conference Journal of Clinical Oncology · February 20, 2021 309 Background: The long-term efficacy and tolerability of nivolumab (NIVO) 3 mg/kg + ipilimumab (IPI) 1 mg/kg Q3W × 4 doses followed by NIVO 3 mg/kg Q2W for previously untreated advanced RCC (aRCC) demonstrated in the registrati ... Full text Cite

ASSET: Alternative schedule sunitinib in metastatic renal cell carcinoma (RCC)—Cardiopulmonary exercise testing (CPET).

Conference Journal of Clinical Oncology · February 20, 2021 300 Background: Sunitinib (SUN) is a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) approved for treatment of advanced RCC and high risk RCC after nephrectomy. Evidence suggests that a 2 week (wk) on, 1 ... Full text Cite

Phase II study of gemcitabine and split-dose cisplatin plus pembrolizumab as neoadjuvant therapy prior to radical cystectomy (RC) in patients with muscle-invasive bladder cancer (MIBC).

Conference Journal of Clinical Oncology · February 20, 2021 396 Background: Cisplatin-based neoadjuvant chemotherapy is standard of care in MIBC with improved pathologic response and overall survival (OS) compared to RC alone. Pembrolizumab (pembro) is active in high-risk non-muscle invas ... Full text Cite

Safety and efficacy outcomes with nivolumab plus ipilimumab in patients with advanced renal cell carcinoma and low Karnofsky performance status: Results from the CheckMate 920 trial.

Conference Journal of Clinical Oncology · February 20, 2021 315 Background: Combination therapy with nivolumab + ipilimumab (NIVO+IPI) has demonstrated long-term efficacy and tolerability for patients (pts) with previously untreated advanced renal cell carcinoma (aRCC). Most pivotal clini ... Full text Cite

Efficacy of the PD-L1 inhibitor avelumab in neuroendocrine or aggressive variant prostate cancer: Results from a phase II, single-arm study.

Conference Journal of Clinical Oncology · February 20, 2021 89 Background: Men with metastatic neuroendocrine/small cell and aggressive variant prostate cancer (NEPC/AVPC) have poor outcomes despite platinum and taxane chemotherapy. These tumors share common features with small cell lung ... Full text Cite

EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors.

Conference Journal of Clinical Oncology · February 20, 2021 394 Background: Cisplatin (cis)-ineligible, platinum-naive patients (pts) with locally advanced or metastatic urothelial carcinoma (la/mUC) who progress on/after PD-1/L1 inhibitors (PD-1/L1-i) have a poor prognosis and few treatm ... Full text Cite

A phase II Salvage Trial of AR Inhibition with ADT and Apalutamide with Radiation therapy followed by docetaxel in men with PSA recurrent prostate cancer (PC) after radical prostatectomy (STARTAR).

Conference Journal of Clinical Oncology · May 20, 2019 TPS5097 Background: Androgen deprivation combined with salvage external beam radiation therapy (RT) have improved survival for patients (pts) with non-metastatic hormone naïve PC and PSA recurrence after radical prostatectomy (RP ... Full text Cite

Immune checkpoint inhibitor response in tumors with LRP1B variants.

Conference Journal of Clinical Oncology · May 20, 2019 e14291 Background: Low-density lipoprotein receptor-related protein 1B (LRP1B) is a putative tumor suppressor gene spanning > 500 kb on chromosome 2. A melanoma study previously reported enrichment of LRP1B mutations in respon ... Full text Cite

Prevalence of pathogenic germline variants in DNA repair by race, age, and ethnicity in men with prostate cancer.

Conference Journal of Clinical Oncology · May 20, 2019 5062 Background: Patients with advanced prostate cancer (PC) frequently harbor pathogenic or likely pathogenic (P/LP) germline variants (GVs) in mismatch repair (MMR) and homologous repair (HR) enzymes which have clinical and tre ... Full text Cite

Evaluation of the patient-reported outcomes common terminology criteria for adverse events (PRO-CTCAE) with abiraterone acetate plus prednisone (AAP), degarelix (D), or the combination in men with biochemically recurrent prostate cancer (BCRPC).

Conference Journal of Clinical Oncology · May 20, 2019 5080 Background: Patient-reported symptoms using the PRO-CTCAE provide insights into the patient experience with care. Earlier use of AAP (an androgen biosynthesis inhibitor plus prednisone) with androgen deprivation therapy in c ... Full text Cite

CheckMate 214 post-hoc analyses of nivolumab plus ipilimumab or sunitinib in IMDC intermediate/poor-risk patients with previously untreated advanced renal cell carcinoma with sarcomatoid features.

Conference Journal of Clinical Oncology · May 20, 2019 4513 Background: Patients (pts) with advanced renal cell carcinoma with sarcomatoid features (sRCC) have poor prognosis and suboptimal outcomes with anti-VEGF targeted therapy. Nivolumab plus ipilimumab (N+I) demonstrated superio ... Full text Cite

Multidimensional flow characterization of circulating immune cells in cisplatin-resistant metastatic urothelial cancer (mUC) patients (pts) treated with pembrolizumab (P) with or without acalabrutinib (acala).

Conference Journal of Clinical Oncology · March 1, 2019 357 Background: Immunotherapy checkpoint inhibitors (ICIs) are now standard treatments (txs) in mUC, with response rates ranging 15-25%. A phase 2 randomized study (NCT02351739) treated 75 pts with mUC with either P or PA. We pro ... Full text Cite

Pembrolizumab in men with heavily treated metastatic castration-resistant prostate cancer (mCRPC).

Conference Journal of Clinical Oncology · March 1, 2019 172 Background: Pembrolizumab is approved for patients with metastatic, microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors who have progressed on prior therapy and have no satisfactory treatm ... Full text Cite

PEAX: Men with metastatic castrate-resistant prostate cancer (mCRPC) treated with either sipuleucel-T (SIP-T), enzalutamide (ENZA) or abiraterone acetate (ABI) undergoing cardiopulmonary exercise testing (CPET).

Conference Journal of Clinical Oncology · March 1, 2019 281 Background: Both ENZA and ABI are associated with significant toxicity to the cardiovascular-musculoskeletal system and physical side effects. However whether they cause a decline in cardiorespiratory fitness (CRF), as conven ... Full text Cite

Phase II trial enzalutamide and androgen deprivation therapy (ADT) with salvage radiation in men with high-risk PSA recurrent prostate cancer (PC): The STREAM trial.

Conference Journal of Clinical Oncology · March 1, 2019 29 Background: Salvage external beam radiotherapy (RT) and hormonal therapy improves survival over RT alone in men with non-metastatic hormone naïve PC and PSA recurrence after radical prostatectomy (RP). We investigated the safe ... Full text Cite

Treatment-free survival (TFS) after discontinuation of first-line nivolumab (NIVO) plus ipilimumab (IPI) or sunitinib (SUN) in intention-to-treat (ITT) and IMDC favorable-risk patients (pts) with advanced renal cell carcinoma (aRCC) from CheckMate 214.

Conference Journal of Clinical Oncology · March 1, 2019 564 Background: TFS characterizes the antitumor activity of immuno-oncology agents after treatment discontinuation. In CheckMate 214, pts with IMDC intermediate/poor-risk aRCC who discontinued first-line NIVO+IPI experienced sign ... Full text Cite

Androgen deprivation therapy (ADT) and cardiovascular mortality (CVD) in men with early-stage prostate cancer (PC) receiving curative radiation therapy (RT).

Conference Journal of Clinical Oncology · March 1, 2018 127 Background: Combined with RT, ADT is a highly effective and utilized treatment for men with localized PC, but some studies suggest that use of ADT leads to increased CVD. We explored the association between ADT and CVD in men ... Full text Cite

Phase II trial of 6 months ADT/abiraterone acetate plus prednisone (AAP) and definitive radiotherapy (AbiRT) for men with intermediate to high risk localized prostate cancer.

Conference Journal of Clinical Oncology · February 20, 2018 11 Background: Combined external beam radiotherapy (RT) and androgen deprivation therapy (ADT) improves survival over RT alone for high risk prostate cancer (PC). Long-term ADT use, currently recommended for high risk PC, also in ... Full text Cite

Association of neuroendocrine phenotype with platinum chemotherapy outcomes in men with metastatic prostate cancer.

Conference Journal of Clinical Oncology · May 20, 2017 e16532 Background: DNA repair defects are common in men with mCRPC, and platinum chemotherapy may have a role in selected patients. We aimed to determine whether neuroendocrine variant prostate cancer (NEPC) is associated with a ... Full text Cite

Phase Ib Trial of Cabazitaxel and Tasquinimod in Men With Heavily Pretreated Metastatic Castration Resistant Prostate Cancer (mCRPC): The CATCH Trial.

Conference Prostate · March 2017 BACKGROUND: Tasquinimod is an immunomodulating and anti-antiangiogenic oral agent with anti-prostate cancer activity in preclinical studies and in clinical trials of men with metastatic castration resistant prostate cancer (mCRPC), including single agent a ... Full text Link to item Cite

Phase Ib trial of docetaxel, prednisone, and pazopanib, in men with metastatic castration resistant prostate cancer (mCRPC).

Conference Journal of Clinical Oncology · January 10, 2016 275 Background: Docetaxel prednisone (DP) is a standard of care for men with metastatic castrate resistant prostate cancer (mCRPC) with median progression-free survival (PFS) of 4-6 months and overall survival (OS) of 19 months, ... Full text Cite

Physician treatment selection in the prospective Metastatic Renal Cell Cancer (MaRCC) Registry.

Conference Journal of Clinical Oncology · January 10, 2016 563 Background: Clinical trials mRCC pts are different from real world pts, resulting in bias in the literature. The MaRCC Registry is designed to survey questions not asked in tri als, such as why physicians make certain managem ... Full text Cite

Front-line management patterns in the prospective metastatic renal cell cancer (MaRCC) registry.

Conference Journal of Clinical Oncology · January 10, 2016 617 Background: Over the past decade, seven agents were approved for metastatic renal cell carcinoma (mRCC) leading to a rapidly evolving clinical landscape. Clinical trials addressing treatment efficacy, sequencing, and other qu ... Full text Cite