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2. Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials

Author

Rediti, Mattia, Fernandez-Martinez, Aranzazu, Venet, David, Rothé, Françoise, Hoadley, Katherine A., Parker, Joel S., Singh, Baljit, Campbell, Jordan D., Ballman, Karla V., Hillman, David W., Winer, Eric P., El-Abed, Sarra, Piccart, Martine, Di Cosimo, Serena, Symmans, William Fraser, Krop, Ian E., Salgado, Roberto, Loi, Sherene, Pusztai, Lajos, Perou, Charles M., Carey, Lisa A., and Sotiriou, Christos

Published
2023
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3. Distinct spatial immune microlandscapes are independently associated with outcomes in triple-negative breast cancer

Author

Carter, Jodi M., Chumsri, Saranya, Hinerfeld, Douglas A., Ma, Yaohua, Wang, Xue, Zahrieh, David, Hillman, David W., Tenner, Kathleen S., Kachergus, Jennifer M., Brauer, Heather Ann, Warren, Sarah E., Henderson, David, Shi, Ji, Liu, Yi, Joensuu, Heikki, Lindman, Henrik, Leon-Ferre, Roberto A., Boughey, Judy C., Liu, Minetta C., Ingle, James N., Kalari, Krishna R., Couch, Fergus J., Knutson, Keith L., Goetz, Matthew P., Perez, Edith A., and Thompson, E. Aubrey

Published
2023
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6. Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D)

Author

Hilbers, Florentine, El-Abed, Sarra, Balta, Vasiliki, Schurmans, Celine, Rosa, Daniela D., Saini, Kamal, Filho, Otto Metzger, McConnell, Robin, Paterson, Vicki, Campbell, Christine, McFadden, Eleanor, Paterson, Emma, Kassab, Garrick, Moreno-Aspitia, Alvaro, Holmes, Eileen M., Jackisch, Christian, de Azambuja, Evandro, Boyle, Frances, Hillman, David W., Korde, Larissa, Fumagalli, Debora, Izquierdo, Miguel A., McCullough, Ann E., Wolff, Antonio C., Pritchard, Kathleen I., Untch, Michael, Guillaume, Sébastien, Ewer, Michael S., Shao, Zhimin, Sim, Sung Hoon, Aziz, Zeba, Demetriou, Georgia, Mehta, Ajay O., Andersson, Michael, Toi, Masakazu, Lang, Istvan, Xu, Binghe, Smith, Ian E., Barrios, Carlos H., Baselga, Jose, Gelber, Richard D., and Piccart-Gebhart, Martine

Published
2021
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7. A clinical calculator to predict disease outcomes in women with triple-negative breast cancer

Author

Polley, Mei-Yin C., Leon-Ferre, Roberto A., Leung, Samuel, Cheng, Angela, Gao, Dongxia, Sinnwell, Jason, Liu, Heshan, Hillman, David W., Eyman-Casey, Abraham, Gilbert, Judith A., Negron, Vivian, Boughey, Judy C., Liu, Minetta C., Ingle, James N., Kalari, Krishna, Couch, Fergus, Carter, Jodi M., Visscher, Daniel W., Nielsen, Torsten O., and Goetz, Matthew P.

Published
2021
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9. Folate receptor alpha expression associates with improved disease-free survival in triple negative breast cancer patients

Author

Norton, Nadine, Youssef, Bahaaeldin, Hillman, David W., Nassar, Aziza, Geiger, Xochiquetzal J., Necela, Brian M., Liu, Heshan, Ruddy, Kathryn J., Polley, Mei-Yin C., Ingle, James N., Couch, Fergus J., Perez, Edith A., Liu, Minetta C., Carter, Jodi M., Leon-Ferre, Roberto A., Boughey, Judy C., Somers, Elizabeth B., Kalari, Krishna R., Visscher, Daniel W., Goetz, Matthew P., and Knutson, Keith L.

Published
2020
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10. PRESTO: A Phase III, Open-Label Study of Intensification of Androgen Blockade in Patients With High-Risk Biochemically Relapsed Castration-Sensitive Prostate Cancer (AFT-19).

Author

Aggarwal, Rahul, Heller, Glenn, Hillman, David W., Xiao, Han, Picus, Joel, Taplin, Mary-Ellen, Dorff, Tanya, Appleman, Leonard, Weckstein, Douglas, Patnaik, Akash, Bryce, Alan, Shevrin, Daniel, Mohler, James, Anderson, Daniel, Rao, Arpit, Tagawa, Scott, Tan, Alan, Halabi, Susan, Dooley, Katharine, and O'Brien, Patrick

Published
2024
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13. Impact of histopathology, tumor-infiltrating lymphocytes, and adjuvant chemotherapy on prognosis of triple-negative breast cancer

Author

Leon-Ferre, Roberto A., Polley, Mei-Yin, Liu, Heshan, Gilbert, Judith A., Cafourek, Victoria, Hillman, David W., Elkhanany, Ahmed, Akinhanmi, Margaret, Lilyquist, Jenna, Thomas, Abigail, Negron, Vivian, Boughey, Judy C., Liu, Minetta C., Ingle, James N., Kalari, Krishna R., Couch, Fergus J., Visscher, Daniel W., and Goetz, Matthew P.

Published
2017
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14. Molecular profile changes in castrate resistant prostate cancer patients pre and post-abiraterone/prednisone treatment

Author

Sicotte, Hugues, Kalari, Krishna R., Qin, Sisi, Dehm, Scott M., Bhargava, Vipul, Gormley, Michael, Tan, Winston, Sinnwell, Jason P., Hillman, David W., Li, Ying, Vedell, Peter T., Carlson, Rachel E., Bryce, Alan H., Jimenez, Raphael E, Weinshilboum, Richard M., Kohli, Manish, and Wang, Liewei

Subjects
Male, Prostatic Neoplasms, Castration-Resistant, Antineoplastic Combined Chemotherapy Protocols, Abiraterone Acetate, Humans, Prednisone, Article, Aurora Kinase A
Abstract

We identified resistance mechanisms to abiraterone acetate/prednisone (AA/P) in patients with metastatic castration-resistant prostate cancer (mCRPC) in the PROMOTE (Prostate Cancer Medically Optimized Genome-Enhanced Therapy) study. We analyzed whole-exome sequencing (WES) and RNA-seq data from 83 patients with metastatic biopsies pre (V1) and after 12 weeks of AA/P treatment (V2). Resistance was determined by time to treatment change (TTTC). At V2, 18 and 11 out of 58 patients had either short (median 3.6 months; range 1.4–4.5) or long- (median 29 months; range 23.5–41.7) term responses, respectively. Non-responders had low expression of TGFBR3 and increased activation of the Wnt pathway, cell cycle, upregulation of AR variants, both pre and post-treatment, with further deletion of AR inhibitor CDK11B post-treatment. Deletion of androgen processing genes, HSD17B11, CYP19A1 were observed in non-responders post-treatment. Genes involved in cell cycle, DNA repair, Wnt-signaling, and Aurora kinase pathways were differentially expressed between the responder and non-responder at V2. Activation of Wnt signaling in non-responder and deactivation of MYC or its target genes in responders was detected via Somatic Copy Number (SCN) loss, somatic mutations, and transcriptomics. Upregulation of genes in the AURKA pathway are consistent with the activation of MYC regulated genes in non-responders. Several genes in the AKT1 axis had increased mutation rate in non-responders. We also found evidence of resistance via PD1 overexpression in responders. Implications: Finally, we identified candidates drugs to reverse AA/P resistance : topoisomerase inhibitors and drugs targeting the cell cycle via the MYC/AURKA/AURKB/TOP2A and/or PI3K/AKT1/MTOR pathways.

Published
2022

15. Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer (Alliance A031201 Trial).

Author

Morris, Michael J., Heller, Glenn, Hillman, David W., Bobek, Olivia, Ryan, Charles, Antonarakis, Emmanuel S., Bryce, Alan H., Hahn, Olwen, Beltran, Himisha, Armstrong, Andrew J., Schwartz, Lawrence, Lewis, Lionel D., Beumer, Jan H., Langevin, Brooke, McGary, Eric C., Mehan, Paul T., Goldkorn, Amir, Roth, Bruce J., Xiao, Han, and Watt, Colleen

Published
2023
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17. Late toxicity of moderately hypofractionated intensity-modulated proton therapy treating the prostate and pelvic lymph nodes for high-risk prostate cancer.

Author

Choo, Richard, Hillman, David W., Mitchell, Cecilia, Daniels, Thomas, Vargas, Carlos, Rwigema, Jean Claude, Corbin, Kimberly, Keole, Sameer, Vora, Sujay, Merrell, Kenneth, Stish, Bradley, Pisansky, Thomas, Davis, Brian J., Amundson, Adam, and Wong, William

Subjects
*PROTON therapy, *LYMPH nodes, *PROSTATE cancer, *ANDROGEN deprivation therapy, *PROSTATE
Abstract

Purpose: To evaluate late gastrointestinal (GI) and genitourinary (GU) toxicity of moderately hypofractionated intensity-modulated proton therapy (IMPT) targeting the prostate and pelvic lymph nodes.Methods and Materials: A target accrual of 56 patients with high-risk or unfavorable intermediate risk prostate cancer were enrolled into a prospective study (ClinicalTrials.gov: XXX) of moderately hypofractionated IMPT. IMPT with pencil beam scanning was utilized to deliver 6750 and 4500 cGy RBE in 25 daily fractions simultaneously to the prostate and pelvic lymph nodes, respectively. All received androgen deprivation therapy. Late GI and GU toxicity was prospectively assessed using CTCAE v4.0, at baseline, weekly during radiotherapy, 3-month post-radiotherapy, and then every six months. Actuarial rates of late GI and GU toxicity were estimated using Kaplan-Meier method.Results: Median age was 75.5 years. Fifty-four patients were available for late toxicity evaluation. Median follow-up was 43.9 months (range: 16-66). The actuarial rate of late grade ≥ 2 GI toxicity at both 2 and 3 years was 7.4% (95% CI: 0.2-14.2%). The actuarial rate of late grade 3 GI toxicity at both 2 and 3 years was 1.9% (95% CI: 0-5.4%). One patient experienced grade 3 GI toxicity with proctitis. The actuarial rate of late grade ≥ 2 GU toxicity was 20.5% (95% CI: 8.9-30.6%) at 2 years, and 29.2 % (95% CI: 15.5-40.7%) at 3 years. None had grade 3 GU toxicity. The presence of baseline GU symptoms was associated with a higher likelihood of experiencing late grade 2 GU toxicity.Conclusions: A moderately hypofractionated IMPT targeting the prostate and regional pelvic lymph nodes was generally well tolerated. Patients with pre-existing GU symptoms had a higher rate of late grade 2 GU toxicity. A phase III study is needed to assess any therapeutic gain of IMPT, in comparison with photon-based radiotherapy. [ABSTRACT FROM AUTHOR]

Published
2023
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20. Benign breast disease and the risk of breast cancer

Author

Blake, Cassann, Sellers, Thomas A., Frost, Marlene H., Lingle, Wilma L., Degnim, Amy C., Ghosh, Karthik, Vierkant, RObert A., Maloney, Shaun D., Pantratz, V.Shane, Hillman, David W., Suman, Vera J., Hohnson, Jo, Melton, Joseph L., III, and Visscher, Daniel W.

Subjects
Breast cancer -- Risk factors, Women -- Health aspects
Abstract

A large group of women with benign breast disease are studied to obtain reliable estimates of the risk of breast cancer. The risk factors for breast cancer include the histologic classification of a benign lesion and a family history of breast cancer.

Published
2005

21. Soluble Human Epidermal Growth Factor Receptor 2 (HER2) Levels in Patients With HER2-Positive Breast Cancer Receiving Chemotherapy With or Without Trastuzumab: Results From North Central Cancer Treatment Group Adjuvant Trial N9831

Author

Moreno-Aspitia, Alvaro, Hillman, David W., Dyar, Stephen H., Tenner, Kathleen S., Gralow, Julie, Kaufman, Peter A., Davidson, Nancy E., Lafky, Jacqueline M., Reinholz, Monica M., Lingle, Wilma L., Kutteh, Leila A., Carney, Walter P., Dueck, Amylou C., and Perez, Edith A.

Published
2013
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26. Benign Breast Disease and the Risk of Breast Cancer

Author

Hartmann, Lynn C., Sellers, Thomas A., Frost, Marlene H., Lingle, Wilma L., Degnim, Amy C., Ghosh, Karthik, Vierkant, Robert A., Maloney, Shaun D., Pankratz, V. Shane, Hillman, David W., Suman, Vera J., Johnson, Jo, Blake, Cassann, Tlsty, Thea, Vachon, Celine M., Melton, L. Joseph, and Visscher, Daniel W.

Published
2005
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33. Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer.

Author

Fernandez-Martinez, Aranzazu, Krop, Ian E., Hillman, David W., Polley, Mei-Yin, Parker, Joel S., Huebner, Lucas, Hoadley, Katherine A., Shepherd, Jonathan, Tolaney, Sara, Henry, N. Lynn, Dang, Chau, Harris, Lyndsay, Berry, Donald, Hahn, Olwen, Hudis, Clifford, Winer, Eric, Partridge, Ann, Perou, Charles M., and Carey, Lisa A.

Published
2020
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34. Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer.

Author

Eastham, James A., Heller, Glenn, Halabi, Susan, Monk III, J. Paul, Beltran, Himisha, Gleave, Martin, Evans, Christopher P., Clinton, Steven K., Szmulewitz, Russell Z., Coleman, Jonathan, Hillman, David W., Watt, Colleen R., George, Saby, Sanda, Martin G., Hahn, Olwen M., Taplin, Mary-Ellen, Parsons, J. Kellogg, Mohler, James L., Small, Eric J., and Morris, Michael J.

Published
2020
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36. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (20CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group

Author

Inwards, David J., Fishkin, Paul A.S., Hillman, David W., Brown, David W., Ansell, Stephen M., Kurtin, Paul J., Fonseca, Rafael, Morton, Roscoe F., Veeder, Michael H., and Witzig, Thomas E.

Subjects
Non-Hodgkin's lymphomas -- Drug therapy, Non-Hodgkin's lymphomas -- Research, Cladribine -- Dosage and administration, Cladribine -- Research, Drug therapy -- Patient outcomes, Health
Published
2008

37. TSPYL Family Regulates CYP17A1 and CYP3A4 Expression: Potential Mechanism Contributing to Abiraterone Response in Metastatic Castration‐Resistant Prostate Cancer.

Author

Qin, Sisi, Liu, Duan, Niu, Nifang, Yu, Jia, Weinshilboum, Richard M., Wang, Liewei, Kohli, Manish, Wang, Liguo, Vedell, Peter T., and Hillman, David W.

Subjects
GENE expression, ENZYME regulation, CASTRATION-resistant prostate cancer, ABIRATERONE acetate, CELL proliferation, CLINICAL trials, CANCER treatment, THERAPEUTICS
Abstract

The testis‐specific Y‐encoded‐like protein (TSPYL) gene family includes TSPYL1 to TSPYL6. We previously reported that TSPYL5 regulates cytochrome P450 (CYP) 19A1 expression. Here we show that TSPYLs, especially TSPYL 1, 2, and 4, can regulate the expression of many CYP genes, including CYP17A1, a key enzyme in androgen biosynthesis, and CYP3A4, an enzyme that catalyzes the metabolism of abiraterone, a CYP17 inhibitor. Furthermore, a common TSPYL1 single nucleotide polymorphism (SNP), rs3828743 (G/A) (Pro62Ser), abolishes TSPYL1's ability to suppress CYP3A4 expression, resulting in reduced abiraterone concentrations and increased cell proliferation. Data from a prospective clinical trial of 87 metastatic castration‐resistant prostate cancer patients treated with abiraterone acetate/prednisone showed that the variant SNP genotype (A) was significantly associated with worse response and progression‐free survival. In summary, TSPYL genes are novel CYP gene transcription regulators, and genetic alteration within these genes significantly influences response to drug therapy through transcriptional regulation of CYP450 genes. [ABSTRACT FROM AUTHOR]

Published
2018
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38. A Phase II Trial of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Patients with Hormone-Refractory Metastatic Prostate Cancer

Author

Heath, Elisabeth I., Hillman, David W., Vaishampayan, Ulka, Sheng, Shijie, Sarkar, Fazlul, Harper, Felicity, Gaskins, Melvin, Pitot, Henry C., Tan, Winston, Ivy, S. Percy, Pili, Roberto, Carducci, Michael A., and Liu, Glenn

Subjects
Immunoassay, Male, Interleukin-6, Reverse Transcriptase Polymerase Chain Reaction, Lactams, Macrocyclic, Interleukin-8, Prostatic Neoplasms, Antineoplastic Agents, Kaplan-Meier Estimate, Middle Aged, Prostate-Specific Antigen, Article, Drug Resistance, Neoplasm, Benzoquinones, Quality of Life, Humans, Serpins, Aged
Abstract

17-Allylamino-17-demethoxygeldanamycin (17-AAG) is a benzoquinone ansamycin antibiotic with antiproliferative activity in several mouse xenograft models, including prostate cancer models. A two-stage phase II study was conducted to assess the activity and toxicity profile of 17-AAG administered to patients with metastatic, hormone-refractory prostate cancer.Patients with at least one prior systemic therapy and a rising prostate-specific antigen (PSA) were eligible. Patients received 17-AAG at a dose of 300 mg/m2 i.v. weekly for 3 of 4 weeks. The primary objective was to assess the PSA response. Secondary objectives were to determine overall survival, to assess toxicity, and to measure interleukin-6, interleukin-8, and maspin levels and quality of life.Fifteen eligible patients were enrolled. The median age was 68 years and the median PSA was 261 ng/mL. Patients received 17-AAG for a median number of two cycles. Severe adverse events included grade 3 fatigue (four patients), grade 3 lymphopenia (two patients), and grade 3 back pain (two patients). The median PSA progression-free survival was 1.8 months (95% confidence interval, 1.3-3.4 months). The 6-month overall survival was 71% (95% confidence interval, 52-100%).17-AAG did not show any activity with regard to PSA response. Due to insufficient PSA response, enrollment was stopped at the end of first stage per study design. The most significant severe toxicity was grade 3 fatigue. Further evaluation of 17-AAG at a dose of 300 mg/m2 i.v. weekly as a single agent in patients with metastatic, hormone-refractory prostate cancer who received at least one prior systemic therapy is not warranted.

Published
2008

39. Impact of histopathology, tumor-infiltrating lymphocytes, and adjuvant chemotherapy on prognosis of triple-negative breast cancer.

Author

Leon-Ferre, Roberto A., Polley, Mei-Yin, Liu, Heshan, Gilbert, Judith A., Cafourek, Victoria, Hillman, David W., Elkhanany, Ahmed, Akinhanmi, Margaret, Lilyquist, Jenna, Thomas, Abigail, Negron, Vivian, Boughey, Judy C., Liu, Minetta C., Ingle, James N., Kalari, Krishna R., Couch, Fergus J., Visscher, Daniel W., and Goetz, Matthew P.

Abstract

Background: Given its high recurrence risk, guidelines recommend systemic therapy for most patients with early-stage triple-negative breast cancer (TNBC). While some clinicopathologic factors and tumor-infiltrating lymphocytes (TILs) are known to be prognostic in patients receiving chemotherapy, their prognostic implications in systemically untreated patients remain unknown.Methods: From a cohort of 9982 women with surgically treated non-metastatic breast cancer, all patients with clinically reported ER-negative/borderline (≤10%) disease were selected for central assessment of ER/PR/HER2, histopathology, Ki-67, and TILs. The impact of these parameters on invasive disease-free survival (IDFS) and overall survival (OS) was assessed using Cox proportional hazards models.Results: Six hundred five patients met the criteria for TNBC (ER/PR < 1% and HER2 negative). Most were T1–2 (95%), N0–1 (86%), grade 3 (88%), and had a Ki-67 >15% (75%). Histologically, 70% were invasive carcinoma of no special type, 16% medullary, 8% metaplastic, and 6% apocrine. The median stromal TIL content was 20%. Four hundred twenty-three (70%) patients received adjuvant chemotherapy. Median OS follow-up was 10.6 years. On multivariate analysis, only higher nodal stage, lower TILs, and the absence of adjuvant chemotherapy were associated with worse IDFS and OS. Among systemically untreated patients (n = 182), the 5-year IDFS was 69.9% (95% CI 60.7–80.5) [T1a: 82.5% (95% CI 62.8–100), T1b: 67.5% (95% CI 51.9–87.8) and T1c: 67.3% (95% CI 54.9–82.6)], compared to 77.8% (95% CI 68.3–83.6) for systemically treated T1N0. Nodal stage and TILs remained strongly associated with outcomes.Conclusions: In early-stage TNBC, nodal involvement, TILs, and receipt of adjuvant chemotherapy were independently associated with IDFS and OS. In systemically untreated TNBC, TILs remained prognostic and the risk of recurrence or death was substantial, even for T1N0 disease. [ABSTRACT FROM AUTHOR]

Published
2018
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40. Whole Blood mRNA Expression-Based Prognosis of Metastatic Renal Cell Carcinoma.

Author

Giridhar, Karthik V., Sosa, Carlos P., Hillman, David W., Sanhueza, Cristobal, Dalpiaz, Candace L., Costello, Brian A., Quevedo, Fernando J., Pitot, Henry C., Dronca, Roxana S., Ertz, Donna, Cheville, John C., Donkena, Krishna Vanaja, and Kohli, Manish

Subjects
MESSENGER RNA, RENAL cell carcinoma, GENE expression, METASTASIS, TUMORS
Abstract

The Memorial Sloan Kettering Cancer Center (MSKCC) prognostic score is based on clinical parameters. We analyzed whole blood mRNA expression in metastatic clear cell renal cell carcinoma (mCCRCC) patients and compared it to the MSKCC score for predicting overall survival. In a discovery set of 19 patients with mRCC, we performed whole transcriptome RNA sequencing and selected eighteen candidate genes for further evaluation based on associations with overall survival and statistical significance. In an independent validation of set of 47 patients with mCCRCC, transcript expression of the 18 candidate genes were quantified using a customized NanoString probeset. Cox regression multivariate analysis confirmed that two of the candidate genes were significantly associated with overall survival. Higher expression of BAG1 [hazard ratio (HR) of 0.14, p < 0.0001, 95% confidence interval (CI) 0.04-0.36] and NOP56 (HR 0.13, p < 0.0001, 95% CI 0.05-0.34) were associated with better prognosis. A prognostic model incorporating expression of BAG1 and NOP56 into the MSKCC score improved prognostication significantly over a model using the MSKCC prognostic score only (p < 0.0001). Prognostic value of using whole blood mRNA gene profiling in mCCRCC is feasible and should be prospectively confirmed in larger studies. [ABSTRACT FROM AUTHOR]

Published
2017
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41. Characteristics associated with spatially resolved immune landscapes in triple-negative breast cancer in the FinXX trial and Mayo Clinic cohort.

Author

Chumsri, Saranya, Carter, Jodi M, Ma, Yaohua, Hinerfeld, Douglas, Brauer, Heather Ann, Warren, Sarah, Joensuu, Heikki, Perez, Edith A., Leon-Ferre, Roberto Antonio, Zahrieh, David, Hillman, David W., Boughey, Judy Caroline, Ingle, James N., Kalari, Krishna Rani, Couch, Fergus, Goetz, Matthew P., Knutson, Keith L., and Thompson, E Aubrey

Published
2023
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42. Depth of PSA nadir and subsequent PSA progression-free survival in patients (pts) with high-risk biochemically relapsed prostate cancer: Results from the phase 3 PRESTO study (AFT-19).

Author

Aggarwal, Rahul Raj, Dooley, Katherine, Hillman, David W., Xiao, Han, Picus, Joel, Taplin, Mary-Ellen, Dorff, Tanya B., Appleman, Leonard Joseph, Weckstein, Douglas Jay, Patnaik, Akash, Bryce, Alan Haruo, Shevrin, Daniel H., Mohler, James L., Anderson, Daniel M., Heller, Glenn, Halabi, Susan, Tan, Alan, Eggener, Scott E., Ryan, Charles J., and Morris, Michael J.

Published
2023
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45. Baseline characteristics associated with PSA progression-free survival in patients (pts) with high-risk biochemically relapsed prostate cancer: Results from the phase 3 PRESTO study (AFT-19).

Author

Aggarwal, Rahul Raj, Heller, Glenn, Hillman, David W., Xiao, Han, Picus, Joel, Taplin, Mary-Ellen, Dorff, Tanya B., Appleman, Leonard Joseph, Weckstein, Douglas Jay, Patnaik, Akash, Bryce, Alan Haruo, Shevrin, Daniel H., Mohler, James, Anderson, Daniel M., Rao, Arpit, Tagawa, Scott T., Tan, Alan, Eggener, Scott E., Ryan, Charles J., and Morris, Michael J.

Published
2023
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46. Common Genetic Variation in CYP17A1 and Response to Abiraterone Acetate in Patients with Metastatic Castration-Resistant Prostate Cancer.

Author

Binder, Moritz, Zhang, Ben Y., Hillman, David W., Kohli, Rhea, Kohli, Tanvi, Lee, Adam, and Kohli, Manish

Subjects
HUMAN genetic variation, ABIRATERONE acetate, PROSTATE cancer patients, PROSTATE cancer treatment, GERM cells
Abstract

Treatment with abiraterone acetate and prednisone (AA/P) prolongs survival in metastatic castration-resistant prostate cancer (mCRPC) patients. We evaluated the genetic variation in CYP17A1 as predictive of response to AA/P. A prospective collection of germline DNA prior to AA/P initiation and follow-up of a mCRPC cohort was performed. Five common single-nucleotide polymorphisms (SNPs) in CYP17A1 identified using a haplotype-based tagging algorithm were genotyped. Clinical outcomes included biochemical response and time to biochemical progression on AA/P. Logistic regression was used to assess the association between tag SNPs and biochemical response. Proportional hazards regression was used to assess the association between tag SNPs and time to biochemical progression. Odds or hazard ratio per minor allele were estimated and p-values below 0.05 were considered statistically significant. Germline DNA was successfully genotyped for four tag SNPs in 87 patients. The median age was 73 years (54-90); the median prostate-specific antigen was 66 ng/dL (0.1-99.9). A single SNP, rs2486758, was associated with lower odds of experiencing a biochemical response (Odds ratio 0.22, 95% confidence interval 0.07-0.63, p = 0.005) and a shorter time to biochemical progression (Hazard ratio 2.23, 95% confidence interval 1.39-3.56, p < 0.001). This tag SNP located in the promoter region of CYP17A1 will need further validation as a predictive biomarker for AA/P therapy. [ABSTRACT FROM AUTHOR]

Published
2016
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47. Randomized Phase II Study of Two Doses of Pixantrone in Patients with Metastatic Breast Cancer (NCCTG N1031, Alliance).

Author

Sideras, Kostandinos, Hillman, David W, Giridhar, Karthik, Ginos, Brenda F, Tenglin, Richard C, Liu, Heshan, Chen, Beiyun, Tan, Winston, Gross, Gerald G, Mowat, Rex B, Dueck, Amylou C, Perez, Edith A, and Moreno-Aspitia, Alvaro

Subjects
DRUG efficacy, CARDIOTOXICITY, MITOXANTRONE, INTRAVENOUS therapy, CONFIDENCE intervals, METASTASIS, ANTINEOPLASTIC agents, TREATMENT effectiveness, RANDOMIZED controlled trials, SURVIVAL analysis (Biometry), QUALITY of life, DESCRIPTIVE statistics, STATISTICAL sampling, PROGRESSION-free survival, BREAST tumors, PATIENT safety, EVALUATION
Abstract

Background Anthracycline use in metastatic breast cancer (MBC) is hindered by cumulative exposure limits and risk of cardiotoxicity. Pixantrone, a novel aza-anthracenedione with structural similarities to mitoxantrone and anthracyclines, is theorized to exhibit less cardiotoxicity, mainly due to lack of iron binding. We conducted a randomized phase II study to evaluate the efficacy and safety of 2 dosing schedules of pixantrone in patients with refractory HER2-negative MBC. Methods Intravenous pixantrone was administered at 180 mg/m2 every 3 weeks (group A) versus 85 mg/m2 on days 1, 8, and 15 of a 28-day cycle (group B). Primary endpoint was objective response rate (ORR) and secondary endpoints included progression-free survival (PFS), median 6-month PFS, overall survival (OS), safety, quality of life, and serial assessment of circulating tumor cells. A 20% ORR was targeted as sufficient for further testing of pixantrone in this patient population. Results Forty-five patients were evaluable, with 2 confirmed partial responses in group A and 1 in group B. The trial was terminated due to insufficient activity. Overall median PFS and OS were 2.8 (95% confidence interval [CI]: 2.0-4.1) and 16.8 (95% CI: 8.9-21.6) months, respectively. Notable overall grade 3-4 adverse events were the following: neutrophil count decrease (62%), fatigue (16%), and decrease in ejection fraction (EF) (4%). Conclusion Pixantrone has insufficient activity in the second- and third-line MBC setting. It appears, however, to have limited cardiotoxicity. (ClinicalTrials.gov ID: NCT01086605). [ABSTRACT FROM AUTHOR]

Published
2022
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48. Phase II trial of sorafenib in patients with metastatic breast cancer previously exposed to anthracyclines or taxanes: North Central Cancer Treatment Group and Mayo Clinic Trial N0336.

Author

Moreno-Aspitia A, Morton RF, Hillman DW, Lingle WL, Rowland KM Jr, Wiesenfeld M, Flynn PJ, Fitch TR, Perez EA, Moreno-Aspitia, Alvaro, Morton, Roscoe F, Hillman, David W, Lingle, Wilma L, Rowland, Kendrith M Jr, Wiesenfeld, Martin, Flynn, Patrick J, Fitch, Tom R, and Perez, Edith A

Published
2009
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49. Prostate volume before and after permanent prostate brachytherapy in patients receiving neoadjuvant androgen suppression.

Author

Solhjem, Matthew C., Davis, Brian J., Pisansky, Thomas M., Wilson, Torrence M., Mynderse, Lance A., Hillman, David W., Herman, Michael G., and King, Bernard F.

Subjects
PROSTATE, PATIENTS, ANDROGENS, RADIOTHERAPY, EDEMA, ANDROSTANE
Abstract

Purpose: Limited duration neoadjuvant cytoreductive hormonal therapy (NHT) is used before the definitive radiotherapeutic management of prostate cancer to decrease target volume size and/or to decrease urinary obstructive symptoms. The purpose of this study is to examine the effect of NHT on prostate volume before permanent prostate brachytherapy (PPB) and on prostatic edema after PPB.Methods and Materials: Between May 1998 and February 2004, 408 patients underwent PPB at our institution and provided research authorization for the use of their records. Of these, 122 (30%) underwent NHT. Of the 122, 78 (64%) underwent transrectal ultrasound before the start of NHT. Patients undergoing PPB who received NHT were compared with a similar non-NHT group (N = 286). Detailed measurements of prostate volume were performed by transrectal ultrasound before and after NHT, if applicable. In addition, intraoperative preimplantation transrectal ultrasound and post-implantation transrectal ultrasound were also performed. Post-implantation computed tomography was per formed within 1 day of PPB.Results: The mean duration of NHT was 4.0 +/- 1.1 months (range, 1-8 months). The mean prostate volume before NHT was 63.3 +/- 22.8 cc (range, 19-138 cc), and after NHT (before PPB), it was 41.6 +/- 16.4 cc (18-98 cc). The median prostate volume decrease after NHT was 22.7 cc or 34.9%. There was no significant difference in the degree of postimplantation prostate edema, as measured by the postimplantation to preimplantation ratio (1.18 +/- 0.05 [range, 0.8-1.9]) for the NHT group and 1.21 +/- 0.03 (range, 0.8-1.9) for the non-NHT group (P = 0.5).Conclusions: Prostate volume decreased by approximately one third after 4 months of NHT. NHT did not affect the degree of post-PPB prostatic edema. [ABSTRACT FROM AUTHOR]

Published
2004
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