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1. Hepatic disease control in patients with intrahepatic cholangiocarcinoma correlates with overall survival

Author

Kevin C. Soares, Joshua S. Jolissaint, Sarah M. McIntyre, Kenneth P. Seier, Mithat Gönen, Carlie Sigel, Naaz Nasar, Andrea Cercek, James J. Harding, Nancy E. Kemeny, Louise C. Connell, Bas Groot Koerkamp, Vinod P. Balachandran, Michael I. D'Angelica, Jeffrey A. Drebin, T. Peter Kingham, Alice C. Wei, and William R. Jarnagin

Subjects
bile duct cancer, biliary neoplasm, cholangiocarcinoma, hepatic artery pump, locoregional therapy, regional chemotherapy, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Purpose The role of locoregional therapy compared to systemic chemotherapy (SYS) for unresectable intrahepatic cholangiocarcinoma (IHC) remains controversial. The importance of hepatic disease control, either as initial or salvage therapy, is also unclear. We compared overall survival (OS) in patients treated with resection, hepatic arterial infusion pump (HAIP) chemotherapy, or SYS as it relates to hepatic recurrence or progression. We also evaluated recurrence after resection to determine the efficacy of locoregional salvage therapy. Patients and Methods In this single‐institution retrospective analysis, patients with biopsy‐proven IHC treated with either curative‐intent resection, HAIP (with or without SYS), or SYS alone were analyzed. Propensity score matching (PSM) was used to compare patients with liver‐limited, advanced disease treated with HAIP versus SYS. The impact of locoregional salvage therapies in patients with liver‐limited recurrence was analyzed in the resection cohort. Results From 2000 to 2017, 714 patients with IHC were treated, 219 (30.7%) with resectable disease, 316 (44.3%) with locally advanced disease, and 179 (25.1%) with metastatic disease. Resected patients were less likely to recur or progress in the liver (hazard ratio [HR] 0.41, 95% CI 0.34–0.45) versus those that received HAIP or SYS (HR 0.58, 95% CI 0.50–0.65 vs. HR 0.63, 95% CI 0.57–0.69, respectively). In resected patients, 161 (64.4%) recurred, with 65 liver‐only recurrences. Thirty of these patients received subsequent locoregional therapy. On multivariable analysis, locoregional therapy was associated with improved OS after isolated liver recurrence (HR 0.46, 95% CI 0.29–0.75; p = 0.002). In patients with locally advanced unresectable or multifocal liver disease (with or without distant organ metastases), PSM demonstrated improved hepatic progression‐free survival in patients treated with HAIP versus SYS (HR 0.65; 95% CI 0.46–0.91; p = 0.01), which correlated with improved OS (HR 0.59, 95% CI 0.43–0.80; p

Published
2023
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2. Genomic stratification beyond Ras/B‐Raf in colorectal liver metastasis patients treated with hepatic arterial infusion

Author

J. Joshua Smith, Walid K. Chatila, Francisco Sanchez‐Vega, Jashodeep Datta, Louise C. Connell, Bryan C. Szeglin, Azfar Basunia, Taryn M. Boucher, Haley Hauser, Isaac Wasserman, Chao Wu, Andrea Cercek, Jaclyn F. Hechtman, Chris Madden, William R. Jarnagin, Julio Garcia‐Aguilar, Michael I. D'Angelica, Rona Yaeger, Nikolaus Schultz, and Nancy E. Kemeny

Subjects
colorectal cancer, floxuridine, implantable infusion pumps, liver, metastasis, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Resection of colorectal liver metastases (CLM) can cure disease, but many patients with extensive disease cannot be fully resected and others recur following surgery. Hepatic arterial infusion (HAI) chemotherapy can convert extensive liver disease to a resectable state or decrease recurrence risk, but response varies and no biomarkers currently exist to identify patients most likely to benefit. Methods We performed a retrospective cohort study of CLM patients receiving HAI chemotherapy whose tumors underwent MSK‐IMPACT sequencing. The frequency of oncogenic alterations and their association with overall survival (OS) and objective response rate were analyzed at the individual gene and signaling pathway levels. Results Three hundred and seventy patients met inclusion criteria: 189 (51.1%) who underwent colorectal liver metastasectomy followed by HAI + systemic therapy (Adjuvant cohort), and 181 (48.9%) with unresectable CLM (Metastatic cohort) who received HAI + systemic therapy, consisting of 63 (34.8%) with extrahepatic disease and 118 (65.2%) with liver‐restricted disease. Genomic alterations were similar in each cohort, and no individual gene or pathway was significantly associated with objective response. Patients in the adjuvant cohort with concurrent Ras/B‐Raf alteration and SMAD4 inactivation had worse prognosis while in the metastatic cohort patients with co‐alteration of Ras/B‐Raf and TP53 had worse OS. Similar findings were observed in a validation cohort. Conclusions Concurrently altered Ras/B‐Raf and SMAD4 mutations were associated with worse survival in resectable patients, while concurrent Ras/B‐Raf and TP53 alterations were associated with worse survival in unresectable patients. The mutual exclusivity of Ras/B‐Raf, SMAD4, and TP53 may have prognostic value for CLM patients receiving HAI.

Published
2019
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3. Figure S2 from Phase II Single-arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair–proficient Metastatic Colorectal Cancer

Author

Leonard B. Saltz, Christopher H. Crane, Nancy Kemeny, Yoshiya Yamada, Stephen Solomon, Joseph Erinjeri, Marinela Capanu, Joanne F. Chou, Krishna Juluru, Travis J. Hollmann, Efsevia Vakiani, Taha Merghoub, Phillip Wong, Pallavi Vedantam, Aliya Holland, Matthew J. Adamow, Martinique Ogle, Mark L. Solter, Pamela Vaiskauskas, Kathleen C. Mcauliffe, Ghassan K. Abou-Alfa, David Faleck, Louise C. Connell, Rona Yaeger, Karuna Ganesh, Anna M. Varghese, Zsofia K. Stadler, Paul B. Romesser, Martin R. Weiser, T. Jonathan Yang, John Cuaron, Diane Reidy-Lagunes, Danny N. Khalil, Andreas Rimner, Abraham J. Wu, Geoffrey Ku, Andrea Cercek, and Neil H. Segal

Abstract

Flow dot plots

Published
2023
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4. Data from Intrahepatic Cholangiocarcinoma with Lymph Node Metastasis: Treatment-Related Outcomes and the Role of Tumor Genomics in Patient Selection

Author

William R. Jarnagin, Alice C. Wei, T. Peter Kingham, Jeffrey A. Drebin, Michael I. D'Angelica, Vinod P. Balachandran, Louise C. Connell, Nancy E. Kemeny, James J. Harding, Andrea Cercek, Efsevia Vakiani, Ramyasree Madupuri, Carlie Sigel, Thomas Boerner, Paul J. Shin, Mithat Gönen, Ritika Kundra, Kenneth P. Seier, Kevin C. Soares, and Joshua S. Jolissaint

Abstract

Purpose:Lymph node metastasis (LNM) drastically reduces survival after resection of intrahepatic cholangiocarcinoma (IHC). Optimal treatment is ill defined, and it is unclear whether tumor mutational profiling can support treatment decisions.Experimental Design:Patients with liver-limited IHC with or without LNM treated with resection (N = 237), hepatic arterial infusion chemotherapy (HAIC; N = 196), or systemic chemotherapy alone (SYS; N = 140) at our institution between 2000 and 2018 were included. Genomic sequencing was analyzed to determine whether genetic alterations could stratify outcomes for patients with LNM.Results:For node-negative patients, resection was associated with the longest median overall survival [OS, 59.9 months; 95% confidence interval (CI), 47.2–74.31], followed by HAIC (24.9 months; 95% CI, 20.3–29.6), and SYS (13.7 months; 95% CI, 8.9–15.9; P < 0.001). There was no difference in survival for node-positive patients treated with resection (median OS, 19.7 months; 95% CI, 12.1–27.2) or HAIC (18.1 months; 95% CI, 14.1–26.6; P = 0.560); however, survival in both groups was greater than SYS (11.2 months; 95% CI, 14.1–26.6; P = 0.024). Node-positive patients with at least one high-risk genetic alteration (TP53 mutation, KRAS mutation, CDKN2A/B deletion) had worse survival compared to wild-type patients (median OS, 12.1 months; 95% CI, 5.7–21.5; P = 0.002), regardless of treatment. Conversely, there was no difference in survival for node-positive patients with IDH1/2 mutations compared to wild-type patients.Conclusions:There was no difference in OS for patients with node-positive IHC treated by resection versus HAIC, and both treatments had better survival than SYS alone. The presence of high-risk genetic alterations provides valuable prognostic information that may help guide treatment.

Published
2023
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5. Data from Phase II Single-arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair–proficient Metastatic Colorectal Cancer

Author

Leonard B. Saltz, Christopher H. Crane, Nancy Kemeny, Yoshiya Yamada, Stephen Solomon, Joseph Erinjeri, Marinela Capanu, Joanne F. Chou, Krishna Juluru, Travis J. Hollmann, Efsevia Vakiani, Taha Merghoub, Phillip Wong, Pallavi Vedantam, Aliya Holland, Matthew J. Adamow, Martinique Ogle, Mark L. Solter, Pamela Vaiskauskas, Kathleen C. Mcauliffe, Ghassan K. Abou-Alfa, David Faleck, Louise C. Connell, Rona Yaeger, Karuna Ganesh, Anna M. Varghese, Zsofia K. Stadler, Paul B. Romesser, Martin R. Weiser, T. Jonathan Yang, John Cuaron, Diane Reidy-Lagunes, Danny N. Khalil, Andreas Rimner, Abraham J. Wu, Geoffrey Ku, Andrea Cercek, and Neil H. Segal

Abstract

Purpose:Immune checkpoint inhibition (ICI) alone is not active in mismatch repair–proficient (MMR-P) metastatic colorectal cancer (mCRC), nor does radiotherapy alone result in objective systemic benefit. However, combined radiotherapy plus ICI can induce systemic antitumor immunity in preclinical and clinical models.Patients and Methods:In this single-center, phase II study, patients with chemotherapy-refractory MMR-P mCRC received durvalumab 1,500 mg plus tremelimumab 75 mg every 4 weeks plus radiotherapy. The primary endpoint was objective response rate (ORR) in nonirradiated lesions. Treatment and efficacy were correlated with peripheral immune cell profiles.Results:We enrolled 24 patients, and report outcomes after a median follow-up of 21.8 (range: 15.9–26.3) months. The ORR was 8.3% (2 patients) [95% confidence interval (CI), 1.0–27.0]. The median progression-free survival was 1.8 (95% CI, 1.7–1.9) months, median overall survival was 11.4 (95% CI, 10.1–17.4) months. Twenty five percent of patients (n = 6) had treatment-related grade 3–4 adverse events. We observed increased circulating CD8+ T lymphocyte activation, differentiation, and proliferation in patients with objective response.Conclusions:This combination of radiotherapy plus ICI study did not meet the prespecified endpoint criteria to be considered worthwhile for further study. However, rare instances of systemic immune augmentation and regression in nonirradiated lesions were observed (an abscopal response). Combination durvalumab and tremelimumab plus radiotherapy is feasible in MMR-P mCRC with a manageable safety profile. Further studies of novel immunotherapy combinations, and identification of biomarkers predictive of abscopal response are warranted.

Published
2023
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6. Supplementary Data from Intrahepatic Cholangiocarcinoma with Lymph Node Metastasis: Treatment-Related Outcomes and the Role of Tumor Genomics in Patient Selection

Author

William R. Jarnagin, Alice C. Wei, T. Peter Kingham, Jeffrey A. Drebin, Michael I. D'Angelica, Vinod P. Balachandran, Louise C. Connell, Nancy E. Kemeny, James J. Harding, Andrea Cercek, Efsevia Vakiani, Ramyasree Madupuri, Carlie Sigel, Thomas Boerner, Paul J. Shin, Mithat Gönen, Ritika Kundra, Kenneth P. Seier, Kevin C. Soares, and Joshua S. Jolissaint

Abstract

Supplementary Data (Figures in separate files)

Published
2023
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7. Figure S3 from Intrahepatic Cholangiocarcinoma with Lymph Node Metastasis: Treatment-Related Outcomes and the Role of Tumor Genomics in Patient Selection

Author

William R. Jarnagin, Alice C. Wei, T. Peter Kingham, Jeffrey A. Drebin, Michael I. D'Angelica, Vinod P. Balachandran, Louise C. Connell, Nancy E. Kemeny, James J. Harding, Andrea Cercek, Efsevia Vakiani, Ramyasree Madupuri, Carlie Sigel, Thomas Boerner, Paul J. Shin, Mithat Gönen, Ritika Kundra, Kenneth P. Seier, Kevin C. Soares, and Joshua S. Jolissaint

Abstract

Figure S3

Published
2023
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8. Table S1 from Phase II Single-arm Study of Durvalumab and Tremelimumab with Concurrent Radiotherapy in Patients with Mismatch Repair–proficient Metastatic Colorectal Cancer

Author

Leonard B. Saltz, Christopher H. Crane, Nancy Kemeny, Yoshiya Yamada, Stephen Solomon, Joseph Erinjeri, Marinela Capanu, Joanne F. Chou, Krishna Juluru, Travis J. Hollmann, Efsevia Vakiani, Taha Merghoub, Phillip Wong, Pallavi Vedantam, Aliya Holland, Matthew J. Adamow, Martinique Ogle, Mark L. Solter, Pamela Vaiskauskas, Kathleen C. Mcauliffe, Ghassan K. Abou-Alfa, David Faleck, Louise C. Connell, Rona Yaeger, Karuna Ganesh, Anna M. Varghese, Zsofia K. Stadler, Paul B. Romesser, Martin R. Weiser, T. Jonathan Yang, John Cuaron, Diane Reidy-Lagunes, Danny N. Khalil, Andreas Rimner, Abraham J. Wu, Geoffrey Ku, Andrea Cercek, and Neil H. Segal

Abstract

Radiation treatment summary

Published
2023
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10. The Rising Incidence of Younger Patients With Colorectal Cancer: Questions About Screening, Biology, and Treatment

Author

Jose Mauricio Mota, Maria Ignez Braghiroli, Paulo M. Hoff, and Louise C. Connell

Subjects
Adult, Gerontology, medicine.medical_specialty, Colorectal cancer, Disease, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Epidemiology, Humans, Medicine, Genetic Predisposition to Disease, Pharmacology (medical), Age of Onset, Young adult, Early Detection of Cancer, business.industry, Incidence, Incidence (epidemiology), Age Factors, Disease Management, Cancer, medicine.disease, Colorectal Neoplasms, Hereditary Nonpolyposis, digestive system diseases, Lynch syndrome, Surgery, Oncology, Population Surveillance, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Age of onset, Colorectal Neoplasms, business
Abstract

Colorectal cancer (CRC) is the third leading cancer diagnosed globally and an important cause of cancer-related mortality. Of interest, while we have witnessed a declining incidence trend over the past few decades in the older population, incidence rates for adolescents and young adults have been increasing steadily. Several factors may well explain this apparent epidemic in the young, namely a lack of routine screening and emerging lifestyle issues such as obesity, lack of exercise, and dietary factors. It is known that both environmental and genetic factors can increase the likelihood of developing CRC. Although inherited susceptibility is associated with the most striking increases in risk, and must always be considered in a young patient with CRC, the majority of CRCs are in fact sporadic rather than familial. Early-onset CRC is a truly heterogeneous disease, with mounting evidence to suggest that this patient population has a distinctive molecular profile, very different to late-onset CRC cases. Currently, both younger and older patients with CRC are treated in essentially the same manner, but with a better understanding of the molecular mechanisms underlying CRC in the young, we will have the opportunity to specifically tailor screening and clinical management strategies in this unique patient population in an effort to improve outcomes. The aim of this review is to outline our current knowledge of the distinguishing features of early-onset CRC, the ongoing research efforts, and the evolving evidence in this field.

Published
2017
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11. Contributors

Author

Ghassan K. Abou-Alfa, Jad Abou Khalil, Pietro Addeo, N. Volkan Adsay, Anil Kumar Agarwal, Farzad Alemi, Peter J. Allen, Ahmed Al-Mukhtar, Thomas A. Aloia, Jesper B. Andersen, Christopher D. Anderson, Vittoria Arslan-Carlon, Horacio J. Asbun, Béatrice Aussilhou, Joseph Awad, Daniel Azoulay, Philippe Bachellier, Talia B. Baker, Zubin M. Bamboat, Jeffrey Stewart Barkun, Claudio Bassi, Olca Basturk, Rachel E. Beard, Pierre Bedossa, Jacques Belghiti, Omar Bellorin-Marin, Marc G.H. Besselink, Anton J. Bilchik, Leslie H. Blumgart, Franz Edward Boas, Lynn A. Brody, Karen T. Brown, Jordi Bruix, David A. Bruno, Elizabeth M. Brunt, Justin M. Burns, Giovanni Butturini, Juan Carlos Caicedo, Mark P. Callery, Abdul Saied Calvino, Danielle H. Carpenter, C. Ross Carter, François Cauchy, Chung Yip Chan, See Ching Chan, William C. Chapman, Daniel Cherqui, Clifford S. Cho, Jin Wook Chung, Jesse Clanton, Bryan Marshall Clary, Sean Patrick Cleary, Kelly M. Collins, John Barry Conneely, Louise C. Connell, Carlos U. Corvera, Guido Costa, Anne M. Covey, Jeffrey S. Crippin, Kristopher P. Croome, Hany Dabbous, Michael I. D'Angelica, Michael D. Darcy, Jeremy L. Davis, Jeroen de Jonge, Ronald P. DeMatteo, Danielle K. DePeralta, Niraj M. Desai, Eduardo de Santibañes, Martin de Santibañes, Euan J. Dickson, Christopher John DiMaio, Richard Kinh Gian Do, Safi Dokmak, Marcello Donati, M.B. Majella Doyle, Vikas Dudeja, Mark Dunphy, Truman M. Earl, Tomoki Ebata, Imane El Dika, Yousef El-Gohary, Itaru Endo, C. Kristian Enestvedt, N. Joseph Espat, Cecilia G. Ethun, Sheung Tat Fan, Paul T. Fanta, Olivier Farges, Cristina R. Ferrone, Ryan C. Fields, Mary Fischer, Sarah B. Fisher, Devin C. Flaherty, Yuman Fong, Scott L. Friedman, Ahmed Gabr, John R. Galloway, David A. Geller, Hans Gerdes, Scott R. Gerst, George K. Gittes, Jaime Glorioso, Jill S. Gluskin, Brian K.P. Goh, Stevan A. Gonzalez, Karyn A. Goodman, Gregory J. Gores, Eduardo H. Gotuzzo, Dirk J. Gouma, Paul D. Greig, James F. Griffin, Christopher M. Halloran, Neil A. Halpern, Chet W. Hammill, Paul D. Hansen, James J. Harding, Ewen M. Harrison, Werner Hartwig, Kiyoshi Hasegawa, Jaclyn F. Hechtman, Julie K. Heimbach, William S. Helton, Alan W. Hemming, J. Michael Henderson, Asher Hirshberg, James R. Howe, Christopher B. Hughes, Christine Iacobuzio-Donahue, William R. Jarnagin, Roger L. Jenkins, Zeljka Jutric, Christoph Kahlert, Joseph Ralph Kallini, Ivan Kangrga, Paul J. Karanicolas, Seth S. Katz, Steven C. Katz, Kaitlyn J. Kelly, Nancy E. Kemeny, Eugene P. Kennedy, Korosh Khalili, Adeel S. Khan, Saboor Khan, Heung Bae Kim, T. Peter Kingham, Allan D. Kirk, David S. Klimstra, Michael Kluger, Stuart J. Knechtle, Jonathan B. Koea, Norihiro Kokudo, Dionysios Koliogiannis, David A. Kooby, Kevin Korenblat, Simone Krebs, Michael J. LaQuaglia, Michael P. LaQuaglia, Nicholas F. LaRusso, Alexis Laurent, Konstantinos N. Lazaridis, Julie N. Leal, Eliza J. Lee, Major Kenneth Lee, Ser Yee Lee, Riccardo Lencioni, Alexandre Liccioni, Michael E. Lidsky, Chung-Wei Lin, David C. Linehan, Roberto Carlos Lopez-Solis, Jeffrey A. Lowell, David C. Madoff, Jason Maggi, Shishir K. Maithel, Ali W. Majeed, Peter Malfertheiner, Giuseppe Malleo, Shennen A. Mao, Giovanni Marchegiani, Luis A. Marcos, James F. Markmann, J. Wallis Marsh, Robert C.G. Martin, Ryusei Matsuyama, Matthias S. Matter, Francisco Juan Mattera, Jessica E. Maxwell, Oscar M. Mazza, Ian D. McGilvray, Colin J. McKay, Doireann M. McWeeney, Jose Melendez, Robin B. Mendelsohn, George Miller, Klaus E. Mönkemüller, Ryutaro Mori, Vitor Moutinho, Masato Nagino, David M. Nagorney, Satish Nagula, Attila Nakeeb, Geir I. Nedredal, John P. Neoptolemos, James Neuberger, Scott L. Nyberg, Rachel O'Connor, John G. O'Grady, Frances E. Oldfield, Karl J. Oldhafer, Kim M. Olthoff, Susan L. Orloff, Alessandro Paniccia, Valérie Paradis, Rowan W. Parks, Gérard Pascal, Stephen M. Pastores, Timothy M. Pawlik, Venu G. Pillarisetty, James Francis Pingpank, C. Wright Pinson, Henry Anthony Pitt, James J. Pomposelli, Fabio Procopio, Michael J. Pucci, Motaz Qadan, Kheman Rajkomar, Srinevas K. Reddy, Maria E. Reig, Joseph Arturo Reza, John Paul Roberts, Piera Marie Cote Robson, Flavio G. Rocha, Garrett Richard Roll, Sean M. Ronnekleiv-Kelly, Alexander S. Rosemurgy, Charles B. Rosen, Pierre F. Saldinger, Riad Salem, Suhail Bakr Salem, Roberto Salvia, Charbel Sandroussi, Dominic E. Sanford, Olivier Scatton, Mark Andrew Schattner, William Palmer Schecter, Hans Francis Schoellhammer, Richard D. Schulick, Lawrence H. Schwartz, Kevin N. Shah, Ross W. Shepherd, Hiroshi Shimada, Masafumi Shimoda, Junichi Shindoh, Hosein Shokouh-Amiri, Jason K. Sicklick, Robert H. Siegelbaum, Gagandeep Singh, Rory L. Smoot, Stephen B. Solomon, Olivier Soubrane, Nicholas Spinelli, John A. Stauffer, Lygia Stewart, Matthew S. Strand, James H. Tabibian, Guido Torzilli, James F. Trotter, Simon Turcotte, Yumirle P. Turmelle, Demetrios J. Tzimas, Thomas Van Gulik, Andrea Vannucci, Jean-Nicolas Vauthey, Diana Vetter, Valérie Vilgrain, Alejandra Maria Villamil, Louis P. Voigt, Charles M. Vollmer, Jack R. Wands, Julia Wattacheril, Sharon Marie Weber, Matthew J. Weiss, Jürgen Weitz, Jens Werner, Megan Winner, John Wong, Dennis Yang, Hooman Yarmohammadi, Charles J. Yeo, Theresa Pluth Yeo, Chang Jin Yoon, Adam Yopp, D. Owen Young, Kai Zhao, Gazi B. Zibari, and George Zogopoulos

Published
2017
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12. Response rates of hepatic arterial infusion pump therapy in patients with metastatic colorectal cancer liver metastases refractory to all standard chemotherapies

Author

Andrea, Cercek, Taryn M, Boucher, Jill S, Gluskin, Ariel, Aguiló, Joanne F, Chou, Louise C, Connell, Marinela, Capanu, Diane, Reidy-Lagunes, Michael, D'Angelica, and Nancy E, Kemeny

Subjects
Adult, Aged, 80 and over, Male, Adolescent, Liver Neoplasms, Antineoplastic Agents, Middle Aged, Survival Analysis, Dexamethasone, Article, Young Adult, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols, Humans, Infusions, Intra-Arterial, Female, Colorectal Neoplasms, Floxuridine, Aged, Follow-Up Studies, Retrospective Studies
Abstract

To evaluate the role of hepatic arterial infusion (HAI) in patients with metastatic colorectal cancer (mCRC) liver metastases (LM) refractory to oxaliplatin, irinotecan, and fluorouracil-based treatments.A search identified patients with mCRC treated after tumor progression on at least three standard systemic therapies.One hundred and ten patients met criteria for inclusion (i.e., progression on at least three standard agents). Fifty seven patients had LM-only and 53 patients had LM and low volume extrahepatic metastases (LME). Patients with LM-only and LME had a response rate (RR) of 33% and 36%, median survival of 20 months and 11.4 months, respectively. Patients with LM-only had progression free survival of 6 months and hepatic progression free survival of 7.56 months. In a secondary analysis, 46 patients were RECIST-refractory to all standard therapies: LM-only (n = 24) and LME (n = 22). LM-only and LME had a RR of 29% and 36%, and median survival 17.2 months and 9.1 months, respectively.Patients with refractory mCRC LM can achieve a response to HAI resulting in antitumor activity and improvement in survival. Responses are rarely seen in such heavily treated patients with systemic therapy alone, suggesting a regional directed approach is useful. J. Surg. Oncol. 2016;114:655-663. © 2016 Wiley Periodicals, Inc.

Published
2016

13. Cost Effectiveness and Cancer Drugs

Author

Louise C. Connell, Jodie E. Battley, Donna M. Graham, and Seamus O'Reilly

Subjects
Cancer Research, medicine.medical_specialty, business.industry, Cost effectiveness, Cancer drugs, Antineoplastic Agents, Drug Costs, Text mining, Oncology, Neoplasms, Humans, Medicine, business, Intensive care medicine
Published
2014
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15. Does Oncotype DX recurrence score correlate with survival benefit in 'good prognosis' patients as estimated by AdjuvantOnline!?

Author

Rose Beamish, Min Yuen Teo, Seamus O'Reilly, Louise C. Connell, and Eugene J. Moylan

Subjects
Gynecology, Oncology, Cancer Research, medicine.medical_specialty, Chemotherapy, medicine.diagnostic_test, business.industry, medicine.medical_treatment, Recurrence score, medicine.disease, Breast cancer, Survival benefit, Internal medicine, medicine, Hormonal therapy, Hormone therapy, Good prognosis, business, Oncotype DX
Abstract

38 Background: An important question for ER positive, node negative breast cancer is the benefit of chemotherapy over hormonal therapy. We sought to explore if a low estimate of chemotherapy benefit, based on AdjuvantOnline, correlated with low risk Oncotype DX score , identifying patients (pts) for whom the “hormone therapy alone” treatment decision would not change. Methods: Our institutional database was reviewed to identify pts with ER positive, HER2 negative, node negative breast cancer submitted for oncotype DX testing. Clinicopathologic data and Oncotype Recurrence Score (RS) were extracted and entered into ‘Adjuvantonline’ to obtain estimated survival benefit gained at 10 years (yrs) (SBG@10). Two datasets were obtained; survival benefit gained at 10 yrs from chemotherapy only (SBG@10+C) and net survival benefit gained at 10 yrs: the absolute difference between combined therapy and hormone therapy (SBG@10 net). Pts were distributed into subgroups SBG@10 ≤3% and >3%. i.e. RS ≤18 versus >18.Correlation between SBG and RS were calculated with Spearman’s Rank method. Distribution of RS were compared with Mann-Whitney and Χ2 tests. Results: We identified 77 pts. For SBG@10+C ≤3% (n=28) and >3% (n=49) subgroups, 16 (57.1%) and 23 (46.7%) had low RS, respectively (p=0.53). Three (10.7%) and 10 (20.4%) in each subgroup had high RS (p=0.48). Distribution of RS between both subgroups was not significantly different, p=0.38. Correlation between RS and SBG@10 in the ≤3% subgroup was weak (rs=0.37, p=0.05). For SBG@10 net ≤3% (n=45) and >3% (n=32) subgroups, 25 (55.6%) and 14 (43.8%) had low RS, respectively (p=0.43). Five (11.1%) and 8 (25%) in each subgroup had high RS (p=0.20). Distribution of RS between both subgroups was not significantly different, p=0.19. Correlation between RS and SGB@10 in the ≤3% subgroup was weak (rs=0.21, p=0.15). Conclusions: Although the decision for additional chemotherapy changed for ≈10% with Oncotype DX, we could not identify a cohort of good prognosis pts for whom Oncotype DX would not significantly alter treatment recommendations. There are no subsets of node negative, ER positive, breast cancer for whom Oncotype DX does not provide independently significant prognostic and predictive information.

Published
2011
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