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202. Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) study (NRG- GI004/SWOG-S1610): A randomized phase III study of mFOLFOX6/bevacizumab combination chemotherapy with or without atezolizumab or atezolizumab monotherapy in the first-line treatment of patients (pts) with deficient DNA mismatch repair (dMMR) metastatic colorectal cancer (mCRC).

Author

Lee, James J., primary, Yothers, Greg, additional, Jacobs, Samuel A., additional, Sanoff, Hanna Kelly, additional, Cohen, Deirdre Jill, additional, Guthrie, Katherine A, additional, Henry, Norah Lynn, additional, Ganz, Patricia A., additional, Kopetz, Scott, additional, Lucas, Peter C., additional, Allegra, Carmen Joseph, additional, Blanke, Charles David, additional, Wolmark, Norman, additional, Hochster, Howard S., additional, George, Thomas J., additional, and Overman, Michael J., additional

Published
2019
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203. Phase I study of nivolumab (Nivo) + nab-paclitaxel (nab-P) + gemcitabine (Gem) in advanced pancreatic cancer (APC).

Author

Wainberg, Zev A., primary, Hochster, Howard S., additional, Kim, Edward Jae-Hoon, additional, George, Ben, additional, Kalyan, Aparna, additional, Chiorean, E. Gabriela, additional, Waterhouse, David Michael, additional, Gutierrez, Martin, additional, Parikh, Aparna Raj, additional, Jain, Rishi, additional, Carrizosa, Daniel R., additional, Soliman, Hatem Hussein, additional, Bhore, Rafia, additional, Banerjee, Sibabrata, additional, Lyons, Larry, additional, Louis, Chrystal Ursula, additional, Ong, Teng Jin, additional, and O'Dwyer, Peter J., additional

Published
2019
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205. Phase II Randomized Trial of Sequential or Concurrent FOLFOXIRI-Bevacizumab Versus FOLFOX-Bevacizumab for Metastatic Colorectal Cancer (STEAM)

Author

Hurwitz, Herbert I., primary, Tan, Benjamin R., additional, Reeves, James A., additional, Xiong, Henry, additional, Somer, Brad, additional, Lenz, Heinz-Josef, additional, Hochster, Howard S., additional, Scappaticci, Frank, additional, Palma, John F., additional, Price, Richard, additional, Lee, John J., additional, Nicholas, Alan, additional, Sommer, Nicolas, additional, and Bendell, Johanna, additional

Published
2018
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206. A phase 1b expansion study of TAS‐102 with oxaliplatin for refractory metastatic colorectal cancer.

Author

Cecchini, Michael, Kortmansky, Jeremy S., Cui, Can, Wei, Wei, Thumar, Jaykumar Ranchobdhai, Uboha, Nataliya V., Hafez, Navid, Lacy, Jill, Fischbach, Neal A., Sabbath, Kert D., Gomez, Christina M., Sporn, Jonathan Reed, Stein, Stacey, and Hochster, Howard S.

Subjects
COLORECTAL cancer, METASTASIS, OXALIPLATIN, PROGRESSION-free survival, TUMOR growth
Abstract

Background: TAS‐102, a novel antimetabolite, is approved for treatment of refractory metastatic colorectal cancer (CRC). This study sought to determine whether the addition of TAS‐102 to oxaliplatin (TAS‐OX) was safe and effective in metastatic CRC previously treated with oxaliplatin. Methods: This investigator‐initiated, open‐label, single‐arm phase 1b study enrolled patients with metastatic CRC previously treated with 5‐fluorouracil, irinotecan, and oxaliplatin. In dose escalation, TAS‐102 was given at 3 dose levels: 25, 30, and 35 mg/m2 twice daily on day 1 to day 5 with 85 mg/m2 oxaliplatin on day 1 in 14‐day cycles. The primary endpoint of dose escalation was the recommended dose for expansion, and in dose expansion, the primary endpoint was overall response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). Results: Forty‐one patients were treated with TAS‐OX. No dose‐limiting toxicities were observed in the 11 patients treated in escalation. The recommended dose for expansion was 35 mg/m2 TAS‐102 twice daily on day 1 to day 5 in combination with 85 mg/m2 oxaliplatin on day 1 in 14‐day cycles. In the intention‐to‐treat population, the ORR was 2.4% (95% CI, 0%‐12.9%) with 1 of 41 patients having a partial response, although 12 (29%) had tumor shrinkage. The median progression‐free survival was 2.7 months (95% CI, 2.4‐4.8 months) and median overall survival was 6.8 months (95% CI, 5.7‐10 months). Conclusions: TAS‐OX is safe with no unexpected toxicities at standard doses of each agent. The combination did not result in a clinically meaningful ORR, although progression‐free survival and overall survival were encouraging in this heavily pretreated population. Lay Summary: For metastatic colorectal cancer, the treatment combination of TAS‐102 and oxaliplatin was found to be well‐tolerated and revealed no unexpected side effects.Twelve of 41 patients had reductions in the size of their tumor, and the study treatment delayed the time to tumor growth as opposed to what would be expected. The combination of TAS‐102 and oxaliplatin is safe with no unexpected toxicities in treatment‐refractory metastatic colorectal cancer. Although the treatment did not reveal a robust radiographic response rate, the disease‐control and progression‐free survival rates were encouraging. [ABSTRACT FROM AUTHOR]

Published
2021
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208. Phase I/II study of PIXY321 in combination with cyclophosphamide and carboplatin in the treatment of ovarian cancer

Author

Runowicz, Carolyn D., Mandeli, John, Speyer, James L., Wadler, Scott, Hochster, Howard, Garrison, Leslie, and Holland, James F.

Subjects
Ovarian cancer, Cyclophosphamide -- Physiological aspects, Carboplatin -- Physiological aspects, Health
Abstract

Ovarian cancer patients undergoing chemotherapy may benefit from a protein treatment that corrects chemotherapy-induced low white cell and platelet counts. Researchers injected the fusion protein PIXY321 into 34 ovarian cancer patients after the second cycle of chemotherapy with cyclophosphamide and carboplatin. The main side effects were redness and hardness at the injection site, and fatigue, fever and loss of appetite. PIXY321 treatments were not effective in increasing white blood cell and platelet counts after multiple cycles of chemotherapy. PIXY321 treatments may be safe and well tolerated by ovarian cancer patients who are also receiving cyclophosphamide and carboplatin. But they may not be able to support larger doses of chemotherapy.

Published
1996

209. Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer : Supported by the ARCAD Group

Author

Goey, Kaitlyn K. H., Sorbye, Halfdan, Glimelius, Bengt, Adams, Richard A., Andre, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Diaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heineman, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans-Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G. H., Punt, Cornelis J. A., Koopman, Miriam, Goey, Kaitlyn K. H., Sorbye, Halfdan, Glimelius, Bengt, Adams, Richard A., Andre, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Diaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heineman, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans-Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G. H., Punt, Cornelis J. A., and Koopman, Miriam

Abstract

Background: Patient characteristics and stratification factors are key features influencing trial outcomes. However, there is substantial heterogeneity in reporting of patient characteristics and use of stratification factors in phase 3 trials investigating systemic treatment of metastatic colorectal cancer (mCRC). We aimed to develop a minimum set of essential baseline characteristics and stratification factors to include in such trials. Methods: We performed a modified, two-round Delphi survey among international experts with wide experience in the conduct and methodology of phase 3 trials of systemic treatment of mCRC. Results: Thirty mCRC experts from 15 different countries completed both consensus rounds. A total of 14 patient characteristics were included in the recommended set: age, performance status, primary tumour location, primary tumour resection, prior chemotherapy, number of metastatic sites, liver-only disease, liver involvement, surgical resection of metastases, synchronous versus metachronous metastases, (K)RAS and BRAF mutation status, microsatellite instability/mismatch repair status and number of prior treatment lines. A total of five patient characteristics were considered the most relevant stratification factors: RAS/BRAF mutation status, performance status, primary tumour sidedness and liver-only disease. Conclusions: This survey provides a minimum set of essential baseline patient characteristics and stratification factors to include in phase 3 trials of systemic treatment of mCRC. Inclusion of these patient characteristics and strata in study protocols and final study reports will improve interpretation of trial results and facilitate cross-study comparisons.

Published
2018
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210. Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group

Author

Team 1 Hemat, Onderzoek Medische Oncologie, Cancer, Goey, Kaitlyn K.H., Sørbye, Halfdan, Glimelius, Bengt, Adams, Richard A., André, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Díaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heinemann, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, Van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G.H., Punt, Cornelis J.A., Koopman, Miriam, Team 1 Hemat, Onderzoek Medische Oncologie, Cancer, Goey, Kaitlyn K.H., Sørbye, Halfdan, Glimelius, Bengt, Adams, Richard A., André, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Díaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heinemann, Volker, Hochster, Howard S., Kaplan, Richard S., Kopetz, Scott, Labianca, Roberto, Lieu, Christopher H., Meropol, Neal J., Price, Timothy J., Schilsky, Richard L., Schmoll, Hans Joachim, Shacham-Shmueli, Einat, Shi, Qian, Sobrero, Alberto F., Souglakos, John, Van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G.H., Punt, Cornelis J.A., and Koopman, Miriam

Published
2018

211. Improved long term survival after intracavitary interleukin-2 and lymphokine-activated killer cells for adults with recurrent malignant glioma

Author

Hayes, Roberta L., Koslow, Maxim, Hiesiger, Emile M., Hymes, Kenneth B., Hochster, Howard S., Moore, Ellery J., Pierz, D. Marie, Chen, Doris K., Budzilovich, Gleb N., and Ransohoff, Joseph

Subjects
Gliomas -- Care and treatment, Interleukin-2 -- Health aspects, Lymphokines -- Health aspects, Health
Abstract

Background. The median survival for adults with glioblastoma multiforme (GBM) is 12 months, despite surgery, radiation, and chemotherapy. Regimens using interleukin-2 (IL-2) plus lymphokine-activated killer (LAK) cells have been beneficial against systemic cancers, albeit with significant toxicity. Methods. Nineteen adults with recurrent malignant glioma (5 GBMs, and 4 anaplastic astrocytomas (AA)), Karnofsky performance status 60 or greater, were treated with intracavitary autologous LAK cells plus IL-2 after reoperation. Lymphokine-activated killer cells and IL-2 were given on day 1, and IL-2 alone was given 5 times during a 2-week cycle. This cycle was repeated at 2 weeks to constitute one 6-week course of therapy. Each two-cycle course of treatment was repeated at 3-month intervals for patients with stable disease or response to therapy. At the conclusion of immunotherapy, all patients were offered chemotherapy, generally carmustine or procarbazine, including responders. Corticosteroids were strictly limited during immunotherapy. Sequential reservoir aspirates were obtained for microbiologic and cytologic analyses. Results. The maximal tolerated dose for a 12-dose course of therapy was 1.2 million international units (MIU) per dose. Dose-limiting, cumulative IL-2-related central nervous system (CNS) toxicity was observed at 2.4 MIU per dose. Three responses were confirmed by computed tomography scan during therapy: one complete response (CR) (1 AA), and two partial responses (PR) (2 GBM); as well as a significant increase in GBM survival. One additional CR (GBM) was observed at 17 months. The median survival for immunotherapy patients with GBM was 53 weeks after reoperation (N = 15) (mean, 87.9 [+ or -] 21.4 weeks, standard error for the mean), with 8 of 15 surviving more than 1 year (53%). The median survival for 18 contemporary patients with GBM reoperated and treated with chemotherapy was 25.5 weeks (mean, 27.4 [+ or -] 3.7 weeks), with 1/18 alive at 1 year (>6%). Six of the 15 patients with GBM had additional surgery or biopsy, and chemotherapy after immunotherapy. The contribution of subsequent chemotherapy to survival cannot be discounted. Conclusions. Lymphokine-activated killer cells and IL-2 can be administered safely within the CNS resulting in improved long term survival in patients with recurrent glioblastoma. Increased survival was associated with significant biologic changes characterized by a regional eosinophilia, and extensive lymphocytic infiltration. A prospective randomized clinical trial is warranted. Cancer 1995; 76:840-52. Key words: interleukin-2, lymphokine-activated killer cells, glioma, glioblastoma, astrocytoma, brain, immunotherapy, eosinophil, survival, biologic response modifiers.

Published
1995

213. Pharmacokinetics of the cardioprotector ADR-529 (ICRF-187) in escalating doses combined with fixed-dose doxorubicin

Author

Hochster, Howard, Liebes, Leonard, Wadler, Scott, Oratz, Ruth, Wernz, James C., Meyers, Marleen, Green, Michael, Blum, Ronald H., and Speyer, James L.

Subjects
Drug interactions -- Research, Doxorubicin -- Dosage and administration, Cardiomyopathy -- Prevention, Heart, Health
Abstract

Background: Although doxorubicin is an anticancer agent with a wide spectrum of activity, therapy with this anthracycline must often be discontinued at a time of benefit to the patient because of the drug's cumulative cardiotoxicity. ICRF-187 (ADR-529, dexrazoxane) is a bisdioxopiperazine compound that protects against cardiac toxicity induced by doxorubicin. Purpose: Our objectives in this study were to determine the maximum tolerated dose of ADR-529 (which uses a different vehicle than ICRF-187) when given with a fixed doxorubicin dose and to determine whether ADR-529 alters doxorubicin pharmacokinetics. Methods: Twenty-five patients were treated with doxorubicin (60 mg/[m.sup.2]) preceded by administration of ADR-529 in escalating dosages (i.e., 60, 300, 600, 750, and 900 mg/[m.sup.2]) to groups of three to nine patients. ADR-529 was administered over a 15-minute period beginning 30 minutes before doxorubicin treatment; the protocol was repeated every 3 weeks. Blood was sampled frequently for drug levels, which were determined by high-pressure liquid chromatography with fluorescence (doxorubicin) and electrochemical detection (ADR-529). Results: Doselimiting neutropenia occurred in four of six previously treated patients at an ADR-529 dose of 600 mg/[m.sup.2]; the dose ratio of ADR-529 to doxorubicin was 10:1. For three additional patients with better Eastern Cooperative Oncology Group performance status and a maximum of one prior chemotherapy regimen, 600 mg/[m.sup.2] was tolerated, but grade 3 or 4 neutropenia occurred in four of six patients who received an ADR-529 dose of 900 mg/[m.sup.2] and in three of four patients at a dose of 750 mg/[m.sup.2]. Doxorubicin's estimated terminal half-life was 39.5 [+ or -] 18.3 (mean [+ or -] SD) hours; the area under the curve for plasma concentration of drug X time (AUC) was 1.74 [+ or -] 0.40 ([mu]g/mL) X hour. Total-body clearance was 598 [+ or -] 142 mL/[m.sup.2] per minute (N = 20), and it did not vary with ADR-529 dose. Estimated distribution and elimination phase half-lives for plasma ADR-529 were 0.46 [+ or -] 0.30 hours and 4.16 [+ or -] 2.94 hours, respectively. Total-body clearance was 111 [+ or -] 87 mL/[m.sup.2] per minute (N = 18); AUC was linear ([r.sup.2] = .92), and the clearance rate was constant ([r.sup.2] = .18) from 60 to 900 mg/[m.sup.2]. Conclusions: Myelotoxicity was dose limiting for ADR-529 at 600-750 mg/[m.sup.2] when given with a fixed dose of doxorubicin at 60 mg/[m.sup.2] (dose ratios of ADR-529 to doxorubicin ranged from 10:1 to 12.5:1). When used in combination, ADR-529 did not perturb doxorubicin's distribution, metabolism, or excretion; therefore, other mechanisms of cardioprotection must be involved. Implications: We recommend that an ADR-529 dose of 600 mg/[m.sup.2] be given with single-agent doxorubicin at a dose of 60 mg/[m.sup.2] in future studies. [J Natl Cancer Inst 84:1725 - 1730, 1992]

Published
1992

214. Modulations of monocyte functions by muramyl tripeptide phosphatidylethanolamine in a phase II study in patients with metastatic melanoma

Author

Liebes, Leonard, Walsh, Christina M., Chachoua, Abraham, Oratz, Ruth, Richards, David, Hochster, Howard, Peace, Denise, Marino, Dierdre, Alba, Susan, Le Sher, Dean, Blum, Ronald H., and Vilcek, Jan

Subjects
Melanoma -- Metastasis, Peptides -- Physiological aspects, Immune response -- Regulation, Biological response modifiers -- Physiological aspects, Health
Abstract

Background: Muramyl tripeptide phosphatidylethanolamine (MTP-PE) is a synthetic analogue of muramyl dipeptide (MDP), a component of bacterial cell walls that has potent in vitro monocyte-activating properties. We conducted a phase II clinical trial of MTP-PE in 30 patients with metastatic melanoma. Purpose: Our purpose was to define a clinical response rate for this agent in patients with advanced melanoma and to evaluate the agent's immunomodulatory properties. Methods: Patients were randomly assigned to 1- or 4-mg dose levels of MTP-PE and received the drug intravenously once a week for 12-24 weeks. Immunological monitoring consisted of measurement of plasma tumor necrosis [factor-alpha] ([TNF-alpha]), neopterin, [interleukin-1-beta], interleukin-6 (IL-6), and [beta.sub.2-microglobulin] levels; phenotyping analysis of expression of human HLA-DR, CD-14 on mononuclear cells; and measurement of in vitro monocyte cytoxicity against SKMel28 targets cells. Results: MTP-PE was well tolerated; fever and chills were the major toxic effects. Plasma [TNF-alpha] levels increased 16-fold 2 hours after the first MTP-PE treatment. Increases in [TNF-alpha] levels after MTP-PE administration continued through week 12, but changes were of a lower magnitude after week 1. Plasma neopterin levels were significantly increased 24 hours after treatment at weeks 1, 6, and 12. A marked increase in IL-6 and a modest rise in [beta.sub.2-microglobulin] levels were also seen at week 1. No significant changes from baseline [IL-1beta] were observed. In the cytotoxicity assay, monocyte cytotoxic activity was significantly increased at weeks 4 and 6. Surface immuno-phenotyping revealed a consistent transient reduction in the number of circulating monocytes 2 hours after MTP-PE was administered. In addition, observed a down-regulation (i.e., a decrease) in the expression of Leu M3 and HLA-DR on monocytes 2 hours after MTP-PE treatment, followed by a recovery 24 hours after treatment. No objective clinical responses were seen in this advanced disease population. Conclusions: We conclude that MTP-PE has pleiotropic and potentially beneficial biologic effects and that further clinical investigations of MTP-PE are justified. Implications: In view of the clear immunomodulatory actions seen in our study and in earlier clinical trials, we believe that MTP-PE deserves further study in adjuvant setting. [J Natl Cancer Inst 84:694-699, 1992]

Published
1992

218. Surgical Outcome Results From SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma.

Author

Ahmad, Syed A., Mai Duong, Sohal, Davendra P. S., Gandhi, Namita S., Beg, Muhammad Shaalan, Wang-Gillam, Andrea, Wade III, James L., Chiorean, Elena Gabriela, Guthrie, Katherine A., Lowy, Andrew M., Philip, Philip A., and Hochster, Howard S.

Abstract

Objective: The optimal neoadjuvant therapy for resectable pancreatic ductal adenocarcinoma (PDA) and the impact on surgical outcomes remains unclear. Methods: S1505 (NCT02562716) was a randomized phase II study of perioperative chemotherapy with mFOLFIRINOX (Arm 1) or gemcitabine/ nab-paclitaxel (Arm 2). Measured parameters included resection rate, margin positivity, pathologic response, and toxicity. Results: Between 2015 and 2018, 147 patients were randomized. Of these, 44 (30%) were deemed ineligible (43 by central review). Of the 103 eligible patients, 77 (76%) completed preoperative therapy and underwent surgery; reasons patients did not undergo surgery included toxicity related to preoperative therapy (n = 9), progression (n = 9), or other (n = 7). Of the 77, 73 (95%) underwent successful resection; 21 (29%) required vascular reconstruction, 62 (85%) had negative (R0) margins, and 24 (33%) had a complete or major pathologic response to therapy. The grade 3-5 postoperative complication rate was 16%. Of the 73 patients completing surgery, 57 (78%) started and 46 (63%) completed postoperative therapy. This study represents the first prospective trial evaluating modern systemic therapy delivered in a neoadjuvant/perioperative format for resectable PDA. Conclusions: We have demonstrated: (1) Based on the high percentage of enrolled, but ineligible patients, it is clear that adherence to strict definitions of resectable PDA is challenging; (2) Patients can tolerate modern systemic therapy and undergo successful surgical resection without prohibitive perioperative complications; (3) Completion of adjuvant therapy in the perioperative format is difficult; (4) Major pathologic response rate of 33% is encouraging. [ABSTRACT FROM AUTHOR]

Published
2020
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220. Perspectives on Treatment of Metastatic Colorectal Cancer with Immune Checkpoint Inhibitor Therapy.

Author

Morse, Michael A., Hochster, Howard, and Benson, Al

Subjects
THERAPEUTIC use of monoclonal antibodies, ATTITUDE (Psychology), COMBINATION drug therapy, COLON tumors, IMMUNOTHERAPY, METASTASIS, GENETIC mutation, PATIENT safety, RECTUM tumors, SURVIVAL, THERAPEUTICS, DRUG approval, IPILIMUMAB
Abstract

Despite lengthening survival, death rates from metastatic colorectal cancer (CRC) remain unacceptably high, with a bright spot being the demonstration of durable responses in patients with CRC who have mismatch repair‐deficient (dMMR) and/or microsatellite instability‐high (MSI‐H) tumors and are treated with immune checkpoint inhibitor therapy. Nivolumab and pembrolizumab, as well as nivolumab in combination with low‐dose ipilimumab—all checkpoint inhibitors—are currently approved by the U.S. Food and Drug Administration (FDA) for patients with MSI‐H/dMMR metastatic CRC that progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Nonetheless, there are a number of questions and considerations in the use of these checkpoint inhibitor therapies. Using a question‐and‐answer format, this review summarizes the scientific rationale for immune checkpoint inhibitor therapy in CRC, including the effects of tumor factors such as genetic aberrations and mutational load on the immune response, particularly in patients with MSI‐H/dMMR disease. We discuss response patterns, response criteria, and immune‐related adverse events using findings from published efficacy and safety data of immune checkpoint inhibitor therapy in metastatic CRC. We also discuss issues surrounding treatment sequencing, incorporating approved checkpoint inhibitors into the current treatment paradigm, and the multiple investigational strategies that may optimize immunotherapy for advanced CRC in the future, including novel combination therapies. Implications for Practice: Colorectal cancer (CRC) is the third most common cancer in the U.S. Despite advances in chemotherapy, survival remains poor for patients with metastatic CRC. Certain immunotherapy agents have demonstrated long‐lasting responses in previously treated patients with immune‐responsive microsatellite instability‐high/mismatch repair‐deficient metastatic CRC, leading to U.S. Food and Drug Administration approval of the immune checkpoint inhibitors nivolumab (with or without low‐dose ipilimumab) and pembrolizumab in this population. Combination therapy (e.g., nivolumab with low‐dose ipilimumab) has demonstrated numerically higher response rates and improved long‐term clinical benefit relative to anti‐programmed death‐1 monotherapy. Ongoing trials are evaluating immunotherapy in the broader CRC population and novel combinations to optimize immunotherapy for advanced CRC. Despite advances in treatment, survival remains poor for patients with colorectal cancer. This article considers the use of immune checkpoint inhibitors, summarizing the rationale for immune checkpoint inhibitor therapy in colorectal cancer. [ABSTRACT FROM AUTHOR]

Published
2020
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223. Correction to: Phase I study combining the aurora kinase a inhibitor alisertib with mFOLFOX in gastrointestinal cancer

Author

Goff, Laura W., primary, Azad, Nilofer S., additional, Stein, Stacey, additional, Whisenant, Jennifer G., additional, Koyama, Tatsuki, additional, Vaishampayan, Ulka, additional, Hochster, Howard, additional, Connolly, Roisin, additional, Weise, Amy, additional, LoRusso, Patricia M., additional, Salaria, Safia N., additional, El-Rifai, Wael, additional, and Berlin, Jordan D., additional

Published
2018
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225. Identification of a Genomic Region between SLC29A1 and HSP90AB1 Associated with Risk of Bevacizumab-Induced Hypertension: CALGB 80405 (Alliance)

Author

Li, Megan, primary, Mulkey, Flora, additional, Jiang, Chen, additional, O’Neil, Bert H., additional, Schneider, Bryan P., additional, Shen, Fei, additional, Friedman, Paula N., additional, Momozawa, Yukihide, additional, Kubo, Michiaki, additional, Niedzwiecki, Donna, additional, Hochster, Howard S., additional, Lenz, Heinz-Josef, additional, Atkins, James N., additional, Rugo, Hope S., additional, Halabi, Susan, additional, Kelly, William Kevin, additional, McLeod, Howard L., additional, Innocenti, Federico, additional, Ratain, Mark J., additional, Venook, Alan P., additional, Owzar, Kouros, additional, and Kroetz, Deanna L., additional

Published
2018
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226. Phase I study combining the aurora kinase a inhibitor alisertib with mFOLFOX in gastrointestinal cancer

Author

Goff, Laura W., primary, Azad, Nilofer S., additional, Stein, Stacey, additional, Whisenant, Jennifer G., additional, Koyama, Tatsuki, additional, Vaishampayan, Ulka, additional, Hochster, Howard, additional, Connolly, Roisin, additional, Weise, Amy, additional, LoRusso, Patricia M., additional, Salaria, Safia N., additional, El-Rifai, Wael, additional, and Berlin, Jordan D., additional

Published
2018
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227. Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group

Author

Goey, Kaitlyn K.H., primary, Sørbye, Halfdan, additional, Glimelius, Bengt, additional, Adams, Richard A., additional, André, Thierry, additional, Arnold, Dirk, additional, Berlin, Jordan D., additional, Bodoky, György, additional, de Gramont, Aimery, additional, Díaz-Rubio, Eduardo, additional, Eng, Cathy, additional, Falcone, Alfredo, additional, Grothey, Axel, additional, Heinemann, Volker, additional, Hochster, Howard S., additional, Kaplan, Richard S., additional, Kopetz, Scott, additional, Labianca, Roberto, additional, Lieu, Christopher H., additional, Meropol, Neal J., additional, Price, Timothy J., additional, Schilsky, Richard L., additional, Schmoll, Hans-Joachim, additional, Shacham-Shmueli, Einat, additional, Shi, Qian, additional, Sobrero, Alberto F., additional, Souglakos, John, additional, Van Cutsem, Eric, additional, Zalcberg, John, additional, van Oijen, Martijn G.H., additional, Punt, Cornelis J.A., additional, and Koopman, Miriam, additional

Published
2018
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229. Rectal Cancer, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology

Author

Benson, Al B., primary, Venook, Alan P., additional, Al-Hawary, Mahmoud M., additional, Cederquist, Lynette, additional, Chen, Yi-Jen, additional, Ciombor, Kristen K., additional, Cohen, Stacey, additional, Cooper, Harry S., additional, Deming, Dustin, additional, Engstrom, Paul F., additional, Grem, Jean L., additional, Grothey, Axel, additional, Hochster, Howard S., additional, Hoffe, Sarah, additional, Hunt, Steven, additional, Kamel, Ahmed, additional, Kirilcuk, Natalie, additional, Krishnamurthi, Smitha, additional, Messersmith, Wells A., additional, Meyerhardt, Jeffrey, additional, Mulcahy, Mary F., additional, Murphy, James D., additional, Nurkin, Steven, additional, Saltz, Leonard, additional, Sharma, Sunil, additional, Shibata, David, additional, Skibber, John M., additional, Sofocleous, Constantinos T., additional, Stoffel, Elena M., additional, Stotsky-Himelfarb, Eden, additional, Willett, Christopher G., additional, Wuthrick, Evan, additional, Gregory, Kristina M., additional, Gurski, Lisa, additional, and Freedman-Cass, Deborah A., additional

Published
2018
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230. Anal Carcinoma, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology

Author

Benson, Al B., primary, Venook, Alan P., additional, Al-Hawary, Mahmoud M., additional, Cederquist, Lynette, additional, Chen, Yi-Jen, additional, Ciombor, Kristen K., additional, Cohen, Stacey, additional, Cooper, Harry S., additional, Deming, Dustin, additional, Engstrom, Paul F., additional, Grem, Jean L., additional, Grothey, Axel, additional, Hochster, Howard S., additional, Hoffe, Sarah, additional, Hunt, Steven, additional, Kamel, Ahmed, additional, Kirilcuk, Natalie, additional, Krishnamurthi, Smitha, additional, Messersmith, Wells A., additional, Meyerhardt, Jeffrey, additional, Mulcahy, Mary F., additional, Murphy, James D., additional, Nurkin, Steven, additional, Saltz, Leonard, additional, Sharma, Sunil, additional, Shibata, David, additional, Skibber, John M., additional, Sofocleous, Constantinos T., additional, Stoffel, Elena M., additional, Stotsky-Himelfarb, Eden, additional, Willett, Christopher G., additional, Wuthrick, Evan, additional, Gregory, Kristina M., additional, and Freedman-Cass, Deborah A., additional

Published
2018
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231. Abstract CT062: A phase I dose escalation study of trifluridine and tipiracil (FTD/TPI) in combination with irinotecan (IRI) in patients with advanced gastrointestinal (GI) tumors

Author

Varghese, Anna M., primary, Cardin, Dana B., additional, Hersch, Jon, additional, Benson, Al B., additional, Hochster, Howard S., additional, Winkler, Robert, additional, Benedetti, Fabio, additional, Hamada, Kensuke, additional, Berlin, Jordan D., additional, and Saltz, Leonard, additional

Published
2018
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233. SWOG S1505: A randomized phase II study of perioperative mFOLFIRINOX vs. gemcitabine/nab-paclitaxel as therapy for resectable pancreatic adenocarcinoma.

Author

Sohal, Davendra, primary, McDonough, Shannon L, additional, Ahmad, Syed A., additional, Gandhi, Namita, additional, Beg, Muhammad Shaalan, additional, Wang-Gillam, Andrea, additional, Guthrie, Katherine, additional, Lowy, Andrew M., additional, Philip, Philip Agop, additional, and Hochster, Howard S., additional

Published
2018
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234. Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) study (NRG- GI004/SWOG-S1610): A randomized phase III study of mFOLFOX6/bevacizumab combination chemotherapy with or without atezolizumab or atezolizumab monotherapy in the first-line treatment of patients with deficient DNA mismatch repair (dMMR) metastatic colorectal cancer.

Author

Lee, James J., primary, Yothers, Greg, additional, Jacobs, Samuel A., additional, Sanoff, Hanna Kelly, additional, Cohen, Deirdre Jill, additional, Guthrie, Katherine A, additional, Henry, Norah Lynn, additional, Ganz, Patricia A., additional, Kopetz, Scott, additional, Lucas, Peter C., additional, Allegra, Carmen Joseph, additional, Blanke, Charles David, additional, Wolmark, Norman, additional, Hochster, Howard S., additional, George, Thomas J., additional, and Overman, Michael J., additional

Published
2018
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236. A phase I expansion study of trifluridine and tipiracil (FTD/TPI) in combination with irinotecan (IRI) and bevacizumab (BEV) in patients with metastatic colorectal cancer (mCRC).

Author

Varghese, Anna M., primary, Cardin, Dana Backlund, additional, Hersch, Jonathan, additional, Benson, Al Bowen, additional, Hochster, Howard S., additional, Winkler, Robert E., additional, Benedetti, Fabio, additional, Hamada, Kensuke, additional, Berlin, Jordan, additional, and Saltz, Leonard B., additional

Published
2018
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237. A randomized phase II study of trastuzumab and pertuzumab (TP) compared to cetuximab and irinotecan (CETIRI) in advanced/metastatic colorectal cancer (mCRC) with HER2 amplification: S1613.

Author

Raghav, Kanwal Pratap Singh, primary, McDonough, Shannon L, additional, Tan, Benjamin R., additional, Denlinger, Crystal S., additional, Magliocco, Anthony Martin, additional, Choong, Nicholas W., additional, Sommer, Nicolas, additional, Scappaticci, Frank A., additional, Campos, Danae, additional, Guthrie, Katherine A, additional, Kopetz, Scott, additional, Fakih, Marwan, additional, and Hochster, Howard S., additional

Published
2018
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238. NCCN Guidelines Insights: Colon Cancer, Version 2.2018

Author

Benson, Al B., primary, Venook, Alan P., additional, Al-Hawary, Mahmoud M., additional, Cederquist, Lynette, additional, Chen, Yi-Jen, additional, Ciombor, Kristen K., additional, Cohen, Stacey, additional, Cooper, Harry S., additional, Deming, Dustin, additional, Engstrom, Paul F., additional, Garrido-Laguna, Ignacio, additional, Grem, Jean L., additional, Grothey, Axel, additional, Hochster, Howard S., additional, Hoffe, Sarah, additional, Hunt, Steven, additional, Kamel, Ahmed, additional, Kirilcuk, Natalie, additional, Krishnamurthi, Smitha, additional, Messersmith, Wells A., additional, Meyerhardt, Jeffrey, additional, Miller, Eric D., additional, Mulcahy, Mary F., additional, Murphy, James D., additional, Nurkin, Steven, additional, Saltz, Leonard, additional, Sharma, Sunil, additional, Shibata, David, additional, Skibber, John M., additional, Sofocleous, Constantinos T., additional, Stoffel, Elena M., additional, Stotsky-Himelfarb, Eden, additional, Willett, Christopher G., additional, Wuthrick, Evan, additional, Gregory, Kristina M., additional, and Freedman-Cass, Deborah A., additional

Published
2018
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239. Cetuximab Combined With Induction Oxaliplatin and Capecitabine, Followed by Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer: SWOG 0713

Author

Leichman, Cynthia Gail, primary, McDonough, Shannon L., additional, Smalley, Stephen R., additional, Billingsley, Kevin G., additional, Lenz, Heinz-Josef, additional, Beldner, Matthew A., additional, Hezel, Aram F., additional, Velasco, Mario R., additional, Guthrie, Katherine A., additional, Blanke, Charles D., additional, and Hochster, Howard S., additional

Published
2018
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240. Phase 1b/2 study of margetuximab (M) plus pembrolizumab (P) in advanced HER2+ gastroesophageal junction (GEJ) or gastric (G) adenocarcinoma (GEA).

Author

Catenacci, Daniel V.T., primary, Park, Haeseong, additional, Lockhart, A. Craig, additional, Gold, Philip Jordan, additional, Enzinger, Peter C., additional, Nordstrom, Jeffrey L., additional, Hong, Sam, additional, Hochster, Howard S., additional, Kelly, Ronan Joseph, additional, Uronis, Hope Elizabeth, additional, Bendell, Johanna C., additional, Oh, Sang Cheul, additional, Park, Se Hoon, additional, Kim, Yeul Hong, additional, Kang, Yoon-Koo, additional, Lee, Keun-Wook, additional, Ng, Matthew CH, additional, Wigginton, Jon M., additional, Davidson-Moncada, Jan Kenneth, additional, and Bang, Yung-Jue, additional

Published
2018
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243. Trial in progress: A multicenter phase II study of pembrolizumab in patients with advanced small bowel adenocarcinomas.

Author

Pedersen, Katrina, primary, Overman, Michael J., additional, Foster, Nathan R., additional, Kim, Sunnie S., additional, Bekaii-Saab, Tanios S., additional, Murphy, Janet E., additional, Boland, Patrick McKay, additional, Hochster, Howard S., additional, Halfdanarson, Thorvardur Ragnar, additional, Wilson, Richard H., additional, Welch, Jack, additional, and McWilliams, Robert R., additional

Published
2018
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244. A phase IB/II randomized study of mFOLFIRINOX (mFFOX) + pegylated recombinant human hyaluronidase (PEGPH20) versus mFFOX alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139).

Author

Ramanathan, Ramesh K., primary, McDonough, Shannon, additional, Philip, Philip Agop, additional, Hingorani, Sunil R., additional, Lacy, Jill, additional, Kortmansky, Jeremy S., additional, Thumar, Jaykumar Ranchodbhai, additional, Chiorean, E. Gabriela, additional, Shields, Anthony Frank, additional, Behl, Deepti, additional, Mehan, Paul Tracy, additional, Gaur, Rakesh, additional, Seery, Tara Elisabeth, additional, Guthrie, Katherine, additional, and Hochster, Howard S., additional

Published
2018
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247. Outcomes of older patients with follicular lymphoma using individual data from 5922 patients in 18 randomized controlled trials

Author

Casulo, Carla, Dixon, Jesse G., Ou, Fang-Shu, Hoster, Eva, Peterson, Bruce A., Hochster, Howard S., Brice, Pauline, Ladetto, Marco, Hiddemann, Wolfgang, Marcus, Robert, Kimby, Eva, Herold, Michael, Nielsen, Tina, Morschhauser, Franck, Rummel, Mathias, Hagenbeek, Anton, Vitolo, Umberto, Salles, Gilles A., Shi, Qian, and Flowers, Christopher R.

Abstract

Limited data exist to describe the clinical features and outcomes for elderly patients with follicular lymphoma (FL). The Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) group performed a prospectively planned pooled analysis of individual patient data from first-line randomized controlled trials (RCTs) and examined associations between age (≤70 vs >70 years), clinical characteristics, and FL outcomes. We identified 18 multicenter clinical RCTs in the FLASH database that enrolled elderly patients (>70 years). Primary end points were early disease outcomes, CR24 and CR30, and progression-free survival (PFS) at 24 months (PFS24). Secondary end points were PFS and overall survival (OS). We identified 5922 previously untreated FL patients from 18 RCTs. Patients age >70 years (vs ≤70 years) more commonly had elevated lactate dehydrogenase, hemoglobin <12 g/dL, ECOG PS ≥2, and elevated β2-microglobulin. Median follow-up was 5.6 years. Patients >70 years did not differ from patients ≤70 years in rates of CR24, CR30, or PFS24. With a median OS of 14.6 years for all patients, median OS was 7.4 and 15.7 years for patients >70 and ≤70 years of age, respectively (hazard ratio = 2.35; 95% confidence interval = 2.03-2.73; P < .001). Age >70 years was a significant predictor of OS and PFS due to higher rates of death without progression, but not PFS24, CR24, or CR30. FL patients >70 years treated on trials have similar early disease outcomes to younger patients. There is no disease-specific outcome difference between age groups. Age alone should not disqualify patients from standard treatments or RCTs.

Published
2021
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248. Effect of Selumetinib and MK-2206 vs Oxaliplatin and Fluorouracil in Patients With Metastatic Pancreatic Cancer After Prior Therapy: SWOG S1115 Study Randomized Clinical Trial.

Author

Chung, Vincent, Chung, Vincent, McDonough, Shannon, Philip, Philip A, Cardin, Dana, Wang-Gillam, Andrea, Hui, Laifong, Tejani, Mohamedtaki A, Seery, Tara E, Dy, Irene A, Al Baghdadi, Tareq, Hendifar, Andrew E, Doyle, L Austin, Lowy, Andrew M, Guthrie, Katherine A, Blanke, Charles D, Hochster, Howard S, Chung, Vincent, Chung, Vincent, McDonough, Shannon, Philip, Philip A, Cardin, Dana, Wang-Gillam, Andrea, Hui, Laifong, Tejani, Mohamedtaki A, Seery, Tara E, Dy, Irene A, Al Baghdadi, Tareq, Hendifar, Andrew E, Doyle, L Austin, Lowy, Andrew M, Guthrie, Katherine A, Blanke, Charles D, and Hochster, Howard S

Abstract

ImportanceKRAS mutations are common in pancreatic cancer, but directly targeting the KRAS protein has thus far been unsuccessful. The aim of this trial was to block the MEK and PI3K/AKT pathways downstream of the KRAS protein as an alternate treatment strategy to slow cancer growth and prolong survival. This was the first cooperative group trial to evaluate this strategy using molecularly targeted oral combination therapy for the treatment of chemotherapy-refractory pancreatic cancer.ObjectiveTo compare selumetinib and MK-2206 vs modified FOLFOX (mFOLFOX) in patients with metastatic pancreatic cancer for whom gemcitabine-based therapy had failed.Design, setting, and participantsSWOG S1115 was a randomized phase 2 clinical trial. Between September 2012 and May 2014, 137 patients with metastatic pancreatic adenocarcinoma for whom gemcitabine-based chemotherapy had failed were randomized to selumetinib plus MK-2206 or mFOLFOX. Patients were randomized in a 1:1 fashion and stratified according to duration of prior systemic therapy and presence of liver metastases.InterventionsPatients received selumetinib 100 mg orally per day plus MK-2206 135 mg orally once per week or mFOLFOX (oxaliplatin, 85 mg/m2 intravenous, and fluorouracil, 2400 mg/m2 intravenous infusion over 46-48 hours) on days 1 and 15 of a 28-day cycle.Main outcomes and measuresThe primary end point of the study was overall survival. Secondary objectives included evaluating toxic effects, objective tumor response, and progression-free survival.ResultsThere were 58 patients in the selumetinib plus MK-2206 (experimental) arm (60% male; median [range] age, 69 [54-88] years) and 62 patients in the mFOLFOX arm (35% male; median [range] age, 65 [34-82] years). In the experimental arm, median overall survival was shorter (3.9 vs 6.7 months; HR, 1.37; 95% CI, 0.90-2.08; P = .15), as was median progression-free survival (1.9 vs 2.0 months; HR, 1.61; 95% CI, 1.07-2.43; P = .02). One vs 5 patients had a partial respons

Published
2017

249. Effect of First-Line Chemotherapy Combined With Cetuximab or Bevacizumab on Overall Survival in Patients With KRAS Wild-Type Advanced or Metastatic Colorectal Cancer: A Randomized Clinical Trial.

Author

Venook, Alan P, Venook, Alan P, Niedzwiecki, Donna, Lenz, Heinz-Josef, Innocenti, Federico, Fruth, Briant, Meyerhardt, Jeffrey A, Schrag, Deborah, Greene, Claire, O'Neil, Bert H, Atkins, James Norman, Berry, Scott, Polite, Blase N, O'Reilly, Eileen M, Goldberg, Richard M, Hochster, Howard S, Schilsky, Richard L, Bertagnolli, Monica M, El-Khoueiry, Anthony B, Watson, Peter, Benson, Al B, Mulkerin, Daniel L, Mayer, Robert J, Blanke, Charles, Venook, Alan P, Venook, Alan P, Niedzwiecki, Donna, Lenz, Heinz-Josef, Innocenti, Federico, Fruth, Briant, Meyerhardt, Jeffrey A, Schrag, Deborah, Greene, Claire, O'Neil, Bert H, Atkins, James Norman, Berry, Scott, Polite, Blase N, O'Reilly, Eileen M, Goldberg, Richard M, Hochster, Howard S, Schilsky, Richard L, Bertagnolli, Monica M, El-Khoueiry, Anthony B, Watson, Peter, Benson, Al B, Mulkerin, Daniel L, Mayer, Robert J, and Blanke, Charles

Abstract

ImportanceCombining biologic monoclonal antibodies with chemotherapeutic cytotoxic drugs provides clinical benefit to patients with advanced or metastatic colorectal cancer, but the optimal choice of the initial biologic therapy in previously untreated patients is unknown.ObjectiveTo determine if the addition of cetuximab vs bevacizumab to the combination of leucovorin, fluorouracil, and oxaliplatin (mFOLFOX6) regimen or the combination of leucovorin, fluorouracil, and irinotecan (FOLFIRI) regimen is superior as first-line therapy in advanced or metastatic KRAS wild-type (wt) colorectal cancer.Design, setting, and participantsPatients (≥18 years) enrolled at community and academic centers throughout the National Clinical Trials Network in the United States and Canada (November 2005-March 2012) with previously untreated advanced or metastatic colorectal cancer whose tumors were KRAS wt chose to take either the mFOLFOX6 regimen or the FOLFIRI regimen as chemotherapy and were randomized to receive either cetuximab (n = 578) or bevacizumab (n = 559). The last date of follow-up was December 15, 2015.InterventionsCetuximab vs bevacizumab combined with either mFOLFOX6 or FOLFIRI chemotherapy regimen chosen by the treating physician and patient.Main outcomes and measuresThe primary end point was overall survival. Secondary objectives included progression-free survival and overall response rate, site-reported confirmed or unconfirmed complete or partial response.ResultsAmong 1137 patients (median age, 59 years; 440 [39%] women), 1074 (94%) of patients met eligibility criteria. As of December 15, 2015, median follow-up for 263 surviving patients was 47.4 months (range, 0-110.7 months), and 82% of patients (938 of 1137) experienced disease progression. The median overall survival was 30.0 months in the cetuximab-chemotherapy group and 29.0 months in the bevacizumab-chemotherapy group with a stratified hazard ratio (HR) of 0.88 (95% CI, 0.77-1.01; P = .08). The median progressi

Published
2017

250. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal–Anal Task Forces whitepaper

Author

Dasari, Arvind, Morris, Van K., Allegra, Carmen J., Atreya, Chloe, Benson, Al B., Boland, Patrick, Chung, Ki, Copur, Mehmet S., Corcoran, Ryan B., Deming, Dustin A., Dwyer, Andrea, Diehn, Maximilian, Eng, Cathy, George, Thomas J., Gollub, Marc J., Goodwin, Rachel A., Hamilton, Stanley R., Hechtman, Jaclyn F., Hochster, Howard, Hong, Theodore S., Innocenti, Federico, Iqbal, Atif, Jacobs, Samuel A., Kennecke, Hagen F., Lee, James J., Lieu, Christopher H., Lenz, Heinz-Josef, Lindwasser, O. Wolf, Montagut, Clara, Odisio, Bruno, Ou, Fang-Shu, Porter, Laura, Raghav, Kanwal, Schrag, Deborah, Scott, Aaron J., Shi, Qian, Strickler, John H., Venook, Alan, Yaeger, Rona, Yothers, Greg, You, Y. Nancy, Zell, Jason A., and Kopetz, Scott

Abstract

An increasing number of studies are describing potential uses of circulating tumour DNA (ctDNA) in the care of patients with colorectal cancer. Owing to this rapidly developing area of research, the Colon and Rectal–Anal Task Forces of the United States National Cancer Institute convened a panel of multidisciplinary experts to summarize current data on the utility of ctDNA in the management of colorectal cancer and to provide guidance in promoting the efficient development and integration of this technology into clinical care. The panel focused on four key areas in which ctDNA has the potential to change clinical practice, including the detection of minimal residual disease, the management of patients with rectal cancer, monitoring responses to therapy, and tracking clonal dynamics in response to targeted therapies and other systemic treatments. The panel also provides general guidelines with relevance for ctDNA-related research efforts, irrespective of indication.

Published
2020
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