lunes, 18 de mayo de 2015
José Baselga, MD, PhD, Inaugurated as President of the AACR
American Association for Cancer Research Inaugurates New Leadership at 2015 Annual Meeting
José Baselga, MD, PhD, Inaugurated as President
4/20/2015
PHILADELPHIA — The American Association for Cancer Research (AACR) welcomes José Baselga, MD, PhD, as president of the organization for 2015-2016. He was inaugurated during the Annual Business Meeting, held here during the AACR Annual Meeting 2015.
Baselga, an internationally recognized physician-scientist whose research focuses on the clinical development of novel molecularly targeted agents for the treatment of cancer, particularly breast cancer, is physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center in New York.
“It is an honor to serve as president of the AACR,” Baselga said. “We are currently in the midst of a revolution in cancer research, where new technologies and therapies are being developed at a record pace. The AACR is uniquely positioned to advance the promise of precision medicine initiatives. As president, I am eager to work with the AACR community as a whole to integrate basic and clinical research, improve access to clinical trials, coordinate our regulatory policies, and increase our ability to collaborate on the many breakthroughs occurring in cancer prevention, detection, and treatment.”
He is a pioneer in the development of treatments for women with HER2-positive breast cancer. He conducted the initial clinical trial that demonstrated that patients with advanced HER2-positive breast cancer benefited from treatment with the anti-HER2 monoclonal antibody trastuzumab. In addition, he led the clinical development of the second anti-HER2 monoclonal antibody to receive U.S. Food and Drug Administration approval, pertuzumab (Perjeta). His most recent focus in the laboratory and clinic is the identification of mechanisms of resistance to anti-HER2 agents and the clinical development of novel agents—including PI3-kinase inhibitors and antiestrogen therapies.
Baselga has been actively involved in the AACR for more than 20 years. Together with Lewis C. Cantley, PhD, Baselga is a founding editor-in-chief of the AACR’s high-impact scientific journal Cancer Discovery. He has served the AACR in many other key capacities, including: Annual Meeting 2013 Program Committee chair, member of the board of directors (2009-2012), and member of the editorial boards of Clinical Cancer Research and Cancer Prevention Research. In addition, Baselga has served on numerous committees, including: chair of the Clinical Trials Committee (2012-2013), chair of the Research Grant Review Committee (2009), member of the Landon Foundation-AACR INNOVATOR Award for International Collaboration in Cancer Research Committee (2006-2008), the Pezcoller Foundation-AACR International Award for Cancer Research Committee (2004-2005), and the AACR Award for Outstanding Achievement in Cancer Research Committee (2002-2003). He was inaugurated into the 2014 class of fellows of the AACR Academy. Additionally, he is a principal of the Stand Up To Cancer Dream Team, “Targeting the PI3K Pathway in Women’s Cancers.”
Baselga has received numerous awards and accolades for his work in cancer research, including the 32nd annual AACR Richard and Hinda Rosenthal Family Foundation Award in 2008 and the Queen Sofía Spanish Institute Gold Medal in 2010. He is an elected member of the American Society for Clinical Investigation, the American Association of Physicians, and the Institute of Medicine. He has also served as a past president of the European Society for Medical Oncology and on the board of directors for the American Society of Clinical Oncology and the European Cancer Organisation.
Prior to becoming physician-in-chief and chief medical officer at Memorial Sloan Kettering Cancer Center, Baselga was the chief of the Division of Hematology/Oncology and associate director of the Massachusetts General Hospital Cancer Center, and professor of medicine at Harvard Medical School in Boston. He was also the director of medical oncology, hematology, and radiation oncology and chairman of medical oncology service at Vall d’Hebron University and Hospital, in Barcelona, Spain, and professor of medicine at the Universitat Autònoma de Barcelona. He also served as a faculty member of the Breast/Gynecological Oncology Service at Memorial Sloan Kettering’s Memorial Hospital.
Baselga received his medical and doctoral degrees from the Universitat Autònoma de Barcelona and completed residencies at Vall d’Hebron University Hospital and the State University of New York Health Science Center at Brooklyn, as well as a fellowship at Memorial Sloan Kettering.
Additionally, Nancy E. Davidson, MD, director of the University of Pittsburgh Cancer Institute and UPMC Cancer Center, was inducted as president-elect, and Carlos L. Arteaga, MD, professor of medicine and cancer biology at Vanderbilt University School of Medicine, associate director for clinical research, director of the Center for Cancer Targeted Therapies, and director of the Breast Cancer Program at Vanderbilt-Ingram Cancer Center, now serves as past-president.
EXO106 Urine Assay and High-Grade Prostate Cancer
Urine Assay Shows Promise as Test for High-Grade Prostate Cancer
Published Online: Sunday, May 17, 2015
James M. McKiernan, MD
James M. McKiernan, MD
A urine assay that targets expression of exosomal messenger RNA (mRNA) demonstrated high negative predictive value for high-grade prostate cancer in a study that validates the emerging test as a tool to help determine whether patients need initial biopsies, according to a report at the American Urological Association Annual Meeting in New Orleans.
The use of the EXO106 test should result in a 27% reduction of prostate needle biopsies while missing fewer than 5% of higher-grade Gleason score (GS) ≥4+3 cancers, researchers indicated.
“Exosomal mRNA can be isolated and analyzed, using a first-catch, random urine,” said principal investigator James M. McKiernan, MD, a professor of Urology and director of Urologic Oncology at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York. “The EXO106 provides a high negative predictive value for high-grade cancer.”
The assay demonstrated significantly better diagnostic performance compared with prostate-specific antigen (PSA) testing alone or PSA plus standard clinical characteristics, he added.
Exosomes are secreted by virtually all cells into biological fluids, as a means of cellular communication. They are lipid bilayer-protected vesicles that remain stable under varying conditions and afford protection for their contents against degradation. Exosomes contain multiple forms of RNA, as well as DNA and protein, said McKiernan.
The structural and molecular characteristics of exosomes lend themselves to potential use as an assay to diagnose high-grade prostate cancer. EXO106 is a urine-based liquid biopsy test that assesses expression of three genes on exosomal RNA: ERG, PCA3, and SPDEF.
Expression patterns undergo evaluation by a multivariate algorithm to predict the presence of high-grade prostate cancer (GS >6), with results reflected in an EXO106 risk score.
Overall, the EXO106 test missed 12 of 148 cases of high-grade (GS ≥7). However, GS 4-predominant pattern (4+3) accounted for three of the false-negatives, and the lower-risk 3+4 pattern associated with three or fewer positive biopsy cores accounted for the remaining false-negatives.
When the definition of high-grade disease was limited to GS ≥4+3, the assay had a false-negative rate of <5%. The EXO106 assay also detected biopsy-confirmed high-grade prostate cancer in more than 90% of cases. More Than 500 Patients Tested McKiernan reported findings from a multicenter evaluation of EXO106. Investigators at 22 centers in the United States enrolled 1560 patients with GS >7 prostate cancer. After exclusion of 9% of urine samples, the study population comprised a training set of 499 patients and a 519-patient intended-use population.
The study included men 50 or older with no previous prostate biopsy, PSA level of 2 ng/mL to 10 ng/mL, and a scheduled biopsy for suspected prostate cancer. Men receiving treatments known to influence PSA levels were excluded. Assay results were based on a first-catch, randomize urine not associated with digital rectal exam (DRE). Samples were shipped to a central laboratory for analysis.
The primary objective was to determine whether the EXO106 assay added to standard of care (PSA, age, race, and family history for prostate cancer) would result in an area under the curve (AUC) superior to that of standard of care. The secondary objective was the binary performance of the EXO106 at a predefined cutpoint (sensitivity, specificity, negative predictive value [NPV], and positive predictive value [PPV]).
The 519-patient primary study population had a media age of 63 and a median prebiopsy PSA level of 5.12 ng/mL. DRE was suspicious in 18% of cases, and 23% of the men had a positive family history.
Biopsies involved a median of 12 cores. The biopsy result was positive in 48% of cases. Biopsies showed GS 6 prostate cancer in 20% of cases, GS 3+4 in 16%, GS 4+3 in 7%, GS 8 in 2%, and GS 9 in 3%. Overall, 28% of the biopsies showed GS ≥3+4.
Analysis of performance characteristrics showed that PSA alone had an AUC of 0.545, increasing to 0.631 for standard of care. The AUC increased to 0.711 for EXO106 alone and to 0.725 for EXO106 plus standard of care. The trial met its primary endpoint by demonstrating significantly better diagnostic performance with the addition of EXO106 to standard of care compared with the standard of care (P <.00004).
Analysis of the EXO106 by performance of the prespecified risk score cutpoint showed a sensitivity of 91.89%, specificity of 33.96%, PPV of 35.70%, and NPV of 91.30%.
Exosome Diagnostics, Inc, the Masschusetts-based company developing the assay, said further outcomes and economic studies are planned for this year with the goal of launching the test commercially in 2016. The company also intends to seek FDA approval for an in vitro diagnostic version of the test.
Full integration of the assay into the current prognostic standard of care before the initial biopsy could save approximately $166 million per year for national health plans and about $29 million per year, Exosome Diagnostics maintains.
McKiernan J, Donovan M, O’Neill V, et al. Validation of a novel non-invasive urine exosome gene expression assay to predict high-grade prostate cancer in patients undergoing initial biopsy with an equivocal PSA. Presented at: AUA Annual Meeting; May 15-19, 2015; New Orleans, LA. Abstract PII-LBA2.
- See more at: http://www.onclive.com/conference-coverage/aua-2015/Urine-Assay-Shows-Promise-as-Test-for-High-Grade-Prostate-Cancer#sthash.GCpSb7oA.dpuf
Published Online: Sunday, May 17, 2015
James M. McKiernan, MD
James M. McKiernan, MD
A urine assay that targets expression of exosomal messenger RNA (mRNA) demonstrated high negative predictive value for high-grade prostate cancer in a study that validates the emerging test as a tool to help determine whether patients need initial biopsies, according to a report at the American Urological Association Annual Meeting in New Orleans.
The use of the EXO106 test should result in a 27% reduction of prostate needle biopsies while missing fewer than 5% of higher-grade Gleason score (GS) ≥4+3 cancers, researchers indicated.
“Exosomal mRNA can be isolated and analyzed, using a first-catch, random urine,” said principal investigator James M. McKiernan, MD, a professor of Urology and director of Urologic Oncology at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York. “The EXO106 provides a high negative predictive value for high-grade cancer.”
The assay demonstrated significantly better diagnostic performance compared with prostate-specific antigen (PSA) testing alone or PSA plus standard clinical characteristics, he added.
Exosomes are secreted by virtually all cells into biological fluids, as a means of cellular communication. They are lipid bilayer-protected vesicles that remain stable under varying conditions and afford protection for their contents against degradation. Exosomes contain multiple forms of RNA, as well as DNA and protein, said McKiernan.
The structural and molecular characteristics of exosomes lend themselves to potential use as an assay to diagnose high-grade prostate cancer. EXO106 is a urine-based liquid biopsy test that assesses expression of three genes on exosomal RNA: ERG, PCA3, and SPDEF.
Expression patterns undergo evaluation by a multivariate algorithm to predict the presence of high-grade prostate cancer (GS >6), with results reflected in an EXO106 risk score.
Overall, the EXO106 test missed 12 of 148 cases of high-grade (GS ≥7). However, GS 4-predominant pattern (4+3) accounted for three of the false-negatives, and the lower-risk 3+4 pattern associated with three or fewer positive biopsy cores accounted for the remaining false-negatives.
When the definition of high-grade disease was limited to GS ≥4+3, the assay had a false-negative rate of <5%. The EXO106 assay also detected biopsy-confirmed high-grade prostate cancer in more than 90% of cases. More Than 500 Patients Tested McKiernan reported findings from a multicenter evaluation of EXO106. Investigators at 22 centers in the United States enrolled 1560 patients with GS >7 prostate cancer. After exclusion of 9% of urine samples, the study population comprised a training set of 499 patients and a 519-patient intended-use population.
The study included men 50 or older with no previous prostate biopsy, PSA level of 2 ng/mL to 10 ng/mL, and a scheduled biopsy for suspected prostate cancer. Men receiving treatments known to influence PSA levels were excluded. Assay results were based on a first-catch, randomize urine not associated with digital rectal exam (DRE). Samples were shipped to a central laboratory for analysis.
The primary objective was to determine whether the EXO106 assay added to standard of care (PSA, age, race, and family history for prostate cancer) would result in an area under the curve (AUC) superior to that of standard of care. The secondary objective was the binary performance of the EXO106 at a predefined cutpoint (sensitivity, specificity, negative predictive value [NPV], and positive predictive value [PPV]).
The 519-patient primary study population had a media age of 63 and a median prebiopsy PSA level of 5.12 ng/mL. DRE was suspicious in 18% of cases, and 23% of the men had a positive family history.
Biopsies involved a median of 12 cores. The biopsy result was positive in 48% of cases. Biopsies showed GS 6 prostate cancer in 20% of cases, GS 3+4 in 16%, GS 4+3 in 7%, GS 8 in 2%, and GS 9 in 3%. Overall, 28% of the biopsies showed GS ≥3+4.
Analysis of performance characteristrics showed that PSA alone had an AUC of 0.545, increasing to 0.631 for standard of care. The AUC increased to 0.711 for EXO106 alone and to 0.725 for EXO106 plus standard of care. The trial met its primary endpoint by demonstrating significantly better diagnostic performance with the addition of EXO106 to standard of care compared with the standard of care (P <.00004).
Analysis of the EXO106 by performance of the prespecified risk score cutpoint showed a sensitivity of 91.89%, specificity of 33.96%, PPV of 35.70%, and NPV of 91.30%.
Exosome Diagnostics, Inc, the Masschusetts-based company developing the assay, said further outcomes and economic studies are planned for this year with the goal of launching the test commercially in 2016. The company also intends to seek FDA approval for an in vitro diagnostic version of the test.
Full integration of the assay into the current prognostic standard of care before the initial biopsy could save approximately $166 million per year for national health plans and about $29 million per year, Exosome Diagnostics maintains.
McKiernan J, Donovan M, O’Neill V, et al. Validation of a novel non-invasive urine exosome gene expression assay to predict high-grade prostate cancer in patients undergoing initial biopsy with an equivocal PSA. Presented at: AUA Annual Meeting; May 15-19, 2015; New Orleans, LA. Abstract PII-LBA2.
- See more at: http://www.onclive.com/conference-coverage/aua-2015/Urine-Assay-Shows-Promise-as-Test-for-High-Grade-Prostate-Cancer#sthash.GCpSb7oA.dpuf
sábado, 16 de mayo de 2015
New Agent Active in Refractory Metastatic Colorectal Cancer
Medscape Medical News > Oncology
New Agent Active in Refractory Metastatic Colorectal Cancer
Roxanne Nelson, RN
May 14, 2015
A novel agent, TAS-102 (Taiho Oncology), modestly improved survival in patients with metastatic colorectal cancer, but more important, it was active in patients who were heavily pretreated and refractory to standard therapies.
Findings from the phase 3 RECOURSE trial, initially presented last year at the World Congress on Gastrointestinal Cancer, were published in the May 14 issue of the New England Journal of Medicine.
In RECOURSE, patients treated with TAS-102 experienced what the researchers describe as a "clinically relevant" prolongation of overall survival in essentially all treatment subgroups, compared with placebo.
Median overall survival was significantly better in the TAS-102 group than in the placebo group (7.1 vs 5.3 months), and the hazard ratio (HR) for death in the TAS-102 group was 0.68 (P < .001). But more important, the compound showed activity in a population in which about half the patients had just finished treatment with a fluoropyrimidine, such as 5-fluorouracil (5-FU) or capecitabine (Xeloda), but had failed to benefit. "These patients experienced a survival benefit when they were given TAS-102, and this confirms what was seen in the laboratory — that TAS-102 is acting in an independent and different manner than the fluoropyrimidines," said lead author Robert J. Mayer, MD, faculty vice president for academic affairs, medical oncologist, and colorectal cancer researcher at the Dana-Farber Cancer Institute in Boston. "In this heavily pretreated group, there was an effect on outcomes," he told Medscape Medical News. The effect was "not only in survival, but in delaying disease progression and in delaying the time for symptoms to develop and for ECOG performance status to change." "This is a modest prolongation of survival, but it is showing that the drug is acting in a different manner. It will undoubtedly lead to opportunities in the very near future to compare TAS-102 with a fluoropyrimidine at an earlier stage in the course of treatment," Dr. Mayer explained. The "benefit in survival is very convincing, and occurs across subgroups," said Anthony J. Olszanski, RPh, MD, director of early clinical drug development at the Fox Chase Cancer Center in Philadelphia. "The survival curves separated early, and the hazard ratio is quite favorable, revealing that treatment with TAS-102 led to a 32% risk reduction in death, compared with placebo, in this population of heavily pretreated individuals," he told Medscape Medical News. "This trial established that heavily pretreated patients refractory to 5-FU benefit from TAS-102, as depicted by a robust but modest improvement in overall survival. This benefit came at the price of manageable toxicity." Induces Response in Refractory Patients
TAS-102 is an orally administered combination of trifluridine, which is a thymidine-based nucleic acid analogue, and tipiracil hydrochloride, which is a thymidine phosphorylase inhibitor. When it was initially studied in Japan, it showed promise in patients with colorectal cancer. This led to small early clinical trials in the United States, which showed that TAS-102 is active in the treatment of refractory disease.
Dr. Mayer and colleagues subsequently conducted their phase 3 trial to evaluate the efficacy and safety of TAS-102 in patients from 13 countries, including Australia, Japan, the United States, and some European countries.
All 800 patients had metastatic colorectal cancer that was refractory to all standard therapies, including fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab. In addition, patients with wild-type KRAS tumors were refractory to cetuximab or panitumumab.
Study participants were randomly assigned in a 2:1 ratio to receive TAS-102 or placebo. The primary end point was overall survival.
More patients in the TAS-102 group than in the placebo group were still alive at 6 months (58% vs 44%) and at 12 months (27% vs 18%). And fewer patients in the TAS-102 group experienced disease progression or death (88% vs 94%).
Median progression-free survival was longer in the TAS-102 group than in the placebo group (2.0 vs 1.7 months; HR, 0.48; P < .001). Of the study participants, 760 were evaluated for tumor response (502 in the TAS-102 group and 258 in the placebo group). A partial response was achieved by eight patients in the TAS-102 group, and a complete response was achieved by one patient in the placebo group. This translated to objective response rates of 1.6% in the TAS-102 group and 0.4% in the placebo group (P = .29). When assessed at least 6 weeks after randomization, more patients in the TAS-102 group than in the placebo group achieved disease control, defined as a complete or partial response or stable disease (44% vs 16%; P < .001). Overall, adverse events of grade 3 or higher occurred more frequently in the TAS-102 group than in the placebo group (69% vs 52%). The most common clinically significant events associated with TAS-102 were neutropenia, which occurred in 38% of those treated, and leukopenia, which occurred in 21%. In addition, 4% of patients in the TAS-102 group developed febrile neutropenia, and one death was related to TAS-102. Also more common in the TAS-102 group than in the placebo group were nausea of grade 3 or higher (2% vs 1%), vomiting (2% vs <1%), and diarrhea (3% vs <1%). Use at Earlier Stage?
The next step will be to study TAS-102 in combination with other agents, and at an earlier stage in the course of the disease, Dr. Mayer explained.
Dr. Olszanski said he agrees that this is a feasible direction for the compound. "In this study, TAS-102 led to stabilization of disease in a heavily pretreated population. In an earlier setting, it could plausibly lead to increased responses," he noted.
"It clearly works through a different mechanism than 5-FU, and further studies at an earlier disease stage will be necessary before it will supplant 5-FU use," Dr. Olszanski added. "This study, as well as others, suggests that TAS-102 works even in patients resistant to 5-FU. TAS-102 works through a mechanism of action not previously exploited in the treatment of colorectal cancer and, as such, will likely become a welcome addition to the current armamentarium of treatment choices for patients."
The study was funded by Taiho Oncology–Taiho Pharmaceutical. Dr. Mayer has disclosed no relevant financial relationships. Several of his coauthors report relationships with industry, including the manufacturer, as detailed in the publication.
N Engl J Med. 2015;372:1909-1918. Abstract
New Agent Active in Refractory Metastatic Colorectal Cancer
Roxanne Nelson, RN
May 14, 2015
A novel agent, TAS-102 (Taiho Oncology), modestly improved survival in patients with metastatic colorectal cancer, but more important, it was active in patients who were heavily pretreated and refractory to standard therapies.
Findings from the phase 3 RECOURSE trial, initially presented last year at the World Congress on Gastrointestinal Cancer, were published in the May 14 issue of the New England Journal of Medicine.
In RECOURSE, patients treated with TAS-102 experienced what the researchers describe as a "clinically relevant" prolongation of overall survival in essentially all treatment subgroups, compared with placebo.
Median overall survival was significantly better in the TAS-102 group than in the placebo group (7.1 vs 5.3 months), and the hazard ratio (HR) for death in the TAS-102 group was 0.68 (P < .001). But more important, the compound showed activity in a population in which about half the patients had just finished treatment with a fluoropyrimidine, such as 5-fluorouracil (5-FU) or capecitabine (Xeloda), but had failed to benefit. "These patients experienced a survival benefit when they were given TAS-102, and this confirms what was seen in the laboratory — that TAS-102 is acting in an independent and different manner than the fluoropyrimidines," said lead author Robert J. Mayer, MD, faculty vice president for academic affairs, medical oncologist, and colorectal cancer researcher at the Dana-Farber Cancer Institute in Boston. "In this heavily pretreated group, there was an effect on outcomes," he told Medscape Medical News. The effect was "not only in survival, but in delaying disease progression and in delaying the time for symptoms to develop and for ECOG performance status to change." "This is a modest prolongation of survival, but it is showing that the drug is acting in a different manner. It will undoubtedly lead to opportunities in the very near future to compare TAS-102 with a fluoropyrimidine at an earlier stage in the course of treatment," Dr. Mayer explained. The "benefit in survival is very convincing, and occurs across subgroups," said Anthony J. Olszanski, RPh, MD, director of early clinical drug development at the Fox Chase Cancer Center in Philadelphia. "The survival curves separated early, and the hazard ratio is quite favorable, revealing that treatment with TAS-102 led to a 32% risk reduction in death, compared with placebo, in this population of heavily pretreated individuals," he told Medscape Medical News. "This trial established that heavily pretreated patients refractory to 5-FU benefit from TAS-102, as depicted by a robust but modest improvement in overall survival. This benefit came at the price of manageable toxicity." Induces Response in Refractory Patients
TAS-102 is an orally administered combination of trifluridine, which is a thymidine-based nucleic acid analogue, and tipiracil hydrochloride, which is a thymidine phosphorylase inhibitor. When it was initially studied in Japan, it showed promise in patients with colorectal cancer. This led to small early clinical trials in the United States, which showed that TAS-102 is active in the treatment of refractory disease.
Dr. Mayer and colleagues subsequently conducted their phase 3 trial to evaluate the efficacy and safety of TAS-102 in patients from 13 countries, including Australia, Japan, the United States, and some European countries.
All 800 patients had metastatic colorectal cancer that was refractory to all standard therapies, including fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab. In addition, patients with wild-type KRAS tumors were refractory to cetuximab or panitumumab.
Study participants were randomly assigned in a 2:1 ratio to receive TAS-102 or placebo. The primary end point was overall survival.
More patients in the TAS-102 group than in the placebo group were still alive at 6 months (58% vs 44%) and at 12 months (27% vs 18%). And fewer patients in the TAS-102 group experienced disease progression or death (88% vs 94%).
Median progression-free survival was longer in the TAS-102 group than in the placebo group (2.0 vs 1.7 months; HR, 0.48; P < .001). Of the study participants, 760 were evaluated for tumor response (502 in the TAS-102 group and 258 in the placebo group). A partial response was achieved by eight patients in the TAS-102 group, and a complete response was achieved by one patient in the placebo group. This translated to objective response rates of 1.6% in the TAS-102 group and 0.4% in the placebo group (P = .29). When assessed at least 6 weeks after randomization, more patients in the TAS-102 group than in the placebo group achieved disease control, defined as a complete or partial response or stable disease (44% vs 16%; P < .001). Overall, adverse events of grade 3 or higher occurred more frequently in the TAS-102 group than in the placebo group (69% vs 52%). The most common clinically significant events associated with TAS-102 were neutropenia, which occurred in 38% of those treated, and leukopenia, which occurred in 21%. In addition, 4% of patients in the TAS-102 group developed febrile neutropenia, and one death was related to TAS-102. Also more common in the TAS-102 group than in the placebo group were nausea of grade 3 or higher (2% vs 1%), vomiting (2% vs <1%), and diarrhea (3% vs <1%). Use at Earlier Stage?
The next step will be to study TAS-102 in combination with other agents, and at an earlier stage in the course of the disease, Dr. Mayer explained.
Dr. Olszanski said he agrees that this is a feasible direction for the compound. "In this study, TAS-102 led to stabilization of disease in a heavily pretreated population. In an earlier setting, it could plausibly lead to increased responses," he noted.
"It clearly works through a different mechanism than 5-FU, and further studies at an earlier disease stage will be necessary before it will supplant 5-FU use," Dr. Olszanski added. "This study, as well as others, suggests that TAS-102 works even in patients resistant to 5-FU. TAS-102 works through a mechanism of action not previously exploited in the treatment of colorectal cancer and, as such, will likely become a welcome addition to the current armamentarium of treatment choices for patients."
The study was funded by Taiho Oncology–Taiho Pharmaceutical. Dr. Mayer has disclosed no relevant financial relationships. Several of his coauthors report relationships with industry, including the manufacturer, as detailed in the publication.
N Engl J Med. 2015;372:1909-1918. Abstract
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