Benefit and harms of new anti-cancer drugs

Vera-Badillo, Francisco E.; Al-Mubarak, Mustafa; Templeton, Arnoud J.; Amir, Eitan

doi:10.1007/s11912-013-0303-y

Cited by 35Statistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of LifeCancer Treatment and Pharmacology

Benefit and harms of new anti-cancer drugs

Vera-Badillo, Francisco E., Al-Mubarak, Mustafa, Templeton, Arnoud J., Amir, Eitan·2013·Current Oncology Reports

DOI 10.1007/s11912-013-0303-y

Open this paper in CoChat — free account

Abstract

Phase III randomized controlled trials (RCTs) assess clinically important differences in endpoints that reflect benefit to and harm of patients. Defining benefit of cancer drugs can be difficult. Overall survival and quality of life are the most relevant primary endpoints, but difficulty in measuring these mean that other endpoints are often used, although their surrogacy or clinical relevance has not always been established. In general, advances in drug development have led to numerous new drugs to enter the market. Pivotal RCT of several new drugs have shown that benefit appeared greater for targeted anticancer agents than for chemotherapeutic agents. This effect seems particularly evident with targeted agents evaluated in biomarker-driven studies. Unfortunately, new therapies have also shown an increase in toxicity. Such toxicity is not always evident in the initial reports of RCTs. This may be a result of a statistical inability to detect differences between arms of RCTs, or occasionally due to biased reporting. There are several examples where reports of new toxicities could only be found in drug labels. In some cases, the small improvement in survival has come at a cost of substantial excess toxicity, leading some to consider such therapy as having equipoise.

Integrity signals

Registry

Crossref · 10.1007/s11912-013-0303-y

Cites

33 of 33 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

No standard instrument exists for grading how much clinical benefit cancer therapies provide.
“To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies [25,26]”
From A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (2015) · cites this paper as [26]

Cost-Effectiveness in Health and Medicine
(1996) · doi:10.1093/oso/9780195108248.001.0001 · Cited by 7,193 · see citing works
Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial.
Burris, H. A., Moore, M. J., Andersen, J., Green, M. R., Rothenberg, M. L., Modiano, M., Cripps, M. C., Portenoy, R. K., Storniolo, A. M., Tarassoff, P. G., et al. (1997) · Journal of Clinical Oncology · doi:10.1200/jco.1997.15.6.2403 · Cited by 5,895 · see citing works
Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group
Moore, M. J., Goldstein, D., Hamm, J., Figer, A., Hecht, J. R., Gallinger, S., Au, H. J., Murawa, P., Walde, D., Wolff, R. A., et al. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.07.9525 · Cited by 3,848 · see citing works
Temsirolimus, Interferon Alfa, or Both for Advanced Renal-Cell Carcinoma
Hudes, G. R., Carducci, M. A., Tomczak, P., Dutcher, J. P., Figlin, R. A., Kapoor, A., Starosławska, E., Sosman, J. A., McDermott, D. F., Bodrogi, I., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa066838 · Cited by 3,645 · see citing works
Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial
Baum, M., Budzar, A. U., Cuzick, J. M., Forbes, J., Houghton, J., Klijn, J. G. M., & Sahmoud, T. (2002) · The Lancet · doi:10.1016/s0140-6736(02)09088-8 · Cited by 1,958 · see citing works
Surrogate End Points in Clinical Trials: Are We Being Misled?
Fleming, T. R., & DeMets, D. L. (1996) · Annals of Internal Medicine · doi:10.7326/0003-4819-125-7-199610010-00011 · Cited by 1,651 · see citing works
Eligibility Criteria of Randomized Controlled Trials Published in High-Impact General Medical Journals
Spall, H. G. C. V., Toren, A., Kiss, A., & Fowler, R. (2007) · JAMA · doi:10.1001/jama.297.11.1233 · Cited by 1,054 · see citing works
Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes
Boutron, I. (2010) · JAMA · doi:10.1001/jama.2010.651 · Cited by 842 · see citing works
Delivering affordable cancer care in high-income countries
Sullivan, R., Peppercorn, J., Sikora, K., Zalcberg, J., Meropol, N. J., Amir, E., Khayat, D., Boyle, P., Autier, P., Tannock, I. F., et al. (2011) · The Lancet Oncology · doi:10.1016/s1470-2045(11)70141-3 · Cited by 718 · see citing works
Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials
Sargent, D. J., Wieand, H. S., Haller, D. G., Gray, R., Benedetti, J. K., Buyse, M., Labianca, R., Seitz, J. F., O'Callaghan, C. J., Francini, G., et al. (2005) · Journal of Clinical Oncology · doi:10.1200/jco.2005.01.6071 · Cited by 713 · see citing works
Detecting an Overall Survival Benefit that Is Derived From Progression-Free Survival
Broglio, K. R., & Berry, D. A. (2009) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djp369 · Cited by 492 · see citing works
Pathologic Complete Response Predicts Recurrence-Free Survival More Effectively by Cancer Subset: Results From the I-SPY 1 TRIAL—CALGB 150007/150012, ACRIN 6657
Esserman, L. J., Berry, D. A., DeMichele, A. M., Carey, L., Davis, S., Buxton, M., Hudis, C., Gray, J. W., Perou, C. M., Yau, C. S. F., et al. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2011.39.2779 · Cited by 438 · see citing works
Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer
Prowell, T. M., & Pazdur, R. M. (2012) · New England Journal of Medicine · doi:10.1056/nejmp1205737 · Cited by 344 · see citing works
Reporting of Safety Results in Published Reports of Randomized Controlled Trials
(2009) · Archives of Internal Medicine · doi:10.1001/archinternmed.2009.306 · Cited by 287 · see citing works
Adverse Events in Randomized Trials
Ioannidis, J. P. A. (2009) · Archives of Internal Medicine · doi:10.1001/archinternmed.2009.313 · Cited by 243 · see citing works
Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer
Kesselheim, A. S. (2011) · JAMA · doi:10.1001/jama.2011.769 · Cited by 231 · see citing works
Accelerated Approval of Oncology Products: The Food and Drug Administration Experience
Johnson, J. R., Ning, Y. M., Farrell, A. T., Justice, R. L., Keegan, P., & Pazdur, R. (2011) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djr062 · Cited by 212 · see citing works
Adverse Event Detection in Drug Development: Recommendations and Obligations Beyond Phase 3
Berlin, J. A., Glasser, S. C., & Ellenberg, S. S. (2008) · American Journal of Public Health · doi:10.2105/ajph.2007.124537 · Cited by 210 · see citing works
The Price We Pay for Progress: A Meta-Analysis of Harms of Newly Approved Anticancer Drugs
Niraula, S., Šeruga, B., Ocaña, A., Shao, T., Goldstein, R., Tannock, I. F., & Amir, E. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2011.40.3824 · Cited by 171 · see citing works
End points in cancer clinical trials and the drug approval process.
Schilsky, R. L. (2002) · PubMed · Cited by 170 · see citing works
Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials
Tsang, R., Colley, L., & Lynd, L. D. (2008) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2008.08.005 · Cited by 139 · see citing works
Population-based differences in treatment outcome following anticancer drug therapies
Ma, B. B. Y., Hui, E. P., & Mok, T. S. K. (2010) · The Lancet Oncology · doi:10.1016/s1470-2045(09)70160-3 · Cited by 136 · see citing works
Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer
Vera-Badillo, F. E., Shapiro, R., Ocana, A., Amir, E., & Tannock, I. F. (2013) · Annals of Oncology · doi:10.1093/annonc/mds636 · Cited by 117 · see citing works
When are ‘positive’ clinical trials in oncology truly positive?
Ocana, A., & Tannock, I. F. (2011) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djq463 · Cited by 110 · see citing works
Reporting of Serious Adverse Drug Reactions of Targeted Anticancer Agents in Pivotal Phase III Clinical Trials
Šeruga, B., Sterling, L., Wang, L. E., & Tannock, I. F. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2010.31.9624 · Cited by 107 · see citing works
Incremental Advance or Seismic Shift? The Need to Raise the Bar of Efficacy for Drug Approval
Sobrero, A. F., & Bruzzi, P. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2009.22.4162 · Cited by 99 · see citing works
Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?
Richey, E. A., Lyons, E. A., Nebeker, J. R., Shankaran, V., McKoy, J. M., Luu, T. H., Nonzee, N. J., Trifilio, S. M., Sartor, O. A., Benson, A. B., et al. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2008.21.1961 · Cited by 85 · see citing works
Oncogenic Targets, Magnitude of Benefit, and Market Pricing of Antineoplastic Drugs
Amir, E., Šeruga, B., Martínez‐López, J., Kwong, R. C., Pandiella, A., Tannock, I. F., & Ocaña, A. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2011.35.2393 · Cited by 68 · see citing works
New FDA Regulation to Improve Safety Reporting in Clinical Trials
Behrman Sherman, R., Woodcock, J., Norden, J., Grandinetti, C., & Temple, R. J. (2011) · New England Journal of Medicine · doi:10.1056/nejmp1103464 · Cited by 50 · see citing works
Clinical benefit in oncology trials: Is this a patient-centred or tumour-centred end-point?
Ohorodnyk, P., Eisenhauer, E. A., & Booth, C. M. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2009.05.033 · Cited by 45 · see citing works
What Constitutes Reasonable Evidence of Efficacy and Effectiveness to Guide Oncology Treatment Decisions?
Sargent, D. J. (2010) · The Oncologist · doi:10.1634/theoncologist.2010-s1-19 · Cited by 36 · see citing works
Endpoints and surrogate endpoints in colorectal cancer: a review of recent developments
Piedbois, P., & Buyse, M. E. (2008) · Current Opinion in Oncology · doi:10.1097/cco.0b013e32830218fe · Cited by 20 · see citing works
Clinical Research: Show Us the Data
Ocaña, A., Amir, E., & Šeruga, B. (2011) · Journal of Clinical Oncology · doi:10.1200/jco.2010.33.1462 · Cited by 10 · see citing works

Flagged first, then by citations

Sorted by citations

A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS)
Cherny, N. I., Sullivan, R., Dafni, U., Kerst, J. M., Sobrero, A., Zielinski, C., de Vries, E. G. E., & Piccart, M. J. (2015) · Annals of Oncology · doi:10.1093/annonc/mdv249 · Cited by 818 · see citing works
ecancermedicalscience
Pantziarka, P., Bouche, G., Meheus, L., Sukhatme, V. V., Sukhatme, V. P., & Vikas, P. (2016) · ecancermedicalscience · doi:10.3332/ecancer.2014.442 · Cited by 173 · see citing works
A Light-Driven Therapy of Pancreatic Adenocarcinoma Using Gold Nanorods-Based Nanocarriers for Co-Delivery of Doxorubicin and siRNA
Yin, F., Yang, C., Wang, Q., Zeng, S., Hu, R., Lin, G., Tian, J., Hu, S., Lan, R. F., Yoon, H. S., et al. (2015) · Theranostics · doi:10.7150/thno.11335 · Cited by 120 · see citing works
Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration
Tibau, A., Moltó, C., Ocaña, A., Templeton, A. J., del Carpio, L. P., Paggio, J. C. D., Barnadas, A., Booth, C. M., & Amir, E. (2017) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djx232 · Cited by 89 · see citing works
Artocarpin, an isoprenyl flavonoid, induces p53-dependent or independent apoptosis via ROS-mediated MAPKs and Akt activation in non-small cell lung cancer cells
Tsai, M.-H., Liu, J., Chiang, Y., Hu, S. C., Hsu, L.-F., Lin, Y., Lin, Z., Lee, H.-C., Chen, M.-C., Huang, C., et al. (2017) · Oncotarget · doi:10.18632/oncotarget.16058 · Cited by 68 · see citing works
Postdiagnosis Weight Change and Survival Following a Diagnosis of Early-Stage Breast Cancer
Feliciano, E. M. C., Kroenke, C. H., Bradshaw, P. T., Chen, W. Y., Prado, C. M. M., Weltzien, E. K., Castillo, A., & Caan, B. J. (2016) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-16-0150 · Cited by 65 · see citing works
European Code against Cancer 4th Edition: Medical exposures, including hormone therapy, and cancer
Friis, S., Kesminiene, A., Espina, C., Auvinen, A. P., Straíf, K., & Schüz, J. (2015) · Cancer Epidemiology · doi:10.1016/j.canep.2015.08.003 · Cited by 43 · see citing works
Synthesis, cytotoxic activity evaluation and HQSAR study of novel isosteviol derivatives as potential anticancer agents
Liu, C., Yu, S., Liu, Y., Dai, X., Wu, Y., Li, R.-J., & Tao, J. (2016) · European Journal of Medicinal Chemistry · doi:10.1016/j.ejmech.2016.03.009 · Cited by 42 · see citing works
Tubulin inhibitors. Selected scaffolds and main trends in the design of novel anticancer and antiparasitic agents
Podolak, M., Holota, S. M., Deyak, Y., Dziduch, K., Dudchak, R., Wujec, M., Bielawski, K., Lesyk, R., & Bielawska, A. (2023) · Bioorganic Chemistry · doi:10.1016/j.bioorg.2023.107076 · Cited by 34 · see citing works
Indazole-based microtubule-targeting agents as potential candidates for anticancer drugs discovery
Pal, D., Song, I., Warkad, S. D., Song, K., Yeom, G. S., Saha, S., Shinde, P. B., & Nimse, S. B. (2022) · Bioorganic Chemistry · doi:10.1016/j.bioorg.2022.105735 · Cited by 33 · see citing works
Can Chemotherapy-Related Acute Care Visits Be Accurately Identified in Administrative Data?
Krzyzanowska, M. K., Enright, K. A., Moineddin, R., Yun, L., Powis, M., Ghannam, M., & Grunfeld, E. (2017) · Journal of Oncology Practice · doi:10.1200/jop.2017.023697 · Cited by 29 · see citing works
Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment
Gyawali, B., Hwang, T. J., Vokinger, K. N., Booth, C. M., Amir, E., & Tibau, A. (2019) · American Society of Clinical Oncology Educational Book · doi:10.1200/edbk_242229 · Cited by 27 · see citing works
Oxygen kinetics in the vitreous substitute perfluorotributylamine: a 19F NMR study in vivo.
Berkowitz, B. A., Wilson, C. A., & Hatchell, D. L. (1991) · PubMed · Cited by 27 · see citing works
Antitumor Effects of Systemic DNAse I and Proteases in an In Vivo Model
Trejo‐Becerril, C., Pérez‐Cárdenas, E., Gutierrez-Diaz, B. T., Cruz-Sigüenza, D. D. L., Taja‐Chayeb, L., González-Ballesteros, M. M., García‐López, P., Chanona, J., & Dueñas‐González, A. (2016) · Integrative Cancer Therapies · doi:10.1177/1534735416631102 · Cited by 26 · see citing works
Diethyldithiocarbamate complexes with metals used as food supplements show different effects in cancer cells
Sedláček, J., Martins, L. M. D. R. S., Daněk, P., Pombeiro, A. J. L., & Cvek, B. (2014) · Journal of Applied Biomedicine · doi:10.1016/j.jab.2014.04.002 · Cited by 23 · see citing works
The European Society for Medical Oncology Magnitude of Clinical Benefit Scale in daily practice: a single institution, real-life experience at the Medical University of Vienna
Kiesewetter, B., Raderer, M., Steger, G. G., Bartsch, R., Pirker, R., Zöchbauer‐Müller, S., Prager, G. W., Krainer, M., Preusser, M., Schmidinger, M., et al. (2016) · ESMO Open · doi:10.1136/esmoopen-2016-000066 · Cited by 21 · see citing works
Barley grass extract causes apoptosis of cancer cells by increasing intracellular reactive oxygen species production
Woo, S. M., Kwon, S.-C., Ko, S., & Cho, S. (2017) · Biomedical Reports · doi:10.3892/br.2017.897 · Cited by 22 · see citing works
Nine-year change in statistical design, profile, and success rates of Phase II oncology trials
Ivanova, A., Paul, B. A., Marchenko, O., Song, G., Patel, N., & Moschos, S. J. (2015) · Journal of Biopharmaceutical Statistics · doi:10.1080/10543406.2015.1092030 · Cited by 21 · see citing works
Preliminary Development and Evaluation of an Algorithm to Identify Breast Cancer Chemotherapy Toxicities Using Electronic Medical Records and Administrative Data
Mandelblatt, J. S., Huang, K., Makgoeng, S. B., Luta, G., Song, J., Tallarico, M., Roh, J. M., Munneke, J. R., Houlston, C. A., McGuckin, M., et al. (2015) · Journal of Oncology Practice · doi:10.1200/jop.2013.001288 · Cited by 18 · see citing works
In and Out, Good and Bad News, of Generalizability of SWOG Treatment Trial Results
Bleyer, A. (2014) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/dju027 · Cited by 16 · see citing works
ClinicalTrials.gov for Facilitating Rapid Understanding of Potential Harms of New Drugs: The Case of Checkpoint Inhibitors
Yang, A. W., Baxi, S. S., & Korenstein, D. R. (2018) · Journal of Oncology Practice · doi:10.1200/jop.2017.025114 · Cited by 13 · see citing works
Target identification of a novel unsymmetrical 1,3,4‐oxadiazole derivative with antiproliferative properties
Lyu, W., Sanna, L., Bordoni, V., Zeng, T., Li, C., Murineddu, G., Pinna, G. A., Kelvin, D. J., & Bagella, L. (2020) · Journal of Cellular Physiology · doi:10.1002/jcp.30120 · Cited by 9 · see citing works
Protecting Mechanisms of Saffron Extract Against Doxorubicin Toxicity in Ischemic Heart
Chahine, N. R., & Chahine, R. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-818462-2.00012-7 · Cited by 8 · see citing works
Implementation of Simulated Annealing-Support Vector Machine on QSAR Study of Indenopyrazole Derivative as Anti-Cancer Agent
Rizqi, M. F., Septiawan, R. R., & Kurniawan, I. (2021) · doi:10.1109/icoict52021.2021.9527416 · Cited by 8 · see citing works
Quantitative mRNA expression analysis of selected genes in patients with early-stage hypothyroidism induced by treatment with iodine-131
GUO, K., Gao, R., Yu, Y., Zhang, W., Yang, Y., & Yang, A. (2015) · Molecular Medicine Reports · doi:10.3892/mmr.2015.4350 · Cited by 7 · see citing works
Establishment and characterization of patient-derived xenograft and its cell line of primary leiomyosarcoma of bone
Oyama, R., Takahashi, M., Kito, F., Sakumoto, M., Shiozawa, K., Qiao, Z., Yoshida, A., Endo, M., Kawai, A., & Kondo, T. (2018) · In Vitro Cellular & Developmental Biology - Animal · doi:10.1007/s11626-018-0258-2 · Cited by 6 · see citing works
Chemistry, biochemistry, and mechanism of pharmacological actions of crocetin
Zeb, A., & Al‐Babili, S. (2025) · European Journal of Medicinal Chemistry · doi:10.1016/j.ejmech.2025.118401 · Cited by 3 · see citing works
Classification of CDK2 Inhibitor as Anti-Cancer Agent by Using Simulated Annealing-Support Vector Machine Methods
Ikhsanurahman, R. Y., Ikhsan, N., & Kurniawan, I. (2022) · International Conference on Data Science and Its Applications (ICoDSA) · doi:10.1109/icodsa55874.2022.9862929 · Cited by 3 · see citing works
Microbiota-Mediated Modulation of Chemotherapeutic Drug Efficacy in Colorectal Cancer: An In-Depth Analysis of Six Key Drugs
Dalal, P., Bajaj, N., Katiyar, U., & Sharma, D. (2025) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.5c00587 · Cited by 1 · see citing works
Synthesis and Study of the Structure–Activity Relationship of Antiproliferative N-Substituted Isosteviol-Based 1,3-Aminoalcohols
Ozsvár, D., Bózsity, N., Zupkó, I., & Szakonyi, Z. (2024) · Pharmaceuticals · doi:10.3390/ph17020262 · Cited by 1 · see citing works
A Novel Prognostic Biomarker, Pfetin, in Gastrointestinal Stromal Tumors: Proteomics Study
Kondo, T. (2014) · Springer eBooks · doi:10.1007/978-94-007-7740-8_26-1
Endocrine and associated consequences of conservative and chemo- and hormonal therapy in cancer treatment: opportunities and extent of the feasibility of correction.
Berstein, L. M. (2015) · Malignant tumours · doi:10.18027/2224-5057-2013-2-12-17
Novel Prognostic Biomarker, Pfetin, in Gastrointestinal Stromal Tumors: Proteomics Study
Kondo, T. (2015) · Biomarkers in disease · doi:10.1007/978-94-007-7696-8_26
Antiproliferative Activity of Novel Isosteviol-Derived 1,3-Aminoalcohols: Synthesis and Structure–Activity Relationships
Rossi, M., Conti, P., & Bianchi, G. F. (2024) · Pharmaceutical Sciences and Drug Design · doi:10.51847/43aohcfff4
Validation de nouvelles cibles thérapeutiques dans le glioblastome par une approche de pharmacologie fonctionnelle
Ariey-Bonnet, J. (2020) · theses.fr (ABES) · doi:10.70675/63ceaea1ze673z40c3z9960zed4c40d88ea9

The Price We Pay for Progress: A Meta-Analysis of Harms of Newly Approved Anticancer Drugs
Niraula, S., Šeruga, B., Ocaña, A., Shao, T., Goldstein, R., Tannock, I. F., & Amir, E. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2011.40.3824 · Cited by 171 · see citing works
Safety and tolerability of cancer drugs studied in phase 3 randomized controlled trials (RCTs) over the last decade.
Ribnikar, D., Goldvaser, H., Ocaña, A., Templeton, A. J., Šeruga, B., & Amir, E. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2018.36.15_suppl.6588
Efficacy, safety and tolerability of drugs studied in phase 3 randomized controlled trials in solid tumors over the last decade
Ribnikar, D., Goldvaser, H., Veitch, Z. W. N., Ocaña, A., Templeton, A. J., Šeruga, B., & Amir, E. (2021) · Scientific Reports · doi:10.1038/s41598-021-90403-3 · Cited by 3 · see citing works
Comparison of results between the first and updated reports of phase III clinical trials (RCTs).
Elimova, E. C., Šeruga, B., Jiang, H., & Tannock, I. F. (2014) · Journal of Clinical Oncology · doi:10.1200/jco.2014.32.15_suppl.6520 · Cited by 3 · see citing works
Associations between safety, tolerability, and toxicity and the reporting of health‐related quality of life in phase III randomized trials in common solid tumors
Saleh, R., Meti, N., Ribnikar, D., Goldvaser, H., Ocaña, A., Templeton, A. J., Šeruga, B., & Amir, E. (2020) · Cancer Medicine · doi:10.1002/cam4.3390 · Cited by 5 · see citing works

Authors: Vera-Badillo, F. E., Al-Mubarak, M., Templeton, A. J., & Amir, E.
Affiliations: University of Toronto (CA)
Corresponding author: Amir, Eitan
ORCID: Vera-Badillo, Francisco E.
Templeton, Arnoud J.
Amir, Eitan
Venue: Current Oncology Reports
Publisher: Springer Science and Business Media LLC
Published: 2013-02-23
Volume: 15
Issue: 3
Pages: 270-275
ISSN: 1523-3790 (ISSN-L)
1534-6269
DOI: 10.1007/s11912-013-0303-y
OpenAlex: W1976794477
Cited by: 35
References: 33
Citations by year: 2025: 2 · 2024: 2 · 2023: 1 · 2022: 2 · 2021: 1 · 2020: 3 · 2019: 1 · 2018: 2 · 2017: 4 · 2016: 5 · 2015: 8 · 2014: 3
FWCI: 1.05
Type: journal article
Language: en
Open access: closed
Licence: www.springer.com/tdm (tdm)
Locations: Current Oncology Reports (publishedVersion)
PubMed (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
Keywords: anticancer agents, targeted therapy, chemotherapy, drug toxicity, surrogate endpoints, overall survival, quality of life, biomarker-driven trials, equipoise, drug labeling, benefit-harm assessment
MeSH terms: Antineoplastic Agents, Cost-Benefit Analysis, Drug Eruptions, Drug Labeling, Female, Humans, Male, Neoplasms, United States, United States Food and Drug Administration, Drug Design, Randomized Controlled Trials as Topic, Risk Assessment, Disease-Free Survival, Neurotoxicity Syndromes

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

Benefit and harms of new anti-cancer drugs

Abstract

Integrity signals

Claims the paper makes

Claims other papers make about this one

Cites

Cited by

Related

Record

About these checks