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JNCI Journal of the National Cancer Institute 2000 92(3):205-216; doi:10.1093/jnci/92.3.205
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Journal of the National Cancer Institute, Vol. 92, No. 3, 205-216, February 2, 2000
© 2000 Oxford University Press

SPECIAL ARTICLE

New Guidelines to Evaluate the Response to Treatment in Solid Tumors

Patrick Therasse, Susan G. Arbuck, Elizabeth A. Eisenhauer, Jantien Wanders, Richard S. Kaplan, Larry Rubinstein, Jaap Verweij, Martine Van Glabbeke, Allan T. van Oosterom, Michaele C. Christian, Steve G. Gwyther

Affiliations of authors: P. Therasse, J. Verweij, M. Van Glabbeke, A. T. van Oosterom, European Organization for Research and Treatment of Cancer, Brussels, Belgium; S. G. Arbuck, R. S. Kaplan, L. Rubinstein, M. C. Christian, National Cancer Institute, Bethesda, MD; E. A. Eisenhauer, National Cancer Institute of Canada Clinical Trials Group, Kingston, ON, Canada; J. Wanders, New Drug Development Office Oncology, Amsterdam, The Netherlands; S. G. Gwyther, East Surrey Healthcare National Health Service Trust, Redhill, U.K.

Correspondence to: Patrick Therasse, M.D., European Organization for Research and Treatment of Cancer Data Center, Avenue Mounier 83/11, 1200 Brussels, Belgium (e-mail: pth{at}eortc.be).

Anticancer cytotoxic agents go through a process by which their antitumor activity—on the basis of the amount of tumor shrinkage they could generate—has been investigated. In the late 1970s, the International Union Against Cancer and the World Health Organization introduced specific criteria for the codification of tumor response evaluation. In 1994, several organizations involved in clinical research combined forces to tackle the review of these criteria on the basis of the experience and knowledge acquired since then. After several years of intensive discussions, a new set of guidelines is ready that will supersede the former criteria. In parallel to this initiative, one of the participating groups developed a model by which response rates could be derived from unidimensional measurement of tumor lesions instead of the usual bidimensional approach. This new concept has been largely validated by the Response Evaluation Criteria in Solid Tumors Group and integrated into the present guidelines. This special article also provides some philosophic background to clarify the various purposes of response evaluation. It proposes a model by which a combined assessment of all existing lesions, characterized by target lesions (to be measured) and nontarget lesions, is used to extrapolate an overall response to treatment. Methods of assessing tumor lesions are better codified, briefly within the guidelines and in more detail in Appendix I. All other aspects of response evaluation have been discussed, reviewed, and amended whenever appropriate.


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Correspondence about this Article

Re: New Guidelines to Evaluate the Response to Treatment in Solid Tumors [Ovarian Cancer]
Ignace Vergote, Gordon J. S. Rustin, Elisabeth A. Eisenhauer, Gunnar B. Kristensen, Eric Pujade-Lauraine, Mahesh K. B. Parmar, Michael Friedlander, Anders Jakobsen, and Jan B. Vermorken
J Natl Cancer Inst 2000 92: 1534-1535. [Extract] [Full Text] [PDF]

Re: New Guidelines to Evaluate the Response to Treatment in Solid Tumors (Ovarian Cancer)
Gordon J. S. Rustin, Michael Quinn, Tate Thigpen, Andreas du Bois, Eric Pujade-Lauraine, Anders Jakobsen, Elizabeth Eisenhauer, Satoru Sagae, Kathryn Greven, Ignace Vergote, Andres Cervantes, and Jan Vermorken
J Natl Cancer Inst 2004 96: 487-488. [Extract] [Full Text] [PDF]



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A. Kim, A. Gillespie, E. Dombi, A. Goodwin, W. Goodspeed, E. Fox, F. M. Balis, and B. C. Widemann
Characteristics of children enrolled in treatment trials for NF1-related plexiform neurofibromas
Neurology, October 20, 2009; 73(16): 1273 - 1279.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
E. Briasoulis, P. Pappas, C. Puozzo, C. Tolis, G. Fountzilas, U. Dafni, M. Marselos, and N. Pavlidis
Dose-Ranging Study of Metronomic Oral Vinorelbine in Patients with Advanced Refractory Cancer
Clin. Cancer Res., October 15, 2009; 15(20): 6454 - 6461.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
K. N. Syrigos, J. Vansteenkiste, P. Parikh, J. von Pawel, C. Manegold, R. G. Martins, L. Simms, K. P. Sugarman, C. Visseren-Grul, and G. V. Scagliotti
Prognostic and predictive factors in a randomized phase III trial comparing cisplatin-pemetrexed versus cisplatin-gemcitabine in advanced non-small-cell lung cancer
Ann. Onc., October 14, 2009; (2009) mdp392v1.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
D. S. Boss, G. K. Schwartz, M. R. Middleton, D. D. Amakye, H. Swaisland, R. S. Midgley, M. Ranson, S. Danson, H. Calvert, R. Plummer, et al.
Safety, tolerability, pharmacokinetics and pharmacodynamics of the oral cyclin-dependent kinase inhibitor AZD5438 when administered at intermittent and continuous dosing schedules in patients with advanced solid tumours
Ann. Onc., October 13, 2009; (2009) mdp377v1.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
H. Joensuu, L. Sailas, T. Alanko, K. Sunela, R. Huuhtanen, M. Utriainen, R. Kokko, P. Bono, T. Wigren, S. Pyrhonen, et al.
Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial
Ann. Onc., October 9, 2009; (2009) mdp397v1.
[Abstract] [Full Text] [PDF]

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 JCOHome page
H. S. Friedman, M. D. Prados, P. Y. Wen, T. Mikkelsen, D. Schiff, L. E. Abrey, W.K. A. Yung, N. Paleologos, M. K. Nicholas, R. Jensen, et al.
Bevacizumab Alone and in Combination With Irinotecan in Recurrent Glioblastoma
J. Clin. Oncol., October 1, 2009; 27(28): 4733 - 4740.
[Abstract] [Full Text] [PDF]

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 JCOHome page
B. J. Monk, M. W. Sill, D. S. McMeekin, D. E. Cohn, L. M. Ramondetta, C. H. Boardman, J. Benda, and D. Cella
Phase III Trial of Four Cisplatin-Containing Doublet Combinations in Stage IVB, Recurrent, or Persistent Cervical Carcinoma: A Gynecologic Oncology Group Study
J. Clin. Oncol., October 1, 2009; 27(28): 4649 - 4655.
[Abstract] [Full Text] [PDF]

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 JCOHome page
M. A. Socinski, E. F. Smit, P. Lorigan, K. Konduri, M. Reck, A. Szczesna, J. Blakely, P. Serwatowski, N. A. Karaseva, T. Ciuleanu, et al.
Phase III Study of Pemetrexed Plus Carboplatin Compared With Etoposide Plus Carboplatin in Chemotherapy-Naive Patients With Extensive-Stage Small-Cell Lung Cancer
J. Clin. Oncol., October 1, 2009; 27(28): 4787 - 4792.
[Abstract] [Full Text] [PDF]

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 Am. J. Roentgenol.Home page
J. Wang, N. Wu, M. D. Cham, and Y. Song
Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Perfusion CT Evaluation of Chemotherapy and Radiation Therapy
Am. J. Roentgenol., October 1, 2009; 193(4): 1090 - 1096.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
J.-C. Soria, F. A. Shepherd, J.-Y. Douillard, J. Wolf, G. Giaccone, L. Crino, F. Cappuzzo, S. Sharma, S. H. Gross, S. Dimitrijevic, et al.
Efficacy of everolimus (RAD001) in patients with advanced NSCLC previously treated with chemotherapy alone or with chemotherapy and EGFR inhibitors
Ann. Onc., October 1, 2009; 20(10): 1674 - 1681.
[Abstract] [Full Text] [PDF]

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 Anticancer ResHome page
K. YAMAMOTO, Y. FUJIWARA, T. NISHIDA, S. TAKIGUCHI, K. NAKAJIMA, H. MIYATA, M. YAMASAKI, M. MORI, and Y. DOKI
Induction Chemotherapy with Docetaxel, 5-FU and CDDP (DFP) for Advanced Gastric Cancer
Anticancer Res, October 1, 2009; 29(10): 4211 - 4215.
[Abstract] [Full Text] [PDF]

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 Anticancer ResHome page
R. MARUYAMA, H. WATAYA, T. SETO, and Y. ICHINOSE
Treatment after the Failure of Gefitinib in Patients with Advanced or Recurrent Non-small Cell Lung Cancer
Anticancer Res, October 1, 2009; 29(10): 4217 - 4221.
[Abstract] [Full Text] [PDF]

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 Anticancer ResHome page
Y. W. MOON, J. H. SOHN, Y. T. KIM, H. CHANG, J. H. JEONG, Y. J. LEE, J. CHANG, S. K. KIM, M. JUNG, S. HONG, et al.
Adenosine Triphosphate-based Chemotherapy Response Assay (ATP-CRA)-guided versus Empirical Chemotherapy in Unresectable Non-small Cell Lung Cancer
Anticancer Res, October 1, 2009; 29(10): 4243 - 4249.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. L. Maitland, K. E. Kasza, T. Karrison, K. Moshier, L. Sit, H. R. Black, S. D. Undevia, W. M. Stadler, W. J. Elliott, and M. J. Ratain
Ambulatory Monitoring Detects Sorafenib-Induced Blood Pressure Elevations on the First Day of Treatment
Clin. Cancer Res., October 1, 2009; 15(19): 6250 - 6257.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
B. I. Rini, J. A. Garcia, M. M. Cooney, P. Elson, A. Tyler, K. Beatty, J. Bokar, T. Mekhail, R.M. Bukowski, G. T. Budd, et al.
A Phase I Study of Sunitinib plus Bevacizumab in Advanced Solid Tumors
Clin. Cancer Res., October 1, 2009; 15(19): 6277 - 6283.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. Ribas, B. Comin-Anduix, B. Chmielowski, J. Jalil, P. de la Rocha, T. A. McCannel, M. T. Ochoa, E. Seja, A. Villanueva, D. K. Oseguera, et al.
Dendritic Cell Vaccination Combined with CTLA4 Blockade in Patients with Metastatic Melanoma
Clin. Cancer Res., October 1, 2009; 15(19): 6267 - 6276.
[Abstract] [Full Text] [PDF]

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 BloodHome page
W. R. Burns, Z. Zheng, S. A. Rosenberg, and R. A. Morgan
Lack of specific {gamma}-retroviral vector long terminal repeat promoter silencing in patients receiving genetically engineered lymphocytes and activation upon lymphocyte restimulation
Blood, October 1, 2009; 114(14): 2888 - 2899.
[Abstract] [Full Text] [PDF]

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 JCOHome page
B. I. Rini, G. Wilding, G. Hudes, W. M. Stadler, S. Kim, J. Tarazi, B. Rosbrook, P. C. Trask, L. Wood, and J. P. Dutcher
Phase II Study of Axitinib in Sorafenib-Refractory Metastatic Renal Cell Carcinoma
J. Clin. Oncol., September 20, 2009; 27(27): 4462 - 4468.
[Abstract] [Full Text] [PDF]

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 JCOHome page
G. Di Lorenzo, G. Carteni, R. Autorino, G. Bruni, M. Tudini, M. Rizzo, M. Aieta, A. Gonnella, P. Rescigno, S. Perdona, et al.
Phase II Study of Sorafenib in Patients With Sunitinib-Refractory Metastatic Renal Cell Cancer
J. Clin. Oncol., September 20, 2009; 27(27): 4469 - 4474.
[Abstract] [Full Text] [PDF]

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 JCOHome page
W. L. Furman, F. Navid, N. C. Daw, M. B. McCarville, L. M. McGregor, S. L. Spunt, C. Rodriguez-Galindo, J. C. Panetta, K. R. Crews, J. Wu, et al.
Tyrosine Kinase Inhibitor Enhances the Bioavailability of Oral Irinotecan in Pediatric Patients With Refractory Solid Tumors
J. Clin. Oncol., September 20, 2009; 27(27): 4599 - 4604.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. A. Sparano, A. N. Makhson, V. F. Semiglazov, S. A. Tjulandin, O. I. Balashova, I. N. Bondarenko, N. V. Bogdanova, G. M. Manikhas, G. P. Oliynychenko, V. A. Chatikhine, et al.
Pegylated Liposomal Doxorubicin Plus Docetaxel Significantly Improves Time to Progression Without Additive Cardiotoxicity Compared With Docetaxel Monotherapy in Patients With Advanced Breast Cancer Previously Treated With Neoadjuvant-Adjuvant Anthracycline Therapy: Results From a Randomized Phase III Study
J. Clin. Oncol., September 20, 2009; 27(27): 4522 - 4529.
[Abstract] [Full Text] [PDF]

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 JCOHome page
J. Bellmunt, C. Theodore, T. Demkov, B. Komyakov, L. Sengelov, G. Daugaard, A. Caty, J. Carles, A. Jagiello-Gruszfeld, O. Karyakin, et al.
Phase III Trial of Vinflunine Plus Best Supportive Care Compared With Best Supportive Care Alone After a Platinum-Containing Regimen in Patients With Advanced Transitional Cell Carcinoma of the Urothelial Tract
J. Clin. Oncol., September 20, 2009; 27(27): 4454 - 4461.
[Abstract] [Full Text] [PDF]

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 JCOHome page
G. Giaccone, P. Zatloukal, J. Roubec, K. Floor, J. Musil, M. Kuta, R. J. van Klaveren, S. Chaudhary, A. Gunther, and S. Shamsili
Multicenter Phase II Trial of YM155, a Small-Molecule Suppressor of Survivin, in Patients With Advanced, Refractory, Non-Small-Cell Lung Cancer
J. Clin. Oncol., September 20, 2009; 27(27): 4481 - 4486.
[Abstract] [Full Text] [PDF]

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 JCOHome page
S. L. Ellard, M. Clemons, K. A. Gelmon, B. Norris, H. Kennecke, S. Chia, K. Pritchard, A. Eisen, T. Vandenberg, M. Taylor, et al.
Randomized Phase II Study Comparing Two Schedules of Everolimus in Patients With Recurrent/Metastatic Breast Cancer: NCIC Clinical Trials Group IND.163
J. Clin. Oncol., September 20, 2009; 27(27): 4536 - 4541.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
D. D. Von Hoff, P. M. LoRusso, C. M. Rudin, J. C. Reddy, R. L. Yauch, R. Tibes, G. J. Weiss, M. J. Borad, C. L. Hann, J. R. Brahmer, et al.
Inhibition of the Hedgehog Pathway in Advanced Basal-Cell Carcinoma
N. Engl. J. Med., September 17, 2009; 361(12): 1164 - 1172.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. D. Demetri, P. G. Casali, J.-Y. Blay, M. von Mehren, J. A. Morgan, R. Bertulli, I. Ray-Coquard, P. Cassier, M. Davey, H. Borghaei, et al.
A Phase I Study of Single-Agent Nilotinib or in Combination with Imatinib in Patients with Imatinib-Resistant Gastrointestinal Stromal Tumors
Clin. Cancer Res., September 15, 2009; 15(18): 5910 - 5916.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
G. D. Demetri, M. C. Heinrich, J. A. Fletcher, C. D.M. Fletcher, A. D. Van den Abbeele, C. L. Corless, C. R. Antonescu, S. George, J. A. Morgan, M. H. Chen, et al.
Molecular Target Modulation, Imaging, and Clinical Evaluation of Gastrointestinal Stromal Tumor Patients Treated with Sunitinib Malate after Imatinib Failure
Clin. Cancer Res., September 15, 2009; 15(18): 5902 - 5909.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
S. E. DePrimo, X. Huang, M. E. Blackstein, C. R. Garrett, C. S. Harmon, P. Schoffski, M. H. Shah, J. Verweij, C. M. Baum, and G. D. Demetri
Circulating Levels of Soluble KIT Serve as a Biomarker for Clinical Outcome in Gastrointestinal Stromal Tumor Patients Receiving Sunitinib following Imatinib Failure
Clin. Cancer Res., September 15, 2009; 15(18): 5869 - 5877.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
T. Bekaii-Saab, J. Markowitz, N. Prescott, W. Sadee, N. Heerema, L. Wei, Z. Dai, A. Papp, A. Campbell, K. Culler, et al.
A Multi-Institutional Phase II Study of the Efficacy and Tolerability of Lapatinib in Patients with Advanced Hepatocellular Carcinomas
Clin. Cancer Res., September 15, 2009; 15(18): 5895 - 5901.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
M. K. Chung, H.-S. Jeong, S. G. Park, J. Y. Jang, Y.-I. Son, J. Y. Choi, S. H. Hyun, K. Park, M.-J. Ahn, Y. C. Ahn, et al.
Metabolic Tumor Volume of [18F]-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Predicts Short-Term Outcome to Radiotherapy With or Without Chemotherapy in Pharyngeal Cancer
Clin. Cancer Res., September 15, 2009; 15(18): 5861 - 5868.
[Abstract] [Full Text] [PDF]

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 JCOHome page
G. R. Blumenschein Jr, U. Gatzemeier, F. Fossella, D. J. Stewart, L. Cupit, F. Cihon, J. O'Leary, and M. Reck
Phase II, Multicenter, Uncontrolled Trial of Single-Agent Sorafenib in Patients With Relapsed or Refractory, Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol., September 10, 2009; 27(26): 4274 - 4280.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. T. Shaw, B. Y. Yeap, M. Mino-Kenudson, S. R. Digumarthy, D. B. Costa, R. S. Heist, B. Solomon, H. Stubbs, S. Admane, U. McDermott, et al.
Clinical Features and Outcome of Patients With Non-Small-Cell Lung Cancer Who Harbor EML4-ALK
J. Clin. Oncol., September 10, 2009; 27(26): 4247 - 4253.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
T. S. Mok, Y.-L. Wu, S. Thongprasert, C.-H. Yang, D.-T. Chu, N. Saijo, P. Sunpaweravong, B. Han, B. Margono, Y. Ichinose, et al.
Gefitinib or Carboplatin-Paclitaxel in Pulmonary Adenocarcinoma
N. Engl. J. Med., September 3, 2009; 361(10): 947 - 957.
[Abstract] [Full Text] [PDF]

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 Eur. J. Cardiothorac. Surg.Home page
H. Decaluwe, P. De Leyn, J. Vansteenkiste, C. Dooms, D. Van Raemdonck, P. Nafteux, W. Coosemans, and T. Lerut
Surgical multimodality treatment for baseline resectable stage IIIA-N2 non-small cell lung cancer. Degree of mediastinal lymph node involvement and impact on survival
Eur. J. Cardiothorac. Surg., September 1, 2009; 36(3): 433 - 439.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
C. L Ronchi, S. Sbiera, L. Kraus, S. Wortmann, S. Johanssen, P. Adam, H. S Willenberg, S. Hahner, B. Allolio, and M. Fassnacht
Expression of excision repair cross complementing group 1 and prognosis in adrenocortical carcinoma patients treated with platinum-based chemotherapy
Endocr. Relat. Cancer, September 1, 2009; 16(3): 907 - 918.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
W. Fenske, H.-U. Volker, P. Adam, S. Hahner, S. Johanssen, S. Wortmann, M. Schmidt, M. Morcos, H.-K. Muller-Hermelink, B. Allolio, et al.
Glucose transporter GLUT1 expression is an stage-independent predictor of clinical outcome in adrenocortical carcinoma
Endocr. Relat. Cancer, September 1, 2009; 16(3): 919 - 928.
[Abstract] [Full Text] [PDF]

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 Endocr Relat CancerHome page
R Srirajaskanthan, G Dancey, A Hackshaw, T Luong, M E Caplin, and T Meyer
Circulating angiopoietin-2 is elevated in patients with neuroendocrine tumours and correlates with disease burden and prognosis
Endocr. Relat. Cancer, September 1, 2009; 16(3): 967 - 976.
[Abstract] [Full Text] [PDF]

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 Therapeutic Advances in Medical OncologyHome page
J. S.W. Lind and E. F. Smit
Review: Angiogenesis inhibitors in the treatment of non-small cell lung cancer
Therapeutic Advances in Medical Oncology, September 1, 2009; 1(2): 95 - 107.
[Abstract] [PDF]

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 Jpn J Clin OncolHome page
Y. H. Kim, K. Kubota, K. Goto, K. Yoh, S. Niho, H. Ohmatsu, N. Saijo, and Y. Nishiwaki
A Phase I Study of Gemcitabine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer and a Performance Status of 2
Jpn. J. Clin. Oncol., September 1, 2009; 39(9): 576 - 581.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
H. Ishida, Y. Miyake, M. Fukunaga, Y. Watanabe, T. Kato, H. Takemoto, and H. Furukawa
A Feasibility Study of UFT/LV and Irinotecan (TEGAFIRI) in Advanced or Metastatic Colorectal Cancer: Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) PROG 0304
Jpn. J. Clin. Oncol., September 1, 2009; 39(9): 601 - 605.
[Abstract] [Full Text] [PDF]

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 JCOHome page
S. Gonias, R. Goldsby, K. K. Matthay, R. Hawkins, D. Price, J. Huberty, L. Damon, C. Linker, A. Sznewajs, S. Shiboski, et al.
Phase II Study of High-Dose [131I]Metaiodobenzylguanidine Therapy for Patients With Metastatic Pheochromocytoma and Paraganglioma
J. Clin. Oncol., September 1, 2009; 27(25): 4162 - 4168.
[Abstract] [Full Text] [PDF]

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 JCOHome page
F. A.L.M. Eskens, N. Steeghs, J. Verweij, J. L. Bloem, O. Christensen, L. van Doorn, J. Ouwerkerk, M. J.A. de Jonge, J. W.R. Nortier, J. Kraetzschmar, et al.
Phase I Dose Escalation Study of Telatinib, a Tyrosine Kinase Inhibitor of Vascular Endothelial Growth Factor Receptor 2 and 3, Platelet-Derived Growth Factor Receptor {beta}, and c-Kit, in Patients With Advanced or Metastatic Solid Tumors
J. Clin. Oncol., September 1, 2009; 27(25): 4169 - 4176.
[Abstract] [Full Text] [PDF]

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 JCOHome page
B. Escudier, J. Roigas, S. Gillessen, U. Harmenberg, S. Srinivas, S. F. Mulder, G. Fountzilas, C. Peschel, P. Flodgren, E. C. Maneval, et al.
Phase II Study of Sunitinib Administered in a Continuous Once-Daily Dosing Regimen in Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
J. Clin. Oncol., September 1, 2009; 27(25): 4068 - 4075.
[Abstract] [Full Text] [PDF]


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