response evaluation criteria in solid tumors


Summary: An internationally recognized set of published rules used for evaluation of cancer treatment that define when tumors found in cancer patients improve, worsen, or remain stable during treatment. These criteria are based specifically on the response of the tumor(s) to treatment, and not on the overall health status of the patient resulting from treatment.

Top Publications

  1. Powles T, O Donnell P, Massard C, Arkenau H, Friedlander T, Hoimes C, et al. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. JAMA Oncol. 2017;3:e172411 pubmed publisher
    ..were safety and confirmed objective response rate (ORR) per blinded independent central review (Response Evaluation Criteria In Solid Tumors [RECIST], version 1.1). A total of 191 patients with UC had received treatment...
  2. Chan J, Deng W, Higgins R, Tewari K, Bonebrake A, Hicks M, et al. A phase II evaluation of brivanib in the treatment of persistent or recurrent carcinoma of the cervix: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol. 2017;146:554-559 pubmed publisher
    ..Based on early results of this phase II trial, brivanib was well tolerated and demonstrated sufficient activity after first stage but trial was stopped due to lack of drug availability. ..
  3. Ott P, Bang Y, Berton Rigaud D, Elez E, Pishvaian M, Rugo H, et al. Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. J Clin Oncol. 2017;35:2535-2541 pubmed publisher
    ..Conclusion Pembrolizumab demonstrated a favorable safety profile and durable antitumor activity in a subgroup of patients with heavily pretreated advanced PD-L1-positive endometrial cancer. ..
  4. Petty R, Dahle Smith A, Stevenson D, Osborne A, Massie D, Clark C, et al. Gefitinib and EGFR Gene Copy Number Aberrations in Esophageal Cancer. J Clin Oncol. 2017;35:2279-2287 pubmed publisher
    ..Results of this study suggest that anti-EGFR therapies should be investigated in prospective clinical trials in different settings in EGFR FISH-positive and, in particular, EGFR-amplified esophageal cancer. ..
  5. Mody R, Naranjo A, Van Ryn C, Yu A, London W, Shulkin B, et al. Irinotecan-temozolomide with temsirolimus or dinutuximab in children with refractory or relapsed neuroblastoma (COG ANBL1221): an open-label, randomised, phase 2 trial. Lancet Oncol. 2017;18:946-957 pubmed publisher
    ..Further evaluation of biomarkers in a larger cohort of patients might identify those most likely to respond to this chemoimmunotherapeutic regimen. National Cancer Institute. ..
  6. Shoji H, Yoshio S, Mano Y, Doi H, Sugiyama M, Osawa Y, et al. Pro-angiogenic TIE-2-expressing monocytes/TEMs as a biomarker of the effect of sorafenib in patients with advanced hepatocellular carcinoma. Int J Cancer. 2017;141:1011-1017 pubmed publisher
    ..The radiologic response was evaluated by modified Response Evaluation Criteria in Solid Tumors (mRECIST)...
  7. Alley E, Lopez J, Santoro A, Morosky A, Saraf S, Piperdi B, et al. Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial. Lancet Oncol. 2017;18:623-630 pubmed publisher
    ..Response was assessed based on investigator review using the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1)...
  8. Mlecnik B, Van Den Eynde M, Bindea G, Church S, Vasaturo A, Fredriksen T, et al. Comprehensive Intrametastatic Immune Quantification and Major Impact of Immunoscore on Survival. J Natl Cancer Inst. 2018;110: pubmed publisher
    ..Response to treatment and prolonged survival of metastatic CRC patients were statistically significantly associated with high-immune densities quantified into the least immune-infiltrated metastasis. ..
  9. Heery C, O Sullivan Coyne G, Madan R, Cordes L, Rajan A, Rauckhorst M, et al. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Lancet Oncol. 2017;18:587-598 pubmed publisher
    ..Based on pharmacokinetics, target occupancy, and immunological analysis, we chose 10 mg/kg every 2 weeks as the dose for further development and phase 3 trials are ongoing. National Cancer Institute and Merck KGaA. ..

More Information


  1. Massard C, Borget I, Farace F, Aspeslagh S, Le Deley M, Le Tourneau C, et al. RECIST response and variation of circulating tumour cells in phase 1 trials: A prospective multicentric study. Eur J Cancer. 2017;83:185-193 pubmed publisher
    ..An early CTC change following therapy does not correlate with RECIST response in patients with advanced cancer enrolled in phase I trials. ..
  2. Hyman D, Smyth L, Donoghue M, Westin S, Bedard P, Dean E, et al. AKT Inhibition in Solid Tumors With AKT1 Mutations. J Clin Oncol. 2017;35:2251-2259 pubmed publisher
    ..was safety; secondary end points were progression-free survival (PFS) and response according to Response Evaluation Criteria in Solid Tumors (RECIST)...
  3. de Azevedo C, Thuler L, de Mello M, de Oliveira Lima J, da Fonte A, Fontão D, et al. Phase II trial of neoadjuvant chemotherapy followed by chemoradiation in locally advanced cervical cancer. Gynecol Oncol. 2017;146:560-565 pubmed publisher
    ..4-98.0) and 71.3% (IC 53.3-83.3), respectively. In our hands NACT in locally advanced cervical cancer patients did not show a meaningful improvement in ORR. Nevertheless, we believe it should be further explored in prospective trials. ..
  4. Ocean A, Starodub A, Bardia A, Vahdat L, Isakoff S, Guarino M, et al. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. Cancer. 2017;123:3843-3854 pubmed publisher
    ..0, and responses were assessed using Response Evaluation Criteria in Solid Tumors, version 1.1...
  5. Franzese C, Fogliata A, Comito T, Tozzi A, Iftode C, Clerici E, et al. Stereotactic/hypofractionated body radiation therapy as an effective treatment for lymph node metastases from colorectal cancer: an institutional retrospective analysis. Br J Radiol. 2017;90:20170422 pubmed publisher
    ..Advances in knowledge: The use of VMAT-SBRT is a viable approach for lymph-node recurrence of CRC. ..
  6. Maio M, Scherpereel A, Calabro L, Aerts J, Cedres Perez S, Bearz A, et al. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017;18:1261-1273 pubmed publisher
    ..Oncology Group performance status of 0 or 1 and measurable disease as defined in the modified Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 for pleural mesothelioma or RECIST version 1.1 for peritoneal mesothelioma...
  7. Shaw A, Kim T, Crino L, Gridelli C, Kiura K, Liu G, et al. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18:874-886 pubmed publisher
    ..endpoint was progression-free survival, assessed by a masked independent review committee using Response Evaluation Criteria in Solid Tumors 1...
  8. Bauml J, Seiwert T, Pfister D, Worden F, Liu S, Gilbert J, et al. Pembrolizumab for Platinum- and Cetuximab-Refractory Head and Neck Cancer: Results From a Single-Arm, Phase II Study. J Clin Oncol. 2017;35:1542-1549 pubmed publisher
    ..Imaging was performed every 6 to 9 weeks. Primary end points: overall response rate (Response Evaluation Criteria in Solid Tumors v1.1, central review) and safety...
  9. Parakh S, Park J, Mendis S, Rai R, Xu W, Lo S, et al. Efficacy of anti-PD-1 therapy in patients with melanoma brain metastases. Br J Cancer. 2017;116:1558-1563 pubmed publisher
    ..8 vs 13.1 months, P=0.039). IC responses to anti-PD-1 antibodies occur in pts with BM, including those with symptomatic BM requiring corticosteroids. Prospective trials evaluating anti-PD-1 therapy in pts with BM are underway. ..
  10. Kang H, Gupta S, Wei W, Lu L, Matrana M, Tannir N, et al. Alternative Response Criteria and Clinical Risk Factors for Assessing Tumor Response in Patients With Metastatic Renal Cell Carcinoma Who Are Receiving Salvage Therapy. AJR Am J Roentgenol. 2017;209:1278-1284 pubmed publisher
    ..The purpose of this study is to compare the prognostic value of various solid tumor response criteria as well as the additive value of clinical risk factors in patients with advanced renal cell carcinoma (RCC)...
  11. Woodward W, Fang P, Arriaga L, Gao H, Cohen E, Reuben J, et al. A Phase 2 Study of Preoperative Capecitabine and Concomitant Radiation in Women With Advanced Breast Cancer. Int J Radiat Oncol Biol Phys. 2017;99:777-783 pubmed publisher
    ..However, patients with TN breast cancer had poor outcomes even when response was achieved. Further study in non-TN patients may be warranted. ..
  12. Chandran S, Somerville R, Yang J, Sherry R, Klebanoff C, Goff S, et al. Treatment of metastatic uveal melanoma with adoptive transfer of tumour-infiltrating lymphocytes: a single-centre, two-stage, single-arm, phase 2 study. Lancet Oncol. 2017;18:792-802 pubmed publisher
    ..Intramural Research Program of the National Institutes of Health, National Cancer Institute, Center for Cancer Research. ..
  13. Chen A, Felix C, Wang P, Hsu S, Basehart V, Garst J, et al. Reduced-dose radiotherapy for human papillomavirus-associated squamous-cell carcinoma of the oropharynx: a single-arm, phase 2 study. Lancet Oncol. 2017;18:803-811 pubmed publisher
    ..Radiotherapy de-escalation has the potential to improve the therapeutic ratio and long-term function for these patients. University of California. ..
  14. Kristeleit R, Davidenko I, Shirinkin V, El Khouly F, Bondarenko I, Goodheart M, et al. A randomised, open-label, phase 2 study of the IDO1 inhibitor epacadostat (INCB024360) versus tamoxifen as therapy for biochemically recurrent (CA-125 relapse)-only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer. Gynecol Oncol. 2017;146:484-490 pubmed publisher
    ..Epacadostat was generally well tolerated. ..
  15. Itchins M, Arena J, Nahm C, Rabindran J, Kim S, Gibbs E, et al. Retrospective cohort analysis of neoadjuvant treatment and survival in resectable and borderline resectable pancreatic ductal adenocarcinoma in a high volume referral centre. Eur J Surg Oncol. 2017;43:1711-1717 pubmed publisher
    ..Treatment with NA was well tolerated. The long observed survival in this group may be explained by lymph node sterilisation by NA, and the achievement of R0 resection in a greater proportion of patients. ..
  16. Gandhi L, Ou S, Shaw A, Barlesi F, Dingemans A, Kim D, et al. Efficacy of alectinib in central nervous system metastases in crizotinib-resistant ALK-positive non-small-cell lung cancer: Comparison of RECIST 1.1 and RANO-HGG criteria. Eur J Cancer. 2017;82:27-33 pubmed publisher
    ..Alectinib demonstrated promising efficacy in the CNS for ALK+ NSCLC patients pretreated with crizotinib, regardless of the assessment criteria used. ..
  17. Dieras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, et al. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18:732-742 pubmed publisher
    ..The safety profile was similar to that reported in previous analyses, reaffirming trastuzumab emtansine as an efficacious and tolerable treatment in this patient population. F Hoffmann-La Roche/Genentech. ..
  18. Oldrini G, Huertas A, Renard Oldrini S, Taste George H, Vogin G, Laurent V, et al. Tumor response assessment by MRI following stereotactic body radiation therapy for hepatocellular carcinoma. PLoS ONE. 2017;12:e0176118 pubmed publisher
    ..assessment was made using MRI, with determination of local and hepatic responses according to Response Evaluation Criteria in Solid Tumors (RECIST) and modified RECIST (mRECIST) criteria during a two-year follow-up...
  19. Szender J, Emmons T, Belliotti S, Dickson D, Khan A, Morrell K, et al. Impact of ascites volume on clinical outcomes in ovarian cancer: A cohort study. Gynecol Oncol. 2017;146:491-497 pubmed publisher
    ..If these findings are confirmed in independent studies, consideration should be made to add the presence of large volume ascites at diagnosis to the staging criteria for ovarian cancer. ..
  20. Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz L, Mandrekar S, et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017;18:e143-e152 pubmed publisher
    ..This guideline will allow consistent conduct, interpretation, and analysis of trials of immunotherapies. ..
  21. Park J, Bagatell R, Cohn S, Pearson A, Villablanca J, Berthold F, et al. Revisions to the International Neuroblastoma Response Criteria: A Consensus Statement From the National Cancer Institute Clinical Trials Planning Meeting. J Clin Oncol. 2017;35:2580-2587 pubmed publisher
    ..Primary and metastatic soft tissue sites will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) and iodine-123 (123I) -metaiodobenzylguanidine (MIBG) scans or [18
  22. Wang C, Christie A, Lin M, Jung M, Weix D, Huelsmann L, et al. Safety and Efficacy of Stereotactic Ablative Radiation Therapy for Renal Cell Carcinoma Extracranial Metastases. Int J Radiat Oncol Biol Phys. 2017;98:91-100 pubmed publisher
    ..LC and toxicity after SAbR were assessed with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and Common Terminology Criteria for Adverse Events (CTCAE) version 4.0...
  23. Gulley J, Rajan A, Spigel D, Iannotti N, Chandler J, Wong D, et al. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol. 2017;18:599-610 pubmed publisher
    ..confirmed stage IIIB or IV NSCLC with squamous or non-squamous histology, measurable disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1...
  24. Baselga J, Im S, Iwata H, Cortes J, De Laurentiis M, Jiang Z, et al. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18:904-916 pubmed publisher
    ..The primary endpoints were progression-free survival by local investigator assessment per Response Evaluation Criteria In Solid Tumors (version 1...