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Xiao-Jing Guo, Ni-Da Cao, Ying Gu, Ying-Jie Zhu, Jian Zheng, Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
Correspondence to: Jian Zheng, Professor, Chief Physician, Department of Oncology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, 725 Wanping South Road, Shanghai 200032, China. zzf725@sina.com
Received: July 7, 2014 Revised: August 18, 2014 Accepted: August 26, 2014 Published online: October 8, 2014
Evaluation criteria like overall survival (OS), progression-free survival (PFS), the response evaluation criteria in solid tumors, quality of life and adverse reactions have been widely used in clinical studies of advanced colorectal cancer. However, these criteria have different significance, and with the development of molecular targeted drugs and new therapies, the drawbacks of these criteria have been revealed. Therefore, searching for new evaluation criteria which can reflect the curative effect in the earlier stage is becoming inevitable.
自1981年WHO[18]颁布实体瘤疗效评定标准, 提出进展(progressive disease, PD)、稳定(stable disease, SD)、部分缓解(partial response, PR)及完全缓解(complete response, CR)后, 实体瘤治疗的疗效评定更为具体. 但是, 该标准仍存在局限, 如: 没有对可测量及目标病灶进行统一规定; 对于肿瘤数目多、直径小的病灶难以准确评估疗效等缺点[19]. 因而, 在2000年美国国立癌症研究所(National Cancer Institute, NCI)和加拿大国立癌症研究所(National Cancer Institute of Canada, NCIC), 欧洲癌症研究和治疗组织(European Organization for Research on Treatment of Cancer, EORTC)提出了实体瘤疗效反应评价标准(Response Evaluation Criteria in Solid Tumors, RECIST1.0)[20], 将双径测量方法(最长径及其垂直径的乘积)改为单径测量法(最长径之和), 明确定义了可测量、不可测量病灶、靶病灶及肿瘤负荷. 然而, 对转移性淋巴结肿大却未阐述明确的判定及评估方法[21]. 因此, 2009年欧洲癌症组织(European Cancer Organisation, ECCO)发布了RECIST1.1实体瘤评价标准[22], 其减少了肿瘤负荷的观察, 讨论了非靶病灶的观察方法, 转移性淋巴结的评定标准并肯定了PET-CT的应用价值.
有学者[32]对Bond试验结果进行了分析, 发现329例采用西妥昔单抗治疗转移性结直肠癌患者中, 治疗6 wk后获得肿瘤缩小的患者中位TTP及PFS明显延长. 并将ETS定义为与基线相比, 治疗6 wk后靶病灶最长直径总和缩小10%. 并且发现ETS较皮疹能够更早地预测西妥昔单抗的治疗效果. Piessevaux等[33]分析了CRYSTAL[34](Cetuximab Combined With Irinotecan in First-Line Therapy for Metastatic Colorectal Cancer)及OPUS[35](cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer)试验结果得出治疗8 wk后肿瘤缩小≥20%的K-ras基因野生型转移性结直肠癌患者使用西妥昔单抗后获得了较长的中位OS及PFS.
Hochster HS, Hart LL, Ramanathan RK, Childs BH, Hainsworth JD, Cohn AL, Wong L, Fehrenbacher L, Abubakr Y, Saif MW. Safety and efficacy of oxaliplatin and fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer: results of the TREE Study.J Clin Oncol. 2008;26:3523-3529.
[PubMed] [DOI]
Grothey A, Sargent D, Goldberg RM, Schmoll HJ. Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment.J Clin Oncol. 2004;22:1209-1214.
[PubMed] [DOI]
Petrelli F, Barni S. Correlation of progression-free and post-progression survival with overall survival in advanced colorectal cancer.Ann Oncol. 2013;24:186-192.
[PubMed] [DOI]
Lindskog EB, Derwinger K, Gustavsson B, Falk P, Wettergren Y. Thymidine phosphorylase expression is associated with time to progression in patients with metastatic colorectal cancer.BMC Clin Pathol. 2014;14:25.
[PubMed] [DOI]
Buyse M, Burzykowski T, Carroll K, Michiels S, Sargent DJ, Miller LL, Elfring GL, Pignon JP, Piedbois P. Progression-free survival is a surrogate for survival in advanced colorectal cancer.J Clin Oncol. 2007;25:5218-5224.
[PubMed] [DOI]
Giessen C, Laubender RP, Ankerst DP, Stintzing S, Modest DP, Mansmann U, Heinemann V. Progression-free survival as a surrogate endpoint for median overall survival in metastatic colorectal cancer: literature-based analysis from 50 randomized first-line trials.Clin Cancer Res. 2013;19:225-235.
[PubMed] [DOI]
Sidhu R, Rong A, Dahlberg S. Evaluation of progression-free survival as a surrogate endpoint for survival in chemotherapy and targeted agent metastatic colorectal cancer trials.Clin Cancer Res. 2013;19:969-976.
[PubMed] [DOI]
Broglio KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival.J Natl Cancer Inst. 2009;101:1642-1649.
[PubMed] [DOI]
Bowater RJ, Bridge LJ, Lilford RJ. The relationship between progression-free and post-progression survival in treating four types of metastatic cancer.Cancer Lett. 2008;262:48-53.
[PubMed] [DOI]
Grothey A, Flick ED, Cohn AL, Bekaii-Saab TS, Bendell JC, Kozloff M, Roach N, Mun Y, Fish S, Hurwitz HI. Bevacizumab exposure beyond first disease progression in patients with metastatic colorectal cancer: analyses of the ARIES observational cohort study.Pharmacoepidemiol Drug Saf. 2014;23:726-734.
[PubMed] [DOI]
Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada.J Natl Cancer Inst. 2000;92:205-216.
[PubMed] [DOI]
Iwamoto S, Hazama S, Kato T, Miyake Y, Fukunaga M, Matsuda C, Bando H, Sakamoto J, Oba K, Mishima H. Multicenter phase II study of second-line cetuximab plus folinic acid/5-fluorouracil/irinotecan (FOLFIRI) in KRAS wild-type metastatic colorectal cancer: the FLIER study.Anticancer Res. 2014;34:1967-1973.
[PubMed] [DOI]
Saiura A, Yamamoto J, Hasegawa K, Oba M, Takayama T, Miyagawa S, Ijichi M, Teruya M, Yoshimi F, Kawasaki S. A combination of oral uracil-tegafur plus leucovorin (UFT + LV) is a safe regimen for adjuvant chemotherapy after hepatectomy in patients with colorectal cancer: safety report of the UFT/LV study.Drug Discov Ther. 2014;8:48-56.
[PubMed] [DOI]
Nakayama G, Tanaka C, Uehara K, Mashita N, Hayashi N, Kobayashi D, Kanda M, Yamada S, Fujii T, Sugimoto H. The impact of dose/time modification in irinotecan- and oxaliplatin-based chemotherapies on outcomes in metastatic colorectal cancer.Cancer Chemother Pharmacol. 2014;73:847-855.
[PubMed] [DOI]
Glimelius B, Sørbye H, Balteskard L, Byström P, Pfeiffer P, Tveit K, Heikkilä R, Keldsen N, Albertsson M, Starkhammar H. A randomized phase III multicenter trial comparing irinotecan in combination with the Nordic bolus 5-FU and folinic acid schedule or the bolus/infused de Gramont schedule (Lv5FU2) in patients with metastatic colorectal cancer.Ann Oncol. 2008;19:909-914.
[PubMed] [DOI]
Maitland ML, Schwartz LH, Ratain MJ. Time to tumor growth: a model end point and new metric system for oncology clinical trials.J Clin Oncol. 2013;31:2070-2072.
[PubMed] [DOI]
Korn EL, Arbuck SG, Pluda JM, Simon R, Kaplan RS, Christian MC. Clinical trial designs for cytostatic agents: are new approaches needed?J Clin Oncol. 2001;19:265-272.
[PubMed] [DOI]
Rubinstein LV, Korn EL, Freidlin B, Hunsberger S, Ivy SP, Smith MA. Design issues of randomized phase II trials and a proposal for phase II screening trials.J Clin Oncol. 2005;23:7199-7206.
[PubMed] [DOI]
De Roock W, Piessevaux H, De Schutter J, Janssens M, De Hertogh G, Personeni N, Biesmans B, Van Laethem JL, Peeters M, Humblet Y. KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab.Ann Oncol. 2008;19:508-515.
[PubMed] [DOI]
Modest DP, Laubender RP, Stintzing S, Giessen C, Schulz C, Haas M, Mansmann U, Heinemann V. Early tumor shrinkage in patients with metastatic colorectal cancer receiving first-line treatment with cetuximab combined with either CAPIRI or CAPOX: an analysis of the German AIO KRK 0104 trial.Acta Oncol. 2013;52:956-962.
[PubMed] [DOI]
Piessevaux H, Buyse M, De Roock W, Prenen H, Schlichting M, Van Cutsem E, Tejpar S. Radiological tumor size decrease at week 6 is a potent predictor of outcome in chemorefractory metastatic colorectal cancer treated with cetuximab (BOND trial).Ann Oncol. 2009;20:1375-1382.
[PubMed] [DOI]
Piessevaux H, Buyse M, Schlichting M, Van Cutsem E, Bokemeyer C, Heeger S, Tejpar S. Use of early tumor shrinkage to predict long-term outcome in metastatic colorectal cancer treated with cetuximab.J Clin Oncol. 2013;31:3764-3775.
[PubMed] [DOI]
Van Cutsem E, Köhne CH, Láng I, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Tejpar S. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status.J Clin Oncol. 2011;29:2011-2019.
[PubMed] [DOI]
Bokemeyer C, Bondarenko I, Hartmann JT, de Braud F, Schuch G, Zubel A, Celik I, Schlichting M, Koralewski P. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study.Ann Oncol. 2011;22:1535-1546.
[PubMed] [DOI]
Suzuki C, Blomqvist L, Sundin A, Jacobsson H, Byström P, Berglund Å, Nygren P, Glimelius B. The initial change in tumor size predicts response and survival in patients with metastatic colorectal cancer treated with combination chemotherapy.Ann Oncol. 2012;23:948-954.
[PubMed] [DOI]
Mansmann UR, Sartorius U, Laubender RP, Giessen CA, Esser R, Heinemann V. Quantitative analysis of the impact of deepness of response on post-progression survival time following first-line treatment in patients with mCRC.J Clin Oncol. 2013;31:abstract 3630.
[PubMed] [DOI]
Claret L, Gupta M, Han K, Joshi A, Sarapa N, He J, Powell B, Bruno R. Evaluation of tumor-size response metrics to predict overall survival in Western and Chinese patients with first-line metastatic colorectal cancer.J Clin Oncol. 2013;31:2110-2114.
[PubMed] [DOI]
Nishino M, Jagannathan JP, Krajewski KM, O'Regan K, Hatabu H, Shapiro G, Ramaiya NH. Personalized tumor response assessment in the era of molecular medicine: cancer-specific and therapy-specific response criteria to complement pitfalls of RECIST.AJR Am J Roentgenol. 2012;198:737-745.
[PubMed] [DOI]
Camidge DR, Bang Y, Kwak EL, Shaw AT, Iafrate AJ, Maki RG, Solomon BJ, Ou SI, Salgia R, Wilner KD. Progression-free survival (PFS) from a phase I study of crizotinib(PF-02341066) in patients with ALK-positive non-small cell lung cancer (NSCLC).J Clin Oncol. 2011;29 suppl:abstract 2501.
[PubMed] [DOI]
Young JM, Badgery-Parker T, Masya LM, King M, Koh C, Lynch AC, Heriot AG, Solomon MJ. Quality of life and other patient-reported outcomes following exenteration for pelvic malignancy.Br J Surg. 2014;101:277-287.
[PubMed] [DOI]
Glaser AW, Fraser LK, Corner J, Feltbower R, Morris EJ, Hartwell G, Richards M, Wagland R. Patient-reported outcomes of cancer survivors in England 1-5 years after diagnosis: a cross-sectional survey.BMJ Open. 2013;3:pii: e002317.
[PubMed] [DOI]
Pullmer R, Linden W, Rnic K, Vodermaier A. Measuring symptoms in gastrointestinal cancer: a systematic review of assessment instruments.Support Care Cancer. 2014; May 28. [Epub ahead of print].
[PubMed] [DOI]
Lévi F, Misset JL, Brienza S, Adam R, Metzger G, Itzakhi M, Caussanel JP, Kunstlinger F, Lecouturier S, Descorps-Declère A. A chronopharmacologic phase II clinical trial with 5-fluorouracil, folinic acid, and oxaliplatin using an ambulatory multichannel programmable pump. High antitumor effectiveness against metastatic colorectal cancer.Cancer. 1992;69:893-900.
[PubMed] [DOI]
Sasaki Y, Hamaguchi T, Arai T, Goto A, Ura T, Muro K, Yamada Y, Shirao K, Shimada Y. Phase I study of combination therapy with irinotecan, leucovorin, and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for advanced colorectal cancer in Japanese patients.Anticancer Res. 2014;34:2029-2034.
[PubMed] [DOI]