Salvage chemotherapy for pretreated gastric cancer: A randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone

Journal of Clinical Oncology

Volumn 30, Issue 13, 2012, Pages 1513-1518

  Kang, Jung Hun ^a   Lee, Soon Il ^b   Lim, Do Hyoung ^b   Park, Keon Woo ^b   Oh, Sung Yong ^c   Kwon, Hyuk Chan ^c   Hwang, In Gyu ^d   Lee, Sang Cheol ^e   Nam, Eunmi ^f   Shin, Dong Bok ^h   Lee, Jeeyun ^g   Park, Joon Oh ^g   Park, Young Suk ^g   Lim, Ho Yeong ^g   Kang, Won Ki ^g   Park, Se Hoon ^g  

^a Gyeongsang National University   (South Korea)

^b Dankook University   (South Korea)

^c Dong A University College of Medicine   (South Korea)

^d Chung Ang University College of Medicine   (South Korea)

^e Soonchunhyang University College of Medicine   (South Korea)

^f Ewha Womans University School of Medicine   (South Korea)

^g Samsung Medical Center   (South Korea)

^h Gachon University   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; DOCETAXEL; EVEROLIMUS; FLUOROPYRIMIDINE DERIVATIVE; HEMOGLOBIN; IRINOTECAN; OXALIPLATIN; SUNITINIB; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DRUG DERIVATIVE; PLATINUM DERIVATIVE; PYRIMIDINE DERIVATIVE; TAXOID;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BEST SUPPORTIVE CARE; CANCER CHEMOTHERAPY; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PATIENT CARE; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SALVAGE CHEMOTHERAPY; SALVAGE THERAPY; STOMACH CANCER; STOMATITIS; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DRUG RESISTANCE; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; MULTIMODALITY CANCER THERAPY; MULTIVARIATE ANALYSIS; PROPORTIONAL HAZARDS MODEL; PROSPECTIVE STUDY; RISK ASSESSMENT; RISK FACTOR; SOUTH KOREA; STOMACH TUMOR; TIME; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COMBINED MODALITY THERAPY; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PLATINUM COMPOUNDS; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; PYRIMIDINES; REPUBLIC OF KOREA; RISK ASSESSMENT; RISK FACTORS; SALVAGE THERAPY; STOMACH NEOPLASMS; TAXOIDS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84862981823     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2011.39.4585     Document Type: Article

References (24)

1. Won YJ, Sung J, Jung KW, et al: Nationwide cancer incidence in Korea, 2003-2005. Cancer Res Treat 41:122-131, 2009
2. Wagner AD, Grothe W, Haerting J, et al: Chemotherapy in advanced gastric cancer: A systematic review and meta-analysis based on aggregate data. J Clin Oncol 24:2903-2909, 2006 (Pubitemid 46630593)
3. Van Cutsem E, Haller D, Ohtsu A: The role of chemotherapy in the current treatment of gastric cancer. Gastric Cancer 5:17-22, 2002 (suppl 1)
4. Kinoshita K, Yonemura Y, Sawa T, et al: 5-Fluorouracil, methotrexate, leucovorin, CDDP and epirubicin (FEPMTX): A wide-spectrum regimen of salvage chemotherapy for high-grade advanced gastric cancer. Hepatogastroenterology 50:1716-1719, 2003 (Pubitemid 37186571)
5. Park SH, Kang WK, Lee HR, et al: Docetaxel plus cisplatin as second-line therapy in metastatic or recurrent advanced gastric cancer progressing on 5-fluorouracil-based regimen. Am J Clin Oncol 27:477-480, 2004 (Pubitemid 39371942)
6. Ohtsu A, Yoshida S, Saito D, et al: An early phase II study of 5-fluorouracil combined with cisplatinum as a second line chemotherapy against metastatic gastric cancer. Jpn J Clin Oncol 21:120-124, 1991
7. Giuliani F, Gebbia V, De Vita F, et al: Docetaxel as salvage therapy in advanced gastric cancer: A phase II study of the Gruppo Oncologico Italia Meridionale (G.O.I.M.). Anticancer Res 23:4219-4222, 2003 (Pubitemid 37474923)
8. Schmitz SH, Voliotis DL, Schimke J, et al: Continuous 5-fluorouracil and leucovorin as a second-line therapy for advanced gastric carcinoma. Oncology 51:502-506, 1994 (Pubitemid 24347031)
9. Taguchi T, Sakata Y, Kanamaru R, et al: Late phase II clinical study of RP56976 (docetaxel) in patients with advanced/recurrent gastric cancer: A Japanese Cooperative Study Group trial (group A) [in Japanese]. Gan To Kagaku Ryoho 25:1915-1924, 1998
10. Futatsuki K, Wakui A, Nakao I, et al: Late phase II study of irinotecan hydrochloride (CPT-11) in advanced gastric cancer: CPT-11 Gastrointestinal Cancer Study Group [in Japanese]. Gan To Kagaku Ryoho 21:1033-1038, 1994 (Pubitemid 24225031)
11. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors: European Organisation for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216, 2000
12. Ji SH, Lim do H, Yi SY, et al: A retrospective analysis of second-line chemotherapy in patients with advanced gastric cancer. BMC Cancer 9:110, 2009
13. Lakatos E: Sample sizes based on the log-rank statistic in complex clinical trials. Biometrics 44:229-241, 1988
14. Thuss-Patience PC, Kretzschmar A, Bichev D, et al: Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer: A randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer 47:2306-2314, 2011
15. Wilson D, Hiller L, Geh JI: Review of secondline chemotherapy for advanced gastric adenocarcinoma. Clin Oncol (R Coll Radiol) 17:81-90, 2005 (Pubitemid 40309884)
16. Moehler M, Al-Batran SE, Andus T, et al: German S3-guideline "Diagnosis and treatment of esophagogastric cancer" [in German]. Z Gastroenterol 49:461-531, 2011
17. Kim J, Sun CL, Mailey B, et al: Race and ethnicity correlate with survival in patients with gastric adenocarcinoma. Ann Oncol 21:152-160, 2010
18. Roth AD, Ajani J: Docetaxel-based chemotherapy in the treatment of gastric cancer. Ann Oncol 14:ii41-ii44, 2003 (suppl 2)
19. Van Cutsem E: The treatment of advanced gastric cancer: New findings on the activity of the taxanes. Oncologist 9:9-15, 2004 (suppl 2)
20. Bleiberg H: CPT-11 in gastrointestinal cancer. Eur J Cancer 35:371-379, 1999
21. Lim do H, Park SH, Park KW, et al: Retrospective analyses of cisplatin-based doublet combination chemotherapy in patients with advanced gastric cancer. BMC Cancer 10:583, 2010
22. Sym S, Park Y, Park S, et al: A randomized phase II study of biweekly irinotecan versus irinotecan plus 5-fluorouracil/leucovorin combination as a salvage chemotherapy in previously treated patients with advanced/metastatic gastric cancer. J Clin Oncol 28:165e, 2010 (suppl 15; abstr e14511)
23. Cherny NI, Abernethy AP, Strasser F, et al: Improving the methodologic and ethical validity of best supportive care studies in oncology: Lessons from a systematic review. J Clin Oncol 27:5476-5486, 2009
24. Park SH, Lee WK, Chung M, et al: Quality of life in patients with advanced gastric cancer treated with second-line chemotherapy. Cancer Chemother Pharmacol 57:289-294, 2006