Adjuvant chemotherapy in completely resected gastric cancer: A randomized phase III trial conducted by GOIRC

Journal of the National Cancer Institute

Volumn 100, Issue 6, 2008, Pages 388-398

  Di Costanzo, Francesco ^a   Gasperoni, Silvia ^a   Manzione, Luigi ^a,b   Bisagni, Giancarlo ^c   Labianca, Roberto ^d   Bravi, Stefano ^e   Cortesi, Enrico ^f   Carlini, Paolo ^g   Bracci, Raffaella ^h   Tomao, Silverio ⁱ   Messerini, Luca ^j   Arcangeli, Annarosa ^k   Torri, Valter ^m   Bilancia, Domenico ^b   Floriani, Irene ^k   Tonato, Maurizio ^l   Dinota, Angelo ^b   Strafiuso, Gennaro ⁿ   Corgna, Enrichetta ^l   Porrozzi, Stella ^l   Boni, Corrado ^c   Rondini, Ermanno ^c   Giunta, Alessandro ^o   Barbara, Monzio Compagnoni ^p   Biagioni, Franco ^q   Cesari, Maurizio ^r   Fornarini, Giuseppe ^s   Nelli, Fabrizio ^s   Carboni, Manlio ^t   Francesco, Cognetti ^u   Ruggeri, Enzo Maria ^u   Andrea, Piga ^h   Adriana, Romiti ^v   Alessandra, Olivetti ^v   Luigi, Masoni ⁱ   De Stefanis, Marinella ^w   Dalla Mola, Angelo ^w   Salvatore, Camera ^x   Francesco, Recchia ^y   De Filippis, Sandro ^y   Loreto, Scipioni ^z   Sandra, Zironi ^aa   Gabriele, Luppi ^aa   Maurizio, Italia ^ab   Stefano, Banducci ^ab   Andrea, Pisani Leretti ^m   Bruno, Massidda ^ac   Teresa, Ionta Maria ^ac   Angelo, Nicolosi ^ad   Rodolfo, Canaletti ^ae   Bruno, Biscottini ^af   Fausto, Grigniani ^ag   Di Costanzo, Federica ^ag   Rossella, Rovei ^ah   Enrico, Croce ^ai   Rosalia, Carroccio ^e   Germana, Gilli ^aj   Carla, Cavalli ^ak   Angelo, Olgiati ^ak   Umberto, Pandolfi ^al   Riccardo, Rossetti ^am   Giovanni, Natalini ^an   Paolo, Foa ^p   Sabina, Oldani ^p   Lorenzo, Bruno ^ao   Stefano, Cascinu ^ap   Giuseppina, Catalano ^aq   Vincenzo, Catalano ^aq   Ferdinando, Lungarotti ^ar   Antonio, Farris ^as   Mario, Trignano ^at   Antonio, Muscogiuri ^au   Franco, Figoli ^av   Maurizio, Leoni ^aw   Giorgio, Papiani ^aw   Gianfranco, Orselli ^ax   Mauro, Antimi ^s   Vincenzo, Bellini ^s   Alessandro, Cabassi ^ay   Antonio, Contu ^az   Antonio, Pazzola ^az   Mario, Frignano ^at   Elena, Lastraioli ^ba   Matilde, Saggese ^bb   Diletta, Bianchini ^bb   Antonuzzo, Lorenzo ^bb   Micol, Mela ^bb   Roberta, Camisa ^bc   more..

^a CAREGGI UNIVERSITY HOSPITAL   (Italy)

^b Oncologia Medica   (Italy)

^c Oncologia Medica   (Italy)

^d OSPEDALI RIUNITI   (Italy)

^e Oncologia Medica   (Italy)

^f SAPIENZA UNIVERSITY OF ROME   (Italy)

^g Scientific Institute   (Italy)

^h Clinica Medica   (Italy)

ⁱ POLICLINICO UMBERTO I   (Italy)

^j UNIVERSITY OF FLORENCE   (Italy)

^k MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^l Divisione di Oncologia Medica   (Italy)

^m Seconda Divisione Chirurgica ^*  (Italy)

ⁿ Dipartimento Chirurgia   (Italy)

^o Seconda Divisione Chirurgica   (Italy)

^p Oncologia Medica   (Italy)

^q UO Oncologia   (Italy)

^r UO Chirurgia Ospedale   (Italy)

^s Oncologia Medica   (Italy)

^t Divisione di Chirurgia Generale A Dipartimento di Chirurgia Generale Speciahta Chirurgiche e Trapianti d'Organo Paride Stefanini   (Italy)

^u Oncologia Medica A San Raffaele IRE   (Italy)

^v Dipartimento di Medicina Sperimentale   (Italy)

^w Oncologia Medica   (Italy)

^x UO Chirurgia Generale   (Italy)

^y Divisione di Oncologia   (Italy)

^z Presidio Ospedoliero Valle Comonica   (Italy)

^aa Universitaria di Modena   (Italy)

^ab Spedali Civili   (Italy)

^ac Cattedra di Oncologia Medica   (Italy)

^ad Dipartimento di SBeB Chirurgia ed Oncologia Clinica   (Italy)

^ae Servizio di Oncologia   (Italy)

^af Presidio Ospedaliero Santa Barbara   (Italy)

^ag Ist di Med Int e Sci Oncologiche   (Italy)

^ah Ist Naz Stud e la Cura dei Tumori   (Italy)

^ai Trapianti Addominali Pizzamiglio   (Italy)

^aj Divisione Oncologia Clinica   (Italy)

^ak Divisione di Medicina Generale   (Italy)

^al USL 13 Regione Siciliana   (Italy)

^am Istituto di Patologia Chirurgica ^*  (Italy)

^an Chirurgia Generale   (Italy)

^ao Istituto di Clinica Chirurgica e Terapia Chirurgica   (Italy)

^ap Divisione di Cardiologia   (Italy)

^aq UO Oncologia Medica   (Italy)

^ar Azienda Sanitaria Locale della Provincia di Foggia   (Italy)

^as Sarobba Maria Giuseppina   (Italy)

^at Istituto di Patologia Chirurgica AOU   (Italy)

^au Medicina Interna   (Italy)

^av Ospedale Civile   (Italy)

^aw Oncologia Medica Ravenna   (Italy)

^ax Chirurgia   (Italy)

^ay Dipartimento di Chirurgia Oncologica   (Italy)

^az Oncologia Medica   (Italy)

^ba Istituto di Patologia Generale   (Italy)

^bb Azienda Ospedaliero Universitaria Careggi   (Italy)

^bc Data Center of GOIRC   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; DEXAMETHASONE; EPIRUBICIN; FLUOROURACIL; FOLINIC ACID; ONDANSETRON; ANTINEOPLASTIC AGENT; FLEP PROTOCOL; TUMOR MARKER; UNCLASSIFIED DRUG;

ADJUVANT THERAPY; ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CARDIOVASCULAR DISEASE; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DISEASE SEVERITY; DRUG FATALITY; DRUG WITHDRAWAL; ELECTROLYTE DISTURBANCE; FEMALE; FOLLOW UP; HOSPITAL CARE; HUMAN; HUMAN TISSUE; KAPLAN MEIER METHOD; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; OPEN STUDY; OTOTOXICITY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; RECURRENT CANCER; STATISTICAL ANALYSIS; STOMACH ADENOCARCINOMA; STOMACH SURGERY; THROMBOCYTOPENIA; ADJUVANT CHEMOTHERAPY; CANCER STAGING; CHEMICALLY INDUCED DISORDER; CHEMISTRY; GASTRECTOMY; HEMATOLOGIC DISEASE; IMMUNOHISTOCHEMISTRY; ITALY; LYMPH NODE METASTASIS; LYMPHADENECTOMY; METHODOLOGY; MIDDLE AGED; PATHOLOGY; PROGNOSIS; STOMACH TUMOR; TREATMENT OUTCOME; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY, ADJUVANT; CISPLATIN; DIARRHEA; DISEASE-FREE SURVIVAL; EPIRUBICIN; FEMALE; FLUOROURACIL; GASTRECTOMY; HEMATOLOGIC DISEASES; HUMANS; IMMUNOHISTOCHEMISTRY; ITALY; KAPLAN-MEIERS ESTIMATE; LEUCOVORIN; LYMPH NODE EXCISION; LYMPHATIC METASTASIS; MALE; MIDDLE AGED; MUCOSITIS; NEOPLASM STAGING; PATIENT COMPLIANCE; PROGNOSIS; PROPORTIONAL HAZARDS MODELS; STOMACH NEOPLASMS; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL; VOMITING;

EID: 41449091327     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djn054     Document Type: Article

References (40)

1. Verdecchia A, Corazziari I, Gatta G, Lisi D, Faivre J, Forman D; EUROCARE Working Group. Explaining gastric cancer survival differences among European countries. Int J Cancer. 2004;109(5):737-741.
2. Peeters KCMJ, van de Velde CJ. Improving treatment outcome for gastric cancer: the role of surgery and adjuvant therapy. J Clin Oncol. 2003;(23 Suppl):272s-273s.
3. Hundahl SA, Phillips JL, Menck HR. The National Cancer Data Base Report on poor survival of U.S. gastric carcinoma patients treated with gastrectomy: Fifth Edition American Joint Committee on Cancer staging, proximal disease, and the "different disease" hypothesis. Cancer. 2000;88(4):921-932.
4. Lim L, Michael M, Mann GB, Leong T. Adjuvant therapy in gastric cancer. J Clin Oncol. 2005;23(25):6220-6232.
5. Hermans J, Bonenkamp JJ, Boon MC, et al. Adjuvant therapy after curative resection for gastric cancer: meta-analysis of randomized trials. J Clin Oncol. 1993;11(8):1441-1447.
6. Earle CC, Maroun JA. Adjuvant chemotherapy after curative resection for gastric cancer in non-Asian patients: revisiting a meta-analysis of randomized trials. Eur J Cancer. 1999;35(7):1059-1064.
7. Mari E, Floriani I, Tinazzi A, et al. Efficacy of adjuvant chemotherapy after curative resection for gastric cancer: a meta-analysis of published randomized trials. A study of the GISCAD (Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente). Ann Oncol. 2000;11(7):837-843.
8. Panzini I, Gianni L, Fattori PP, et al. Adjuvant chemotherapy in gastric cancer: a meta-analysis of randomized trials and a comparison with previous meta-analyses. Tumori. 2002;88(1):21-27.
9. Van Cutsem E, Moiseyenko VM, Tjulandin S, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006;24(31):4991-4997.
10. Bouché O, Raoul JL, Bonnetain F, et al. Randomized multicenter phase II trial of a biweekly regimen of fluorouracil and leucovorin (LV5FU2), LV5FU2 plus cisplatin, or LV5FU2 plus irinotecan in patients with previously untreated metastatic gastric cancer: a Fédération Francophone de Cancérologie Digestive Group Study - FFCD 9803. J Clin Oncol. 2004;22(21):4319-4328.
11. Cocconi G, Bella M, Zironi S, et al. FAM combination versus PELF combination (cisplatin, epirubicin, leucovorin, 5-fluorouracil) in advanced gastric cancer. A prospective randomized trial of the Italian Oncology Group for Clinical Research (GOIRC). J Clin Oncol. 1994;12(12):2687-2693.
12. Cocconi G, Carlini P, Gamboni A, et al. Italian Oncology Group for Clinical Research. Cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) is more active than 5-fluorouracil, doxorubicin and methotrexate (FAMTX) in advanced gastric carcinoma. Ann Oncol. 2003;14(8):1258-1263.
13. Thara E, Semba S, Thara H. Molecular biological observations in gastric cancer. Semin Oncol. 1996;23(3):307-315.
14. Aranda M, Naquira H, Karque R, Mendoza H, Sepulveda C, Silva C. Mutations of the p53 suppressor gene in gastric adenocarcinoma. Rev Med Chil. 1998;126(5):525-532.
15. Tsigris C, Karayiannakis AJ, Syrigos KN, et al. Clinical significance of soluble c-erbB-2 levels in the serum and urine of patients with gastric cancer. Anticancer Res. 2002;22(5):3061-3065.
16. Yeh KH, Shun CT, Chen CL, et al. High expression of thymidylate synthase is associated with the drug resistance of gastric carcinoma to high dose 5-fluorouracil-based systemic chemotherapy. Cancer. 1998;82(9):1626-1631.
17. Wang H, Zhang Y, Cao L, et al. HERG K+ channel, a regulator of tumor cell apoptosis and proliferation. Cancer Res. 2002;62(17):4843-4848.
18. Sobin LH, Wittekind Ch, eds.; TNM Classification of Malignant Tumors. 5th ed. International Union Against Cancer (UICC). New York: John Wiley and Sons, Inc., 1997.
19. Hamilton SR, Aaltonen LA. World Health Organization Classification of Tumors. Pathology and Genetics of Tumours of the Digestive System. Lyon, France: IARC Press; 2000.
20. Rosemberger WF, Lachin JM. Randomization in Clinical Trials, Theory and Practice. 2002 Wiley Series in Probability and Statistics. New York: John Wiley and Sons; 2002.
21. Karpeh MS, Leon L, Klimistra D, Brennan M. Lymph node staging in gastric cancer: is location more important than number?. Ann Surg. 2000;232(3):362-371.
22. Grambsch P, Therneau T. Proportional hazards tests and diagnostics based on weighted residuals. Biometrika. 1994;81(3):515-526.
23. Maruyama K. The most important prognostic factors for gastric cancer patients: a study using univariate and multivariate analyses. Scand J Gastroenterol Suppl. 1987;22(2):63-68.
24. Adachi Y, Oshiro T, Mori M, Maehara Y, Sugimachi K. Prediction of early and late recurrence after curative resection for gastric carcinoma. Cancer. 1996;77(12):2445-2448.
25. Shiraishi N, Inomata M, Osawa N, Yasuda K, Adachi Y, Kitano S. Early and late recurrence after gastrectomy for gastric carcinoma. Univariate and multivariate analyses. Cancer. 2000;89(2):255-261.
26. SAS Institute Inc. SAS/STATTM User's Guide, Version 6. 4th ed. Vols 1 and 2. Cary, NC: SAS Institute Inc.; 1990.
27. Bajetta E, Buzzoni R, Mariani L, et al. Adjuvant chemotherapy in gastric cancer: 5-year results of a randomised study by the Italian Trials in Medical Oncology (ITMO) Group. Ann Oncol. 2002;13(2):299-307.
28. De Vita F, Giuliani F, Orditura M, Maiello E, Galizia G, Di Martino N. Adjuvant chemotherapy with epirubicin, leucovorin, 5-fluorouracil and etoposide regimen in resected gastric cancer patients: a randomized phase III trial by the Gruppo Oncologico Italia Meridionale (GOIM 9602 Study). Ann Oncol. 2007;18(8):1354-1358.
29. Bouché O, Ychou M, Burtin P, et al.; Federation Francophone de Cancerologie Digestive Group. Adjuvant chemotherapy with 5-fluorouracil and cisplatin compared with surgery alone for gastric cancer: 7-year results of the FFCD randomized phase III trial. Ann Oncol. 2005;16(9):1488-1497.
30. Nitti D, Wils J, Guimaraes Dos Santos J, et al. Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG. Ann Oncol. 2006;17(2):262-269.
31. Bozzetti F, Marubini E, Bonfanti G, Miceli R, Piano C, Gennari R. Subtotal versus total gastrectomy for gastric cancer: five-year survival rates in a multicenter randomized Italian trial. Italian Gastrointestinal Tumor Study Group. Ann Surg. 1999;230(2):170-178.
32. Bonenkamp JJ, Hermans J, Sasako M, et al.; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999;340(9):9908-9914.
33. Degiuli M, Sasako M, Ponti A, Soldati T, Danese F, Calvo F. Morbidity and mortalità after D2 gastrectomy for gastric cancer: results of the Italian Gastric Cancer Study Group Prospective Multicenter Surgical Study. J Clin Oncol. 1998;16(4):1490-1493.
34. Macdonald J, Smalley S, Benedetti J, et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001;345(10):725-730.
35. Cunningham D, Allum W, Stenning S, et al. Perioperative chemotherapy vs surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006;355(1):1-20.
36. Wu AW, Xu GW, Wang HY, Ji JF, Tang JL. Neoadjuvant chemotherapy versus none for resectable gastric cancer. Cochrane Database Syst Rev. 2007;2:CD005047. doi:10.1002/14651858.
37. Bedikian AY, Chen TT, Khankhanian N, et al. The natural history of gastric cancer and prognostic factors influencing survival. J Clin Oncol. 1984;2(4):305-310.
38. Cascinu S, Labianca R, Barone C, et al. Adjuvant treatment of high-risk, radically resected gastric cancer patients with 5-fluorouracil, leucovorin, cisplatin, and epidoxorubicin in a randomized controlled trial. J Natl Cancer Inst. 2007;99(8):601-607.
39. Sakamoto AJ, Morita S, Kodera Y, Kobayashi M, Miyashitaand Y, Macdonald JS. A randomized phase III trial of post-operative adjuvant oral fluoropyrimidine versus sequential paclitaxel/oral fluoropyrimidine; and UFT versus S1 for T3/T4 gastric carcinoma: the Stomach Cancer Adjuvant Multi-institutional Trial Group (Samit) Trial. Jpn. J Clin Oncol. 2005;35(11):672-675.
40. Sakuramoto S, Sasako M, Yamaguchi T, et al. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007;357(18):1810-1820.