Phase i study of matuzumab in combination with 5-fluorouracil, leucovorin and cisplatin (PLF) in patients with advanced gastric and esophagogastric adenocarcinomas

Investigational New Drugs

Volumn 31, Issue 3, 2013, Pages 642-652

  Trarbach, Tanja ^a   Przyborek, Marta ^a   Schleucher, Norbert ^b   Heeger, Steffen ^c   Lüpfert, Christian ^c   Vanhoefer, Udo ^b  

^a UNIVERSITY HOSPITAL ESSEN   (Germany)

^b Marien Krankenhaus Hamburg   (Germany)

^c MERCK KGAA   (Germany)

Author keywords

Cisplatin; Gastric; Gastroesophageal; Matuzumab; PLF

Indexed keywords

CISPLATIN; EPIDERMAL GROWTH FACTOR RECEPTOR; FLUOROURACIL; FOLINIC ACID; MATUZUMAB;

ABDOMINAL PAIN; ACNE; ADULT; ADVANCED CANCER; AGED; ARTICLE; CLINICAL ARTICLE; COHORT ANALYSIS; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; DYSPEPSIA; EPISTAXIS; ESOPHAGEAL ADENOCARCINOMA; ESOPHAGOGASTRIC ADENOCARCINOMA; FATIGUE; FEMALE; FEVER; HAND FOOT SYNDROME; HUMAN; HUMAN TISSUE; LEUKOPENIA; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PARONYCHIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SKIN BIOPSY; STOMACH ADENOCARCINOMA; STOMATITIS; THROMBOSIS; VOMITING;

ADENOCARCINOMA; ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; ESOPHAGEAL NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; RECEPTOR, EPIDERMAL GROWTH FACTOR; SKIN; STOMACH NEOPLASMS;

EID: 84879117062     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-012-9848-0     Document Type: Article

References (45)

1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D (2011) Global cancer statistics. CA Cancer J Clin 61(2):69-90. doi: 10.3322/caac.20107
2. Ferlay J, Parkin DM, Steliarova-Foucher E (2010) Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 46(4):765-781. doi: 10.1016/j.ejca.2009.12.014
3. Pinto C, Di Fabio F, Barone C, Siena S, Falcone A, Cascinu S, Rojas Llimpe FL, Stella G, Schinzari G, Artale S, Mutri V, Giaquinta S, Giannetta L, Bardelli A, Martoni AA (2009) Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma (DOCETUX study). Br J Cancer 101(8):1261-1268. doi: 10.1038/sj.bjc.6605319
4. Wagner AD, Grothe W, Haerting J, Kleber G, Grothey A, Fleig WE (2006) Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol 24(18):2903-2909. doi: 10.1200/JCO.2005.05.0245
5. Boku N, Ohtsu A, Shimada Y, Shirao K, Seki S, Saito H, Sakata Y, Hyodo I (1999) Phase II study of a combination of irinotecan and cisplatin against metastatic gastric cancer. J Clin Oncol 17(1):319-323
6. Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR (2008) Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 358(1):36-46. doi: 10.1056/NEJMoa073149
7. Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI (2009) Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol 20(4):666-673. doi: 10.1093/annonc/mdn717
8. Koizumi W, Tanabe S, Saigenji K, Ohtsu A, Boku N, Nagashima F, Shirao K, Matsumura Y, Gotoh M (2003) Phase I/II study of S-1 combined with cisplatin in patients with advanced gastric cancer. Br J Cancer 89(12):2207-2212. doi: 10.1038/sj.bjc.6601413
9. Lenz HJ, Lee FC, Haller DG, Singh D, Benson AB 3rd, Strumberg D, Yanagihara R, Yao JC, Phan AT, Ajani JA (2007) Extended safety and efficacy data on S-1 plus cisplatin in patients with untreated, advanced gastric carcinoma in a multicenter phase II study. Cancer 109(1):33-40. doi: 10.1002/cncr.22329
10. Lutz MP, Wilke H, Wagener DJ, Vanhoefer U, Jeziorski K, Hegewisch-Becker S, Balleisen L, Joossens E, Jansen RL, Debois M, Bethe U, Praet M, Wils J, Van Cutsem E (2007) Weekly infusional high-dose fluorouracil (HD-FU), HD-FU plus folinic acid (HD-FU/FA), or HD-FU/FA plus biweekly cisplatin in advanced gastric cancer: randomized phase II trial 40953 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group and the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol 25(18):2580-2585. doi: 10.1200/JCO.2007.11.1666
11. Ohtsu A, Shimada Y, Shirao K, Boku N, Hyodo I, Saito H, Yamamichi N, Miyata Y, Ikeda N, Yamamoto S, Fukuda H, Yoshida S (2003) Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol 21(1):54-59
12. Roth AD, Fazio N, Stupp R, Falk S, Bernhard J, Saletti P, Koberle D, Borner MM, Rufibach K, Maibach R, Wernli M, Leslie M, Glynne-Jones R, Widmer L, Seymour M, de Braud F (2007) Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: a randomized phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol 25(22):3217-3223. doi: 10.1200/JCO.2006.08.0135
13. Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA (2006) 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 24(31):4991-4997. doi: 10.1200/JCO.2006.06.8429
14. Ajani JA, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Awad L, Van Cutsem E (2007) Quality of life with docetaxel plus cisplatin and fluorouracil compared with cisplatin and fluorouracil from a phase III trial for advanced gastric or gastroesophageal adenocarcinoma: the V-325 Study Group. J Clin Oncol 25(22):3210-3216. doi: 10.1200/JCO.2006.08.3956
15. Ajani JA, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Marabotti C, Van Cutsem E (2007) Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma: the V-325 Study Group. J Clin Oncol 25(22):3205-3209. doi: 10.1200/JCO.2006.10.4968
16. Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, Rethwisch V, Seipelt G, Homann N, Wilhelm G, Schuch G, Stoehlmacher J, Derigs HG, Hegewisch-Becker S, Grossmann J, Pauligk C, Atmaca A, Bokemeyer C, Knuth A, Jager E (2008) Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol 26(9):1435-1442. doi: 10.1200/JCO.2007.13.9378
17. Dank M, Zaluski J, Barone C, Valvere V, Yalcin S, Peschel C, Wenczl M, Goker E, Cisar L, Wang K, Bugat R (2008) Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol 19(8):1450-1457. doi: 10.1093/annonc/mdn166
18. Moehler M, Kanzler S, Geissler M, Raedle J, Ebert MP, Daum S, Flieger D, Seufferlein T, Galle PR, Hoehler T (2010) A randomized multicenter phase II study comparing capecitabine with irinotecan or cisplatin in metastatic adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol 21(1):71-77. doi: 10.1093/annonc/mdp269
19. Loupakis F, Masi G, Fornaro L, Vasile E, Allegrini G, Fontana E, Granetto C, Salvatore L, Mentuccia L, Andreuccetti M, Cortesi E, Merlano M, Cascinu S, Falcone A (2010) Phase II study of sequential cisplatin plus 5-fluorouracil/leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV followed by docetaxel plus 5-FU/LV in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma. Cancer Chemother Pharmacol 66(3):559-566. doi: 10.1007/s00280-009-1196-1
20. Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M (2008) S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 9(3):215-221. doi: 10.1016/S1470-2045(08)70035-4
21. Ajani JA, Rodriguez W, Bodoky G, Moiseyenko V, Lichinitser M, Gorbunova V, Vynnychenko I, Garin A, Lang I, Falcon S (2010) Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: the FLAGS trial. J Clin Oncol 28(9):1547-1553. doi: 10.1200/JCO.2009.25.4706
22. Takashima A, Yamada Y, Nakajima TE, Kato K, Hamaguchi T, Shimada Y (2009) Standard first-line chemotherapy for metastatic gastric cancer in Japan has met the global standard: evidence from recent phase III trials. Gastrointest Cancer Res 3(6):239-244
23. Hofheinz RD, Al-Batran SE, Ridwelski K, Gorg C, Wehle K, Birth M, Fetscher S, Scheiber H, Lukan N, Lordick F (2010) Population-based patterns of care in the first-line treatment of patients with advanced esophagogastric adenocarcinoma in Germany. Onkologie 33(10):512-518. doi: 10.1159/000319699
24. Wagner AD, Unverzagt S, Grothe W, Kleber G, Grothey A, Haerting J, Fleig WE (2010) Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev (3):CD004064. doi: 10.1002/14651858.CD004064.pub3
25. Al-Batran SE, Hartmann JT, Hofheinz R, Homann N, Rethwisch V, Probst S, Stoehlmacher J, Clemens MR, Mahlberg R, Fritz M, Seipelt G, Sievert M, Pauligk C, Atmaca A, Jager E (2008) Biweekly fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgemeinschaft Internistische Onkologie. Ann Oncol 19(11):1882-1887. doi: 10.1093/annonc/mdn403
26. Ott K, Sendler A, Becker K, Dittler HJ, Helmberger H, Busch R, Kollmannsberger C, Siewert JR, Fink U (2003) Neoadjuvant chemotherapy with cisplatin, 5-FU, and leucovorin (PLF) in locally advanced gastric cancer: a prospective phase II study. Gastric Cancer 6(3):159-167. doi: 10.1007/s10120-003-0245-4
27. Stahl M, Muller C, Koster W, Wilke H (2005) Second-line chemotherapy of advanced disseminated gastric cancer after cisplatin, infusional 5-fluorouracil, folinic acid (PLF): benefit dependent on progression-free interval after first-line therapy. Onkologie 28(10):499-502. doi: 10.1159/000087136
28. Hirono Y, Tsugawa K, Fushida S, Ninomiya I, Yonemura Y, Miyazaki I, Endou Y, Tanaka M, Sasaki T (1995) Amplification of epidermal growth factor receptor gene and its relationship to survival in human gastric cancer. Oncology 52(3):182-188
29. Itakura Y, Sasano H, Shiga C, Furukawa Y, Shiga K, Mori S, Nagura H (1994) Epidermal growth factor receptor overexpression in esophageal carcinoma. An immunohistochemical study correlated with clinicopathologic findings and DNA amplification. Cancer 74(3):795-804
30. Shimada Y, Imamura M, Watanabe G, Uchida S, Harada H, Makino T, Kano M (1999) Prognostic factors of oesophageal squamous cell carcinoma from the perspective of molecular biology. Br J Cancer 80(8):1281-1288. doi: 10.1038/sj.bjc.6690499
31. Yonemura Y, Sugiyama K, Fujimura T, Kamata T, Fushida S, Yamaguchi A, De Aretxebala X, Miwa K, Miyazaki I (1989) Epidermal growth factor receptor status and S-phase fractions in gastric carcinoma. Oncology 46(3):158-161
32. Han SW, Oh DY, Im SA, Park SR, Lee KW, Song HS, Lee NS, Lee KH, Choi IS, Lee MH, Kim MA, Kim WH, Bang YJ, Kim TY (2009) Phase II study and biomarker analysis of cetuximab combined with modified FOLFOX6 in advanced gastric cancer. Br J Cancer 100(2):298-304. doi: 10.1038/sj.bjc.6604861
33. Lordick F, Luber B, Lorenzen S, Hegewisch-Becker S, Folprecht G, Woll E, Decker T, Endlicher E, Rothling N, Schuster T, Keller G, Fend F, Peschel C (2010) Cetuximab plus oxaliplatin/leucovorin/5-fluorouracil in first-line metastatic gastric cancer: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Br J Cancer 102(3):500-505. doi: 10.1038/sj.bjc.6605521
34. Yeh K, Hsu C, Hsu C, Lin C, Shen Y, Wu ST, Choiu T, Chao Y, Cheng A (2009) Phase II study of cetuxumab plus weekly cisplatin and 24-hour infusion of high-dose 5-fluorouracil and leucovorin for the first-line tretment of advanced gastric cancer. J Clin Oncol 27 (15S):Abstract 4567
35. Zhang XD, Xu J, Shen L, Wang J, Liang J, Xu N, Bai Y, Wang J (2008) A phase II study of cetuximab with cisplatin and capecitabine (Xeloda) as first-line treatment in advanced gastric cancer. J Clin Oncol 56 (15S):Abstract 15663
36. Vanhoefer U, Tewes M, Rojo F, Dirsch O, Schleucher N, Rosen O, Tillner J, Kovar A, Braun AH, Trarbach T, Seeber S, Harstrick A, Baselga J (2004) Phase I study of the humanized antiepidermal growth factor receptor monoclonal antibody EMD72000 in patients with advanced solid tumors that express the epidermal growth factor receptor. J Clin Oncol 22(1):175-184. doi: 10.1200/JCO.2004.05.114
37. Graeven U, Kremer B, Sudhoff T, Killing B, Rojo F, Weber D, Tillner J, Unal C, Schmiegel W (2006) Phase I study of the humanised anti-EGFR monoclonal antibody matuzumab (EMD 72000) combined with gemcitabine in advanced pancreatic cancer. Br J Cancer 94(9):1293-1299. doi: 10.1038/sj.bjc.6603083
38. Kollmannsberger C, Schittenhelm M, Honecker F, Tillner J, Weber D, Oechsle K, Kanz L, Bokemeyer C (2006) A phase I study of the humanized monoclonal anti-epidermal growth factor receptor (EGFR) antibody EMD 72000 (matuzumab) in combination with paclitaxel in patients with EGFR-positive advanced non-small-cell lung cancer (NSCLC). Ann Oncol 17(6):1007-1013. doi: 10.1093/annonc/mdl042
39. Rao S, Starling N, Cunningham D, Benson M, Wotherspoon A, Lupfert C, Kurek R, Oates J, Baselga J, Hill A (2008) Phase I study of epirubicin, cisplatin and capecitabine plus matuzumab in previously untreated patients with advanced oesophagogastric cancer. Br J Cancer 99(6):868-874. doi: 10.1038/sj.bjc.6604622
40. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) 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 92(3):205-216
41. Rao S, Starling N, Cunningham D, Sumpter K, Gilligan D, Ruhstaller T, Valladares-Ayerbes M, Wilke H, Archer C, Kurek R, Beadman C, Oates J (2010) Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) compared with epirubicin, cisplatin and capecitabine alone as first-line treatment in patients with advanced oesophago-gastric cancer: a randomised, multicentre open-label phase II study. Ann Oncol 21(11):2213-2219. doi: 10.1093/annonc/mdq247
42. Graziano F, Santini D, Testa E, Catalano V, Beretta GD, Mosconi S, Tonini G, Lai V, Labianca R, Cascinu S (2003) A phase II study of weekly cisplatin, 6S-stereoisomer leucovorin and fluorouracil as first-line chemotherapy for elderly patients with advanced gastric cancer. Br J Cancer 89(8):1428-1432. doi: 10.1038/sj.bjc.6601280
43. Pinto C, Di Fabio F, Siena S, Cascinu S, Rojas Llimpe FL, Ceccarelli C, Mutri V, Giannetta L, Giaquinta S, Funaioli C, Berardi R, Longobardi C, Piana E, Martoni AA (2007) Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study). Ann Oncol 18(3):510-517. doi: 10.1093/annonc/mdl459
44. Ohtsu A, Shah MA, Van Cutsem E, Rha SY, Sawaki A, Park SR, Lim HY, Yamada Y, Wu J, Langer B, Starnawski M, Kang YK (2011) Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol 29(30):3968-3976. doi: 10.1200/JCO.2011.36.2236
45. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK (2010) Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet 376(9742):687-697. doi: 10.1016/S0140-6736(10)61121-X