Phase II multicentre study of efficacy and feasibility of dose-intensified preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) in resectable gastroesophageal cancer

Cancer Chemotherapy and Pharmacology

Volumn 74, Issue 1, 2014, Pages 141-150

  Jary, Marine ^a   Ghiringhelli, Francois ^b   Jacquin, Marion ^a   Fein, Francine ^a   Nguyen, Thierry ^a   Cleau, Denis ^c   Nerich, Virginie ^a,d   El Gani, Maryame ^d   Mathieu, Pierre ^a   Valmary Degano, Séverine ^a,d   Arnould, Laurent ^b   Lassabe, Catherine ^e   Lamfichekh, Najib ^f   Fratté, Serge ^e   Paget Bailly, Sophie ^a   Bonnetain, Franck ^a,d   Borg, Christophe ^a,d   Kim, Stefano ^a  

^a UNIVERSITY HOSPITAL OF BESANÇON   (France)

^b Georges Francois Leclerc Cancer Center   (France)

^c Department of Gastroenterology Hospital of Vesoul   (France)

^d UNIVERSITÉ DE FRANCHE COMTÉ   (France)

^e GESC Dept   (France)

^f Hospital of Belfort Montbeliard   (France)

Author keywords

Cisplatin; Epirubicin; Gastroesophageal cancer; Neoadjuvant; Paclitaxel; Preoperative

Indexed keywords

CISPLATIN; EPIRUBICIN; PACLITAXEL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ACUTE KIDNEY FAILURE; ADULT; AGED; ALOPECIA; ANASTOMOSIS LEAKAGE; ANEMIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURGERY; CANCER SURVIVAL; CLINICAL ARTICLE; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ESOPHAGEAL ADENOCARCINOMA; FATIGUE; FEASIBILITY STUDY; FEBRILE NEUTROPENIA; FEMALE; FEVER; FOLLOW UP; GASTROESOPHAGEAL ADENOCARCINOMA; GASTROINTESTINAL CARCINOMA; HISTOPATHOLOGY; HUMAN; INFECTION; LEUKOPENIA; LUNG EMBOLISM; LUNG INFECTION; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; ORAL MUCOSITIS; PARESTHESIA; PERIPHERAL NEUROPATHY; PERSONAL EXPERIENCE; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; POSTOPERATIVE COMPLICATION; PREOPERATIVE PERIOD; PRIORITY JOURNAL; THROMBOCYTOPENIA; VOMITING;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMOTHERAPY-INDUCED FEBRILE NEUTROPENIA; CISPLATIN; COHORT STUDIES; DRUG MONITORING; EPIRUBICIN; ESOPHAGEAL NEOPLASMS; ESOPHAGUS; FEASIBILITY STUDIES; FEMALE; FOLLOW-UP STUDIES; HUMANS; LEUKOPENIA; MALE; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM STAGING; PACLITAXEL; PILOT PROJECTS; SEVERITY OF ILLNESS INDEX; STOMACH; STOMACH NEOPLASMS; SURVIVAL ANALYSIS;

EID: 84903817261     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-014-2482-0     Document Type: Article

References (38)

1. Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, Participants MT (2006) Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med 355:11-20
2. Ychou M, Boige V, Pignon JP, Conroy T, Bouche O, Lebreton G, Ducourtieux M, Bedenne L, Fabre JM, Saint-Aubert B, Geneve J, Lasser P, Rougier P (2011) Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. J Clin Oncol 29:1715-1721
3. 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 24:4991-4997 (Pubitemid 46631401)
4. Biffi R, Fazio N, Luca F, Chiappa A, Andreoni B, Zampino MG, Roth A, Schuller JC, Fiori G, Orsi F, Bonomo G, Crosta C, Huber O (2010) Surgical outcome after docetaxel-based neoadjuvant chemotherapy in locally-advanced gastric cancer. World J Gastroenterol 16:868-874
5. Moebus V, Jackisch C, Lueck HJ, du Bois A, Thomssen C, Kurbacher C, Kuhn W, Nitz U, Schneeweiss A, Huober J, Harbeck N, von Minckwitz G, Runnebaum IB, Hinke A, Kreienberg R, Konecny GE, Untch M (2010) Intense dose-dense sequential chemotherapy with epirubicin, paclitaxel, and cyclophosphamide compared with conventionally scheduled chemotherapy in high-risk primary breast cancer: mature results of an AGO phase III study. J Clin Oncol 28:2874-2880
6. Untch M, von Minckwitz G, Konecny GE, Conrad U, Fett W, Kurzeder C, Luck HJ, Stickeler E, Urbaczyk H, Liedtke B, Beckmann MW, Salat C, Harbeck N, Muller V, Schmidt M, Hasmuller S, Lenhard M, Nekljudova V, Lebeau A, Loibl S, Fasching PA (2011) PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel, and CMF versus a standard-dosed epiru-bicin-cyclophosphamide followed by paclitaxel with or without darbepoetin alfa in primary breast cancer-outcome on prognosis. Ann Oncol 22:1999-2006
7. Katsumata N, Yasuda M, Isonishi S, Takahashi F, Michimae H, Kimura E, Aoki D, Jobo T, Kodama S, Terauchi F, Sugiyama T, Ochiai K (2013) Long-term results of dose-dense paclitaxel and carboplatin versus conventional paclitaxel and carboplatin for treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (JGOG 3016): a randomised, controlled, open-label trial. Lancet Oncol 14:1020-1026
8. Frasci G, D'Aiuto G, Comella P, Thomas R, Botti G, Di Bonito M, De Rosa V, Iodice G, Rubulotta MR, Comella G (2006) Weekly cisplatin, epirubicin, and paclitaxel with granulocyte colony-stimulating factor support vs triweekly epirubicin and paclitaxel in locally advanced breast cancer: final analysis of a sicog phase III study. Br J Cancer 95:1005-1012 (Pubitemid 44606826)
9. Frasci G, D'Aiuto G, Comella P, D'Aiuto M, Di Bonito M, Ruffolo P, Iodice G, Petrillo A, Lastoria S, Oliviero P, Capasso I, Montella M, Siani C, Santangelo M, Vizioli L, Comella G (2010) Preoperative weekly cisplatin, epirubicin, and paclitaxel (PET) improves prognosis in locally advanced breast cancer patients: an update of the Southern Italy Cooperative Oncology Group (SICOG) randomised trial 9908. Ann Oncol 21:707-716
10. Frasci G, D'Aiuto G, Comella P, Thomas R, Botti G, Di Bonito M, D'Aiuto M, Romano G, Rubulotta MR, Comella G (2005) A 2-month cisplatin-epirubicin- paclitaxel (PET) weekly combination as primary systemic therapy for large operable breast cancer: a phase II study. Ann Oncol 16:1268-1275 (Pubitemid 41158470)
11. Zheng Y, Li F, Qi B, Luo B, Sun H, Liu S, Wu X (2007) Application of perioperative immunonutrition for gastrointestinal surgery: a meta-analysis of randomized controlled trials. Asia Pac J Clin Nutr 16(Suppl 1):253-257 (Pubitemid 46524610)
12. Mariette C, Alves A, Benoist S, Bretagnol F, Mabrut JY, Slim K (2005) Perioperative care in digestive surgery. Guidelines for the French society of digestive surgery (SFCD). Ann Chir 130:108-124 (Pubitemid 40298916)
13. Weimann A, Braga M, Harsanyi L, Laviano A, Ljungqvist O, Soeters P, Jauch KW, Kemen M, Hiesmayr JM, Horbach T, Kuse ER, Vestweber KH (2006) ESPEN guidelines on enteral nutrition: surgery including organ transplantation. Clin Nutr 25:224-244 (Pubitemid 43832525)
14. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M (2009) The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 250:187-196
15. Becker K, Mueller JD, Schulmacher C, Ott K, Fink U, Busch R, Bottcher K, Siewert JR, Hofler H (2003) Histomorphology and grading of regression in gastric carcinoma treated with neoadjuvant chemotherapy. Cancer 98:1521-1530 (Pubitemid 37151509)
16. Fleming TR (1982) One-sample multiple testing procedure for phase II clinical trials. Biometrics 38:143-151
17. Moreno Gonzalez E, Gonzalez-Pinto I, Garcia Garcia I, Gomez Sanz R, Loinaz Segurola C, Bercedo Martinez J, Figueroa Andollo J, Palma Carazo F, Marcello Fernandez M (1992) Esophageal resection by cervico-abdominal approach without thoracotomy. Surg Today 22:517-522 (Pubitemid 23001052)
18. Ajani JA, Bentrem DJ, Besh S, D'Amico TA, Das P, Denlinger C, Fakih MG, Fuchs CS, Gerdes H, Glasgow RE, Hayman JA, Hofstetter WL, Ilson DH, Keswani RN, Kleinberg LR, Korn WM, Lockhart AC, Meredith K, Mulcahy MF, Orringer MB, Posey JA, Sasson AR, Scott WJ, Strong VE, Varghese TK, Jr, Warren G, Washington MK, Willett C, Wright CD, McMillian NR et al (2013) Gastric cancer, version 2.2013: featured updates to the NCCN guidelines. J Natl Compr Cancer Netw 11:531-546
19. Csendes A, Burdiles P, Rojas J, Braghetto I, Diaz JC, Maluenda F (2002) A prospective randomized study comparing D2 total gastrectomy versus D2 total gastrectomy plus splenectomy in 187 patients with gastric carcinoma. Surgery 131:401-407 (Pubitemid 34289730)
20. Yu W, Choi GS, Chung HY (2006) Randomized clinical trial of splenectomy versus splenic preservation in patients with proximal gastric cancer. Br J Surg 93:559-563
21. Becker K, Langer R, Reim D, Novotny A, Meyer zum Buschenfelde C, Engel J, Friess H, Hofler H (2011) Significance of histopathological tumor regression after neoadjuvant chemotherapy in gastric adenocarcinomas: a summary of 480 cases. Ann Surg 253:934-939
22. Lowy AM, Mansfield PF, Leach SD, Pazdur R, Dumas P, Ajani JA (1999) Response to neoadjuvant chemotherapy best predicts survival after curative resection of gastric cancer. Ann Surg 229:303-308 (Pubitemid 30191763)
23. Fields RC, Strong VE, Gonen M, Goodman KA, Rizk NP, Kelsen DP, Ilson DH, Tang LH, Brennan MF, Coit DG, Shah MA (2011) Recurrence and survival after pathologic complete response to preoperative therapy followed by surgery for gastric or gastrooesophageal adenocarcinoma. Br J Cancer 104:1840-1847
24. Lorenzen S, Thuss-Patience P, Al-Batran SE, Lordick F, Haller B, Schuster T, Pauligk C, Luley K, Bichev D, Schumacher G, Homann N (2013) Impact of pathologic complete response on disease-free survival in patients with esophagogastric adenocarcinoma receiving preoperative docetaxel-based chemotherapy. Ann Oncol 24:2068-2073
25. Hironaka S, Ueda S, Yasui H, Nishina T, Tsuda M, Tsumura T, Sugimoto N, Shimodaira H, Tokunaga S, Moriwaki T, Esaki T, Nagase M, Fujitani K, Yamaguchi K, Ura T, Hamamoto Y, Morita S, Okamoto I, Boku N, Hyodo I (2013) Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 trial. J Clin Oncol 31:4438-4444
26. 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 25:3210-3216 (Pubitemid 47325603)
27. Ferri LE, Ades S, Alcindor T, Chasen M, Marcus V, Hickeson M, Artho G, Thirlwell MP (2012) Perioperative docetaxel, cisplatin, and 5-fluorouracil (DCF) for locally advanced esophageal and gastric adenocarcinoma: a multicenter phase II trial. Ann Oncol 23:1512-1517
28. Fiteni F, Nguyen T, Borg C, Benzidane B, Nerich V, Heyd B, Pivot X, Kim S (2012) Docetaxel, cisplatin and fluorouracil as perioperative chemotherapy in resectable gastroesophageal carcinoma: a retrospective analysis. Ann Oncol 23(Suppl 9):ix224-ix257
29. Homann N, Pauligk C, Luley K, Werner Kraus T, Bruch HP, Atmaca A, Noack F, Altmannsberger HM, Jager E, Al-Batran SE (2012) Pathological complete remission in patients with oesophagogastric cancer receiving preoperative 5-fluorouracil, oxaliplatin and docetaxel. Int J Cancer 130:1706-1713
30. Thuss-Patience PC, Hofheinz RD, Arnold D, Florschutz A, Daum S, Kretzschmar A, Mantovani-Loffler L, Bichev D, Breithaupt K, Kneba M, Schumacher G, Glanemann M, Schlattmann P, Reichardt P, Gahn B (2012) Perioperative chemotherapy with docetaxel, cisplatin and capecitabine (DCX) in gastro-oesophageal adenocarcinoma: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO){dagger}. Ann Oncol 23:2827-2834
31. Messager M, Lefevre JH, Pichot-Delahaye V, Souadka A, Piessen G, Mariette C (2011) The impact of perioperative chemotherapy on survival in patients with gastric signet ring cell adenocarcinoma: a multicenter comparative study. Ann Surg 254:684-693; discussion 693
32. Piessen G, Messager M, Leteurtre E, Jean-Pierre T, Mariette C (2009) Signet ring cell histology is an independent predictor of poor prognosis in gastric adenocarcinoma regardless of tumoral clinical presentation. Ann Surg 250:878-887
33. Bastholt L, Dalmark M, Gjedde SB, Pfeiffer P, Pedersen D, Sandberg E, Kjaer M, Mouridsen HT, Rose C, Nielsen OS, Jakobsen P, Bentzen SM (1996) Dose-response relationship of epirubicin in the treatment of postmenopausal patients with metastatic breast cancer: a randomized study of epirubicin at four different dose levels performed by the Danish Breast Cancer Cooperative Group. J Clin Oncol 14:1146-1155
34. 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 24:2903-2909 (Pubitemid 46630593)
35. Gandara DR, Perez EA, Phillips WA, Lawrence HJ, DeGregorio M (1989) Evaluation of cisplatin dose intensity: current status and future prospects. Anticancer Res 9:1121-1128 (Pubitemid 19266366)
36. Shitara K, Yuki S, Tahahari D, Nakamura M, Kondo C, Tsuda T, Kii T, Tsuji Y, Utsunomiya S, Ichikawa D, Hosokawa A, Ishiguro A, Sakai D, Hironaka S, Oze I, Matsuo K, Muro K (2014) Randomised phase II study comparing dose-escalated weekly paclitaxel vs standard-dose weekly paclitaxel for patients with previously treated advanced gastric cancer. Br J Cancer 110:271-277
37. http://clinicaltrials.gov/show/NCT01216644. Accessed 5 Jan 2014
38. http://clinicaltrials.gov/show/NCT01515748. Accessed 5 Jan 2014