A randomized phase 2 trial of neoadjuvant chemotherapy in resectable pancreatic cancer: Gemcitabine alone versus gemcitabine combined with cisplatin

Annals of Surgical Oncology

Volumn 14, Issue 7, 2007, Pages 2088-2096

  Palmer, Daniel H ^a   Stocken, Deborah D ^a   Hewitt, Helen ^a   Markham, Catherine E ^b   Hassan, A Bassim ^a   Johnson, Philip J ^a   Buckels, John A C ^b   Bramhall, Simon R ^b  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b QUEEN ELIZABETH HOSPITAL   (United Kingdom)

Author keywords

Cisplatin; Gemcitabine; Neoadjuvant chemotherapy; Pancreatic cancer; Randomized phase 2 trial

Indexed keywords

CIPROFLOXACIN; CISPLATIN; DEXAMETHASONE; GEMCITABINE; GRANISETRON;

ADJUVANT CHEMOTHERAPY; ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; FATIGUE; FEMALE; HUMAN; INFECTION; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PANCREAS CANCER; PANCREAS SURGERY; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE; UNSPECIFIED SIDE EFFECT; VOMITING;

ADENOCARCINOMA; ADULT; AGED; ANTINEOPLASTIC AGENTS; CISPLATIN; DEOXYCYTIDINE; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOADJUVANT THERAPY; PANCREATECTOMY; PANCREATIC NEOPLASMS;

EID: 34250816847     PISSN: 10689265     EISSN: 15344681     Source Type: Journal    
DOI: 10.1245/s10434-007-9384-x     Document Type: Article

References (47)

1. Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin 2000; 50:7-33
2. Ries LAG, Miller BA, Hankey BF, eds. SEER Cancer Statistics Review: Tables and Graphs. Bethesda, MD: National Cancer Institute, 1994
3. Bramhall SR, Allum WH, Jones AG, Allwood A, Cummins C, Neoptolemos JP. Incidence, treatment and survival in 13,560 patients with pancreatic cancer: an epidemiological study in the West Midlands. Br J Surg 1995; 82:111-5
4. Trede M, Schwall G, Saeger HD. Survival after pancreatoduodenectomy: 118 consecutive resections without an operative mortality. Ann Surg 1990; 211:447-58
5. Russell RC. Surgical resection for cancer of the pancreas. Baillieres Clin Gastroenterol 1990; 4:889-916
6. Gall FP, Kessler H, Hermanek P. Surgical treatment of ductal pancreatic carcinoma. Eur J Surg Oncol 1991; 17:173-81
7. Andren-Sandberg A, Ahren B, Tranberg KG, Bengmark S. Surgical treatment of pancreatic cancer. The Swedish experience. Int J Pancreatol 1991; 9:145-51
8. Edge SB, Schmieg R Jr, Rosenlof LK, Wilhelm MC. Pancreas cancer resection outcome in American university centers in 1989-1990. Cancer 1993; 71:3502-8
9. Cameron JL, Pitt HA, Yeo CJ, Lillemoe KD, Kaufman HS, Coleman J. One hundred and forty-five consecutive pancreatoduodenectomies without mortality. Ann Surg 1993; 217:430-8
10. Nitecki SS, Sarr MG, Colby TV, van Heerden JA. Long-term survival after resection for ductal adenocarcinoma of the pancreas. Is it really improving? Ann Surg 1995; 221:59-66
11. Evans DB, Abbruzzese JL, Willett CG. Cancer of the pancreas. In: De Vita, Hellman S, Rosenberg SA, (eds). Cancer: Principles and Practice of Oncology. 6th ed. Philadelphia: Lippincott, Williams and Wilkins, 2001:1126-61
12. Kaiser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg 1985; 120:899-903
13. Klinkenbijl JH, Jeekel J, Sahmoud T, et al. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC Gastrointestinal Tract Cancer Cooperative Group. Ann Surg 1999; 230:776-82
14. Neoptolemos JP, Stocken DD, Friess H, et al. European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med 2004; 350:1200-10
15. Spitz FR, Abbruzzese JL, Lee JE, et al. Preoperative and postoperative chemoradiation strategies in patients treated with pancreaticoduodenectomy for adenocarcinoma of the pancreas. J Clin Oncol 1997; 15:928-37
16. Yeo CJ, Abrams RA, Grochow LB, et al. Pancreaticoduodenectomy for pancreatic adenocarcinoma: postoperative adjuvant chemoradiation improves survival. A prospective, single-institution experience. Ann Surg 1997; 225:621-33
17. Hoffman JP, Lipsitz S, Pisansky T, Weese JL, Solin L, Benson AB 3rd. Phase II trial of preoperative radiation therapy and chemotherapy for patients with localized, resectable adenocarcinoma of the pancreas: an Eastern Cooperative Oncology Group Study. J Clin Oncol 1998; 16:317-23
18. Breslin TM, Hess KR, Harbison DB, et al. Neoadjuvant chemoradiotherapy for adenocarcinoma of the pancreas: treatment variables and survival duration. Ann Surg Oncol 2001; 8:123-32
19. Brunner TB, Grabenbauer GG, Klein P, et al. Phase I trial of strictly time-scheduled gemcitabine and cisplatin with concurrent radiotherapy in patients with locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys 2003; 55:144-53
20. Staley CA, Lee JE, Cleary KR, et al. Preoperative chemoradiation, pancreaticoduodenectomy, and intraoperative radiation therapy for adenocarcinoma of the pancreatic head. Am J Surg 1996; 171:118-24
21. Aristu J, Canon R, Pardo F, et al. Surgical resection after preoperative chemoradiotherapy benefits selected patients with unresectable pancreatic cancer. Am J Clin Oncol 2003; 26:30-6
22. Casper ES, Green MR, Kelsen DP, Heelan RT, Brown TD, Flombaum CD. Phase II trial of gemcitabine in patients with adenocarcinoma of the pancreas. Invest New Drugs 1994; 12:29-34
23. Carmichael J, Fink U, Russell RCG, Spittle MF, Harris A, Spiessl G. Phase II study of gemcitabine in patients with advanced pancreatic cancer. Br J Cancer 1995; 73:101-5
24. Burris HA, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol 1997; 15:2403-13
25. Bergman AM, Ruiz van Haperen VW, Veerman G, Kuiper CM, Peters GJ. Synergistic interaction between cisplatin and gemcitabine in vitro. Clin Cancer Res 1996; 2:521-30
26. Crul M, van Waardenburg RC, Bocxe S, et al. DNA repair mechanisms involved in gemcitabine cytotoxicity and in the interaction between gemcitabine and cisplatin. Biochem Pharmacol 2003; 65:275-82
27. Cardenal F, Lopez-Cabrerizo MP, Anton A, et al. Randomized phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 1999; 17:12-8
28. von der Maase H, Hansen SW, Roberts JT, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18:3068-77
29. Hussain SA, Stocken DD, Riley P, et al. A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer. Br J Cancer 2004; 91:844-9
30. Heinemann V, Wilke H, Mergenthaler HG, et al. Gemcitabine and cisplatin in the treatment of advanced or metastatic pancreatic cancer. Ann Oncol 2000; 11(11):1399-403
31. Philip PA, Zalupski MM, Vaitkevicius VK, et al. Phase II study of gemcitabine and cisplatin in the treatment of patients with advanced pancreatic carcinoma. Cancer 2001; 92:569-77
32. Brodowicz T, Wolfram RM, Kostler WJ, et al. Phase II study of gemcitabine in combination with cisplatin in patients with locally advanced and/or metastatic pancreatic cancer. Anticancer Drugs 2000; 11:623-8
33. Colucci G, Giuliani F, Gebbia V, et al. Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma: a prospective, randomized phase III study of the Gruppo Oncologia dell'Italia Meridionale. Cancer 2002; 94:902-10
34. Heinemann V, Quietzsch D, Gieseler F, et al. A phase III trial comparing gemcitabine plus cisplatin vs gemcitabine alone in advanced pancreatic carcinoma (abstract 1003). Proc Am Soc Clin Oncol 2003;22
35. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41
36. Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep 1985; 69:1375-81
37. Neuhaus P, Oettle H, Post S, et al. A randomised, prospective, multicenter, phase III trial of adjuvant chemotherapy with gemcitabine vs observation in patients with resected pancreatic cancer (abstract 4013). J Clin Oncol, 2005 ASCO Annual Meeting Proceedings 23(16S) Part I of II (June 1 suppl), 2005:4013
38. Pisters PW, Hudec WA, Lee JE, et al. Preoperative chemoradiation for patients with pancreatic cancer: toxicity of endobiliary stents. J Clin Oncol 2000; 18:860-7
39. Warshaw AL. Implications of peritoneal cytology for staging of early pancreatic cancer. Am J Surg 1991; 161:26-9
40. Hyoty MK, Mattila JJ, Salo K, Nordback IH. Intraoperative fine needle aspiration cytologic examination of pancreatic lesions. Surg Gynecol Obstet 1991; 173:193-7
41. Jarufe NP, Coldam C, Mayer AD, Mirza DF, Buckels JAC, Bramhall SR. Favourable prognostic factors in a large UK experience of adenocarcinoma of the head of the pancreas and periampullary region. Dig Surg 2004; 21:202-9
42. Gudjonsson B. Cancer of the pancreas 50 years of surgery. Cancer 1987; 60:2284-303
43. Baumel H, Huguier M, Manderscheid JC, Fabre JM, Houry S, Fagot H. Results of resection for cancer of the exocrine pancreas: a study from the French Association of Surgery. Br J Surg 1994; 81:102-7
44. Cameron JL, Crist DW, Sitzmann JV, et al. Factors influencing survival after pancreaticoduodenectomy for pancreatic cancer. Am J Surg 1991; 161:120-4
45. Funovics JM, Karner J, Pratschner T, Fritsch A. Current trends in the management of carcinoma of the pancreatic head. Hepatogastroenterology 1989; 36:450-5
46. Willett CG, Lewandrowski K, Warshaw AL, Efird J, Compton CC. Resection margins in carcinoma of the head of the pancreas. Implications for radiation therapy. Ann Surg 1993; 217:144-8
47. Lillemoe KD, Cameron JL, Yeo CJ, et al. Pancreaticoduodenectomy. Does it have a role in the palliation of pancreatic cancer? Ann Surg 1996; 223:718-25