Consensus report of the national cancer institute clinical trials planning meeting on pancreas cancer treatment.
Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality, despite significant improvements in diagnostic imaging and operative mortality rates. The 5-year survival rate remains less than 5% because of microscopic or gross metastatic disease at time of diagnosis. The Clinical Trials Planning Meeting in pancreatic cancer was convened by the National Cancer Institute's Gastrointestinal Cancer Steering Committee to discuss the integration of basic and clinical knowledge in the design of clinical trials in PDAC. Major emphasis was placed on the enhancement of research to identify and validate the relevant targets and molecular pathways in PDAC, cancer stem cells, and the microenvironment. Emphasis was also placed on developing rational combinations of targeted agents and the development of predictive biomarkers to assist selection of patient subsets. The development of preclinical tumor models that are better predictive of human PDAC must be supported with wider availability to the research community. Phase III clinical trials should be implemented only if there is a meaningful clinical signal of efficacy and safety in the phase II setting. The emphasis must therefore be on performing well-designed phase II studies with uniform sets of basic entry and evaluation criteria with survival as a primary endpoint. Patients with either metastatic or locally advanced PDAC must be studied separately.
Philip
Philip A
PA
Karmanos Cancer Institute, Wayne State University, Detroit, MI 48201, USA. philipp@karmanos.org
Mooney
Margaret
M
Jaffe
Deborah
D
Eckhardt
Gail
G
Moore
Malcolm
M
Meropol
Neal
N
Emens
Leisha
L
O'Reilly
Eileen
E
Korc
Murray
M
Ellis
Lee
L
Benedetti
Jacqueline
J
Rothenberg
Mace
M
Willett
Christopher
C
Tempero
Margaret
M
Lowy
Andrew
A
Abbruzzese
James
J
Simeone
Diane
D
Hingorani
Sunil
S
Berlin
Jordan
J
Tepper
Joel
J
D000818:Animals; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D021441:Carcinoma, Pancreatic Ductal / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D004195:Disease Models, Animal; D018572:Disease-Free Survival; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D008297:Male; D051379:Mice; D054547:National Cancer Institute (U.S.); D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D010180:Pancreatectomy / Q000379:methods; D010190:Pancreatic Neoplasms / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D017410:Practice Guidelines as Topic; D011379:Prognosis; D018570:Risk Assessment; D016019:Survival Analysis; D014481:United States