Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial

Yan-Shen Shan | Paul Ross | Daniel Palmer | Jens T Siveke | Andrew Dean | Tomislav Dragovich | Paolo Piacentini | Vincent Chung | Hye Jin Choi | Chang-Fang Chiu | Thomas Seufferlein | David Cunningham | Antonio Cubillo | Joon-Oh Park | K. Rau | C. Sternberg | T. Bekaii-Saab | T. Seufferlein | C. Barrios | G. Bodoky | R. Wadlow | D. Cunningham | I. Láng | E. Bayever | Chung-Pin Li | W. Ma | Kuan-Der Lee | Jun Suk Kim | P. Ross | Li‐Tzong Chen | Jen‐Shi Chen | D. Palmer | F. Franke | N. Tebbutt | W. Edenfield | F. Braiteh | I. Chung | David Chang | J. Blanc | J. Raoul | R. Hubner | J. Siveke | M. Wit | T. Csoszi | G. Schwartsmann | T. Macarulla | C. Chiu | M. Šmakal | Teresa Macarulla | Y. Shan | T. Dragovich | György Bodoky | Yeu-Chin Chen | Li-Tzong Chen | Chung-Pin Li | Andrea Wang-Gillam | U. Pelzer | L. Fein | D. Richards | Kyung-Hun Lee | C. Bampton | D. D. Hoff | V. Moyo | Niall Tebbutt | L. Mangel | H. Choi | R. Iaffaioli | A. Wang-Gillam | A. Dean | G. Jameson | B. Belanger | N. Dhindsa | Kyung-Hun Lee | Bruce Belanger | Gilberto Schwartsmann | R. Mena | Cora Sternberg | Victor Moyo | Wen Wee Ma | Jean-Luc Raoul | Kuan-Der Lee | Fadi Braiteh | Jamil Asselah | Carlos Henrique Barrios | Martin Smakal | Kun-Ming Rau | Uwe Pelzer | Richard A Hubner | Navreet Dhindsa | Eliel Bayever | Gayle Jameson | Tanios Bekaii-Saab | Istvan Lang | Joon Oh Park | Ik Joo Chung | Maike de Wit | S. Pant | Jean F Blanc | Daniel D Von Hoff | Clarence Adoo | Thomas Anderson | Alan Azambuja | Carolyn Bampton | Melichar Bohuslav | David Chang | Jen-Shi Chen | Tibor Csoszi | Linda DeMarco | William Edenfield | Luis Enrique Fein | Fábio Franke | Martin Fuchs | Vega Gonzales-Cruz | Alberto Gozza | Rivera Herrero Fernando | Rosario Iaffaioli | Jitka Jakesova | Zsuzsanna Kahan | Misagh Karimi | Ernesto Korbenfeld | Fa-Chyi Lee | Lara Lipton | Laszlo Mangel | Raul Mena | Shubham Pant | Javier Gallego Plazas | Cooray Prasad | Donald Richards | Luis Schlittler | Vladimira Stahalova | Jeferson Jose Vinholes | Raymond Wadlow | Milkos Wenczl | Mark Wong | A. Cubillo | Z. Kahán | J. Asselah | V. Chung | F. Lee | J. G. Plazas | A. Azambuja | M. Wong | Thomas Anderson | M. Fuchs | Yeu-Chin Chen | J. Vinholes | Misagh Karimi | E. Korbenfeld | P. Piacentini | A. Gozza | Melichar Bohuslav | L. DeMarco | L. Schlittler | L. Lipton | Clarence S. Adoo | Vega Gonzales-Cruz | R. Fernando | Jitka Jakešová | C. Prasad | V. Stahalova | Milkos Wenczl | Kuan-Der Lee | David D Chang | T. Csőszi | J. Jakešová

[1]  F. Bonnetain,et al.  PEPCOL: A randomized noncomparative phase II study of PEP02 (MM-398) or irinotecan in combination with leucovorin and 5-fluorouracil as second-line therapy in patients with unresectable metastatic colorectal cancer--A GERCOR Study. , 2015 .

[2]  K. Yeh,et al.  Phase I study of nanoliposomal irinotecan (PEP02) in advanced solid tumor patients , 2015, Cancer Chemotherapy and Pharmacology.

[3]  U. Nielsen,et al.  Preclinical activity of nanoliposomal irinotecan is governed by tumor deposition and intratumor prodrug conversion. , 2014, Cancer research.

[4]  R. Korn,et al.  261 Lesion characterization with ferumoxytol MRI in patients with advanced solid tumors and correlation with treatment response to MM-398, nanoliposomal irinotecan (nal-IRI) , 2014 .

[5]  B. Dörken,et al.  Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. , 2014, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  M. Moore,et al.  PANCREOX: A randomized phase 3 study of 5FU/LV with or without oxaliplatin for second-line advanced pancreatic cancer (APC) in patients (pts) who have received gemcitabine (GEM)-based chemotherapy (CT). , 2014 .

[7]  A. Ko,et al.  Beyond first-line chemotherapy for advanced pancreatic cancer: an expanding array of therapeutic options? , 2014, World journal of gastroenterology.

[8]  David Goldstein,et al.  Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. , 2013, The New England journal of medicine.

[9]  M. Tempero,et al.  A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer , 2013, British Journal of Cancer.

[10]  F. J. Ramos,et al.  A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma. , 2013, Annals of oncology : official journal of the European Society for Medical Oncology.

[11]  E. Raymond,et al.  FOLFIRI regimen in metastatic pancreatic adenocarcinoma resistant to gemcitabine and platinum-salts. , 2012, World journal of gastroenterology.

[12]  S. Barni,et al.  FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study , 2012, Cancer Chemotherapy and Pharmacology.

[13]  K. Behrns FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer , 2012 .

[14]  I. Sobhani,et al.  5-Fluorouracil/Leucovorin Combined with Irinotecan and Oxaliplatin (FOLFIRINOX) as Second-Line Chemotherapy in Patients with Metastatic Pancreatic Adenocarcinoma , 2011, Oncology.

[15]  Pierre Michel,et al.  FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. , 2011, The New England journal of medicine.

[16]  M. Reni,et al.  XELIRI or FOLFIRI as salvage therapy in advanced pancreatic cancer. , 2010, Anticancer research.

[17]  G. Colucci,et al.  Irinotecan Plus Bolus/Infusional 5-Fluorouracil and Leucovorin in Patients With Pretreated Advanced Pancreatic Carcinoma: A Multicenter Experience of the Gruppo Oncologico Italia Meridionale , 2010, American journal of clinical oncology.

[18]  C. Jeong,et al.  Pilot study of irinotecan/oxalipltin (IROX) combination chemotherapy for patients with gemcitabine- and 5-fluorouracil- refractory pancreatic cancer , 2010, Investigational New Drugs.

[19]  D. Park,et al.  A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer , 2009, British Journal of Cancer.

[20]  J. K. Lee,et al.  Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer , 2007, Cancer Chemotherapy and Pharmacology.

[21]  M. Tempero,et al.  Excess Toxicity Associated with Docetaxel and Irinotecan in Patients with Metastatic, Gemcitabine-Refractory Pancreatic Cancer: Results of a Phase II Study , 2008, Cancer investigation.

[22]  P. Murawa,et al.  Erlotinib Plus Gemcitabine Compared With Gemcitabine Alone in Patients With Advanced Pancreatic Cancer: A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group , 2023, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[23]  Alex Sparreboom,et al.  Pharmacogenetics of irinotecan metabolism and transport: an update. , 2006, Toxicology in vitro : an international journal published in association with BIBRA.

[24]  A. Manni,et al.  Combined Irinotecan and Oxaliplatin in Patients with Advanced Pre-Treated Pancreatic Cancer , 2004, Oncology.

[25]  M. Reni,et al.  Salvage Chemotherapy with Mitomycin, Docetaxel, and Irinotecan (MDI Regimen) in Metastatic Pancreatic Adenocarcinoma: A Phase I and II Trial , 2004, Cancer investigation.

[26]  W. Scheithauer,et al.  Irinotecan plus raltitrexed vs raltitrexed alone in patients with gemcitabine-pretreated advanced pancreatic adenocarcinoma , 2003, British Journal of Cancer.

[27]  R. Schilsky,et al.  An investigational new drug treatment program for patients with gemcitabine , 1999, Cancer.

[28]  D. V. Von Hoff,et al.  Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. , 1997, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.