PMID- 25963019
OWN - NLM
STAT- MEDLINE
DCOM- 20150909
LR  - 20181202
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 51
IP  - 11
DP  - 2015 Jul
TI  - First-line single-agent panitumumab in frail elderly patients with wild-type KRAS 
      metastatic colorectal cancer and poor prognostic factors: A phase II study of the 
      Spanish Cooperative Group for the Treatment of Digestive Tumours.
PG  - 1371-80
LID - S0959-8049(15)00349-4 [pii]
LID - 10.1016/j.ejca.2015.04.013 [doi]
AB  - BACKGROUND: Frail elderly patients with metastatic colorectal cancer (mCRC) are 
      not candidates for chemotherapy. Monotherapy with anti-epidermal growth factor 
      receptor (EGFR) monoclonal antibodies may be an option for these patients with 
      few systemic toxic effects. PATIENTS AND METHODS: Single-arm, multicentre, phase 
      II trial including patients ⩾ 70y ears with wild-type (WT) KRAS (exon 2) mCRC, 
      Eastern Cooperative Oncology Group (ECOG) status ⩽ 3, KPC (Kohne Prognostic 
      Classification)--defined intermediate or high risk status, frailty and/or 
      ineligibility for chemotherapy. Patients received panitumumab until progression 
      or unacceptable toxicity. The primary end-point was progression free survival 
      (PFS) rate at 6 months. RESULTS: The study included 33 patients 
      (intention-to-treat (ITT) population). Median age: 81 years; sex: 66.7% male; 
      high-risk KPC status: 45.4%. Median treatment duration was 14 weeks and 6-month 
      PFS rate was 36.4% (95% confidence interval (CI): 20.0-52.8). The objective 
      response rate: 9.1% (95% CI: 0-18.9) (all partial responses), and there were 18 
      stable diseases (54.5%). Median PFS was 4.3 months (95% CI: 2.8-6.4) and median 
      overall survival (OS) was 7.1 months (95% CI: 5.0-12.3). There were no deaths or 
      grade 4-5 adverse events (AEs) related to panitumumab and the most common grade 
      3-related AE was rash acneiform (15.2%). A significant association between 
      clinical response and RAS status was observed (P=0.037). In the WT RAS subgroup 
      (WT exons 2, 3, and 4 of KRAS and NRAS, N = 15), 6-month PFS rate was 53.3% (95% 
      CI: 30.1-75.2) and median PFS and OS were 7.9 and 12.3 months, respectively. 
      CONCLUSIONS: Single-agent panitumumab is active and well tolerated and may be a 
      therapeutic option for high-risk frail elderly patients with WT RAS tumours 
      considered not candidates for chemotherapy (clinicaltrials.gov identifier 
      NCT01126112).
CI  - Copyright (c) 2015 Elsevier Ltd. All rights reserved.
FAU - Sastre, J
AU  - Sastre J
AD  - Medical Oncology Department, Hospital Clinico San Carlos, c/Martin Lagos s/n, 
      28040 Madrid, Spain. Electronic address: jsastre.hcsc@salud.madrid.org.
FAU - Massuti, B
AU  - Massuti B
AD  - Medical Oncology Service, Hospital General Universitario de Alicante, Pintor 
      Baeza, 12, 03010 Alicante, Spain.
FAU - Pulido, G
AU  - Pulido G
AD  - Oncology Service, Hospital Reina Sofia, University of Cordoba, Maimonides 
      Institute of Biomedical Research (IMIBIC), Avda. Menendez Pidal, s/n, 14004 
      Cordoba, Spain; Spanish Cancer Network (RTICC), Instituto de Salud Carlos III, C/ 
      Sinesio Delgado, 4, 28029 Madrid, Spain.
FAU - Guillen-Ponce, C
AU  - Guillen-Ponce C
AD  - Medical Oncology Service, Hospital Ramon y Cajal, Ctra. de Colmenar Viejo, km. 
      9100, 28034 Madrid, Spain.
FAU - Benavides, M
AU  - Benavides M
AD  - Medical Oncology Service, Hospital Regional Universitario, Avenida Carlos Haya, 
      s/n, 29010 Malaga, Spain.
FAU - Manzano, J L
AU  - Manzano JL
AD  - Catalan Institute of Oncology Badalona, Hospital Universitario Germans Trias i 
      Pujol, Crta. Can Ruti-Cami Escoles, s/n, 08916 Badalona, Barcelona, Spain.
FAU - Reboredo, M
AU  - Reboredo M
AD  - Medical Oncology Service, Hospital Universitario A Coruna - Hospital Teresa 
      Herrera, As Xubias, s/n, 15006 A Coruna, Spain.
FAU - Rivera, F
AU  - Rivera F
AD  - Medical Oncology Service, Hospital Marques de Valdecilla, Avenida Valdecilla, 
      s/n, 39008 Santander, Cantabria, Spain.
FAU - Gravalos, C
AU  - Gravalos C
AD  - Medical Oncology Service, Hospital 12 de Octubre, Madrid, Avda de Cordoba, s/n, 
      28041 Madrid, Spain.
FAU - Safont, M J
AU  - Safont MJ
AD  - Medical Oncology Service, Hospital General Universitario, Av. de les Tres Creus, 
      2, 46014 Valencia, Spain.
FAU - Martinez Villacampa, M
AU  - Martinez Villacampa M
AD  - Catalan Institute of Oncology LHospitalet, Hospital Duran i Reynals, Avinguda 
      Granvia de l'Hospitalet, 199-203, 08908 l'Hospitalet de Llobregat, Barcelona, 
      Spain.
FAU - Llovet, P
AU  - Llovet P
AD  - Medical Oncology Department, Hospital Clinico San Carlos, c/Martin Lagos s/n, 
      28040 Madrid, Spain.
FAU - Dotor, E
AU  - Dotor E
AD  - Medical Oncology Service, Corporacio Sanitaria Parc Tauli, Parc Tauli 1, 08208 
      Sabadell, Barcelona, Spain.
FAU - Diaz-Rubio, E
AU  - Diaz-Rubio E
AD  - Medical Oncology Department, Hospital Clinico San Carlos, c/Martin Lagos s/n, 
      28040 Madrid, Spain.
FAU - Aranda, E
AU  - Aranda E
AD  - Oncology Service, Hospital Reina Sofia, University of Cordoba, Maimonides 
      Institute of Biomedical Research (IMIBIC), Avda. Menendez Pidal, s/n, 14004 
      Cordoba, Spain; Spanish Cancer Network (RTICC), Instituto de Salud Carlos III, C/ 
      Sinesio Delgado, 4, 28029 Madrid, Spain.
CN  - Spanish Cooperative Group for the Treatment of Digestive Tumours TTD
LA  - eng
SI  - ClinicalTrials.gov/NCT01126112
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150508
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (KRAS protein, human)
RN  - 0 (Proto-Oncogene Proteins)
RN  - 6A901E312A (Panitumumab)
RN  - EC 3.6.5.2 (Proto-Oncogene Proteins p21(ras))
RN  - EC 3.6.5.2 (ras Proteins)
SB  - IM
MH  - Age Factors
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antineoplastic Agents/*therapeutic use
MH  - Colorectal Neoplasms/*drug therapy/enzymology/genetics/pathology
MH  - Disease-Free Survival
MH  - Female
MH  - Genes, ras
MH  - Humans
MH  - Male
MH  - Neoplasm Metastasis
MH  - Panitumumab
MH  - Prognosis
MH  - Proto-Oncogene Proteins/genetics
MH  - Proto-Oncogene Proteins p21(ras)
MH  - Spain
MH  - ras Proteins/genetics
OTO - NOTNLM
OT  - Colorectal cancer
OT  - Elderly patients
OT  - First-line
OT  - Frailty
OT  - Monotherapy
OT  - Panitumumab
FIR - Sastre, Javier
IR  - Sastre J
FIR - Diaz Rubio, Eduardo
IR  - Diaz Rubio E
FIR - Massuti Sureda, B
IR  - Massuti Sureda B
FIR - Gravalos Castro, C
IR  - Gravalos Castro C
FIR - Robles, L
IR  - Robles L
FIR - Guillen, C
IR  - Guillen C
FIR - Aranda, E
IR  - Aranda E
FIR - Pulido, G
IR  - Pulido G
FIR - Dotor, E
IR  - Dotor E
FIR - Rivera, F
IR  - Rivera F
FIR - Manzano, J Luis
IR  - Manzano J
FIR - Sastre, J
IR  - Sastre J
FIR - Diaz Rubio, E
IR  - Diaz Rubio E
FIR - Benavides, M
IR  - Benavides M
FIR - Martinez Villacampa, M
IR  - Martinez Villacampa M
FIR - Reboredo, M
IR  - Reboredo M
FIR - Safont, M J
IR  - Safont MJ
FIR - Dotor, E
IR  - Dotor E
FIR - Ruiz, I
IR  - Ruiz I
FIR - de Mena
IR  - de Mena
FIR - Rodriguez, S
IR  - Rodriguez S
FIR - Escalona, N
IR  - Escalona N
FIR - Monar, L
IR  - Monar L
FIR - Valveny, N
IR  - Valveny N
EDAT- 2015/05/13 06:00
MHDA- 2015/09/10 06:00
CRDT- 2015/05/13 06:00
PHST- 2015/02/19 00:00 [received]
PHST- 2015/04/10 00:00 [revised]
PHST- 2015/04/21 00:00 [accepted]
PHST- 2015/05/13 06:00 [entrez]
PHST- 2015/05/13 06:00 [pubmed]
PHST- 2015/09/10 06:00 [medline]
AID - S0959-8049(15)00349-4 [pii]
AID - 10.1016/j.ejca.2015.04.013 [doi]
PST - ppublish
SO  - Eur J Cancer. 2015 Jul;51(11):1371-80. doi: 10.1016/j.ejca.2015.04.013. Epub 2015 
      May 8.