PMID- 31280434
OWN - NLM
STAT- MEDLINE
DCOM- 20210111
LR  - 20210111
IS  - 1699-3055 (Electronic)
IS  - 1699-048X (Linking)
VI  - 22
IP  - 4
DP  - 2020 Apr
TI  - First-line panitumumab plus docetaxel and cisplatin in advanced gastric and 
      gastro-oesophageal junction adenocarcinoma: results of a phase II trial.
PG  - 495-502
LID - 10.1007/s12094-019-02151-6 [doi]
AB  - PURPOSE: Panitumumab is extensively used for RAS-WT metastatic colorectal cancer. 
      This study assessed the efficacy and safety of panitumumab plus first-line 
      chemotherapy [docetaxel (DOC) and cisplatin (CIS)] in treatment-naive advanced 
      gastric or gastro-oesophageal junction (GEJ) adenocarcinoma (ADC) patients. 
      METHODS: Phase II, open-label, single-arm study includes treatment-naive advanced 
      gastric or GEJ-ADC patients from ten Spanish centres. Patients received 
      panitumumab (6 mg/kg) plus DOC and CIS (50 mg/m(2) both) every 2 weeks until 
      disease progression, unacceptable toxicity, or patient withdrawal. Primary 
      endpoint: objective response rate (ORR); main secondary endpoints: disease 
      control rate (DCR), duration of response (DoR), time to progressive disease 
      (TTP), progression-free-survival (PFS), overall survival (OS), and safety. 
      RESULTS: Forty-four patients were included; median age: 67.8 (range 43.3-82.7) 
      years, 68.2% male. The ORR was 27.3% (95% CI 15.0, 42.8); median PFS and OS: 5.0 
      (95% CI 3.6, 6.9) and 7.2 (5.5, 9.0) months, respectively. Median TTP, DCR and 
      DoR: 5.3 (range 3.8-7.0) months, 70.5% (95% CI 54.8, 83.2%), and 4.8 (1.8, NE) 
      months. Median panitumumab treatment duration: 11.9 (range 0.1-34.9) weeks; 25.0% 
      patients had a dose reduction and 40.9% discontinued treatment. Grade 3-4 adverse 
      events (AEs): 68.2%/22.2% patients. Most common AEs: asthenia (75.0%) and mucosal 
      inflammation (54.5%). Serious AEs were experienced by 54.6% patients; 9.1%, 
      13.6%, and 15.9% related to panitumumab, DOC, and CIS, respectively. Three (6.8%) 
      patients died due to AEs not related to study treatment. CONCLUSIONS: The 
      addition of panitumumab to standard chemotherapy as the first-line treatment in 
      advanced gastric or GEJ-ADC does not appear to improve the efficacy outcomes.
FAU - Quintero Aldana, G
AU  - Quintero Aldana G
AUID- ORCID: 0000-0002-1445-1887
AD  - Department of Medical Oncology, Hospital Universitario Lucus Augusti, Calle 
      Doctor Ulises Romero, 1, 27003, Lugo, Spain. gquinteroaldana@gmail.com.
FAU - Salgado, M
AU  - Salgado M
AD  - Department of Medical Oncology, Complejo Hospitalario Universitario de Ourense, 
      Ourense, Spain.
FAU - Candamio, S
AU  - Candamio S
AD  - Department of Medical Oncology, Complejo Hospitalario Universitario de Santiago 
      de Compostela, Santiago de Compostela, Spain.
FAU - Mendez, J C
AU  - Mendez JC
AD  - Department of Medical Oncology, Centro Oncologico de Galicia, A Coruna, Spain.
FAU - Jorge, M
AU  - Jorge M
AD  - Department of Medical Oncology, Complejo Hospitalario Xeral Cies, Vigo, Spain.
FAU - Reboredo, M
AU  - Reboredo M
AD  - Department of Medical Oncology, Complejo Hospitalario Universitario A Coruna, A 
      Coruna, Spain.
FAU - Vazquez Tunas, L
AU  - Vazquez Tunas L
AD  - Department of Medical Oncology, Complejo Hospitalario de Pontevedra, Pontevedra, 
      Spain.
FAU - Romero, C
AU  - Romero C
AD  - Department of Medical Oncology, Hospital POVISA, Vigo, Spain.
FAU - Covela, M
AU  - Covela M
AD  - Department of Medical Oncology, Hospital Universitario Lucus Augusti, Calle 
      Doctor Ulises Romero, 1, 27003, Lugo, Spain.
FAU - Fernandez Montes, A
AU  - Fernandez Montes A
AD  - Department of Medical Oncology, Complejo Hospitalario Universitario de Ourense, 
      Ourense, Spain.
FAU - Carmona, M
AU  - Carmona M
AD  - Department of Medical Oncology, Hospital Universitario Lucus Augusti, Calle 
      Doctor Ulises Romero, 1, 27003, Lugo, Spain.
FAU - Vidal Insua, Y
AU  - Vidal Insua Y
AD  - Department of Medical Oncology, Complejo Hospitalario Universitario de Santiago 
      de Compostela, Santiago de Compostela, Spain.
FAU - Lopez, R
AU  - Lopez R
AD  - Department of Medical Oncology, Complejo Hospitalario Universitario de Santiago 
      de Compostela, Santiago de Compostela, Spain.
AD  - CIBERONC, Madrid, Spain.
CN  - Galician Oncological Research Group (GGIO)
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20190706
PL  - Italy
TA  - Clin Transl Oncol
JT  - Clinical & translational oncology : official publication of the Federation of 
      Spanish Oncology Societies and of the National Cancer Institute of Mexico
JID - 101247119
RN  - 15H5577CQD (Docetaxel)
RN  - 6A901E312A (Panitumumab)
RN  - Q20Q21Q62J (Cisplatin)
SB  - IM
MH  - Adenocarcinoma/*drug therapy
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Cisplatin/administration & dosage/adverse effects
MH  - Docetaxel/administration & dosage/adverse effects
MH  - *Esophagogastric Junction
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Panitumumab/administration & dosage/adverse effects
MH  - Prospective Studies
MH  - Stomach Neoplasms/*drug therapy/mortality
OTO - NOTNLM
OT  - Cisplatin
OT  - Docetaxel
OT  - Gastric cancer
OT  - Gastro-oesophageal junction
OT  - Panitumumab
EDAT- 2019/07/08 06:00
MHDA- 2021/01/12 06:00
CRDT- 2019/07/08 06:00
PHST- 2019/03/15 00:00 [received]
PHST- 2019/05/29 00:00 [accepted]
PHST- 2019/07/08 06:00 [pubmed]
PHST- 2021/01/12 06:00 [medline]
PHST- 2019/07/08 06:00 [entrez]
AID - 10.1007/s12094-019-02151-6 [pii]
AID - 10.1007/s12094-019-02151-6 [doi]
PST - ppublish
SO  - Clin Transl Oncol. 2020 Apr;22(4):495-502. doi: 10.1007/s12094-019-02151-6. Epub 
      2019 Jul 6.