title: Phase II trial of miniDOX (reduced dose docetaxel-oxaliplatin-capecitabine) in "suboptimal" patients with advanced gastric cancer (AGC). TTD 08-02.
abstract: OBJECTIVE
  Chemotherapy has improved the overall survival (OS) in patients (pts) with advanced gastric cancer (AGC). Docetaxel (D), oxaliplatin (O) and capecitabine (C) have shown interesting activity in this setting. We defined "suboptimal" pts as those with PS ECOG = 2, weight loss 10-25% and/or age ≥70 years. This population is usually underrepresented in AGC clinical trials.
  
  
  METHODS
  We explored in 43 previously untreated "suboptimal" AGC pts the effect of "miniDOX" regimen (D: 40 mg/m(2) iv, day 1; O: 80 mg/m(2) iv, day 1; C: 625 mg/m(2) po bid, day 1 to day 21, every 21 days; after six courses, only C was maintained). Primary end point was response rate (RR), and secondary end points were adverse events (AE), progression-free survival (PFS) and overall survival (OS).
  
  
  RESULTS
  Patients characteristics: PS ECOG = 2: 12 pts; weight loss 10-25%: 23 pts; median age 73.3 years (range 40-87; 28 pts were ≥70 years); 32 males; locally advanced: 8 pts/metastatic: 35 pts; primary site: gastric 32 pts/EGJ 11. Worst AE per pt (grade 3-4): neutropenia: 5 pts (febrile neutropenia: 3); pulmonary embolism (PE): 4 pts (3 of them suffered sudden death); diarrhea: 9 pts; paronychia: 2 pts; ictus: 1 pt; renal failure: 1 pt (this pt suffered infection/bacteriemia without neutropenia and died); hand-foot syndrome: 4 pts and asthenia: 5 pts.
  
  
  RESULTS
  CR: 1 pt, PR: 23 pts (RR: 56%), SD: 12 pts, progression: 3 pts, no determined: 4 pts. Median and 1 year actuarial PFS and OS were 5.5 months/18% and 13.3 months/52%, respectively.
  
  
  CONCLUSIONS
  Although miniDOX's toxicity (mainly PE)has been important, its activity has been promising in "suboptimal" pts with AGC, and this combination should be further investigated in this setting.
authors.affiliation: Servicio de Oncologia Medica, Hospital Universitario Marqués de Valdecilla, 39008, Santander, Spain, oncrhf@humv.es.
authors.forename: F
authors.initials: F
authors.lastname: Rivera
authors.forename: B
authors.initials: B
authors.lastname: Massutí
authors.forename: M
authors.initials: M
authors.lastname: Salcedo
authors.forename: J
authors.initials: J
authors.lastname: Sastre
authors.forename: J
authors.initials: J
authors.lastname: Martínez Galán
authors.forename: M
authors.initials: M
authors.lastname: Valladares-Ayerbes
authors.forename: R
authors.initials: R
authors.lastname: Serrano
authors.forename: Ma L
authors.initials: ML
authors.lastname: García de Paredes
authors.forename: J L
authors.initials: JL
authors.lastname: Manzano
authors.forename: M
authors.initials: M
authors.lastname: Galán
authors.forename: M
authors.initials: M
authors.lastname: Alsina
authors.forename: A L
authors.initials: AL
authors.lastname: Yuste Izquierdo
authors.forename: C
authors.initials: C
authors.lastname: López
authors.forename: E
authors.initials: E
authors.lastname: Díaz-Rubio
authors.forename: V
authors.initials: V
authors.lastname: Conde
authors.forename: M
authors.initials: M
authors.lastname: Reboredo
authors.forename: Ma T
authors.initials: MT
authors.lastname: Cano
authors.forename: V
authors.initials: V
authors.lastname: Pachón
authors.forename: E
authors.initials: E
authors.lastname: Aranda
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D023381:Endpoint Determination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin; D018579:Patient Selection; D013274:Stomach Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil