Phase II trial of miniDOX (reduced dose docetaxel–oxaliplatin–capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC). TTD 08-02

Purpose 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...

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Published in:Cancer chemotherapy and pharmacology 2015-02, Vol.75 (2), p.319-324
Main Authors: Rivera, F., Massutí, B., Salcedo, M., Sastre, J., Martínez Galán, J., Valladares-Ayerbes, M., Serrano, R., de Paredes, Mª. L. García, Manzano, J. L., Galán, M., Alsina, M., Yuste Izquierdo, A. L., López, C., Díaz-Rubio, E., Conde, V., Reboredo, M., Cano, Mª. T., Pachón, V., Aranda, E.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antimetabolites, Antineoplastic - administration & dosage
Antineoplastic Agents - administration & dosage
Antineoplastic Agents, Phytogenic - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cancer Research
Capecitabine
Deoxycytidine - administration & dosage
Deoxycytidine - adverse effects
Deoxycytidine - analogs & derivatives
Deoxycytidine - therapeutic use
Disease-Free Survival
Endpoint Determination
Female
Fluorouracil - administration & dosage
Fluorouracil - adverse effects
Fluorouracil - analogs & derivatives
Fluorouracil - therapeutic use
Humans
Male
Medicine
Medicine & Public Health
Middle Aged
Oncology
Organoplatinum Compounds - administration & dosage
Organoplatinum Compounds - adverse effects
Organoplatinum Compounds - therapeutic use
Original Article
Patient Selection
Pharmacology/Toxicology
Stomach Neoplasms - drug therapy
Survival Analysis
Taxoids - administration & dosage
Taxoids - adverse effects
Taxoids - therapeutic use
Treatment Outcome
Weight Loss - drug effects
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Summary:Purpose 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. Response: 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.
ISSN:0344-5704
1432-0843
DOI:10.1007/s00280-014-2641-3