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Rivera, Fernando; Massuti, Bartomeu; Salcedo, Matilde; Sastre, Javier; Martínez-Galán, Joaquina; Valladares-Ayerbes, Manuel; Serrano, Raquel; Garcia De Paredes, Marisa; Tabernero, Josep; Galan, M. Carmen; Mozo, Jose Luis Manzano; Diaz Rubio, Eduardo; Conde, Veronica; Reboredo, Margarita; Vazquez, Silvia; Layos Romero, Laura; Pascual, Francisco Javier Ramos; Aranda, Enrique

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

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  • Media type: E-Article
  • Title: Phase II trial of miniDOX (reduced-dose docetaxel/oxaliplatin/capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC): TTD 08-02
  • Contributor: Rivera, Fernando; Massuti, Bartomeu; Salcedo, Matilde; Sastre, Javier; Martínez-Galán, Joaquina; Valladares-Ayerbes, Manuel; Serrano, Raquel; Garcia De Paredes, Marisa; Tabernero, Josep; Galan, M. Carmen; Mozo, Jose Luis Manzano; Diaz Rubio, Eduardo; Conde, Veronica; Reboredo, Margarita; Vazquez, Silvia; Layos Romero, Laura; Pascual, Francisco Javier Ramos; Aranda, Enrique
  • imprint: American Society of Clinical Oncology (ASCO), 2013
  • Published in: Journal of Clinical Oncology
  • Language: English
  • DOI: 10.1200/jco.2013.31.4_suppl.87
  • ISSN: 1527-7755; 0732-183X
  • Keywords: Cancer Research ; Oncology
  • Origination:
  • Footnote:
  • Description: <jats:p> 87 </jats:p><jats:p> Background: Chemotherapy has improved overall survival (OS) in patients (p) with AGC and docetaxel (D), oxaliplatin (O) and capecitabine (X), have shown consistent activity in this setting. We defined "Suboptimal" p as those with PS ECOG-2 and/or 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 p the "miniDOX" regimen (D: 40 mg/m2 iv, d1; O: 80 mg/m2 iv d1; C: 625 mg/m2 po bid, d1 to 21, every 21d; after 6 courses only C was maintained). D and O dose were allowed to be increased to 45 and 90 mg/m2 respectively (dose level +1) and to 50 and 100 mg/m2 (level +2) if less than grade 2 toxicity after the first 2 courses. One p that did not received any dose of chemotherapy, was included in the ITT efficacy analysis but not in the safety analysis. Primary endpoint was Response Rate (RR), Toxicity, Progression Free Survival (PFS) and OS were secondary objectives. Results: p characteristics: PS ECOG-2:12 p, Weigh loss 10-25%:23 p; median age 73.3 years (40-87); 32 males; locally advanced:8 p/metastatic:35 p; Primary site:Gastric 32 p/ EGJ 11; In 19 p the dose of D and O were increased to level +1 and in 8 of them to level +2. Worst toxicity per p (Grade 3-4): neutropenia: 5 p (3 of them with febrile neutropenia); pulmonary embolism (PE):4 p (3 of them suffered sudden death and the PE was suspected but not confirmed); diarrhea:9 p; paronychia:2 p; CVA:1 p; renal failure:1 p (this p suffered infection/bacteriemia without neutropenia and died); hand-foot syndrome:4 p and asthenia:5 p. Response: CR:1 p, PR:23 p (RR: 56%), SD:12 p, Progression:3 p, No determined:4 p; With a median follow-up of 27 months, 36 p have died (toxicity:4 p, progressive disease:32 p). Median and 1 year actuarial PFS and OS are 5.5 months/19% and 13.3 months/54% respectively. Conclusions: Although relevant the toxicity of miniDOX has been found, its activity is encouraging in "suboptimal" pts with AGC and this combination should be further investigated in this setting. Clinical trial information: NCT00733616. </jats:p>
  • Access State: Open Access