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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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Abstract

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/m2 iv, day 1; O: 80 mg/m2 iv, day 1; C: 625 mg/m2 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.

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Acknowledgments

The authors thank the patients and the medical and nursing staff of all the participating institutions. Dr. F. Rivera; H. Marqués de Valdecilla (Santander), Dr. B. Massutí; H. General Universitario (Alicante), Dr. J. Sastre; H. Universitario Clínico San Carlos (Madrid), Dra. J. Martínez; H. Virgen de las Nieves (Granada), Dr. M. Valladares; C. H. Universitario (La Coruña), Dr. E. Aranda; H. Reina Sofía (Córdoba), Dra. Mª. Luisa García de Paredes; H. Ramón y Cajal, Dr. J. L. Manzano; ICO. H. Germans Trias i Pujol (Barcelona), Dra. M. Galán; ICO Hospitalet (Barcelona), and Dr. F. J. Ramos; H. Universitari Vall d’Hebrón (Barcelona). TTD Data Center: Inma Ruiz de Mena and Susana Rodríguez. Monitoring, Statistics and Data Management: Dynamic Solutions: Phase II, multicenter, single-arm study was supported by the TTD, Madrid, Spain (Study TTD-08-02): clinicaltrials.gov identifier NTC00733616. Financial support for this research was provided by Roche and Sanofi-Aventis. This study was supported by the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD), Madrid, Spain.

Conflict of interest

F. Rivera has received honoraria for advisory activities from Amgen, Roche, Merck-Serono, Celgene, Sanofi-Aventis and Bayer, has received research fundings from Amgen, Roche, Merck-Serono, Celgene, Sanofi-Aventis and Bayer and has received accommodations and expenses from Amgen, Roche, Merck-Serono, Celgene, Sanofi-Aventis and Bayer. J. Sastre and M. Valladares have received honoraria for advisory activities from Roche and Sanofi-Aventis. E. Aranda has received honoraria for advisory activities from: Amgen, Bayer, Celgene, Merk, Roche, Sanofi.

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Correspondence to F. Rivera.

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On behalf of the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD).

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Rivera, F., Massutí, B., Salcedo, M. et al. Phase II trial of miniDOX (reduced dose docetaxel–oxaliplatin–capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC). TTD 08-02. Cancer Chemother Pharmacol 75, 319–324 (2015). https://doi.org/10.1007/s00280-014-2641-3

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  • DOI: https://doi.org/10.1007/s00280-014-2641-3

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