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A phase II study of docetaxel and oxaliplatin combination in recurrent gastric cancer patients after fluoropyrimidine and/or cisplatin adjuvant treatment: a Korean Cancer Study Group Protocol ST06-02.

AbstractBACKGROUND:
Surgery alone is no longer an adequate standard of care for patients with resectable gastric cancer. Thus, research efforts should focus on which regimens are the most effective for patients with recurrent gastric cancer after combined treatment with surgery and perioperative or adjuvant chemotherapy.
METHODS:
Patients with histologically confirmed and measurable advanced gastric cancer who showed a relapse even after fluoropyrimidine and/or cisplatin-based adjuvant chemotherapy received docetaxel (35 mg/m(2)) intravenously on day 1 and 8 plus oxaliplatin (100 mg/m(2)) intravenously on day 1 every 3 weeks until disease progression or unacceptable toxicity.
RESULTS:
A total of 34 patients with relapsed advanced gastric cancer who had received adjuvant chemotherapy with fluoropyrimidine and/or cisplatin for a median of 6 months (range, 1-48 months) were enrolled in this trial; 22 (64.7 %) patients had been exposed to both agents. Their median age was 58 years (range, 50-68 years). The overall response rate was 55.9 % (95 % confidence interval (CI), 38.3-73.5 %), including 1 complete response and 18 partial responses. At a median follow-up duration of 28.5 months (range, 9.2-50.7 months), the median progression-free survival for all patients was 5.3 months (95 % CI, 4.4-6.1 months) and the median overall survival was 13.8 months (95 % CI, 11.1-16.4 months). The most common grade 3 or 4 hematologic and nonhematologic toxicities were neutropenia (47.1 %) and diarrhea (17.6 %), respectively. Five patients (14.7 %) experienced febrile neutropenia.
CONCLUSIONS:
Docetaxel and oxaliplatin combination chemotherapy was active and tolerable in patients with recurrent gastric cancer after fluoropyrimidine and/or cisplatin-based adjuvant chemotherapy.
AuthorsYoon Hee Choi, Sang Cheul Oh, Jun Suk Kim, Seung-Hyun Nam, Bong-Seog Kim, Sang-Hee Cho, Ik Joo Chung, Eun-Kee Song, Chang-Yeol Yim, Jin Ho Baek, Hei-Cheul Jeung, Young Seon Hong, Sung Hyun Yang, Hye Jin Kang
JournalCancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 70 Issue 5 Pg. 665-72 (Nov 2012) ISSN: 1432-0843 [Electronic] Germany
PMID22926638 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Drug Combinations
  • Organoplatinum Compounds
  • Taxoids
  • Oxaliplatin
  • Deoxycytidine
  • S 1 (combination)
  • Tegafur
  • Docetaxel
  • Oxonic Acid
  • Capecitabine
  • Cisplatin
  • Fluorouracil
Topics
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Capecitabine
  • Chemotherapy, Adjuvant (methods)
  • Cisplatin (administration & dosage)
  • Combined Modality Therapy
  • Deoxycytidine (administration & dosage, analogs & derivatives)
  • Disease-Free Survival
  • Docetaxel
  • Drug Combinations
  • Female
  • Fluorouracil (administration & dosage, analogs & derivatives)
  • Follow-Up Studies
  • Humans
  • Korea
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local
  • Organoplatinum Compounds (administration & dosage)
  • Oxaliplatin
  • Oxonic Acid (administration & dosage)
  • Stomach Neoplasms (drug therapy, pathology, therapy)
  • Survival Rate
  • Taxoids (administration & dosage)
  • Tegafur (administration & dosage)
  • Treatment Outcome

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