Phase 2 study of adjuvant chemotherapy with docetaxel, capecitabine, and cisplatin in patients with curatively resected stage IIIB-IV gastric cancer.

Abstract

OBJECTIVE:

Postoperative chemotherapy with S-1 or capecitabine plus oxaliplatin is a standard treatment for resectable gastric cancer (GC). However, survival outcomes of stage IIIB-IV (M0) GC cases are still poor. We investigated the efficacy and safety of docetaxel, capecitabine, and cisplatin (DXP) in patients with stage IIIB-IV GC.

METHODS:

This was a single-arm phase 2 study that included patients with stage IIIB-IV GC who underwent D2 gastrectomy. Patients received six cycles of docetaxel [60 mg/m2 on day 1 (D1)], capecitabine (1,875 mg/m2/day on D1-14), and cisplatin (60 mg/m2 on D1) every 3 weeks. The primary end-point was recurrence-free survival (RFS).

RESULTS:

A total of 46 GC patients between January 2007 and August 2008 were included. After a median follow-up of 56.1 months (range 52.2-64.1), the median RFS and overall survival (OS) were 26.9 months (95 % CI 7.5-46.4) and 43.9 months (95 % CI 29.2-58.7), respectively. The 5-year RFS and OS rates were 39.1 and 41.3 %, respectively. The most common grade 3/4 toxicities were neutropenia (40 %), anorexia (22 %), and febrile neutropenia (15 %).

CONCLUSIONS:

Adjuvant DXP is feasible and effective for patients with stage IIIB-IV GC. A phase 3 study comparing triplet and doublet regimens for these patients is ongoing.

• Authors: Shinkyo Yoon, Changhoon Yoo, Min-Hee Ryu, Myoung Joo Kang, Baek-Yeol Ryoo, Sook Ryun Park, Jeong Hwan Yook, Sung Tae Oh, Moon-Won Yoo, Byung Sik Kim, Yoon-Koo Kang
• Journal: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association (Gastric Cancer) Vol. 20 Issue 1 Pg. 182-189 (Jan 2017) ISSN: 1436-3305 [Electronic] Japan
• PMID: 26661592 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Taxoids
• Docetaxel
• Capecitabine
• Cisplatin

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Capecitabine (administration & dosage)
• Chemotherapy, Adjuvant
• Cisplatin (administration & dosage)
• Docetaxel
• Female
• Follow-Up Studies
• Gastrectomy
• Humans
• Male
• Middle Aged
• Neoplasm Invasiveness
• Neoplasm Staging
• Prognosis
• Stomach Neoplasms (drug therapy, pathology, surgery)
• Survival Rate
• Taxoids (administration & dosage)
• Young Adult