Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma.

Abstract

OBJECTIVES:

The Intergroup 0116 study has demonstrated a significant survival benefit for completely resected (R0) gastric cancer patients treated with a fluorouracil/leucovorin chemoradiotherapy regimen. However, this regimen is also toxic and less effective in terms of distant disease control. Therefore, a more efficacious and safer regimen is urgently needed.

METHODS:

Patients with R0 resected gastric carcinoma received up to two 21-day cycles of postoperative adjuvant preradiation and postradiation DCF chemotherapy (docetaxel 37.5 mg/m on days 1 and 8, cisplatin 25 mg/m on days 1 to 3, and a continuous infusion of fluorouracil 750 mg/m on days 1 to 5), respectively. Chemoradiotherapy between preradiation and postradiation chemotherapy was initiated on day 43 and consisted of intensity-modulated radiotherapy (45 Gy) plus concurrent docetaxel 20 mg/m weekly for 5 weeks.

RESULTS:

A total of 55 patients were evaluated and 76% (42) of patients completed the prescribed therapy. With a median follow-up of 61 months, the 3- and 5-year progression-free survival rates were 67% (95% confidence interval [CI], 54%-80%) and 59% (95% CI, 46%-72%), respectively; and the 3- and 5-year overall survival rates were 72% (95% CI, 60%-84%) and 61% (95% CI, 48%-74%), respectively. The most common grade 3 or greater toxicity, during the chemotherapy phase, was neutropenia (24%). Common grade 3/4 toxicities during concurrent chemoradiotherapy were nausea (32%), vomiting (26%), fatigue (15%), and anorexia (19%).

CONCLUSIONS:

These results demonstrate that this adjuvant regimen is active with an acceptable toxicity profile. A randomized phase 3 trial comparing the Intergroup 0116 chemoradiotherapy regimen with this regimen is underway.

• Authors: Yong Liu, Guoqi Zhao, Yi Xu, Tiening Zhang, Zhixiao Chen, Ge Yan, Wenzhi Tu, Ye Hu, Ying Chen, Xia He, Xiaodong Li, Hui Chen, Shengyu Yao, Zhekai Hu, Xuming Chen, Tingfeng Chen
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 41 Issue 7 Pg. 619-625 (07 2018) ISSN: 1537-453X [Electronic] United States
• PMID: 28263232 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Docetaxel
• Cisplatin
• Fluorouracil

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Chemoradiotherapy (mortality)
• Chemoradiotherapy, Adjuvant (mortality)
• Cisplatin (administration & dosage)
• Docetaxel (administration & dosage)
• Female
• Fluorouracil (administration & dosage)
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Prognosis
• Stomach Neoplasms (pathology, therapy)
• Survival Rate
• Young Adult