Docetaxel plus S-1 versus cisplatin plus S-1 in unresectable gastric cancer without measurable lesions: a randomized phase II trial (HERBIS-3).

Abstract

BACKGROUND:

Cisplatin plus S-1 (CS) is the standard first-line chemotherapy for advanced gastric cancer (AGC) in Japan. A previous phase III trial showed that docetaxel plus S-1 (DS) was effective for AGC without measurable lesions, but no studies have compared these two regimens.

METHODS:

Eligible patients had unresectable or recurrent HER2-negative AGC without measurable lesions. Patients were randomized to DS (docetaxel 40 mg/m2 on day 1, S-1 80-120 mg on days 1-14, every 3 weeks) or CS (cisplatin 60 mg/m2 on day 8, S-1 80-120 mg on days 1-21, every 5 weeks). The primary endpoint was overall survival (OS).

RESULTS:

All patients had unresectable primary disease. Sixty-one patients were randomly assigned to DS (n = 30) or CS (n = 31). One CS patient was ineligible due to HER2 positivity. The median number of cycles was 9.5 (range 2-49) with DS and 5.5 (range 1-10) with CS. There were no treatment-related deaths. The most common grade 3-4 non-hematological toxicity was fatigue (7% with DS, 13% with CS), followed by anorexia (3% with DS, 10% with CS) and diarrhea (3% with DS, 10% with CS). The 2-year OS rates were 43.3% with DS and 30.0% with CS (log-rank P = 0.113), with a hazard ratio of 0.617 (95% confidence interval 0.337-1.128), indicating non-inferiority of DS to CS with respect to OS (P < 0.001).

CONCLUSIONS:

DS showed slightly but nonsignificantly less toxicity and higher efficacy than CS for AGC without measurable lesions. DS should be further investigated in phase III trials.

• Authors: Yukinori Kurokawa, Jin Matsuyama, Kazuhiro Nishikawa, Atsushi Takeno, Yutaka Kimura, Kazumasa Fujitani, Ryohei Kawabata, Yoichi Makari, Tetsuji Terazawa, Hisato Kawakami, Daisuke Sakai, Toshio Shimokawa, Taroh Satoh
• Journal: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association (Gastric Cancer) Vol. 24 Issue 2 Pg. 428-434 (Mar 2021) ISSN: 1436-3305 [Electronic] Japan
• PMID: 32779034 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)

Chemical References

• Drug Combinations
• S 1 (combination)
• Tegafur
• Docetaxel
• Oxonic Acid
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Cisplatin (administration & dosage)
• Docetaxel (administration & dosage)
• Drug Combinations
• Female
• Humans
• Male
• Middle Aged
• Oxonic Acid (administration & dosage)
• Proportional Hazards Models
• Stomach Neoplasms (drug therapy, mortality)
• Survival Rate
• Tegafur (administration & dosage)
• Treatment Outcome