Erschienen in:
26.02.2019 | Original Article
A study of second-line irinotecan plus cisplatin vs. irinotecan alone in platinum-naïve patients with early relapse of gastric cancer refractory to adjuvant S-1 monotherapy: exploratory subgroup analysis of the randomized phase III TRICS trial
verfasst von:
Kazuhiro Nishikawa, Kenta Murotani, Kazumasa Fujitani, Hitoshi Inagaki, Yusuke Akamaru, Shinya Tokunaga, Masakazu Takagi, Shigeyuki Tamura, Naotoshi Sugimoto, Tadashi Shigematsu, Takaki Yoshikawa, Tohru Ishiguro, Masato Nakamura, Hiroko Hasegawa, Satoshi Morita, Yumi Miyashita, Akira Tsuburaya, Junichi Sakamoto, Toshimasa Tsujinaka
Erschienen in:
Cancer Chemotherapy and Pharmacology
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Ausgabe 5/2019
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Abstract
Backgrounds
Many patients with gastric cancer relapse during or early after adjuvant chemotherapy. The standard treatment for early relapse patients is a second-line chemotherapy (SLC) based on irinotecan, taxanes, or a platinum-based chemotherapy. The platinum-containing biweekly irinotecan plus cisplatin (IRI/CDDP) combination was assumed to be promising in several reports of clinical trials as SLC. TRICS trial, a randomized phase III study of IRI/CDDP vs. IRI in platinum-naïve gastric cancers refractory to S-1 monotherapy, revealed that both irinotecan-based chemotherapies were effective and well tolerated.
Methods
This study analyzed 108 patients in the TRICS trial who experienced early relapse. Patients receiving IRI/CDDP (IRI, 60 mg/m2; CDDP, 30 mg/m2, q2w) versus IRI (150 mg/m2, q2w) were compared regarding overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety.
Results
The OS was 14.0 (95% confidence interval [CI]: 11.0–21.2) and 14.0 (95% CI: 10.7–16.5) months for IRI/CDDP and IRI, respectively (hazard ratio [HR]: 0.782; 95% CI: 0.515–1.188, P = 0.249). No significant differences were observed for PFS (5.0 vs. 4.5 months, respectively; HR: 0.802; 95% CI: 0.543–1.185, P = 0.268) or ORR (19.6% [95% CI: 9.4–33.9%] vs. 23.3% [95% CI: 11.8–38.6%], respectively). The incidence of grade 3–4 anemia was higher for IRI/CDDP than for IRI (20% vs. 0%, respectively; P = 0.0006).
Conclusion
Our study showed no significant survival differences between IRI/CDDP and IRI in platinum-naïve patients who relapsed during or within 6 months after S-1 adjuvant therapy; therefore, IRI may be a good option in this population.
Clinical trial information
UMIN 000002571.