LONSURF alone in mGC or GEJ cancer
LONSURF alone in mGC or GEJ cancer
LONSURF alone was studied in the TAGS trial.1,2
TAGS study design
TAGS was a multinational, randomized, double-blind, placebo-controlled, Phase 3 trial (N=507).2
Inclusion criteria2
- Age ≥18 years (≥20 years in Japan)
- Histologically confirmed, nonresectable metastatic gastroesophageal junction (GEJ) or gastric cancer
- ECOG performance status (PS) of 0 or 1
- Received postoperative adjuvant chemotherapy and radiotherapy, or pre- and postoperative adjuvant chemotherapy if they had recurrence <6 months of completion of the adjuvant chemotherapy
- Received at least 2 prior regimens, including:
- Fluoropyrimidine
- Platinum agent
- Taxane and/or irinotecan
- HER2 therapy in patients with HER2-positive tumors
- Were refractory to/intolerant of last prior therapy
2:1 Randomization1,2
LONSURF + best supportive care
(n=337)
35 mg/m2/dose (up to 80 mg/dose) twice daily after meals on Days 1-5 and 8-12 of each 28-day cycle
Placebo + best supportive care
(n=170)
Twice daily after meals on Days 1-5 and 8-12 of each 28-day cycle
After the first dose of study medication, all patients were followed for progression at scheduled 8-week intervals with computed tomography (CT) until progression. After the end of treatment, all patients were followed up for survival every 4 weeks until death or loss to follow-up, or until the targeted number of events (deaths) was met.2
Key baseline characteristics2
| Baseline characteristics of patients in the TAGS trial2 | LONSURF(n=337) | Placebo(n=170) |
|---|---|---|
| Age, years | ||
| <65 | 54% | 56% |
| Sex | ||
| Male | 75% | 69% |
| Female | 25% | 31% |
| ECOG PS | ||
| 0 | 36% | 40% |
| 1 | 64% | 60% |
| HER2 status | ||
| Positive | 20% | 16% |
| Negative | 61% | 62% |
| Number of prior therapies | ||
| 2 prior therapies | 37% | 38% |
| 3 prior therapies | 40% | 35% |
| ≥4 prior therapies | 23% | 27% |
| Primary site | ||
| Gastric | 71% | 71% |
| GEJ | 29% | 28% |
| Number of metastatic sites | ||
| 1-2 | 46% | 42% |
| ≥3 | 54% | 58% |
| Prior systemic treatments | ||
| Platinum therapy | 100% | 100% |
| Fluoropyrimidine-based therapy | >99%* | 100% |
| Taxane therapy† | 92% | 87% |
| Irinotecan therapy† | 54% | 58% |
| Ramucirumab therapy | 34% | 32% |
| Anti-HER2 therapy | 18% | 14% |
| Immunotherapy (anti-PD-1/PD-L1) | 7% | 4% |
| Prior treatments | ||
| Gastrectomy | 44% | 44% |
*One patient did not receive a fluoropyrimidine.
†All patients received irinotecan or taxane or both.
PRIMARY ENDPOINT
Help extend survival in metastatic gastric or GEJ cancer with LONSURF alone
Overall Survival (OS) (N=507)1-3
SECONDARY ENDPOINTS
Help prolong progression-free survival
Progression-free Survival1-3
Disease control rate (DCR)2,3
LONSURF (n=290) | Placebo (n=145) | |
|---|---|---|
| DCR | 44% (128) | 14% (21) |
| Complete response | 0% (1) | 0% (0) |
| Partial response | 4% (12) | 2% (3) |
| Stable response | 40% (115) | 12% (18) |
DCR=complete response + partial response + stable disease.
NCCN Guidelines® in metastatic gastric cancer or GEJ adenocarcinoma
Recommended
NCCN Category 1
The National Comprehensive Cancer Network® (NCCN®) recommends trifluridine and
tipiracil (LONSURF) as a Category 1 third-line or subsequent treatment option for
certain patients with metastatic gastric cancer or GEJ adenocarcinoma.4,5
Category 2A=based upon lower-level evidence, there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.