Editor's note: It rains continuously and you don't know the end of spring, but when it clears up, you will feel the depth of summer. In this issue, Professor Liang Han from Tianjin Medical University Cancer Hospital, editor-in-chief of the literature recommendation column Gastric Cancer , recommends relevant literature in the field of gastric cancer. The talents of the "beam" came together for an intellectual appointment for exchange of ideas.
Phase II
Gastric Cancer Editor-in-Chief Professor Liang Han highly recommends
Compiled by Dr. Huang Wenbai: "FOLFIRI combined with ramucirumab versus paclitaxel combined with ramucirumab as a second-line regimen for the treatment of advanced or metastatic patients with or without docetaxel" Efficacy of patients with gastroesophageal adenocarcinoma: results from the phase II RAMIRIS study of the AIO German Gastric Cancer Research Collaboration Group"
Expert profile
Professor Liang Han
Director and Chief Physician of the Gastric Cancer Center of Tianjin Medical University Cancer Hospital
Director of the Chinese Anti-Cancer Association Director of Tianjin Anti-Cancer Association Cancer Association Director
Chairman-elect of the Oncology Surgery Committee of the Chinese Medical Doctor Association
Chairman of the Gastric Cancer Special Committee of the Chinese Anti-Cancer Association
Dr. Huang Wenbai
Resident physician in the Department of Gastric Oncology, Tianjin Medical University Cancer Hospital
Purpose
Ramucirumab ( RAM) and paclitaxel are second-line standard treatments for patients with metastatic gastroesophageal adenocarcinoma. We report the safety and efficacy of FOLFIRI plus RAM versus paclitaxel plus RAM after failure of platinum- or fluorouracil-based chemotherapy.
Methods
This is an investigator-initiated multi-center phase II clinical trial. Patients with gastroesophageal adenocarcinoma were randomly assigned to the FOLFIRI combined with RAM group (Group A) or the paclitaxel combined with RAM group (Group B). The primary endpoint is the 6-month OS rate. If the 6-month OS rate in Group A is ≥65%, further research will be conducted.
Results
111 patients (65% of patients had previously received docetaxel treatment) were included in the study, and 110 patients were in the ITT population (72 patients in group A; 38 patients in group B). The enrollment process (Figure 1) and baseline situation (Table 1) are as follows:
Figure 1. CONSORT diagram. *For n=1 patient: no data on treatment
Table 1. Baseline characteristics
The 6-month OS rate of group A was 54% (95% CI 44-67), the study did not meet the primary study endpoint compared with historical controls. Compared between the two groups, OS was similar (HR 0.97, 95% CI 0.62-1.52), while the ORR and PFS of group A were numerically better than those of group B (ORR 22% vs 11%; PFS 3.9 vs 3.7 months, HR 0.73 ). These differences were mainly attributed to the greater efficacy of group A in patients who had previously received docetaxel (HR 0.49; ORR 25% vs 8%), with the median PFS of the two groups being 4.6 months and 2.1 months respectively ( HR=0.49, 95% CI 0.29-0.83), and the median OS were 7.5 months and 6.6 months (HR=0.81, 95% CI 0.47-1.43) respectively (Figure 2). In the safety population (n=106 patients), grade 3-5 AEs were similar between the two groups (75% in group A; 68% in group B) (Table 2).
Figure 2. Kaplan-Meier plot of progression-free survival for all randomly assigned patients (a); docetaxel-pretreated patients (b), patients without prior docetaxel (c); Kaplan-Meier plot of overall survival for all randomly assigned patients ( d); docetaxel-pretreated patients (e), patients without prior docetaxel (f).
Table 2. Adverse events
Conclusion
RAMIRIS study proved the feasibility of FOLFIRI combined with RAM. The study results were negative, but patients previously treated with docetaxel may benefit from this combination.
Chief Editor's Comments
Ramucirumab has poor efficacy in the first-line treatment of advanced gastric cancer. The phase III RAINFALL study examined cisplatin combined with capecitabine /5-FU±RAM in the treatment of untreated metastatic gastric or gastroesophageal junction glands. For cancer patients, the combined RAM group had limited prolongation of mPFS (5.7 vs 5.4 months, HR=0.753, P=0.0106), and OS did not reach the study endpoint (P=0.68)
[1]. The efficacy of RAM in the second-line treatment of advanced gastric cancer is promising. The REGAR
D and RAINBOW studies have successively confirmed that RAM shows significant survival benefit in the second-line treatment, whether used alone or in combination with paclitaxel.
[2,3]
, RAINBOW-ASIA The study also reached the preset endpoint, showing effectiveness and safety consistent with global standards.
[4].
This study (RAMIRIS) is a study exploring other application modes of RAM in second-line treatment. Although it failed to meet the primary study endpoint, patients who have previously received docetaxel may benefit from this combination therapy.
[5], we look forward to more research results to provide a basis for further broadening the indications of RAM.
Click to download to view the original study ↓↓↓
The efficacy of FOLFIRI combined with ramucirumab versus paclitaxel combined with ramucirumab as a second-line regimen in patients with advanced or metastatic gastroesophageal adenocarcinoma treated with or without docetaxel : Results from the AIO German Gastric Cancer Research Collaboration Phase II RAMIRIS study
Reference
1. Fuchs CS, et al. Lancet Oncol. 2019 May;20(5): e242. PMID: 30718072.
2. Fuchs CS, et al. Lancet 2014 Jan 4;383(9911):31-39. PMID: 24094768.
3. Wilke H, et al. Lancet Oncol. 2014 Oct;15(11):1224-35. PMID: 25240821.
4. Rui-Hua Xu, et al. 2021 ASCO GI. Abstract 199.
5. Lorenzen S, et al. Eur J Cancer. 2022 Apr; 165:48-57. PMID: 35202974.
Copyright Statement
The copyright of this article belongs to Yiyuehui. Welcome to forward and share. If any other media needs to reprint or quote the copyrighted content of this website, it must obtain authorization and indicate "Reprinted from: Yiyuehui" in a prominent position.
