Ramucirumab as First-Line Therapy in Combination with Cisplatin and Fluoropyrimidine in Patients with Metastatic Gastric or Gastro-Oesophageal Junction Adenocarcinoma (RAINFALL): A Global, Randomised, Double-Blinded, Placebo-Controlled, Phase 3 Trial

Fuchs, Charles S.; Shitara, Kohei; Bartolomeo, Maria Di; Al-Batran, Salah-Eddin; Cutsem, Éric Van; Ilson, David H.; Alsina, María; Chau, Ian; Lacy, Jill; Ducreux, Michel; Méndez, Guillermo; Alavez, Alejandro Molina; Takahari, Daisuke; Mansoor, Wasat; Enzinger, Peter C.; Gorbounova, Vera; Wainberg, Zev A.; Hegewisch‐Becker, Susanna; Ferry, D. K.; Ji, Lin; Carlesi, Roberto; Das, Mayukh; Shah, Manish A.; Group, RAINFALL Study

doi:10.2139/ssrn.3221440

Cited by 31 publications

(41 citation statements)

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“…145 Due to the results of the international phase III RAINFALL trial, in which treatment with ramucirumab did not reduce the risk of disease progression or death in treatment-naïve patients with metastatic gastroesophageal adenocarcinoma, the addition of ramucirumab to first-line chemotherapy is not recommended at this time. 172 Fam-trastuzumab Deruxtecan-nxki Fam-trastuzumab deruxtecan-nxki is an antibody-drug conjugate consisting of trastuzumab and a cytotoxic topoisomerase I inhibitor connected by a cleavable tetrapeptidebased linker. The efficacy and safety of fam-trastuzumab deruxtecan-nxki in advanced or metastatic gastric or EGJ adenocarcinoma was evaluated in the phase II DESTINY-Gastric01 trial, which included 188 patients with progressive disease after at least 2 prior lines of therapy, including trastuzumab.…”

Section: Ramucirumabmentioning

confidence: 99%

Esophageal and Esophagogastric Junction Cancers, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology

Ajani

D’Amico

Bentrem

et al. 2023

Journal of the National Comprehensive Cancer Network

163

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Cancers originating in the esophagus or esophagogastric junction constitute a major global health problem. Esophageal cancers are histologically classified as squamous cell carcinoma (SCC) or adenocarcinoma, which differ in their etiology, pathology, tumor location, therapeutics, and prognosis. In contrast to esophageal adenocarcinoma, which usually affects the lower esophagus, esophageal SCC is more likely to localize at or higher than the tracheal bifurcation. Systemic therapy can provide palliation, improved survival, and enhanced quality of life in patients with locally advanced or metastatic disease. The implementation of biomarker testing, especially analysis of HER2 status, microsatellite instability status, and the expression of programmed death-ligand 1, has had a significant impact on clinical practice and patient care. Targeted therapies including trastuzumab, nivolumab, ipilimumab, and pembrolizumab have produced encouraging results in clinical trials for the treatment of patients with locally advanced or metastatic disease. Palliative management, which may include systemic therapy, chemoradiation, and/or best supportive care, is recommended for all patients with unresectable or metastatic cancer. Multidisciplinary team management is essential for all patients with locally advanced esophageal or esophagogastric junction cancers. This selection from the NCCN Guidelines for Esophageal and Esophagogastric Junction Cancers focuses on the management of recurrent or metastatic disease.

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Section: Ramucirumabmentioning

confidence: 99%

Esophageal and Esophagogastric Junction Cancers, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology

Ajani

D’Amico

Bentrem

et al. 2023

Journal of the National Comprehensive Cancer Network

163

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“…In our study, we found chemotherapy was associated with worse OS in AYAs. This can be explained by that although chemotherapy resulted in survival benefits for GC patients, it may cause some adverse events, such as gastric hemorrhage, peritonitis, cardiac arrest, septic shock, acute kidney injury, and sudden death, which increased the risk of death 31 . Intraoperative radiation allowed delivering enhanced radiation to the localized area without affecting surrounding tissues during the surgery 32 .…”

Section: Discussionmentioning

confidence: 99%

“…This can be explained by that although chemotherapy resulted in survival benefits for GC patients, it may cause some adverse events, such as gastric hemorrhage, peritonitis, cardiac arrest, septic shock, acute kidney injury, and sudden death, which increased the risk of death. 31 Intraoperative radiation allowed delivering enhanced radiation to the localized area without affecting surrounding tissues during the surgery. 32 An existing study showed that intraoperative radiation was correlated with the low locoregional tumor recurrence, but did not have benefit on the long-term survival.…”

Section: Discussionmentioning

confidence: 99%

Trend of gastric cancer incidence and death rate in adolescents and young adults: A retrospective cohort study based on the Surveillance, Epidemiology, and End Results (SEER) database

Wen

Shen

2022

J of Gastro and Hepatol

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Background and Aim Less attentions are paid into the adolescents and young adults (AYAs) diagnosed with gastric cancer (GC). Our study aims to explore incidence rate trend, death rate trend, and prognostic factors for overall survival (OS) and cancer‐specific survival (CSS) in AYAs with GC. Methods A retrospective cohort study based on the Surveillance, Epidemiology, and End Results (SEER) database was performed. Joinpoint regression analysis was used to calculate average annual percent change (AAPC) with 95% confidence interval (CI) for incidence and death rate trends. Prognostic factors for OS and CSS were investigated using Cox proportional hazard model and gray test, respectively, with results shown as hazard ratio (HR) with 95% CI. Results Although no statistical significance, incidence rate trend showed a tendency to an increase in AYAs (AAPC = 0.2, 95% CI: −0.2–0.6). All‐cause death rate trends were declined both in AYAs and middle‐aged and elderly people (MAEP), with AAPC value of −0.6 (95% CI: −0.8 to −0.5) and −0.5 (95% CI: −0.6 to −0.4), respectively. AYAs had a lower risk of all‐cause death (HR: 0.87, 95% CI: 0.84–0.90) but a higher risk of GC‐specific death (HR: 1.11, 95% CI: 1.07–1.15) than MAEP. Chemotherapy (HR: 1.27, 95% CI: 1.16–1.40) and intraoperative radiation (HR: 2.89, 95% CI: 1.13–7.37) were, respectively, identified as risk factors for worse OS and CSS in AYAs. Conclusions AYAs had a higher risk of GC‐specific death, indicating more attention should be paid into AYAs with GC.

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“…Consequently, the targeting of angiogenesis by inhibiting VEGFs is a promising strategy for cancer treatment (12). Several reports have demonstrated the efficacy of this treatment strategy in lung, breast, renal, hepatic, and colon cancers (12)(13)(14)(15). Antiangiogenic treatment is also considered one of the potential treatment methods to benefit and increase the survival of patients with cancer and drug resistance, even in those who have been heavily pretreated (16)(17)(18)(19).…”

Section: Introductionmentioning

confidence: 99%

The efficacy and safety of apatinib in patients with heavily pretreated end-stage cancer: a retrospective study

Li¹,

Zhou²,

Wang³

et al. 2023

Transl Cancer Res

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Background: Anti-angiogenesis therapy has been a vital treatment option in a variety of cancers. Assessing the efficacy and safety of apatinib in patients with heavily pretreated end-stage cancer is essential.Methods: Thirty patients with end-stage cancer who were heavily pretreated were enrolled in this study.All patients received oral administration of apatinib (125-500 mg/d) between May 2015 and November 2016. Dose reduction or elevation was conducted based on adverse events and doctors' judgments.Results: Prior to the apatinib treatment, the enrolled patients received a median of 1.2 surgeries (range, 0-7), 1.6 sessions of radiotherapies (range, 0-6), and 10.2 cycles of chemotherapy (range, 0-60); 43.3% of patients had uncontrolled local lesions, 83.3% of patients had uncontrolled multiple metastases, and 30.0% of patients had both. After the treatment, 25 patients had valuable data, 6 (24.0%) patients achieved partial response (PR), and 12 (48.0%) patients had stable disease (SD). The disease control rate (DCR) was 72.0%.The PR and SD rates were 20.0% and 40.0%, respectively, and the DCR was 60.0% in the intent-to-treat (ITT) analysis. Meanwhile, the median progression-free survival (PFS) was 2.6 (range, 0.7-5.4) months, and the median overall survival (OS) was 3.8 (range, 1.0-12.0) months. Furthermore, the PR rate and DCR in patients with squamous cell cancer (SCC) were 45.5% and 81.8%, respectively; those in patients with adenocarcinoma (ADC) were 8.3% and 58.3%, respectively. The adverse events were generally mild. The most common adverse events were hyperbilirubinemia (53.3%), elevated transaminase (36.7%), anemia (30.0%), thrombocytopenia (30.0%), hematuria (30.0%), fatigue (26.7%), and leukopenia (20.0%). Conclusions:The results of this study demonstrate the efficacy and safety of apatinib and support the further development of apatinib as a potential treatment option for patients with heavily pretreated end-stage cancer.

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Ramucirumab as First-Line Therapy in Combination with Cisplatin and Fluoropyrimidine in Patients with Metastatic Gastric or Gastro-Oesophageal Junction Adenocarcinoma (RAINFALL): A Global, Randomised, Double-Blinded, Placebo-Controlled, Phase 3 Trial

Cited by 31 publications

References 0 publications

Esophageal and Esophagogastric Junction Cancers, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology

Esophageal and Esophagogastric Junction Cancers, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology

Trend of gastric cancer incidence and death rate in adolescents and young adults: A retrospective cohort study based on the Surveillance, Epidemiology, and End Results (SEER) database

The efficacy and safety of apatinib in patients with heavily pretreated end-stage cancer: a retrospective study

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