Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study

Bartolomeo, Maria Di; Niger, Monica; Tirino, Giuseppe; Petrillo, Angelica; Berenato, Rosa; Laterza, Maria Maddalena; Pietrantonio, Filippo; Morano, Federica; Antista, Maria; Lonardi, Sara; Fornaro, Lorenzo; Tamberi, Stefano; Giommoni, Elisa; Zaniboni, Alberto; Rimassa, Lorenza; Tomasello, Gianluca; Sava, Teodoro; Spada, Massimiliano; Latiano, Tiziana Pia; Bittoni, Alessandro; Bertolini, A.; Proserpio, Ilaria; Bencardino, Katia; Graziano, Francesco; Beretta, Giordano Domenico; Galdy, Salvatore; Ventriglia, Jole; Scagnoli, Simone; Spallanzani, Andrea; Longarini, Raffaella; Vita, Ferdinando De

doi:10.1007/s11523-018-0562-5

Cited by 33 publications

(38 citation statements)

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“…In the second-line setting, patients underwent PR between September 2015 and September 2018 ( Table 1). The results of second-line therapy in this cohort of patients parallel findings in the RAMos study [20]. The overall response rate was 17.5%, with 7 partial responses in the 40 patients.…”

Section: Resultssupporting

confidence: 77%

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Glycolytic competence in gastric adenocarcinomas negatively impacts survival outcomes of patients treated with salvage paclitaxel-ramucirumab

et al. 2020

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Introduction For energy production, cancer cells maintain a high rate of glycolysis instead of oxidative phosphorylation converting glucose into lactic acid. This metabolic shift is useful to survive in unfavorable microenvironments. We investigated whether a positive glycolytic profile (PGP) in gastric adenocarcinomas may be associated with unfavorable outcomes under an anticancer systemic therapy, including the anti-angiogenic ramucirumab. Materials and methods Normal mucosa (NM) and primary tumor (PT) of 40 metastatic gastric adenocarcinomas patients who received second-line paclitaxel-ramucirumab (PR) were analyzed for mRNA expression of the following genes: HK-1, HK-2, PKM-2, LDH-A, and GLUT-1. Patients were categorized with PGP when at least a doubling of mRNA expression (PT vs. NM) in all glycolytic core enzymes (HK-1 or HK-2, PKM-2, LDH-A) was observed. PGP was also related to TP53 mutational status. Results Mean LDH-A, HK-2, PKM-2 mRNA expression levels were significantly higher in PT compared with NM. 18 patients were classified as PGP, which was associated with significantly worse progression-free and overall survival times. No significant association was observed between PGP and clinical-pathologic features, including TP53 positive mutational status, in 28 samples. Conclusions Glycolytic proficiency may negatively affect survival outcomes of metastatic gastric cancer patients treated with PR systemic therapy. TP53 mutational status alone does not seem to explain such a metabolic shift.

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Section: Resultssupporting

confidence: 77%

“…Italian institutions involved in the RAMos retrospective study [20] were asked to participate in the present study. To evaluate the results of a translational analysis in a homogeneous population of patients, this retrospective investigation focused on patients treated with the combination of ramucirumab and paclitaxel only.…”

Section: Methodsmentioning

confidence: 99%

Glycolytic competence in gastric adenocarcinomas negatively impacts survival outcomes of patients treated with salvage paclitaxel-ramucirumab

et al. 2020

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“…Thus, also patients who are not fit for second line chemotherapy might have a benefit, if treated with ramucirumab as a monotherapy. These promising results were affirmed by the "real-life" efficacy data on ramucirumab treatment in the RAMoss study (median OS 8.0 months; 95% CI 7.09-8.9) [27].…”

Section: Second Linementioning

confidence: 81%

New Treatment Options for Advanced Gastroesophageal Tumours: Mature for the Current Practice?

Puhr

Preusser

Prager

2020

Cancers

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Several clinical trials attempted to identify novel treatment options for advanced gastroesophageal tumours in first, second and further lines. Although results of targeted therapy regimens were mainly disappointing, novel immunotherapy agents showed promising activity, which led to their approval in second and third lines in many countries. This review focuses on the results of recent clinical trials investigating novel agents including targeted therapies, immunotherapy components and chemotherapies and discuss their current impact as well as current approval status on the treatment armamentarium of advanced gastroesophageal tumours.

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“…Такие клинические факторы, как ECOG ≥ 1, поражение брюшины, наличие асцита, низкая дифференцировка опухоли, наличие первичной опухоли, были выделены как независимые факторы неблагоприятного прогноза продолжительности жизни больных при анализе данных REGARD + RAINBOW [24]. В итальянском исследовании RAMoss ECOG ≥ 1 и наличие перитонеальной диссеминации также явились неблагоприятными прогностическими факторами [25].…”

Section: обсуждение полученных результатовunclassified

Results of the use of ramucirumab in combination with irinotecan and fluoropyrimidines in the second-line chemotherapy for disseminated gastric cancer

et al. 2019

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Background: Several studies show that the combination chemotherapy with ramucirumab allows to improve the treatment results of advanced gastric cancer (GC). Irinotecan with fluoropyrimidines is own of the second line chemotherapy options for these patients. As angiogenesis inhibitors can enhance the efficacy of chemotherapy, we investigated the combination of irinotecan and fluoropyrimidines with ramucirumab in metastatic GC.Methods: Eligible patients had advanced morphologically verified GC and disease progression during or within 4 months following first-line therapy. They received FOLFIRI plus ramucirumab (8 mg/kg on day 1) or XELIRI in combination with ramucirumab (8 mg/kg on days 1 and 8). The primary end point was progression-free survival (PFS). Secondary end-points were disease control rate (DCR) and safety.Results: Between September 2015 and April 2019, 39 patients (pts) were enrolled and 38 were evaluated for efficacy and toxicity. Median number of cycles was 9 (2-20). Seven patients achieved a partial response (PR) for an overall response rate of 17.9%. A total of 29 (74.4%) patients had stable disease (SD) for a DCR of 92.3%. With a median follow up 7,5 months, median PFS was 7.58 months (95% CI 6.6-8.5) and the median OS has not yet been reached. Median duration of PR response was 8,7 months (4,11-10,94+) and median duration of SD was 4,14 months (1,84-11,99+). The main treatment-related grade 3 or 4 adverse events were neutropenia (7/38; 18.4%), anemia (1/38; 2.6%) and diarrhea (2/38; 4.3%).The most frequent adverse events of special interest (AESIs) any grade were hypertension (16/38; 42.1%), bleeding/hemorrhage (10/38; 26.3%), proteinuria (6/38; 15.7%) and venous thromboembolic events (10/38; 26,3%). Gastrointestinal perforation developed in two patients (2/38; 5.3%). No treatment-related deaths occurred.Conclusion: In our research ramucirumab with irinotecan and fluoropyrimidines demonstrate the high activity and a manageable safety profile in patients with pre-treated metastatic GC

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Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study

Abstract: These "real-life" efficacy data on ramucirumab treatment are in line with previous randomized trials. Ramucirumab is well tolerated in daily clinical practice.

Cited by 33 publications

References 20 publications

Glycolytic competence in gastric adenocarcinomas negatively impacts survival outcomes of patients treated with salvage paclitaxel-ramucirumab

Glycolytic competence in gastric adenocarcinomas negatively impacts survival outcomes of patients treated with salvage paclitaxel-ramucirumab

New Treatment Options for Advanced Gastroesophageal Tumours: Mature for the Current Practice?

Results of the use of ramucirumab in combination with irinotecan and fluoropyrimidines in the second-line chemotherapy for disseminated gastric cancer

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