Ramucirumab in the treatment of refractory metastatic gastric cancer: results from the RamSelGa trial.

Date 29 September 2019
Event ESMO 2019 Congress
Session Poster Display session 2
Topics Gastric Cancer
Presenter Alexey Tryakin
Citation Annals of Oncology (2019) 30 (suppl_5): v253-v324. 10.1093/annonc/mdz247
Authors A. Tryakin1, E. Perminova2, D. Stroyakovsky2, T. Titova3, D. Yukalchuk4, D. Ponomarenko5, N. Beliak6, G.M. Teletaeva7, E. Ratner8, A. Mochalova9, O.O. Gordeeva10, A. Meshcheryakov11, A.S. Zhabina12, S. Gamayunov13, A. Smolin14, A. Povyshev15, M. Andrievsckih16, M. Fedyanin17, I. Tsimafeyeu18, N. Besova19
  • 1Clinical Pharmacology And Chemotherapy, N.N. Blokhin National Medical Research Centre of Oncology, 115478 - Moscow/RU
  • 2Chemotherapy, Moscow city oncologic hospital №62, Moscow, 143423 - Moscow/RU
  • 3Chemotherapy, N.N. Blokhin National Medical Research Centre of Oncology, 115478 - Moscow/RU
  • 4Chemotherapy, Regional Oncology dispensary, 664001 - Irkutck/RU
  • 5Chemotherapy, Irkutsk Regional Oncology dispensary, 664001 - Irkutck/RU
  • 6Chemotherapy, Saint-Petersburg City Clinical Oncology Dispensary, 198255 - Saint-Petersburg/RU
  • 7Chemotherapy, N.N. Petrov National Medical Research Center of Oncology, 197758 - Saint-Petersburg/RU
  • 8Chemotherapy, Republican clinical oncological dispensary, Kazan, 420029 - Kazan/RU
  • 9Chemotherapy, Clinical Hospital №1 Medsi, 1143676 - Moscow/RU
  • 10Chemotherapy And Combined Treatments Modalities, N.N. Blokhin National Medical Research Centre of Oncology, 115516 - Moscow/RU
  • 11Chemotherapy And Combined Treatments Modalities, N.N. Blokhin National Medical Research Centre of Oncology, 117535 - Moscow/RU
  • 12Chemotherapy, City Cancer Center, St.Petersburg, 197758 - Saint-Petersburg/RU
  • 13Department Of Radiotherapy And Surgical Treatment Of Thoracic Diseases, National Medical Research Radiological Center of the Ministry of Health of the Russian Federation. A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER, 249030 - Obninsk/RU
  • 14Chemotherapy, N.N. Burdenko Main Military Clinical Hospital-Ministry of Defence of Russian Federation, 105229 - Moscow/RU
  • 15Chemotherapy, Khanty-Mansiysk Regional Oncology dispensary, 628007 - Khanty-Mansiysk/RU
  • 16Chemotherapy, Chelyabinsk Regional Oncology dispensary, 454004 - Chelyabinsk/RU
  • 17Clinical Pharmacology And Chemotherapy, N.N. Blokhin National Medical Research Centre of Oncology, 117535 - Moscow/RU
  • 18Moscow Office, Russian Society of Clinical Oncology, 119019 - Moscow/RU
  • 19Chemotherapy, N.N. Blokhin National Medical Research Centre of Oncology, 117535 - Moscow/RU

Abstract

Background

Ramucirumab is a preferred second-line treatment option for patients with chemorefractory metastatic gastric cancer (mGC). RamSelGa study was conducted by the Russian Society of Clinical Oncology and assessed real-world data on the use of ramucirumab in this population.

Methods

To be included in the study patients had to progress on previous platinum and fluoropyrimidine-based chemotherapy and receive ramucirumab-based therapy in second or later lines. Primary end-point was overall survival (OS). Secondary end-points included progression-free survival (PFS) and safety.

Results

One hundred forty-five pts with mGA were enrolled in 14 centers. ECOG performance status 0, 1 and 2 had 19 (13%), 102 (70%) and 24 (17%) patients. Ramucirumab was used in second- and later-lines in 126 and 19 patients, respectively. Ramucirumab was combined with weekly paclitaxel in 109 (75%) patients or irinotecan-based chemotherapy (mostly FOLFIRI) in 24 (17%) patients. Median duration of second-line ramucirumab was 4.7 (range, 0.5-34.1) months, 17 (13%) patients received therapy for ≥12 months. Median OS was 9.2 months in patients treated with ramucirumab in the second-line setting. OS and PFS data are summarized in the table. VEGF-related toxicity (all grades) included epistaxis (36%), proteinuria >1g/day (4.2%), and arterial hypertension (30%); grade 3-5 toxicity was bleeding (4.1%) and brain ischemia (0.7%, grade 5). Three patients (2%) discontinued therapy due to toxicity.Table:

797P

RegimensSecond- line, n = 126Median PFS, monthsMedian OS, monthsLater- lines, n = 19Median PFS, monthsMedian OS, months
ramucirumab + paclitaxel955.59.2143.15.5
ramucirumab + irinotecan-based247.010.30--
others + ramucirumab45.510.135.25.6
ramucirumab alone32.42.52--

Conclusions

These "real-life" efficacy data of ramucirumab in patients with mGC are in line with previous randomized trials. Ramucirumab is well tolerated in daily clinical practice. Irinotecan-based regimens could be effective and warrant further investigation.

Clinical trial identification

russco25072017.

Editorial acknowledgement

Legal entity responsible for the study

Russian Society of Clinical Oncology (RUSSCO).

Funding

Has not received any funding.

Disclosure

A. Tryakin: Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eli Lilly and Company. All other authors have declared no conflicts of interest.