Ramucirumab 8 / Paclitaxel 80, adenocarcinoma esophagogastric junction and stomach

Indication(s)

• Gastric Cancer; ICD-10 C16.-, C16.0
• Esophageal Cancer (Adenocarcinoma Esophagogastric Junction (AEG)); ICD-10 C15.-

Protocol classification

• Classification: alternative
• Intensity: Standard dose
• Therapy mode: Second line
• Therapy intention: palliative

Cycles

Cycle length 28 days, recommended cycles: 5

Risks

• Emetogenicity (MASCC/ESMO): low (10-30%)
• Neutropenia: high (21-40%)
• Febrile Neutropenia: low (<10%)
• Thrombocytopenia below 50 000/µl: low (<10%)
• Anemia Hb below 8g/dl: moderate (6-15%)
• Hypertension: CTC AE °1-2: 10%; °3-4: 14%
• Proteinuria: CTC AE °1-2: 15%; °3-4: 1%
• Fatigue: CTC AE °1-2: 45%; °3-4: 12%
• Infusion Reaction: CTC AE °1-2: 5%; °3-4: 1%
• Hemorrhage: CTC AE °1-2: 38%; °3-4: 5%
• Neuropathy: CTC AE °1-2: 38%; °3-4: 8%

Therapy

Concomitant therapy supplements

Dexamethasone for antiemesis and Ramucirumab allergy prophylaxis are covered by Paclitaxel allergy prophylaxis. For infusion reactions, see the respective summary of product characteristics.

Notes

Therapy is continued until progression or the occurrence of unacceptable side effects. In the study, a median of 4.5 cycles were administered (range 2.5-8).

Cycles

Cycle length 28 days, recommended cycles: 5

Controls:

• Blood count: on day 1 and subsequently weekly
• ECG Risk of developing a conduction disorder during paclitaxel therapy, ECG monitoring every 3 cycles.
• Day 1: GOT, GPT, GGT, Bilirubin, AP, Cholinesterase Liver function monitoring before and during paclitaxel therapy, Ramucirumab: liver function monitoring before therapy.
• Day 1: Blood pressure Ramucirumab: continuous monitoring before and during therapy
• Day 1: Urine protein excretion Ramucirumab: risk of proteinuria during therapy

Pharmacokinetics

Cimetidin: CYP450 Inhibitor, vielschichtige Interaktionen möglich

Original indication

Met. or progressive gastric cancer and adeno-ca of the esophagogastric junction, second line, progression within 4 months after first line, ECOG 0-1

Original author

Wilke H (2014)

Origin

Abteilung für Onkologie/Hämatologie, Kliniken Essen-Mitte, Deutschland, RAINBOW Study Group, RAINBOW Studie

References

• Wilke H, Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial., Lancet Oncol 2014 Oct;15(11):1224-35 [PMID]

Recommendations

• 09/2016: European Society for Medical Oncology
• 06/2021: National Comprehensive Cancer Network

Status

Valid since 2021-07-04, Version 1.2, last updated 2021-07-04

Last modification: V1.2: Protocol name changed V1.1: Cato test done. Revision of allergy prophylaxis according to the SmPC, change of H2- antagonist for Paclitaxel from Ranitidine to Cimetidine according to DGHO recommendations 10/2019. V1.0: Duration and sequence of substances according to primary literature in line with the Ramucirumab SmPC.

Important notice

The copyrighted protocols are treatment recommendations. The information contained in this compilation on cytostatic drugs, concomitant medication and other therapeutic procedures, as well as dosage and application information, is continuously reviewed with all due care by the authors and editors involved. Nevertheless, the publishers and authors do not assume any liability for the correctness - also with regard to possible printing errors.

The protocols may not be changed in terms of content.

Diagnosis, indication for therapy and treatment of malignant diseases must be carried out in each individual case by the hematologist and oncologist on his or her own responsibility. The treating physician is obligated to this personal responsibility to weigh in each case before a diagnostic or therapeutic measure, indication, contraindications, dosage and application under consideration of the specialized information or other documents of the manufacturers. This applies in particular to rarely used preparations or preparations that are new to the market.

The publishers and authors assume no liability for the accuracy of the contents. The application is at the own responsibility of the treating physician. ©Onkopti.