Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Kan Cyramza® (ramucirumab) kombineras med strålning?

Ingen information finns tillgänglig om samtidig strålning med läkande avsikt eftersom detta inte var tillåtet i kliniska studier med Cyramza. Tidigare strålbehandling accepterades i allmänhet om den utfördes >28 dagar före randomisering.

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Palliative Radiation

Palliative Radiation in the Cyramza Clinical Trials.1-4

Study

Permissions

Patient data

RELAY

Palliative radiation therapy was permitted for irradiating small areas of painful metastases that could not be managed adequately using systemic or local analgesics.

Such areas must not have constituted progressive disease (PD) or met Response Evaluation Criteria in Solid Tumors (RECIST) criteria for PD.1,2

No data on patients is available.1,2

RAINBOW

Palliative radiation to symptomatic sites of disease was allowed per the clinical study protocol.1,3

No information is available as no patients in the ramucirumab plus paclitaxel arm received concurrent palliative radiation.1,3

REACH-2

palliative radiation to symptomatic sites of disease was allowed per the clinical study protocol. 

7 patients (3.6%) in the ramucirumab arm and 2 patients (2.1%) in the placebo arm received palliative radiotherapy.1,4

Prior Radiation 

Prior radiation in the Cyramza clinical trials.1-7 

Study

Permissions

RAINBOW

Patients could participate if they stopped radiation 28 days prior to randomization.3

REGARD

Patients could participate if they stopped radiation for gastric cancer 2 weeks prior to randomization.5

REVEL

Patients could participate if they stopped 

  • chest radiotherapy 28 days prior to randomization
  • local or palliative radiation treatment 7 days prior to randomization and provided that 25% or less of total bone marrow had been irradiated
  • CNS radiation 14 days prior to randomization.6

RAISE

Patients could participate if they stopped

  • any radiation 14 days prior to randomization, or
  • wide-field (full-dose pelvic) 28 days prior to randomization.7

REACH-2

Patients could participate if they stopped any hepatic locoregional therapy, including radiation, 28 days prior to randomization.4

RELAY

Patients could participate if they stopped 

  • local palliation or prevention of symptoms (such as pain, bleeding, or obstruction) 7 days prior to enrollment and provided that 25% or less of total bone marrow had been irradiated. 
  • thoracic radiotherapy 28 days before enrollment.2 

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669. https://doi.org/10.1016/S1470-2045(19)30634-5

3Wilke H, Muro K, Van Cutsem E, et al. 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;15(11):1224-1235. http://dx.doi.org/10.1016/S1470-2045(14)70420-6

4Zhu AX, Kang YK, Yen CJ, et al. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(2):282-296. http://dx.doi.org/10.1016/S1470-2045(18)30937-9

5Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31-39. http://dx.doi.org/10.1016/S0140-6736(13)61719-5

6Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673. http://dx.doi.org/10.1016/S0140-6736(14)60845-X

7Tabernero J, Yoshino T, Cohn AL, et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015;16(5):499-508. http://dx.doi.org/10.1016/S1470-2045(15)70127-0

Datum fӧr senaste ӧversyn 2019 M02 15


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