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

Cyramza® (ramucirumab): Strålning

I kliniska prövningar med Cyramza fick patienterna inte genomgå samtidig strålbehandling i kurativt syfte.

Radiation with Curative Intent

Concurrent radiation therapy with curative intent was not permitted to be administered to patients during ramucirumab clinical studies; therefore, no information is available on the concurrent use of ramucirumab and radiation with curative intent.1,2

Palliative Radiation

RELAY Study

The RELAY trial was a phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial in patients (N=449) with previously untreated EGFR mutation-positive, metastatic NSCLC. All patients had an EGFR mutation of exon 19 deletion or exon 21 L858R and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, EGFR status, and EGFR testing method) to receive treatment with erlotinib (150 mg/day) plus ramucirumab (10 mg/kg every 2 weeks; n=224) or placebo (10 mg/kg every 2 weeks; n=225) until disease progression or unacceptable toxicity.2,3

In this study, 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 PD or met RECIST criteria for PD.2 There are no data with regard to patients who may have received palliative radiation in RELAY.1,2 

RAINBOW Study

The RAINBOW trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with metastatic or locally advanced nonresectable gastric or GEJ adenocarcinoma following disease progression during or within 4 months after last dose of first-line platinum plus fluoropyrimidine combination chemotherapy with or without an anthracycline and an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by region, measurable vs nonmeasurable disease, and time to TTP on first-line therapy) to receive ramucirumab (8 mg/kg days 1 and 15) plus paclitaxel (80 mg/m2 days 1, 8, and 15) (n=330) or placebo (days 1 and 15) plus paclitaxel (80 mg/m2 days 1, 8, and 15) (n=335) of a 28-day cycle until disease progression, unacceptable toxicity, withdrawal, or death.4

In this study, palliative radiation to symptomatic sites of disease was allowed per the clinical study protocol. No patients in the ramucirumab plus paclitaxel arm received concurrent palliative radiation; therefore, no information on the efficacy or safety of ramucirumab in combination with palliative radiation is available.1

REACH-2 Study

The REACH-2 trial was a phase 3, global, randomized, double-blind, placebo-controlled study that compared ramucirumab plus BSC and placebo plus BSC in patients with advanced HCC and elevated baseline AFP following first-line sorafenib. Patients were assigned in a 2:1 ratio (stratified by geographic region, baseline ECOG PS, and macrovascular invasion) to receive ramucirumab 8 mg/kg IV plus BSC (n=197) or placebo plus BSC (n=95) every 14 days until disease progression or unacceptable toxicity, or until discontinuation criteria were met.5 

In this study, palliative radiation to symptomatic sites of disease was allowed per the clinical study protocol. There were 7 patients (3.6%) in the ramucirumab arm and 2 patients (2.1%) in the placebo arm who received palliative radiotherapy.1

References

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

2. Nakagawa 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

3. Nakagawa K, Garon E, Seto T, et al. RELAY: A multicenter, double-blind, randomized, phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC). Talk presented at: 55th Annual Meeting of the American Society of Clinical Oncology (ASCO); May 31-June 4, 2019; Chicago, IL. https://meetinglibrary.asco.org/record/173373/abstract

4. Wilke 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

5. Zhu 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

Glossary

AFP = alpha-fetoprotein

BSC = best supportive care

ECOG = Eastern Cooperative Oncology Group

EGFR = epidermal growth factor receptor

GEJ = gastroesophageal junction

HCC = hepatocellular carcinoma

IV = intravenous

NSCLC = non-small cell lung cancer

PD = progressive disease

PS = performance status

RECIST = Response Evaluation Criteria in Solid Tumors

TTP = time-to-progression

Datum fӧr senaste ӧversyn 2019 M02 15


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