Cyramza® (Ramucirumab)

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Ramucirumab: The REVEL Study

Patients treated with ramucirumab plus docetaxel had a significantly longer median OS than patients treated with placebo plus docetaxel. The most common AEs among patients who received ramucirumab were fatigue, decreased appetite, and diarrhea.

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Study Design

The REVEL trial was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in patients with pathologically confirmed, squamous or nonsquamous, stage IV NSCLC with disease progression during or after 1 prior platinum-based chemotherapy. Prior treatment with bevacizumab and prior maintenance therapy were allowed and all patients had an ECOG PS of 0 or 1. Patients were randomly assigned in a 1:1 ratio (stratified by sex, region, PS, and previous maintenance therapy) to receive treatment with ramucirumab (10 mg/kg every 3 weeks) plus docetaxel (75 mg/m2 every 3 weeks) (n=628) or placebo plus docetaxel (75 mg/m2 every 3 weeks) (n=625) until disease progression, unacceptable toxicity, withdrawal, or death.1

Efficacy Results

Patients treated with ramucirumab plus docetaxel had a significantly longer median OS than patients treated with placebo plus docetaxel (10.5 months vs 9.1 months; HR=0.86; 95% CI: 0.75-0.98; p=.023).1 Efficacy endpoint results are summarized in Efficacy Endpoint Results.

Efficacy Endpoint Results1,2

Endpoint

RAM + DOC
n=628

PBO + DOC
n=625

Median OS, mo (95% CI)

10.5 (9.5-11.2)

9.1 (8.4-10.0)

HR (95% CI); p value

0.86 (0.75-0.98); p=.023

Median PFS, mo (95% CI)

4.5 (4.2-5.4)

3.0 (2.8-3.9)

HR (95% CI); p value

0.76 (0.68-0.86); p<.0001

ORR (CR + PR), n (%)a

144 (23)

85 (14)

P value

p<.0001

DCR (CR + PR + SD), n (%)

402 (64)

329 (53)

P value

p<.0001

Abbreviations: CR = completed response; DCR = disease control rate; DOC = docetaxel; HR = hazard ratio; ORR = objective response rate; OS = overall survival; PBO = placebo; PFS = progression-free survival; PR = partial response; RAM = ramucirumab; SD = stable disease.

aInvestigator-assessed.

Safety Results

In the ramucirumab-plus-docetaxel group compared to the placebo-plus-docetaxel group grade ≥3 TEAEs were reported in 495 (79%) patients vs 444 (71%) patients.1 Treatment emergent adverse events that occurred in ≥10% of patients are summarized in Treatment-Emergent Adverse Events That Occurred in ≥10% of Patients.

Treatment-Emergent Adverse Events That Occurred in ≥10% of Patients1

TEAE

Any Grade
n (%)

Grade ≥3
n (%)

Any Grade
n (%)

Grade ≥3
n (%)

RAM + DOC
n=627

PBO + DOC
n=618

Fatigue

343 (55)

88 (14)

309 (49)

65 (10)

Decreased appetite

182 (29)

14 (2)

154 (25)

8 (1)

Diarrhea

199 (32)

29 (5)

171 (27)

19 (3)

Nausea

169 (27)

7 (1)

170 (27)

9 (1)

Alopecia

162 (26)

NA

156 (25)

NA

Stomatitis

146 (23)

27 (4)

80 (13)

10 (2)

Neuropathy

145 (23)

17 (3)

126 (20)

10 (2)

Dyspnea

138 (22)

24 (4)

149 (24)

51 (8)

Cough

133 (21)

3 (<1)

128 (20)

5 (1)

Pyrexia

104 (17)

3 (<1)

80 (13)

2 (<1)

Peripheral edema

102 (16)

0

53 (8)

2 (<1)

Constipation

101 (16)

1 (<1)

108 (17)

6 (1)

Mucosal inflammation

101 (16)

18 (3)

43 (7)

3 (<1)

Vomiting

87 (14)

8 (1)

88 (14)

12 (2)

Lacrimation increased

84 (13)

1 (<1)

28 (4)

0

Myalgia

78 (12)

4 (1)

65 (10)

4 (1)

Arthralgia

72 (11)

7 (1)

49 (8)

4 (1)

Back pain

71 (11)

7 (1)

53 (8)

2 (<1)

Abdominal pain

68 (11)

5 (1)

61 (10)

8 (1)

Dysgeusia

67 (11)

NA

46 (7)

NA

Insomnia

67 (11)

3 (<1)

51 (8)

1 (<1)

Headache

66 (11)

3 (<1)

67 (11)

6 (1)

Abbreviations: DOC = docetaxel; NA = not applicable; PBO = placebo; RAM = ramucirumab; TEAE = treatment-emergent adverse event.

References

1Garon 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

2Pérol M, Ciuleanu, TE, Arrieta O, et al. REVEL: A randomized, double-blind, phase III study of docetaxel (DOC) and ramucirumab (RAM; IMC-1121B) versus DOC and placebo (PL) in the second-line treatment of stage IV non-small cell lung cancer (NSCLC) following disease progression after one prior platinum-based therapy. Talk presented at: 50th Annual Meeting of the American Society of Clinical Oncology (ASCO); May 30-June 3, 2014; Chicago, IL. http://meetinglibrary.asco.org/content/92344?media=vm

Glossary

AE = adverse event

ECOG = Eastern Cooperative Oncology Group

HR = hazard ratio

NSCLC = non-small cell lung cancer

OS = overall survival

PS = performance status

TEAE = treatment-emergent adverse event

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Fecha de la última revisión: 2020 M04 01


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