Cyramza® (Ramucirumab)

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Ramucirumab: Use in Third or Later Line for Gastric Cancer

The use of ramucirumab in third- or later-line for the treatment of gastric cancer has been evaluated in retrospective analyses.

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Retrospective Analysis

Kawai, 2020

Study Design

A multicenter, retrospective, observational study was conducted to evaluate the safety and efficacy of ramucirumab monotherapy in the salvage line treatment of Japanese patients with advanced gastric cancer.1

Patients were eligible for inclusion in the analysis if they

  • were ≥18 years of age
  • had histologically proven gastric or GEJ adenocarcinoma
  • had an ECOG PS ≤2
  • initiated ramucirumab monotherapy as third- or later-line treatment between June 2015 and April 2017, and
  • had disease refractory to, or intolerant of, fluoropyrimidine and taxane.1

Analysis of Patients Who Received Treatment in Third- or Later-Line

Baseline Patient Characteristics

A total of 51 patients met the eligibility requirements for inclusion in this analysis.1 Baseline patient characteristics related to prior treatment are summarized in Baseline Patient Characteristics Related to Prior Treatment.

Baseline Patient Characteristics Related to Prior Treatment1

Characteristic

Ramucirumab
(n=51)
n (%)

≥2 years since initiation of first-line treatment

22 (43)

Number of prior therapies

2

7 (14)

3

25 (49)

4

12 (24)

5

7 (14)

Agents of prior therapy

S-1

43 (84)

Capecitabine

14 (27)

5-FU

6 (12)

Cisplatin

39 (76)

Oxaliplatin

17 (33)

Paclitaxel

46 (90)

Docetaxel

9 (18)

Irinotecan

41 (80)

Trastuzumab

15 (29)

ICI

11 (21)

Other

12 (23)

Abbreviations: 5-FU = 5-fluorouracil; ICI = immune checkpoint inhibitor. 

Treatment Exposure

All patients in this analysis received ramucirumab monotherapy at a dose of 8 mg/kg every 2 weeks. Treatment was continued until PD, unacceptable toxicity, or patient decision. The median number of cycles administered was 4 (range, 1-31) and a total of 281 cycles were administered for all 51 patients.1

Efficacy Results

Efficacy results are summarized in Efficacy Results. A univariate analysis found that NLR <2.5 and previous gastrectomy were associated with a statistically significant longer PFS (p=.002 and p=.019, respectively). No background factors were found to be significant prognostic factors for OS.1

Efficacy Results1

Outcome

Ramucirumab

ORRa, %

2

PR, n

1

DCRa, %

17

Median PFS, months (95% CI)

1.8 (1.6-2.2)

Median OS, months (95% CI)

5.1 (4.0-6.8)

Abbreviations: DCR = disease control rate; ORR = overall response rate; OS = overall survival; PFS = progression-free survival; PR = partial response.

aAmong patients with measurable lesions (n=42).

Safety Results

Adverse events that occurred in at least 10% of patients during treatment are summarized in Adverse Events That Occurred in ≥10% of Patients.

Adverse Events That Occurred in ≥10% of Patients1

Adverse Event

Any grade
n (%)

Grade ≥3
n (%)

Neutropenia

9 (18)

0

Anemia

18 (35)

2 (4)

Fatigue

19 (37)

1 (2)

Anorexia

19 (37)

1 (2)

Hypertension

18 (35)

2 (4)

Proteinuria

15 (29)

2 (4)

Bleeding

5 (10)

1 (2)

Paulson, 2018

Study Design

A retrospective, observational cohort study was conducted to characterize gastric cancer patients in the United States who received ramucirumab. The objectives of this study included the assessment of

  • demographic characteristics
  • clinical characteristics
  • treatment patterns, and
  • survival outcomes

associated with the use of ramucirumab alone or in combination with cytotoxic agents for the treatment of gastric or GEJ cancer.2  

Patients were eligible for inclusion in the analysis if they

  • were ≥18 years of age at the time of initiation of ramucirumab
  • had a documented diagnosis of gastric or GEJ cancer
  • initiated ramucirumab between April 21, 2014 and June 30, 2016
  • received care at a US Oncology Network facility, and
  • had ≥2 office visits during the study observation period.2

Data were collected via electronic health records and death was verified in the social security death index.2

Analysis of Patients Who Received Treatment in Third or Later Line

The majority of patients (80.6%) included in this analysis received ramucirumab in the second line.2 The initial line of therapy that included ramucirumab is summarized in Initial Line of Therapy That Included Ramucirumab. Exposure to ramucirumab among patients who received ramucirumab in third or later lines is summarized in  Summary of Ramucirumab Exposure in Third and Later Lines of Treatment.

Initial Line of Therapy That Included Ramucirumab2

Line of Therapy With Ramucirumab, n (% of Patients)a 

Total Study Cohort
(n=505) 

Monotherapy Cohort
(n=115)

Combination Therapy Cohort
(n=390)

First line

15 (2.97) 

4 (3.48) 

11 (2.82)

Second line

407 (80.59)

65 (56.52)

342 (87.69)

Third line

58 (11.49) 

31 (26.96)

27 (6.92) 

Fourth or later line

18 (3.56)

13 (11.30)

5 (1.28)

Unknown

7 (1.39)

2 (1.74)

5 (1.28)

ap<.0001 (calculated based on a Fisher’s Exact test).

 Summary of Ramucirumab Exposure in Third and Later Lines of Treatment2

Exposure to Ramucirumab 

Total Study Cohort
(n=511)

Ramucirumab in Third Line
(n=61)a

Ramucirumab in Fourth or Later Line
(n=19)a

Mean number of infusions (SD)

6.86 (6.11)

6.00 (4.98)

5.47 (6.08)

Median number of infusions (IQR)

5 (3-9)

5 (3-6)

4 (2-7)

Abbreviations: IQR = interquartile range; SD = standard deviation. 

aEvaluable patients; patients may have received ramucirumab in multiple lines of therapy.

The majority of patients in this study received ramucirumab in combination with cytotoxic agents (77.2%). Line of therapy was a predictive factor associated with the use of monotherapy versus combination therapy. Compared with patients who received ramucirumab in first-line treatment, patients receiving ramucirumab as

  • third line of therapy were 4.39 times more likely to receive monotherapy (p=.0244), and
  • fourth line of therapy were 9.82 times more likely to receive monotherapy (p<.0047).2 

Ongoing Clinical Study

A randomized, phase 3 study comparing irinotecan with or without ramucirumab for the treatment of Japanese patients with advanced gastric cancer is ongoing and recruiting patients for participation (RINDBeRG; UMIN000023065).3,4 Eligible patients must have

  • histologically proven gastric or esophagogastric adenocarcinoma
  • unresectable or recurrent disease
  • ECOG PS <2
  • ≥2 lines of chemotherapy with platinum, fluoropyrimidines, taxanes, and ramucirumab
  • no prior use of irinotecan, and
  • disease progression during prior chemotherapy containing ramucirumab.3

Patients will be randomized (1:1) ratio to receive irinotecan 150 mg/m2 alone or in combination with ramucirumab 8 mg/kg. The primary endpoint is OS. Secondary endpoints include 

  • PFS
  • TTF
  • RR
  • DCR, and
  • safety.3

References

1Kawai S, Fukuda N, Yamamoto S, et al. Retrospective observational study of salvage line ramucirumab monotherapy for patients with advanced gastric cancer. BMC Cancer. 2020;20(1):338. https://doi.org/10.1186/s12885-020-06865-7

2Paulson AS, Hess LM, Liepa AM, et al. Ramucirumab for the treatment of patients with gastric or gastroesophageal junction cancer in community oncology practices. Gastric Cancer. 2018;21(5):831-844. http://dx.doi.org/10.1007/s10120-018-0796-z

3Sakai D, Boku N, Kodera Y, et al. An intergroup phase III trial of ramucirumab plus irinotecan in third or more line beyond progression after ramucirumab for advanced gastric cancer (RINDBeRG trial). Poster presented at: 54th Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Accessed June 1, 2020. https://meetinglibrary.asco.org/record/165419/poster

4An intergroup phase III trial of ramucirumab plus irinotecan in third or more line beyond progression after ramucirumab for advanced gastric cancer. UMIN Clinical Trials Registry identifier: UMIN000023065. Updated July 27, 2018. Accessed June 1, 2020. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026585

Abbreviations

ECOG = Eastern Cooperative Oncology Group

DCR = disease control rate

GEJ = gastroesophageal junction

NLR = neutrophil-lymphocyte ratio

OS = overall survival

PD = progressive disease

PFS = progression-free survival

PS = performance status

RR = response rate

TTF = time-to-treatment failure

Fecha de la última revisión: 2020 M10 15


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