Efficacy and tolerability of ramucirumab monotherapy or in combination with paclitaxel in gastric cancer patients from the Expanded Access Program Cohort by the Korean Cancer Study Group (KCSG)

Jung, Minkyu; Ryu, Min Hee; Oh, Do Youn; Kang, Myounghee; Zang, Dae Young; Hwang, In Gyu; Lee, Moon Hyoung; Kim, Ki Hyang; Shim, Byoung Yong; Song, Eun Kee; Sym, Sun Jin; Han, Hye Sook; Park, Young Lee; Lee, Hyun Woo; Lee, Moon Hee; Koo, Dong Hoe; Song, Hong Suk; Lee, Nam-Su; Yang, Sung Hyun; Choi, Dae Ro; Hong, Young Seon; Lee, Kyoung Eun; Maeng, Chi Hoon; Baek, Jin Ho; Kim, Samyong; Kim, Yeul Hong; Rha, Sun Young; Cho, Jae Yong; Kang, Yoon Koo

doi:10.1007/s10120-018-0806-1

Cited by 26 publications

(50 citation statements)

References 22 publications

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“…In our cohort, ramucirumab plus paclitaxel treatment yielded numerically shorter median PFS and OS durations (3.35 and 7.76 months, respectively) than those previously reported in the Expanded Access Program ( 17 ) (3.8 and 8.6 months, respectively) and the Rainbow trial ( 5 ) (4.4 and 9.6 months, respectively). When considered together with the higher percentage of patients with an ECOG performance status 2 in our study (6.9% vs. 3.1%) ( 17 ) and 0% ( 5 ), these decreases in survival may reflect the application of this regimen to a wider range of patients in routine practice.…”

Section: Discussioncontrasting

confidence: 54%

“…Among these potential markers, neutrophil-to-lymphocyte ratio (NLR) was shown to be correlated well with the clinical outcomes of patients with gastric cancer who underwent surgical resection ( 8 - 10 ) or received palliative first-line ( 11 - 14 ) and second-line ( 15 , 16 ) systemic chemotherapy. A previous study suggested NLR as a prognostic factor in patients with gastric cancer who were treated with ramucirumab monotherapy or ramucirumab plus paclitaxel ( 17 ); however, inhomogeneous treatment regimen and lack of mechanistic explanation in that study warrant further validation of its clinical value and an investigation of biological features linked to NLR.…”

Section: Introductionmentioning

confidence: 87%

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Clinical implications of neutrophil-to-lymphocyte ratio and MDSC kinetics in gastric cancer patients treated with ramucirumab plus paclitaxel

Kim

Ryu

Yoon

et al. 2020

Chinese Journal of Cancer Research

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Objective We aimed to investigate the prognostic value of neutrophil-to-lymphocyte ratio (NLR) and myeloid-derived suppressor cells (MDSCs) in gastric cancer patients treated with second-line ramucirumab plus paclitaxel. Methods A total of 116 patients with advanced or metastatic gastric cancer who receive ramucirumab plus paclitaxel were prospectively enrolled. Fresh blood samples were collected before and after treatment, and flow cytometry was performed to assess the proportions of monocytic (mMDSCs) and granulocytic MDSCs (gMDSCs). Results Median age was 58 years and 71 (61.2%) patients were male. A baseline NLR≥2.94 was associated with significantly poorer progression-free survival (PFS) and overall survival (OS) vs . an NLR<2.94 (P=0.011 and P=0.002, respectively). In multivariate analysis, an NLR≥2.94 was independently associated with poorer PFS [hazard ratio (HR)=1.58; 95% confidence interval (95% CI): 1.01−2.49, P=0.046] and OS (HR=1.77; 95% CI: 1.04−3.04, P=0.036). While mMDSC counts did not significantly change following two cycles of therapy (P=0.530), gMDSC counts decreased significantly after two treatment cycles (P=0.025) but tended to increase in patients with progressive disease after two treatment cycles (P=0.098). A progressive increase in gMDSC counts (≥44%) was associated with a significantly shorter PFS and OS vs . a gMDSC count increase <44% (P=0.001 and P=0.003, respectively). Conclusions The baseline NLR may help guide clinical decisions during ramucirumab plus paclitaxel therapy for gastric cancer. Our gMDSC kinetics data warrant further clinical validation and mechanistic investigation.

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Section: Discussioncontrasting

confidence: 54%

Section: Introductionmentioning

confidence: 87%

Clinical implications of neutrophil-to-lymphocyte ratio and MDSC kinetics in gastric cancer patients treated with ramucirumab plus paclitaxel

Kim

Ryu

Yoon

et al. 2020

Chinese Journal of Cancer Research

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“…From a pooled analysis of REGARD and RAINBOW trials, Fuchs et al [27] reported that 12 clinical and laboratory factors, including a high neutrophil and low lymphocyte count, at the start of ramucirumab monotherapy are negative prognostic factors for OS. From Korean retrospective cohort data of ramucirumab mono-or combination therapy, Jung et al [28] reported that the NLR and albumin are independent prognostic factors for the PFS and OS. Our results also supported these findings.…”

Section: Discussionmentioning

confidence: 99%

Retrospective observational study of salvage line ramucirumab monotherapy for patients with advanced gastric cancer

et al. 2020

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Background: Ramucirumab monotherapy as a second-line treatment for advanced gastric cancer (AGC) prolongs survival compared to the best supportive care. However, in clinical practice, ramucirumab monotherapy is sometimes used as third-or later-line treatment for AGC refractory to fluoropyrimidine and taxanes. This study evaluated the efficacy and safety of salvage-line ramucirumab monotherapy for treating AGC. Methods: The subjects of this retrospective study were advanced gastric or gastro-esophageal junction adenocarcinoma patients who received ramucirumab monotherapy after failure of 2 or more prior regimens containing fluoropyrimidine and taxanes but not ramucirumab. Results: From June 2015 to April 2017, 51 patients were enrolled. The median progression-free survival (PFS) and overall survival (OS) were 1.8 (95% confidence interval [CI] = 1.6-2.2) and 5.1 (95% CI = 4.0-6.8) months, respectively. The objective response and disease control rates were 2 and 17%, respectively. Grade 3 adverse events (AEs; e.g., anemia, fatigue, hypertension, proteinuria, intestinal bleeding) occurred in seven (13%) patients, but no grade 4 AEs and treatment-related deaths were observed. A neutrophil-lymphocyte ratio (NLR) of < 2.5 and previous gastrectomy were associated with better PFS. Conclusions: Salvage-line ramucirumab monotherapy has acceptable toxicity and comparable efficacy to second-line treatment; therefore, we consider physicians might choose this therapy as a salvage-line treatment option for AGC refractory to the standard therapies.

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“…The hazard ratios of PFS and OS in NLR post were higher, which was thought to have greater effects on PFS and OS. Therefore, it is better to consider changing the regimen before progression, when NLR post exceeds the threshold of 5 and they were treated with nivolumab; therefore, the study of Jung et al [ 12 ] and the study of NSCLC [ 7 – 9 ] that included treatment with nivolumab were referred to for the NLR cut-off value (Table 4 ). Nivolumab was different from the other cytotoxic agents, so nivolumab monotherapy for NSCLC was used as the reference.…”

Section: Discussionmentioning

confidence: 99%

“…A previous study found that a baseline NLR < 5, which is commonly used as an NLR threshold, was associated with an improved survival in lung cancer patients treated with nivolumab [ 7 ], and in gastric cancer patients treated with paclitaxel and ramucirumab therapy [ 12 ]. We, therefore, used 5 as the NLR cut-off value in this study.…”

Section: Methodsmentioning

confidence: 99%

Neutrophil-to-lymphocyte ratio as a predictive or prognostic factor for gastric cancer treated with nivolumab: a multicenter retrospective study

et al. 2018

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IntroductionThe neutrophil-to-lymphocyte ratio (NLR) is effective as a predictive factor for lung cancer treated with nivolumab. The objective of this study was to determine the effectiveness of NLR for patients with advanced gastric cancer (AGC) treated with nivolumab.MethodsThis was a multicenter, retrospective study of patients with AGC treated with nivolumab from June 2017 to December 2017. The NLRs were calculated before the first cycle (NLRpre) and two weeks after the first administration (NLRpost).ResultsTwenty-six patients were enrolled (males 19, females 7) with a median age of 64 years. The overall response rate was 15%. The median PFS was 80 days (range, 11 – 265) and the median OS was 290 days (range, 21 – 332). Stratified with high NLR (≥5) and low NLR (<5), the median PFS was shorter in the high NLRpre arm (87 vs. 45 days; p=0.066) and significantly shorter in the high NLRpost arm (94 vs. 28 days; p=0.014). The median OS was significantly shorter in the high NLRpre arm (290 vs. 175 days; p=0.008) and in the high NLRpost arm (290 vs. 69 days; p<0.001).ConclusionNLR may be an effective prognostic factor in patients with AGC treated with nivolumab.

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Efficacy and tolerability of ramucirumab monotherapy or in combination with paclitaxel in gastric cancer patients from the Expanded Access Program Cohort by the Korean Cancer Study Group (KCSG)

Abstract: In the Korean EAP cohort, ramucirumab showed similar efficacy to the results of the previous trials for gastric cancer. However, the level of GI perforation was slightly increased in the ramucirumab plus paclitaxel group.

Cited by 26 publications

References 22 publications

Clinical implications of neutrophil-to-lymphocyte ratio and MDSC kinetics in gastric cancer patients treated with ramucirumab plus paclitaxel

Clinical implications of neutrophil-to-lymphocyte ratio and MDSC kinetics in gastric cancer patients treated with ramucirumab plus paclitaxel

Retrospective observational study of salvage line ramucirumab monotherapy for patients with advanced gastric cancer

Neutrophil-to-lymphocyte ratio as a predictive or prognostic factor for gastric cancer treated with nivolumab: a multicenter retrospective study

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